A noninterventional study documenting use and success of implants with a new chemically modified titanium surface in daily dental practice.

PubMed

Luongo, Giuseppe; Oteri, Giacomo

2010-01-01

A new chemically modified titanium surface, SLActive, has recently been developed. The results obtained in controlled clinical trials indicate that this implant can be safely used and that it offers predictable results. The goal of this noninterventional study was to verify that the success rates of implants used in daily dental practice are comparable to those reported in controlled clinical trials. This study was a prospective, noninterventional study using implants with a chemically modified surface according to the daily dental practice procedures applied by private practitioners. The choice of the implantation procedure and the loading protocol were the responsibility of the investigator and were chosen according to the patient's needs. Thirty clinical centers actively participated in this study, and 226 patients were treated, of which, 8 patients were lost to follow-up. Because of the noninterventional design of the study, the patients were not selected according to strictly defined inclusion/exclusion criteria. Thus, the study included individuals with risk factors such as smoking (24%), untreated gingivitis or periodontitis (9%), and bruxism (6%). The implants were equally distributed between mandible (46%) and maxilla (54%). A bone augmentation procedure was done in 31% of the cases. Early loading (functional loading between 48 hours and 3 months after implant insertion) was applied most frequently (48%), followed by the conventional loading protocol (3 to 6 months after implant placement, 34%). Immediate restoration and immediate loading were rare (7% and 2%, respectively). Of 276 implants inserted and documented, 5 implants failures were reported, all of which were associated with a sinus floor augmentation procedure. The survival rate was 98.2% at the 1-year follow-up visit. The results showed that implants with a chemically modified surface can be successfully restored with success rates similar to those reported in formal clinical trials under more controlled conditions.

Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity.

PubMed

Flachenecker, Peter; Henze, Thomas; Zettl, Uwe K

2014-01-01

Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice. © 2014 S. Karger AG, Basel.

Effect of water, sanitation and hygiene interventions on active trachoma in North and South Wollo zones of Amhara Region, Ethiopia: A Quasi-experimental study.

PubMed

Tadesse, Beselam; Worku, Alemayehu; Kumie, Abera; Yimer, Solomon Abebe

2017-11-01

Trachoma is chronic kerato conjunctivitis, which is caused by repeated infection with Chlamydia trachomatis bacterium. It is hyper endemic in many rural areas of Ethiopia. The objective of this study was to measure the effect of water, sanitation and hygiene interventions on active trachoma in selected woredas of North and South Wollo zones of Amhara Region, Ethiopia. A community based quasi-experimental study was conducted from October 2014 to December 2015 among children aged 1-8 years at baseline and among one year older same children after intervention. A four-stage random cluster-sampling technique was employed to select study participants. From each selected household, one child was clinically assessed for active trachoma. Structured questionnaire was used to collect socio demographic and behavioral data. MacNemar test was applied to compare the prevalence of active trachoma between baseline and after the intervention period at both intervention and non-intervention study areas. The prevalence of active trachoma was reduced from baseline prevalence of 26% to 18% after one-year intervention period in the intervention woredas (P≤0.001). MacNemar test result showed significant reduction of active trachoma prevalence after the intervention period in the intervention woredas compared to the non-intervention woredas (P≤0.001). Water, sanitation and hygiene related activities were significantly improved after the intervention period in the intervention woredas (P<0.05). There was a significant reduction of active trachoma prevalence between the baseline and after the intervention period in the intervention woredas, but not in the non-intervention ones. Improved water, sanitation and hygiene interventions contributed to the reduction of active trachoma. However, the magnitude of active trachoma prevalence observed after the intervention is still very high in the studied areas of North and South Wollo Zones communities. To achieve the global trachoma elimination target by the year 2020 as set by the WHO, continued WaSH interventions and periodic monitoring, evaluation and reporting of the impact of WaSH on active trachoma is warranted.

Next-generation sequencing diagnostics of bacteremia in sepsis (Next GeneSiS-Trial): Study protocol of a prospective, observational, noninterventional, multicenter, clinical trial.

PubMed

Brenner, Thorsten; Decker, Sebastian O; Grumaz, Silke; Stevens, Philip; Bruckner, Thomas; Schmoch, Thomas; Pletz, Mathias W; Bracht, Hendrik; Hofer, Stefan; Marx, Gernot; Weigand, Markus A; Sohn, Kai

2018-02-01

Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime. In this context, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care, although they are associated with relevant limitations. Accordingly, culture-independent molecular diagnostic procedures might be of help for the identification of the causative pathogen in infected patients. The concept of an unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) has recently been identified to be a promising diagnostic platform for critically ill patients suffering from bloodstream infections. Although this new approach might be more sensitive and specific than culture-based state-of-the-art technologies, additional clinical trials are needed to exactly define the performance as well as clinical value of a NGS-based approach. Next GeneSiS is a prospective, observational, noninterventional, multicenter study to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in patients with suspected or proven sepsis [according to recent sepsis definitions (sepsis-3)] by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard (culture-based) microbiological diagnostics. The clinical value of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients' management based on NGS results. Further subgroup analyses will focus on the clinical value especially for patients suffering from a failure of empiric treatment within the first 3 days after onset [as assessed by death of the patient or lack of improvement of the patient's clinical condition (in terms of an inadequate decrease of SOFA-score) or persistent high procalcitonin levels]. This prospective, observational, noninterventional, multicenter study for the first time investigates the performance as well as the clinical value of a NGS-based approach for the detection of bacteremia in patients with sepsis and may therefore be a pivotal step toward the clinical use of NGS in this indication. DRKS-ID: DRKS00011911 (registered October 9, 2017) https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011911; ClinicalTrials.gov Identifier: NCT03356249 (registered November 29, 2017) https://clinicaltrials.gov/ct2/show/NCT03356249.

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting - results from a German noninterventional study.

PubMed

Andresen, Viola; Miehlke, Stephan; Beck, Elmar; Wiseman, Gwen; Layer, Peter

2018-05-09

 Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany.  This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C. Severity of abdominal pain and bloating and frequency of bowel movements were assessed over 5 study visits. Treatment-related adverse events were recorded.  The study enrolled 375 patients; the mean observation duration was 4.4 months. Linaclotide marketing was halted during the study period for economic reasons, accounting for low patient numbers and short observation duration. Linaclotide significantly reduced mean (standard deviation [SD]) scores between treatment start (visit 1) and study end (visit 5) for abdominal pain intensity (visit 1: 4.87 [2.63] vs. visit 5: 2.40 [2.20], p < 0.0001), mean [SD] bloating intensity (visit 1: 5.30 [2.70] vs. visit 5: 2.86 [2.34], p < 0.0001), and increased mean [SD] bowel movement frequency (visit 1: 2.71 [1.80] vs. 4.38 [1.86], p < 0.0001). Diarrhea, occurring in 5.1 % of patients, was the most common adverse event.  Linaclotide is effective in improving the major symptoms of IBS-C and demonstrates a favorable safety profile in the real-world environment of routine clinical practice. DRKS (www.drks.de/): DRKS00005088. © Georg Thieme Verlag KG Stuttgart · New York.

XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation

PubMed Central

Camm, A John; Amarenco, Pierre; Haas, Sylvia; Hess, Susanne; Kirchhof, Paulus; van Eickels, Martin; Turpie, Alexander GG

2014-01-01

Atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke. The Phase III ROCKET AF (Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial showed that rivaroxaban, an oral, direct Factor Xa inhibitor, was noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF. Compared with warfarin, rivaroxaban significantly reduced rates of intracranial and fatal hemorrhages, although not rates of bleeding overall. XANTUS (Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation) is a prospective, international, observational, postauthorization, noninterventional study designed to collect safety and efficacy data on the use of rivaroxaban for stroke prevention in AF in routine clinical practice. The key goal is to determine whether the safety profile of rivaroxaban established in ROCKET AF is also observed in routine clinical practice. XANTUS is designed as a single-arm cohort study to minimize selection bias, and will enroll approximately 6,000 patients (mostly from Europe) with nonvalvular AF prescribed rivaroxaban, irrespective of their level of stroke risk. Overall duration of follow-up will be 1 year; the first patient was enrolled in June 2012. Similar studies (XANTUS-EL [Xarelto® for Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation, Eastern Europe, Middle East, Africa and Latin America] and XANAP [Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific]) are ongoing in Latin America and Asia-Pacific. Data from these studies will supplement those from ROCKET AF and provide practical information concerning the use of rivaroxaban for stroke prevention in AF. PMID:25083135

Effectiveness, tolerability and acceptance of an oral estradiol/levonorgestrel formulation for the treatment of menopausal complaints: a non-interventional observational study over six cycles of 28 days.

PubMed

Rouskova, Daniela; Mittmann, Katrin; Schumacher, Ulrike; Dietrich, Horst; Zimmermann, Thomas

2014-10-01

Use of hormone therapy for menopausal complaints is a subject of controversy and increased uncertainty and concerns. This non-interventional study aimed to investigate a marketed oral formulation containing 1 mg estradiol and 0.04 mg levonorgestrel for continuous treatment of menopausal symptoms for approximately 6 months in women visiting gynecological practices in Germany. Changes in the menopause rating scale (MRS) total and sub-domain scores after three and six 28-d cycles served as primary endpoint. Skin- and hair-related complaints, quality of sexual life and subjective satisfaction with the treatment were assessed. Adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding were evaluated. MRS scores improved significantly above 5 points of clinical relevance as compared to baseline (n = 736, p < 0.0001). Skin- and hair-related symptoms abated; quality of sexual life improved. AEs were registered in 9.9% of the participants. No unexpected ADRs were reported. Bleeding episodes consistently decreased; >75% of the subjects were amenorrheic throughout the study. Medication's effectiveness and tolerability was rated very good/good by >80% of the participants, who also continued treatment. This estradiol/low-dose levonorgestrel formulation safely alleviates menopausal symptoms in peri- and postmenopausal women with add-on benefits regarding dermatological and sexual life complaints.

Standard operating procedures for antibiotic therapy and the occurrence of acute kidney injury: a prospective, clinical, non-interventional, observational study.

PubMed

Nachtigall, Irit; Tafelski, Sascha; Günzel, Karsten; Uhrig, Alexander; Powollik, Robert; Tamarkin, Andrey; Wernecke, Klaus D; Spies, Claudia

2014-06-12

Acute kidney injury (AKI) occurs in 7% of hospitalized and 66% of Intensive Care Unit (ICU) patients. It increases mortality, hospital length of stay, and costs. The aim of this study was to investigate, whether there is an association between adherence to guidelines (standard operating procedures (SOP)) for potentially nephrotoxic antibiotics and the occurrence of AKI. This study was carried out as a prospective, clinical, non-interventional, observational study. Data collection was performed over a total of 170 days in three ICUs at Charité - Universitaetsmedizin Berlin. A total of 675 patients were included; 163 of these had therapy with vancomycin, gentamicin, or tobramycin; were >18 years; and treated in the ICU for >24 hours. Patients with an adherence to SOP >70% were classified into the high adherence group (HAG) and patients with an adherence of <70% into the low adherence group (LAG). AKI was defined according to RIFLE criteria. Adherence to SOPs was evaluated by retrospective expert audit. Development of AKI was compared between groups with exact Chi2-test and multivariate logistic regression analysis (two-sided P <0.05). LAG consisted of 75 patients (46%) versus 88 HAG patients (54%). AKI occurred significantly more often in LAG with 36% versus 21% in HAG (P = 0.035). Basic characteristics were comparable, except an increased rate of soft tissue infections in LAG. Multivariate analysis revealed an odds ratio of 2.5-fold for LAG to develop AKI compared with HAG (95% confidence interval 1.195 to 5.124, P = 0.039). Low adherence to SOPs for potentially nephrotoxic antibiotics was associated with a higher occurrence of AKI. Current Controlled Trials ISRCTN54598675. Registered 17 August 2007.

Standard operating procedures for antibiotic therapy and the occurrence of acute kidney injury: a prospective, clinical, non-interventional, observational study

PubMed Central

2014-01-01

Introduction Acute kidney injury (AKI) occurs in 7% of hospitalized and 66% of Intensive Care Unit (ICU) patients. It increases mortality, hospital length of stay, and costs. The aim of this study was to investigate, whether there is an association between adherence to guidelines (standard operating procedures (SOP)) for potentially nephrotoxic antibiotics and the occurrence of AKI. Methods This study was carried out as a prospective, clinical, non-interventional, observational study. Data collection was performed over a total of 170 days in three ICUs at Charité – Universitaetsmedizin Berlin. A total of 675 patients were included; 163 of these had therapy with vancomycin, gentamicin, or tobramycin; were >18 years; and treated in the ICU for >24 hours. Patients with an adherence to SOP >70% were classified into the high adherence group (HAG) and patients with an adherence of <70% into the low adherence group (LAG). AKI was defined according to RIFLE criteria. Adherence to SOPs was evaluated by retrospective expert audit. Development of AKI was compared between groups with exact Chi2-test and multivariate logistic regression analysis (two-sided P <0.05). Results LAG consisted of 75 patients (46%) versus 88 HAG patients (54%). AKI occurred significantly more often in LAG with 36% versus 21% in HAG (P = 0.035). Basic characteristics were comparable, except an increased rate of soft tissue infections in LAG. Multivariate analysis revealed an odds ratio of 2.5-fold for LAG to develop AKI compared with HAG (95% confidence interval 1.195 to 5.124, P = 0.039). Conclusion Low adherence to SOPs for potentially nephrotoxic antibiotics was associated with a higher occurrence of AKI. Trial registration Current Controlled Trials ISRCTN54598675. Registered 17 August 2007. PMID:24923469

Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study.

PubMed

Freeman, Robert; Foley, Steve; Rosa Arias, José; Vicente, Eduardo; Grill, Robert; Kachlirova, Zuzana; Stari, Anny; Huang, Moses; Choudhury, Nurul

2018-05-01

Observational studies can provide evidence about patient outcomes in routine clinical practice. This prospective, non-interventional study (BELIEVE) is the largest real-world European study to date to assess quality-of-life, treatment satisfaction, resource utilization, and persistence in patients with overactive bladder (OAB) who were prescribed mirabegron as part of routine clinical practice. The primary objective was to evaluate change from baseline in quality-of-life based on overactive bladder questionnaire (OAB-q) sub-scales. Secondary objectives included evaluation of treatment persistence, patient satisfaction, healthcare resource utilization and adverse events (AEs). Follow-up was for 12 months with visit windows at 2-4 and 10-12 months. Median change from baseline in total OAB-q and its sub-scales (Health-related quality-of-life [HRQoL] and symptom bother scale) were assessed. Overall, 862 patients were enrolled from eight European countries. In the Full Analysis Set (FAS), 73.7% were female, mean age was 61.2 years; 47.7% ≥65 years. At baseline, 41.3% had switched from other OAB treatments, 42.2% were treatment naïve, 10.1% were lapsed, and 6.4% were on combination treatment. Symptom bother and HRQoL total scores improved from baseline to 2-4 and 10-12 months. There was a notable improvement in dry rate, increasing from 34.9% at baseline to 43.7% at 10-12 months in the FAS, and a reduction in pad use. Persistence was high, with 53.8% of FAS patients remaining on mirabegron at 10-12 months. Overall, no unexpected safety issues were observed and AEs were consistent with the known safety profile of mirabegron. Patients receiving mirabegron in a real-world setting reported meaningful improvements in QoL and health status, with a persistence rate of 53.8% at 12 months for the FAS. No unexpected safety issues were observed, and AEs were consistent with the known safety profile of mirabegron.

Time series evaluation of an intervention to increase statin tablet splitting by general practitioners.

PubMed

Polinski, Jennifer M; Schneeweiss, Sebastian; Maclure, Malcolm; Marshall, Blair; Ramsden, Samuel; Dormuth, Colin

2011-02-01

Tablet splitting, in which a higher-dose tablet is split to get 2 doses, reduces patients' drug costs. Statins can be split safely. General practitioners (GPs) may not direct their patients to split statins because of safety concerns or unawareness of costs. Medical chart inserts provide cost-effective education to physicians. The aim of this study was to assess whether providing GPs with statin-splitting chart inserts would increase splitting rates, and to identify predictors of splitting. In 2005 and 2006, we faxed a statin chart insert to British Columbia GPs with a request for a telephone interview. Consenting GPs were mailed 3 statin chart inserts and interviewed by phone (the intervention). In an interrupted time series, we compared monthly rates of statin-splitting prescriptions among intervention and nonintervention GPs before, during, and after the intervention. In multivariate logistic regressions accounting for patient clustering, predictors of splitting included physician and patient demographics and the specific statin prescribed. Of 5051 GPs reached, 282 (6%) agreed to the intervention. Before the intervention, GPs' splitting rate was 2.6%; after intervention, GPs' splitting rate was 7.5%. The rate for the nonintervention GPs was 4.4%. Intervention GPs were 1.68 (95% CI, 1.12-2.53) times more likely to prescribe splitting after the intervention than were nonintervention GPs. Other predictors were a patient's female sex (odds ratio [OR] = 1.26; 95% CI, 1.18-1.34), lower patient income (OR = 1.33; 95% CI, 1.18-1.34), and a lack of drug insurance (OR = 1.89; 95% CI, 1.69-2.04). An inexpensive intervention was effective in producing a sustained increase in GPs' splitting rate during 22 months of observed follow-up. Expanding statin-splitting education to all GPs might reduce prescription costs for many patients and payors. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

PubMed Central

Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăţ, Carmen; Rugină, Sorin; Negruţiu, Lucian; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

2014-01-01

Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice. Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily. Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir. Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania. Trial registration NCT01253967 PMID:25276665

Real-world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.

PubMed

Wing, Kevin; Williamson, Elizabeth; Carpenter, James R; Wise, Lesley; Schneeweiss, Sebastian; Smeeth, Liam; Quint, Jennifer K; Douglas, Ian

2018-03-25

Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study, we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Using individual patient data from the landmark COPD Towards a Revolution in COPD Health (TORCH) trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people between 1 January 2004 and 1 January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 11997). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency (protocol no. 17_114R). An application to use the TORCH trial data made to clinicalstudydatarequest.com has been approved. In addition to scientific publications, dissemination methods will be developed based on discussions with patient groups with COPD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

CONIFER - Non-Interventional Study to Evaluate Therapy Monitoring During Deferasirox Treatment of Iron Toxicity in Myelodysplastic Syndrome Patients with Transfusional Iron Overload.

PubMed

Bruch, Harald-Robert; Dencausse, Yves; Heßling, Jörg; Michl, Gerlinde; Schlag, Rudolf; Skorupa, Alexandra; Schneider-Schranz, Cornelia; Wolf, Sebastian; Schulte, Clemens; Tesch, Hans

2016-01-01

The non-interventional study CONIFER was designed to assess the safety and clinical practicability of deferasirox for the treatment of transfusional iron overload in myelodysplastic syndrome (MDS) patients. Patients included in the study were diagnosed with MDS and received at least 1 treatment with deferasirox. The observation period covered the time from the initial visit until the last follow-up. The data of 99 patients with MDS scored mainly as International Prognostic Scoring System (IPSS) low and intermediate 1 were evaluated. The mean age of the participants was 75 years and 58% of the patients were male. Iron overload was assessed by serum ferritin level (mean baseline serum ferritin 2,080 ± 1,244 µg/l). Patients were treated for a mean duration of 16 months (mean daily dose at baseline 11.8 ± 7.0 mg/kg). Stratification of serum ferritin levels by deferasirox dose showed a reduction at the higher but no reduction at the lower dose (< 15 mg/kg vs. ≥ 15 mg/kg and < 20 mg/kg vs. ≥ 20 mg/kg). The majority of patients (81%) were affected by at least 1 adverse event, with decreased renal creatinine clearance being the most frequent. Higher doses (≥ 15 mg/kg) of deferasirox effectively and safely reduced serum ferritin levels in MDS patients with transfusional iron overload. © 2016 S. Karger GmbH, Freiburg.

Triptorelin for the relief of lower urinary tract symptoms in men with advanced prostate cancer: results of a prospective, observational, grouped-analysis study

PubMed Central

Gil, Thierry; Aoun, Fouad; Cabri, Patrick; Perrot, Valérie; van Velthoven, Roland

2017-01-01

Background: Lower urinary tract symptoms (LUTSs) may develop in men with prostate cancer (PCa) and can impact quality of life (QoL). Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy are standard treatment for PCa, however, data are limited on their effects on LUTSs. A grouped analysis of national observational, non-interventional studies initiated in clinical practice was performed to assess the effectiveness of triptorelin in reducing moderate or severe LUTSs, measured using the International Prostate Symptom Score (IPSS) in men with advanced or metastatic PCa. Methods: Men with PCa and LUTSs scheduled to receive triptorelin (3-month or 1-month extended release formulation) were recruited into prospective, non-interventional studies at centres in Algeria, Australia, Belgium, China, Hungary, Romania and South Korea. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTSs, assessed by IPSS, after 48 weeks. Secondary endpoints included: total IPSS, QoL due to urinary symptoms (IPSS Question 8) and prostate-specific antigen (PSA) levels at 24 and 48 weeks. Results: A total of 2701 patients were recruited; 1851 patients with moderate or severe LUTSs at baseline (IPSS > 7), received triptorelin and had follow-up IPSS (efficacy population). The proportion of patients with moderate or severe LUTSs was reduced to 67.2% from baseline at week 48, following a reduction to 75.9% at week 24: the overall time effect was significant (p < 0.001). QoL due to urinary symptoms significantly improved from a mean score of 3.7 at baseline, to adjusted means of 2.5 and 2.1, at weeks 24 and 48, respectively (p < 0.001 versus baseline). Mean PSA levels were reduced from 158.8 ng/ml at baseline to 11.5 and 16.0 ng/ml at weeks 24 and 48, respectively. Conclusions: Within the limitations of these observational studies, improvements in LUTSs and QoL observed after 24 weeks and maintained at 48 weeks indicate that triptorelin-induced effects improve LUTSs in patients with advanced PCa. PMID:28747996

Addressing the unit of analysis in medical care studies: a systematic review.

PubMed

Calhoun, Aaron W; Guyatt, Gordon H; Cabana, Michael D; Lu, Downing; Turner, David A; Valentine, Stacey; Randolph, Adrienne G

2008-06-01

We assessed the frequency that patients are incorrectly used as the unit of analysis among studies of physicians' patient care behavior in articles published in high impact journals. We surveyed 30 high-impact journals across 6 medical fields for articles susceptible to unit of analysis errors published from 1994 to 2005. Three reviewers independently abstracted articles using previously published criteria to determine the presence of analytic errors. One hundred fourteen susceptible articles were found published in 15 journals, 4 journals published the majority (71 of 114 or 62.3%) of studies, 40 were intervention studies, and 74 were noninterventional studies. The unit of analysis error was present in 19 (48%) of the intervention studies and 31 (42%) of the noninterventional studies (overall error rate 44%). The frequency of the error decreased between 1994-1999 (N = 38; 65% error) and 2000-2005 (N = 76; 33% error) (P = 0.001). Although the frequency of the error in published studies is decreasing, further improvement remains desirable.

Improving women's knowledge of prostaglandin induction of labour through the use of information brochures: a quasi-experimental study.

PubMed

Cooper, Megan; Warland, Jane

2011-12-01

To gain a better understanding of women's baseline level of knowledge of induction of labour (IOL) and determine whether giving written information at the time IOL is decided, results in significant differences in knowledge and understanding of the process. Fifty pregnant women undergoing antenatal care at a small maternity hospital were recruited. A quasi experimental trial was conducted with non random selection of participants, 25 selected to act as the control group and 25 selected as the intervention group. The study was conducted to determine women's knowledge of IOL both before (non-intervention) and after (intervention) the introduction of a written information brochure. Statistically significant increases in knowledge were evident in the intervention group for knowledge about action (p=0.002) and timing of prostaglandins (p=0.03), the number of side effects known (p<0.0001) as well as time to birth (p=0.001) indicating an increased understanding of the process as a result of reading an information brochure. These results suggest that those in the non-intervention group lacked knowledge pertinent to IOL, even though they have consented to and actually arrived at the hospital prepared to undergo the IOL procedure. The most significant disparity noted between the intervention and non-intervention groups was women's knowledge of side effects of prostaglandin. Further to this, many women in the non-intervention group had unrealistic expectations of both the time for drug action and likely time from prostaglandin administration to birth. In contrast women in the intervention group knew about the common side effects of prostaglandin and possessed a more realistic understanding of the likely time to birth following this procedure. The results indicate that a specifically designed information brochure explaining the process of IOL in plain language has the effect of enhancing women's knowledge. This area of study warrants further investigation, especially research into the role of written information to improve women's understanding across other areas of maternity care education provision. Copyright © 2010 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Comparison of Self-Efficacy for Managing Chronic Disease between patients with systemic sclerosis and other chronic conditions: a systematic review.

PubMed

Thombs, Brett D; Kwakkenbos, Linda; Riehm, Kira E; Saadat, Nazanin; Fedoruk, Claire

2017-02-01

The complexity and burden of systemic sclerosis (SSc) pose challenges to developing and sustaining disease management self-efficacy. The objective of this systematic review was to compare scores on a commonly used self-efficacy measure, the Self-Efficacy for Managing Chronic Disease (SEMCD) Scale, between SSc and other diseases. Data sources included the CINAHL, EMBASE, MEDLINE, and Scopus databases, searched through January 25, 2016, and reference lists of included articles and relevant reviews. Studies in any language that reported total SEMCD scores or individual item scores in adult non-psychiatric medical patients were eligible. We identified one eligible non-intervention study of SSc patients (n = 553), 13 other non-intervention studies, and 21 studies with pre-intervention data for patients enrolled in a self-management program or a trial of a program. Of 13 non-intervention studies with published total score means in cancer, cardiovascular disease, Parkinson's disease, spinal cord injuries, organ transplant candidates and recipients, dialysis, and lupus, SEMCD scores were statistically significantly lower (poorer self-efficacy) in SSc than 6 other disease samples, not significantly different from 6, and significantly higher than lupus patients. Compared to 18 studies of patients in self-management programs or trials with published total score means, SSc patients were similar or lower than 9 samples and significantly higher than 9 samples. Compared to patients with other diseases not enrolled in programs to improve self-efficacy, SSc patients report lower self-efficacy scores than most patient groups. Rigorously tested self-care interventions designed to meet the unique needs of patients with SSc are needed.

Parental Positive Reinforcement with Deviant Children: Does It Make a Difference?

ERIC Educational Resources Information Center

Forehand, Rex

1986-01-01

Considers effectiveness of parental positive reinforcement with deviant children by reviewing the following: (1) non-intervention studies, (2) intervention studies, and (3) consumer (parental) satisfaction studies. Results indicate that parents view positive reinforcement as effective and useful although positive reinforcement is not sufficient to…

Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.

PubMed

Fox, Erin E; Bulger, Eileen M; Dickerson, Aisha S; del Junco, Deborah J; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J; Holcomb, John B; Schreiber, Martin A; Cotton, Bryan A; Phelan, Herb A; Cohen, Mitchell J; Myers, John G; Alarcon, Louis H; Muskat, Peter; Wade, Charles E; Rahbar, Mohammad H

2013-07-01

In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented. Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.

Waiver of consent in non-interventional, observational emergency research: the PROMMTT experience

PubMed Central

Fox, Erin E.; Bulger, Eileen M.; Dickerson, Aisha S.; del Junco, Deborah J.; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J.; Holcomb, John B.; Schreiber, Martin A.; Cotton, Bryan A.; Phelan, Herb A.; Cohen, Mitchell J.; Myers, John G.; Alarcon, Louis H.; Muskat, Peter; Wade, Charles E.; Rahbar, Mohammad H.

2013-01-01

Background In the PRospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study, waiver of consent was utilized because previous literature reported low response rates and subsequent bias. The goal of this manuscript is to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. Methods PROMMTT enrolled trauma patients receiving at least one unit of red blood cells within 6 hours after admission at ten US Level 1 Trauma Centers. Local Institutional Review Boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent, but was allowed to retain data on patients unable to be consented. Results Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%) and no patient or legally-authorized representative refused to give consent. Thirty-six (30%) patients died and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, six of the local IRBs approved collection of residual blood samples, one had prior approval to collect timed blood samples under a separate protocol, and three reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Conclusions Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If Site 8’s IRB had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection, and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Non-interventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study. Level of Evidence Prospective, Level II PMID:23778508

A stress management workshop improves residents' coping skills.

PubMed

McCue, J D; Sachs, C L

1991-11-01

We describe the effectiveness of a stress management workshop designed for physicians. Of the 64 medicine, pediatrics, and medicine-pediatrics residents who agreed to participate in the workshop, the 43 who could be freed from clinical responsibilities constituted the intervention group; the 21 residents who could not be freed from clinical responsibilities were asked to be the nonintervention group. The ESSI Stress Systems Instrument and Maslach Burnout Inventory were administered to control subjects and workshop participants 2 weeks before and 6 weeks after the workshop. The half-day workshops taught management of the stresses of medical practice through: (1) learning and practicing interpersonal skills that increase the availability of social support; (2) prioritization of personal, work, and educational demands; (3) techniques to increase stamina and attend to self-care needs; (4) recognition and avoidance of maladaptive responses; and (5) positive outlook skills. Overall, the ESSI Stress Systems Instrument test scores for the workshop participants improved (+1.27), while the nonintervention group's mean scores declined (-0.65). All 21 individual ESSI Stress Systems Instrument scale items improved for the workshop, compared with eight of 21 items for the nonintervention group. The workshop group improved in the Maslach Burnout Inventory emotional exhaustion scale and deteriorated less than the nonintervention group in the depersonalization scale. We conclude that a modest, inexpensive stress management workshop was received positively, and can lead to significant short-term improvement in stress and burnout test scores for medicine and pediatrics residents.

A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson's disease.

PubMed

Woitalla, Dirk; Dunac, Antoine; Safavi, Ali; Ceravolo, Maria-Gabriella; Gomez Esteban, Juan Carlos; Pavese, Nicola; Asgharnejad, Mahnaz; Joeres, Lars; Schuller, Jan-Christof; Chaudhuri, K Ray

2018-06-19

PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson's disease (PD) patients. Patients previously received levodopa for ≥6 months as monotherapy/in combination with another dopamine-agonist (DA). Primary variable: Unified PD Rating Scale (UPDRS) Part-II change from baseline to end-of-observation-period (EOP). 91 younger/99 older patients started rotigotine; 68 younger/62 older patients completed the study. Most switched from levodopa+another DA. Addition of rotigotine as first DA was more common in older patients (20.2% vs.15.4%). Mean ± SD rotigotine-exposure: 6.1 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. At EOP, improvement in mean UPDRS-II was greater in younger patients (p = 0.0289). UPDRS-II responder-rate (≥20% decrease in UPDRS-II score) was higher in younger patients (42.3% vs. 25.9%). Improvement across age groups was similar on PD Sleep Scale-2 and Clinical Global Impressions-Improvement Scale. Adverse drug reactions (ADRs), and discontinuations because of ADRs, were more common among older patients. There were no new safety signals. Despite low rotigotine doses, when added to levodopa/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.

Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction.

PubMed

Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

2015-01-01

This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI.

Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

PubMed Central

Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

2015-01-01

This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

Low-dose 5-fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms - results of a non-interventional study.

PubMed

Reinhold, U; Hadshiew, I; Melzer, A; Prechtl, A

2017-03-01

As an in situ carcinoma, actinic keratoses should be treated early. Previous studies on the efficacy of a low-dose 0.5% 5-fluorouracil solution in combination with 10% salicylic acid (low-dose 5-FU/SA) are mostly related to lesions appearing on the head and face. In contrast, actinic keratoses (AK) lesions of the upper extremities are considered to be difficult to treat. The efficacy of low-dose 5-FU/SA in the treatment of actinic keratoses on the hands and/or forearms was studied for the first time in this non-interventional study (NIS) under practical conditions in a large patient population. In addition to the clinical course during therapy and a follow-up period, the length of application and adherence were documented. As part of this NIS, 649 patients with AK were treated at 207 centres with low-dose 5-FU/SA. The data of the study were recorded at baseline, optionally during an intermediate examination, at the end of therapy and during a final assessment. The average number of AK lesions decreased during the entire observation period by 92%. Side-effects were documented only rarely in the form of local skin reactions (2%). The attending physicians assessed the efficacy, tolerability and safety of the therapy as being predominantly very good or good (in each case ≥90%). AK lesions on the hands and/or forearms were effectively treated with low-dose 5-FU/SA under routine conditions in dermatological practice and the treatment was well tolerated. © 2016 European Academy of Dermatology and Venereology.

Existential autonomy: why patients should make their own choices.

PubMed

Madder, H

1997-08-01

Savulescu has recently introduced the "rational non-interventional paternalist" model of the patient-doctor relationship. This paper addresses objections to such a model from the perspective of an anaesthetist. Patients need to make their own decisions if they are to be fully autonomous. Rational non-interventional paternalism undermines the importance of patient choice and so threatens autonomy. Doctors should provide an evaluative judgment of the best medical course of action, but ought to restrict themselves to helping patients to make their own choices rather than making such choices for them.

Existential autonomy: why patients should make their own choices.

PubMed Central

Madder, H

1997-01-01

Savulescu has recently introduced the "rational non-interventional paternalist" model of the patient-doctor relationship. This paper addresses objections to such a model from the perspective of an anaesthetist. Patients need to make their own decisions if they are to be fully autonomous. Rational non-interventional paternalism undermines the importance of patient choice and so threatens autonomy. Doctors should provide an evaluative judgment of the best medical course of action, but ought to restrict themselves to helping patients to make their own choices rather than making such choices for them. PMID:9279743

Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study.

PubMed

Bedke, Jens; Grimm, Marc-Oliver; Grünwald, Viktor

2018-05-01

Renal cell carcinoma (RCC) represents the seventh (men) respectively tenth (women) most frequent cancer in western countries. After one or more lines of VEGF-targeted therapy, immunotherapy with nivolumab is strongly recommended in patients with metastatic RCC. Nivolumab is the first, and so far, only approved PD-1 immune checkpoint inhibitor to demonstrate a gain in overall survival in RCC. We describe herein design and rationale of trial CA209653 ('NIS NORA'), a prospective, noninterventional cohort study investigating the effectiveness of nivolumab. This systematic collection of real-world effectiveness data will recruit 323 patients with advanced RCC to provide a precise estimate for overall survival over a 5-year follow-up period (Trial registration: NCT02940639).

The impact of a workplace catering initiative on dietary intakes of salt and other nutrients: a pilot study.

PubMed

Geaney, F; Harrington, J; Fitzgerald, Ap; Perry, Ij

2011-08-01

Owing to modern lifestyles, individuals are dependent on out-of-home eating. The catering sector can have a pivotal role in influencing our food choices. The objective of the present study was to examine the impact of a structured catering initiative on food choices in a public sector workplace setting. A cross-sectional comparison study in two hospitals, one of which had implemented a catering initiative designed to provide nutritious food while reducing sugar, fat and salt intakes. Two public sector hospitals in Cork, Ireland. A total of 100 random participants aged 18-64 years (fifty intervention, fifty non-intervention) who consumed at least one main meal in the hospital staff canteen daily. Each respondent was asked to complete one anonymous 24 h dietary recall and questionnaire. Food and nutrient analysis was conducted using WISP (Weighed Intake Software Program). Reported mean intakes of total sugars (P < 0·001), total fat (P < 0·000), saturated fat (P < 0·000) and salt (P < 0·046) were significantly lower in the intervention hospital when adjusted for age and gender. In the intervention hospital, 72 % of respondents, compared with 42 % in the non-intervention hospital, complied with the recommended under-3 daily servings of food high in fat and sugar (P < 0·005). In the intervention hospital, 43 % of respondents exceeded the recommended salt intake of 4-6 g/d, compared with 57 % in the non-intervention hospital. Structured catering initiatives in the workplace are a potentially important option in the promotion of healthy food choices. Targeted public health programmes and health policy changes are needed to motivate caterers in the public sector and other industries to develop interventions that promote a healthy diet.

The effects of PECS teaching to Phase III on the communicative interactions between children with autism and their teachers.

PubMed

Carr, Deborah; Felce, Janet

2007-04-01

The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h classroom observations recorded communications between the children and their teachers. These occurred: 6 weeks before teaching; during the week immediately prior to teaching; during the week immediately following teaching. For the control group, two 2-h observations were separated by a 5-week interval without PECS teaching. Communicative initiations and dyadic interactions increased significantly between the children and teachers in the PECS group but not for the control group.

Epidemiological data, efficacy and safety of a paracetamol-tramadol fixed combination in the treatment of moderate-to-severe pain. SALZA: a post-marketing study in general practice.

PubMed

Mejjad, O; Serrie, A; Ganry, H

2011-05-01

To evaluate the efficacy and safety of the paracetamol-tramadol combination (PTC) in treating moderate-to-severe pain, in patients aged 65 years and over within general practitioner (GP) practice centers. This was an observational, non-interventional, longitudinal, multicenter, open, non-comparative, prospective study. This intermediary analysis was of patients recruited before the French Health Authority confirmation (25th June, 2009) of the EMEA decision to withdraw all analgesics containing dextropropoxyphen. Trial registration information: This study has been submitted for approval to the CNIL and French Medical Council (CNOM) only. A total of 2663 patients aged 65 years or over were assessed 1 month after inclusion in the study. PTC was prescribed as first-line treatment in 30% of patients and, in the other cases, after failed or inadequate efficacy (69.8%), and/or as a result of safety problems (7.8%) with at least one other analgesic. During the month of the study period 14.7% of patients received an additional rescue analgesic. The study confirmed the efficacy of PTC with regard to pain intensity (-3.1 points reduction of pain scored 6.1 points on inclusion), pain relief (64.8% of patients experienced significant pain relief), patient satisfaction (90.5% of patients satisfied or completely satisfied) and clinical global impression evaluated by the patient (78.7% much or very much improved), regardless of the pain etiologies or duration of the underlying pathology. PTC was well-tolerated in this patient group, who had a mean age of 73.6 ± 6.6 years. A total of 119 patients (4.5%) reported at least one adverse event (AE). All were known and predictable AEs. This percentage is comparable to that found under similar conditions in patients of all ages (4.2%). PTC, due to the complementary action of its two analgesics, is effective in treating the different types of pain in a GP's practice setting and is well-tolerated, even in an elderly population. Study limitations include all those inherent to non-interventional and open-label observations.

Safety and efficacy of azacitidine in Belgian patients with high-risk myelodysplastic syndromes, acute myeloid leukaemia, or chronic myelomonocytic leukaemia: results of a real-life, non-interventional post-marketing survey.

PubMed

Beguin, Y; Selleslag, D; Meers, S; Graux, C; Bries, G; Deeren, D; Vrelust, I; Ravoet, C; Theunissen, K; Voelter, V; Potier, H; Trullemans, F; Noens, L; Mineur, P

2015-02-01

We evaluated azacitidine (Vidaza(®)) safety and efficacy in patients with myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), and chronic myelomonocytic leukaemia (CMML), in a real-life setting. Treatment response, dose, and schedule were assessed. This non-interventional, post-marketing survey included 49/50 patients receiving azacitidine at 14 Belgian haematology centres from 2010-2012. Treatment-emergent adverse events (TEAEs), including treatment-related TEAEs, and serious TEAEs (TESAEs) were recorded throughout the study. Treatment response [complete response (CR), partial response (PR), haematological improvement (HI), stable disease (SD), treatment failure (TF)) and transfusion-independence (TI) were evaluated at completion of a 1-year observation period (1YOP) or at treatment discontinuation, and overall survival (OS), at study conclusion. The median age of patients was 74·7 (range: 43·9-87·8) years; 69·4% had MDS, 26·5% had primary or secondary AML, and 4·1% had CMML. Treatment-related TEAEs, grade 3-4 TEAEs, and TESAEs were reported in 67·3%, 28·6%, and 18·4% of patients, respectively. During 1YOP, patients received a median of 7 (1-12) treatment cycles. Treatment response was assessed for 38/49 patients. Among MDS and CMML patients (n = 29), 41·4% had CR, PR, or HI, 41·4% had SD, and 17·2% had TF. Among AML patients (n = 9), 44·4% had CR or PR, 33·3% had SD, and 22·2% had TF. TI was observed in 14/32 (43·8%) patients who were transfusion-dependent at baseline. Median (95% confidence interval) OS was 490 (326-555) days; 1-year OS estimate was 0·571 (0·422-0·696). Our data support previous findings that azacitidine has a clinically acceptable safety profile and shows efficacy.

Volunteer driven home safety intervention results in significant reduction in pediatric injuries: A model for community based injury reduction.

PubMed

Falcone, Richard A; Edmunds, Patrick; Lee, Emily; Gardner, Dawne; Price, Kimberly; Gittelman, Michael; Pomerantz, Wendy; Besl, John; Madhavan, Gowri; Phelan, Kieran J

2016-07-01

Home based injuries account for a significant number of injuries to children between 1 and 5years old. Evidence-based safety interventions delivered in the home with installation of safety equipment have been demonstrated to reduce injury rates. The aim of this study was to evaluate the impact of a community based volunteer implemented home safety intervention. In partnership with a community with high injury rates for children between 1 and 5years old, a home safety bundle was developed and implemented by volunteers. The safety bundle included installing evidence based safety equipment. Monthly community emergency room attended injury rates as well as emergency room attended injuries occurring in intervention and nonintervention homes was tracked throughout the study. Between May 2012 and May 2014 a total of 207 homes with children 1-5years old received the home safety bundle. The baseline monthly emergency room attended injury rate for children aged 1-5years within our target community was 11.3/1000 and that within our county was 8.7/1000. Following the intervention current rates are now 10.3/1000 and 9.2/1000 respectively. Within intervention homes the injury rate decreased to 4.2/1000 while the rate in the homes not receiving the intervention experienced an increase in injury rate to 12/1000 (p<0.05). When observed vs. expected injuries were examined the intervention group demonstrated 59% fewer injuries while the nonintervention group demonstrated a 6% increase (p<0.05). Children in homes that received a volunteer-provided, free home safety bundle experienced 59% fewer injuries than would have been expected. By partnering with community leaders and organizing volunteers, proven home safety interventions were successfully provided to 207 homes during a two-year period, and a decline in community injury rates for children younger than 5years was observed compared to county wide injury rates. Copyright © 2016 Elsevier Inc. All rights reserved.

Time series evaluation of an intervention to increase statin tablet splitting by general practitioners

PubMed Central

Polinski, Jennifer M.; Schneeweiss, Sebastian; Maclure, Malcolm; Marshall, Blair; Ramsden, Samuel; Dormuth, Colin

2011-01-01

Background Tablet splitting, in which a higher-dose tablet is split to get two doses, reduces patients’ drug costs. Statins can be split safely. General practitioners (GPs) may not direct their patients to split statins because of safety concerns or unawareness of costs. Medical chart inserts provide cost-effective education to physicians. We evaluated whether providing GPs with statin splitting chart inserts would increase splitting rates and identified predictors of splitting. Methods In 2005–2006, we faxed a statin chart insert to British Columbia GPs with a request for a telephone interview. Consenting GPs were mailed 3 statin chart inserts and interviewed by phone (the intervention). In an interrupted time series, we compared monthly rates of statin splitting prescriptions among intervention and non-intervention GPs before, during, and after the intervention. In multivariate logistic regressions accounting for patient clustering, predictors of splitting included physician and patient demographics and the specific statin prescribed. Results Of 5,051 GPs reached, 282 (6%) agreed to the intervention. Before the intervention, GPs’ splitting rate was 2.6%; after, intervention GPs’ splitting rate was 7.5%, non-intervention GPs’ was 4.4%. Intervention GPs were 1.68 (95% CI 1.12–2.53) times more likely to prescribe splitting after the intervention than were non-intervention GPs. Other predictors were a patient’s female sex (OR=1.26, 95% CI 1.18–1.34), lower patient income (OR=1.33, 95% CI 1.18–1.34), and no drug insurance (OR=1.89, 95% CI 1.69–2.04). Interpretation An inexpensive intervention was effective in producing a sustained increase in GPs’ splitting rate during 22 months of observed follow-up. Expanding statin splitting education to all GPs could reduce prescription costs for many patients and payors. PMID:21497707

The efficacy of teachers' responses to incidents of bullying and victimization: The mediational role of moral disengagement for bullying.

PubMed

Campaert, Kristel; Nocentini, Annalaura; Menesini, Ersilia

2017-09-01

Teachers respond differently to bullying and victimization. Socio-cognitive and moral domain theory suggest that students process teachers' behavior cognitively and that teachers' responses to incidents of bullying and victimization could affect students' level of moral disengagement. We examined the mediating effect of students' moral disengagement between types of teachers' responses to situations of bullying and victimization and individual bullying using multilevel mediation modelling. Participants were 609 students (50% boys, age M = 11.47, SD = 1.14) of central Italy, nested in 34 classes. Students rated the frequency of self-reported bullying and of teachers' responses to incidents of bullying and victimization on a 5-point Likert scale. Teachers' responses to bullying included non-intervention, mediation, group discussion, and sanctions. Teachers' responses to victimization included non-intervention, mediation, group discussion, and victim support. Results indicated that in the teachers' responses to incidents of bullying model, a significant indirect effect of non-intervention (β = .03; 95%CI [.01, .05]) and of sanctions (β = -.02; 95%CI [-.04, -.01]) on bullying through moral disengagement was found at the individual level. Similarly, in the model on teachers' responses toward victims there was a significant indirect effect through moral disengagement of non-intervention (β = .03; 95%CI [.02, .04]) and victim support (β = -.01; 95%CI [-.02, -.001]). At the class level there were no significant indirect effects. In sum, results indicated that moral disengagement is an important mediator at the individual level and suggest including teachers in anti-bullying interventions with a specific focus on their role for moral development. © 2017 Wiley Periodicals, Inc.

Use of Electrocautery for Coagulation and Wound Complications in Caesarean Sections

PubMed Central

Moreira, Cristiane M.; Amaral, Eliana

2014-01-01

Objective. To evaluate the safety of electrocautery for coagulation during Caesarean sections. Study Design. A randomized, controlled, clinical pilot study was performed at a university maternity hospital. After admission for delivery and decision to perform a C-section, volunteers were randomized to either the intervention group (use of electrocautery for coagulation) or nonintervention group. The women were examined at the time of postpartum discharge (day 3), at days 7 to 10, and again at days 30 to 40 for signs of infection, hematoma, seroma, or dehiscence. Data were analyzed using an intention-to-treat analysis, and risk ratios were calculated. Results. No significant differences were found between the two groups. Only 2.8% of patients in the intervention group developed surgical wound complications during hospitalization. However, 7 to 10 days following discharge, these rates reached 23.0% and 15.4% in the intervention and nonintervention groups, respectively (RR = 1.50, 95% CI = 0.84–2.60). Conclusion. Further studies should confirm whether the use of electrocautery for coagulation does not increase the risk of surgical wound complications in patients undergoing Caesarean sections. PMID:25143985

Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium.

PubMed

Fahrleitner-Pammer, A; Papaioannou, N; Gielen, E; Feudjo Tepie, M; Toffis, C; Frieling, I; Geusens, P; Makras, P; Boschitsch, E; Callens, J; Anastasilakis, A D; Niedhart, C; Resch, H; Kalouche-Khalil, L; Hadji, P

2017-12-01

Persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium found that persistence with denosumab remains consistently high after 24 months in patients at high risk of fracture. Continued persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of clinical practice evaluated medication-taking behavior of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium and factors influencing persistence. Subcutaneous denosumab (60 mg every 6 months) was assigned according to prescribing information and local guidelines before and independently of enrollment; outcomes were recorded during routine practice for up to 24 months. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection and adherence as administration of subsequent injections within 6 months ± 4 weeks of the previous injection. Medication coverage ratio (MCR) was calculated as the proportion of time a patient was covered by denosumab. Associations between pre-specified baseline covariates and 24-month persistence were assessed using multivariable logistic regression. The 24-month analyses included 1479 women (mean age 66.3-72.5 years) from 140 sites; persistence with denosumab was 75.1-86.0%, adherence 62.9-70.1%, and mean MCR 87.4-92.4%. No covariate had a significant effect on persistence across all four countries. For three countries, a recent fall decreased persistence; patients were generally older with chronic medical conditions. In some countries, other covariates (e.g., older age, comorbidity, immobility, and prescribing reasons) decreased persistence. Adverse drug reactions were reported in 2.3-6.9% patients. Twenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics. Further studies are needed to identify determinants of low persistence.

A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer

PubMed Central

Gil, Thierry; Aoun, Fouad; Cabri, Patrick; Maisonobe, Pascal

2015-01-01

Objectives: Few studies have assessed the effect of gonadotropin-releasing hormone (GnRH) agonists, such as triptorelin, on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer. Therefore, multiple, national observational, noninterventional studies were initiated to assess the effectiveness of triptorelin in reducing moderate or severe LUTS [International Prostate Symptom Score (IPSS) >7] in men with prostate cancer starting triptorelin therapy in clinical practice. Methods: Prospective, noninterventional, multicentre studies of LUTS located in Algeria, Belgium, China, Hungary, Romania and South Korea, in patients who were scheduled to receive triptorelin (3-month extended release or 1-month formulation) in clinical practice. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks as assessed by IPSS. Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks. Results: In total, 2461 patients were recruited in the studies; 1282 patients had moderate or severe LUTS at baseline (IPSS > 7), received triptorelin and had follow-up IPSS. Mean total IPSS was reduced from 18.2 [95% confidence interval (CI) 17.8–18.5] at baseline to 11.9 (95% CI 11.5–12.3; p < 0.001) and 10.6 (95% CI 10.2–11.0; p < 0.001) at weeks 24 and 48, respectively. Mean PSA levels were reduced from 117.9 ng/ml (95% CI 93.8–141.9) at baseline to 8.5 ng/ml (95% CI 5.2–11.7) and 16.6 ng/ml (95% CI 7.4–25.8) at weeks 24 and 48, respectively. There was a significant correlation between total IPSS change from baseline and PSA change from baseline at weeks 24 and 48 (ρ = 0.3 and 0.2, p < 0.001). Conclusions: The improvement in LUTS in men with locally advanced or metastatic prostate cancer after 24–48 weeks suggests that triptorelin is effective in improving LUTS in this subgroup of patients. PMID:26161142

Implementing situation-background-assessment-recommendation in an anaesthetic clinic and subsequent information retention among receivers: A prospective interventional study of postoperative handovers.

PubMed

Randmaa, Maria; Swenne, Christine L; Mårtensson, Gunilla; Högberg, Hans; Engström, Maria

2016-03-01

Communication errors cause clinical incidents and adverse events in relation to surgery. To ensure proper postoperative patient care, it is essential that personnel remember and recall information given during the handover from the operating theatre to the postanaesthesia care unit. Formalizing the handover may improve communication and aid memory, but research in this area is lacking. The objective of this study was to evaluate whether implementing the communication tool Situation-Background-Assessment-Recommendation (SBAR) affects receivers' information retention after postoperative handover. A prospective intervention study with an intervention group and comparison nonintervention group, with assessments before and after the intervention. The postanaesthesia care units of two hospitals in Sweden during 2011 and 2012. Staff involved in the handover between the operating theatre and the postanaesthesia care units within each hospital. Implementation of the communication tool SBAR in one hospital. The main outcome was the percentage of recalled information sequences among receivers after the handover. Data were collected using both audio-recordings and observations recorded on a study-specific protocol form. Preintervention, 73 handovers were observed (intervention group, n = 40; comparison group, n = 33) involving 72 personnel (intervention group, n = 40; comparison group, n = 32). Postintervention, 91 handovers were observed (intervention group, n = 44; comparison group, n = 47) involving 57 personnel (intervention group, n = 31; comparison group, n = 26). In the intervention group, the percentage of recalled information sequences by the receivers increased from 43.4% preintervention to 52.6% postintervention (P = 0.004) and the SBAR structure improved significantly (P = 0.028). In the comparison group, the corresponding figures were 51.3 and 52.6% (P = 0.725) with no difference in SBAR structure. When a linear regression generalised estimating equation model was used to account for confounding influences, we were unable to show a significant difference in the information recalled between the intervention group and the nonintervention group over time. Compared with the comparison group with no intervention, when SBAR was implemented in an anaesthetic clinic, we were unable to show any improvement in recalled information among receivers following postoperative handover. Current controlled trials http://www.controlled-trials.com Identifier: ISRCTN37251313.

Effects of post-fire wood management strategies on vegetation recovery and land surface temperature (LST) estimated from Landsat images

NASA Astrophysics Data System (ADS)

Vlassova, Lidia; Pérez-Cabello, Fernando

2016-02-01

The study contributes remote sensing data to the discussion about effects of post-fire wood management strategies on forest regeneration. Land surface temperature (LST) and Normalized Differenced Vegetation Index (NDVI), estimated from Landsat-8 images are used as indicators of Pinus halepensis ecosystem recovery after 2008 fire in areas of three post-fire treatments: (1) salvage logging with wood extraction from the site on skidders in suspended position (SL); (2) snag shredding in situ leaving wood debris in place (SS) performed two years after the event; and (3) non-intervention control areas (CL) where all snags were left standing. Six years after the fire NDVI values ∼0.5 estimated from satellite images and field radiometry indicate considerable vegetation recovery due to efficient regeneration traits developed by the dominant plant species. However, two years after management activities in part of the burnt area, the effect of SL and SS on ecosystem recovery is observed in terms of both LST and NDVI. Statistically significant differences are detected between the intervened areas (SL and SS) and control areas of non-intervention (CL); no difference is registered between zones of different intervention types (SL and SS). CL areas are on average 1 °C cooler and 10% greener than those corresponding to either SL or SS, because of the beneficial effects of burnt wood residuals, which favor forest recovery through (i) enhanced nutrient cycling in soils, (ii) avoidance of soil surface disturbance and mechanical damage of seedlings typical to the managed areas, and (iii) ameliorated microclimate. The results of the study show that in fire-resilient ecosystems, such as P. halepensis forests, NDVI is higher and LST is lower in areas with no management intervention, being an indication of more favorable conditions for vegetation regeneration.

Atrial fibrillation management, outcomes and predictors of stable disease in daily practice: prospective non-interventional study.

PubMed

Bosch, Ralph F; Kirch, Wilhelm; Theuer, Juergen-Detlef; Pittrow, David; Kohlhaußen, Annette; Willich, Stefan N; Bonnemeier, Hendrik

2013-08-10

We aimed to describe the current management of patients with atrial fibrillation (AF) by cardiologists, and to identify predicting factors for a stable disease course. 2753 consecutive patients with ECG-confirmed AF in the previous 12 months were documented in a 1-year observational (non-interventional) study from 616 centers. Stable disease was defined as having neither AF related intervention nor change in antiarrhythmic therapy in the previous 12 months. Stepwise selection of parameters for multivariate regression was used to identify factors for stable AF. At baseline, paroxysmal AF was reported in 33.5%, persistent in 26.7%, and permanent in 39.7%; rate control alone was the prevailing antiarrhythmic strategy (64.2%). Drugs for thromboembolic prevention were administered in 93.8%, with a clear predominance of oral anticoagulants (OAC), alone or in combination with antiplatelet drugs. Electrical or pharmacological conversions were reported in 23.6%. A total of 96 (3.5%) patients in the total cohort experienced stroke, 72 patients (2.6%) TIA, and 24 (0.9%) arterial embolism. 26% were hospitalized during follow-up (0.4 events per patient), and 9.4% developed incident heart failure (42% prevalence at follow-up). The rate of stable patients was 43.4%. In the multivariate model male gender, history of stroke, and permanent (vs. persistent) AF were associated with stable disease. Conversely, the factors chronic heart failure, impaired left ventricular function, rhythm-control (vs. other), OAC and antiplatelet therapy were significantly correlated with unstable disease. The relatively low proportion of stable patients and in particular, the high hospitalization and stroke rate indicate difficulties in everyday management of patients with AF. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Should the standard dimethyl sulfoxide concentration be reduced? Results of a European Group for Blood and Marrow Transplantation prospective noninterventional study on usage and side effects of dimethyl sulfoxide.

PubMed

Morris, Curly; de Wreede, Liesbeth; Scholten, Marijke; Brand, Ronald; van Biezen, Anja; Sureda, Anna; Dickmeiss, Ebbe; Trneny, Marek; Apperley, Jane; Chiusolo, Patrizia; van Imhoff, Gustaaf W; Lenhoff, Stig; Martinelli, Giovanni; Hentrich, Marcus; Pabst, Thomas; Onida, Francesco; Quinn, Michael; Kroger, Nicolaus; de Witte, Theo; Ruutu, Tapani

2014-10-01

Dimethyl sulfoxide (DMSO) is essential for the preservation of liquid nitrogen-frozen stem cells, but is associated with toxicity in the transplant recipient. In this prospective noninterventional study, we describe the use of DMSO in 64 European Blood and Marrow Transplant Group centers undertaking autologous transplantation on patients with myeloma and lymphoma and analyze side effects after return of DMSO-preserved stem cells. While the majority of centers continue to use 10% DMSO, a significant proportion either use lower concentrations, mostly 5 or 7.5%, or wash cells before infusion (some for selected patients only). In contrast, the median dose of DMSO given (20 mL) was much less than the upper limit set by the same institutions (70 mL). In an accompanying statistical analysis of side effects noted after return of DMSO-preserved stem cells, we show that patients in the highest quartile receiving DMSO (mL and mL/kg body weight) had significantly more side effects attributed to DMSO, although this effect was not observed if DMSO was calculated as mL/min. Dividing the myeloma and lymphoma patients each into two equal groups by age we were able to confirm this result in all but young myeloma patients in whom an inversion of the odds ratio was seen, possibly related to the higher dose of melphalan received by young myeloma patients. We suggest better standardization of preservation method with reduced DMSO concentration and attention to the dose of DMSO received by patients could help reduce the toxicity and morbidity of the transplant procedure. © 2014 AABB.

Effects of a Preschool Intervention on Cognitive Development among East-African Preschool Children: A Flexibly Time-Coded Growth Model

ERIC Educational Resources Information Center

Malmberg, Lars-Erik; Mwaura, Peter; Sylva, Kathy

2011-01-01

The aim of the study is to investigate the effects of the Madrasa Resource Center (MRC), a child-centered intervention program, on East-African (Kenya, Zanzibar, and Uganda) preschool children's cognitive development. Altogether 321 children (153 non-intervention and 168 intervention) participated in a cross-sequential study over three time-points…

Use of electrocautery for coagulation and wound complications in Caesarean sections.

PubMed

Moreira, Cristiane M; Amaral, Eliana

2014-01-01

To evaluate the safety of electrocautery for coagulation during Caesarean sections. A randomized, controlled, clinical pilot study was performed at a university maternity hospital. After admission for delivery and decision to perform a C-section, volunteers were randomized to either the intervention group (use of electrocautery for coagulation) or nonintervention group. The women were examined at the time of postpartum discharge (day 3), at days 7 to 10, and again at days 30 to 40 for signs of infection, hematoma, seroma, or dehiscence. Data were analyzed using an intention-to-treat analysis, and risk ratios were calculated. No significant differences were found between the two groups. Only 2.8% of patients in the intervention group developed surgical wound complications during hospitalization. However, 7 to 10 days following discharge, these rates reached 23.0% and 15.4% in the intervention and nonintervention groups, respectively (RR = 1.50, 95% CI = 0.84-2.60). Further studies should confirm whether the use of electrocautery for coagulation does not increase the risk of surgical wound complications in patients undergoing Caesarean sections.

Social learning theory parenting intervention promotes attachment-based caregiving in young children: randomized clinical trial.

PubMed

O'Connor, Thomas G; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen

2013-01-01

Parenting programs for school-aged children are typically based on behavioral principles as applied in social learning theory. It is not yet clear if the benefits of these interventions extend beyond aspects of the parent-child relationship quality conceptualized by social learning theory. The current study examined the extent to which a social learning theory-based treatment promoted change in qualities of parent-child relationship derived from attachment theory. A randomized clinical trial of 174 four- to six-year-olds selected from a high-need urban area and stratified by conduct problems were assigned to a parenting program plus a reading intervention (n = 88) or nonintervention condition (n = 86). In-home observations of parent-child interactions were assessed in three tasks: (a) free play, (b) challenge task, and (c) tidy up. Parenting behavior was coded according to behavior theory using standard count measures of positive and negative parenting, and for attachment theory using measures of sensitive responding and mutuality; children's attachment narratives were also assessed. Compared to the parents in the nonintervention group, parents allocated to the intervention showed increases in the positive behavioral counts and sensitive responding; change in behavioral count measures overlapped modestly with change in attachment-based changes. There was no reliable change in children's attachment narratives associated with the intervention. The findings demonstrate that standard social learning theory-based parenting interventions can change broader aspects of parent-child relationship quality and raise clinical and conceptual questions about the distinctiveness of existing treatment models in parenting research.

Why female sex workers participate in HIV research: the illusion of voluntariness.

PubMed

Reed, Elizabeth; Fisher, Celia B; Blankenship, Kim M; West, Brooke S; Khoshnood, Kaveh

2017-07-01

The purpose of this study was to examine factors influencing the motivation for and perceived voluntariness of participation in non-intervention HIV research among female sex workers (FSW) in India. FSW (n = 30) who participated in non-intervention HIV studies in the previous three years were recruited from a local community-based organization. Semi-structured qualitative interviews focused on women's personal and economic motivations for participation and their perceptions of the informed consent process. Interviews were audio-recorded, translated, transcribed, and reviewed for common themes. Content analysis indicated that while many women reported willing participation, reports of obligatory participation were also a common theme. Obligations included money-related pressures and coercion by other FSW, social pressures, not wanting to disappoint the researchers, and perceiving that they had a contractual agreement to complete participation as a result of signing the consent form. Findings suggest a need for additional efforts during and following informed consent to prevent obligatory participation in HIV research studies among FSW. Findings emphasize the importance of integrating ongoing participant feedback into research ethics practices to identify issues not well addressed via standard ethics protocols when conducting HIV research among vulnerable populations.

Prevention of Substance Use among Adolescents through Social and Emotional Training in School: A Latent-Class Analysis of a Five-Year Intervention in Sweden

ERIC Educational Resources Information Center

Kimber, Birgitta; Sandell, Rolf

2009-01-01

The study considers the impact of a program for social and emotional learning in Swedish schools on use of drugs, volatile substances, alcohol and tobacco. The program was evaluated in an effectiveness study. Intervention students were compared longitudinally with non-intervention students using nonparametric latent class analysis to identify…

Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study

PubMed Central

Paris, A; Gonnet, N; Chaussard, C; Belon, P; Rocourt, F; Saragaglia, D; Cracowski, J L

2008-01-01

Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18–60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day−1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day−1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. What is already known about this subject The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. PMID:18251757

The Uses of Force on Spaceship Earth: Revolution and Intervention in the '70's. A Study Guide.

ERIC Educational Resources Information Center

Rivera, Charles R.; And Others

The relationship between internal revolution and subsequent intervention by a foreign power is examined in this guide book for senior high students. Why nations pursue a policy of military intervention and what other alternatives are available are two major questions investigated. Intervention and non-intervention are both determined policies that…

Effectiveness of a Stress-Relief Initiative for Primary Caregivers of Adolescents with Intellectual Disability

ERIC Educational Resources Information Center

Hu, Jung; Lin, Jin-Ding; Yen, Chia-Feng; Loh, Ching-Hui; Hsu, Shang-Wei; Lin, Lan-Ping; Wu, Sheng-Ru

2010-01-01

Background: This study provides a perspective on the mental health status and analyses the effectiveness of a stress-relief program for primary caregivers of adolescents with intellectual disability (ID). Method: Seventy-seven primary caregivers of people with ID were recruited (intervention group, n = 31; non-intervention group, n = 46) to the…

Mechanical Properties of the Plantarflexor Musculotendinous Unit during Passive Dorsiflexion in Children with Cerebral Palsy Compared with Typically Developing Children

ERIC Educational Resources Information Center

Alhusaini, Adel A. A.; Crosbie, Jack; Shepherd, Roberta B.; Dean, Catherine M.; Scheinberg, Adam

2010-01-01

Aim: To examine the passive length-tension relations in the myotendinous components of the plantarflexor muscles of children with and without cerebral palsy (CP) under conditions excluding reflex muscle contraction. Method: A cross-sectional, non-interventional study was conducted in a hospital outpatient clinic. Passive torque-angle…

[Regional Differences in the Care of Patients with Neovascular Age-Related Macular Degeneration, Based on the Non-Interventional OCEAN Study].

PubMed

Ziemssen, F; Hufenbach, U; Wiedon, A; Scheffler, M; Bertelmann, T

2016-12-01

Background: The main cause of blindness in the elderly in Germany is neovascular age-related macular degeneration (nAMD). In the non-interventional OCEAN study, data were prospectively collected on the routine clinical care of patients treated with the drug ranibizumab. Patients: As part of an interim analysis within the ongoing study (NCT02194803), stratification was performed by the 17 regions of the German associations of panel physicians and by areas of different population density. Only data were analysed for patients for whom the first treatment with ranibizumab was documented. Results: A total of 5,606 patients were documented. The present manuscript reviews 2,658 treatment-naive patients with nAMD, documented by 324 ophthalmologists. Most patients receiving an intravitreal injection were female (60 %). The average patient was aged 77.7 ± 8.2 years at study start. The great majority of patients had statutory health insurance (91 %). At baseline, fluorescein angiography (FLA) was performed for 72 % of patients, while optical coherence tomography (OCT) was carried out for 76 %. A combination of both was performed for 54 % of patients, varying regionally from 26 % (Saxony-Anhalt) to 100 % (Berlin). The average waiting time between the first examination and the first injection was 20.0 ± 18.5 days. With different statistical models (ANOVA adjusted, with/without interactions), significant effects on treatment delay were found for district type (population density), federal state and type of specialist. Conclusion: No major regional differences were observed in the demographic characteristics of the patient population. The main regional disparities in the care of nAMD patients were in the application of diagnostic methods and the waiting times between the first examination and the first drug administration. The regional variations in treatment delays could clearly influence the risk of worse functional outcome. Georg Thieme Verlag KG Stuttgart · New York.

Tolerability and safety of the intravenous immunoglobulin octagam® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

PubMed

Wietek, Stefan; Svorc, Daniel; Debes, Anette; Svae, Tor-Einar

2018-05-01

To provide detailed data on the tolerability and safety of octagam ® 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies. A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam ® 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam ® 10%, with a particular focus on thromboembolic events (TEEs). ADRs were analysed at the case and event level. In this analysis of 112 patients receiving octagam ® 10% (mean dose 0.4 g/kg/infusion), there were five cases with at least one adverse drug reaction (ADR) associated with 626 infusions of octagam ® 10% (case incidence of 0.8% per infusion). ADRs were of mild or moderate severity. There were a total of 10 events, most commonly back pain (n = 3) and headache (n = 2). Nausea, dizziness and a sensation of heaviness were also reported. The remaining two events involved drug exposure during pregnancy. There were no TEEs or other serious ADRs. In this subgroup analysis of patients who received octagam ® 10% (manufactured using an amended process) in two PASS studies, the overall ADR rate was low, with ADRs occurring in only 0.8% of all infusions. No TEEs or other serious ADRs were reported. Routine clinical use of octagam ® 10% was safe and well tolerated, with no unexpected safety issues, in patients with ITP. The two studies from which data were taken are registered with the International Standard Randomised Controlled Trial Number Registry, numbers ISRCTN58800347 and ISRCTN02245668.

Surveillance and Control of Aedes albopictus in the Swiss-Italian Border Region: Differences in Egg Densities between Intervention and Non-intervention Areas

PubMed Central

Suter, Tobias T.; Flacio, Eleonora; Feijoó Fariña, Begoña; Engeler, Lukas; Tonolla, Mauro; Regis, Lêda N.; de Melo Santos, Maria A. V.; Müller, Pie

2016-01-01

Background Aedes albopictus, the Asian tiger mosquito, originates from the tropical and subtropical regions of Southeast Asia. Over the recent decades it has been passively spread across the globe, primarily through the used tyre trade and passive transportation along major traffic routes. A. albopictus is a proven vector for many arboviruses, most notably chikungunya and dengue, with recent outbreaks also in continental Europe. In southern Switzerland, in the Canton of Ticino A. albopictus was spotted for the first time in 2003. Since then the local authorities have implemented a control programme based on larval source reduction. Despite these efforts, mosquito densities have increased over the last decade, casting doubts on the effectiveness of such larval control programmes. Methodology/Principal Findings The Italian communities just across the Swiss-Italian border lack a control programme. This motivated us to compare the intervention and the non-intervention areas side by side in an attempt to find evidence for, or against, the effectiveness of larval A. albopictus control. Using ovitraps and a randomised sampling scheme, we examined the seasonal and spatial abundance of A. albopictus in sylvatic and urban environments across the Swiss-Italian border in 2012 and 2013. In the urban environments of the non-intervention area, egg densities were 2.26 times higher as compared to the intervention area. In the sylvatic environments, as compared to the urban environments, egg densities were 36% in the intervention area and 18% in the non-intervention area. Conclusions/Significance Though alternative explanations are also valid, the results support the hypothesis that the Ticino intervention programme does have an impact. At the same time the data also suggest that current larval interventions fall short in gaining full control over the mosquito, calling for the evaluation of additional, or alternative, approaches. Ideally, these should also consider inclusion of the neighbouring Italian communities in the surveillance and control efforts. PMID:26734946

An Intervention to Decrease Adolescent Indoor Tanning: A Multi-Method Pilot Study

PubMed Central

Lazovich, DeAnn; Choi, Kelvin; Rolnick, Cheri; Jackson, Jody M.; Forster, Jean; Southwell, Brian

2013-01-01

Purpose Indoor tanning usually begins during adolescence, but few strategies exist to discourage adolescent use. We developed and tested a parent–teenager intervention to decrease indoor tanning use. Methods Through focus groups, we identified key messages to enhance parent–teenager communication about indoor tanning, and then developed a pamphlet for parents and postcards for adolescents to use in a direct mail experiment with randomly selected households. Two weeks after the mailing, we asked intervention parents (n = 87) and adolescents (n = 69) and nonintervention parents (n = 31) and adolescents (n = 28) about intervention receipt and content recall, parental concern, monitoring, parent–teenager conversations, and indoor tanning intention. Results In intervention households, 54% of mothers and 56% of girls recalled receipt and reported reading materials, but few boys and no fathers did. Among mothers, 57% in intervention households indicated concern about daughters’ indoor tanning, and 25% would allow daughters to tan indoors, whereas 43% of nonintervention mothers had concerns and 46% would allow indoor tanning. Fewer girls in intervention households than in nonintervention households thought parents would allow indoor tanning (44% vs. 65%), and fewer intended to tan indoors (36% vs. 60%). Most mothers and daughters who read the intervention materials also reported discussions about indoor tanning. Moreover, the less likely girls were to think that their mothers would allow indoor tanning, the less likely it was that they intended to tan indoors, a relationship mediated by perceptions of maternal monitoring. Conclusions A systematic qualitative and quantitative research approach yielded well-received indoor tanning prevention messages for mothers and female adolescents. Enhancing maternal monitoring has potential to decrease adolescent indoor tanning. PMID:23601614

Weight control in schizophrenic patients through Sakata's Charting of Daily Weight Pattern and its associations with temperament and character.

PubMed

Miyoshi, Ryoei; Matsuo, Hisae; Naono-Nagatomo, Keiko; Ozono, Kazuhiko; Araki, Ryuji; Ishikawa, Michiko; Abe, Hiroshi; Taniguchi, Hiroshi; Ishida, Yasushi

2014-02-01

This study examined whether daily self-monitoring of weight and monthly interviews with a doctor improved eating habits and led to weight loss, and whether temperament and character traits affect weight change in persons with schizophrenia. Participants used Sakata's Charting of Daily Weight Pattern to monitor their weight daily. In addition, Sakata's Eating Behavior Questionnaire was administered to evaluate eating-behavior awareness. The Temperament and Character Inventory (TCI) was used to assess participants' temperament and character. Fifty patients were divided into two groups: the intervention group (n = 25) filled in Sakata's Charting of Daily Weight Pattern every day; was interviewed monthly by a doctor about weight management; was weighed monthly. The non-intervention group (n = 25) was only weighed monthly. The body mass index (mean ± standard error: 0.59 ± 0.10 kg/m(2), p < 0.001) of the intervention group decreased significantly while their scores on Sakata's Eating Behavior Questionnaire significantly improved albeit marginally. Conversely, body mass index increased significantly (0.66 ± 0.18 kg/m(2), p < 0.001) in the non-intervention group, whose scores on Sakata's Eating Behavior Questionnaire did not change significantly. Weight change and TCI scores were not correlated for the intervention group, but scores for "self-directedness" and weight gain in the non-intervention group had a marginally significant negative correlation (r = -0.33, p < 0.10). Our results suggest that monitoring one's weight daily on Sakata's Charting of Daily Weight Pattern led to improvements in eating behavior and a decrease in BMI of patients with schizophrenia. Copyright © 2013 Elsevier B.V. All rights reserved.

An environmental intervention to increase fruit and salad purchases in a cafeteria.

PubMed

Jeffery, R W; French, S A; Raether, C; Baxter, J E

1994-11-01

This study explored the hypothesis that consumption of fruit and salad in a cafeteria setting would increase if the variety of offerings was increased and their price reduced. Food purchases in a cafeteria setting were observed during 3 weeks of baseline observation, 3 weeks of intervention, and 3 weeks of return to baseline conditions. Intervention consisted of doubling the number of fruit choices, increasing salad ingredient selections by three, and reducing the price of both fruit and salad by 50%. The primary outcome measures in the study were daily sales of fruit and salad as assessed by cash register receipts. Fruit and salad purchases increased threefold in the intervention period compared to those in the nonintervention periods. Women and those trying to control their weight were most likely to make these nutritious food choices. Results of this study support the argument that increasing the number of nutritious food choices and making them more attractive economically may be important to changing food choice behavior. Further exploration of the practical application of the concept is recommended.

Effectiveness of Test-Enhanced Learning (TEL) in lectures for undergraduate medical students

PubMed Central

Ayyub, Aisha; Mahboob, Usman

2017-01-01

Objective: To determine the effectiveness of Test-Enhanced learning as a learning tool in lectures for undergraduate medical students Method: This quantitative, randomized controlled trial included eighty-four students of 4th year MBBS from Yusra Medical & Dental College, Islamabad. The duration of study was from March 2016 to August 2016. After obtaining the informed consent; participants were equally assigned to interventional and non-interventional study groups through stratified randomization. Single best answer MCQs of special pathology were used as data collection instrument after validation. A pre- and post-test was taken from both groups, before and after the intervention, respectively and their results were compared using SPSS version 21. Results: There were 13 male (31%) and 29 female (69%) participants in each study group who showed an equivalent baseline performance on pre-test (p=0.95). Statistically significant difference was found among mean scores of interventional and non-interventional study groups at exit exam (p=0.00). Interventional group also showed a significant improvement in their post-test scores (mean: 17.17±1.59) as compared to pre-test scores (mean: 6.19±1.81). Conclusions: Test-enhanced learning has significant effect on improving the learning of course content delivered to undergraduate medical students through lectures. PMID:29492055

Comparably high retention and low relapse rates in different subpopulations of bipolar patients in a German non-interventional study.

PubMed

Kraemer, Susanne; Minarzyk, Anette; Eppendorfer, Steffen; Henneges, Carsten; Hundemer, Hans-Peter; Wilhelm, Stefan; Grunze, Heinz

2013-07-17

Although a range of pharmacotherapeutical options are available for the treatment of bipolar disorder, patient non-adherence to prescribed treatment regimens and early treatment discontinuation remain among the primary obstacles to effective treatment. Therefore, this observational study assessed time on mood stabilizing medication and retention rates in patients with bipolar disorder (BD). In an 18-month, prospective, multicenter, non-interventional study conducted in Germany 761 outpatients (≥18 years) with BD and on maintenance therapy were documented. For analysis, patients were stratified by baseline medication: monotherapy olanzapine (OM, N = 186), lithium (LM, N = 152), anticonvulsants (N = 216), other mood stabilizing medication (OMS, N = 44); combination therapy olanzapine/lithium (N = 47), olanzapine/anticonvulsant (N = 68), other combinations (OC, N = 48). Continuation on medication was assessed as retention rates with 95% confidence intervals. Time to discontinuation and relapse-free time were calculated by Kaplan-Meier analysis. A relapse was defined as increase to CGI-BP >3, worsening of CGI-BP by ≥2 points, hospitalization or death related to BD. A Cox regression was calculated for the discontinuation of mood stabilizing therapy (reference: OM). Logistic regression models with stepwise forward selection were used to explore possible predictors of maintenance of treatment and relapse. After 540 days (18 months), the overall retention rate of baseline medication was 87.7%, without notable differences between the cohorts. The overall mean time on mood stabilizing treatment was 444.7 days, with a range of 377.5 (OMS) to 481 (LM) by cohort. 74.0% of all patients were without relapse, with rates between the cohorts ranging from 58.4% (OC) to 80.2% (LM). Retention rates exceeded controlled trial results in all treatment cohorts, in addition to other explanations possibly reflecting that the physicians were expertly adapting treatment regimens to the individual patient's disease characteristics and special needs.

Treosulfan in the Treatment of Advanced Ovarian Cancer - Results of a German Multicenter Non-interventional Study.

PubMed

Chekerov, Radoslav; Kaltenecker, Gabriele; Reichert, Dietmar; Göhler, Thomas; Klare, Peter; Oskay-Özcelik, Gülten; Sauer, Uwe; Wischnik, Arthur; Vehling-Kaiser, Ursula; Becker, Martin; Hutzschenreuter, Ulrich; Ammon, Andreas; Heidrich-Lorsbach, Elke; Sehouli, Jalid

2015-12-01

Data on routine systemic treatment of patients with ovarian cancer are currently available only to a limited degree. The alkylating agent treosulfan is approved in oral (p.o.) and intravenous (i.v.) form for the treatment of ovarian carcinoma. The present non-interventional study analyzed the clinical use of treosulfan in Germany, evaluating the mode of application, toxicity, and response and survival rate. Two hundred and forty-eight ovarian cancer patients in 57 Centers, who received treosulfan mainly either i.v. (5,000-8,000 mg/m(2) d1, q21d or q28d) or p.o. (400-600 mg/m(2) d1-14 or 21, q28d) for at least one therapy cycle were evaluable and were included in the study. With a median age of 70 years (range=36-92 years), predominantly elderly patients received treosulfan treatment. Most participants presented serous histology (131, 52.8%) and advanced-stage FIGO III (122, 49%) or IV (55, 22%) disease. Median ECOG status was 1 (range=0-2), whereas cardiac co-morbidity was common (31%). Treosulfan was usually administered as second- (26%), third- (21%) or fourth-line (17%) therapy. Two hundred and one patients received i.v. and 47 p.o. The most common reason for dose modifications was due to hematological toxicity (46%). The main reason for a therapy discontinuation was progressive disease (38.5%). Response was observed in 25.8% of participants, disease stabilization in 28.6 % and progress in 45.6%. The median progression-free and overall survival was 196 and 405 days, respectively. In predominantly elderly and heavily pre-treated patients with recurrent ovarian cancer, treosulfan featured a clinical relevant efficacy and well-manageable, mostly hematological, toxicity, which resulted in a positive therapeutic index. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.

PubMed

Fruehauf, Stefan; Otremba, Burkhard; Stötzer, Oliver; Rudolph, Christine

2016-11-01

Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy. This was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled. Among the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22-92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment. Biosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies. ClinicalTrials.gov identifier, NCT01627990. Hospira Inc, A Pfizer Company, Lake Forest, IL, USA.

Conduct Problems in Children Attending Pre-Primary Schools in Rural Areas of Pakistan

ERIC Educational Resources Information Center

Bhamani, Shelina; Ayub, Nadia

2014-01-01

The aim of this study was to explore the conduct problems faced by school going children in the rural areas of Pakistan. Two hypotheses were formulated to explore the significant differences between the intervention and non-intervention groups and gender on the variables of conduct and internalization. The data of a total 386 young children were…

Persistence, adherence, and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany, Austria, Greece, and Belgium: 12-month results from a European non-interventional study.

PubMed

Hadji, P; Papaioannou, N; Gielen, E; Feudjo Tepie, M; Zhang, E; Frieling, I; Geusens, P; Makras, P; Resch, H; Möller, G; Kalouche-Khalil, L; Fahrleitner-Pammer, A

2015-10-01

Persistence with and adherence to osteoporosis therapy are critical for fracture reduction. This non-interventional study is evaluating medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in Germany, Austria, Greece, and Belgium. Patients were representative of the PMO population and highly persistent with and adherent to denosumab at 12 months. Persistence with and adherence to osteoporosis therapy are important for optimal treatment efficacy, namely fracture reduction. This ongoing, non-interventional study will evaluate medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in routine practice in four European countries. The study enrolled women who had been prescribed subcutaneous denosumab (60 mg every 6 months) in accordance with prescribing information and local guidelines. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection. Adherence was defined as receiving two consecutive injections within 6 months ± 4 weeks of each other. Medication coverage ratio (MCR) was calculated using the time a patient was covered with denosumab, as assessed from prescription records. Treatment was assigned prior to and independently of enrollment; outcomes are recorded during routine practice. These planned 12-month interim analyses included data from 1500 patients from 141 sites. Mean age was 66.4-72.4 years, mean baseline total hip T-scores ranged from -2.0 to -2.1 and femoral neck T-scores from -2.2 to -2.6, and 30.7-62.1% of patients had prior osteoporotic fracture. Persistence was 87.0-95.3%, adherence 82.7-89.3%, and MCR 91.3-95.4%. In a univariate analysis, increased age, decreased mobility, and increased distance to the clinic were associated with significantly decreased persistence; parental history of hip fracture was associated with significantly increased persistence. These data extend the real-world evidence regarding persistence with and adherence to denosumab, both of which are critical for favorable clinical outcomes, including fracture risk reduction.

Study design of PANGAEA 2.0, a non-interventional study on RRMS patients to be switched to fingolimod.

PubMed

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2016-08-08

The therapeutic options for patients with Multiple Sclerosis (MS) have steadily increased due to the approval of new substances that now supplement traditional first-line agents, demanding a paradigm shift in the assessment of disease activity and treatment response in clinical routine. Here, we report the study design of PANGAEA 2.0 (Post-Authorization Non-interventional GermAn treatment benefit study of GilEnyA in MS patients), a non-interventional study in patients with relapsing-remitting MS (RRMS) identify patients with disease activity and monitor their disease course after treatment switch to fingolimod (Gilenya®), an oral medication approved for patients with highly active RRMS. In the first phase of the PANGAEA 2.0 study the disease activity status of patients receiving a disease-modifying therapy (DMT) is evaluated in order to identify patients at risk of disease progression. This evaluation is based on outcome parameters for both clinical disease activity and magnetic resonance imaging (MRI), and subclinical measures, describing disease activity from the physician's and the patient's perspective. In the second phase of the study, 1500 RRMS patients identified as being non-responders and switched to fingolimod (oral, 0.5 mg/daily) are followed-up for 3 years. Data on relapse activity, disability progression, MRI lesions, and brain volume loss will be assessed in accordance to 'no evidence of disease activity-4' (NEDA-4). The modified Rio score, currently validated for the evaluation of treatment response to interferons, will be used to evaluate the treatment response to fingolimod. The MS management software MSDS3D will guide physicians through the complex processes of diagnosis and treatment. A sub-study further analyzes the benefits of a standardized quantitative evaluation of routine MRI scans by a central reading facility. PANGAEA 2.0 is being conducted between June 2015 and December 2019 in 350 neurological practices and centers in Germany, including 100 centers participating in the sub-study. PANGAEA 2.0 will not only evaluate the long-term benefit of a treatment change to fingolimod but also the applicability of new concepts of data acquisition, assessment of MS disease activity and evaluation of treatment response for the in clinical routine. BfArM6532; Trial Registration Date: 20/05/2015.

Prevention and treatment of chemotherapy-induced neutropenia with the biosimilar filgrastim: a non-interventional observational study of clinical practice patterns.

PubMed

Tesch, Hans; Ulshöfer, Thomas; Vehling-Kaiser, Ursula; Ottillinger, Bertram; Bulenda, Dietmar; Turner, Matthew

2015-01-01

Biosimilars are similar but non-identical versions of existing biological drugs. The HEXAFIL study was an observational study that assessed the clinical usage, safety and efficacy of the biosimilar filgrastim in routine clinical practice in Germany. A total of 1,337 cancer patients received the biosimilar filgrastim for primary prophylaxis (PP), secondary prophylaxis (SP) or interventional treatment (TX) plus chemotherapy. Data including neutropenic complications and adverse events (AEs) were documented for up to 3 consecutive cycles. In cycle 1, 44.9% of the patients received the biosimilar filgrastim as PP, 31.0% as SP, and 23.6% as TX. Approximately 90% of the patients required no modifications to their chemotherapy regimen, with lower rates among the PP/SP versus the TX patients. Neutropenic complications occurred in 7.9%, 6.9%, and 3.9% of the patients (cycles 1, 2, and 3, respectively). Only 1.8% of the patients experienced febrile neutropenia during cycle 1. Earlier and longer filgrastim treatment reduced grade 3/4 leukopenia and neutropenic complications. The observed safety/tolerability profile was as expected; the most common AE (4.3%) was musculoskeletal back/bone pain. In this observational real-life study of clinical practice, the biosimilar filgrastim was effective and well tolerated, with results consistent with those reported in phase II and phase III trials. © 2015 S. Karger GmbH, Freiburg.

Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany.

PubMed

Krüger, Klaus; Burmester, Gerd R; Wassenberg, Siegfried; Bohl-Bühler, Martin; Thomas, Matthias H

2018-06-14

The Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM). Prospective non-interventional study with 24-month observation per patient. 158 office-based and clinical-based physicians in Germany. GLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions. Of the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9±13.4 years, 72.8% women, 64.7% biologic-naïve), 501 with psoriatic arthritis (PsA, 50.5±12.1 years, 54.1% women, 56.5% biologic-naïve) and 483 with ankylosing spondylitis (AS, 43.6±12.3 years, 66.5% men, 61.0% biologic-naïve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p<0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p<0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians' clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%-56.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24. GLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials. NCT01313858. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Rivaroxaban in patients with atrial fibrillation: from ROCKET AF to everyday practice.

PubMed

Barón-Esquivias, Gonzalo; Marín, Francisco; Sanmartín Fernandez, Marcelo

2017-05-01

Registries and non-interventional studies offer relevant and complementary information to clinical trials, since they have a high external validity. Areas covered: The information regarding the efficacy and safety of rivaroxaban compared with warfarin, or rivaroxaban alone in clinical practice was reviewed in this manuscript. For this purpose, a search on MEDLINE and EMBASE databases was performed. The MEDLINE and EMBASE search included both medical subject headings (MeSH) and keywords including: atrial fibrillation (AF) OR warfarin OR clinical practice OR ROCKET AF AND rivaroxaban. Case reports were not considered. Expert commentary: In ROCKET AF, rivaroxaban was at least as effective as warfarin for the prevention of stroke in patients with nonvalvular AF at high risk of stroke, but, importantly, with a lesser risk of intracranial, critical and fatal bleedings. A number of observational comparative and non-comparative studies, with more than 60,000 patients included treated with rivaroxaban, have analyzed the efficacy and safety of rivaroxaban in real-life patients with AF in different clinical settings. These studies have shown that in clinical practice, rates of stroke and major bleeding were consistently lower than those reported in ROCKET AF, likely due to the lower thromboembolic and bleeding risk observed in these patients.

The Effects of PECS Teaching to Phase III on the Communicative Interactions between Children with Autism and Their Teachers

ERIC Educational Resources Information Center

Carr, Deborah; Felce, Janet

2007-01-01

The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h…

[Subgroup Analysis of the Non-interventional REASON Study: PFS and OS According to Age, Smoking History, Gender, and Histology in NSCLC Patients Treated with Gefitinib or Chemotherapy].

PubMed

Schuette, W; Eberhardt, W E E; Waller, C; Schirmacher, P; Dietel, M; Zirrgiebel, U; Radke, S; Thomas, M

2016-09-01

Assessment of several clinical factors on progression-free (PFS) and overall survival (OS) in NSCLC patients (pts.) (stage IV) with mutated epidermal growth factor receptor (EGFRm+) treated with gefitinib (gef) or with chemotherapy (CT) under real-world conditions. 285 EGFRm+ pts. of the non-interventional REASON study treated with gef (n = 206) or CT (n = 79) as first-line therapy or with gef (n = 213) or CT (n = 61) in any line throughout the course of therapy were analyzed according to age, gender, smoking history and histology. Compared with CT, patients treated with gef showed prolongation of PFS and OS in all subgroups. PFS was significantly increased in women and non-smokers. OS was significantly increased in women, non-smokers, (ex)-smokers, patients with adenocarcinoma and elderly patients when treated with gef compared to CT. Female gender turned out to be an independent positive predictive factor for OS in patients treated with gef (HRmale: 1.74, p = 0.0009). A clinical benefit of gef was shown for all analyzed clinical subgroups of EGFRm+ pts. This was confirmed for the female gender in a multivariate analysis. © Georg Thieme Verlag KG Stuttgart · New York.

Experimental test of postfire management in pine forests: impact of salvage logging versus partial cutting and nonintervention on bird-species assemblages.

PubMed

Castro, Jorge; Moreno-Rueda, Gregorio; Hódar, José A

2010-06-01

There is an intense debate about the effects of postfire salvage logging versus nonintervention policies on regeneration of forest communities, but scant information from experimental studies is available. We manipulated a burned forest area on a Mediterranean mountain to experimentally analyze the effect of salvage logging on bird-species abundance, diversity, and assemblage composition. We used a randomized block design with three plots of approximately 25 ha each, established along an elevational gradient in a recently burned area in Sierra Nevada Natural and National Park (southeastern Spain). Three replicates of three treatments differing in postfire burned wood management were established per plot: salvage logging, nonintervention, and an intermediate degree of intervention (felling and lopping most of the trees but leaving all the biomass). Starting 1 year after the fire, we used point sampling to monitor bird abundance in each treatment for 2 consecutive years during the breeding and winter seasons (720 censuses total). Postfire burned-wood management altered species assemblages. Salvage logged areas had species typical of open- and early-successional habitats. Bird species that inhabit forests were still present in the unsalvaged treatments even though trees were burned, but were almost absent in salvage-logged areas. Indeed, the main dispersers of mid- and late-successional shrubs and trees, such as thrushes (Turdus spp.) and the European Jay (Garrulus glandarius) were almost restricted to unsalvaged treatments. Salvage logging might thus hamper the natural regeneration of the forest through its impact on assemblages of bird species. Moreover, salvage logging reduced species abundance by 50% and richness by 40%, approximately. The highest diversity at the landscape level (gamma diversity) resulted from a combination of all treatments. Salvage logging may be positive for bird conservation if combined in a mosaic with other, less-aggressive postfire management, but stand-wide management with harvest operations has undesirable conservation effects.

Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study.

PubMed

Timmermann, Lars; Oehlwein, Christian; Ransmayr, Gerhard; Fröhlich, Holger; Will, Edgar; Schroeder, Hanna; Lauterbach, Thomas; Bauer, Lars; Kassubek, Jan

2017-01-01

To evaluate Parkinson's disease (PD)-associated pain as perceived by the patients (subjective characterization), and how this may change following initiation of rotigotine transdermal patch. SP1058 was a non-interventional study conducted in routine clinical practice in Germany and Austria in patients experiencing PD-associated pain (per the physician's assessment). Data were collected at baseline (ie, before rotigotine initiation) and at a routine visit after ≥25 days (-3 days allowed) of treatment on a maintenance dose of rotigotine (end of study [EoS]). Pain perception was assessed using the 12-item Pain Description List of the validated German Pain Questionnaire (each item ranked 0 = 'not true' to 3 = 'very true'). Primary effectiveness variable: change from baseline to EoS in the sum score of the 4 'affective dimension' items of the Pain Description List. Secondary effectiveness variables: change from baseline to EoS in Unified Parkinson's Disease Rating Scale (UPDRS) II, III, and II+III scores, and Parkinson's Disease Questionnaire (PDQ-8) total score (PD-related quality-of-life). Other variables included scores of the eight 'sensory dimension' items of the Pain Description List. Of 93 enrolled patients (mean [SD] age: 71.1 [9.0] years; male: 48 [52%]), 77 (83%) completed the study, and 70 comprised the full analysis set. The mean (SD) change from baseline in the sum score of the four 'affective dimension' items was -1.3 (2.8) indicating a numerical improvement (baseline: 3.9 [3.4]). In the 'sensory dimension', pain was mostly perceived as 'pulling' at baseline (49/70 [70%]); 'largely true'/'very true'). Numerical improvements were observed in all UPDRS scores (mean [SD] change in UPDRS II+III: -5.3 [10.5]; baseline: 36.0 [15.9]), and in PDQ-8 total score (-2.0 [4.8]; baseline: 10.7 [5.9]). Adverse drug reactions were consistent with dopaminergic stimulation and transdermal administration. The perception of the 'affective dimension' of PD-associated pain numerically improved in patients treated with rotigotine. ClinicalTrials.gov identifier: NCT01606670; https://clinicaltrials.gov/ct2/show/NCT01606670?term=NCT01606670&rank=1.

Cardiovascular safety of vildagliptin in patients with type 2 diabetes: A European multi-database, non-interventional post-authorization safety study.

PubMed

Williams, Rachael; de Vries, Frank; Kothny, Wolfgang; Serban, Carmen; Lopez-Leon, Sandra; Chu, Changan; Schlienger, Raymond

2017-10-01

The aim of this non-interventional, multi-database, analytical cohort study was to assess the cardiovascular (CV) safety of vildagliptin vs other non-insulin antidiabetic drugs (NIADs) using real-world data from 5 European electronic healthcare databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest (myocardial infarction [MI], acute coronary syndrome [ACS], stroke, congestive heart failure [CHF], individually and as a composite) were estimated using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738 054) used vildagliptin at any time during the study, with an average follow-up time of 1.4 years, resulting in a cumulative current vildagliptin exposure of 28 330 person-years. The adjusted IRRs (vildagliptin [±other NIADs] vs other NIADs) were in the range of 0.61 to 0.97 (MI), 0.55 to 1.60 (ACS), 0.02 to 0.77 (stroke), 0.49 to 1.03 (CHF), and 0.22 to 1.02 (composite CV outcomes). The IRRs and their 95% CIs were close to 1, demonstrating no increased risk of adverse CV events, including the risk of CHF, with vildagliptin vs other NIADs in real-world conditions. © 2017 Crown copyright. Diabetes, Obesity and Metabolism © 2017 John Wiley & Sons Ltd.

Factors influencing initial choice of insulin therapy in a large international non-interventional study of people with type 2 diabetes

PubMed Central

Freemantle, N; Balkau, B; Danchin, N; Wang, E; Marre, M; Vespasiani, G; Kawamori, R; Home, P D

2012-01-01

Aim To use baseline characteristics of the Cardiovascular Risk Evaluation in people with type 2 Diabetes on Insulin Therapy study population to identify factors that could explain the choice of insulin therapy when beginning insulin. Methods The source, non-interventional, longitudinal, long-term study involves 314 centres in 12 countries in five regions. People were enrolled having started any insulin regimen in the previous 12 months. To identify factors associated with the choice of insulin regimen, multivariable backward logistic regression was performed on eligible physician and participant explanatory variables. Results Participants (N = 3031) had mean age 62 years, diabetes duration 11 years, body mass index 29.3 kg/m2 and an HbA1c of 9.5%. Participants in Japan had less hypertension, smoked more and used fewer concomitant medications than those of other regions. Only physician location (rural or urban) influenced the choice of insulin in Japan. In the other four-regions-combined, physician location, specialty, sex and practice type influenced choice of insulin as did participant location, baseline HbA1c, use of glucose-lowering therapies and prior insulin secretagogue use. Conclusion Choice of initial insulin regimen was influenced by several physician and participant characteristics in Canada and Europe, but only by physician location in Japan. PMID:22519930

Post-marketing studies: the work of the Drug Safety Research Unit.

PubMed

Mackay, F J

1998-11-01

The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.

Obesity or Underweight-What is Worse in Pregnancy?

PubMed

Agrawal, Sumi; Singh, Abha

2016-12-01

This study was conducted to compare underweight and obese women and their weight gain during pregnancy on fetomaternal outcome. This is a prospective, non-interventional, observational study on 1000 women (BMI between 20 and 30 were excluded). Women attending ANC OPD with singleton pregnancy at or before 16 weeks were included and BMI calculated in early pregnancy. Their weight gain during pregnancy was noted. Any complications in the mother or perinate were noted. Incidence of obesity in our institute was 17 % and that of underweight was 18 %. Pre-eclampsia, gestational hypertensions, gestational DM, antepartum hemorrhage, all were more common among obese women, while anemia was more common in the underweight. Post-dated pregnancy, induction of labor, cesarean delivery, and postpartum complications were more common in obese women. Fetal complications were also higher in obese patients. Lower as well as higher prepregnancy BMI is an independent risk factor that is associated with increased morbidity and mortality in both the mother and the fetus.

The impact of a science-based integrated instructional protocol on the motivation, reading comprehension, and science achievement of fourth and fifth graders

NASA Astrophysics Data System (ADS)

Stephens, Kathy E.

The purpose of this study was to determine the impact of implementing an integrated instructional protocol of science-based informational texts as teacher read alouds, student independent reading, and written journal responses on motivation, reading comprehension, and science achievement of fourth- and fifth-grade students with attention to specific student groups, including gender and ethnicities. A mixed methods research design included a 12-week intervention conducted with 68 fourth and fifth graders and 30 nonintervention fourth and fifth graders. Participating fourth and fifth graders completed the comprehension subtest of the Gates-MacGinitie Reading Test ([GMRT] MacGinitie, MacGinitie, Maria, & Dreyer, 2000) and the Texas Assessment of Knowledge and Skills ([TAKS] Texas Education Agency [TEA], 2005a). The Reading Survey of the Motivation to Read Profile ([MRP], Gambrell, Palmer, Codling, & Mazzoni, 1996) served as another quantitative data source. Qualitative data sources included classroom observations, key informant interviews, and student journal entries. The GMRT results indicated that the intervention fourth graders demonstrated the largest growth in reading comprehension achievement. Significant differences were noted by GMRT results between the intervention and nonintervention fourth graders. A significant difference was found between fourth-grade males and females on the GMRT, with a larger gain posted by the females. No significant differences were found on the GMRT in fifth grade Reading TAKS results indicated a significant difference between intervention fourth-grade Hispanic and African American students, while fifth-grade Science TAKS results indicated no significant differences. The MRP Reading Survey results indicated no significant differences; however, fourth-grade Hispanic and fifth-grade male students demonstrated significant growth. Classroom observations documented the progress of the 12-week intervention; 9 primary instructional and behavioral themes with 40 subcategories were discovered using open coding (Berg, 2004). Data were collected from the MRP Conversational Interview (Gambrell et al., 1996) with 12 key informants, and their journal entries provided evidence of the impact of the instructional protocol. Findings from this study seemed to confirm that students may experience improvement in reading comprehension after participation in an integrated instructional protocol. Findings also suggested gaps in minority ethnicities may be minimized, while female students continued to outscore male students.

International, prospective haemovigilance study on methylene blue-treated plasma.

PubMed

Noens, L; Vilariño, Ma D; Megalou, A; Qureshi, H

2017-05-01

Methylene blue is a phenothiazine dye, which in combination with visible light has virucidal and bactericidal properties, disrupting the replication of a broad range of enveloped viruses and some non-enveloped viruses. The study objective was to collect data on adverse reactions occurring with methylene blue plasma administered in a routine clinical practice environment and document their characteristics and severity. This was an open label, multicentre, non-controlled, non-randomized, non-interventional study. Patients who receive a methylene blue plasma transfusion were observed for any signs and symptoms (adverse reactions) within 24 h safter the start of the transfusion, in different hospitals for a study duration of at least 1 year. A total of 19 315 methylene blue plasma units were transfused. There were eight patients with adverse reactions recorded during the study, one of them serious. Two had more than one reaction (two and four, respectively). Three patients had previous transfusions with methylene blue plasma only. Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units. © 2017 International Society of Blood Transfusion.

COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015), a global--clinical evaluations, serum biomarkers, genetic studies and neuroimaging--prospective, multicenter, non-interventional, long-term study on Parkinson's disease progression.

PubMed

Santos-García, Diego; Mir, Pablo; Cubo, Esther; Vela, Lydia; Rodríguez-Oroz, Mari Cruz; Martí, Maria José; Arbelo, José Matías; Infante, Jon; Kulisevsky, Jaime; Martínez-Martín, Pablo

2016-02-25

Parkinson's disease (PD) is a progressive neurodegenerative disorder causing motor and non-motor symptoms that can affect independence, social adjustment and the quality of life (QoL) of both patients and caregivers. Studies designed to find diagnostic and/or progression biomarkers of PD are needed. We describe here the study protocol of COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015), an integral PD project based on four aspects/concepts: 1) PD as a global disease (motor and non-motor symptoms); 2) QoL and caregiver issues; 3) Biomarkers; 4) Disease progression. Observational, descriptive, non-interventional, 5-year follow-up, national (Spain), multicenter (45 centers from 15 autonomous communities), evaluation study. Specific goals: (1) detailed study (clinical evaluations, serum biomarkers, genetic studies and neuroimaging) of a population of PD patients from different areas of Spain, (2) comparison with a control group and (3) follow-up for 5 years. COPPADIS-2015 has been specifically designed to assess 17 proposed objectives. approximately 800 non-dementia PD patients, 600 principal caregivers and 400 control subjects. Study evaluations: (1) baseline includes motor assessment (e.g., Unified Parkinson's Disease Rating Scale part III), non-motor symptoms (e.g., Non-Motor Symptoms Scale), cognition (e.g., Parkinson's Disease Cognitive Rating Scale), mood and neuropsychiatric symptoms (e.g., Neuropsychiatric Inventory), disability, QoL (e.g., 39-item Parkinson's disease Quality of Life Questionnaire Summary-Index) and caregiver status (e.g., Zarit Caregiver Burden Inventory); (2) follow-up includes annual (patients) or biannual (caregivers and controls) evaluations. Serum biomarkers (S-100b protein, TNF-α, IL-1, IL-2, IL-6, vitamin B12, methylmalonic acid, homocysteine, uric acid, C-reactive protein, ferritin, iron) and brain MRI (volumetry, tractography and MTAi [Medial Temporal Atrophy Index]), at baseline and at the end of follow-up, and genetic studies (DNA and RNA) at baseline will be performed in a subgroup of subjects (300 PD patients and 100 control subjects). Study periods: (1) recruitment period, from November, 2015 to February, 2017 (basal assessment); (2) follow-up period, 5 years; (3) closing date of clinical follow-up, May, 2022. Public/Private. COPPADIS-2015 is a challenging initiative. This project will provide important information on the natural history of PD and the value of various biomarkers.

Partial response to proton pump inhibitor therapy for GERD: observational study of patient characteristics, burden of disease, and costs in the USA.

PubMed

Stålhammar, Nils-Olov; Spiegel, Brennan M; Granstedt Löfman, Helena; Karlsson, Maria; Wahlqvist, Peter; Næsdal, Jørgen; Nelson, M Todd; Despiégel, Nicolas

2012-01-01

Disease burden and associated costs are not well understood among patients with gastroesophageal reflux disease (GERD) who have persistent symptoms despite optimized proton pump inhibitor (PPI) therapy. The aim of this study was to investigate disease burden and costs of GERD in partial responders to PPI therapy. The Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US (REMAIN US) study was a 12-month, multicenter, noninterventional, observational study of 552 partial PPI responders in the USA. Participating sites were comprised of family practice (n = 30), internal medicine (n = 8), and specialist (gastroenterologist) centers (n = 15). GERD symptoms, health-related quality of life (HRQL), and impact on productivity were evaluated from patient-reported outcome instruments. Resource utilization data were also collected. Patients had a high symptom burden, impaired HRQL, and reduced productivity while at work and in daily activities, despite optimized PPI therapy. Mean annual GERD-related costs were US$9944 per patient, comprising total direct costs and mean productivity loss costs of US$4068 and US$5876 per patient, respectively. Patients with GERD and a partial response to PPI therapy have considerable direct and indirect costs, along with substantial impairments in HRQL and productivity.

Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study)

PubMed Central

Pedersen, Elena Didenko; Stenager, Egon; Vadgaard, JL; Jensen, MB; Schmid, R; Meland, N; Magnussen, G; Frederiksen, Jette L

2018-01-01

Background Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. Objective To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart® and assess injection-site reactions and treatment satisfaction. Methods This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13–23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. Results Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. Conclusion RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated. PMID:29720872

Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study).

PubMed

Pedersen, Elena Didenko; Stenager, Egon; Vadgaard, J L; Jensen, M B; Schmid, R; Meland, N; Magnussen, G; Frederiksen, Jette L

2018-01-01

Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart ® and assess injection-site reactions and treatment satisfaction. This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13-23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated.

[The HAROW study: an example of outcomes research: a prospective, non-interventional study comparing treatment options in localized prostate cancer].

PubMed

Herden, J; Ernstmann, N; Schnell, D; Weißbach, L

2014-12-01

The HAROW study was initiated to investigate the provision of ongoing medical care for patients with localized prostate cancer in a prospective, noninterventional setting and to investigate treatment options (Hormonal treatment, Active surveillance, Radiotherapy, Operation, Watchful waiting) under real-life conditions. A total of 3169 patients were enrolled by 259 participating physicians in private practice in Germany. The median follow-up was 28.4 months. At 6-month intervals, the treating physicians reported data on clinical parameters, clinical course of disease, and quality of patient-physician interaction. The highest proportion of patients with low risk tumor was found in the defensive treatment groups (AS and WW). As expected, the AS group showed the highest progression rate. In all, 112 AS patients (23.9%) changed therapeutic strategy, 21 of them upon medical advice in the absence of any signs of progression. Metastases were seen most frequently in the WW group (1.5%). No metastases occurred in AS patients. Medical support in managing the disease reached high scores in all groups, the highest in AS. The data enable a differentiated comparative analysis of patient and tumor characteristics of each treatment group. Indication of AS was predominantly consistent with the guideline. The high rate of AS termination based on the physician's recommendation rather than on clinical progression is remarkable, and may be interpreted as a kind of insecurity in dealing with AS. Results regarding communication indicate that patients appreciated being involved in treatment decisions.

Blue-enriched office light competes with natural light as a zeitgeber.

PubMed

Vetter, Céline; Juda, Myriam; Lang, Dieter; Wojtysiak, Andreas; Roenneberg, Till

2011-09-01

Circadian regulation of human physiology and behavior (eg, body temperature or sleep-timing), depends on the "zeitgeber" light that synchronizes them to the 24-hour day. This study investigated the effect of changing light temperature at the workplace from 4000 Kelvin (K) to 8000 K on sleep-wake and activity-rest behavior. An experimental group (N=27) that experienced the light change was compared with a non-intervention group (N=27) that remained in the 4000 K environment throughout the 5-week study period (14 January to 17 February). Sleep logs and actimetry continuously assessed sleep-wake behavior and activity patterns. Over the study period, the timing of sleep and activity on free days steadily advanced parallel to the seasonal progression of sunrise in the non-intervention group. In contrast, the temporal pattern of sleep and activity in the experimental group remained associated with the constant onset of work. The results suggest that artificial blue-enriched light competes with natural light as a zeitgeber. While subjects working under the warmer light (4000 K) appear to entrain (or synchronize) to natural dawn, the subjects who were exposed to blue-enriched (8000 K) light appear to entrain to office hours. The results confirm that light is the dominant zeitgeber for the human clock and that its efficacy depends on spectral composition. The results also indicate that blue-enriched artificial light is a potent zeitgeber that has to be used with diligence.

Pharmacological treatment for attention deficit hyperactivity disorder: functional outcomes in children and adolescents from non-Western countries.

PubMed

Altin, Murat; El-Shafei, Ahmed A; Yu, Maria; Desaiah, Durisala; Treuer, Tamas; Zavadenko, Nikolay; Gao, Hong Yun

2013-09-13

Functional outcomes were measured over a 12-month period in children and adolescents with attention deficit hyperactivity disorder (ADHD) after they received monotherapy. Prospective, observational, noninterventional study. Conducted in six non-Western countries. Outpatients 6 to 17 years of age with a verified diagnosis of ADHD in accordance with the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR), together with their physicians, decided to initiate or switch treatment for ADHD. Patients were prescribed pharmacological monotherapy: methylphenidate (n=221), nootropic agents (n=91), or atomoxetine (n=234). Patients were followed for changes in their functional status and quality of life, which were assessed with the Child Health and Illness Profile-Child Edition (CHIP-CE) Achievement domain. At the end of the study, a mean improvement on the CHIP-CE Achievement domain score was observed for all countries and therapies except in Taiwan, where patients received atomoxetine, and in Lebanon, where patients received methylphenidate. No patient experienced a serious adverse event during the study. Four patients discontinued due to a treatment-emergent adverse event. After 12 months of treatment, clinical and functional outcomes were improved in children and adolescents from non-Western countries who initiated and remained on their prescribed pharmacological monotherapy.

Efficacy of the low-dose combined oral contraceptive chlormadinone acetate/ethinylestradiol: physical and emotional benefits.

PubMed

Heskamp, Marie-Luise S; Schramm, Georg A K

2010-01-01

This study investigated the effects of the low-dose combined oral contraceptive (COC) 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara, Balanca) on cycle-related physical and emotional disorders in women >or=25 years of age. A prospective, non-interventional, observational study of 3772 women over six cycles was conducted in 303 office-based gynecological centers throughout Germany. CMA/EE provided high contraceptive efficacy with a Pearl index of 0 (95% confidence interval=0.00-0.22) and was generally well tolerated, with no statistically significant weight changes during the observation period (p=.147). CMA/EE intake resulted in a statistically significant improvement in cycle-related physical and emotional symptoms, with a 67% overall reduction in sum score for number and intensity of cycle-related symptoms per patient. The results of this study in women >or=25 years of age support previous findings that 2.0 mg CMA/0.03 mg EE is an effective low-dose COC, with an excellent tolerability profile, with the additional benefits of significantly reducing both cycle-related physical and emotional symptoms (p

Cost-effectiveness of intensive smoking cessation therapy among patients with small abdominal aortic aneurysms.

PubMed

Mani, Kevin; Wanhainen, Anders; Lundkvist, Jonas; Lindström, David

2011-09-01

Smoking cessation is one of the few available strategies to decrease the risk for expansion and rupture of small abdominal aortic aneurysms (AAAs). The cost-effectiveness of an intensive smoking cessation therapy in patients with small AAAs identified at screening was evaluated. A Markov cohort simulation model was used to compare an 8-week smoking cessation intervention with adjuvant pharmacotherapy and annual revisits vs nonintervention among 65-year-old male smokers with a small AAA identified at screening. The smoking cessation rate was tested in one-way sensitivity analyses in the intervention group (range, 22%-57%) and in the nonintervention group (range, 3%-30%). Literature data on the effect of smoking on AAA expansion and rupture was factored into the model. The intervention was cost-effective in all tested scenarios and sensitivity analyses. The smoking cessation intervention was cost-effective due to a decreased need for AAA repair and decreased rupture rate even when disregarding the positive effects of smoking cessation on long-term survival. The incremental cost/effectiveness ratio reached the willingness-to-pay threshold value of €25,000 per life-year gained when assuming an intervention cost of > €3250 or an effect of ≤ 1% difference in long-term smoking cessation between the intervention and nonintervention groups. Smoking cessation resulted in a relative risk reduction for elective AAA repair by 9% and for rupture by 38% over 10 years of follow-up. An adequate smoking cessation intervention in patients with small AAAs identified at screening can cost-effectively increase long-term survival and decrease the need for AAA repair. Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Socioeconomic risk factors for cholera in different transmission settings: An analysis of the data of a cluster randomized trial in Bangladesh.

PubMed

Saha, Amit; Hayen, Andrew; Ali, Mohammad; Rosewell, Alexander; Clemens, John D; Raina MacIntyre, C; Qadri, Firdausi

2017-09-05

Cholera remains a threat globally, and socioeconomic factors play an important role in transmission of the disease. We assessed socioeconomic risk factors for cholera in vaccinated and non-vaccinated communities to understand whether the socioeconomic risk factors differ by transmission patterns for cholera. We used data from a cluster randomized control trial conducted in Dhaka, Bangladesh. There were 90 geographic clusters; 30 in each of the three arms of the study: vaccine (VAC), vaccine plus behavioural change (VBC), and non-intervention. The data were analysed for the three populations: (1) vaccinees in the vaccinated communities (VAC and VBC arms), (2) non-vaccinated individuals in the vaccinated communities and (3) all individuals in the non-vaccinated communities (non-intervention arm). A generalized estimating equation with logit link function was used to evaluate the risk factors for cholera among these different populations adjusting for household level correlation in the data. A total of 528 cholera and 226 cholera with severe dehydration (CSD) in 268,896 persons were observed during the two-year follow-up. For population 1, the cholera risk was not associated with any socioeconomic factors; however CSD was less likely to occur among individuals living in a household having ≤4 members (aOR=0.55, 95% CI=0.32-0.96). Among population 2, younger participants and individuals reporting diarrhoea during registration were more likely to have cholera. Females and individuals reporting diarrhoea during registration were at increased risk of CSD. Among population 3, individuals living in a household without a concrete floor, in an area with high population density, closer to the study hospital, or not treating drinking water were at significantly higher risk for both cholera and CSD. The profile of socioeconomic factors associated with cholera varies by individuals' vaccination status as well as the transmission setting. In a vaccinated community where transmission would be expected to be lower, socioeconomic factors may not increase the risk of the disease. Copyright © 2017. Published by Elsevier Ltd.

Bioethics of the refusal of blood by Jehovah's Witnesses: Part 2. A novel approach based on rational non-interventional paternalism.

PubMed

Muramoto, O

1998-10-01

Most physicians dealing with Jehovah's Witnesses (JWs) who refuse blood-based treatment are uncertain as to any obligation to educate patients where it concerns the JW blood doctrine itself. They often feel they must unquestioningly comply when demands are framed as religiously based. Recent discussion by dissidents and reformers of morally questionable policies by the JW organisation raise ethical dilemmas about "passive" support of this doctrine by some concerned physicians. In this paper, Part 2, I propose that physicians discuss the misinformation and irrationality behind the blood doctrine with the JW patient by raising questions that provide new perspectives. A meeting should be held non-coercively and in strict confidence, and the patient's decision after the meeting should be fully honoured (non-interventional). A rational deliberation based on new information and a new perspective would enable a certain segment of JW patients to make truly informed, autonomous and rational decisions.

Rational non-interventional paternalism: why doctors ought to make judgments of what is best for their patients.

PubMed

Savulescu, J

1995-12-01

This paper argues that doctors ought to make all things considered value judgments about what is best for their patients. It illustrates some of the shortcomings of the model of doctor as 'fact-provider'. The 'fact-provider' model fails to take account of the fact that practising medicine necessarily involves making value judgments; that medical practice is a moral practice and requires that doctors reflect on what ought to be done, and that patients can make choices which fail to express their autonomy and which are based on mistaken judgments of value. If doctors are properly to respect patient autonomy and to function as moral agents, they must make evaluations of what their patients ought to do, all things considered. This paper argues for 'rational, non-interventional paternalism'. This is a practice in which doctors form conceptions of what is best for their patients and argue rationally with them. It differs from old-style paternalism in that it is not committed to doing what is best.

Bioethics of the refusal of blood by Jehovah's Witnesses: Part 2. A novel approach based on rational non-interventional paternalism.

PubMed Central

Muramoto, O

1998-01-01

Most physicians dealing with Jehovah's Witnesses (JWs) who refuse blood-based treatment are uncertain as to any obligation to educate patients where it concerns the JW blood doctrine itself. They often feel they must unquestioningly comply when demands are framed as religiously based. Recent discussion by dissidents and reformers of morally questionable policies by the JW organisation raise ethical dilemmas about "passive" support of this doctrine by some concerned physicians. In this paper, Part 2, I propose that physicians discuss the misinformation and irrationality behind the blood doctrine with the JW patient by raising questions that provide new perspectives. A meeting should be held non-coercively and in strict confidence, and the patient's decision after the meeting should be fully honoured (non-interventional). A rational deliberation based on new information and a new perspective would enable a certain segment of JW patients to make truly informed, autonomous and rational decisions. PMID:9800583

Preservative-free tafluprost 0.0015% in the treatment of patients with glaucoma and ocular hypertension.

PubMed

Erb, Carl; Lanzl, Ines; Seidova, Seid-Fatima; Kimmich, Friedemann

2011-07-01

The objective of this study was to evaluate efficacy, local tolerability, and safety of this first-in-class preservative-free prostaglandin preparation in patients with ocular hypertension and glaucoma. Patients with glaucoma or ocular hypertension who required a change of medication or were naïve to treatment were included in this noninterventional and observational study. Noninterventional means that no influence was made upon the decision of the physicians to include specific patients and upon the treatment algorithm used. German law for observational studies does not allow any influence on the choice of drugs used, patient selection, masking, and comparator treatment regimens. The main aim of this observational study was to collect "real-life data" on the efficacy and safety of a new medical treatment after approval in a large patient population. Participating ophthalmologists were asked to provide anonymous patient data collected during regular visits by filling a simple data entry form. Intraocular pressure (IOP) readings were recorded at baseline (previous therapy or untreated) and 6-12 weeks after changing medical treatment to or initiating treatment with preservative-free tafluprost once daily. Changes in the IOP were evaluated over the study period for all patients as well as for specific pretreatment subgroups. Local comfort was determined using a five-point scale (very good, good, satisfactory, less satisfactory, not acceptable) before and after the change of medical treatment. All adverse events were recorded. Data from 2123 patients with glaucoma or ocular hypertension were considered for the final evaluation. Medication was changed in 41.1% of patients due to tolerability issues and in 25.6% of patients due to insufficient efficacy with prior medication. In all patients preservative-free tafluprost 0.0015% lowered IOP from 19.5 ± 4.4 mmHg (baseline) to 16.4 ± 2.9 mmHg after 6-12 weeks. Preservativefree tafluprost also significantly lowered the IOP in all monotherapy subgroups: treatment-naïve patients (n=440): 22.6 ± 3.9 mmHg (baseline) to 16.7 ± 2.7 mmHg (week 6-12); beta blockers (n=307): 20.3 ± 3.5 mmHg (baseline) to 16.7 ± 2.6 mmHg (week 6-12); carbonic anhydrase inhibitors (n=158): 19.0 ± 3.6 mmHg (baseline) to 16.0 ± 2.6 mmHg (week 6-12); prostaglandin analogs (PGAs; n=447): 16.8 ± 2.9 mmHg (baseline) to 15.8 ± 2.6 mmHg (week 6-12). Local comfort was rated as "very good" or "good" by 85.6% of patients at the final visit (P<0.001). Only few adverse events occurred during the treatment period: 18 patients (0.8%) discontinued medical treatment with preservative-free tafluprost due to local intolerance; six patients (0.3%) due to efficacy issues; four patients complained about systemic side effects (0.2%); and two patients preferred to use a multidose treatment regimen (0.2%). Although this study was limited by its observational design the results demonstrate that preservative-free tafluprost 0.0015% was effective, generally well tolerated, and safe in a broad and heterogeneous patient population.

Research and Evaluations of the Health Aspects of Disasters, Part VII: The Relief/Recovery Framework.

PubMed

Birnbaum, Marvin L; Daily, Elaine K; O'Rourke, Ann P

2016-04-01

The principal goal of research relative to disasters is to decrease the risk that a hazard will result in a disaster. Disaster studies pursue two distinct directions: (1) epidemiological (non-interventional); and (2) interventional. Both interventional and non-interventional studies require data/information obtained from assessments of function. Non-interventional studies examine the epidemiology of disasters. Interventional studies evaluate specific interventions/responses in terms of their effectiveness in meeting their respective objectives, their contribution to the overarching goal, other effects created, their respective costs, and the efficiency with which they achieved their objectives. The results of interventional studies should contribute to evidence that will be used to inform the decisions used to define standards of care and best practices for a given setting based on these standards. Interventional studies are based on the Disaster Logic Model (DLM) and are used to change or maintain levels of function (LOFs). Relief and Recovery interventional studies seek to determine the effects, outcomes, impacts, costs, and value of the intervention provided after the onset of a damaging event. The Relief/Recovery Framework provides the structure needed to systematically study the processes involved in providing relief or recovery interventions that result in a new LOF for a given Societal System and/or its component functions. It consists of the following transformational processes (steps): (1) identification of the functional state prior to the onset of the event (pre-event); (2) assessments of the current functional state; (3) comparison of the current functional state with the pre-event state and with the results of the last assessment; (4) needs identification; (5) strategic planning, including establishing the overall strategic goal(s), objectives, and priorities for interventions; (6) identification of options for interventions; (7) selection of the most appropriate intervention(s); (8) operational planning; (9) implementation of the intervention(s); (10) assessments of the effects and changes in LOFs resulting from the intervention(s); (11) determination of the costs of providing the intervention; (12) determination of the current functional status; (13) synthesis of the findings with current evidence to define the benefits and value of the intervention to the affected population; and (14) codification of the findings into new evidence. Each of these steps in the Framework is a production function that facilitates evaluation, and the outputs of the transformation process establish the current state for the next step in the process. The evidence obtained is integrated into augmenting the respective Response Capacities of a community-at-risk. The ultimate impact of enhanced Response Capacity is determined by studying the epidemiology of the next event.

A Randomized Controlled Trial of Mindfulness Versus Yoga: Effects on Depression and/or Anxiety in College Students.

PubMed

Falsafi, Nasrin

2016-11-01

Depression and anxiety disorders are two of the most common mental disorders in the United States. These disorders are prevalent among college students. The main objective of this study is to compare the effectiveness of two different types of intervention practices (mindfulness vs. yoga) and a noninterventional control group in mitigating the effects of depression and/or anxiety in college students. A sample of 90 students (both genders) over age 18 who had a diagnosis of anxiety and/or depression was recruited from 11,500 undergraduate college students in a mid-size university. The study's design included stratified-randomized controlled repeated measures with three groups: a mindfulness intervention group, a yoga-only intervention group, and a noninterventional group. Participants were randomly assigned to the aforementioned three groups. Participants in the intervention groups received an 8-week training either in mindfulness or yoga. Depressive, anxiety, stress symptoms, self-compassion, and mindfulness were measured at baseline, Week 4, Week 8, and Week 12. Depressive, anxiety, and stress symptoms decreased significantly (p < .01) from baseline to follow-up conditions in both the mindfulness and yoga intervention groups. The changes in mindfulness scores were also significant in both groups. However, the changes in self-compassion scores were significant only in the mindfulness intervention group. No significant changes in the control group were demonstrated. The findings from this study can provide useful information to nurses and other health care providers. This study may have implications for a cost-effective treatment for depression and anxiety. © The Author(s) 2016.

Strategy and Intervention versus Nonintervention: A Matter of Theory?

ERIC Educational Resources Information Center

Goolishian, Harold A.; Anderson, Harlene

1992-01-01

Considers whether or not intervention and strategy are necessary components of competent therapy. Sees passive listening and expert interpretations as consequences of psychodynamic theory; active manipulation of social structure and strategic intervention into feedback as consequences of mechanical assumptions of structural and cybernetic theory;…

Epidemiological evaluations of the efficacy of slow-released praziquantel-medicated bars for dogs in the prevention and control of cystic echinococcosis in man and animals.

PubMed

Wei, Jiao; Cheng, Fu; Qun, Qu; Nurbek; Xu, Shi-Dong; Sun, Li-Feng; Han, Xin-Kui; Muhan; Han, Ling-Ling; Irixiati; Jie, Peng; Zhang, Ke-Jiu; Islayin; Chai, Jun-jie

2005-12-01

To assess the epidemiological efficacy of type SRP III slow-released praziquantel-medicated bars for dogs in the prevention and control of cystic echinococcosis in man and livestock, praziquantel-medicated bars were implanted subcutaneously in over 90% of dogs in villages in north Xinjiang, China, where cystic echinococcosis is highly endemic. After implantation, infection rate of Echinococcus granulosus in dogs, specific antibodies in children and prevalence of echinococcosis in one-year-old lambs were observed for 3 years. Coproantigen of E. granulosus was positive in 41.2% of the dogs at the start of experiment. In the second and third year after medicated-bar implantation, coproantigen was undetectable in any dogs examined, while 3.0% of dogs were positive at the end of the fourth year. The antibody positive rate in 7-year-old pupils, that was 41.2% before the experiment, declined gradually and it was 5.4% in the fourth year, while children in the non-intervention control area showed 30.6% seropositivity. The prevalence of hydatid disease in children aged 7-16 years also declined significantly. The prevalence of hydatidosis in lambs one year of age was 44.8% in the first year, dropping to 10.7% in the fourth year, while in the non-intervention control area the level of infection was 46.4%. These results demonstrated not only that the slow released praziquantel-medicated bars efficiently blocked reinfection in dogs at least for 2 years, but also the measure was effective in preventing transmission of cystic echinococcosis to both man and livestock.

Cheilitis in acne vulgaris patients with no previous use of systemic retinoid products.

PubMed

Balighi, Kamran; Daneshpazhooh, Maryam; Lajevardi, Vahideh; Talebi, Shahin; Azizpour, Arghavan

2017-08-01

Isotretinoin is commonly used in the treatment of acne vulgaris. While one of the more common side-effects is cheilitis, we have observed an increased incidence of cheilitis prior to the commencement of systemic isotretinoin. The aim of this study was to assess the prevalence of cheilitis among acne vulgaris patients. A non-interventional cross-sectional study of patients with acne vulgaris. Patients with previous use of systemic retinoids were excluded. The patients were examined for signs and symptoms of cheilitis. Of a total of 400 patients, 134 (34%) had evidence of cheilitis at initial presentation. Two-thirds (63%) were female (P < 0.001). The distribution of the cheilitis was as follows; 55% on the lower lip, 30% on both lips, and 16% on the upper lip. Over a quarter (27%) of patients with cheilitis had acne excorie, compared with only 8% of patients with no signs of cheilitis. Our findings suggest that cheilitis is quite common among acne vulgaris patients even before treatment with isotretinoin. © 2016 The Australasian College of Dermatologists.

Cinnarizine and dimenhydrinate in the treatment of vertigo in medical practice.

PubMed

Scholtz, Arne-Wulf; Ilgner, Justus; Loader, Benjamin; Pritschow, Bernd W; Weisshaar, Gerhard

2016-05-01

The efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in the treatment of vertigo of various origins have been investigated in a prospective, noninterventional study involving private practices throughout Germany. A total of 1275 patients with an average age of 61.2 years participated in the study. The vertigo symptoms, measured by a validated mean vertigo score (primary efficacy endpoint) improved by 61 % in the course of the observational period (median: 6 weeks). Concomitant symptoms frequently associated with vertigo such as nausea, vomiting and tinnitus were also markedly reduced by 84, 85 and 51 %, respectively. Overall efficacy has been rated by the physicians as 'very much improved' or 'much improved' in 95 % of the patients. A total of 47 patients (3.7 %) reported 51 adverse drug reactions (all nonserious). The results indicate a good tolerability and efficacy of the fixed combination of cinnarizine and dimenhydrinate in the treatment of vertigo in daily medical practice, which is in line with previous findings of numerous interventional, randomised, double-blind, controlled clinical trials.

Interventional management of neuropathic pain: NeuPSIG recommendations

PubMed Central

Dworkin, Robert H.; O’Connor, Alec B.; Kent, Joel; Mackey, Sean C.; Raja, Srinivasa N.; Stacey, Brett R.; Levy, Robert M.; Backonja, Miroslav; Baron, Ralf; Harke, Henning; Loeser, John D.; Treede, Rolf-Detlef; Turk, Dennis C.; Wells, Christopher D.

2015-01-01

Neuropathic pain (NP) is often refractory to pharmacologic and non-interventional treatment. On behalf of the International Association for the Study of Pain Neuropathic Pain Special Interest Group (NeuPSIG), the authors evaluated systematic reviews, clinical trials, and existing guidelines for the interventional management of NP. Evidence is summarized and presented for neural blockade, spinal cord stimulation (SCS), intrathecal medication, and neurosurgical interventions in patients with the following peripheral and central NP conditions: herpes zoster and postherpetic neuralgia (PHN); painful diabetic and other peripheral neuropathies; spinal cord injury NP; central post-stroke pain; radiculopathy and failed back surgery syndrome (FBSS); complex regional pain syndrome (CRPS); and trigeminal neuralgia and neuropathy. Due to the paucity of high-quality clinical trials, no strong recommendations can be made. Four weak recommendations based on the amount and consistency of evidence, including degree of efficacy and safety, are: (1) epidural injections for herpes zoster; (2) steroid injections for radiculopathy; (3) SCS for FBSS; and (4) SCS for CRPS type 1. Based on the available data, we recommend not to use sympathetic blocks for PHN nor RF lesions for radiculopathy. No other conclusive recommendations can be made due to the poor quality of available of data. Whenever possible, these interventions should either be part of randomized clinical trials or documented in pain registries. Priorities for future research include randomized clinical trials; long-term studies; and head-to-head comparisons among different interventional and non-interventional treatments. PMID:23748119

Individual patient data meta-analysis of organ failure in acute pancreatitis: protocol of the PANCREA II study.

PubMed

Das, Stephanie L M; Papachristou, George I; De Campos, Tercio; Panek, Jozefa; Poves Prim, Ignasi; Serrablo, Alejandro; Parks, Rowan W; Uomo, Generoso; Windsor, John A; Petrov, Maxim S

2013-09-10

Organ failure is a major determinant of mortality in patients with acute pancreatitis. These patients usually require admission to high dependency or intensive care units and consume considerable health care resources. Given a low incidence rate of organ failure and a lack of large non-interventional studies in the field of acute pancreatitis, the characteristics of organ failure that influence outcomes of patients with acute pancreatitis remain largely unknown. Therefore, the Pancreatitis Across Nations Clinical Research and Education Alliance (PANCREA) aims to conduct a meta-analysis of individual patient data from prospective non-interventional studies to determine the influence of timing, duration, sequence, and combination of different organ failures on mortality in patients with acute pancreatitis. Pancreatologists currently active with acute pancreatitis clinical research will be invited to contribute. To be eligible for inclusion patients will have to meet the criteria of acute pancreatitis, develop at least one organ failure during the first week of hospitalization, and not be enrolled into an intervention study. Raw data will then be collated and checked. Individual patient data analysis based on a logistic regression model with adjustment for confounding variables will be done. For all analyses, corresponding 95% confidence intervals and P values will be reported. This collaborative individual patient data meta-analysis will answer important clinical questions regarding patients with acute pancreatitis that develop organ failure. Information derived from this study will be used to optimize routine clinical management and improve care strategies. It can also help validate outcome definitions, allow comparability of results and form a more accurate basis for patient allocation in further clinical studies.

PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study.

PubMed

Cairoli, Carlos; Reyes, Luis Antonio; Henneges, Carsten; Sorsaburu, Sebastian

2014-01-01

Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.

Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study

PubMed Central

Saboo, Banshi; Reddy, Gundam Chandrasekhara; Juneja, Subhashchander; Kedia, Ashok Kumar; Manjrekar, Pravin; Rathod, Rahul

2015-01-01

Primary objective - evaluate effectiveness and safety of acarbose/metformin fixed dose FDC on glycemic control in Indian T2DM patients in real life clinical setting. Secondary objective - evaluate safety and satisfaction of treatment. Materials and Methods: Open-label, prospective, multicentre, single-arm, non-interventional study. Patients included were aged ≥18 years with T2DM on Acarbose (25/50 mg) and Metformin (500 mg) FDC. Glycemic parameters were recorded during observation. Results: Total 9364 patients were enrolled in the study (mean age, 50.7 years and 60.1% were male). Mean (SD) FBG and PPG was significantly reduced by 42.4 (32.6) mg/dl (P < 0.0001) and 80.2 (49.7) mg/dl (P < 0.0001) respectively at the end of observation. Mean (SD) HbA1c reduced by -1.0% (0.8) to 7.3% (0.7) at the last follow-up visit (P <0.0001). Majority of patients (97.5%) and physicians (98.42%) were satisfied with acarbose/metformin FDC treatment. Also, significant reduction in body weight by -1.7 (2.2) kg was observed (P < 0.0001). Patients with known T2DM and newly diagnosed showed a similar glycemic control (P < 0.0001). Drug-related adverse events were reported by only 1.4% patients mostly gastrointestinal. Conclusions: Acarbose/metformin FDC was efficacious, safe well accepted in routine clinical practice. It was well-tolerated without significant risk of hypoglycemia and can be used in early T2DM management PMID:25593840

RAS mutation prevalence among patients with metastatic colorectal cancer: a meta-analysis of real-world data.

PubMed

Kafatos, George; Niepel, Daniela; Lowe, Kimberley; Jenkins-Anderson, Sophie; Westhead, Hal; Garawin, Tamer; Traugottová, Zuzana; Bilalis, Antonios; Molnar, Edit; Timar, Jozsef; Toth, Erika; Gouvas, Nikolaos; Papaxoinis, George; Murray, Samuel; Mokhtar, Nadia; Vosmikova, Hana; Fabian, Pavel; Skalova, Alena; Wójcik, Piotr; Tysarowski, Andrzej; Barugel, Mario; van Krieken, J Han; Trojan, Jörg

2017-07-27

A confirmed wild-type RAS tumor status is commonly required for prescribing anti-EGFR treatment for metastatic colorectal cancer. This noninterventional, observational research project estimated RAS mutation prevalence from real-world sources. Aggregate RAS mutation data were collected from 12 sources in three regions. Each source was analyzed separately; pooled prevalence estimates were then derived from meta-analyses. The pooled RAS mutation prevalence from 4431 tumor samples tested for RAS mutation status was estimated to be 43.6% (95% CI: 38.8-48.5%); ranging from 33.7% (95% CI: 28.4-39.3%) to 54.1% (95% CI: 51.7-56.5%) between sources. The RAS mutation prevalence estimates varied among sources. The reasons for this are not clear and highlight the need for further research.

Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers' Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area.

PubMed

Cates, Joan R; Shafer, Autumn; Diehl, Sandra J; Deal, Allison M

2011-01-01

Routine vaccination against human papillomavirus (HPV), the main cause of cervical cancer, is recommended for 11-12 year old girls, yet vaccine uptake is low. This study evaluates a social marketing campaign initiated by 13 North Carolina counties to raise awareness among parents and reduce barriers to accessing the vaccine in a primarily rural area. The 3-month campaign targeted mothers of girls ages 11-12 and healthcare practices serving pre-teen girls in four counties. Principles of social marketing were: product (recommended vaccine against HPV), price (cost, perception of safety and efficacy, and access), promotion (posters, brochures, website, news releases, doctor's recommendation), and place (doctors' offices, retail outlets). We analyzed (1) website traffic, hotline calls, and media placement; (2) cross-sectional surveys of mothers and providers; and (3) HPV immunization rates in intervention versus non-intervention counties. Of respondent mothers (n=225), 82% heard or saw campaign messages or materials. Of respondent providers (n=35), 94% used campaign brochures regularly or occasionally in conversations with parents. HPV vaccination rates within six months of campaign launch were 2% higher for 9-13 year old girls in two of the four intervention counties compared to 96 non-intervention counties. This evaluation supports campaign use in other primarily rural and underserved areas.

Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers’ Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area

PubMed Central

Cates, Joan R.; Shafer, Autumn; Diehl, Sandra J.; Deal, Allison M.

2011-01-01

Routine vaccination against human papillomavirus (HPV), the main cause of cervical cancer, is recommended for 11–12 year old girls, yet vaccine uptake is low. This study evaluates a social marketing campaign initiated by 13 North Carolina counties to raise awareness among parents and reduce barriers to accessing the vaccine in a primarily rural area. The 3-month campaign targeted mothers of girls ages 11–12 and healthcare practices serving pre-teen girls in four counties. Principles of social marketing were: product (recommended vaccine against HPV), price (cost, perception of safety and efficacy, and access), promotion (posters, brochures, website, news releases, doctor’s recommendation), and place (doctors’ offices, retail outlets). We analyzed (1) website traffic, hotline calls, and media placement; (2) cross-sectional surveys of mothers and providers; and (3) HPV immunization rates in intervention versus non-intervention counties. Of respondent mothers (n=225), 82% heard or saw campaign messages or materials. Of respondent providers (n=35), 94% used campaign brochures regularly or occasionally in conversations with parents. HPV vaccination rates within six months of campaign launch were 2% higher for 9–13 year old girls in two of the four intervention counties compared to 96 non-intervention counties. This evaluation supports campaign use in other primarily rural and underserved areas. PMID:21804767

Observational Park-based Physical Activity Studies: A Systematic Review of the Literature

PubMed Central

Joseph, Rodney P.; Maddock, Jay E.

2016-01-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4,558 (Range= 815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. PMID:27311337

Observational Park-based physical activity studies: A systematic review of the literature.

PubMed

Joseph, Rodney P; Maddock, Jay E

2016-08-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4558 (Range=815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. Copyright © 2016 Elsevier Inc. All rights reserved.

The level of recognition of physical symptoms in patients with a major depression episode in the outpatient psychiatric practice in Puerto Rico: An observational study

PubMed Central

Tamayo, Jorge M; Román, Karis; Fumero, Juan J; Rivas, María

2005-01-01

Background This study was designed to evaluate the psychiatrists' level of recognition of somatic symptoms associated to a major depressive episode (MDE) (DSM-IV-TR criteria) and the impact of those somatic symptoms on the treatment effectiveness. Methods This non-interventional study was conducted in 25 medical offices in Puerto Rico from February to December 2003. It had 2 visits separated by 8 weeks. The level of recognition was determined by: the correlation between the physician clinical evaluation and their patients' self-evaluations through different validated instruments using kappa statistics. Chi-square test was used to evaluate the impact of somatic symptoms on treatment antidepressants' effectiveness. Results All the 145 recruited patients reported the presence of at least one somatic symptom associated with their current MDE. In the two visits covered by the study, a fair agreement between the psychiatrists' and the patients' reports was noted for headache, abdominal pain and upper limb pains (0.4003 ≤ κ ≥ 0.6594). For other painful symptoms and painless somatic symptoms, the Kappa values obtained were non-significant. Slight but significant reductions in depression and painful symptoms severity were observed after 8 weeks of treatment. A proportional relationship between the pain and depression severity was observed (p < 0.0001). Conclusion The study results show that somatic symptoms: are very common in depressed Puerto Rican patients; are significant under-reported by psychiatrists; and have a significant impact on the antidepressant effectiveness. PMID:15967039

Implementation research to improve quality of maternal and newborn health care, Malawi.

PubMed

Brenner, Stephan; Wilhelm, Danielle; Lohmann, Julia; Kambala, Christabel; Chinkhumba, Jobiba; Muula, Adamson S; De Allegri, Manuela

2017-07-01

To evaluate the impact of a performance-based financing scheme on maternal and neonatal health service quality in Malawi. We conducted a non-randomized controlled before and after study to evaluate the effects of district- and facility-level performance incentives for health workers and management teams. We assessed changes in the facilities' essential drug stocks, equipment maintenance and clinical obstetric care processes. Difference-in-difference regression models were used to analyse effects of the scheme on adherence to obstetric care treatment protocols and provision of essential drugs, supplies and equipment. We observed 33 health facilities, 23 intervention facilities and 10 control facilities and 401 pregnant women across four districts. The scheme improved the availability of both functional equipment and essential drug stocks in the intervention facilities. We observed positive effects in respect to drug procurement and clinical care activities at non-intervention facilities, likely in response to improved district management performance. Birth assistants' adherence to clinical protocols improved across all studied facilities as district health managers supervised and coached clinical staff more actively. Despite nation-wide stock-outs and extreme health worker shortages, facilities in the study districts managed to improve maternal and neonatal health service quality by overcoming bottlenecks related to supply procurement, equipment maintenance and clinical performance. To strengthen and reform health management structures, performance-based financing may be a promising approach to sustainable improvements in quality of health care.

Long-acting nifedipine for hypertensive patients in the Middle East and Morocco: observations on efficacy and tolerability of monotherapy or combination therapy

PubMed Central

Ghoneim, Raafat AL; Omar, Abdalla Kamal; Sebastian, VJ; Kassab, Roland; Akijian, George; Hafiz, Meryem; Schmidt, Birgit

2013-01-01

Background The Middle Eastern and North African region of developing countries is associated with poor rates of blood pressure (BP) control and antihypertensive prescribing patterns. This post hoc analysis of data from an international observational study aimed to investigate the efficacy and tolerability of long-acting nifedipine (30 mg or 60 mg; monotherapy or in combination) in the Middle Eastern and Moroccan populations defined as having high cardiovascular risk. Methods This was a prospective, noninterventional, multicenter observational study. Observations from patients (aged ≥ 18 years) with treated or untreated hypertension from the Middle East (Jordan, Saudi Arabia, Kuwait, Lebanon, Qatar, United Arab Emirates, and Yemen) and Morocco are presented. Hypertension grade and cardiovascular risk were defined at baseline, and systolic/diastolic BP change was defined at post-baseline visits (≤3). Adverse events and ratings of therapy efficacy and patient/physician satisfaction were recorded. Results The study included 1466 patients from the Middle East and 524 from Morocco. Characteristics of the populations differed, with a more severe hypertension profile in Moroccan patients. Despite these differences, nifedipine reduced BP to a similar extent in each group, with efficacy dependent on cardiovascular risk factors such as hypertension grade and age. Few adverse drug reactions occurred and nifedipine was well-tolerated in both populations. Efficacy and satisfaction with therapy were rated highly. Conclusion Good rates of BP control were observed with nifedipine in patients with moderate-to-severe hypertension and high added risk. Published data in these countries suggest poor antihypertensive prescribing patterns and BP control; these data confirm this trend and suggest that suboptimal dosing may be prevalent. PMID:23807860

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study.

PubMed

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-11-01

Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. A single-blinded quasi-experimental study with a one-group pretest-posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm(2). The non-intervention group had no significant changes in ROM or NPRS scores. After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials.

The immediate effects of thoracic transverse mobilization in patients with the primary complaint of mechanical neck pain: a pilot study

PubMed Central

McGregor, CIndy; Boyles, Robert; Murahashi, Laura; Sena, Tanya; Yarnall, Robert

2014-01-01

Objective: Posterior-to-anterior (PA) vertebral mobilization to the thoracic spine has been studied as an intervention for neck pain. Our purpose was to explore effects of a different mobilization technique, transverse vertebral pressure, on cervical range of motion (ROM) and pain when applied to the thoracic spine among participants with neck pain. Methods: A single-blinded quasi-experimental study with a one-group pretest–posttest design. A transverse group consisted of 21 participants whose neck pain increased with active movements. A non-intervention group of 20 asymptomatic participants was included simply to ensure rater blinding. The treatment group received Grades IV to IV+ transverse mobilizations at T1 through T4 bilaterally. Measurements taken immediately after intervention included pre/post cervical ROM, distant pressure pain threshold (PPT), and a numerical pain rating scale (NPRS). Analysis utilized t-tests and ordinal counterparts. Results: The transverse group demonstrated significant gains in extension and bilateral rotation (P≤0.005) but not flexion or side-bend. A total of 57% of mobilized participants reported clinically meaningful decreased pain (P<0.001). Seven participants exceeded the PPT MDC95 of 0.36 kg/cm2. The non-intervention group had no significant changes in ROM or NPRS scores. Discussion: After 8 minutes of transverse mobilization to the upper thoracic spine, significant gains in cervical extension and bilateral rotation, and decreased pain scores were found. There were no adverse effects. Unlike other mobilization studies, PPT changes at a remote site were statistically but not clinically meaningful. Findings suggest that transverse mobilization would be a productive topic for controlled clinical trials. PMID:25395827

Motivations for participating in a non-interventional gender-based violence survey in a low-income setting in South Africa.

PubMed

Sikweyiya, Yandisa; Nduna, Mzikazi; Shai, Nwabisa; Jewkes, Rachel

2017-06-29

Qualitative study of motivations to participate in research into violence and other sensitive issues can help interpretation of findings from community based quantitative surveys. It is equally important to conduct research that may enable a deeper understanding on what motivates people to participate in GBV studies. To date, not much research has been conducted to investigate the factors that influence non-enrolment and enrolment in GBV studies from the viewpoint of the real participants. The present study sought to explore people's reasons for participating in a non-intervention GBV community-based survey in Gauteng province, South Africa. Twenty-two qualitative in-depth interviews were conducted with adult black African men and women who had participated in a gender-based violence survey conducted in a low-income setting in South Africa. Some participants reported motives for survey participation which could be interpreted as altruistic. Their motives included a desire to contribute to advancement of knowledge and to share life experiences so that unknown others could learn from these experiences. Yet, some participants hoped their participation will result in personal benefit or that they may be helped with their socio-economic challenges. The analysis further revealed a complex relationship between altruism and self-interest motives for participating in the survey amongst some of the participants. We conclude that it is difficult to discern which motive was primary or preceded the other. This is because such motives are not fixed, probably multiple and owing to their fluidity, may shift in people's minds at different times and depending on the nature of the conversation. Moreover, there may be a shift in the weight given to different motives over time.

Intersectionality of Ethno-Cultural Identities and Construal of Distant Suffering Outgroups

ERIC Educational Resources Information Center

Palasinski, Marek; Abell, Jackie; Levine, Mark

2012-01-01

In this paper, we explore how white Catholic men talk about the indirect dilemma of non-intervention for black ethnic outgroups. We illustrate how they mobilise global categorisation (all humanity) and use various forms of denial to deal with their non-involvement. Having analyzed representative fragments of their prejudice avoidance talk, we…

Evaluation of a Peer-Led Drug Abuse Risk Reduction Project for Runaway/Homeless Youths.

ERIC Educational Resources Information Center

Fors, Stuart W.; Jarvis, Sara

1995-01-01

Evaluates the Drug Prevention in Youth risk reduction program that was implemented in shelters for runaway/homeless youths in the southeastern United States. An evaluation strategy was developed allowing for comparisons between peer-led, adult-led and nonintervention groups. Well-trained and motivated peer/near-peer leaders made particularly…

Preliminary Evaluation of the "Playing the Game" Sexual Assault Prevention Theatre Program

ERIC Educational Resources Information Center

Thatcher, W. Gregory

2011-01-01

Purpose: To compare the effectiveness of a one-time sexual assault prevention theatre performance against a similar content video performance and a non-intervention control group. Methods: Using the College Date Rape Attitudes and Behaviors Survey, four-hundred ninety-seven students provided matched pairs data for analysis. Results: At a…

Rational non-interventional paternalism: why doctors ought to make judgments of what is best for their patients.

PubMed Central

Savulescu, J

1995-01-01

This paper argues that doctors ought to make all things considered value judgments about what is best for their patients. It illustrates some of the shortcomings of the model of doctor as 'fact-provider'. The 'fact-provider' model fails to take account of the fact that practising medicine necessarily involves making value judgments; that medical practice is a moral practice and requires that doctors reflect on what ought to be done, and that patients can make choices which fail to express their autonomy and which are based on mistaken judgments of value. If doctors are properly to respect patient autonomy and to function as moral agents, they must make evaluations of what their patients ought to do, all things considered. This paper argues for 'rational, non-interventional paternalism'. This is a practice in which doctors form conceptions of what is best for their patients and argue rationally with them. It differs from old-style paternalism in that it is not committed to doing what is best. PMID:8778455

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7)

PubMed Central

Deal, Linda S.; DiBenedetti, Dana B.; Nelson, Lauren; Fehnel, Sheri E.; Brown, T. Michelle

2016-01-01

Objective Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Methods Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014–July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Results Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Conclusions Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED. PMID:27486542

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7).

PubMed

Herman, Barry K; Deal, Linda S; DiBenedetti, Dana B; Nelson, Lauren; Fehnel, Sheri E; Brown, T Michelle

2016-01-01

Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition.

PubMed

Cummings, Jeffrey; Mintzer, Jacobo; Brodaty, Henry; Sano, Mary; Banerjee, Sube; Devanand, D P; Gauthier, Serge; Howard, Robert; Lanctôt, Krista; Lyketsos, Constantine G; Peskind, Elaine; Porsteinsson, Anton P; Reich, Edgardo; Sampaio, Cristina; Steffens, David; Wortmann, Marc; Zhong, Kate

2015-01-01

Agitation is common across neuropsychiatric disorders and contributes to disability, institutionalization, and diminished quality of life for patients and their caregivers. There is no consensus definition of agitation and no widespread agreement on what elements should be included in the syndrome. The International Psychogeriatric Association formed an Agitation Definition Work Group (ADWG) to develop a provisional consensus definition of agitation in patients with cognitive disorders that can be applied in epidemiologic, non-interventional clinical, pharmacologic, non-pharmacologic interventional, and neurobiological studies. A consensus definition will facilitate communication and cross-study comparison and may have regulatory applications in drug development programs. The ADWG developed a transparent process using a combination of electronic, face-to-face, and survey-based strategies to develop a consensus based on agreement of a majority of participants. Nine-hundred twenty-eight respondents participated in the different phases of the process. Agitation was defined broadly as: (1) occurring in patients with a cognitive impairment or dementia syndrome; (2) exhibiting behavior consistent with emotional distress; (3) manifesting excessive motor activity, verbal aggression, or physical aggression; and (4) evidencing behaviors that cause excess disability and are not solely attributable to another disorder (psychiatric, medical, or substance-related). A majority of the respondents rated all surveyed elements of the definition as "strongly agree" or "somewhat agree" (68-88% across elements). A majority of the respondents agreed that the definition is appropriate for clinical and research applications. A provisional consensus definition of agitation has been developed. This definition can be used to advance interventional and non-interventional research of agitation in patients with cognitive impairment.

An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease.

PubMed

Müller, Thomas; Tolosa, Eduardo; Badea, Letitia; Asgharnejad, Mahnaz; Grieger, Frank; Markowitz, Michael; Nondonfaz, Xavier; Bauer, Lars; Timmermann, Lars

2018-06-01

Real-world data from large cohorts of patients with Parkinson's disease on the long-term effectiveness of different dopamine-substituting drug therapies are rare. The objective of this study was to obtain information on real-world management of PD with dopamine-substituting drugs. SP0854 (NCT00599339) was a prospective, multicenter, non-interventional, multiple-cohort, post-authorization safety study of rotigotine versus other dopaminergic therapies. The study was also part of a European Medicines Agency risk-management plan for the non-ergoline dopamine agonist rotigotine, focussing on cardiovalvular fibrosis. Eligible patients requiring monotherapy with a dopamine agonist, or levodopa in combination with a dopamine agonist were followed for ≤ 33 months; 1531 of 2195 patients completed the study. Mean motor scores improved for all dopamine-substituting treatments. Patients with more severe motor-symptoms/increased disability were more likely to receive levodopa alone or in combination with a DA at study onset. More patients who started on combination therapy with levodopa remained on this treatment versus those starting on dopaminergic monotherapy. This real-world study showed that the dopamine-substituting therapies were efficacious, with a safety profile consistent with that expected of dopaminergic treatments. Cardiovalvular pathology was rare and not found to be causally-related to rotigotine.

Smoking patterns, depression, and sociodemographic variables among Flemish women during pregnancy and the postpartum period.

PubMed

De Wilde, Katrien S; Trommelmans, Leen C; Laevens, Hans H; Maes, Lea R; Temmerman, Marleen; Boudrez, Hedwig L

2013-01-01

Relationships among feelings of depression, smoking behavior, and educational level during pregnancy have been documented. Feelings of depression may contribute to persistent smoking during pregnancy. No longitudinal studies assessing feelings of depression in women with different antepartum and postpartum smoking patterns are available. The aim was to determine relationships between depressive symptoms, sociodemographic characteristics, and smoking pattern during and after pregnancy. An observational, prospective, noninterventional study was conducted. Data were collected during two stages of pregnancy (T0: <;16 weeks and T1: 32-34 weeks) and postpartum (T2: >6 weeks) in 523 Flemish women. Feelings of depression (measured using the Beck Depression Inventory [BDI]), smoking behavior, and sociodemographic variables were analyzed using a general linear mixed model implemented in SAS Proc MIXED. Smokers and initial smokers reported significantly more depressive symptoms at all time points compared with recent ex-smokers, nonsmokers, and initial nonsmokers (p <; .001). The three-way interaction among time point, smoking pattern, and educational level was significant (p = .02). Evolution of mean BDI over time differed by educational level. Among participants with a secondary school certificate or less, differences were observed between smokers and nonsmokers, recent ex-smokers and initial nonsmokers, and nonsmokers and initial nonsmokers. Among participants with a college or university degree, no differences were observed. A wide variety of smoking patterns were observed during pregnancy and early postpartum. Smoking patterns were associated with depression and showed complex interactions with educational level. Assessment and intervention for both smoking and depression are needed throughout the perinatal period to support the health of mothers, their infants, and families.

Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction.

PubMed

Özlek, Bülent; Özlek, Eda; Çelik, Oğuzhan; Çil, Cem; Doğan, Volkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Kahraman, Serkan; Ösken, Altuğ; Rencüzoğulları, İbrahim; Tanık, Veysel Ozan; Bekar, Lütfü; Çakır, Mustafa Ozan; Kaya, Bedri Caner; Tibilli, Hakan; Çelik, Yunus; Başaran, Özcan; Mert, Kadir Uğur; Sevinç, Samet; Demirci, Erkan; Dondurmacı, Engin; Biteker, Murat

2018-05-01

Although almost half of chronic heart failure (HF) patients have mid-range (HFmrEF) and preserved left-ventricular ejection fraction (HFpEF), no studies have been carried out with these patients in our country. This study aims to determine the demographic characteristics and current status of the clinical background of HFmrEF and HFpEF patients in a multicenter trial. A comPrehensive, ObservationaL registry of heart faiLure with mid range and preserved ejectiON fraction (APOLLON) trial will be an observational, multicenter, and noninterventional study conducted in Turkey. The study population will include 1065 patients from 12 sites in Turkey. All data will be collected at one point in time and the current clinical practice will be evaluated (ClinicalTrials.gov number NCT03026114). We will enroll all consecutive patients admitted to the cardiology clinics who were at least 18 years of age and had New York Heart Association class II, III, or IV HF, elevated brain natriuretic peptide levels within the last 30 days, and an left ventricular ejection fraction (LVEF) of at least 40%. Patients fulfilling the exclusion criteria will not be included in the study. Patients will be stratified into two categories according to LVEF: mid-range EF (HFmrEF, LVEF 40%-49%) and preserved EF (HFpEF, LVEF ≥50%). Regional quota sampling will be performed to ensure that the sample was representative of the Turkish population. Demographic, lifestyle, medical, and therapeutic data will be collected by this specific survey. The APOLLON trial will be the largest and most comprehensive study in Turkey evaluating HF patients with a LVEF ≥40% and will also be the first study to specifically analyze the recently designated HFmrEF category.

The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study.

PubMed

Moots, Robert J; Xavier, Ricardo M; Mok, Chi Chiu; Rahman, Mahboob U; Tsai, Wen-Chan; Al-Maini, Mustafa H; Pavelka, Karel; Mahgoub, Ehab; Kotak, Sameer; Korth-Bradley, Joan; Pedersen, Ron; Mele, Linda; Shen, Qi; Vlahos, Bonnie

2017-01-01

To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6-24 months with ETN, ADL, or IFX. ADA and trough drug concentrations were measured by independent assays ≤2 days before the next scheduled dose. Efficacy measurements included Disease Activity Score 28-joint count (DAS28), low disease activity (LDA), remission, and erythrocyte sedimentation rate (ESR). Targeted medical histories of injection site/infusion reactions, serum sickness, and thromboembolic events were collected. Baseline demographics of the 595 patients (ETN: n = 200; ADL: n = 199; IFX: n = 196) were similar across groups. The mean duration of treatment was 14.6, 13.5, and 13.1 months for ETN, ADL, and IFX, respectively. All ETN-treated patients tested negative for ADA, whereas 31.2% and 17.4% patients treated with ADL and IFX, respectively, tested positive. In ADL- or IFX-treated patients, those with ADA had significantly lower trough drug concentrations. There were negative correlations between trough drug levels and both CRP and ESR in ADL- and IFX-treated patients. DAS28-ESR LDA and remission rates were higher in patients without ADA. The rate of targeted medical events reported was low. ADA were detected in ADL- and IFX-treated but not ETN-treated patients. Patients without ADA generally showed numerically better clinical outcomes than those with ADA. This study was registered on www.ClinicalTrials.gov (NCT01981473).

MP-AzeFlu provides rapid and effective allergic rhinitis control: results of a non-interventional study in Romania.

PubMed

Agache, I; Doros, I C; Leru, P M; Bucur, I; Poenaru, M; Sarafoleanu, C

2018-03-01

Allergic Rhinitis and its Impact on Asthma (ARIA) and the European Union (EU) recommend a shift to guide allergic rhinitis (AR) treatment decisions from symptom severity to disease control, using a simple visual analogue scale (VAS). Using this VAS we assessed, in a real-life study in Romania, the effectiveness of MP-AzeFlu nasal spray. In this multi-centre, prospective, non-interventional study, 253 patients (over 11 years old) with moderate-to-severe AR were prescribed MP-AzeFlu and assessed their symptoms on a VAS (0 (not at all bothersome) to 100 mm (very bothersome)) on Days 0, 1, 3, 7 and 14. The proportion of patients who achieved a defined VAS score cut-off for well-controlled (38 mm) AR were also calculated. Patients perception of disease control was assessed on Day 3. MP-AzeFlu use was associated with a mean (standard deviation) VAS score reduction from 78.4 (15.1) mm at baseline to 14.7 (15.1) mm on the last day. Effectiveness was consistent irrespective of disease severity, phenotype or patient age. 83.4% of patients achieved the smaller than 39 mm well-controlled VAS score cut-off by last day and 95.2% considered their symptoms to be well- or partly controlled at Day 3. MP-AzeFlu provided rapid, effective and sustained AR symptom control in a real-life setting in Romania, irrespective of severity, phenotype or patient age, aligning with ARIA and EU recommendations and supporting the position of MP-AzeFlu as the drug of choice for the treatment of moderate-to-severe AR.

[Study of the beneficial effects of triptorelin on lower urinary tract symptoms in Algeria in patients with non-localized prostate cancer].

PubMed

Hachi, K; Boualga, K; Chettibi, K; Harouni, M; Ounnoughene, M; Bekkat-Berkani, N; Maisonobe, P; Yousfi, M J

2018-05-20

This study aims to assess the effectiveness of triptorelin on lower urinary tract symptoms (LUTS) in Algerian patients with non-localized prostate cancer in routine practice. This prospective, observational, non-interventional, multicentre study was conducted in Algeria. Included patients who had locally advanced or metastatic prostate cancer and were treated with triptorelin 11.25mg given every 12 weeks. LUTS were evaluated with the International Prostate Symptom Score (IPSS) until week 48 after treatment initiation. An IPSS>7 indicated moderate to severe LUTS. The primary objective of the study was to determine the distribution of IPSS at week 48. This study enrolled 193 patients at 21 centres. A total of 144 participants had IPSS available at baseline and after baseline (136 patients had moderate to severe LUTS and eight had mild LUTS at baseline). At week 48, amongst the 116 patients with IPSS available and moderate to severe LUTS at baseline, 94 (81.0%) had moderate to severe LUTS and 22 (19.0%) had mild LUTS. At week 48, the eight patients with mild symptoms at baseline remained in this category. The proportion of patient with severe LUTS decreased from 53.7% at baseline to 12.1% at week 48. Adverse events were reported in 22.9% of participants. A reduction of LUTS is observed in patients with locally advanced or metastatic prostate cancer treated with triptorelin in routine practice. This is in agreement with similar observational studies of triptorelin conducted in other countries. 4. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Burden of Infantile Hemangioma on Family: An International Observational Cross-Sectional Study.

PubMed

Cazeau, Christine; Blei, Francine; Gonzáles Hermosa, María Del Rosario Fátima; Cavalli, Riccardo; Boccara, Olivia; Fölster-Holst, Regina; Berdeaux, Gilles; Delarue, Alain; Voisard, Jean-Jacques

2017-05-01

Infantile hemangioma (IH) is the most frequent benign tumor of infancy resulting from vascular proliferation. Data regarding the burden on families of children with IHs are limited. This study aimed to characterize IHs and provide a comprehensive evaluation of the burden of IHs on parents of children requiring systemic treatment in the United States and Europe. This noninterventional cross-sectional study included infants with newly diagnosed IH requiring systemic treatment. A parent or family member completed two questionnaires (Family Member questionnaire; Hemangioma Family Burden [HFB] questionnaire). A total of 693 individuals were evaluable in five countries. IHs were observed in more girls than boys (66%-83% female) and the mean age at inclusion was 0.44 to 1.4 years. Approximately half of patients had superficial IHs, approximately 70% of cases affected the head, and approximately 80% of cases were moderate or severe. Most patients received propranolol treatment. Their child's IH affected more than 70% of parents in each country, but fewer than 10% were offered psychological support. Approximately half of all parents reported that their child's IH affected their professional life. The global HFB score was significantly (p < 0.001) greater with greater IH severity. More than 90% of parents in each country were satisfied with the care of their child's disease. This international study using the validated HFB questionnaire provides further insight into the burden of IH and highlights potential areas for future focus in assisting families with affected children. © 2017 Wiley Periodicals, Inc.

Registry of Hypogonadism in Men (RHYME): design of a multi-national longitudinal, observational registry of exogenous testosterone use in hypogonadal men.

PubMed

Rosen, Raymond C; Wu, Frederick C W; Behre, Hermann M; Roehrborn, Claus G; Schröder, Fritz H; Siami, Flora S; Martha, Julia F; Finn, Joseph D; Araujo, Andre B

2013-03-01

Despite the prevalence of hypogonadism (HG) and widespread use of testosterone therapy, little is known about the safety/effectiveness of long-term testosterone use. The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry assessing prostate health and other outcomes associated with testosterone treatment in men. Observational patient disease registry. RHYME is a non-interventional disease registry with longitudinal data collection on a large sample (N = 999) of well-characterized, hypogonadal men aged 18 years or older. The Registry will prospectively evaluate male patients diagnosed with HG, who have not previously been treated with testosterone therapy. Key design features include: (1) broad inclusion/exclusion criteria, (2) standardized central laboratory hormone assays, (3) independent adjudication of prostate biopsies and mortalities, (4) standard of care treatment, (5) comprehensive medical record and questionnaire data at six months and annually post-enrollment and (6) adequate statistical power for assessing prostate endpoints at 36 months. A total of 25 clinical sites in six European countries (Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom) have completed recruitment for the study. Recruitment was initiated in May 2009, and completed in December 2011. Data collection is ongoing with a minimum of two years of follow-up on all patients.

A simple strategy to reduce stereotype threat for orthopedic residents.

PubMed

Gomez, Everlyne; Wright, James G

2014-04-01

Stereotype threat, defined as the predicament felt by people in either positive or negative learning experiences where they could conform to negative stereotypes associated with their own group membership, can interfere with learning. The purpose of this study was to determine if a simple orientation session could reduce stereotype threat for orthopedic residents. The intervention group received an orientation on 2 occasions focusing on their possible responses to perceived poor performance in teaching rounds and the operating room (OR). Participants completed a survey with 7 questions typical for stereotype threat evaluating responses to their experiences. The questions had 7 response options with a maximum total score of 49, where higher scores indicated greater degree of experiences typical of stereotype threat. Of the 84 eligible residents, 49 participated: 22 in the nonintervention and 27 in the intervention group. The overall scores were 29 and 29.4, and 26.2 and 25.8 in the nonintervention and intervention groups for their survey responses to perceived poor performance in teaching rounds (p = 0.85) and the OR (p = 0.84), respectively. Overall, responses typical of stereotype threat were greater for perceived poor performance at teaching rounds than in the OR (p = 0.001). Residents experience low self-esteem following perceived poor performance, particularly at rounds. A simple orientation designed to reduce stereotype threat was unsuccessful in reducing this threat overall. Future research will need to consider longer-term intervention as possible strategies to reduce perceived poor performance at teaching rounds and in the OR.

Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

PubMed

Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z

2016-11-01

A new fibrinogen concentrate Clottafact ® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable. © 2016 International Society of Blood Transfusion.

Heparin as a pharmacologic intervention to induce positive scintiscan in occult gastrointestinal bleeding

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

Chaudhuri, T.K.; Brantly, M.

1984-04-01

The value of using heparin as a pharmacologic intervention to induce a positive scintiscan was studied in a patient with chronic occult gastrointestinal bleeding. When all standard diagnostic tests (upper and lower gastrointestinal series, upper and lower endoscopy, and conventional noninterventional Tc-99m RBC imaging) fail to detect and localize gastrointestinal bleeding in a patient who has definite clinical evidence (guaiac positive stool and dropping hemoglobin, hematocrit) of chronic occult gastrointestinal oozing, heparin may be used (with proper precaution) as a last resort to aid in the scintigraphic detection and localization of chronic occult gastrointestinal bleeding.

Design characteristics of the Corrona Japan rheumatoid arthritis registry.

PubMed

Yamanaka, Hisashi; Kishimoto, Mitsumasa; Pappas, Dimitrios A; Greenberg, Jeffrey D; Kremer, Joel M; Tanaka, Yoshiya

2018-01-01

The primary objective is to prospectively study the comparative safety and effectiveness of older and newer classes of nonbiologic DMARDs (Disease-modifying antirheumatic drugs), biologic DMARDs and targeted synthetic therapies approved for rheumatoid arthritis (RA) in a real-world patient population in Japan. Prospective, multicenter, noninterventional, observational study across geographic distribution of both private and public institutions for patients with RA who are newly prescribed one of the following medications: (1) methotrexate; (2) anti-TNF biologic DMARDs; (3) non-TNF biologic DMARDs; and (4) approved JAK inhibitors at the time of enrollment into the registry. Target enrollment is currently 2000 subjects. Baseline and follow-up data on patient demographics, medical history, disease activity, laboratory results, comorbidities, hospitalizations, and targeted safety events are obtained via Physician and Patient Questionnaires. Fifty sites are anticipated to participate with 40 sites ethics committee (EC) approved at the time of submission consisting of 23% clinics, 21% private academic hospitals, 29% private mid-sized to large hospitals, 15% national academic hospitals, and 12% national hospitals. The Corrona Japan RA Registry will provide real-world evidence from both private and public institutions on the comparative effectiveness and safety of recently approved RA therapies in Japan.

A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures.

PubMed

Steinhoff, Bernhard J; Eckhardt, Klaus; Doty, Pamela; De Backer, Marc; Brunnert, Marcus; Schulze-Bonhage, Andreas

2016-05-01

This noninterventional, observational, postauthorization safety study (SP0942, NCT00771927) evaluated the incidence of predefined cardiovascular- (CV) and psychiatric-related treatment-emergent adverse events (TEAEs), in patients with epilepsy and uncontrolled partial-onset seizures, when initiating adjunctive therapy with lacosamide or another approved antiepileptic drug (AED) according to standard medical practice. Active recording of predefined TEAEs of interest took place at three-monthly recommended visits for up to 12months. Of 1004 patients who received at least one dose of adjunctive AEDs, 511 initially added lacosamide therapy, 493 added another AED, 69 were ≥65years of age, and 72 took concomitant antiarrhythmic drugs. Patients in the lacosamide cohort had a higher median frequency of partial-onset seizures (6.0 versus 3.5 per 28days) despite taking more concomitant AEDs (84.9% versus 66.9% took ≥2) at baseline. Patients who added lacosamide took a modal dose of 200mg/day over the treatment period (n=501), and 50.1% (256/511) completed 12months of treatment. Fifty-one point nine percent (256/493) of patients who added another AED completed the study, with the most commonly added AED being levetiracetam (28.4%). Four patients (0.8%) in each cohort, all <65years of age, reported predefined CV-related TEAEs. None were considered serious or led to discontinuation. One event each of sinus bradycardia (lacosamide), atrioventricular block first degree (lacosamide), and syncope (other AED) were judged to be treatment-related. Another patient in the other AED cohort reported bradycardia while taking concomitant antiarrhythmic drugs. Predefined psychiatric-related TEAEs were reported by 21 patients (4.1%) in the lacosamide cohort and 27 patients (5.5%) in the other AED cohort. Depression was the most common to be treatment-related (7/11 and 12/18 of patients reporting treatment-related psychiatric TEAEs, respectively). Serious psychiatric-related TEAEs were reported by four patients who added lacosamide (two cases of depression, two of suicide attempt) and one who added another AED (depression). Seven deaths occurred, all of which were considered unrelated/unlikely related to study medication. This thorough evaluation revealed a low incidence of predefined CV- and psychiatric-related TEAEs in patients taking adjunctive AED therapy according to standard medical practice. No specific safety concerns related to adjunctive lacosamide therapy were noted. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Management of bipolar disorder in the intercontinental region: an international, multicenter, non-interventional, cross-sectional study in real-life conditions.

PubMed

Samalin, Ludovic; Vieta, Eduard; Okasha, Tarek Ahmed; Uddin, Mm Jalal; Ahmadi Abhari, Seyed Ali; Nacef, Fethi; Mishyiev, Vyacheslav; Aizenberg, Dovi; Ratner, Yaël; Melas-Melt, Lydie; Sedeki, Idir; Llorca, Pierre Michel

2016-05-16

Most of the existing data on real-life management of bipolar disorder are from studies conducted in western countries (mostly United States and Europe). This multinational, observational cohort study aimed to describe the management and clinical outcomes of bipolar patients in real-life conditions across various intercontinental countries (Bangladesh, Egypt, Iran, Israel, Tunisia, and Ukraine). Data on socio-demographic and disease characteristics, current symptomatology, and pharmacological treatment were collected. Comparisons between groups were performed using standard statistical tests. Overall, 1180 patients were included. The median time from initial diagnosis was 80 months. Major depressive disorder was the most common initial diagnosis. Mood stabilizers and antipsychotics were the most common drugs being prescribed at the time of the study. Antidepressants (mainly selective serotonin uptake inhibitors [SSRIs]) were administered to 36.1% of patients. Patients with bipolar I disorder received higher number of antipsychotics and anxiolytics than those with bipolar II disorder (p < 0.001). Presence of depressive symptoms was associated with an increase in antidepressant use (p < 0.001). Bipolar disorder real-life management practice, irrespective of region, shows a delay in diagnosis and an overuse of antidepressants. Clinical decision-making appears to be based on a multidimensional approach related to current symptomatology and type of bipolar disorder.

Management of bipolar disorder in the intercontinental region: an international, multicenter, non-interventional, cross-sectional study in real-life conditions

PubMed Central

Samalin, Ludovic; Vieta, Eduard; Okasha, Tarek Ahmed; Uddin, MM. Jalal; Ahmadi Abhari, Seyed Ali; Nacef, Fethi; Mishyiev, Vyacheslav; Aizenberg, Dovi; Ratner, Yaël; Melas-Melt, Lydie; Sedeki, Idir; Llorca, Pierre Michel

2016-01-01

Most of the existing data on real-life management of bipolar disorder are from studies conducted in western countries (mostly United States and Europe). This multinational, observational cohort study aimed to describe the management and clinical outcomes of bipolar patients in real-life conditions across various intercontinental countries (Bangladesh, Egypt, Iran, Israel, Tunisia, and Ukraine). Data on socio-demographic and disease characteristics, current symptomatology, and pharmacological treatment were collected. Comparisons between groups were performed using standard statistical tests. Overall, 1180 patients were included. The median time from initial diagnosis was 80 months. Major depressive disorder was the most common initial diagnosis. Mood stabilizers and antipsychotics were the most common drugs being prescribed at the time of the study. Antidepressants (mainly selective serotonin uptake inhibitors [SSRIs]) were administered to 36.1% of patients. Patients with bipolar I disorder received higher number of antipsychotics and anxiolytics than those with bipolar II disorder (p < 0.001). Presence of depressive symptoms was associated with an increase in antidepressant use (p < 0.001). Bipolar disorder real-life management practice, irrespective of region, shows a delay in diagnosis and an overuse of antidepressants. Clinical decision-making appears to be based on a multidimensional approach related to current symptomatology and type of bipolar disorder. PMID:27181262

U.S. Democratization Strategy: Origins and Obstacles

DTIC Science & Technology

2008-09-01

war was destroying Europe and Wilson’s non-intervention had won favor with the U.S. electorate, unwilling to partake in what Zara Steiner has aptly...33 Stanley Weintraub, Silent Night (New York: Simon and Schuster, 2001), p. 167. 34 Zara Steiner, The...Platter (Baltimore and London: The Johns Hopkins University Press, 2001). Steiner, Zara , The Lights that Failed: European International History

A Longitudinal Assessment of the Associations among Response Access, Attention Problems, and Aggression during Childhood

ERIC Educational Resources Information Center

Van Eck, Kathryn; Flory, Kate; Malone, Patrick S.

2013-01-01

Children with ADHD symptoms often display social competence deficits, yet mechanisms for their social difficulties remain unclear. Using data from the normative sample of non-intervention respondents (N = 387; 50% male; 49% non-European-American; age at initial assessment: M = 6.5 years, SD = 0.48) in the Fast Track project (Lochman and CPPRG…

Implementation research to improve quality of maternal and newborn health care, Malawi

PubMed Central

Wilhelm, Danielle; Lohmann, Julia; Kambala, Christabel; Chinkhumba, Jobiba; Muula, Adamson S; De Allegri, Manuela

2017-01-01

Abstract Objective To evaluate the impact of a performance-based financing scheme on maternal and neonatal health service quality in Malawi. Methods We conducted a non-randomized controlled before and after study to evaluate the effects of district- and facility-level performance incentives for health workers and management teams. We assessed changes in the facilities’ essential drug stocks, equipment maintenance and clinical obstetric care processes. Difference-in-difference regression models were used to analyse effects of the scheme on adherence to obstetric care treatment protocols and provision of essential drugs, supplies and equipment. Findings We observed 33 health facilities, 23 intervention facilities and 10 control facilities and 401 pregnant women across four districts. The scheme improved the availability of both functional equipment and essential drug stocks in the intervention facilities. We observed positive effects in respect to drug procurement and clinical care activities at non-intervention facilities, likely in response to improved district management performance. Birth assistants’ adherence to clinical protocols improved across all studied facilities as district health managers supervised and coached clinical staff more actively. Conclusion Despite nation-wide stock-outs and extreme health worker shortages, facilities in the study districts managed to improve maternal and neonatal health service quality by overcoming bottlenecks related to supply procurement, equipment maintenance and clinical performance. To strengthen and reform health management structures, performance-based financing may be a promising approach to sustainable improvements in quality of health care. PMID:28670014

Recruiting adolescents into qualitative tobacco research studies: experiences and lessons learned.

PubMed

McCormick, L K; Crawford, M; Anderson, R H; Gittelsohn, J; Kingsley, B; Upson, D

1999-03-01

An increasing barrier to the development and implementation of effective youth smoking prevention and cessation programs involves recruiting adolescents into research studies. Even for non-intervention studies, issues of consent, confidentiality, and motivation to participate are important considerations. In 1996, 11 Prevention Research Center sites across the country conducted qualitative research using focus groups to explore ethnic differences in smoking among adolescents. The diversity in strategies used to interest, motivate, and retain potential focus group subjects provided a rich data set for information about effective strategies and challenges to recruitment. This article presents an overview of recruitment methods used in a multi-site qualitative study on adolescent tobacco use, reports on successful and less successful strategies, and provides recommendations for future recruitment.

Effect of triptorelin on lower urinary tract symptoms in Australian prostate cancer patients

PubMed Central

Woo, Henry H; Murphy, Declan G; Testa, Gerard M; Grummet, Jeremy P; Chong, Michael; Stork, Andrew P

2017-01-01

Purpose Prostate cancer is often comorbidly associated with lower urinary tract symptoms (LUTS), but few studies have assessed the effects of androgen deprivation therapy on LUTS in this patient group. Patients and methods We conducted a prospective, noninterventional, multicenter, observational study to assess the effectiveness of triptorelin (11.25 mg every 12 weeks) over 48 weeks in men presenting with local stage T3/4 prostate cancer and moderate to severe LUTS (International Prostate Symptom Score [IPSS] >7) in a routine practice setting in Australia. Results Of the 44 men who enrolled, effectiveness data were available for 39 men. By the end of the study, 30% of men no longer met the IPSS criteria for moderate to severe LUTS. The proportion of patients with moderate to severe LUTS was 69.6% (16/23) at week 48 and 76.9% (30/39) at the last available visit (coprimary outcomes). An IPSS reduction of ≥3 from week 0 was observed in 47% of men at week 4, 56% at week 24, 61% (14/23) at week 48, and 61.5% (24/39) at the last available visit. Quality of life was rated as mostly satisfied-to-delighted by 39.5% of patients at week 0, 53.9% at week 24, and 77.3% at week 48. Triptorelin was well tolerated with 8 treatment-related adverse events reported, half of which were hot flushes; 5 patients discontinued due to the reported treatment-related adverse events. Conclusion This observational study suggests that triptorelin improves moderate to severe LUTS in prostate cancer patients in a routine clinical practice setting. PMID:28261572

Clinical and economic impact of etanercept in real-life: a prospective, non-interventional study of etanercept in the treatment of patients with moderate to severe plaque psoriasis in private dermatologist settings (ESTHER).

PubMed

Larsen, Christian Grønhøj; Andersen, Peter Hundevadt; Lorentzen, Henrik; Zachariae, Claus; Huldt-Nystrøm, Theis; Dotterud, Lars Kåre; Lindkvist, Rose-Marie; Qvitzau, Susanne

2013-01-01

Real-life data on the therapeutic effectiveness and costs of etanercept are scarce. To assess the clinical and economic impact of etanercept in patients with psoriasis in Denmark and Norway. This prospective, non-interventional study in a private dermatologist care setting in Denmark and Norway included patients ≥18 years with moderate to severe plaque psoriasis, selected for treatment with etanercept. Assessments during 1 year from etanercept initiation included Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area and Severity Index (SAPASI) and adverse events. Direct and indirect costs were calculated. 163 subjects were enrolled. Baseline mean SAPASI was 19.1 . Proportion of patients with ≥50% decrease in SAPASI from baseline was 85% and 81% at weeks 24 and 52. DLQI decreased significantly from 11.4 (7.0) to 3.2 (4.3) and 3.7 (4.6) at weeks 24 and 52. Total annual costs increased from 78,000 to 286,000 DKK (p<0.0001), mainly due to the cost of etanercept. Outpatient-care costs and loss-of-productivity costs decreased from 9,500 to 5,000 (p = 0.0002), and from 33,000 to 18,000 DKK (p = 0.0105), respectively. The decrease in costs was more pronounced in patients who also had psoriatic arthritis. Cost increase was greatest during the first 6 months. Etanercept treatment was associated with decreased psoriasis severity and improved quality of life. Cost increase was driven by medication, while costs of outpatient care and loss-of-productivity decreased. Maintained improved quality of life was accompanied by decreasing cost during the second 6 month period of etanercept treatment. There were no new safety signals reported.

Positron emission mammography in the diagnosis of breast cancer. Is maximum PEM uptake value a valuable threshold for malignant breast cancer detection?

PubMed

Müller, F H H; Farahati, J; Müller, A G; Gillman, E; Hentschel, M

2016-01-01

To evaluate the diagnostic value (sensitivity, specificity) of positron emission mammography (PEM) in a single site non-interventional study using the maximum PEM uptake value (PUVmax). In a singlesite, non-interventional study, 108 patients (107 women, 1 man) with a total of 151 suspected lesions were scanned with a PEM Flex Solo II (Naviscan) at 90 min p.i. with 3.5 MBq 18F-FDG per kg of body weight. In this ROI(region of interest)-based analysis, maximum PEM uptake value (PUV) was determined in lesions, tumours (PUVmaxtumour), benign lesions (PUVmaxnormal breast) and also in healthy tissues on the contralateral side (PUVmaxcontralateral breast). These values were compared and contrasted. In addition, the ratios of PUVmaxtumour / PUVmaxcontralateral breast and PUVmaxnormal breast / PUVmaxcontralateral breast were compared. The image data were interpreted independently by two experienced nuclear medicine physicians and compared with histology in cases of suspected carcinoma. Based on a criteria of PUV>1.9, 31 out of 151 lesions in the patient cohort were found to be malignant (21%). A mean PUVmaxtumour of 3.78 ± 2.47 was identified in malignant tumours, while a mean PUVmaxnormal breast of 1.17 ± 0.37 was reported in the glandular tissue of the healthy breast, with the difference being statistically significant (p < 0.001). Similarly, the mean ratio between tumour and healthy glandular tissue in breast cancer patients (3.15 ± 1.58) was found to be significantly higher than the ratio for benign lesions (1.17 ± 0.41, p < 0.001). PEM is capable of differentiating breast tumours from benign lesions with 100% sensitivity along with a high specificity of 96%, when a threshold of PUVmax >1.9 is applied.

Side effects during subcutaneous immunotherapy in children with allergic diseases.

PubMed

Tophof, Max A; Hermanns, Anne; Adelt, Thomas; Eberle, Peter; Gronke, Christine; Friedrichs, Frank; Knecht, Roland; Mönter, Ernst; Schöpfer, Helmut; Schwerk, Nicolaus; Steinbach, Jörg; Umpfenbach, Hans-Ulrich; Weißhaar, Christian; Wilmsmeyer, Brigitte; Bufe, Albrecht

2018-05-01

Allergen-specific immunotherapy is the only causal form of therapy for IgE-mediated allergic diseases. Subcutaneous immunotherapy (SCIT) is considered safe and well tolerated in adults, yet there is less evidence of safety in the pediatric population. A non-interventional prospective observing longitudinal study was carried out to determine the incidence of local and systemic side effects by SCIT, routinely performed in pediatric patients. A total of 581 pediatric patients were observed in 18 study centers between March 2012 and October 2014, recording 8640 treatments and 10 015 injections. A total of 54.6% of the patients experienced immediate local side effects at least once; delayed local side effects were seen in 56.1%. Immediate systemic adverse reactions occurred in 2.2% of patients; 7.4% experienced delayed systemic side effects. However, severe systemic side effects (grade III in the classification of Ring and Messmer) were seen in 0.03% of all treatments, all appearing within 30 minutes after the injections. No grade IV reactions were observed. In addition, many potential risk factors were investigated, yet only a few were found to be associated with the occurrence of side effects. Subcutaneous immunotherapy is a safe form of therapy in pediatric patients, with similar rates of local side effects compared to adult patients and low rates of severe systemic side effects. However, local and systemic reactions occurring later than 30 minutes after injection were observed more often than expected, which makes it essential to be attentive on behalf of pediatricians, patients, and parents. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Anticommunism Versus Nonintervention in Latin America

DTIC Science & Technology

1966-04-08

insistence of the Latin governments, another conference of American states was called at Chapultepec , near Mexico City, in 1945. There, the principles...overthrown in 195^ by an anti-Communist liberation army led by Colonel Carlos Castillo Armas. Castillo Armas became Provisional President in...contributed to the success of Castillo Armas’ liberation army in bringing about the downfall of tho Arbenz regime. The United States, as the leader

Restoring the Unwritten Alliance: Brazil-U.S. Relations

DTIC Science & Technology

2013-01-01

interests versus values, Brazil emphasizes its constitutional values more than at any other time in its history. Self -determination, nonintervention...an entire division to Europe. Unfortunately, Brazil’s rise to preeminence in South America was inter- rupted by authoritarian military rule that...memory of its authoritarian past, when the military regime collected intelligence to deter internal dissent.38 U.S. officials have the next 4

Adaptive Non-Interventional Heuristics for Covariation Detection in Causal Induction: Model Comparison and Rational Analysis

ERIC Educational Resources Information Center

Hattori, Masasi; Oaksford, Mike

2007-01-01

In this article, 41 models of covariation detection from 2 x 2 contingency tables were evaluated against past data in the literature and against data from new experiments. A new model was also included based on a limiting case of the normative phi-coefficient under an extreme rarity assumption, which has been shown to be an important factor in…

The Profile of Patients and Current Practice of Treatment of Upper Limb Muscle Spasticity with Botulinum Toxin Type A: An International Survey

ERIC Educational Resources Information Center

Bakheit, Abdel Magid

2010-01-01

To document the current practice in relation with the treatment of patients with upper limb spasticity with botulinum toxin type A to inform future research in this area. We designed an international, cross-sectional, noninterventional survey of current practice. Nine hundred and seventy-four patients from 122 investigational centres in 31…

A simple strategy to reduce stereotype threat for orthopedic residents

PubMed Central

Gomez, Everlyne; Wright, James G.

2014-01-01

Background Stereotype threat, defined as the predicament felt by people in either positive or negative learning experiences where they could conform to negative stereotypes associated with their own group membership, can interfere with learning. The purpose of this study was to determine if a simple orientation session could reduce stereotype threat for orthopedic residents. Methods The intervention group received an orientation on 2 occasions focusing on their possible responses to perceived poor performance in teaching rounds and the operating room (OR). Participants completed a survey with 7 questions typical for stereotype threat evaluating responses to their experiences. The questions had 7 response options with a maximum total score of 49, where higher scores indicated greater degree of experiences typical of stereotype threat. Results Of the 84 eligible residents, 49 participated: 22 in the nonintervention and 27 in the intervention group. The overall scores were 29 and 29.4, and 26.2 and 25.8 in the nonintervention and intervention groups for their survey responses to perceived poor performance in teaching rounds (p = 0.85) and the OR (p = 0.84), respectively. Overall, responses typical of stereotype threat were greater for perceived poor performance at teaching rounds than in the OR (p = 0.001). Conclusion Residents experience low self-esteem following perceived poor performance, particularly at rounds. A simple orientation designed to reduce stereotype threat was unsuccessful in reducing this threat overall. Future research will need to consider longer-term intervention as possible strategies to reduce perceived poor performance at teaching rounds and in the OR. PMID:24666454

Does raising awareness in families reduce environmental tobacco smoke exposure in wheezy children?

PubMed Central

Can, Demet; Gunay, Ilker; Karkıner, Canan Sule Unsal; Gunay, Turkan; Cimrin, Dilek; Nalcabasmaz, Tugba

2017-01-01

Introduction Environmental tobacco smoke (ETS) is thought to increase the severity and number of attacks in wheezy children. Objective assessments are needed to change the behavior of families to reduce the exposure of wheezy children to ETS. Aim To determine whether informing families about their children’s urinary cotinine levels curtailed the exposure of children to ETS. Material and methods A survey was used to determine the ETS exposure level, and the urinary cotinine level of each patient was tested. Children with positive urinary cotinine levels were included in the second part of the study. The families were randomly divided into two groups: an intervention group that was advised about urinary cotinine levels by telephone and a non-intervention group that was not so advised. The groups were followed-up 2 months later, and urinary cotinine levels were measured once again. Results The intervention group contained 65 children of average age of 24.4 ±8.9 months, of whom 46 (70.8%) were male. The non-intervention group contained 69 children of average age of 25.3 ±9.8 months (p > 0.05), of whom 52 (75.4%) were male. The urinary cotinine levels at the time of the second interview were lower in both groups. The number of cigarettes that fathers smoked at home decreased in the intervention group (p = 0.037). Conclusions Presenting objective evidence on ETS exposure to families draws attention to their smoking habits. Measurement of cotinine levels is cheap, practical, and noninvasive. Combined with education, creating awareness by measuring cotinine levels may be beneficial. PMID:28951711

Comfrey: A Clinical Overview

PubMed Central

Staiger, Christiane

2012-01-01

Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd. PMID:22359388

An observational study to evaluate the clinical practice of cardiovascular risk management among hypertensive patients in Turkey.

PubMed

Kozan, Omer

2011-09-01

We evaluated clinical practice in cardiovascular risk management and related patient compliance among Turkish hypertensive patients. This noninterventional, observational study included 1023 patients (620 women, 403 men; mean age 58.4 ± 10.6 years) with essential hypertension, from 50 centers across Turkey. Patients were evaluated at a cross-sectional phase and a follow-up phase of nine months. Data obtained at the cross-sectional phase included patient demographics, medical and past history, cardiovascular risk status, and current practice patterns regarding cardiovascular risk management. The mean duration of hypertension was 8.1 ± 7.1 years. The mean body mass index was 30.3 ± 5.2 kg/m2 and systolic and diastolic blood pressures (BP) were 147.8 ± 22.4 and 88.9 ± 12.5 mmHg, respectively. Ten-year coronary heart disease risk and risk level were significantly higher in males, and significantly increased in the presence of diabetes, metabolic syndrome, and renal disease and/or microalbuminuria (p<0.05). In past year history of cardiovascular risk management, 7.3% of the patients did not have BP measurements; no diet was recommended to 15.6%; 79.3% had high BP levels, and patient compliance with antihypertensive drug treatment and dietary recommendations were 87.7% and 62.5%, respectively. A similar profile was observed for dyslipidemia and diabetes mellitus. The physicians' efforts to motivate the patients to quit smoking, to lose weight, and involve in physical exercise were far below satisfactory levels, and the patients' compliance rates with these recommendations were even lower. Our study demonstrates that hypertensive patients are not adequately evaluated for cardiovascular risk, which is significantly increased in the presence of various cardiovascular risk factors such as diabetes, metabolic syndrome, and renal disease.

An analysis of ranibizumab treatment and visual outcomes in real-world settings: the UNCOVER study.

PubMed

Eldem, Bora; Lai, Timothy Y Y; Ngah, Nor Fariza; Vote, Brendan; Yu, Hyeong Gon; Fabre, Alban; Backer, Arthur; Clunas, Nathan J

2018-05-01

To describe intravitreal ranibizumab treatment frequency, clinical monitoring, and visual outcomes (including mean central retinal thickness [CRT] and visual acuity [VA] changes from baseline) in neovascular age-related macular degeneration (nAMD) in real-world settings across three ranibizumab reimbursement scenarios in the Middle East, North Africa, and the Asia-Pacific region. Non-interventional multicenter historical cohort study of intravitreal ranibizumab use for nAMD in routine clinical practice between April 2010 and April 2013. Eligible patients were diagnosed with nAMD, received at least one intravitreal ranibizumab injection during the study period, and had been observed for a minimum of 1 year (up to 3 years). Reimbursement scenarios were defined as self-paid, partially-reimbursed, and fully-reimbursed. More than three-fourths (n = 2521) of the analysis population was partially-reimbursed for ranibizumab, while 16.4% (n = 532) was fully-reimbursed, and 5.8% was self-paid (n = 188). The average annual ranibizumab injection frequency was 4.1 injections in the partially-reimbursed, 4.7 in the fully-reimbursed and 2.6 in the self-paid populations. The average clinical monitoring frequency was estimated to be 6.7 visits/year, with similar frequencies observed across reimbursement categories. On average, patients experienced VA reduction of -0.7 letters and a decrease in CRT of -44.4 μm. The greatest mean CRT change was observed in the self-paid group, with -92.6 μm. UNCOVER included a large, heterogeneous ranibizumab-treated nAMD population in real-world settings. Patients in all reimbursement scenarios attained vision stability on average, indicating control of disease activity.

Is safety of childhood growth hormone therapy related to dose? Data from a large observational study.

PubMed

Sävendahl, Lars; Pournara, Effie; Pedersen, Birgitte Tønnes; Blankenstein, Oliver

2016-05-01

Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group. We found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk-ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure; P < 0.0001 for all). Except for SAEs in the intermediate-risk group (P = 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported. We conclude that safety data from NordiNet(®) IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found. © 2016 European Society of Endocrinology.

The association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C: an observational, multicenter study in Turkey.

PubMed

Dökmeci, Abdulkadir; Ustündağ, Yücel; Hulagu, Saadettin; Tuncer, Ilyas; Akdoğan, Meral; Demirsoy, Hüseyin; Köklü, Seyfettin; Güzelbulut, Fatih; Doğan, Ibrahim; Demir, Ali; Akarsu, Mesut; Yüceyar, Hakan; Ozdoğan, Osman Cavit; Ozdener, Fatih; Erdoğan, Seda

2014-10-01

To evaluate the association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C. A total of 104 chronic hepatitis C patients were included in this non-interventional, open-label, observational, multicenter, cross-sectional study conducted at 20 gastroenterology clinics in Turkey. The primary end point was the correlation between stage of hepatic fibrosis and insulin resistance evaluated via the homeostasis model of assessment-insulin resistance index. Confounders of hepatic fibrosis and insulin resistance were the secondary end points. The mean age of patients was 52.8 years; 65.4% were female. Type 2 diabetes was present in 6.8% and insulin resistance noted in 38.0% of patients. Further, 45.7% of the patients had mild (A0/A1) and the remaining had moderate/severe (A2/A3) hepatic necroinflammatory activity. Patient distribution according to Metavir fibrosis stage was as follows: F0/F1 (57.0%); F2 (6.5%); F3 (23.7%); and F4 (12.9%). A univariate analysis revealed significant positive correlations between Metavir fibrosis stage and insulin resistance (r=0.297; p=0.007). Logistic regression analysis showed that significant predictors of insulin resistance were high alanine transaminase levels (odds ratio, 0.97; 95% confidence interval, 0.944-0.997) and liver fibrosis stage (odds ratio, 0.114; 95% confidence interval, 0.021-0.607). Our findings revealed significant associations between insulin resistance and hepatic fibrosis.

The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review.

PubMed

Weiss, H-R; Goodall, D

2008-06-01

Traditionally, the treatment options for adolescent idiopathic scoliosis (AIS), the most common form of scoliosis, are exercises; in-patient rehabilitation; braces and surgery. The outcomes of treatments are usually compared with the natural history or observation (non-intervention). The aim of this paper was to provide a synopsis of all treatment options in the light of evidence based practice (EBP). A systematic review was carried out using the most encompassing databases available. Literature has been searched for the outcome parameter ''rate of progression'' and only prospective controlled studies that have considered the treatment versus the natural history have been included. The search strategy included the following terms: ''adolescent idiopathic scoliosis''; ''idiopathic scoliosis''; ''natural history''; ''observation''; ''physiotherapy''; ''physical therapy''; ''rehabilitation''; ''bracing''; ''orthotics'' and ''surgery''. Prospective short-term studies have been found to support outpatient physiotherapy. One prospective controlled study was found to support scoliosis in-patient rehabilitation (SIR). One prospective multi-centre study, a long-term prospective controlled study and a meta-analysis have been found to support bracing. No controlled study, neither short, mid nor long-term, was found to reveal any substantial evidence to support surgery as a treatment for this condition. There is some evidence supporting the conservative treatment for AIS. No substantial evidence has been found in terms of prospective controlled studies to support surgical intervention. In light of the unknown long-term effects of surgery, a randomised controlled trial (RCT) seems necessary. Due to the presence of evidence to support conservative treatments, a plan to compose a RCT for conservative treatment options seems unethical. But it is also important to conclude that the evidence for conservative treatments is weak in number and length.

An Initial Investigation of the Generalization of a School-Based Social Competence Intervention for Youth with High-Functioning Autism

PubMed Central

Schmidt, Carla; Stichter, Janine P.; Lierheimer, Kristin; McGhee, Stephanie; O'Connor, Karen V.

2011-01-01

This study evaluated the impact of generalization of the Social Competence Intervention-Adolescent (SCI-A) curriculum in a school setting for individuals with high-functioning autism or Asperger's Syndrome (N = 6). This study examined to what degree the generalization of the SCI-A curriculum could be measured when delivered in a school setting. Across the six participants preliminary results suggest improvement on teacher reports of social skills and executive functioning. Some improvements were also evident in direct measures of facial-expression recognition. Data collected in the nonintervention settings indicated that some generalization of social interaction skills may have occurred for all six participants. Future research directions are discussed. PMID:22937252

An observational study of powered wheelchair provision in Italy.

PubMed

Salatino, Claudia; Andrich, Renzo; Converti, R M; Saruggia, M

2016-01-01

Powered wheelchairs are complex and expensive assistive devices that must be selected and configured on the basis of individual user needs, lifestyle, motivation, driving ability, and environment. Providing agencies often require evidence that their financial investment will lead to a successful outcome. The authors surveyed a sample of 79 users who had obtained powered wheelchairs from a Regional Health Service in Italy in the period 2008-2013. Follow-up interviews were conducted at the users' homes in order to collect information about wheelchair use, and its effectiveness, usefulness, and economic impact. The instruments used in the interviews included an introductory questionnaire, QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology), PIADS (Psychosocial Impact of Assistive Devices Scale), FABS/M (Facilitators and Barriers Survey/Mobility), and SCAI (Siva Cost Analysis Instrument). The results indicated positive outcomes, especially in relation to user satisfaction and psychosocial impact. A number of barriers were identified in various settings that sometimes restrict user mobility, and suggest corrective actions. The provision of a powered wheelchair generated considerable savings in social costs for most users: an average of about $38,000 per person over a projected 5-year period was estimated by comparing the cost of the intervention with that of non-intervention.

The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study

PubMed Central

Moots, Robert J.; Xavier, Ricardo M.; Mok, Chi Chiu; Rahman, Mahboob U.; Tsai, Wen-Chan; Al-Maini, Mustafa H.; Pavelka, Karel; Mahgoub, Ehab; Kotak, Sameer; Korth-Bradley, Joan; Pedersen, Ron; Mele, Linda; Shen, Qi; Vlahos, Bonnie

2017-01-01

Objective To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. Methods This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6–24 months with ETN, ADL, or IFX. ADA and trough drug concentrations were measured by independent assays ≤2 days before the next scheduled dose. Efficacy measurements included Disease Activity Score 28-joint count (DAS28), low disease activity (LDA), remission, and erythrocyte sedimentation rate (ESR). Targeted medical histories of injection site/infusion reactions, serum sickness, and thromboembolic events were collected. Results Baseline demographics of the 595 patients (ETN: n = 200; ADL: n = 199; IFX: n = 196) were similar across groups. The mean duration of treatment was 14.6, 13.5, and 13.1 months for ETN, ADL, and IFX, respectively. All ETN-treated patients tested negative for ADA, whereas 31.2% and 17.4% patients treated with ADL and IFX, respectively, tested positive. In ADL- or IFX-treated patients, those with ADA had significantly lower trough drug concentrations. There were negative correlations between trough drug levels and both CRP and ESR in ADL- and IFX-treated patients. DAS28-ESR LDA and remission rates were higher in patients without ADA. The rate of targeted medical events reported was low. Conclusion ADA were detected in ADL- and IFX-treated but not ETN-treated patients. Patients without ADA generally showed numerically better clinical outcomes than those with ADA. Trial registration This study was registered on www.ClinicalTrials.gov (NCT01981473). PMID:28448562

Variables that influence BRAF mutation probability: A next-generation sequencing, non-interventional investigation of BRAFV600 mutation status in melanoma.

PubMed

Gaiser, Maria Rita; Skorokhod, Alexander; Gransheier, Diana; Weide, Benjamin; Koch, Winfried; Schif, Birgit; Enk, Alexander; Garbe, Claus; Bauer, Jürgen

2017-01-01

The incidence of melanoma, particularly in older patients, has steadily increased over the past few decades. Activating mutations of BRAF, the majority occurring in BRAFV600, are frequently detected in melanoma; however, the prognostic significance remains unclear. This study aimed to define the probability and distribution of BRAFV600 mutations, and the clinico-pathological factors that may affect BRAF mutation status, in patients with advanced melanoma using next-generation sequencing. This was a non-interventional, retrospective study of BRAF mutation testing at two German centers, in Heidelberg and Tübingen. Archival tumor samples from patients with histologically confirmed melanoma (stage IIIB, IIIC, IV) were analyzed using PCR amplification and deep sequencing. Clinical, histological, and mutation data were collected. The statistical influence of patient- and tumor-related characteristics on BRAFV600 mutation status was assessed using multiple logistic regression (MLR) and a prediction profiler. BRAFV600 mutation status was assessed in 453 samples. Mutations were detected in 57.6% of patients (n = 261), with 48.1% (n = 102) at the Heidelberg site and 66.0% (n = 159) at the Tübingen site. The decreasing influence of increasing age on mutation probability was quantified. A main effects MLR model identified age (p = 0.0001), center (p = 0.0004), and melanoma subtype (p = 0.014) as significantly influencing BRAFV600 mutation probability; ultraviolet (UV) exposure showed a statistical trend (p = 0.1419). An interaction model of age versus other variables showed that center (p<0.0001) and melanoma subtype (p = 0.0038) significantly influenced BRAF mutation probability; age had a statistically significant effect only as part of an interaction with both UV exposure (p = 0.0110) and melanoma subtype (p = 0.0134). This exploratory study highlights that testing center, melanoma subtype, and age in combination with UV exposure and melanoma subtype significantly influence BRAFV600 mutation probability in patients with melanoma. Further validation of this model, in terms of reproducibility and broader relevance, is required.

Effect of breast-feeding on the development of atopic dermatitis during the first 3 years of life--results from the GINI-birth cohort study.

PubMed

Laubereau, Birgit; Brockow, Inken; Zirngibl, Angelika; Koletzko, Sibylle; Gruebl, Armin; von Berg, Andrea; Filipiak-Pittroff, Birgit; Berdel, Dietrich; Bauer, Carl Peter; Reinhardt, Dietrich; Heinrich, Joachim; Wichmann, H-Erich

2004-05-01

To investigate if exclusive breast-feeding for 4 months is associated with atopic dermatitis during the first 3 years of life. Data on 3903 children were taken from yearly parental-administered questionnaires from a birth cohort study in Germany (recruited 1995-1998) comprised of a noninterventional (NI) and an interventional (I) subgroup. Outcomes were physician-diagnosed atopic dermatitis (AD) and itchy rash. Multiple logistic regression was performed for the entire cohort and stratified by family history of allergy and by study group adjusting for a fixed set of risk factors for allergies. Exclusive breast-feeding (52 % of children) was not associated with higher risk for AD either in the entire cohort (OR(adj,) 0.95; 95% CI, 0.79-1.14) or if stratified by family history of AD. In the I subgroup, but not in the NI subgroup, exclusive breast-feeding showed a significant protective effect on AD if compared with conventional cow's milk formula (OR(adj), 0.64; 95% CI, 0.45-0.90). These findings do not support the hypothesis that exclusive breast-feeding is a risk factor for development of atopic dermatitis but is protective if compared with conventional cow's milk. Observational studies might not be able to effectively control for selection bias and reverse causation.

Assessment of liver and cardiac iron overload using MRI in patients with chronic anemias in Latin American countries: results from ASIMILA study.

PubMed

Cancado, Rodolfo; Watman, Nora P; Lobo, Clarisse; Chona, Zulay; Manzur, Fernando; Traina, Fabiola; Park, Miriam; Drelichman, Guillermo; Zarate, Juan Pablo; Marfil, Luis

2018-04-17

A multicenter, noninterventional, observational study was conducted in the Latin American countries including Argentina, Brazil, Colombia, Mexico, and Venezuela to assess the prevalence of liver and cardiac iron overload using magnetic resonance imaging (MRI) in patients with chronic anemias except thalassemia. Patients aged >10 years with transfusion-dependent anemias, except thalassemia, either with <20 units of red blood cell (RBC) transfusions with serum ferritin (SF) levels >2000 ng/mL or with ≥20 units of RBC transfusions regardless of SF level in their lifetime, were enrolled. Iron overload was assessed using MRI. Among 175 patients included, the majority had sickle cell disease (SCD; 52%), followed by aplastic anemia (AA; 17.7%), myelodysplastic syndrome (MDS; 8.6%), Diamond-Blackfan anemia (DBA; 4%), pure red cell aplasia (1.1%), and others (16.6%). Liver iron overload was observed in 76.4% of patients, while cardiac iron overload was seen in 19.2% when assessed by MRI. The prevalence of iron overload was 80.2% in patients with SCD, 73.3% in MDS, 77.4% in AA, 100% in pure red cell aplasia, 71.4% in DBA, and 68.9% in other transfusion-related disorders. A moderate correlation between liver iron concentration (LIC) and SF was observed in patients with SCD and MDS (r = 0.47 and r = 0.61, respectively). All adverse events reported were consistent with the published data for deferasirox or underlying disease. A high prevalence of iron overload in this patient population in Latin American countries indicates that a better diagnosis and management of iron overload is required in these countries.

Beyond the traditional definition of breakthrough pain: an observational study.

PubMed

Gatti, Antonio; Gentili, Marta; Iorno, Vittorio; Mammucari, Massimo; Tufaro, Giuseppe; Lazzari, Marzia; Sabato, Alessandro Fabrizio

2013-03-01

Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions. This was a prospective, non-interventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (<3 months) or chronic (>3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) non-chronic non-oncological pain. The correlation between BTP and gender was also investigated. Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P < 0.001). No differences were reported in terms of number and severity of daily BTP episodes. BTP was more frequent in females with non-oncological pain (P = 0.04). Females had a significantly higher pain severity (P = 0.02) than males. BTP is frequently reported in patients who do not have BTP according to the traditional definition. BTP frequency and severity is similar in oncological and non-oncological pain.

Effect of Community-based Behavior Change Communication on Delivery and Newborn Health Care Practices in a Resettlement Colony of Delhi.

PubMed

Parashar, Mamta; Singh, Sv; Kishore, Jugal; Kumar, Ajay; Bhardwaj, Milan

2013-01-01

Neonatal morbidity and mortality in India continue to be high. Among other reasons, newborn care practices are major contributors for such high rates. To assess the effect of behavior change communication (BCC) package among pregnant women regarding neonatal care. Semistructured and pretested schedule was used to interview 200 multigravidas on various aspects of neonatal care. Based on the preliminary data, BCC package was designed and implemented in intervention block in the community. Follow-up was done to find out change in their behavior. Data were analyzed using Epi info and Fischer exact test and chi-square test were applied in the baseline data. A P value of less than 0.05 was considered significant. Effect of the BCC package is given in terms of relative risk. BCC package increased 1.76 times higher number of deliveries conducted by trained dais in intervention group. There was significant improvement in using sterile cord tie (P = 0.01), applied nothing to the cord (P < 0.0001) and giving bath to their baby within 6 h of birth (P = 0.02) in intervention group as compared to nonintervention group. Significant difference was found between the two groups with regard to breastfeeding practices of baby. Harmful practices were reduced in the intervention group. Significant improvement was found in intervention group as compared to nonintervention group with regard to knowledge of danger signals, physiological variants, management of breastfeeding-related problems, and awareness of skin-to-skin technique for the management of hypothermic baby. Inadequate knowledge and adverse practices regarding neonatal care among mothers in study areas were found. BCC package had favorable impact on behavior of mothers for neonatal care in intervention group.

Effect of a Quality Improvement Program to Improve Guideline Adherence and Attainment of Clinical Standards in Dialysis Care: Report of Outcomes in Year 1.

PubMed

Youssouf, Sajeda; Nache, Azri; Wijesekara, Chandrakumaran; Middleton, Rachel J; Lewis, David; Shurrab, Aladdin E; O'Riordan, Edmond; Lappin, Lesley P; O'Donoghue, Donal; Kalra, Philip A; Hegarty, Janet

2017-01-01

Best practice in dialysis is synthesised in clear international guidelines. However, a large gap remains between the international guidelines and the actual delivery of care. In this paper, we report outcomes for the first year of a multifaceted dialysis improvement programme in our network. One year collaborative involving 3 haemodialysis units and a peritoneal dialysis (PD) programme involving 299 dialysis patients. Each unit addressed a different indicator (unit A - catheter-related bloodstream infection [CRBSI], unit B - pre-dialysis blood pressure [BP], unit C - dialysis dose, unit D - anaemia) with a shared aim to match the top 10% in the UK. Tailored multifaceted approaches include a modified collaborative methodology with an aim, framework, driver diagram, learning sessions, facilitated meetings, plan-do-study-act cycles and continuous measurement. Analysis of outcomes, costings, erythropoietin stimulating agent and iron use, and safety culture attributes. Unit A reduced CRBSI from 2.65 to 0.5 per 1,000 catheter days (p = 0.02). Unit B improved attainment of target BP from 37.5 to 67.2% (p = 0.003). Unit C improved attainment of target urea reduction ratio from 75.8 to 91.4% (p = 0.04). PD unit D improved attainment of target haemoglobin from 45.5 to 62.7% (p = 0.01), with no significant change in the indicators in a non-intervention unit. Safety culture attributes improved. Costs associated with admission for fluid overload and infection, erythropoietin, iron and thrombokinase use decreased 36% (£415,620-£264,143). Units that took part in this collaborative improved guideline adherence compared both to their own pre-intervention performance and a non-intervention unit. Such multifaceted interventions are a useful methodology to improve dialysis care. © 2017 S. Karger AG, Basel.

The evaluation of a standardized call/recall system for childhood immunizations in Wandsworth, England.

PubMed

Atchison, Christina; Zvoc, Miro; Balakrishnan, Ravikumar

2013-06-01

To improve uptake of childhood immunizations in Wandsworth we developed a standardized call/recall system based on parents being sent three reminders and defaulters being referred to a Health Visitor. Thirty-two out of 44 primary care practices in the area implemented the intervention in September 2011. The aim of this study was to evaluate the implementation, delivery and impact on immunization uptake of the new call/recall system. To assess implementation and delivery, a mixed method approach was used including qualitative (structured interviews) and quantitative (data collected at three months post-implementation) assessment. To assess the impact, we used Student's t test to compare the difference in immunization uptake rates between intervention and non-intervention practices before and after implementation. The call/recall system was viewed positively by both parents and staff. Most children due or overdue immunizations were successfully captured by the 1st invitation reminder. After three invitations, between 87.3 % (MMR1) and 92.2 % (pre-school booster) of children identified as due or overdue immunizations successfully responded. Prior to implementation there was no difference in uptake rates between intervention and non-intervention practices. Post-implementation uptake rates for DTaP/IPV/Hib, MMR1, MMR2 and the pre-school booster were significantly greater in the intervention practices. Similar findings were seen for PCV and Hib/MenC boosters, although the differences were not statistically significant at the 5 % level. Following the successful implementation of a standardized call/recall system in Wandsworth, other regions or primary care practices may wish to consider introducing a similar system to help improve their immunization coverage levels.

Interest in Integrative Medicine Among Postmenopausal Hormone Receptor–Positive Breast Cancer Patients in the EvAluate-TM Study

PubMed Central

Hack, Carolin C.; Fasching, Peter A.; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W.; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesslet, Thomas; Fischer, Gunnar; Henschen, Stefan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M.; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y.; Wallwiener, Diethelm; Kümmel, Sherko; Beckmann, Matthias W.; Paepke, Daniela

2016-01-01

Background. Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine. Methods. The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor–positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine. Results. Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly (P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources. Conclusions. This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor. PMID:27627986

Interest in Integrative Medicine Among Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study.

PubMed

Hack, Carolin C; Fasching, Peter A; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesslet, Thomas; Fischer, Gunnar; Henschen, Stefan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y; Wallwiener, Diethelm; Kümmel, Sherko; Beckmann, Matthias W; Paepke, Daniela

2017-06-01

Breast cancer patients often use complementary and alternative medicine, but few prospectively collected data on the topic are available specifically for postmenopausal breast cancer patients. A large prospective study was therefore conducted within a noninterventional study in order to identify the characteristics of patients interested in integrative medicine. The EvAluate-TM study is a prospective, multicenter noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive primary breast cancer. Between 2008 and 2009, 5045 postmenopausal patients were enrolled at 339 certified breast centers in Germany. As part of the data collection process, patients were asked at the baseline about their interest in and information needs relating to integrative medicine. Of the 5045 patients recruited, 3411 responded to the questionnaire on integrative medicine and took part in the analysis, 1583 patients expressed an interest in integrative medicine, and 1828 patients declared no interest. Relevant predictors of interest in integrative medicine were age, body mass index, tumor size, previous chemotherapy, and use of concomitant medications for other medical conditions. Interest in integrative medicine declined highly significantly ( P < .001) with age (<50 years, 74.1%; 50-60 years, 54.1%; >65 years, 38.0%). Patients in favor of integrative medicine were significantly less satisfied with the information received about individual treatments and antihormonal therapy. Patients with interest in integrative medicine were more often interested in rehabilitation and fitness, nutritional counseling, and additional support from self-help organizations. These women were mostly interested in receiving information about their disease and integrative medicine from a physician, rather than from other sources. This study shows that a considerable proportion of postmenopausal breast cancer patients are interested in integrative medicine. Information about integrative medicine should therefore be provided as part of patient care for this group. It was found that receiving concomitant medication for other medical conditions is one of the main predictors for women not being interested in integrative medicine. This group of patients may need special attention and individualized information about integrative medicine. Additionally, most patients were interested in obtaining the relevant information from their doctor.

The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia.

PubMed

Joshi, Kruti; Mao, Lian; Biondi, David M; Millet, Robert

2018-01-29

Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of "real-world" patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual. This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12. A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort. Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes. Clinical Trial Registry: NCT01181960 . Registered 12 August 2010.

Impact of irritability: a 2-year observational study of outpatients with bipolar I or schizoaffective disorder.

PubMed

Berk, Lesley; Hallam, Karen T; Venugopal, Kamalesh; Lewis, Andrew James; Austin, David W; Kulkarni, Jayashri; Dodd, Seetal; de Castella, Anthony; Fitzgerald, Paul B; Berk, Michael

2017-05-01

Many people experience irritability when manic, hypomanic, or depressed, yet its impact on illness severity and quality of life in bipolar and schizoaffective disorders is poorly understood. This study aimed to examine the relationship between irritability and symptom burden, functioning, quality of life, social support, suicidality, and overall illness severity in a naturalistic cohort of people with bipolar I or schizoaffective disorder. We used data from 239 adult outpatients with bipolar I or schizoaffective disorder in the Bipolar Comprehensive Outcomes Study (BCOS) - a non-interventional observational study with a 2-year follow-up period. Baseline demographic and clinical characteristics of participants with and without irritability were compared. A mixed-model repeated measures analysis was conducted to examine the longitudinal effect of irritability on clinical and quality-of-life variables over follow-up using significant baseline variables. At baseline, 54% of participants were irritable. Baseline irritability was associated with illness severity, mania, depression, psychotic symptoms, suicidality, poor functioning, and quality of life, but not diagnosis (schizoaffective/bipolar disorder). Participants with irritability were less likely to have a partner and perceived less adequate social support. On average, over follow-up, those with irritability reported more symptoms, functional impairment, and suicidality. Furthermore, the effects of irritability could not be fully explained by illness severity. Irritability was associated with more negative symptomatic, functional, and quality-of-life outcomes and suicidality. The identification, monitoring, and targeted treatment of irritability may be worth considering, to enhance health and wellbeing outcomes for adults with bipolar and schizoaffective disorders. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[No clinical evidence for an enhanced bleeding tendency due to perioperative treatment with bromelain].

PubMed

Johann, K; Eschmann, K; Meiser, P

2011-06-01

Systemic enzyme therapy with bromelain resembles a sensible alternative to nonsteroidal antiinflammatory drugs for the treatment of sports injuries, with particular consideration of therapeutic benefits and possible risks. Beyond aftertreatment of sports injuries, bromelain is used postoperatively as well. Besides the desired effects remission of oedema and pain relief, however, the postoperative use of bromelain raises uncertainty in some patients and physicians since an enhanced bleeding tendency in case of concomitant therapy with anticoagulants was described as a possible interaction. Therefore, the goal of this study was to investigate the clinical relevance of this interaction. In two non-interventional studies, altogether 260 patients were peri- or postoperatively (cruciate ligament- or coxarthrosis surgery) treated with bromelain (n = 129, 1000 - 3000 F. I. P. units/day) or diclofenac (n = 131; 150 mg/day) under concomitant thrombosis prophylaxis with low molecular weight heparin. Parameters tested were prothrombin time, thrombin time, activated partial thromboplastin time, fibrinogen and tolerability of the medication. Only marginal changes and a low variability of coagulation parameters were observed in both treatment groups (bromelain vs. diclofenac) in both studies. Elevated laboratory parameters were observed in both treatment groups for thrombin time which is very likely attributable to the therapy with low molecular weight heparin, due to the substantially parallel course of this parameter in both treatment groups. Therapy with bromelain was superior to the treatment with diclofenac concerning the number and the severity of undesirable effects, as was expected. The presented studies therefore support the previous clinical evidence that a perioperative treatment with bromelain is well tolerated and does not lead to an increased risk of haemorrhage when used concomitantly with low molecular weight heparin. © Georg Thieme Verlag KG Stuttgart · New York.

Two-year intervention trial to control of fish-borne zoonotic trematodes in giant gourami (Osphronemus goramy) and striped catfish (Pangasianodon hypophthalmus) in nursery ponds in the Mekong Delta, Vietnam.

PubMed

Madsen, H; Thien, P C; Nga, H T N; Clausen, J H; Dalsgaard, A; Murrell, K D

2015-12-01

Fish-borne zoonotic trematode parasites (FZT) pose a food safety and public health problem in Vietnam. The transmission cycle is complex as domestic animals, especially dogs, cats, fish-eating birds and pigs together with humans serve as reservoir hosts and contribute to FZT egg contamination of aquaculture ponds and the environment. This intervention trial was conducted to determine the effectiveness of various on-farm interventions, including reduction in FZT egg contamination through treatment of infected people and domestic animals, reduction in snail density through mud removal from aquaculture ponds prior to fish stocking, and various other measures in reducing FZT infection in juvenile striped catfish (Pangasianodon hypophthalmus) and giant gourami (Osphronemus goramy). Interventions were implemented on 5 farms for each fish species during production cycles in 2009 and 2010 while 5 similar farms for each species served as control. For both fish species, both prevalence and intensity of infection did not differ significantly between intervention and non-intervention farms prior to the interventions. The interventions significantly reduced both prevalence and intensity of FZT infection in the juvenile fish compared to control ponds. For giant gourami, odds of infection in intervention ponds was 0.13 (95% CL: 0.09-0.20; p<0.001) of that in non-intervention ponds after the 2009 trial and 0.07 (0.03-0.14; p<0.001) after the 2010 trial. For striped catfish, these figures were 0.17 (0.08-0.35; p<0.001) after the 2009 trial while after the 2010 trial all ponds with interventions were free from infection. Metacercariae intensity (no. of metacercariae/fish) in giant gourami from intervention ponds was 0.16 (0.11-0.23; p<0.001) of that in fish from non-intervention ponds after the 2009 trial and 0.07 (0.04-0.15; p<0.001) after the 2010 trial; for striped catfish these figures were 0.18 (0.09-0.36; p<0.001) and 0.00 (confidence limits not estimated), respectively. The aquaculture farm pond intervention approaches taken in this trial have the potential to reduce or eliminate FZT infections in fish and may be implemented across the entire region if adjusted to local conditions and fish species. Copyright © 2015 Elsevier B.V. All rights reserved.

SCOPEOUT: sustainability and spread of quality improvement activities in long-term care- a mixed methods approach.

PubMed

Cranley, Lisa A; Hoben, Matthias; Yeung, Jasper; Estabrooks, Carole A; Norton, Peter G; Wagg, Adrian

2018-03-12

Interventions to improve quality of care for residents of long-term care facilities, and to examine the sustainability and spread of such initiatives, remain a top research priority. The purpose of this exploratory study was to assess the extent to which activities initiated in a quality improvement (QI) collaborative study using care aide led teams were sustained or spread following cessation of the initial project and to identify factors that led to its success. This study used an exploratory mixed methods study design and was conducted in seven residential long-term care facilities in two Canadian provinces. Sustainability and spread of QI activities were assessed by a questionnaire over five time points for 18 months following the collaborative study with staff from both intervention with non-intervention units. Semi-structured interviews were conducted with care managers at six and 12 months. QI team success in applying the QI model was ranked as high, medium, or low using criteria developed by the research team. Descriptive statistics, bivariate analyses, and General Estimating Equations were used to analyze the data. Interview data were analyzed using thematic analysis. In total, 683 surveys were received over the five time periods from 476 unique individuals on a facility unit. Seven managers were interviewed. A total of 533 surveys were analyzed. While both intervention and non-intervention units experienced a decline over time in all outcome measures, this decline was significantly less pronounced on intervention units. Facilities with medium and high success ranking had significantly higher scores in all four outcomes than facilities with a low success ranking. Care aides reported significantly less involvement of others in QI activities, less empowerment and less satisfaction with the quality of their work life than regulated care providers. Manager interviews provided evidence of sustainability of QI activities on the intervention units in four of the seven facilities up to 18 months following the intervention and demonstrated the need for continued staff and leadership engagement. Sustainability of a QI project which empowers and engages care aides is possible and achievable, but requires ongoing staff and leadership engagement.

Paramedic Application of a Triage Sieve: A Paper-Based Exercise.

PubMed

Cuttance, Glen; Dansie, Kathryn; Rayner, Tim

2017-02-01

Introduction Triage is the systematic prioritization of casualties when there is an imbalance between the needs of these casualties and resource availability. The triage sieve is a recognized process for prioritizing casualties for treatment during mass-casualty incidents (MCIs). While the application of a triage sieve generally is well-accepted, the measurement of its accuracy has been somewhat limited. Obtaining reliable measures for triage sieve accuracy rates is viewed as a necessity for future development in this area. The goal of this study was to investigate how theoretical knowledge acquisition and the practical application of an aide-memoir impacted triage sieve accuracy rates. Two hundred and ninety-two paramedics were allocated randomly to one of four separate sub-groups, a non-intervention control group, and three intervention groups, which involved them receiving either an educational review session and/or an aide-memoir. Participants were asked to triage sieve 20 casualties using a previously trialed questionnaire. The study showed the non-intervention control group had a correct accuracy rate of 47%, a similar proportion of casualties found to be under-triaged (37%), but a significantly lower number of casualties were over-triaged (16%). The provision of either an educational review or aide-memoir significantly increased the correct triage sieve accuracy rate to 77% and 90%, respectively. Participants who received both the educational review and aide-memoir had an overall accuracy rate of 89%. Over-triaged rates were found not to differ significantly across any of the study groups. This study supports the use of an aide-memoir for maximizing MCI triage accuracy rates. A "just-in-time" educational refresher provided comparable benefits, however its practical application to the MCI setting has significant operational limitations. In addition, this study provides some guidance on triage sieve accuracy rate measures that can be applied to define acceptable performance of a triage sieve during a MCI. Cuttance G , Dansie K , Rayner T . Paramedic application of a triage sieve: a paper-based exercise. Prehosp Disaster Med. 2017;32(1):3-13.

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A1chieve study.

PubMed

Chraibi, Abdelmjid; Belmejdoub, Ghizlane

2013-11-01

The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66 726) in routine clinical care across four continents. Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Rabat-Sale-Zemmour-Zaer region, Morocco. A total of 424 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 177), insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.1%) and insulin user (mean HbA1c: 9.4%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA1c (insulin naïve: -2.5%, insulin users: -1.8%). Major hypoglycaemia was observed in the insulin user group after 24 weeks (0.1 events/patient-year). SADRs were reported in 0.5% of insulin users. Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

Rupatadine in Established Treatment Schemes Improves Chronic Spontaneous Urticaria Symptoms and Patients' Quality of Life: a Prospective, Non-interventional Trial.

PubMed

Metz, Martin; Weller, Karsten; Neumeister, Claudia; Izquierdo, Iñaki; Bödeker, Rolf-Hasso; Schwantes, Ulrich; Maurer, Marcus

2015-12-01

Chronic spontaneous urticaria (CSU) is a common and hard to treat condition associated with a substantial negative impact on patients' quality of life (QoL). Clinical studies have shown that rupatadine is effective and safe in the treatment of CSU, but data from routine clinical care are scarce. Therefore, we assessed the effectiveness and tolerability of rupatadine in established dosages on CSU activity and patients' QoL in a routine daily practice setting. This was an open, prospective, non-interventional study performed in 146 dermatological practices in Germany. CSU patients for whom treatment with rupatadine was indicated were eligible to participate. Key symptoms of urticaria activity and their impact on patients' QoL were assessed at the beginning and the end of treatment. Adverse events (AEs) and withdrawals, as well as the dosage regimens chosen, were documented. Patients and physicians were requested to rate effectiveness and tolerability of therapy at the final visit. All statistical analyses were descriptive. The majority of the 660 patients screened to be treated (median age 44 years, IQR = 31-59 years, n = 654) received rupatadine 10 mg tablets once (477 patients) or twice (105 patients) daily for a median time of 28 days. After treatment, 93.2% of the patients (606/650) reported a clear overall improvement of symptoms. Rupatadine significantly reduced the urticaria activity score (UAS7) as well as the frequency and severity of existing angioedema episodes. Similarly all domains of the urticaria-specific QoL questionnaire (CU-Q 2 oL) were markedly improved. The majority of physicians and patients rated rupatadine treatment as effective and well tolerated. There were 39 (5.9%) early treatment withdrawals, and 21 patients (3.2%) experienced AEs. Rupatadine when given according to the routine treating schemes improves symptoms and CU-Q 2 oL of CSU patients; the drug is also safe and well tolerated. Dr. R. Pfleger GmbH.

Feasibility and usefulness of ultrasonography in idiopathic intracranial hypertension or secondary intracranial hypertension.

PubMed

Lochner, Piergiorgio; Brio, Francesco; Zedde, Maria Luisa; Sanguigni, Sandro; Coppo, Lorenzo; Nardone, Raffaele; Naldi, Andrea; Sola, Daniele; Stolz, Erwin

2016-06-02

Transorbital sonography (TOS) has been proven to be able to non-invasively detect elevated intracranial pressure. In this condition TOS shows an increase in optic nerve sheath diameter (ONSD). It has been suggested that internal jugular vein valve insufficiency (IJVVI) may represent a factor contributing to the pathogenesis of idiopathic intracranial hypertension (IIH). The aim of this study was to investigate whether patients with IIH or secondary IH have higher ONSD values and higher frequency of IJVVI compared to subjects without IH. Twenty-one patients with newly diagnosed IIH or secondary IH were prospectively evaluated and compared with 21 age, gender and BMI-matched controls. Experienced vascular sonographers used B-mode TOS to evaluate ONSD, optic nerve diameter (OND) and IJVVI. CSF opening pressures were also measured. ONSD values were significantly higher in patients (6.50 ± 0.67) than controls (5.73 ± 0.66; p < 0.0001). No differences were found in OND values between patients (2.99 ± 0.26) and controls (2.93 ± 0.41; p = 0.574). No correlation was demonstrated between ONSD and CSF opening pressure (r = 0,086) (p = 0.73). No difference in frequency of IJVVI between patients (11/42 valves, 26 %) and controls (9/42, 21 %) was observed (p = 0.777). Increased ONSD values detected by TOS support the diagnosis of IH. Our results do not support the hypothesis of a venous congestion as a potential factor contributing to the pathogenesis of IIH. Not applicable. Observational, non-interventional study.

A Study of Concept Mapping as an Instructional Intervention in an Undergraduate General Chemistry Calorimetry Laboratory

NASA Astrophysics Data System (ADS)

Stroud, Mary W.

This investigation, rooted in both chemistry and education, considers outcomes occurring in a small-scale study in which concept mapping was used as an instructional intervention in an undergraduate calorimetry laboratory. A quasi-experimental, multiple-methods approach was employed since the research questions posed in this study warranted the use of both qualitative and quantitative perspectives and evaluations. For the intervention group of students, a convenience sample, post-lab concept maps, written discussions, quiz responses and learning surveys were characterized and evaluated. Archived quiz responses for non-intervention students were also analyzed for comparison. Students uniquely constructed individual concept maps containing incorrect, conceptually correct and "scientifically thin" calorimetry characterizations. Students more greatly emphasized mathematical relationships and equations utilized during the calorimetry experiment; the meaning of calorimetry concepts was demonstrated to a lesser extent.

Quiet Eye and Performance in Sport: A Meta-Analysis.

PubMed

Lebeau, Jean-Charles; Liu, Sicong; Sáenz-Moncaleano, Camilo; Sanduvete-Chaves, Susana; Chacón-Moscoso, Salvador; Becker, Betsy Jane; Tenenbaum, Gershon

2016-10-01

Research linking the "quiet eye" (QE) period to subsequent performance has not been systematically synthesized. In this paper we review the literature on the link between the two through nonintervention (Synthesis 1) and intervention (Synthesis 2) studies. In the first synthesis, 27 studies with 38 effect sizes resulted in a large mean effect (d = 1.04) reflecting differences between experts' and novices' QE periods, and a moderate effect size (d = 0.58) comparing QE periods for successful and unsuccessful performances within individuals. Studies reporting QE duration as a percentage of the total time revealed a larger mean effect size than studies reporting an absolute duration (in milliseconds). The second synthesis of 9 articles revealed very large effect sizes for both the quiet-eye period (d = 1.53) and performance (d = 0.84). QE also showed some ability to predict performance effects across studies.

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

PubMed

Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with minimum safety concerns in the actual clinical practice. The observed treatment persistence suggests that tafluprost can be used long term owing to its benefit-risk profile. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

[The safety of long-term administration of losartan in current clinical practice: a non-intervention NCT-CZ 14/04/LOZ study].

PubMed

Krupicka, J; Ceypová, K; Kristenová, P; Hauser, T

2008-11-01

Losartan is the longest used angiotensin II receptor blocker in clinical practice. It is one of the first-line drugs for the treatment of hypertensive disease and there is enough data available today about its use in the treatment of the disease, including some specific situations (left ventricular hypertrophy, cerebrovascular accidents) and cases when the hypertension disease combines with another disease (e.g. diabetic nephropathy). The primary objective of the non-intervention multicentre prospective observational open clinical assessment NCT-CZ 14/04/LOZ was to verify on a large sample of patients the safety of Lozap and Lozap H in current clinical practice. The six-month clinical study enrolled patients with recently diagnosed hypertension and/or poorly controlled hypertension [blood pressure > or = 140/90 mm Hg: 4432 patients (96%); blood pressure: < or = 139/89 mm Hg 84 patients (2%); value unspecified: 83 patients (2%)]. A standard form was used for data acquisition. A total of 4,599 patients was enrolled (of which 2,386 women, i.e. 51.9%) with mean age 61 +/- 12 years (18-95 years; median 60 years) with additional risk factors (cardiovascular diseases in 48%, diabetes mellitus in 33%, lipid metabolism disorder in 42%, obesity in 45% and smoking in 26% of cases, respectively). 2,631 patients (57%) had previously diagnosed hypertension. The average blood pressure (BP) at enrolment in the study was 159/95mm Hg (median 160/95 mm Hg), and the average heart rate was 76 strokes/min (median 76). The most frequently used dose was 50 mg of losartan (Lozap or Lozap H)--in 4,006 patients (87%) at enrolment in the study and in 3,982 patients (87%) at the end of the study. Adverse effects related to the treatment during the study were reported in a total of 9 patients (0.2%). The therapy was assessed as well tolerated in 96% of patients (4,409), as fairly tolerated in 3% of patients (131) and as poorly tolerated in 0.1% of patients (4). Systolic and diastolic blood pressure decreased by 23mm Hg and 14mm Hg respectively to a mean value of 136/81 mm Hg (median 135/80mm Hg) (P < 0.001 for both systolic and diastolic BP). Improvement in patient status was recorded in 93% of cases (4,254 patients) and no change was recorded in 6% of cases (294 patients). Losartan in the form of Lozap or Lozap is a safe and effective treatment of patients with hypertensive disease. It is effective and safe beginning with the dose of 50 mg and its combination with a diuretic represents a good and safe therapy in patients with insufficient BP response to a 50 mg dose of losartan alone. In case of poor blood pressure response the dose has to be titrated to 100 mg.

Quality of life as an endpoint for atrial fibrillation research: pitfalls and practice.

PubMed

Newman, David

2004-07-01

There have been few health-related quality-of-life (HR-QOL) studies of atrial fibrillation in nontreated cohorts, even though it often is used as an endpoint in clinical trials. Nonintervention data now available are selected for those in whom novel therapies are most often offered. These data suggest that atrial fibrillation confers an HR-QOL impact commensurate with postangioplasty and significant coronary disease groups. The correlation of HR-QOL measures and formal measures of atrial fibrillation "burden" (frequency or duration) is either poor or unknown (in the case of permanent atrial fibrillation). HR-QOL tools, although relevant, may not be as precise as traditional outcome measures. As a result, a 0.5 standard deviation unit of change in scale is needed to be considered moderate. There is a need to use validated instruments that are hypothesized to be sensitive to any intervention under study. The most studied area in atrial fibrillation has been that of ablation and pacing as rate control strategy. Depending on selection bias, SF-36 full standard deviation unit changes have been observed. Less controlled studies have documented significant benefit to left atrial ablative strategies. Device- and drug-based strategies in atrial fibrillation management have not demonstrated significant HR-QOL benefits, other than one controlled evaluation of an atrial defibrillator. Further study is needed both to refine instrument precision and to translate HR-QOL data into the denominator of cost-efficacy evaluations.

Analysis of the North Carolina long-term care polypharmacy initiative: a multiple-cohort approach using propensity-score matching for both evaluation and targeting.

PubMed

Trygstad, Troy K; Christensen, Dale B; Wegner, Steve E; Sullivan, Rob; Garmise, Jennifer M

2009-09-01

The high cost and undesirable consequences of polypharmacy are well-recognized problems among elderly long-term care (LTC) residents. Despite the implementation of the 1987 Omnibus Budget Reconciliation Act, which requires pharmacist review of drug regimens in this setting, medical and drug costs for LTC residents have continued to increase. This study evaluates the North Carolina Long-Term Care Polypharmacy Initiative, a large-scale medication therapy management program (MTMP) that combined drug utilization review activities with drug regimen review techniques. This was a prospective records-based study that used a difference-in-difference model with both historical and nonintervention group controls. To ensure equivalence among subjects, propensity scoring was used to match study subjects from participating LTC facilities with comparison subjects from nonparticipating facilities. Residents with interventions were grouped for analysis by intervention type-retrospective only, prospective only, or dual type (residents with both prospective and retrospective interventions)-and by intervention stage-review, recommendation, and drug change-plus an all-inclusive "all types" grouping that aggregated groups by intervention type, for a total of 10 total cohorts. In the overall population of 5255 study subjects identified, a US $21.63 per member per month drug-cost savings was observed. Although only 1 of 10 cohorts had a change in the number of drug fills, substantial reductions in 2 of 5 types of drug alerts were observed in all 10 cohorts. A reduction in the relative risk for hospitalization (0.84 [95% CI, 0.71-1.00]) was observed in the cohort of residents receiving a retrospective review. This Initiative suggests that an MTMP can be quickly launched in a large number of LTC facility residents to produce monetary drug-cost savings and improved health outcomes. Additionally, the evaluation of this program illustrates the utility of using propensity scoring techniques to target future intervention groups in a cost-effective manner.

Retention, dosing, tolerability and patient reported seizure outcome of Zonisamide as only add-on treatment under real-life conditions in adult patients with partial onset seizures: Results of the observational study ZOOM.

PubMed

Hamer, Hajo; Baulac, Michel; McMurray, Rob; Kockelmann, Edgar

2016-01-01

Zonisamide is licensed for adjunctive therapy for partial-onset seizures with or without secondary generalisation in patients 6 years and older and as monotherapy for the treatment of partial seizures in adult patients with newly diagnosed epilepsy, and shows a favourable pharmacokinetic profile with low interaction potential with other drugs. The aim of the present study was to gather real-life data on retention and modalities of zonisamide use when administered as only add-on treatment to a current AED monotherapy in adult patients with partial-onset seizures. This multicenter observational study was performed in 4 European countries and comprised three visits: baseline, and after 3 and 6 months. Data on patients' retention, reported efficacy, tolerability and safety, and quality of life was collected. Of 100 included patients, 93 could be evaluated. After 6 months, the retention rate of zonisamide add-on therapy was 82.8%. At this time, a reduction of seizure frequency of at least 50% was observed in 79.7% of patients, with 43.6% reporting seizure freedom over the last 3 months of the study period. Adverse events were reported by 19.4% of patients, with fatigue, agitation, dizziness, and headache being most frequent. Approximately 25% of patients were older than 60 years, many of whom suffered from late-onset epilepsy. Compared to younger patients, these patients showed considerable differences with regard to their antiepileptic drug regimen at baseline, and slightly higher responder and retention rates at 6 months. Despite limitations due to the non-interventional open-label design and the low sample size, the results show that zonisamide as only add-on therapy is well retained, indicating effectiveness in the majority of patients under real-life conditions. Copyright © 2015. Published by Elsevier Ltd.

QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.

PubMed

Ziemssen, Tjalf; Calabrese, Pasquale; Penner, Iris-Katharina; Apfel, Rainer

2016-04-01

Treatment of symptoms and signs beyond the expanded disability status scale remains a major target in multiple sclerosis. QualiCOP was an observational, non-interventional, open-label study conducted at 170 sites in Germany. Of the 754 enrolled patients, 96 % had relapsing-remitting multiple sclerosis (MS) and were either disease-modifying therapy naïve (de novo, n = 481) or previously treated (n = 237) with once-daily, subcutaneous 20-mg/mL glatiramer acetate (GA). Assessments of relapse rate, disease progression, overall functioning, quality of life (QoL), cognition, fatigue, and depression were performed over 24 months. GA treatment over 24 months was associated with reduced annual relapse rate for previously treated (from 0.98 to 0.54 relapses) and de novo (from 0.81 to 0.48 relapses) patients. Multiple Sclerosis Functional Composite scores showed slight improvement in both cohorts (all p < 0.01). Paced Auditory Serial Addition Test and Multiple Sclerosis Inventory Cognition scale scores showed robust improvement in cognition among previously treated and de novo cohorts (all p < 0.001). General Depression Scale scores showed significantly reduced depressive symptoms (p < 0.001). Disease severity, fatigue, and QoL were stable over the observational period. These real-world findings suggest that patients with MS show benefit from GA treatment in important QoL parameters beyond standard measures of relapse and disease severity.

Real-world Outcomes of Multiple Myeloma: Retrospective Analysis of the Czech Registry of Monoclonal Gammopathies.

PubMed

Hájek, Roman; Jarkovsky, Jiri; Maisnar, Vladimír; Pour, Ludek; Špička, Ivan; Minařík, Jiri; Gregora, Evžen; Kessler, Petr; Sýkora, Michal; Fraňková, Hana; Campioni, Marco; DeCosta, Lucy; Treur, Maarten; Gonzalez-McQuire, Sebastian; Bouwmeester, Walter

2018-06-01

Real-world data on patient outcomes and treatment patterns in multiple myeloma (MM) are limited. The present noninterventional, observational, retrospective analysis of prospectively collected Czech patient medical record data from the Registry of Monoclonal Gammopathies estimated real-world outcomes in adults with a diagnosis of symptomatic MM made between May 2007 and June 2014. In total, 2446 patients had initiated first-line treatment. The median overall survival since the diagnosis (primary endpoint) was 50.3 months (95% confidence interval, 46.1-54.5 months) and decreased with each successive treatment line. A similar trend was observed for progression-free survival and the depth of response. In line with European guidelines and clinical practice, bortezomib-, thalidomide-, and lenalidomide-based regimens were most commonly used across all treatment lines (42.3%, 28.9%, and 18.4%, respectively). In the first line, bortezomib and thalidomide were used most often, with lenalidomide the most commonly used agent in the relapse setting (second to fourth lines). Exploratory analyses revealed that younger age (≤ 65 years), lower international staging system stage, and previous stem cell transplantation were associated with significant improvements in overall and progression-free survival, especially in the early treatment lines. The present study is the first analysis of Czech data from the Registry of Monoclonal Gammopathies, and it provides important insights into the real-world management of MM for physicians and healthcare providers. Copyright © 2018 Elsevier Inc. All rights reserved.

Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.

PubMed

Cohen, Alexander T; Ay, Cihan; Hainaut, Philippe; Décousus, Hervé; Hoffmann, Ulrich; Gaine, Sean; Coppens, Michiel; da Silva, Pedro Marques; Castro, David Jimenez; Amann-Vesti, Beatrice; Brüggenjürgen, Bernd; Levy, Pierre; Bastida, Julio Lopez; Vicaut, Eric; Laeis, Petra; Fronk, Eva-Maria; Zierhut, Wolfgang; Malzer, Thomas; Bramlage, Peter; Agnelli, Giancarlo

2018-01-01

Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104-183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. ClinicalTrials.gov Identifier: NCT02943993.

Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research.

PubMed

Wolf, Armin; Kampik, Anselm

2014-04-01

To assess healthcare processes during treatment of neovascular age-related macular degeneration (AMD) in patients under real-life conditions and evaluate efficacy of monthly visual acuity (VA) assessment in a pro re nata treatment regime. A multicentre, prospective, non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab. Patients completed a 3-month loading phase with monthly intravitreal injections of 0.5 mg ranibizumab, followed by a 12-month maintenance phase during which investigators documented VA, additional injections, metamorphopsias, routine ophthalmological examinations and adverse events at monthly follow-up visits. Efficacy analysis included change from baseline in best-corrected VA (BCVA) based on descriptive statistics. A total of 2,232 patients were enrolled throughout Germany and 1,729 patients (mean age 77.8 years, 63.2 % women) comprised the efficacy population with a complete set of data. In the clinical setting recorded in our study, only a minority of patients underwent optical coherence tomography during the maintenance phase (71 of 1,729 patients). Patients received a mean total of 4.5 injections; three injections during upload phase and 1.5 additional injections during maintenance phase. Over half of the patients (51.4 %) did not receive additional injections. Mean decimal BCVA increased during the upload phase, (from LogMAR mean of 0.201 at baseline to 0.219 at Month 4) but displayed a decline over time (0.192 at Month 15). Ranibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients, as shown by initial gains in BCVA. However, maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA, ANCHOR and CATT trials, most likely due to a low number of retreatments, and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies. This phase IV non-interventional health services research study was conducted under the Novartis internal registration code, CRFB002ADE10.

Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study.

PubMed

Dennhardt, Nils; Beck, Christiane; Huber, Dirk; Sander, Bjoern; Boehne, Martin; Boethig, Dietmar; Leffler, Andreas; Sümpelmann, Robert

2016-08-01

In pediatric anesthesia, preoperative fasting guidelines are still often exceeded. The objective of this noninterventional clinical observational cohort study was to evaluate the effect of an optimized preoperative fasting management (OPT) on glucose concentration, ketone bodies, acid-base balance, and change in mean arterial blood pressure (MAP) during induction of anesthesia in children. Children aged 0-36 months scheduled for elective surgery with OPT (n = 50) were compared with peers studied before optimizing preoperative fasting time (OLD) (n = 50) who were matched for weight, age, and height. In children with OPT (n = 50), mean fasting time (6.0 ± 1.9 h vs 8.5 ± 3.5 h, P < 0.001), deviation from guideline (ΔGL) (1.2 ± 1.4 h vs 3.7 ± 3.1 h, P < 0.001, ΔGL>2 h 8% vs 70%), ketone bodies (0.2 ± 0.2 mmol·l(-1) vs 0.6 ± 0.6 mmol·l(-1) , P < 0.001), and incidence of hypotension (MAP <40 mmHg, 0 vs 5, P = 0.022) were statistically significantly lower and MAP after induction was statistically significantly higher (55.2 ± 9.5 mmHg vs 50.3 ± 9.8 mmHg, P = 0.015) as compared to children in the OLD (n = 50) group. Glucose, lactate, bicarbonate, base excess, and anion gap did not significantly differ. Optimized fasting times improve the metabolic and hemodynamic condition during induction of anesthesia in children younger than 36 months of age. © 2016 John Wiley & Sons Ltd.

High-Fiber Orange Juice as a Nutrition Supplement in Women: A Randomized, Double-Blind, Placebo-Controlled Study of Tolerance and Effectiveness.

PubMed

Bergamasco, Christiane; Horie, Lilian Mika; Torrinhas, Raquel Susana; Waitzberg, Dan L

2015-11-01

The daily consumption of dietary fiber is frequently below suggested recommendations. Using a double-blind, controlled, randomized study, we assessed the efficiency and tolerance of a fiber-enriched orange juice to supplement fiber intake in women. After 1 week of noninterventional observation, 192 healthy adult women ingested 400 mL of orange juice for 21 days, which either was not (placebo group) or was enriched with fiber (fiber group). Orange juice ingestion was registered daily and controlled for each week during the study period. Macronutrient, fiber, and energy intake were determined using a 3-day food record, validated food chemical composition databases, and the "Pro Diet" software. Gastrointestinal symptoms were self-evaluated daily by scoring 4 grades of symptom intensity and using a visual analog scale to grade pain severity. No changes were observed for macronutrient and energy ingestion. For the placebo group (n = 97), the total fiber intake record was under the daily recommended value. In contrast, the fiber group (n = 95) displayed higher comparative values of total and soluble fiber consumption (P ≤ .001), achieving the daily recommended values of fiber intake. Both groups reported an increased frequency of slight bloating and rumbles over time (P ≤ .05). The fiber group also experienced a higher frequency of slight flatulence over time (P = .002). Consumption of fiber-enriched orange juice was efficient to achieve the daily fiber intake recommendation for women, was not accompanied by intense adverse events, and may represent a suitable method to supplement fiber intake in woman. © 2014 American Society for Parenteral and Enteral Nutrition.

The Alzheimer's Disease Cooperative Study Prevention Instrument Project: Longitudinal Outcome of Behavioral Measures as Predictors of Cognitive Decline

PubMed Central

Banks, Sarah Jane; Raman, Rema; He, Feng; Salmon, David P.; Ferris, Steven; Aisen, Paul; Cummings, Jeffrey

2014-01-01

Background/Methods The Alzheimer's Disease Cooperative Study Prevention Instrument Project is a longitudinal study that recruited 644 cognitively healthy older subjects (aged between 75 and 93 years, 58% women) at baseline and evaluated their cognitive change over 4 years. The study was structured like a clinical trial to anticipate a prevention trial and to determine the performance of novel trial instruments in a longitudinal non-interventional trial framework. Behavioral symptoms were assessed at baseline. Results The existence of participant-reported behavioral symptoms at baseline predicted conversion to Clinical Dementia Rating scale score ≥0.5 over the 4-year period. Conclusions The results imply that early anxiety and depression may be harbingers of future cognitive decline, and that patients exhibiting such symptoms, even in the absence of co-occurring cognitive symptoms, should be closely followed over time. PMID:25685141

Treatment of painful radiculopathies with capsaicin 8% cutaneous patch.

PubMed

Baron, R; Treede, R D; Birklein, F; Cegla, T; Freynhagen, R; Heskamp, M L; Kern, K U; Maier, C; Rolke, R; Seddigh, S; Sommer, C; Ständer, S; Maihöfner, C

2017-08-01

The treatment of neuropathic pain due to low-back (lumbosacral) radiculopathies, a common source of neuropathic pain, is challenging and often requires a multimodal therapeutic approach. The capsaicin 8% patch is the first topical analgesic licensed for peripheral neuropathic pain. To evaluate this treatment, a subset of patients with painful radiculopathy (lumbar and cervical, including ventral and dorsal rami) enrolled into the multicenter, non-interventional QUEPP study (Qutenza 2 - safety and effectiveness in peripheral neuropathic pain) was analyzed. Of the 1044 study participants, 50 were diagnosed with painful radiculopathy as only peripheral neuropathic pain syndrome and were eligible for evaluation. Patients received a single treatment (visit 1) with follow-up visits 2-5 at weeks 1-2, 4, 8 and 12. Parameters assessed at all visits included pain intensity, neuropathy symptoms and side effects. Quality of life (SF-12) and painDETECT 1 questionnaires were completed at baseline and final visit. Data was analyzed by patch application site and duration of pain. Topical treatment led to a significant decrease of pain intensity between weeks 1/2 and week 12 versus baseline at the application sites representing dermatomes of ventral (N = 26) and dorsal rami (N = 13) of spinal nerves. A significant decline (p ≤ .001) of numeric pain rating scale scores was observed between weeks 1/2 following patch application and the end of observation (week 12) in the overall radiculopathy group (N = 50), and the groups with either 3 months to 2 years (N = 14) or >2 years (N = 23) duration of pain. Pain relief of at least 30% was observed in 50.0%, 71.4% and 39.1% of patients in the respective groups. Four patients experienced in total seven adverse drug reactions (application site pain or pruritus). Effective neuropathic pain relief was observed after patch application within the innervation territories of both dorsal and ventral branches of the spinal nerve. Further controlled randomized trials are indicated.

Social Communication Effects of Peer-Mediated Recess Intervention for Children with Autism

PubMed Central

McFadden, Brandon; Kamps, Debra; Heitzman-Powell, Linda

2015-01-01

Children with ASD face enormous challenges in the area of social functioning. Research has shown that impairments in social functioning distinguish this population from both typically developing children and children with disabilities. This study incorporated several evidence-based social skills-teaching procedures (i.e., direct instruction, priming, prompting, peer-mediation, contingent reinforcement, and token economies) directly in the recess setting to increase appropriate social behaviors for four children with ASD (ages 6–8). Elements of Peer Networks and Pivotal Response Training (two types of social skills intervention packages in the literature) were included. Results showed significant increases in social communication between focus children and their peers, as well as generalization of skills to non-intervention recesses. PMID:26312064

Reversal of coronary atherosclerosis: Role of life style and medical management.

PubMed

Parsons, Christine; Agasthi, Pradyumna; Mookadam, Farouk; Arsanjani, Reza

2018-05-17

Atherosclerotic coronary artery disease continues to be a major global health burden in developing and developed nations. Newer imaging techniques afford an accurate assessment of plaque burden and characteristics as well as the effects of treatment. Lifestyle interventions and pharmacotherapy remain the mainstay of non-interventional treatment of coronary atherosclerosis, with reversal seen in many studies. In addition, control of modifiable risk factors can be beneficial. As a better understanding of atherosclerosis pathophysiology is achieved, new therapeutic targets and combination therapies may join the armamentarium that promotes regression of atherosclerotic plaque. We present a review of the literature regarding lifestyle and medical therapies that can promote the reversal of coronary atherosclerosis. Copyright © 2018. Published by Elsevier Inc.

China’s Evolving Foreign Policy in Africa: A New Direction for China’s Non-Intervention Strategy?

DTIC Science & Technology

2014-09-01

Xiaoping instituted economic reforms aimed at opening up China’s economy to international trade and China began on its path towards double- digit growth.99...rebellion by the nomadic Tuaregs in the north paved the way for Al Qaeda in the Lands of the Islamic Maghreb (AQIM)’s takeover of Northern Mali. The...marginalization through the creation of a formal state with formal, defined borders. The nomadic lifestyle of the Tuaregs was no longer accepted under

Do clinical safety charts improve paramedic key performance indicator results? (A clinical improvement programme evaluation).

PubMed

Ebbs, Phillip; Middleton, Paul M; Bonner, Ann; Loudfoot, Allan; Elliott, Peter

2012-07-01

Is the Clinical Safety Chart clinical improvement programme (CIP) effective at improving paramedic key performance indicator (KPI) results within the Ambulance Service of New South Wales? The CIP intervention area was compared with the non-intervention area in order to determine whether there was a statistically significant improvement in KPI results. The CIP was associated with a statistically significant improvement in paramedic KPI results within the intervention area. The strategies used within this CIP are recommended for further consideration.

Explaining Humanitarian Intervention in Libya and Non-Intervention in Syria

DTIC Science & Technology

2012-06-01

Russia will Veto every attempt to prepare an intervention like in Libya. Michael Heath , “Russia Won’t Allow Libya-Style Syria Solution”, Bloomberg...www.un.org/apps/news/story.asp?NewsID=39935 (accessed February, 20 2012). 295 Ibid. 296 Neil McFarquhar. “U.N. Resolution on Syria Blocked by Russia and...russia_says_nato_exceeds_libya_mandate_fix_urgent/4745764.html (accessed March 30, 2012). 448 Ibid. 449 Michael Heath . “Russia Won’t Allow Libya-Style Syria Solution, Lavrov

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study).

PubMed

Reich, Kristian; Hartl, Christoph; Gambichler, Thilo; Zschocke, Ina

2016-01-01

Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group. In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months. Data from 127 patients (aged 6-17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders. The KIDS FUTURE study - for the first time - included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study. © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Icodextrin does not impact infectious and culture-negative peritonitis rates in peritoneal dialysis patients: a 2-year multicentre, comparative, prospective cohort study

PubMed Central

Vychytil, Andreas; Remón, César; Michel, Catherine; Williams, Paul; Rodríguez-Carmona, Ana; Marrón, Belén; Vonesh, Ed; van der Heyden, Synke; Filho, Jose C. Divino

2008-01-01

Background. Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. The different biocompatibility profile of icodextrin-containing peritoneal dialysis (PD) solutions may have a positive influence on peritoneal host defence. Furthermore, cases of sterile peritonitis potentially associated with icodextrin have been reported. Methods. The primary objective of this multicentre, longitudinal, observational, non-interventional, prospective cohort study, which included 722 PD patients, was to evaluate the incidence of overall peritonitis in patients treated with icodextrin-containing PD solutions (Extraneal™) used during one long-dwell exchange/day compared with those treated with non-icodextrin-containing PD solutions. The secondary objective was to determine if culture-negative peritonitis rates differed between patients treated with icodextrin from two independent manufacturers. All peritonitis episodes were assessed by a Steering Committee in a blind manner. Results. There was no significant difference between icodextrin-treated and control patients in the adjusted overall, culture-positive or culture-negative peritonitis rates. When stratified by the icodextrin supplier, there was no significant difference in the adjusted rate of culture-negative peritonitis episodes between groups. Conclusion. Subjects receiving icodextrin as part of their PD regimen experienced neither a higher rate of culture-negative peritonitis nor a lower rate of infectious peritonitis compared with non-icodextrin users. There was no significant influence of the icodextrin raw material supplier on peritonitis rates. PMID:18556747

Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study

PubMed Central

Ehler, Edvard; Zakine, Benjamin; Maisonobe, Pascal; Simonetta-Moreau, Marion

2012-01-01

Objectives Real-life data on response to Botulinum toxin A (BoNT-A) in cervical dystonia (CD) are sparse. An expert group of neurologists was convened with the overall aim of developing a definition of treatment response, which could be applied in a non-interventional study of BoNT-A-treated subjects with CD. Design International, multicentre, prospective, observational study of a single injection cycle of BoNT-A as part of normal clinical practice. Setting 38 centres across Australia, Belgium, Czech Republic, France, Germany, The Netherlands, Portugal, Russia and the UK. Participants 404 adult subjects with idiopathic CD. Most subjects were women, aged 41–60 years and had previously received BoNT-A. Outcome measures Patients were classified as responders if they met all the following four criteria: magnitude of effect (≥25% improvement Toronto Western Spasmodic Torticollis Rating Scale), duration of effect (≥12-week interval between the BoNT-A injection day and subject-reported waning of treatment effect), tolerability (absence of severe related adverse event) and subject's positive Clinical Global Improvement (CGI). Results High rates of response were observed for magnitude of effect (73.6%), tolerability (97.5%) and subject's clinical global improvement (69.8%). The subjective duration of effect criterion was achieved by 49.3% of subjects; 28.6% of subjects achieved the responder definition. Factors most strongly associated with response were age (<40 years; OR 3.9, p<0.05) and absence of baseline head tremor (OR 1.5; not significant). Conclusions Three of four criteria were met by most patients. The proposed multidimensional definition of response appears to be practical for routine practice. Unrealistically high patient expectation and subjectivity may influence the perception of a quick waning of effect, but highlights that this aspect may be a hurdle to response in some patients. Clinical registration number (NCT00833196; ClinicalTrials.gov). PMID:22700836

Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients.

PubMed

Ann, Heawon; Kim, Ki Hyon; Choi, Hyun Young; Chang, Hyun Ha; Han, Sang Hoon; Kim, Kye Hyung; Lee, Jin Soo; Kim, Yeon Sook; Park, Kyung Hwa; Kim, Young Keun; Sohn, Jang Wook; Yun, Na Ra; Lee, Chang Seop; Choi, Young Wha; Lee, Yil Seob; Kim, Shin Woo

2017-09-01

Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea. Copyright © 2017 by The Korean Society of Infectious Diseases and Korean Society for Chemotherapy

Making Heat Visible: Promoting Energy Conservation Behaviors Through Thermal Imaging.

PubMed

Goodhew, Julie; Pahl, Sabine; Auburn, Tim; Goodhew, Steve

2015-12-01

Householders play a role in energy conservation through the decisions they make about purchases and installations such as insulation, and through their habitual behavior. The present U.K. study investigated the effect of thermal imaging technology on energy conservation, by measuring the behavioral effect after householders viewed images of heat escaping from or cold air entering their homes. In Study 1 ( n = 43), householders who received a thermal image reduced their energy use at a 1-year follow-up, whereas householders who received a carbon footprint audit and a non-intervention control demonstrated no change. In Study 2 ( n = 87), householders were nearly 5 times more likely to install draught proofing measures after seeing a thermal image. The effect was especially pronounced for actions that addressed an issue visible in the images. Findings indicate that using thermal imaging to make heat loss visible can promote energy conservation.

Making Heat Visible

PubMed Central

Goodhew, Julie; Pahl, Sabine; Auburn, Tim; Goodhew, Steve

2015-01-01

Householders play a role in energy conservation through the decisions they make about purchases and installations such as insulation, and through their habitual behavior. The present U.K. study investigated the effect of thermal imaging technology on energy conservation, by measuring the behavioral effect after householders viewed images of heat escaping from or cold air entering their homes. In Study 1 (n = 43), householders who received a thermal image reduced their energy use at a 1-year follow-up, whereas householders who received a carbon footprint audit and a non-intervention control demonstrated no change. In Study 2 (n = 87), householders were nearly 5 times more likely to install draught proofing measures after seeing a thermal image. The effect was especially pronounced for actions that addressed an issue visible in the images. Findings indicate that using thermal imaging to make heat loss visible can promote energy conservation. PMID:26635418

Effect of transitioning from extended-release methylphenidate onto osmotic, controlled-release methylphenidate in children/adolescents with ADHD: results of a 3-month non-interventional study.

PubMed

Wolff, Christian; Alfred, Adam; Lindermüller, Anton; Rettig, Klaus; Mattejat, Fritz; Gerwe, Martin; Slawik, Lara; Schäuble, Barbara

2011-01-01

To explore the clinical outcomes of children/adolescents with ADHD who transitioned from extended-release methylphenidate (ER MPH, Medikinet Retard) to osmotic release oral system (OROS) MPH (Concerta). Medikinet Retard is a registered trade name of Medice, Bad Iserlohn, Germany. Concerta is a registered trade name of Janssen-Cilag GmbH, Neuss, Germany. This prospective, non-interventional study included patients aged 6 to 18 years with a confirmed diagnosis of ADHD who experienced insufficient clinical response and/or poor tolerability on ER MPH. Patients transitioned onto OROS MPH and were followed for 12 weeks. Symptoms, functional outcome, health-related quality of life, safety and tolerability were assessed. 180 patients were included in the intention-to-treat analysis. The mean ER MPH dose before switching was 28.2 mg/day; mean OROS MPH starting dose was 38.1 mg/day, increasing to 41.2 mg/day at the final visit. Mean treatment duration was 79.49 ± 24.22 days (median 85; range 7-136). Several symptomatic and functional outcomes under OROS MPH treatment changed from baseline and included the Conners' Parent Rating Scale (CPRS; -11.7 ± 11.3; p < 0.0001), C-GAS (12.3 ± 15.2; p < 0.0001) and ILC-LQ0-28 (parents' rating 2.9 ± 4.3 and patients' rating 2.8 ± 3.8; both p < 0.0001). Improvements in social interactions, playing with other children, doing household chores, or school homework, going to bed, and behavior towards visitors/at visits were noted (p < 0.0001). Approximately 40% of patients reported better sleep quality and appetite (p < 0.0001), and 72.8% expressed satisfaction with OROS MPH therapy compared to previous ER MPH. OROS MPH was well tolerated; the most common AEs after switching, with an incidence >2% and possibly related to therapy, were involuntary muscle contractions (tics; 8.9%), insomnia (7.2%) and anorexia (5.0%). No relevant changes in body weight or vital signs were observed. Three patients reported four serious AEs, but none were considered related to OROS MPH. Limitations included those associated with the uncontrolled, open-label design, possible inclusion bias and non-validation of the CPRS in a German population. Transitioning onto OROS MPH improved functionality, symptom control and decreased burden of disease in patients with ADHD who had insufficient response to, and/or poor tolerability of ER MPH. Similarly, care givers benefited from patients' treatment and reported significant reduction in their burden of disease and improvement of their quality of life upon the child's transition onto OROS MPH.

Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study.

PubMed

Kann, Peter H; Bergmann, Simona; Bidlingmaier, Martin; Dimopoulou, Christina; Pedersen, Birgitte T; Stalla, Günter K; Weber, Matthias M; Meckes-Ferber, Stefanie

2018-02-13

The adverse effects of growth hormone (GH) deficiency (GHD) in adults (AGHD) on metabolism and health-related quality of life (HRQoL) can be improved with GH substitution. This investigation aimed to design a score summarising the features of GHD and evaluate its ability to measure the effect of GH substitution in AGHD. The Growth hormone deficiency and Efficacy of Treatment (GET) score (0-100 points) assessed (weighting): HRQoL (40%), disease-related days off work (10%), bone mineral density (20%), waist circumference (10%), low-density lipoprotein cholesterol (10%) and body fat mass (10%). A prospective, non-interventional, multicentre proof-of-concept study investigated whether the score could distinguish between untreated and GH-treated patients with AGHD. A 10-point difference in GET score during a 2-year study period was expected based on pre-existing knowledge of the effect of GH substitution in AGHD. Of 106 patients eligible for analysis, 22 were untreated GHD controls (9 females, mean ± SD age 52 ± 17 years; 13 males, 57 ± 13 years) and 84 were GH-treated (31 females, age 45 ± 13 years, GH dose 0.30 ± 0.16 mg/day; 53 males, age 49 ± 15 years, GH dose 0.25 ± 0.10 mg/day). Follow-up was 706 ± 258 days in females and 653 ± 242 days in males. The GET score differed between the untreated control and treated groups with a least squares mean difference of + 10.01 ± 4.01 (p = 0.0145). The GET score appeared to be a suitable integrative instrument to summarise the clinical features of GHD and measure the effects of GH substitution in adults. Exercise capacity and muscle strength/body muscle mass could be included in the GET score. NCT number: NCT00934063 . Date of registration: 02 July 2009.

Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers.

PubMed

Park, Peter W; Casiano, Errol M; Escoto, Laarni; Claveria, Angelica M

2011-10-01

Varenicline, an α4β2 receptor nicotinic receptor partial agonist, is known to be an effective aid for smoking cessation. To date, few observational studies of varenicline have been conducted. This prospective, non-interventional, post-marketing surveillance study (NCT00794365) was designed to monitor the efficacy and safety of varenicline for 12 weeks in Filipino smokers who were motivated to quit. This study was conducted between July 2, 2008, and November 23, 2009, in 70 centers throughout the Philippines. Participants were adult smokers who were prescribed varenicline (0.5 mg orally once daily, days 1 to 3; 0.5 mg twice daily, days 4 to 7; 1 mg twice daily for the remainder of a 12-week treatment period) for the first time. Participants made five clinic visits (weeks 0, 1, 4, 8, and 12). Adverse events (AEs) were recorded at each clinic visit and up to 28 days after administration of the last study treatment. Seven-day point prevalence of smoking cessation was measured at weeks 4, 8, and 12. A total of 330 participants were enrolled into the study, of whom 251 (76.1%) completed the study. At the end of week 12, 57.6% (95% confidence interval, 52.0, 63.0) of participants had been abstinent for the previous 7 days. The most frequently reported AEs were headache (5.5%), dizziness (3.9%), and nausea (3.6%). Ten participants (3.0%) permanently discontinued varenicline treatment due to AEs, and 13 (3.9%) reduced their varenicline dose or discontinued treatment temporarily due to AEs. There were no reports of any serious AEs, deaths, suicidal ideation, or behavior. The results of this study in adult Filipino smokers prescribed varenicline for the first time during routine clinical practice demonstrate that varenicline was well tolerated and efficacious as an aid for smoking cessation.

[Evaluation of effect of indacaterol (Onbrez) and/or glycopyrronium (Seebri) treatment on Quality of Life of COPD patients in medical practice in Poland - observational study (OSQO)].

PubMed

Płusa, Tadeusz; Physicians From Medical Centers In Poland, Group Of

2017-10-23

Indacaterol, as well glycopyronium has been reimbursed lately in Poland, so patients have a greater access to this treatment in medical practice. Physicians do not realize the potential benefit of once daily ultra-LABA indacaterol and/or modern LAMA with fast-acting glycopyrronium on treatment results. The aim of the study was to evaluate the impact of routinely administered treatment with either indacaterol (Onbrez) or glycopyrronium (Seebri) or both on patient reported outcomes in form of the health status (CCQ score - clinical COPD questionnaire) and level of dyspnoea (mMRC - modified Medical Research Council) in treatment naive COPD patients after the change of treatment as addon from any other COPD treatment in "real life" settings. This study was designed as an observational, non-interventional and multicenter project in COPD patients being treated with Onbrez and/or Seebri in 32 medical centers in Poland. The observation period covered 6 months from the first taking of Onbrez and/or Seebri. No diagnostic or monitoring or treatment procedures have been applied to the patients, other than those which are applied in the course of standard, current practice. The total number of enrolled patients was 633. Because of inability of verification the medical records or failure to meet data collection requirements 587 patients enrolled to the registry has been evaluated. Within this number of patients 171 had delayed the time of visits or they had not second visit. Due to therapy change additional 20 patients has been withdrawn. 396 patients were taken for the final analysis. Improvement of mMRC and CCQ scores was observed in all treatment groups e.g. indacaterol solely, glycopyrronium solely and combination therapy of indacaterol and glypyrronium. The study revealed that the best results can be achieved with combination therapy accordingly with clinical recommendation for COPD treatment (GOLD). The results have been achieved in the real world settings, showing that this treatment may be used in daily routine practice by general practitioners.

Current practice in continuous renal replacement therapy: An epidemiological multicenter study.

PubMed

Tomasa Irriguible, T M; Sabater Riera, J; Poch López de Briñas, E; Fort Ros, J; Lloret Cora, M J; Roca Antònio, J; Navas Pérez, A; Ortiz Ballujera, P; Servià Goixart, L; González de Molina Ortiz, F J; Rovira Anglès, C; Rodríguez López, M; Roglan Piqueras, A

2017-05-01

The aim of the study is to ascertain the most relevant aspects of the current management of renal replacement therapy (RRT) in critically ill patients, and to analyze renal function recovery and mortality in patients undergoing RRT. A non-interventional three-month observational study was made in 2012, with a follow-up period of 90 days, in 21 centers in Catalonia (Spain). Demographic information, severity scores and clinical data were obtained, as well as RRT parameters. patients aged ≥ 16 years admitted to Intensive Care Units (ICUs) and subjected to RRT. A total of 261 critically ill patients were recruited, of which 35% had renal dysfunction prior to admission. The main reason for starting RRT was oliguria; the most widely used RRT modality was hemodiafiltration; and the median prescribed dose at baseline was 35mL/kg/h. The median time of RRT onset from ICU admission was one day. The mortality rate at 30 and 90 days was 46% and 54%, respectively, and was associated to greater severity scores and a later onset of RRT. At discharge, 85% of the survivors had recovered renal function. Current practice in RRT in Catalonia abides with the current clinical practice guidelines. Mortality related to RRT is associated to later onset of such therapy. The renal function recovery rate at hospital discharge was 85% among the patients subjected to RRT. Copyright © 2016 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A1chieve study

PubMed Central

Chraibi, Abdelmjid; Belmejdoub, Ghizlane

2013-01-01

Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66 726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Rabat-Sale-Zemmour-Zaer region, Morocco. Results: A total of 424 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 177), insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.1%) and insulin user (mean HbA1c: 9.4%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA1c (insulin naïve: −2.5%, insulin users: −1.8%). Major hypoglycaemia was observed in the insulin user group after 24 weeks (0.1 events/patient-year). SADRs were reported in 0.5% of insulin users. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia. PMID:24404470

Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension

PubMed Central

Tamçelik, Nevbahar; Izgi, Belgin; Temel, Ahmet; Yildirim, Nilgun; Okka, Mehmet; Özcan, Altan; Yüksel, Nurşen; Elgin, Ufuk; Altan, Çiğdem; Ozer, Baris

2017-01-01

Objective The objective of this study was to assess the intraocular pressure (IOP)-lowering efficacy, tolerability, safety, and usage patterns of prostaglandin analog/prostamide (PGA/P)-containing topical ocular hypotensives in ocular hypertension (OHT) and primary open-angle glaucoma in the Turkish clinical setting. Methods This non-interventional, multicenter study enrolled previously treated patients who failed to achieve target IOP (or experienced unacceptable adverse events [AEs]) and were prescribed a PGA/P-containing IOP-lowering agent. Treatment was initiated at baseline (V1), and patients returned at weeks 4–6 (V2) and 8–12 (V3). The primary efficacy measure was the change in IOP from baseline at V3 in each eye. The secondary measures were physician’s assessment of IOP-lowering efficacy, patients (%) reaching target IOP determined at V1, hyperemia score, physician and patient assessment of study treatment tolerability at V3, and AE frequency/severity. A subgroup analysis of patients receiving the most common study treatment was conducted. All analyses were performed using the safety population (patients who received one or more doses and had any data available). Results Of 358 enrolled patients, 60.6% had primary open-angle glaucoma, 29.9% had secondary open-angle glaucoma (protocol amendment), and 13.1% had OHT; 13 patients had multiple diagnoses. At V3, the mean IOP change from baseline was ≥−4.2 mmHg (≥21.1%). IOP met or was lower than the target in 81.7% of patients, 95% exhibited none to mild conjunctival hyperemia (most common AE), and tolerability was rated good/very good by >91.1% of patients and physicians. The results were similar in patients who received the most common study treatment, bimatoprost 0.03%/timolol 0.5% (bim/tim; n=310). Conclusion PGA/P-containing medications, including bim/tim, significantly reduced IOP in previously treated patients with open-angle glaucoma or OHT; most reached their target IOP or an IOP even lower than their target and reported good/very good tolerability. PGA/P-containing medications such as bim/tim should be considered as a safe, effective therapeutic option for Turkish patients who exhibit poor response, tolerance, or adherence to their previous therapy. PMID:28458511

Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study.

PubMed

Takeuchi, Tsutomu; Nakajima, Ryo; Komatsu, Shuichi; Yamazaki, Kiyotaka; Nakamura, Tomohiro; Agata, Naoki; Igarashi, Ataru; Tango, Toshiro; Tanaka, Yoshiya

2017-03-01

The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan. Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire. All patients who received ADA were followed for 48 weeks to evaluate safety and effectiveness. Of the 1808 patients analyzed, 825, 243, and 740 patients were PWs, PTWs, and HMs, respectively. WPAI/RA domain scores significantly improved at weeks 12, 24, and 48 in all groups, with maximum improvement observed for PWs (p < 0.05). Additionally, remission rates (according to Disease Activity Score 28, erythrocyte sedimentation rate, Simplified Disease Activity Index, or Health Assessment Questionnaire-Disability Index scores) and EuroQol 5-Dimension 3-Level scores significantly increased from baseline to 48 weeks in all groups (p < 0.0001). Analysis of patient subgroups revealed better WPAI/RA outcomes for patients who were biologic-naïve, treated with concomitant methotrexate, or with RA duration of ≤2 years (p < 0.05). The rate of serious adverse events over 48 weeks of ADA treatment was 5.23%. Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA. AbbVie GK and Eisai Co., Ltd. ClinicalTrials.gov identifier, NCT01346488.

Reductions in Medication-Related Hospitalizations in Older Adults with Medication Management by Hospital and Community Pharmacists: A Quasi-Experimental Study.

PubMed

Pellegrin, Karen L; Krenk, Les; Oakes, Sheena Jolson; Ciarleglio, Anita; Lynn, Joanne; McInnis, Terry; Bairos, Alistair W; Gomez, Lara; McCrary, Mercedes Benitez; Hanlon, Alexandra L; Miyamura, Jill

2017-01-01

To evaluate the association between a system of medication management services provided by specially trained hospital and community pharmacists (Pharm2Pharm) and rates and costs of medication-related hospitalization in older adults. Quasi-experimental interrupted time series design comparing intervention and nonintervention hospitals using a mixed-effects analysis that modeled the intervention as a time-dependent variable. Sequential implementation of Pharm2Pharm at six general nonfederal acute care hospitals in Hawaii with more than 50 beds in 2013 and 2014. All five other such hospitals served as a contemporaneous comparison group. Adult inpatients who met criteria for being at risk for medication problems (N = 2,083), 62% of whom were aged 65 or older. A state-wide system of medication management services provided by specially trained hospital and community pharmacists serving high-risk individuals from hospitalization through transition to home and for up to 1 year after discharge. Medication-related hospitalization rate per 1,000 admissions of individuals aged 65 and older, adjusted for case mix; estimate of costs of hospitalizations and actual costs of pharmacist services. The predicted, case mix-adjusted medication-related hospitalization rate of individuals aged 65 and older was 36.5% lower in the Pharm2Pharm hospitals after implementation than in the nonintervention hospitals (P = .01). The estimated annualized cost of avoided admissions was $6.6 million. The annual cost of the pharmacist services for all Pharm2Pharm participants was $1.8 million. The Pharm2Pharm model was associated with an estimated 36% reduction in the medication-related hospitalization rate for older adults and a 2.6:1 return on investment, highlighting the value of pharmacists as drug therapy experts in geriatric care. © 2016 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

Genetic and antigenic characterization of H5, H6 and H9 avian influenza viruses circulating in live bird markets with intervention in the center part of Vietnam.

PubMed

Chu, Duc-Huy; Okamatsu, Masatoshi; Matsuno, Keita; Hiono, Takahiro; Ogasawara, Kohei; Nguyen, Lam Thanh; Van Nguyen, Long; Nguyen, Tien Ngoc; Nguyen, Thuy Thu; Van Pham, Dong; Nguyen, Dang Hoang; Nguyen, Tho Dang; To, Thanh Long; Van Nguyen, Hung; Kida, Hiroshi; Sakoda, Yoshihiro

2016-08-30

A total of 3,045 environmental samples and oropharyngeal and cloacal swabs from apparently healthy poultry have been collected at three live bird markets (LBMs) at which practices were applied to reduce avian influenza (AI) virus transmission (intervention LBMs) and six conventional LBMs (non-intervention LBMs) in Thua Thien Hue province in 2014 to evaluate the efficacy of the intervention LBMs. The 178 AI viruses, including H3 (19 viruses), H4 (2), H5 (8), H6 (30), H9 (114), and H11 (5), were isolated from domestic ducks, muscovy ducks, chickens, and the environment. The prevalence of AI viruses in intervention LBMs (6.1%; 95% CI: 5.0-7.5) was similar to that in non-intervention LBMs (5.6%; 95% CI: 4.5-6.8; χ(2)=0.532; df=1; P=0.53) in the study area. Eight H5N6 highly pathogenic avian influenza (HPAI) viruses were isolated from apparently healthy ducks, muscovy ducks, and an environmental sample in an intervention LBM. The hemagglutinin genes of the H5N6 HPAI viruses belonged to the genetic clade 2.3.4.4, and the antigenicity of the H5N6 HPAI viruses differed from the H5N1 HPAI viruses previously circulating in Vietnam. Phylogenetic and antigenic analyses of the H6 and H9 viruses isolated in both types of LBMs revealed that they were closely related to the viruses isolated from domestic birds in China, Group II of H6 viruses and Y280 lineage of H9 viruses. These results indicate that the interventions currently applied in LBMs are insufficient to control AI. A risk analysis should be conducted to identify the key factors contributing to AI virus prevalence in intervention LBMs. Copyright © 2016 Elsevier B.V. All rights reserved.

How much can we save? Impact of different emission scenarios on future snow cover in the Alps

NASA Astrophysics Data System (ADS)

Marty, Christoph; Schlögl, Sebastian; Bavay, Mathias; Lehning, Michael

2017-02-01

This study focuses on an assessment of the future snow depth for two larger Alpine catchments. Automatic weather station data from two diverse regions in the Swiss Alps have been used as input for the Alpine3D surface process model to compute the snow cover at a 200 m horizontal resolution for the reference period (1999-2012). Future temperature and precipitation changes have been computed from 20 downscaled GCM-RCM chains for three different emission scenarios, including one intervention scenario (2 °C target) and for three future time periods (2020-2049, 2045-2074, 2070-2099). By applying simple daily change values to measured time series of temperature and precipitation, small-scale climate scenarios have been calculated for the median estimate and extreme changes. The projections reveal a decrease in snow depth for all elevations, time periods and emission scenarios. The non-intervention scenarios demonstrate a decrease of about 50 % even for elevations above 3000 m. The most affected elevation zone for climate change is located below 1200 m, where the simulations show almost no snow towards the end of the century. Depending on the emission scenario and elevation zone the winter season starts half a month to 1 month later and ends 1 to 3 months earlier in this last scenario period. The resulting snow cover changes may be roughly equivalent to an elevation shift of 500-800 or 700-1000 m for the two non-intervention emission scenarios. At the end of the century the number of snow days may be more than halved at an elevation of around 1500 m and only 0-2 snow days are predicted in the lowlands. The results for the intervention scenario reveal no differences for the first scenario period but clearly demonstrate a stabilization thereafter, comprising much lower snow cover reductions towards the end of the century (ca. 30 % instead of 70 %).

Changes in Underlying Determinants Explain Rapid Increases in Child Linear Growth in Alive & Thrive Study Areas between 2010 and 2014 in Bangladesh and Vietnam123

PubMed Central

Headey, Derek; Frongillo, Edward A; Tran, Lan Mai; Rawat, Rahul; Ruel, Marie T; Menon, Purnima

2017-01-01

Background: Child linear growth sometimes improves in both intervention and comparison groups in evaluations of nutrition interventions, possibly because of spillover intervention effects to nonintervention areas or improvements in underlying determinants of nutritional change in both areas. Objective: We aimed to understand what changes in underlying socioeconomic characteristics and behavioral factors are important in explaining improvements in child linear growth. Methods: Baseline (2010) and endline (2014) surveys from the Alive & Thrive impact evaluation were used to identify the underlying determinants of height-for-age z scores (HAZs) among children aged 24–48 mo in Bangladesh (n = 4311) and 24–59 mo in Vietnam (n = 4002). Oaxaca-Blinder regression decompositions were used to examine which underlying determinants contributed to HAZ changes over time. Results: HAZs improved significantly between 2010 and 2014 in Bangladesh (∼0.18 SDs) and Vietnam (0.25 SDs). Underlying determinants improved substantially over time and were larger in Vietnam than in Bangladesh. Multiple regression models revealed significant associations between changes in HAZs and socioeconomic status (SES), food security, maternal education, hygiene, and birth weight in both countries. Changes in HAZs were significantly associated with maternal nutrition knowledge and child dietary diversity in Bangladesh, and with prenatal visits in Vietnam. Improvements in maternal nutrition knowledge in Bangladesh accounted for 20% of the total HAZ change, followed by maternal education (13%), SES (12%), hygiene (10%), and food security (9%). HAZ improvements in Vietnam were accounted for by changes in SES (26%), prenatal visits (25%), hygiene (19%), child birth weight (10%), and maternal education (7%). The decomposition models in both countries performed well, explaining >75% of the HAZ changes. Conclusions: Decomposition is a useful and simple technique for analyzing nonintervention drivers of nutritional change in intervention and comparison areas. Improvements in underlying determinants explained rapid improvements in HAZs between 2010 and 2014 in Bangladesh and Vietnam. PMID:28122930

Changes in Underlying Determinants Explain Rapid Increases in Child Linear Growth in Alive & Thrive Study Areas between 2010 and 2014 in Bangladesh and Vietnam.

PubMed

Nguyen, Phuong Hong; Headey, Derek; Frongillo, Edward A; Tran, Lan Mai; Rawat, Rahul; Ruel, Marie T; Menon, Purnima

2017-03-01

Background: Child linear growth sometimes improves in both intervention and comparison groups in evaluations of nutrition interventions, possibly because of spillover intervention effects to nonintervention areas or improvements in underlying determinants of nutritional change in both areas. Objective: We aimed to understand what changes in underlying socioeconomic characteristics and behavioral factors are important in explaining improvements in child linear growth. Methods: Baseline (2010) and endline (2014) surveys from the Alive & Thrive impact evaluation were used to identify the underlying determinants of height-for-age z scores (HAZs) among children aged 24-48 mo in Bangladesh ( n = 4311) and 24-59 mo in Vietnam ( n = 4002). Oaxaca-Blinder regression decompositions were used to examine which underlying determinants contributed to HAZ changes over time. Results: HAZs improved significantly between 2010 and 2014 in Bangladesh (∼0.18 SDs) and Vietnam (0.25 SDs). Underlying determinants improved substantially over time and were larger in Vietnam than in Bangladesh. Multiple regression models revealed significant associations between changes in HAZs and socioeconomic status (SES), food security, maternal education, hygiene, and birth weight in both countries. Changes in HAZs were significantly associated with maternal nutrition knowledge and child dietary diversity in Bangladesh, and with prenatal visits in Vietnam. Improvements in maternal nutrition knowledge in Bangladesh accounted for 20% of the total HAZ change, followed by maternal education (13%), SES (12%), hygiene (10%), and food security (9%). HAZ improvements in Vietnam were accounted for by changes in SES (26%), prenatal visits (25%), hygiene (19%), child birth weight (10%), and maternal education (7%). The decomposition models in both countries performed well, explaining >75% of the HAZ changes. Conclusions: Decomposition is a useful and simple technique for analyzing nonintervention drivers of nutritional change in intervention and comparison areas. Improvements in underlying determinants explained rapid improvements in HAZs between 2010 and 2014 in Bangladesh and Vietnam.

Quality of care and economic considerations of active surveillance of men with prostate cancer

PubMed Central

2018-01-01

The current health care climate mandates the delivery of high-value care for patients considering active surveillance for newly-diagnosed prostate cancer. Value is defined by increasing benefits (e.g., quality) for acceptable costs. This review discusses quality of care considerations for men contemplating active surveillance, and highlights cost implications at the patient, health-system, and societal level related to pursuit of non-interventional management of men diagnosed with localized prostate cancer. In general, most quality measures are focused on prostate cancer care in general, rather that active surveillance patients specifically. However, most prostate cancer quality measures are pertinent to men seeking close observation of their prostate tumors with active surveillance. These include accurate documentation of clinical stage, informed discussion of all treatment options, and appropriate use of imaging for less-aggressive prostate cancer. Furthermore, interventions that may help improve the quality of care for active surveillance patients are reviewed (e.g., quality collaboratives, judicious antibiotic use, etc.). Finally, the potential economic impact and benefits of broad acceptance of active surveillance strategies are highlighted. PMID:29732278

Quality of care and economic considerations of active surveillance of men with prostate cancer.

PubMed

Filson, Christopher P

2018-04-01

The current health care climate mandates the delivery of high-value care for patients considering active surveillance for newly-diagnosed prostate cancer. Value is defined by increasing benefits (e.g., quality) for acceptable costs. This review discusses quality of care considerations for men contemplating active surveillance, and highlights cost implications at the patient, health-system, and societal level related to pursuit of non-interventional management of men diagnosed with localized prostate cancer. In general, most quality measures are focused on prostate cancer care in general, rather that active surveillance patients specifically. However, most prostate cancer quality measures are pertinent to men seeking close observation of their prostate tumors with active surveillance. These include accurate documentation of clinical stage, informed discussion of all treatment options, and appropriate use of imaging for less-aggressive prostate cancer. Furthermore, interventions that may help improve the quality of care for active surveillance patients are reviewed (e.g., quality collaboratives, judicious antibiotic use, etc.). Finally, the potential economic impact and benefits of broad acceptance of active surveillance strategies are highlighted.

Lymphangioma circumscriptum of the penis mimicking venereal lesions.

PubMed

Gupta, S; Radotra, B D; Javaheri, S M; Kumar, B

2003-09-01

Lymphangioma circumscriptum (LC) involving the penis is rare. We report two patients with penile LC. The lesions developed in early infancy in one patient, and during puberty in the other. The lesions resembled molluscum contagiosum in one and genital warts in the other. The first patient was previously treated with a diagnosis of venereal disease. A literature search found only 4 LC patients with penile lesions reported in the English literature. These cases are presented for their rarity, and to increase diagnostic vigilance and desirability of non-intervention.

PROGNOSTIC VALUE OF SHAPE-DESCRIPTIVE FACTORS FOR THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

PubMed

Pfau, Maximilian; Lindner, Moritz; Goerdt, Lukas; Thiele, Sarah; Nadal, Jennifer; Schmid, Matthias; Schmitz-Valckenberg, Steffen; Sadda, SriniVas R; Holz, Frank G; Fleckenstein, Monika

2018-05-16

To systematically compare the prognostic value of multiple shape-descriptive factors in the natural course of the disease. A total of 296 eyes of 201 patients (female patients 130; mean age: 72.2 ± 13.08 years) with a median follow-up of 2.38 years from 2 prospective, noninterventional natural history studies (Fundus-Autofluorescence-in-Age-related-Macular-Degeneration [clinicaltrials.gov identifier NCT00393692], Directional-Spread-in-Geographic-Atrophy [NCT02051998]) were included in the analysis. Serial fundus autofluorescence images were annotated using semiautomated image analysis software to determine the lesion area, circularity, perimeter, and caliper diameters. These variables and the fundus autofluorescence phenotype were evaluated for prediction of the future square root progression rates using linear mixed-effects models. For the combined model, leave-one-out cross validation on patient level (Scenario 1: previously unknown patient) resulted in a goodness-to-fit (R value) of 0.244 and leave-one-out cross validation on visit level (Scenario 2: previous observation of the patient) in a R value of 0.391. This indicated that shape-descriptive factors could explain 24.4% of the variance in geographic atrophy progression in previously unknown patients and 39.1% in patients with previous observation. These findings confirm the relevance of shape-descriptive factors and previous progression as prognostic variables for geographic atrophy progression. However, a substantial part of the remaining variation in geographic atrophy progression seems to depend on other variables, some of which are visible in optical coherence tomography.

Predisposing factors for early retirement in patients with schizophrenia in Germany.

PubMed

Schnabel, Reinhard; Friedel, Heiko; Erfurth, Andreas; Angermayer, Matthias; Clouth, Johannes; Eichmann, Florian

2008-08-01

Although early retirement causes major changes in the life of schizophrenic patients and is among the major cost factors to be covered by payers, the causes leading to early retirement of schizophrenic patients have not been investigated in detail. Therefore, the objective of this retrospective non-interventional case-control study was to generate hypotheses on predisposing factors for early retirement in schizophrenia. Logistic regression was used to explore potential predisposing parameters with regard to their effect on the outcome early retirement. As the study results indicate, schizophrenia severity, assistance or care in the patient's everyday life, age and antipsychotic treatment with typical antipsychotics are linked to the occurrence of early retirement. Further research should be planned to confirm or refute the hypotheses determined in this retrospective analysis and to determine whether atypical antipsychotics could help to avoid early retirement and to improve the situation of schizophrenic patients.

Comparisons of low-intensity versus moderate-intensity combined aerobic and resistance training on body composition, muscle strength, and functional performance in older women.

PubMed

Shiotsu, Yoko; Yanagita, Masahiko

2018-06-01

This study aimed to examine the effects of exercise order of combined aerobic and low- or moderate-intensity resistance training into the same session on body composition, functional performance, and muscle strength in healthy older women. Furthermore, this study compared the effects of different (low- vs moderate-) intensity combined training. A total of 60 healthy older women (age 61-81 y) were randomly assigned to five groups that performed aerobic exercise before low-intensity resistance training (AR-L, n = 12) or after resistance training (RA-L, n = 12), performed aerobic exercise before moderate-intensity resistance training (AR-M, n = 12) or after resistance training (RA-M, n = 12), or nonintervention control conditions (CON, n = 12). Body composition, functional performance, and muscle strength were evaluated before and after the 10-week training. No effects of exercise order of combined aerobic and low- or moderate-intensity resistance training (AR-L vs RA-L, AR-M vs RA-M) were observed in body composition, functional performance, or muscle strength, whereas the effects of training intensity of combined training (AR-L vs AR-M, RA-L vs RA-M) were observed on functional performance. All combined trainings significantly increased muscle strength and gait ability (P < 0.01, respectively). Functional reach test significantly increased in the AR-M and RA-M groups (P < 0.01, respectively), and there were significant group differences between AR-L and AR-M (P = 0.002), RA-L and RA-M (P = 0.014). Preliminary findings suggest that combined aerobic and low- or moderate-intensity resistance training increases muscle strength and improves gait ability, regardless of the exercise order. Also, greater improvement in dynamic balance capacity, a risk factor associated with falling, is observed in moderate-intensity combined training.

Costs and outcomes of treating chronic hepatitis C patients in routine care - results from a nationwide multicenter trial.

PubMed

Stahmeyer, J T; Krauth, C; Bert, F; Pfeiffer-Vornkahl, H; Alshuth, U; Hüppe, D; Mauss, S; Rossol, S

2016-02-01

Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly. © 2015 John Wiley & Sons Ltd.

The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study

PubMed Central

Al-Arouj, M; Hassoun, A A K; Medlej, R; Pathan, M F; Shaltout, I; Chawla, M S; Hristoskova, S; DiTommaso, S; Kadwa, M Y

2013-01-01

SUMMARY Aims To assess, in a real-world setting, the effect of vildagliptin compared with sulphonylurea (SU) treatment on hypoglycaemia in Muslim patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. Methods This multinational, non-interventional study, conducted in Asia and the Middle East, included Muslim adult patients with T2DM who received treatment with vildagliptin or SU as add-on to metformin or monotherapy. During a ∼16-week observation period, data were collected up to 6 weeks before and 6 weeks after Ramadan fasting. The primary study objective was to compare the proportion of patients with ≥ 1 hypoglycaemic event (HE) during fasting. Results Of > 1300 patients enrolled in the study, 684 were treated with vildagliptin and 631 with SUs. Significantly fewer patients experienced ≥ 1 HE with vildagliptin compared with those receiving SUs (5.4% vs. 19.8%, respectively; p < 0.001); no vildagliptin-treated patients reported a grade 2 HE, vs. 4 SU-treated patients (p = 0.053). Mean HbA1c changes from baseline were vildagliptin: –0.24%, SUs: +0.02% (p < 0.001). Mean body weight reductions from baseline were vildagliptin: –0.76 kg, SUs: –0.13 kg (p < 0.001). A higher proportion of SU-treated patients experienced adverse events (AEs) compared with vildagliptin (22.8% vs. 10.2%). This difference was driven by hypoglycaemia as the most common AE. Conclusions In this real-world study of fasting Muslim patients with T2DM, vildagliptin was associated with significantly fewer hypoglycaemic episodes compared with SU therapy. This outcome is particularly meaningful when viewed in the context of good glycaemic and weight control observed in vildagliptin-treated patients. Vildagliptin was well tolerated in this patient population. Linked Comment: Ahmed. Int J Clin Pract 2013; 67: 933–4. PMID:24001317

PSA response to cabazitaxel is associated with improved progression-free survival in metastatic castration-resistant prostate cancer: the non-interventional QoLiTime study.

PubMed

Hammerer, Peter; Al-Batran, Salah-Eddin; Windemuth-Kieselbach, Christine; Keller, Martin; Hofheinz, Ralf-Dieter

2018-03-01

To evaluate the association between prostate-specific antigen (PSA) response and progression-free and overall survival in men with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel. Men with mCRPC receiving cabazitaxel (25 mg/m 2 , every 3 weeks) plus oral prednis(ol)one (10 mg/day) were enrolled in the non-interventional, prospective QoLiTime study. Main outcome measures were progression-free survival and overall survival, in all patients and in those who showed a ≥ 50 or a ≥ 30% decrease in PSA relative to baseline after four cycles of cabazitaxel, as well as quality-of-life parameters. Of the 527 men (median age 72 years), 266 received ≥ 4 cycles of cabazitaxel and had PSA response data. After four cycles, 34.6% of men achieved a PSA decrease ≥ 50% and 49.6% a decrease ≥ 30%. Median progression-free survival was 7.7 (95% CI 6.2, 9.5) months, and overall survival was 19.5 (95% CI 16.0, 30.9) months, corresponding to 1-year event rates of 39.4 and 78.8%, respectively. Median progression-free survival was longer in PSA responders versus non-responders (15.7 vs 5.5 months at 50% cut-off; 15.7 vs 5.3 months for 30% cut-off; both P < 0.0001). Overall survival (50% cut-off) was 23.3 months in responders and 16.0 months in non-responders (P = 0.068); corresponding data at the 30% cut-off are 21.7 and 16.0 months (P = 0.057). Overall, 55.4% of men experienced ≥ 1 adverse event, 59.6% of whom had a serious adverse event. PSA response after four cycles of cabazitaxel is associated with improved progression-free survival in men with mCRPC treated with cabazitaxel plus prednis(ol)one.

[Administration of Cardiodoron® in patients with functional cardiovascular disorders and/or sleep disorders--results of a prospective, non-interventional study].

PubMed

Rother, Claudia

2013-01-01

Functional cardiovascular disorders (FCD) can be attributed to around 25-40% of all heart patients, i.e. organic causes are not detectable. Characteristic symptoms are tachycardia, palpitations, cardiac arrhythmia, hyperventilation, vertigo, vasovagal syncopes and sleep disorders, with the latter being a problem of its own. Disturbed vegetative rhythms form the basis of these diseases. The medicinal product Cardiodoron counteracts the dysfunctional vegetative rhythmicity with 3 medicinal plants--Primula veris (common cowslip), Hyoscyamus niger (black henbane) and Onopordum acanthium (cotton thistle). By means of a prospective, multicentre, non-interventional study, the development of disease-specific disorders during treatment with Cardiodoron (drops) was supposed to be shown. Between September 2009 and March 2012, 92 physicians documented 501 patients suffering from functional cardiovascular and/or sleep disorders who have been treated with Cardiodoron for 3-6 months. After an initial examination, a final examination after 90 (± 10) days and, in case of continuation of therapy, a follow-up examination after 90 (± 10) days were carried out. Besides 30 symptoms assessed by the physicians, the patients rated their condition on the basis of the complaints list according to v. Zerssen (B-L and B-L') and the Pittsburgh Sleep Quality Index (PSQI) according to Buysse. The severity of functional cardiovascular disorders as well as sleep disorders was significantly reduced. The same applies for all of the documented 30 disease-specific symptoms. Furthermore, the total score of the complaints list was significantly reduced as well as the PSQI. The largest effect regarding all parameters was detectable after 3 months. Continuation of Cardiodoron therapy stabilised the symptomatology once more and resulted in further improvement. On average, patients reported initial improvement after 13 days of treatment. Tolerability was almost consistently assessed with 'very good / good'. Accordingly, the acceptance of the preparation by the patients was good, which resulted in a very good compliance of 70%. 52% of the patients used additional therapies. Cardiodoron shows positive effects in medical practice; it is a well-tolerated medicinal product for treatment of functional cardiovascular and/or sleep disorders with or without concomitant therapies. © 2013 S. Karger GmbH, Freiburg.

Fatigue, Pain, Anxiety and Depression in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

PubMed

Merkies, Ingemar S J; Kieseier, Bernd C

2016-01-01

In the clinical evaluation of patients with Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), scant attention is paid to symptoms such as fatigue, pain and anxiety/depression. We aimed at addressing seminal studies that focused on the burden of these symptoms and their impact on quality of life (QoL) in these conditions. Fatigue, pain, and anxiety/depression are increasingly being recognized in patients with GBS and CIDP, although their pathophysiological provenance remains unknown. Fatigue and pain are significant in terms of prevalence and intensity, may be a presenting symptom, and can persist for years after apparent functional recovery, suggesting residual injury. Anxiety/depression has also been examined although studies are limited. Despite their negative impact on QoL, the long-term dynamics of these symptoms in patients with GBS and particularly CIDP receiving therapy in routine clinical practice have not been systematically evaluated. Such observations formed the basis for the ongoing (GAMEDIS) studies evaluating the effect of Gamunex on fatigue and depression in patients with CIDP, of which some preliminary data are presented. Strength and sensory deficits are the main areas of focus in patients with GBS and CIDP, but they do not explain the total reduction in QoL, suggesting the possible role of other complaints. A more comprehensive approach to patient care demands that factors such as pain, fatigue and anxiety/depression receive greater attention. The non-interventional GAMEDIS studies are expected to provide valuable insight into the long-term effectiveness of Gamunex in everyday practice. © 2016 S. Karger AG, Basel.

Impact of an ultraviolet air sterilizer on cardiac surgery patients, a randomized clinical trial.

PubMed

Heredia-Rodríguez, María; Álvarez-Fuente, Elisa; Bustamante-Munguira, Juan; Poves-Alvarez, Rodrigo; Fierro, Inmaculada; Gómez-Sánchez, Esther; Gómez-Pesquera, Estefanía; Lorenzo-López, Mario; Eiros, José María; Álvarez, Francisco Javier; Tamayo, Eduardo

2018-05-25

Numerous studies have evaluated the use of ultraviolet-C devices for terminal disinfection in hospitals, however, to date there is little information about the device's final impact on patients. We investigated the effect of an ultraviolet air sterilizer (UVAS) on the clinical outcomes of cardiac surgery patients. This random, prospective and non-interventional study included 1097 adult patients undergoing elective cardiac surgery: 522 stayed in an ICU room with UVAS (Medixair ® ) and 575 patients ICU room without UVAS and were used as a control. The primary outcome measure was to evaluate the effect of a UVAS on the overall prevalence of nosocomial infections in postoperative cardiac patients in ICUs. No significant differences in ventilator-associated pneumonia (4.6% vs. 5.0%, p=0.77) and total infection (14.0% vs. 15.5%, p=0.45) rates were detected in patients with and without the UVAS. The length of stay in the intensive care unit and at the hospital was similar in both groups, UVAS (4.6 (8.2) days and 18.3 (5.5) days) and without UVAS (4.6 (7.3) days and 19.2 (18.6) days). The 30-day in-hospital mortality rate was 5.3%, no significant differences between groups were observed (p=0.053). Novel ultraviolet-C technology has not been shown to significantly reduce nosocomial infections or mortality rates in cardiac surgery patients. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice.

PubMed

Vermersch, Patrick; Trojano, Maria

2016-01-01

Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS). The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD. This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (≥20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability. Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients. In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms. © 2016 S. Karger AG, Basel.

Vildagliptin vs sulfonylurea in Indian Muslim diabetes patients fasting during Ramadan

PubMed Central

Shete, Abhijit; Shaikh, Aheson; Nayeem, K Javeed; Rodrigues, Lily; Ali, Mohamed Sheikamunadeen Sadiq; Shah, Parag; Khanna, Rajiv; Majid, Sarfaraj; Rasheed, Sabeer A; Shaikh, Shehla; Rahman, Tawfiqur

2013-01-01

AIM: To compare the use of vildagliptin and sulfonylurea with or without metformin in Indian Muslim patients with type 2 diabetes mellitus, fasting during Ramadan. METHODS: This was a 4-wk, multicenter, non-interventional, open-label, observational study. Incidence of hypoglycemic events (HEs), adverse events, and changes in glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose, postprandial plasma glucose and body weight were measured pre- and post-Ramadan. RESULTS: Totally, 97 patients were recruited and all completed the study (vildagliptin group, n = 55; sulfonylurea group, n = 42). HEs were reported in low frequencies in both the vildagliptin and the sulfonylurea groups [0 vs 2 (4.8%) patients, respectively]. Interestingly, HbA1c reduced by -0.43% (-4.71 mmol/mol) in the vildagliptin group [8.75% (72.10 mmol/mol) to 8.32% (67.38 mmol/mol), P = 0.009] while in the sulfonylurea group there was a small increase by 0.01% [0.08 mmol/mol; 8.64% (70.92 mmol/mol) to 8.65% (71.00 mmol/mol), P = 0.958]. Higher percentage of vildagliptin-treated patients achieved HbA1c < 7.0% (< 53 mmol/mol) compared with sulfonylurea (16.4% vs 4.8%). Mean decrease in the body weight was 1.2 kg and 0.03 kg, respectively (P < 0.001). Both treatment groups were well tolerated during Ramadan. CONCLUSION: Vildagliptin is an attractive treatment option for Indian patients with type 2 diabetes mellitus who are fasting during Ramadan. PMID:24379927

Vildagliptin vs sulfonylurea in Indian Muslim diabetes patients fasting during Ramadan.

PubMed

Shete, Abhijit; Shaikh, Aheson; Nayeem, K Javeed; Rodrigues, Lily; Ali, Mohamed Sheikamunadeen Sadiq; Shah, Parag; Khanna, Rajiv; Majid, Sarfaraj; Rasheed, Sabeer A; Shaikh, Shehla; Rahman, Tawfiqur

2013-12-15

To compare the use of vildagliptin and sulfonylurea with or without metformin in Indian Muslim patients with type 2 diabetes mellitus, fasting during Ramadan. This was a 4-wk, multicenter, non-interventional, open-label, observational study. Incidence of hypoglycemic events (HEs), adverse events, and changes in glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose, postprandial plasma glucose and body weight were measured pre- and post-Ramadan. Totally, 97 patients were recruited and all completed the study (vildagliptin group, n = 55; sulfonylurea group, n = 42). HEs were reported in low frequencies in both the vildagliptin and the sulfonylurea groups [0 vs 2 (4.8%) patients, respectively]. Interestingly, HbA1c reduced by -0.43% (-4.71 mmol/mol) in the vildagliptin group [8.75% (72.10 mmol/mol) to 8.32% (67.38 mmol/mol), P = 0.009] while in the sulfonylurea group there was a small increase by 0.01% [0.08 mmol/mol; 8.64% (70.92 mmol/mol) to 8.65% (71.00 mmol/mol), P = 0.958]. Higher percentage of vildagliptin-treated patients achieved HbA1c < 7.0% (< 53 mmol/mol) compared with sulfonylurea (16.4% vs 4.8%). Mean decrease in the body weight was 1.2 kg and 0.03 kg, respectively (P < 0.001). Both treatment groups were well tolerated during Ramadan. Vildagliptin is an attractive treatment option for Indian patients with type 2 diabetes mellitus who are fasting during Ramadan.

Efficacy and tolerability of preservative-free eye drops containing a fixed combination of dorzolamide and timolol in glaucoma patients.

PubMed

Renieri, Giulia; Führer, Katrin; Scheithe, Karl; Lorenz, Katrin; Pfeiffer, Norbert; Thieme, Hagen

2010-12-01

To evaluate the efficacy and tolerability of preservative-free eye drops (dorzolamide/timolol) in routine management of preservative-sensitive glaucoma patients. Data from 2,298 glaucoma patients requiring intraocular pressure (IOP) reduction and suffering from intolerance to benzalkonium chloride or active agents of previously used eye drops were valid for baseline and safety analysis in this prospective, open, noncomparative, multicenter, noninterventional study. Patients were treated with preservative-free dorzolamide/timolol eye drops for 12 weeks. Main efficacy endpoint was IOP reduction after 12 weeks of treatment. Two thousand forty-nine patients were considered for efficacy analysis. Tolerability was assessed by evaluating adverse drug reactions. Mean baseline IOP was 20.8 mmHg. Baseline IOP was reduced to 16.7 mmHg after 12 weeks of treatment corresponding to a mean absolute (percent) change of -4.1 mmHg (-17.3%). The proportion of patients with IOP ≤21 mmHg increased from 59.9% at baseline to 94.6% after 12 weeks. The most frequently reported ocular adverse drug reactions were burning eyes (2.4%) and hyperemia (0.9%). Local tolerability improved in 79.3% of patients compared to their previous glaucoma therapy. This observational study confirms the IOP lowering effect of preservative-free eye drops containing the fixed combination of dorzolamide/timolol in a large patient's population. The drug was well tolerated and improved the local tolerability in the vast majority of patients.

Innovations in adult influenza vaccination in China, 2014-2015: Leveraging a chronic disease management system in a community-based intervention.

PubMed

Yi, Bo; Zhou, Suizan; Song, Ying; Chen, Enfu; Lao, Xuyin; Cai, Jian; Greene, Carolyn M; Feng, Luzhao; Zheng, Jiandong; Yu, Hongjie; Dong, Hongjun

2018-04-03

To evaluate a community-based intervention that leveraged the non-communicable disease management system to increase seasonal influenza vaccination coverage among older adults in Ningbo, China. From October 2014 - March 2015, we piloted the following on one street in Ningbo, China: educating community healthcare workers (C-HCWs) about influenza and vaccination; requiring C-HCWs to recommend influenza vaccination to older adults during routine chronic disease follow-up; and opening 14 additional temporary vaccination clinics. We selected a non-intervention street for comparison pre- and post-intervention vaccine coverage. In April 2016, we interviewed a random sample of unvaccinated older adults on the intervention street to ask why they remained unvaccinated. Pre-intervention influenza vaccine coverage among adults aged 60 years and older on both streets was 0.3%. Post-intervention, coverage among adults 60 years and older was 19% (1338/7013) on the intervention street and 0.4% (20/5500) on the non-intervention street (p<0.01). Among vaccinated older adults, 98% reported their main reason for vaccination was receiving a C-HCW's recommendation, 90% were vaccinated at temporary vaccination clinics, and 53% paid for vaccine (10 USD) out-of-pocket. Reasons for not getting vaccinated among 150 unvaccinated adults (response rate = 75%) included: good health (39%); not trusting C-HCWs' recommendations (24%); not knowing where to get vaccinated (17%); and not wanting to pay (9%). Recommending influenza vaccination within a non-communicable disease management system, combined with adding vaccination sites, increased vaccine coverage among older adults in Ningbo, China.

Age at disease onset and peak ammonium level rather than interventional variables predict the neurological outcome in urea cycle disorders.

PubMed

Posset, Roland; Garcia-Cazorla, Angeles; Valayannopoulos, Vassili; Teles, Elisa Leão; Dionisi-Vici, Carlo; Brassier, Anaïs; Burlina, Alberto B; Burgard, Peter; Cortès-Saladelafont, Elisenda; Dobbelaere, Dries; Couce, Maria L; Sykut-Cegielska, Jolanta; Häberle, Johannes; Lund, Allan M; Chakrapani, Anupam; Schiff, Manuel; Walter, John H; Zeman, Jiri; Vara, Roshni; Kölker, Stefan

2016-09-01

Patients with urea cycle disorders (UCDs) have an increased risk of neurological disease manifestation. Determining the effect of diagnostic and therapeutic interventions on the neurological outcome. Evaluation of baseline, regular follow-up and emergency visits of 456 UCD patients prospectively followed between 2011 and 2015 by the E-IMD patient registry. About two-thirds of UCD patients remained asymptomatic until age 12 days [i.e. the median age at diagnosis of patients identified by newborn screening (NBS)] suggesting a potential benefit of NBS. In fact, NBS lowered the age at diagnosis in patients with late onset of symptoms (>28 days), and a trend towards improved long-term neurological outcome was found for patients with argininosuccinate synthetase and lyase deficiency as well as argininemia identified by NBS. Three to 17 different drug combinations were used for maintenance therapy, but superiority of any single drug or specific drug combination above other combinations was not demonstrated. Importantly, non-interventional variables of disease severity, such as age at disease onset and peak ammonium level of the initial hyperammonemic crisis (cut-off level: 500 μmol/L) best predicted the neurological outcome. Promising results of NBS for late onset UCD patients are reported and should be re-evaluated in a larger and more advanced age group. However, non-interventional variables affect the neurological outcome of UCD patients. Available evidence-based guideline recommendations are currently heterogeneously implemented into practice, leading to a high variability of drug combinations that hamper our understanding of optimised long-term and emergency treatment.

An intervention to improve cause-of-death reporting in New York City hospitals, 2009-2010.

PubMed

Madsen, Ann; Thihalolipavan, Sayone; Maduro, Gil; Zimmerman, Regina; Koppaka, Ram; Li, Wenhui; Foster, Victoria; Begier, Elizabeth

2012-01-01

Poor-quality cause-of-death reporting reduces reliability of mortality statistics used to direct public health efforts. Overreporting of heart disease has been documented in New York City (NYC) and nationwide. Our objective was to evaluate the immediate and longer-term effects of a cause-of-death (COD) educational program that NYC's health department conducted at 8 hospitals on heart disease reporting and on average conditions per certificate, which are indicators of the quality of COD reporting. From June 2009 through January 2010, we intervened at 8 hospitals that overreported heart disease deaths in 2008. We shared hospital-specific data on COD reporting, held conference calls with key hospital staff, and conducted in-service training. For deaths reported from January 2009 through June 2011, we compared the proportion of heart disease deaths and average number of conditions per death certificate before and after the intervention at both intervention and nonintervention hospitals. At intervention hospitals, the proportion of death certificates that reported heart disease as the cause of death decreased from 68.8% preintervention to 32.4% postintervention (P < .001). Individual hospital proportions ranged from 58.9% to 79.5% preintervention and 25.9% to 45.0% postintervention. At intervention hospitals the average number of conditions per death certificate increased from 2.4 conditions preintervention to 3.4 conditions postintervention (P < .001) and remained at 3.4 conditions a year later. At nonintervention hospitals, these measures remained relatively consistent across the intervention and postintervention period. This NYC health department's hospital-level intervention led to durable changes in COD reporting.

Using Multitouch Collaboration Technology to Enhance Social Interaction of Children with High-Functioning Autism.

PubMed

Gal, Eynat; Lamash, Liron; Bauminger-Zviely, Nirit; Zancanaro, Massimo; Weiss, Patrice L Tamar

2016-01-01

Children with high-functioning Autism Spectrum Disorder (HFASD) have major difficulties in social communication skills, which may impact their performance and participation in everyday life. The goal of this study was to examine whether the StoryTable, an intervention paradigm based on a collaborative narrative, multitouch tabletop interface, enhanced social interaction for children with HFASD, and to determine whether the acquired abilities were transferred to behaviors during other tasks. Fourteen boys with HFASD, aged 7-12 years, participated in a 3-week, 11-session intervention. Social interactions during two nonintervention tasks were videotaped at three points in time, one prior to the intervention (pre), a second immediately following the intervention (post) and a third three weeks after the intervention (follow-up). The video-recorded files were coded using the Friendship Observation Scale to ascertain the frequencies of positive and negative social interactions and collaborative play. Differences in these behaviors were tested for significance using nonparametric statistical tests. There were significantly higher rates of positive social interactions and collaborative play, and lower rates of negative social interactions following the intervention suggesting generalization of the social skills learned during the intervention. Improvement was maintained when tested three weeks later. These findings provide support for the use of collaborative technology-based interventions within educational settings to enhance social interaction of children with HFASD.

Treatment and outcomes of an Australian cohort of outpatients with bipolar I or schizoaffective disorder over twenty-four months: implications for clinical practice

PubMed Central

2012-01-01

Background The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with ‘real-world’ treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication. Methods Participants prescribed either conventional mood stabilizers (CMS; n = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale – Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data. Results On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24 months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine ± CMS (61%;) cohorts. Conclusions Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome. PMID:23244301

The Variability of Childhood Diarrhea in Karachi, Pakistan, 2002–2006

PubMed Central

Luby, Stephen P.; Agboatwalla, Mubina; Hoekstra, Robert M.

2011-01-01

Diarrhea burden is often estimated using cross-sectional surveys. We measured variability in diarrhea prevalence among children < 5 years of age living in squatter settlements in central Karachi, Pakistan. We pooled data from non-intervention control households from studies conducted from 2002 through 2006. The prevalence of diarrhea varied on average by 29% from one week to the next, by 37% from one month to the next, and during peak diarrhea season by 32% from one year to the next. During 24 months when the same nine neighborhoods were under surveillance, each month the prevalence of diarrhea varied by at least an order of magnitude from the lowest to the highest prevalence neighborhood, and each neighborhood recorded the highest diarrhea prevalence during at least one month. Cross-sectional surveys are unreliable measures of diarrhea prevalence. PMID:21633021

[Acceptance and commitment therapy (ACT) and improving chess performance in promising young chess-players].

PubMed

Ruiz, Francisco J; Luciano, Carmen

2009-08-01

Acceptance and Commitment Therapy (ACT) is shown to be effective in relatively distant fields from the so-called psychological disorders. One of these areas is sport performance improvement. The aim of the current study is to expand the application of brief ACT protocols to improve chess-players' performance. In a previous study, a brief protocol was applied to international-level adult chess-players that was effective. The current study aims to apply an equivalent brief ACT protocol, but in this case, applied in a group format to promising young chess-players. In addition, this brief protocol is compared to a non-intervention control condition. Results show that the ACT brief protocol improved the performance in 5 out of 7 participants, and that none of the chess-players in the control condition reached the established change criterion. The differences between the conditions in chess performance were statistically significant. The results are discussed, emphasizing the replicated impact of a brief ACT protocol on the improvement of chess-players' performance.

Relapsed chronic lymphocytic leukemia retreated with rituximab: interim results of the PERLE study.

PubMed

Chaoui, Driss; Choquet, Sylvain; Sanhes, Laurence; Mahé, Béatrice; Hacini, Maya; Fitoussi, Olivier; Arkam, Yazid; Orfeuvre, Hubert; Dilhuydy, Marie-Sarah; Barry, Marly; Jourdan, Eric; Dreyfus, Brigitte; Tempescul, Adrian; Leprêtre, Stéphane; Bardet, Aurélie; Leconte, Pierre; Maynadié, Marc; Delmer, Alain

2017-06-01

This prospective non-interventional study assessed the management of relapsed/refractory CLL after one or two treatments with rituximab, and retreatment with a rituximab-based regimen. An interim analysis was performed at the end of the induction period in 192 evaluable patients. Median age was 72 years [35-89], first relapse (55%), and second relapse (45%). Rituximab administered during first (68%), second (92%), or both treatment lines (20%). R-bendamustine administered in 56% of patients, R-purine analogs (21%), and R-alkylating agents (19%). The overall response rate (ORR) was 74.6%, in favor of R-purine analogs (90%), R-bendamustine (75%), and R-alkylating agents (69%). Lower ORR in Del 17p patients (43%) and third time rituximab (31%). Most frequent adverse events were hematological (23% patients) including neutropenia (11%) and infections (12%); grade 3/4 AEs (23% patients), mainly hematological (18%); death during induction treatment (7%). This first large study focusing on relapsed/refractory CLL patients retreated with rituximab-based regimens is still ongoing.

The Role of Phonological versus Morphological Skills in the Development of Arabic Spelling: An Intervention Study.

PubMed

Taha, Haitham; Saiegh-Haddad, Elinor

2016-06-01

The current study investigated the contribution of two linguistic intervention programs, phonological and morphological to the development of word spelling among skilled and poor native Arabic readers, in three grades: second, fourth and sixth. The participants were assigned to three experimental groups: morphological intervention, phonological intervention and a non-intervention control group. Phonological awareness, morphological awareness, and spelling abilities were tested before and after the intervention. Participants from both linguistic intervention programs and in all grades made significant progress in linguistic awareness and spelling after the intervention. The results showed that both intervention programs were successful in promoting children's spelling skills in both groups. Also, older poor readers showed a stronger response to the morphological intervention than the older skilled readers. A transfer effect was found with the phonological training contributing to the morphological skills and vice versa. The results of the current study were discussed in the light of developmental and psycholinguistic views of spelling acquisition as well as the characteristics of Arabic language and orthography.

Emotion Dysregulation and Loss-of-Control Eating in Children and Adolescents

PubMed Central

Kelly, Nichole R.; Tanofsky-Kraff, Marian; Vannucci, Anna; Ranzenhofer, Lisa M.; Altschul, Annie M.; Schvey, Natasha A.; Shank, Lisa M.; Brady, Sheila M.; Galescu, Ovidiu; Kozlosky, Merel; Yanovski, Susan Z.; Yanovski, Jack A.

2016-01-01

Objective To examine the associations among self-reported loss-of-control (LOC) eating, emotion dysregulation, body mass, and objective energy intake among youth. Emotion dysregulation may be one individual factor that promotes excess energy intake and increases in body mass among youth with LOC eating. Methods Children and adolescents (N=230; 8 to 17 years) enrolled in a non-intervention study completed a structured interview to determine the presence or absence of self-reported LOC eating. Children’s emotion dysregulation was assessed via parent-report with the Child Behavior Checklist. Youth also completed two test meals to capture “binge” and “normal” eating. Body composition was examined using air displacement plethysmography. Results After controlling for relevant covariates, youth with self-reported LOC eating had higher parent-reported emotion dysregulation than those without LOC. Parent-reported emotion dysregulation was also associated with greater observed energy intake (after accounting for body mass), as well as higher fat mass. Emotion dysregulation also moderated associations between LOC status/sex and body mass variables; among youth with self-reported LOC eating and girls, those with high parent-described emotion dysregulation (versus low) had significantly higher fat mass and BMIz. Conclusions Data from the current study suggest that emotion dysregulation may play a role in energy intake and obesity, particularly among youth with self-reported LOC eating and girls. Additional studies are needed to identify the prospective mechanisms linking poor emotion regulation and LOC eating. These mechanisms, in turn, may inform future interventions targeting excess energy intake and obesity in pediatric samples. PMID:27505194

Performance of a Quantitative PCR-Based Assay and Beta-d-Glucan Detection for Diagnosis of Invasive Candidiasis in Very-Low-Birth-Weight Preterm Neonatal Patients (CANDINEO Study)

PubMed Central

Ramos, Jose Tomas; Villar, Sonia; Bouza, Emilio; Bergon-Sendin, Elena; Perez Rivilla, Alfredo; Collados, Caridad Tapia; Andreu, Mariano; Reyes, Candelaria Santana; Campos-Herrero, María Isolina; de Heredia, Jon López; Herrera, María Cruz López; Alonso, Paloma Anguita; Pallás-Alonso, Carmen Rosa

2017-01-01

ABSTRACT An epidemiological, multicenter, noninterventional, observational case-control study was conducted to describe the performance of serum beta-d-glucan (BDG) and Candida PCR in blood, serum, and sterile samples for the diagnosis of invasive candidiasis (IC) in very-low-birth-weight (VLBW) preterm neonates and to compare these techniques with culture of samples from blood and other sterile sites. Seventeen centers participated in the study, and the number of episodes analyzed was 159. A total of 9 episodes of IC from 9 patients (7 confirmed and 2 probable) and 150 episodes of suspected sepsis from 117 controls were identified. The prevalence of IC was 5.7% (95% confidence interval [95% CI], 2.1 to 9.3). The mortality was significantly higher in episodes of IC (44.4%) than in the non-IC episodes (11.1%, P < 0.01). The sensitivity and specificity of the PCR performed on blood/serum samples were 87.5% and 81.6%, respectively. The sensitivity and specificity of the BDG results were lower (75.0% and 64.6%). For cases with negative culture results, the PCR and the BDG results were positive in 27 (17.4%) and 52 (33.5%) episodes, respectively. The presence of multiorgan failure, improvement with empirical antifungal therapy, thrombocytopenia, and Candida colonization were significantly associated (P < 0.01) with PCR or BDG positivity regardless of the results of the cultures. Serum BDG analysis and Candida PCR could be used as complementary diagnostic techniques to detect IC in VLBW neonates. PMID:28659321

Early Detection of Increased Intracranial Pressure Episodes in Traumatic Brain Injury: External Validation in an Adult and in a Pediatric Cohort.

PubMed

Güiza, Fabian; Depreitere, Bart; Piper, Ian; Citerio, Giuseppe; Jorens, Philippe G; Maas, Andrew; Schuhmann, Martin U; Lo, Tsz-Yan Milly; Donald, Rob; Jones, Patricia; Maier, Gottlieb; Van den Berghe, Greet; Meyfroidt, Geert

2017-03-01

A model for early detection of episodes of increased intracranial pressure in traumatic brain injury patients has been previously developed and validated based on retrospective adult patient data from the multicenter Brain-IT database. The purpose of the present study is to validate this early detection model in different cohorts of recently treated adult and pediatric traumatic brain injury patients. Prognostic modeling. Noninterventional, observational, retrospective study. The adult validation cohort comprised recent traumatic brain injury patients from San Gerardo Hospital in Monza (n = 50), Leuven University Hospital (n = 26), Antwerp University Hospital (n = 19), Tübingen University Hospital (n = 18), and Southern General Hospital in Glasgow (n = 8). The pediatric validation cohort comprised patients from neurosurgical and intensive care centers in Edinburgh and Newcastle (n = 79). None. The model's performance was evaluated with respect to discrimination, calibration, overall performance, and clinical usefulness. In the recent adult validation cohort, the model retained excellent performance as in the original study. In the pediatric validation cohort, the model retained good discrimination and a positive net benefit, albeit with a performance drop in the remaining criteria. The obtained external validation results confirm the robustness of the model to predict future increased intracranial pressure events 30 minutes in advance, in adult and pediatric traumatic brain injury patients. These results are a large step toward an early warning system for increased intracranial pressure that can be generally applied. Furthermore, the sparseness of this model that uses only two routinely monitored signals as inputs (intracranial pressure and mean arterial blood pressure) is an additional asset.

Acarbose reduces body weight irrespective of glycemic control in patients with diabetes: results of a worldwide, non-interventional, observational study data pool.

PubMed

Schnell, Oliver; Weng, Jianping; Sheu, Wayne H-H; Watada, Hirotaka; Kalra, Sanjay; Soegondo, Sidartawan; Yamamoto, Noriyuki; Rathod, Rahul; Zhang, Cheryl; Grzeszczak, Wladyslaw

2016-01-01

The objective of this study is to examine the effect of acarbose, an alpha-glucosidase inhibitor, on body weight in a real-life setting by pooling data from post-marketing surveillance. Data from 10 studies were pooled (n=67,682) and the effect of acarbose on body weight was analysed taking into account baseline body weight, glycemic parameters and other baseline characteristics. The mean relative reduction in body weight was 1.45 ± 3.24% at the 3-month visit (n=43,510; mean baseline 73.4 kg) and 1.40 ± 3.28% at the last visit (n=54,760; mean baseline 73.6 kg) (both p<0.0001). These reductions were dependent on baseline body weight (overweight: -1.33 ± 2.98% [n=13,498; mean baseline 71.6 kg]; obese: -1.98 ± 3.40% [n=20,216; mean baseline 81.3 kg]). When analysed by baseline glycemic parameter quartiles, the reduction was independent of fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA1c) and postprandial glucose excursion (PPGE). A bivariate analysis of covariance identified female sex, South East Asian and East Asian ethnicity, younger age, higher body mass index, short duration of diabetes, and no previous treatment as factors likely to impact positively on body weight reduction with acarbose. This post-hoc analysis showed that acarbose treatment reduces body weight independent of glycemic control status but dependent on baseline body weight. Copyright © 2016. Published by Elsevier Inc.

Validation of a Host Response Assay, Septicyte™ LAB, for Discriminating Sepsis from SIRS in the ICU.

PubMed

Miller Iii, Russell R; Lopansri, Bert K; Burke, John P; Levy, Mitchell; Opal, Steven; Rothman, Richard E; D'Alessio, Franco R; Sidhaye, Venkataramana K; Aggarwal, Neil R; Balk, Robert; Greenberg, Jared A; Yoder, Mark; Patel, Gourang; Gilbert, Emily; Afshar, Majid; Parada, Jorge P; Martin, Greg S; Esper, Annette M; Kempker, Jordan A; Narasimhan, Mangala; Tsegaye, Adey; Hahn, Stella; Mayo, Paul; van der Poll, Tom; Schultz, Marcus J; Scicluna, Brendon P; Klein Klouwenberg, Peter; Rapisarda, Antony; Seldon, Therese A; McHugh, Leo C; Yager, Thomas D; Cermelli, Silvia; Sampson, Dayle; Rothwell, Victoria; Newman, Richard; Bhide, Shruti; Kirk, James T; Navalkar, Krupa; Davis, Roy F; Brandon, Roslyn A; Brandon, Richard B

2018-04-06

A molecular test to distinguish between sepsis and systemic inflammation of non-infectious etiology could potentially have clinical utility. This study evaluated the diagnostic performance of a molecular host response assay (SeptiCyte™ LAB) designed to distinguish between sepsis and non-infectious systemic inflammation in critically ill adults. The study employed a prospective, observational, non-interventional design, and recruited a heterogeneous cohort of adult critical care patients from seven sites in the USA (N=249). An additional group of 198 patients, recruited in the large MARS consortium trial in the Netherlands (clinicaltrials.gov identifier: NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. Performance of SeptiCyte™ LAB was compared to retrospective physician diagnosis by a panel of three experts. In receiver operating characteristic curve analysis, SeptiCyte™ LAB had an estimated area under curve of 0.82-0.89 for discriminating sepsis from non-infectious systemic inflammation. The relative likelihood of sepsis versus non-infectious systemic inflammation was found to increase with increasing test score (range 0-10). In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables including procalcitonin. Performance of the assay was not significantly affected by demographic variables including age, sex, or race/ethnicity. SeptiCyte™ LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation. Clinical trial registrations available at clinicaltrials.gov, IDs NCT02127502 and NCT01905033.

Can Simply Answering Research Questions Change Behaviour? Systematic Review and Meta Analyses of Brief Alcohol Intervention Trials

PubMed Central

McCambridge, Jim; Kypri, Kypros

2011-01-01

Background Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials. Methodology/Principal Findings Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (−0.17 to 27.6) grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink) and 1 point (0.1 to 1.9) in AUDIT score. There was no difference in quantity per drinking day. Conclusions/Significance Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report. PMID:21998626

Nurse-Patient Communication Interactions in the Intensive Care Unit

PubMed Central

Happ, Mary Beth; Garrett, Kathryn; Thomas, Dana DiVirgilio; Tate, Judith; George, Elisabeth; Houze, Martin; Radtke, Jill; Sereika, Susan

2011-01-01

Background The inability to speak during critical illness is a source of distress for patients, yet nurse-patient communication in the intensive care unit has not been systematically studied or measured. Objectives To describe communication interactions, methods, and assistive techniques between nurses and nonspeaking critically ill patients in the intensive care unit. Methods Descriptive observational study of the nonintervention/usual care cohort from a larger clinical trial of nurse-patient communication in a medical and a cardiothoracic surgical intensive care unit. Videorecorded interactions between 10 randomly selected nurses (5 per unit) and a convenience sample of 30 critically ill adults (15 per unit) who were awake, responsive, and unable to speak because of respiratory tract intubation were rated for frequency, success, quality, communication methods, and assistive communication techniques. Patients self-rated ease of communication. Results Nurses initiated most (86.2%) of the communication exchanges. Mean rate of completed communication exchange was 2.62 exchanges per minute. The most common positive nurse act was making eye contact with the patient. Although communication exchanges were generally (>70%) successful, more than one-third (37.7%) of communications about pain were unsuccessful. Patients rated 40% of the communication sessions with nurses as somewhat difficult to extremely difficult. Assistive communication strategies were uncommon, with little to no use of assistive communication materials (eg, writing supplies, alphabet or word boards). Conclusions Study results highlight specific areas for improvement in communication between nurses and nonspeaking patients in the intensive care unit, particularly in communication about pain and in the use of assistive communication strategies and communication materials. PMID:21362711

Effectiveness of a social relations intervention program for aggressive and nonaggressive, rejected children.

PubMed

Lochman, J E; Coie, J D; Underwood, M K; Terry, R

1993-12-01

A sample of 52 Black aggressive, rejected and nonaggressive, rejected children were randomly assigned to receive a social relations intervention or to be in a nonintervention control group. The school-based intervention for fourth-grade children focused on positive social skill training and cognitive-behavioral strategies to promote deliberate, nonimpulsive problem solving. At both the post-treatment and the 1-year follow-up assessments, the social relations intervention was found to be effective only with the aggressive, rejected children. Implications for the importance of assessing subtypes of rejected children are discussed.

Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study

PubMed Central

2012-01-01

Background Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment. Methods This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites’ medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics. Results At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study. Conclusions In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted. PMID:23216976

Correlation between changes in quality of life and symptomatic improvement in Chinese patients switched from typical antipsychotics to olanzapine.

PubMed

Montgomery, William; Kadziola, Zbigniew; Ye, Wenye; Xue, Hai Bo; Liu, Li; Treuer, Tamás

2015-01-01

The aim of this study was to investigate the correlation between changes in symptoms and changes in self-reported quality of life among Chinese patients with schizophrenia who were switched from a typical antipsychotic to olanzapine during usual outpatient care. This post hoc analysis was conducted using data from the Chinese subgroup (n=475) of a multicountry, 12-month, prospective, noninterventional, observational study. The primary publication previously reported the efficacy, safety, and quality of life among patients who switched from a typical antipsychotic to olanzapine. Patients with schizophrenia were included if their symptoms were inadequately controlled with a typical antipsychotic and they were switched to olanzapine. Symptom severity was measured using the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity scale (CGI-S). Health-Related Quality of Life (HRQOL) was assessed using the World Health Organization Quality of Life-Abbreviated (WHOQOL-BREF). Paired t-tests were performed to assess changes from baseline to endpoint. Pearson's correlation coefficients (r) were used to assess the correlations between change in symptoms (BPRS and CGI-S scores) and change in HRQOL (WHOQOL-BREF scores). Symptoms and HRQOL both improved significantly over the 12 months of treatment (P<0.001). Significant correlations were observed between changes from baseline to end of study on the BPRS and the CGI-S and each of the WHOQOL-BREF four domain scores and two overall quality-of-life questions. The correlation coefficients ranged from r=-0.45 to r=-0.53 for the BPRS and WHOQOL-BREF. The correlation coefficients were slightly smaller between the CGI-S and WHOQOL-BREF, ranging from r=-0.33 to r=-0.40. For patients with schizophrenia, assessing quality of life has the potential to add valuable information to the clinical assessment that takes into account the patient's own perspective of well-being.

Exploring reasons for the observed inconsistent trial reports on intra-articular injections with hyaluronic acid in the treatment of osteoarthritis: Meta-regression analyses of randomized trials.

PubMed

Johansen, Mette; Bahrt, Henriette; Altman, Roy D; Bartels, Else M; Juhl, Carsten B; Bliddal, Henning; Lund, Hans; Christensen, Robin

2016-08-01

The aim was to identify factors explaining inconsistent observations concerning the efficacy of intra-articular hyaluronic acid compared to intra-articular sham/control, or non-intervention control, in patients with symptomatic osteoarthritis, based on randomized clinical trials (RCTs). A systematic review and meta-regression analyses of available randomized trials were conducted. The outcome, pain, was assessed according to a pre-specified hierarchy of potentially available outcomes. Hedges׳s standardized mean difference [SMD (95% CI)] served as effect size. REstricted Maximum Likelihood (REML) mixed-effects models were used to combine study results, and heterogeneity was calculated and interpreted as Tau-squared and I-squared, respectively. Overall, 99 studies (14,804 patients) met the inclusion criteria: Of these, only 71 studies (72%), including 85 comparisons (11,216 patients), had adequate data available for inclusion in the primary meta-analysis. Overall, compared with placebo, intra-articular hyaluronic acid reduced pain with an effect size of -0.39 [-0.47 to -0.31; P < 0.001], combining very heterogeneous trial findings (I(2) = 73%). The three most important covariates in reducing heterogeneity were overall risk of bias, blinding of personnel and trial size, reducing heterogeneity with 26%, 26%, and 25%, respectively (Interaction: P ≤ 0.001). Adjusting for publication/selective outcome reporting bias (by imputing "null effects") in 24 of the comparisons with no data available reduced the combined estimate to -0.30 [-0.36 to -0.23; P < 0.001] still in favor of hyaluronic acid. Based on available trial data, intra-articular hyaluronic acid showed a better effect than intra-articular saline on pain reduction in osteoarthritis. Publication bias and the risk of selective outcome reporting suggest only small clinical effect compared to saline. Copyright © 2016 Elsevier Inc. All rights reserved.

Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study.

PubMed

Ferrières, Jean; Dallongeville, Jean; Rossignol, Michel; Bénichou, Jacques; Caro, J Jaime; Getsios, Denis; Hernandez, Luis; Abenhaim, Lucien; Grimaldi-Bensouda, Lamiae

To evaluate the real-life impact of ezetimibe on cardiovascular (CV) morbidity and mortality in France. To estimate the number of non-fatal and fatal CV events that could be prevented and corresponding number of patients needed to treat (NNT) with ezetimibe to prevent one CV event over 5 years. Non-interventional 48-month follow-up cohort conducted in hypercholesterolemic patients starting on ezetimibe <3 months at study entry, either as monotherapy or combined with statins. Prediction modeling using discrete event simulation with calibrated Framingham CV risk equations was applied to data from pivotal clinical trials on ezetimibe and real-life data derived from the cohort. A total of 3215 patients in the cohort accumulated 9314 person-years of follow-up for an average of 2.9 years. Mean age was 61.5 (standard deviation [SD] = 10.7), 54.6% were males, and 27.0% had a history of CV disease. Baseline LDL-cholesterol averaged 4.1 mmol/L (159 mg/dL; SD = 1.0) and HDL-C 1.6 mmol/L (62 mg/dL; SD = 0.5). LDL-C decreased in the first 12 months in ezetimibe-LLT (lipid-lowering therapy) initiators, switchers (monotherapy), and combination therapy with a statin by respectively 21.3%, 6.4%, and 29.1%. The corresponding predicted rate reductions of CV events (non-fatal and fatal) compared to no treatment or to a statin (combination therapy) were respectively 8, 2, and 12 per 1000 patients treated over 5 years, with a global NNT of 143 patients over 5 years. These results, accounting for observed CV event rates, risk factors evolution over time and adherence to treatment in real life, were consistent with those from clinical trials. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea.

PubMed

Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung

2016-08-01

The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.

America and the age of genocide: labeling a third-party conflict "genocide" decreases support for intervention among ingroup-glorifying Americans because they down-regulate guilt and perceived responsibility to intervene.

PubMed

Leidner, Bernhard

2015-12-01

Drawing on research on the collapse of compassion and group processes and interrelations, four experiments investigated how labeling a conflict "genocide" affects distant bystanders' support for intervention. The genocide label (compared with no label or the label "not a genocide") weakened Americans' support for intervention in a crisis analogous to Darfur. Ingroup glorification moderated this effect such that the genocide label decreased support at high levels of glorification (Studies 1-3). Ingroup attachment, if anything, moderated such that the genocide label increased support at high levels of attachment (Studies 1 and 3). Importantly, the effects occurred even when controlling for conservatism (Studies 1 and 3), gender, religion, military affiliation, and level of education (Study 2). Decreases in anticipated guilt over possible nonintervention (Studies 1 and 3) among high glorifiers, and a subsequent decrease in perceived obligation to intervene (Study 3), mediated the effect of the genocide label on support for intervention. © 2015 by the Society for Personality and Social Psychology, Inc.

Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction.

PubMed

Rubio-Aurioles, Eusebio; El-Meliegy, Amr; Abdulwahed, Samer; Henneges, Carsten; Sorsaburu, Sebastian; Gurbuz, Sirel

2015-02-01

Phosphodiesterase type 5 (PDE5) inhibitors have discontinuation rates as high as 60% in men with erectile dysfunction. Treatment satisfaction has been significantly associated with treatment continuation. Understanding key characteristics in terms of treatment preference, relationship, and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally. The objective was to identify subgroups of interest in the pooled database of two observational studies conducted in Latin America (LA) and Middle East/North Africa (MENA) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline. Two identical prospective, non-interventional, observational, studies in MENA (N = 493) and LA (N = 511) treated men with an 'on demand' (pro re nata, PRN) PDE5 inhibitor (sildenafil, tadalafil, vardenafil, or lodenafil) during 6 months. In this post-hoc meta-analysis of two observational studies with equal design, pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations, satisfaction, self-esteem, and patient-partner relationships. Decision tree analyses, with and without weighting, were used to identify and describe key features. In each analysis of patient expectations, patient-partner relationship, and self-esteem, we describe the two major subgroups at baseline for each decision tree. Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors (59%) highlighted the importance of treatment effect duration, second to partner satisfaction with treatment, while patients prescribed short-acting PDE5 inhibitors (32%) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion. Further insights regarding patients, partner relationship characteristics, and treatment expectations were identified. Our analyses have described key characteristics, such as self- and partner perceptions, sexual attitudes, and treatment expectations in relation to the patients' country and prescribed treatment, which might guide treatment decisions in MENA and LA men with ED.

Reducing Patients’ Unmet Concerns in Primary Care: the Difference One Word Can Make

PubMed Central

Robinson, Jeffrey D.; Elliott, Marc N.; Beckett, Megan; Wilkes, Michael

2007-01-01

Context In primary, acute-care visits, patients frequently present with more than 1 concern. Various visit factors prevent additional concerns from being articulated and addressed. Objective To test an intervention to reduce patients’ unmet concerns. Design Cross-sectional comparison of 2 experimental questions, with videotaping of office visits and pre and postvisit surveys. Setting Twenty outpatient offices of community-based physicians equally divided between Los Angeles County and a midsized town in Pennsylvania. Participants A volunteer sample of 20 family physicians (participation rate = 80%) and 224 patients approached consecutively within physicians (participation rate = 73%; approximately 11 participating for each enrolled physician) seeking care for an acute condition. Intervention After seeing 4 nonintervention patients, physicians were randomly assigned to solicit additional concerns by asking 1 of the following 2 questions after patients presented their chief concern: “Is there anything else you want to address in the visit today?” (ANY condition) and “Is there something else you want to address in the visit today?” (SOME condition). Main Outcome Measures Patients’ unmet concerns: concerns listed on previsit surveys but not addressed during visits, visit time, unanticipated concerns: concerns that were addressed during the visit but not listed on previsit surveys. Results Relative to nonintervention cases, the implemented SOME intervention eliminated 78% of unmet concerns (odds ratio (OR) = .154, p = .001). The ANY intervention could not be significantly distinguished from the control condition (p = .122). Neither intervention affected visit length, or patients’; expression of unanticipated concerns not listed in previsit surveys. Conclusions Patients’ unmet concerns can be dramatically reduced by a simple inquiry framed in the SOME form. Both the learning and implementation of the intervention require very little time. PMID:17674111

The effectiveness of pharmaceutical interventions for obesity: weight loss with orlistat and sibutramine in a United Kingdom population-based cohort

PubMed Central

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

2015-01-01

Aims Drug treatments for obesity have proven efficacy from randomized trials, but their effectiveness in routine clinical practice is unknown. We assessed the effects on weight and body mass index (BMI) of orlistat and sibutramine when delivered in routine primary care. Methods We used United Kingdom data from the Clinical Practice Research Datalink to estimate the effects of orlistat or sibutramine on weight and BMI over 3 years following treatment initiation. For comparison, we matched each patient with up to five obese patients receiving neither drug. Mixed effects linear regression with splines was used to model change in weight and BMI. Mean change with 95% confidence intervals (CI) was estimated. Results We identified 100 701 patients receiving orlistat, 15 355 receiving sibutramine and 508 140 non-intervention patients, with body mass index of 37.2, 36.6 and 33.2 kg m−2, respectively. Patients receiving orlistat lost, on average, 0.94 kg month−1 (0.93 to 0.95) over the first 4 months. Weight gain then occurred, although weight remained slightly below baseline at 3 years. Patients receiving sibutramine lost, 1.28 kg month−1 (1.26 to 1.30) over the first 4 months, but by 3 years had exceeded baseline weight. Non-intervention patients had slight increases in weight throughout the 3 year period, with gains ranging between 0.01 and 0.06 kg month−1. Conclusions Orlistat and sibutramine had early effects on weight loss, not sustained over 3 years. As new treatments for obesity are approved, their effectiveness should be measured in routine clinical practice, as effectiveness may be considerably less than seen in randomized trials. PMID:25641659

Prevalence and risk factors for cervical and lumbar spondylosis in interventional electrophysiologists.

PubMed

Birnie, David; Healey, Jeff S; Krahn, Andrew D; Ahmad, Kamran; Crystal, Eugene; Khaykin, Yaariv; Chauhan, Vijay; Philippon, Francois; Exner, Derek; Thibault, Bernard; Hruczkowski, Tomascz; Nery, Pablo; Keren, Arieh; Redfearn, Damian

2011-09-01

  The volume and complexity of interventional electrophysiology procedures have increased greatly over the last 20 years. Anecdotal reports from Canada and elsewhere have suggested an important prevalence of neck and back problems in interventional electrophysiologists. To quantify the scope of neck and back problems, we surveyed 70 interventional electrophysiologists in Canada using an electronic survey with in person and email reminders. We also surveyed an age- and gender-matched group of noninterventional cardiologists. We received responses from a total of 58 of 70 interventional electrophysiologists (response rate 82.8%). There was a significantly higher prevalence of cervical spondylosis among electrophysiologists compared to matched noninterventional cardiologists (20.7% compared to 5.5%, P = 0.033). There was a trend for increased prevalence of lumbar spondylosis (25.9% compared to 16.7%, P = 0.298). Among electrophysiologists, those with cervical spondylosis were older (49.83 ± 10.48 years compared to 44.57 ± 9.20, P = 0.092) and had worked in the specialty for longer in comparison to unaffected physicians (19.67 ± 10.06 years compared to 13.37 ± 8.97 years, P = 0.039). All other variables including gender, height, weight, BMI, type of lead, weekly average lead time, and % of time standing in electrophysiology laboratory were not different. On multivariable analysis there were no independent predictors of disease. There is a significant increased prevalence of cervical spondylosis among interventional electrophysiologists. Programs to improve ergonomics and minimize time spent wearing lead are needed. The same vigilance that is used to ensure radiation safety in the laboratory should be applied to create ergonomic safety.  © 2011 Wiley Periodicals, Inc.

Recent non-interventional advances in cancer pain among Singapore patients.

PubMed

Saw, Constance L L; Chew, Lita; Goh, Cynthia

2012-09-01

Pain is a common symptom in cancer patients, but very little information about the prevalence, severity, and treatment of pain in cancer patients in Singapore is available. Therefore, our prospective survey in the National Cancer Centre (NCC) outpatients is incorporated in this report. In addition, a review concerning the recent advances on non-interventional pain management in cancer treatment, which is relevant in the context, is discussed. For the prospective survey, a questionnaire was distributed for self-administration by patients while waiting for consultation at the NCC outpatient departments. Literature searches on advances in pain management were conducted, reviewed and discussed. In the last decade, there have been advances in pain pharmacology ranging from wider therapeutic options and management approaches to novel delivery techniques. Acupuncture and massage therapy became increasingly popular among cancer patients. Some clinical trials of acupuncture show benefits in palliation of cancer pain. From the prospective survey, 41.2% of the responders reported pain in the past week, and only 70.8% talked to their doctors about their pain. One third of the patients received analgesics. Of these, 86.5% said that they were taking the prescribed medications, however, 37.4% admitted to having difficulties taking them. Non-drug methods were used by 25.4% of the patients. Medicated oil, cream or gel was used by 49.3%; only 2.6% reported use of Chinese herbs. Pain is a significant symptom in outpatients attending a cancer centre, affecting 41.2% of the patients. Although majority of patients who suffered from pain reported this to doctors, much more medical effort is needed to help patients to relieve their pain and proper complementary therapy could be considered.

Impact of eating probiotic yogurt on colonization by Candida species of the oral and vaginal mucosa in HIV-infected and HIV-uninfected women.

PubMed

Hu, Haihong; Merenstein, Daniel J; Wang, Cuiwei; Hamilton, Pilar R; Blackmon, Mandy L; Chen, Hui; Calderone, Richard A; Li, Dongmei

2013-10-01

Candidiasis in HIV/AIDS patients continues to be a public health problem. Antifungal therapies are not always effective and may result in complications, such as the development of drug-resistant strains of Candida species. This study evaluated the impact of probiotic consumption on Candida colonization of the oral and vaginal mucosa. A pilot study was conducted in 24 women (17 HIV-infected, 7 HIV-uninfected) from the Women's Interagency HIV Study. The women underwent a 60-day initiation period with no probiotic consumption, followed by two 15-day consumption periods, with a different probiotic yogurt (DanActive™ or YoPlus™ yogurt) during each interval. There was a 30-day washout period between the two yogurt consumption periods. Oral and vaginal culture swabs were collected on days 0, 60, 74, and 120. Candida was detected by inoculating each swab in both Sabouraud's dextrose agar with or without chloramphenicol and CHROMagar. Less fungal colonization among women was observed when the women consumed probiotic yogurts (54 % of the women had vaginal fungal colonization during the non-probiotic yogurt consumption period, 29 % during the DanActive™ period, and 38 % during YoPlus™ yogurt consumption period), and HIV-infected women had significantly lower vaginal fungal colonization after they consumed DanActive™ yogurt compared to the non-intervention periods (54 vs 29 %, p = 0.03). These data are promising, but as expected in a small pilot study, there were some significant changes but also some areas where colonization was not changed. This type of conflicting data is supportive of the need for a larger trial to further elucidate the role of probiotic yogurts in fungal growth in HIV-infected women.

Impact of Eating Probiotic Yogurt on Colonization by Candida Species of the Oral and Vaginal Mucosa in HIV-Infected and HIV-Uninfected Women

PubMed Central

Hu, Haihong; Wang, Cuiwei; Hamilton, Pilar R.; Blackmon, Mandy L.; Chen, Hui; Calderone, Richard A.; Li, Dongmei

2014-01-01

Background Candidiasis in HIV/AIDS patients continues to be a public health problem. Antifungal therapies are not always effective and may result in complications, such as the development of drug-resistant strains of Candida species. Objectives This study evaluated the impact of probiotic consumption on Candida colonization of the oral and vaginal mucosa. Patients/Methods A pilot study was conducted in 24 women (17 HIV-infected, 7 HIV-uninfected) from the Women's Interagency HIV Study. The women underwent a 60-day initiation period with no probiotic consumption, followed by two 15-day consumption periods, with a different probiotic yogurt (DanActive™ or YoPlus™ yogurt) during each interval. There was a 30-day washout period between the two yogurt consumption periods. Oral and vaginal culture swabs were collected on days 0, 60, 74, and 120. Candida was detected by inoculating each swab in both Sabouraud's dextrose agar with or without chloramphenicol and CHROMagar. Results Less fungal colonization among women was observed when the women consumed probiotic yogurts (54 % of the women had vaginal fungal colonization during the non-probiotic yogurt consumption period, 29 % during the DanActive™ period, and 38 % during YoPlus™ yogurt consumption period), and HIV-infected women had significantly lower vaginal fungal colonization after they consumed DanActive™ yogurt compared to the nonintervention periods (54 vs 29 %, p = 0.03). Conclusions These data are promising, but as expected in a small pilot study, there were some significant changes but also some areas where colonization was not changed. This type of conflicting data is supportive of the need for a larger trial to further elucidate the role of probiotic yogurts in fungal growth in HIV-infected women. PMID:23925786

The impact of FDG-PET/CT in the management of patients with vulvar and vaginal cancer.

PubMed

Robertson, N L; Hricak, H; Sonoda, Y; Sosa, R E; Benz, M; Lyons, G; Abu-Rustum, N R; Sala, E; Vargas, H A

2016-03-01

To evaluate the changes in prognostic impression and patient management following PET/CT in patients with vulvar and vaginal carcinoma; and to compare PET/CT findings with those of conventional imaging modalities. We summarized prospectively and retrospectively collected data for 50 consecutive patients from our institution that enrolled in the National Oncologic PET Registry and underwent FDG-PET/CT for a suspected or known primary or recurrent vulvar/vaginal cancer. 54/83 (65%) studies included had a diagnosis of vulvar cancer, and the remaining 29/83 (35%), a diagnosis of vaginal cancer. Following FDG-PET/CT, the physician's prognostic impression changed in 51% of cases. A change in patient management, defined as a change to/from a non-interventional strategy (observation or additional imaging), to/from an interventional strategy (biopsy or treatment), was documented in 36% of studies. The electronic records demonstrated that 95% of the management strategies recorded in the physician questionnaires were implemented as planned. MRI and/or CT were performed within one month of the FDG-PET/CT in 20/83 (24%) and 28/83 (34%) cases, respectively. FDG-PET/CT detected nodes suspicious for metastases on 29/83 (35%) studies performed. MRI and CT detected positive nodes on 6 and 11 studies respectively. Distant metastases were identified in 10 cases imaged with FDG-PET and 5 cases that had additional conventional CT imaging. All suspicious lesions seen on CT were positively identified on PET/CT. In 4 cases, an abnormality identified on PET/CT, was not seen on diagnostic CT. FDG-PET/CT may play an important role in the management of vulvar and vaginal carcinoma. Copyright © 2015 Elsevier Inc. All rights reserved.

ADenoVirus Initiative Study in Epidemiology (ADVISE): Results of a multicentric epidemiology study in Spain.

PubMed

Muñoz-Hernández, A M; Duquesroix, B; Benítez-Del-Castillo, J M

2018-03-01

Non-interventional, observational, epidemiology study to assess clinical characteristics and frequency of adenovirus conjunctivitis diagnosed by AdenoPlus ® in patients who presented with signs and symptoms of acute conjunctivitis. Safety aspects during use of the test were analyzed as well. This analysis presents the data obtained from the 386 patients enrolled in Spain. Patients had to present with acute signs and symptoms of conjunctivitis ≤7days. The minimum age was 1year old. Patients who had already used local antiviral therapies, topical steroids or immuno-modulators were not allowed to enter the study. A standardized questionnaire was used to collect patient's ocular history and test results. A total of 386 patients were recruited in 22 sites, being analyzed 329 patients. Among them, the percentage of "AdenoPlus ® positive" was 36,2% (119/329). Before the test was performed, in 84,1% of the cases, investigators believed that the conjunctivitis was of viral origin but only 50,3% of the investigators had their clinical assessment confirmed by the test. Patients who tested positive for adenoviral conjunctivitis presented higher percentages of signs and symptoms than the rest of the patients. None of the signs or symptoms could be qualified as pathognomonic of the disease, being difficult for the clinicians to perform an accurate diagnosis. AdenoPlus ® test is an antigen based immunoassay test that detects the presence of adenovirus directly from tears, and it can be an useful tool to help early differential diagnosis in patients with conjunctivitis signs and symptoms lasting for less than or equal to 7days. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

ICARUS study: prevalence and clinical features of impulse control disorders in Parkinson's disease.

PubMed

Antonini, Angelo; Barone, Paolo; Bonuccelli, Ubaldo; Annoni, Karin; Asgharnejad, Mahnaz; Stanzione, Paolo

2017-04-01

Impulse control disorders/other compulsive behaviours ('ICD behaviours') occur in Parkinson's disease (PD), but prospective studies are scarce, and prevalence and clinical characteristics of patients are insufficiently defined. To assess the presence of ICD behaviours over a 2-year period, and evaluate patients' clinical characteristics. A prospective, non-interventional, multicentre study (ICARUS (Impulse Control disorders And the association of neuRopsychiatric symptoms, cognition and qUality of life in ParkinSon disease); SP0990) in treated Italian PD outpatients. Study visits: baseline, year 1, year 2. Surrogate primary variable: presence of ICD behaviours and five ICD subtypes assessed by modified Minnesota Impulsive Disorder Interview (mMIDI). 1069/1095 (97.6%) patients comprised the Full Analysis Set. Point prevalence of ICD behaviours (mMIDI; primary analysis) was stable across visits: 28.6% (306/1069) at baseline, 29.3% (292/995) at year 1, 26.5% (245/925) at year 2. The most prevalent subtype was compulsive eating, followed by punding, compulsive sexual behaviour, gambling and buying disorder. Patients who were ICD positive at baseline were more likely to be male, younger, younger at PD onset, have longer disease duration, more severe non-motor symptoms (including mood and sexual function), depressive symptoms, sleep impairment and poorer PD-related quality of life. However, they did not differ from the ICD-negative patients in their severity of PD functional disability, motor performance and cognitive function. Prevalence of ICD behaviours was relatively stable across the 2-year observational period. ICD-positive patients had more severe depression, poorer sleep quality and reduced quality of life. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Overview of the Oral HIV/AIDS Research Alliance Program

PubMed Central

Shiboski, C.H.; Webster-Cyriaque, J.Y.; Ghannoum, M.; Greenspan, J.S.; Dittmer, D.

2011-01-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance’s main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving—in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally. PMID:21441477

Overview of the oral HIV/AIDS Research Alliance Program.

PubMed

Shiboski, C H; Webster-Cyriaque, J Y; Ghannoum, M; Greenspan, J S; Dittmer, D

2011-04-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance's main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving-in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally.

Role of MRI in differentiating various causes of non-traumatic paraparesis and tetraparesis.

PubMed

Ahmed, Nisar; Akram, Hamid; Qureshi, Ishtiaq Ahmed

2004-10-01

To assess the frequency of various causes of non-traumatic paraparesis and tetraparesis in adults based only on the findings of magnetic resonance imaging (MRI). Non-interventional descriptive study carried out from May 2001 to October 2002 at Radiology Department, CMH, Rawalpindi. A total of 100 adult patients who presented with non-traumatic paraparesis or tetraparesis, were studied. MRI spine of all the patients and MRI brain of selected patients, was carried out. Based on MRI findings alone causes of non-traumatic paraparesis and tetraparesis were categorized. Paraparesis was more frequent than tetraparesis. Cord compression was found in 72% cases. Neoplastic compression, infective spondylitis and non-compressive myelopathies were the main causes of paraparesis while spondylotic myelopathy was the main cause of tetraparesis. Based upon MRI findings causes of non-traumatic paraparesis or tetraparesis can be subcategorized into spondylotic, infective or neoplastic cord compression and non-compressive myelopathies. Further subcategorization of neoplastic lesions according to their compartment of origin can also be done.

The use of non-steroidal anti-inflammatory drugs for patent ductus arteriosus closure in preterm infants.

PubMed

Benitz, William E; Bhombal, Shazia

2017-10-01

Over the last four decades, non-steroidal anti-inflammatory drugs have been widely used to induce closure of the patent ductus arteriosus (PDA) in preterm infants. Evidence to support this practice is lacking, despite performance of >50 randomized trials. The credibility of those trials may have been compromised by high rates of open treatment in controls, era of study prior to advent of modern practices, or inclusion of insufficient numbers of very immature infants. Meta-analyses show little impact of those factors on main conclusions. Essentially all trials reporting important long-term outcomes (other than mortality) initiated treatment within five days after birth, so no evidence regarding later treatment is available. Accruing clinical experience suggests that long-term outcomes are not compromised, and may be improved, with non-interventional management strategies. Future studies to identify preterm infants at greatest risk of potential harm from a persistent PDA, particularly after the second postnatal week, are urgently needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Circadian rhythm : Influence on Epworth Sleepiness Scale score].

PubMed

Herzog, M; Bedorf, A; Rohrmeier, C; Kühnel, T; Herzog, B; Bremert, T; Plontke, S; Plößl, S

2017-02-01

The Epworth Sleepiness Scale (ESS) is frequently used to determine daytime sleepiness in patients with sleep-disordered breathing. It is still unclear whether different levels of alertness induced by the circadian rhythm influence ESS score. The aim of this study is to investigate the influence of circadian rhythm-dependent alertness on ESS performance. In a monocentric prospective noninterventional observation study, 97 patients with suspected sleep-disordered breathing were investigated with respect to daytime sleepiness in temporal relationship to polysomnographic examination and treatment. The Karolinska Sleepiness Scale (KSS) and the Stanford Sleepiness Scale (SSS) served as references for the detection of present sleepiness at three different measurement times (morning, noon, evening), prior to and following a diagnostic polysomnography night as well as after a continuous positive airway pressure (CPAP) titration night (9 measurements in total). The KSS, SSS, and ESS were performed at these times in a randomized order. The KSS and SSS scores revealed a circadian rhythm-dependent curve with increased sleepiness at noon and in the evening. Following a diagnostic polysomnography night, the scores were increased compared to the measurements prior to the night. After the CPAP titration night, sleepiness in the morning was reduced. KSS and SSS reflect the changes in alertness induced by the circadian rhythm. The ESS score war neither altered by the intra-daily nor by the inter-daily changes in the level of alertness. According to the present data, the ESS serves as a reliable instrument to detect the level of daytime sleepiness independently of the circadian rhythm-dependent level of alertness.

Outcomes Among Chronically Ill Adults in a Medical Home Prototype

PubMed Central

Liss, David T.; Fishman, Paul A.; Rutter, Carolyn M.; Grembowski, David; Ross, Tyler R.; Johnson, Eric A.; Reid, Robert J.

2014-01-01

Objectives To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Study Design Nonequivalent pretest-posttest control group design. Methods PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Results Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care–sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. Conclusions A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses. PMID:24304182

All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis.

PubMed

Ogura, Takashi; Azuma, Arata; Inoue, Yoshikazu; Taniguchi, Hiroyuki; Chida, Kingo; Bando, Masashi; Niimi, Yuka; Kakutani, Shinichi; Suga, Moritaka; Sugiyama, Yukihiko; Kudoh, Shoji; Nukiwa, Toshihiro

2015-09-01

Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease with a median survival of 2-5 years and limited treatment options. In 2008, pirfenidone became the first drug to be approved for IPF treatment in Japan. The aim of this study was to assess the safety of pirfenidone for IPF treatment in a clinical setting. We conducted a safety-oriented post-marketing surveillance of all patients with IPF who were administered pirfenidone in the first year after its launch in Japan. This was a prospective, non-interventional, observational study. Case report forms were used to collect survey data, comprising adverse events, acute exacerbations, patient demographics, concomitant drug use, and concurrent treatment data. Of the 1371 patients available for safety evaluation, two-thirds had stage III-IV disease. The incidence of total adverse drug reactions (ADRs) was 64.6%. ADRs with an incidence of ≥3% were decreased appetite, photosensitivity reaction, nausea, abdominal discomfort, malaise, somnolence, and hepatic function abnormal. This safety profile was consistent with the findings in phase II and III trials in Japan. The discontinuation rates due to adverse events at 12 months for each disease stage were similar; however, discontinuation caused by disease progression increased with disease severity. Treatment with pirfenidone stabilized both vital capacity and subjective symptoms in most patients (70-80%) treated for at least 6 months. This post-marketing surveillance in Japan showed that pirfenidone was generally well tolerated in patients with IPF, including those with severe lung function impairment. Copyright © 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

Efficacy and safety of biosimilar filgrastim in primary and secondary prevention of febrile neutropenia

PubMed Central

Kraj, Leszek; Krawczyk-Lipiec, Joanna; Górniewska, Joanna; Orlik, Grzegorz

2017-01-01

Neutropenia and febrile neutropenia (FN) are among the most common side effects/complications of chemotherapy. The aim of the present study was to evaluate the practice of the use of biosimilar filgrastim in the primary and secondary prevention of FN, and assess its efficacy and safety. A multi-center, non-interventional epidemiological study of 170 cancer patients aged 23–82 years was conducted. Data were collected via a questionnaire completed based on medical documentation and patient examination over five chemotherapy visits. The risk of FN related to the chemotherapy protocol used was in the range of 10–20% in >50% of the patients (53.5%) and a majority (74.7%) had additional FN risk factors. 60% of the patients received filgrastim as primary prevention of FN, and 40% received it as secondary prevention. In 40.6% of cases, six cycles of chemotherapy were used. More than 90% of patients continued chemotherapy according to the initial recommended dose. In majority of patients, no FN was observed following the final cycle of chemotherapy. Median neutrophil count at visit 1 was 2.2×103/µl and did not fall below that level. Majority of patients (>70%) performed self-injections of filgrastim, and 86.3% of patients were continuing therapy with this drug at the last visit. No treatment-related side effects were recorded. The use of biosimilar filgrastim in the primary and secondary prevention of FN allows to maintain initial chemotherapy dosage. Furthermore, the use of biosimilar filgrastim is safe and tolerable, and has a high acceptance by patients. PMID:28804626

A French observational study describing the use of human polyvalent immunoglobulins in hematological malignancy-associated secondary immunodeficiency.

PubMed

Benbrahim, Omar; Viallard, Jean-François; Choquet, Sylvain; Royer, Bruno; Bauduer, Frédéric; Decaux, Olivier; Crave, Jean-Charles; Fardini, Yann; Clerson, Pierre; Levy, Vincent

2018-04-12

To describe the characteristics of patients suffering from secondary immunodeficiencies (SID) associated with hematological malignancies (HM), who started immunoglobulins replacement therapy (IgRT), physicians' expectations regarding IgRT and IgRT modalities. Non-interventional, prospective French cross-sectional study. The analysis included 231 patients (66±12 years old) suffering from multiple myeloma (MM) (N=64), chronic lymphoid leukemia (CLL) (N=84), aggressive non-Hodgkin B-cell lymphoma (aNHL) (N=32), indolent NHL (N=39), acute leukemia (N=6), Hodgkin disease (N=6). Of the HM, 47% were currently treated, 42% were relapsing or refractory, 23% of patients had received an autologous hematopoietic stem-cell transplant and 5% an allograft. Serum immunoglobulins trough levels in 195 individuals were less than 5g/L in 68.7% of cases. Most patients had a history of recurrent infections. Immunoglobulin dose was about 400 mg/kg/month. Half of patients started with subcutaneous infusion. When starting IgRT, physicians mainly expected to prevent severe and moderate infections. They also anticipated improvement in quality of life and survival which is beyond evidence-based medicine. NHL is a frequent condition motivating IgRT besides well recognized indications. Physicians mainly based the decision of starting IgRT on hypogammaglobulinemia and recurrence of infections but, irrespective of current recommendations, were also prepared to start IgRT prophylactically even in the absence of a history of infections. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

Increased access to care and appropriateness of treatment at private sector drug shops with integrated management of malaria, pneumonia and diarrhoea: a quasi-experimental study in Uganda.

PubMed

Awor, Phyllis; Wamani, Henry; Tylleskar, Thorkild; Jagoe, George; Peterson, Stefan

2014-01-01

Drug shops are a major source of care for children in low income countries but they provide sub-standard care. We assessed the feasibility and effect on quality of care of introducing diagnostics and pre-packaged paediatric-dosage drugs for malaria, pneumonia and diarrhoea at drug shops in Uganda. We adopted and implemented the integrated community case management (iCCM) intervention within registered drug shops. Attendants were trained to perform malaria rapid diagnostic tests (RDTs) in each fever case and count respiratory rate in each case of cough with fast/difficult breathing, before dispensing recommended treatment. Using a quasi-experimental design in one intervention and one non-intervention district, we conducted before and after exit interviews for drug seller practices and household surveys for treatment-seeking practices in May-June 2011 and May-June 2012. Survey adjusted generalized linear models and difference-in-difference analysis was used. 3759 (1604 before/2155 after) household interviews and 943 (163 before/780 after) exit interviews were conducted with caretakers of children under-5. At baseline, no child at a drug shop received any diagnostic testing before treatment in both districts. After the intervention, while no child in the non-intervention district received a diagnostic test, 87.7% (95% CI 79.0-96.4) of children with fever at the intervention district drug shops had a parasitological diagnosis of malaria, prior to treatment. The prevalence ratios of the effect of the intervention on treatment of cough and fast breathing with amoxicillin and diarrhoea with ORS/zinc at the drug shop were 2.8 (2.0-3.9), and 12.8 (4.2-38.6) respectively. From the household survey, the prevalence ratio of the intervention effect on use of RDTs was 3.2 (1.9-5.4); Artemisinin Combination Therapy for malaria was 0.74 (0.65-0.84), and ORS/zinc for diarrhoea was 2.3 (1.2-4.7). iCCM can be utilized to improve access and appropriateness of care for children at drug shops.

Physiogenomic analysis of the Puerto Rican population.

PubMed

Ruaño, Gualberto; Duconge, Jorge; Windemuth, Andreas; Cadilla, Carmen L; Kocherla, Mohan; Villagra, David; Renta, Jessica; Holford, Theodore; Santiago-Borrero, Pedro J

2009-04-01

Admixture in the population of the island of Puerto Rico is of general interest with regards to pharmacogenetics to develop comprehensive strategies for personalized healthcare in Latin Americans. This research was aimed at determining the frequencies of SNPs in key physiological, pharmacological and biochemical genes to infer population structure and ancestry in the Puerto Rican population. A noninterventional, cross-sectional, retrospective study design was implemented following a controlled, stratified-by-region, random sampling protocol. The sample was based on birthrates in each region of the island of Puerto Rico, according to the 2004 National Birth Registry. Genomic DNA samples from 100 newborns were obtained from the Puerto Rico Newborn Screening Program in dried-blood spot cards. Genotyping using a physiogenomic array was performed for 332 SNPs from 196 cardiometabolic and neuroendocrine genes. Population structure was examined using a Bayesian clustering approach as well as by allelic dissimilarity as a measure of allele sharing. The Puerto Rican sample was found to be broadly heterogeneous. We observed three main clusters in the population, which we hypothesize to reflect the historical admixture in the Puerto Rican population from Amerindian, African and European ancestors. We present evidence for this interpretation by comparing allele frequencies for the three clusters with those for the same SNPs available from the International HapMap project for Asian, African and European populations. Our results demonstrate that population analysis can be performed with a physiogenomic array of cardiometabolic and neuroendocrine genes to facilitate the translation of genome diversity into personalized medicine.

Optical coherence tomography patterns as predictors of visual outcome in dengue-related maculopathy.

PubMed

Teoh, Stephen C; Chee, Caroline K; Laude, Augustinus; Goh, Kong Y; Barkham, Timothy; Ang, Brenda S

2010-03-01

The purpose of this study was to characterize the presentations, long-term outcomes, and visual prognostic factors in dengue-related maculopathy of 41 patients with dengue fever and impaired vision from dengue-related maculopathy in a retrospective noninterventional and observational series. The medical records of patients with dengue-related maculopathy diagnosed over 18 months between July 2004 and December 2005 at The Eye Institute, Tan Tock Seng Hospital and Communicable Disease Center, Singapore, were reviewed and followed up for 24 months. Visual acuity and symptoms (presence of scotoma on automated visual fields and Amsler grid) were correlated with optical coherence tomography evaluation. Mean age was 28.7 years and there were more men (53.7%). The most common visual complaints were blurring of vision (51.2%) and central scotoma (34.1%). Most patients recovered best-corrected visual acuity >20/40. Optical coherence tomography showed 3 patterns of maculopathy: 1) diffuse retinal thickening; 2) cystoid macular edema; and 3) foveolitis. The visual outcome was independent of the extent of edema, but scotomata persisted longest in patients with foveolitis and shortest with those with diffuse retinal thickening. Dengue-associated ocular inflammation is an emerging ophthalmic condition and often involves the posterior segment. Prognosis is variable. Patients usually regain good vision but may retain persistent scotomata even at 2 years despite clinical resolution of the disease. Optical coherence tomography patterns in dengue maculopathy are useful for characterization, monitoring, and prognostication of the visual defect.

Quality of life and physicians' perception in myelodysplastic syndromes

PubMed Central

Oliva, Esther Natalie; Finelli, Carlo; Santini, Valeria; Poloni, Antonella; Liso, Vincenzo; Cilloni, Daniela; Impera, Stefana; Terenzi, Adelmo; Levis, Alessandro; Cortelezzi, Agostino; Ghio, Riccardo; Musto, Pellegrino; Semenzato, Gianpietro; Clissa, Cristina; Lunghi, Teresa; Trappolini, Silvia; Gaidano, Valentina; Salvi, Flavia; Reda, Gianluigi; Villani, Oreste; Binotto, Gianni; Cufari, Patrizia; Cavalieri, Elena; Spiriti, Maria Antonietta Aloe

2012-01-01

To detect factors associated with quality of life (QOL) of patients with myelodysplastic syndrome (MDS) and to compare the MDS patients’ self-assessed QOL with that perceived by their physicians. In an observational, non-interventional, prospective, multicentre study, QOL was evaluated in 148 patients with newly diagnosed low- and intermediate-risk IPSS MDS. QOL measures (QOL-E v.2, LASA and EQ-5D) and patient-related candidate determinants of QOL were assessed for up to 18 months. Patients' QOL scores were compared with those obtained by appointed hematologists’ assessment and with ECOG performance status (PS). Fatigue was not prevalent at diagnosis, though physical QOL and energy levels were low. Transfusion-dependent patients had worse QOL scores. In multivariate analysis, Hb levels and comorbidities were a major determinant of QOL. Physicians’ perception of patients’ well-being correlated with patients’ QOL. Physicians underestimated the impact of disturbances on patients’ QOL, mainly in the MDS-specific components. ECOG PS did not discriminate patients according to QOL status. In conclusion, the association of anemia with QOL is confirmed, while co-morbidities emerge as an independent predictor of QOL in MDS. Fatigue is not a major concern. ECOG PS is not a valuable surrogate of patient’s QOL, thus highlighting that physician’s judgment of patient’s well-being must not substitute patient-reported outcomes. Appropriate questionnaires should be used to assess MDS patients’ QOL in order to improve communication and therapeutic choice. PMID:22762033

Outcomes among chronically ill adults in a medical home prototype.

PubMed

Liss, David T; Fishman, Paul A; Rutter, Carolyn M; Grembowski, David; Ross, Tyler R; Johnson, Eric A; Reid, Robert J

2013-10-01

To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Nonequivalent pretest-posttest control group design. PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care-sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses.

Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study.

PubMed

Khunti, K; Alsifri, S; Aronson, R; Cigrovski Berković, M; Enters-Weijnen, C; Forsén, T; Galstyan, G; Geelhoed-Duijvestijn, P; Goldfracht, M; Gydesen, H; Kapur, R; Lalic, N; Ludvik, B; Moberg, E; Pedersen-Bjergaard, U; Ramachandran, A

2016-09-01

To determine the global extent of hypoglycaemia experienced by patients with diabetes using insulin, as there is a lack of data on the prevalence of hypoglycaemia in developed and developing countries. This non-interventional, multicentre, 6-month retrospective and 4-week prospective study using self-assessment questionnaire and patient diaries included 27 585 patients, aged ≥18 years, with type 1 diabetes (T1D; n = 8022) or type 2 diabetes (T2D; n = 19 563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. The primary endpoint was the proportion of patients experiencing at least one hypoglycaemic event during the observational period. During the prospective period, 83.0% of patients with T1D and 46.5% of patients with T2D reported hypoglycaemia. Rates of any, nocturnal and severe hypoglycaemia were 73.3 [95% confidence interval (CI) 72.6-74.0], 11.3 (95% CI 11.0-11.6) and 4.9 (95% CI 4.7-5.1) events/patient-year for T1D and 19.3 (95% CI 19.1-19.6), 3.7 (95% CI 3.6-3.8) and 2.5 events/patient-year (95% CI 2.4-2.5) for T2D, respectively. The highest rates of any hypoglycaemia were observed in Latin America for T1D and Russia for T2D. Glycated haemoglobin level was not a significant predictor of hypoglycaemia. We report hypoglycaemia rates in a global population, including those in countries without previous data. Overall hypoglycaemia rates were high, with large variations between geographical regions. Further investigation into these differences may help to optimize therapy and reduce the risk of hypoglycaemia. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

[Conversion to tapentadol PR improves analgesia and quality of life in patients with severe and chronic pain despite using tramadol > 300 mg/d].

PubMed

Richter, Uwe; Waldmann-Rex, Susanne; Lehmann, Ute

2015-06-01

This subgroup analysis of a non-interventional study involving general practitioners and internists investigated the administration of tapentadol PR (prolonged release) in patients with widely-utilized tramadol pretreatment in routine clinical practice in Germany. Data of all patients in the study cohort who had tramadol as the only opioid in their previous therapy were included in the analysis (n = 685); among them especially the 99 patients with tramadol dosages exceeding 300 mg/d were focused. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, sleep and quality of life parameters, and tolerability of tapentadol PR. Back pain was the most common cause of pain (n = 86/99), other pain diagnoses were (partly additionally) recorded in 68 cases. A mixed type of pain dominated. The previous tramadol therapy was usually combined with non-opioids (n = 74), co-analgesics (n = 44) and analgesic rescue medication (n = 35). Tapentadol PR therapy reduced the mean initial pain intensity of 7.3 ± 1.5 to 3.1 ± 1.8 points (NRS-11, 11-point pain scale, n = 96) at the end of observation, using an average dosage of 218.7 mg/d. Tapentadol PR was finally applied as the sole analgesic in 32/95 patients. 69/96 patients achieved a clinically meaningful pain relief of at least 50 %, while 63 patients gained a pain reduction of ≥ 4 NRS-points. 89/95 patients reached or exceeded their additional individual treatment goal. This was accompanied by a significant decrease in pain-related impairments of daily activities and an improvement in quality of life with an overall good tolerability of tapentadol PR. Treatment with tapentadol PR was assessed positively by physicians and patients. Data analysis shows a clinically relevant benefit in patients unsuccessfully pretreated with tramadol by consecutive conversion to the potent analgesic tapentadol PR.

Prospective observational study to evaluate risk factors for falls in institutionalized elderly people: the role of cystatin C.

PubMed

Peláez, Verónica Centeno; Ausín, Lourdes; Mambrilla, Marta Ruiz; Gonzalez-Sagrado, Manuel; Pérez Castrillón, José Luis

2015-08-01

To evaluate the role of balance and gait disorders, comorbidities and laboratory abnormalities in the occurrence of falls in an institutionalized elderly population. We made a non-interventional, prospective, observational study in elderly institutionalized people. Comorbidities and information on treatments were obtained. Function and cognition were measured using the Katz Index, the Tinetti Balance and Gait, lower extremity function tests and the Mini-Mental test. At the inclusion, the analytical was made including cystatin C. Falls were recorded for 20 months after inclusion. Patients with falls were older (85 ± 7 vs. 82 ± 8, p = 0.04) and more often female (88 vs. 12 %, p = 0.01). Dyslipidemia, hypertension and antihypertensive treatment were associated with an increased risk of falls. Cystatin C was higher in patients with falls (0.96 ± 0.21 vs. 1.12 ± 0.29, p = 0.02). Functional tests showed differences in the Tinetti balance test (15 ± 2 vs. 13 ± 3, p = 0.04) and lower extremity function balance test (2.8 ± 1.2 vs. 2.2 ± 1.2, p = 0.05). The Mini-Mental State Examination (MMSE) scores were worse in patients with falls (22 ± 4 vs. 25 ± 4, p = 0.01). Only female status (6.2, p = 0.03), the MMSE scores (1.2, p = 0.02) and cystatin C (5.3, p = 0.02) were independent risk factors for falls after logistic regression. Female sex, cognitive impairment and cystatin C were risk factors for falls in non-dependent institutionalized elderly people.

Health-related quality of life in a national cohort of patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.

PubMed

Roman, Antonio; Barbera, Joan Albert; Castillo, Maria Jesús; Muñoz, Rocío; Escribano, Pilar

2013-05-01

Patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) experience impaired health-related quality of life (HRQL). The objective of this study was to evaluate HRQL in a nation-wide sample. This is a prospective, multicenter, non-interventional study of HRQL including 139 (89%) PAH and 17 (11%) CTEPH patients (women 70.5%; mean age, 52.2) recruited from 21 Spanish hospitals. 55% had idiopathic PAH, 34% other PAH and 11% CTEPH. HRQL was measured using the Short Form 36 Health Survey (SF-36) and EuroQoL-5D (baseline and after 6 months). HRQL in the patients with PAH or CTEPH was impaired. The physical component of SF-36 and the EuroQol-5D correlated with the functional class (FC). Mean EuroQol-5D visual analogical scale (EQ-5D VAS) scores were 73.5±18.4, 62.9±20.7 and 51.3±16.0 (P<.0001) in patients with FC I, II and III, respectively. Every increase of one FC represented a loss of 4.0 on the PCS SF-36 and a loss of 9.5 on the EQ-5D VAS. Eight patients who died or received a transplant during the study period presented poorer initial HRQL compared with the rest of the population. No significant changes in HRQL were observed in survivors after 6 months of follow-up. HRQL is impaired in this population, especially in PAH/CTEPH patients near death. HRQL measurements could help predict the prognosis in PAH and CTPH and provide additional information in these patients. Copyright © 2012 SEPAR. Published by Elsevier Espana. All rights reserved.

Real-world data on eslicarbazepine acetate as add-on to antiepileptic monotherapy.

PubMed

Holtkamp, M; McMurray, R; Bagul, M; Sousa, R; Kockelmann, E

2016-07-01

To assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add-on treatment over 6 months in a real-world adult population with partial-onset seizures. This non-interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add-on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected. After 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE-10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue. This study shows that ESL was well tolerated and efficacious as add-on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed. © 2016 Esai Europe Ltd. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd.

Rapid ongoing decline of Baird's tapir in Cusuco National Park, Honduras.

PubMed

McCANN, Niall P; Wheeler, Phil M; Coles, Tim; Bruford, Michael W

2012-12-01

During the International Tapir Symposium 16-21 Oct 2011, the conservation of Baird's tapir (Tapirus bairdii) in Honduras received a boost with the signing of a memorandum of understanding between the Minister Director of the Honduran Institute of Conservation and Forestry (ICF) and the Tapir Specialist Group (TSG). Despite this agreement, accelerating levels of hunting and habitat loss continue to pose a threat to Baird's tapir in Honduras. An ongoing study in Cusuco National Park in northwestern Honduras has been monitoring changes in population dynamics of Baird's tapir since 2006 through the collection of occupancy data. The study has identified an increase in hunting pressure, coinciding with a drastic decline in the encounter rate with Baird's tapir spoor. Here, we examine the significance of a range of demographic variables on Baird's tapir occupancy in Cusuco National Park using the software PRESENCE, and simulate the effects of different management strategies on the future dynamics of the population using the stochastic simulation software VORTEX. The predictions of the theoretical population models are compared to observed changes in occupancy levels. We found that non-intervention resulted in the local extinction of Baird's tapir within a very short time frame, but that various intervention models enabled the population to recover to near carrying capacity. Occupancy and extinction probability were shown to respond markedly to the increase in hunting pressure; and occupancy models supported the future population predictions generated by VORTEX. Our study suggests that immediate intervention is required to reduce hunting pressure to near historical levels to prevent the imminent local extinction of the species. © 2012 Wiley Publishing Asia Pty Ltd, ISZS and IOZ/CAS.

Insulin detemir in the management of type 2 diabetes in non-Western countries: safety and effectiveness data from the A₁chieve observational study.

PubMed

Zilov, Alexey; El Naggar, Nabil; Shah, Siddharth; Shen, Chunduo; Haddad, Jihad

2013-09-01

This subgroup analysis of the A₁chieve study examined data from 15,545 people who started treatment with insulin detemir ± oral glucose-lowering drugs in routine clinical care. A₁chieve was a 24-week, international, prospective, non-interventional study of people with type 2 diabetes from non-Western nations starting treatment with basal insulin detemir, bolus insulin aspart or biphasic insulin aspart 30, alone or in combination, to evaluate their safety and effectiveness in routine clinical practice. HbA₁c for the global cohort improved after 24 weeks from 9.5 ± 1.6% by -2.0 ± 1.6% [80 ± 17 by -22 ± 17 mmol/mol] (-2.1 ± 1.6% [-23 ± 17 mmol/mol] for insulin-naïve participants; -1.6 ± 1.7% [-17 ± 19 mmol/mol] for prior insulin users). Fasting plasma glucose and postprandial plasma glucose were also significantly reduced (p<0.001), irrespective of prior therapy or geographical region. The incidence of major hypoglycaemia decreased significantly over 24 weeks in both the insulin-naïve and insulin-experienced groups (p<0.0001). Mean body weight decreased overall by -0.4 ± 4.0 kg and blood pressure, lipid profiles, and self-reported quality of life improved over 24 weeks for all people starting treatment with insulin detemir. People with type 2 diabetes in poor glycaemic control starting treatment with insulin detemir reported significant improvements in glycaemic control with improved treatment tolerability, irrespective of prior treatment and geographical region, after 24 weeks. Copyright © 2013. Published by Elsevier Ireland Ltd.

[Direct health care costs in patients with type 2 diabetes mellitus six months after starting insulin treatment in Spain: the INSTIGATE study].

PubMed

Costi, María; Smith, Helen; Reviriego, Jesús; Castell, Conxa; Goday, Alberto; Dilla, Tatiana

2011-01-01

The INSTIGATE study was designed to assess direct health care costs incurred by patients with type 2 diabetes mellitus (T2DM) who start insulin therapy in Spain. It was a multicenter, observational, non-interventional, prospective study. Direct costs per patient in standard clinical practice were assessed for 6 months before and after the start of insulin therapy from the perspective of the Spanish health care system perspective. A total of 188 patients (42.6% women) with a mean age of 65.3 years, a mean body mass index of 29.7 kg/m(2), and a mean disease duration of 10.7 years were assessed. Before insulin therapy was started, mean (standard deviation) values of various clinical parameters were: hemoglobin A(1c) (%), 9.22 (1.58); fasting plasma glucose (mmol/L), 12.03 (3.62); and total cholesterol (mmol/L), 4.90 (1.1). These values decreased after insulin therapy was started. Mean total direct health care costs per patient 6 months before and after insulin start were €639 and €1,110, respectively. Mean total costs 6 months after insulin was started included costs of hospitalization (30.5%, €339), insulin (16.2%, €180), primary care (14.3%, €159), blood glucose monitoring (13.8%, €153), specialized care (13.3%, €148), oral antidiabetics (7.8%, €87), and other diabetes-related treatments (3.9%, €43). The clinical outcomes of T2DM patients improved after insulin therapy was started. This improvement was associated to increases in resource utilization and direct health care costs in the first 6 months of insulin therapy. Copyright © 2010 SEEN. Published by Elsevier Espana. All rights reserved.

A simple tool to evaluate common disorders: validation of a "proctological symptom scale".

PubMed

Kraemer, Matthias; Kara, David; Rzepisko, Michael; Sayfan, Joel

2015-05-01

Proctological symptomatology is of little complexity and therefore appears particularly suitable for comparative evaluation by visual scales. We devised a "proctological symptom scale" (PSS) with separate scales for four cardinal proctological symptoms: pain, itching/irritation, discharge/moisture, and bleeding. The objective of this study was to evaluate the PSS among proctological patients and non-proctological controls. This was a single center non-interventional observational study on 229 proctological patients and 133 controls. The main outcome measures investigated were age- and sex-stratified comparison of the non-proctological cohort and the controls, effect of therapeutic intervention on scale values in a subset of patients with haemorrhoidal disease, and sensitivity of the PSS to detect therapeutic failure in this subset of patients. The PSS was found to significantly differentiate between proctological patients and controls. Gender and age had no significant influence on PSS values in the proctological cohort. The intervention (one session of rubber band ligation in patients with haemorrhoidal disease) was reflected by a significantly improved overall PSS. In 16 cases within this group, the PSS got worse. A case-by-case follow-up of these patients showed that 14 of the 16 patients ended up with surgery (or with the advice to have surgery). The PSS reliably differentiates proctological patients from non-proctological controls. Following intervention, the PSS reliably differentiated therapeutic success from failure. We find the PSS to be a simple and useful tool in our clinical routine since it provides an easily obtainable and reproducible basis for the visit-by-visit assessment of proctological patients. The PSS may also be suitable for studies to measure and compare symptomatic improvement and success of different therapies in proctology.

Predictors and incidence of hospitalization due to respiratory syncytial virus (RSV)-associated lower respiratory tract infection (LRTI) in non-prophylaxed moderate-to-late preterm infants in Bosnia and Herzegovina.

PubMed

Maksić, Hajrija; Heljić, Suada; Skokić, Fahrija; Šumanović-Glamuzina, Darinka; Milošević, Veroslava; Zlatanović, Almir; Gerard, Notario

2018-04-27

Prematurity is a risk factor for respiratory syncytial virus (RSV)-associated lower respiratory tract infections (LRTIs), due to immature humoral and cell-mediated immune system in preterm newborns, as well as their incomplete lung development. Palivizumab, a humanized monoclonal antibody against the F glycoprotein of RSV, is licensed for the prevention of severe RSV LRTI in children at high risk for the disease. This study is a part of a larger observational, retrospective-prospective epidemiological study (PONI) conducted at 72 sites across 23 countries in the northern temperate zone. The aim of our non-interventional study was to identify common predictors and factors associated with RSV LRTI hospitalization in non-prophylaxed, moderate-to-late preterm infants, born between 33 weeks and 0 days and 35 weeks and 6 days of gestation, and less than 6 months prior to or during the RSV season in Bosnia and Herzegovina (B&H). A total of 160 moderate-to-late preterm infants were included from four sites in B&H (Sarajevo, Tuzla, Mostar, and Banja Luka). We identified several significant intrinsic and extrinsic factors to be associated with the risk of RSV LRTI hospitalization in the preterm infants, including: comorbidities after birth, shorter hospital stay, admission to NICU/PICU while in the maternity ward, household smoking, low maternal age, breast feeding, number of family members, and history of family/paternal atopy. Overall, our results indicated that the risk of RSV LRTI in preterm newborns can be associated with different environmental and social/cultural factors, and further research is needed to comprehensively evaluate these associations.

Newborn screening: A disease-changing intervention for glutaric aciduria type 1.

PubMed

Boy, Nikolas; Mengler, Katharina; Thimm, Eva; Schiergens, Katharina A; Marquardt, Thorsten; Weinhold, Natalie; Marquardt, Iris; Das, Anibh M; Freisinger, Peter; Grünert, Sarah C; Vossbeck, Judith; Steinfeld, Robert; Baumgartner, Matthias R; Beblo, Skadi; Dieckmann, Andrea; Näke, Andrea; Lindner, Martin; Heringer, Jana; Hoffmann, Georg F; Mühlhausen, Chris; Maier, Esther M; Ensenauer, Regina; Garbade, Sven F; Kölker, Stefan

2018-05-01

Untreated individuals with glutaric aciduria type 1 (GA1) commonly present with a complex, predominantly dystonic movement disorder (MD) following acute or insidious onset striatal damage. Implementation of GA1 into newborn screening (NBS) programs has improved the short-term outcome. It remains unclear, however, whether NBS changes the long-term outcome and which variables are predictive. This prospective, observational, multicenter study includes 87 patients identified by NBS, 4 patients missed by NBS, and 3 women with GA1 identified by positive NBS results of their unaffected children. The study population comprises 98.3% of individuals with GA1 identified by NBS in Germany during 1999-2016. Overall, cumulative sensitivity of NBS is 95.6%, but it is lower (84%) for patients with low excreter phenotype. The neurologic outcome of patients missed by NBS is as poor as in the pre-NBS era, and the clinical phenotype of diagnosed patients depends on the quality of therapeutic interventions rather than noninterventional variables. Presymptomatic start of treatment according to current guideline recommendations clearly improves the neurologic outcome (MD: 7% of patients), whereas delayed emergency treatment results in acute onset MD (100%), and deviations from maintenance treatment increase the risk of insidious onset MD (50%). Independent of the neurologic phenotype, kidney function tends to decline with age, a nonneurologic manifestation not predicted by any variable included in this study. NBS is a beneficial, disease-changing intervention for GA1. However, improved neurologic outcome critically depends on adherence to recommended therapy, whereas kidney dysfunction does not appear to be impacted by recommended therapy. Ann Neurol 2018;83:970-979. © 2018 American Neurological Association.

Performance of a Quantitative PCR-Based Assay and Beta-d-Glucan Detection for Diagnosis of Invasive Candidiasis in Very-Low-Birth-Weight Preterm Neonatal Patients (CANDINEO Study).

PubMed

Ramos, Jose Tomas; Villar, Sonia; Bouza, Emilio; Bergon-Sendin, Elena; Perez Rivilla, Alfredo; Collados, Caridad Tapia; Andreu, Mariano; Reyes, Candelaria Santana; Campos-Herrero, María Isolina; de Heredia, Jon López; Herrera, María Cruz López; Alonso, Paloma Anguita; Pallás-Alonso, Carmen Rosa; Cuenca-Estrella, Manuel

2017-09-01

An epidemiological, multicenter, noninterventional, observational case-control study was conducted to describe the performance of serum beta-d-glucan (BDG) and Candida PCR in blood, serum, and sterile samples for the diagnosis of invasive candidiasis (IC) in very-low-birth-weight (VLBW) preterm neonates and to compare these techniques with culture of samples from blood and other sterile sites. Seventeen centers participated in the study, and the number of episodes analyzed was 159. A total of 9 episodes of IC from 9 patients (7 confirmed and 2 probable) and 150 episodes of suspected sepsis from 117 controls were identified. The prevalence of IC was 5.7% (95% confidence interval [95% CI], 2.1 to 9.3). The mortality was significantly higher in episodes of IC (44.4%) than in the non-IC episodes (11.1%, P < 0.01). The sensitivity and specificity of the PCR performed on blood/serum samples were 87.5% and 81.6%, respectively. The sensitivity and specificity of the BDG results were lower (75.0% and 64.6%). For cases with negative culture results, the PCR and the BDG results were positive in 27 (17.4%) and 52 (33.5%) episodes, respectively. The presence of multiorgan failure, improvement with empirical antifungal therapy, thrombocytopenia, and Candida colonization were significantly associated ( P < 0.01) with PCR or BDG positivity regardless of the results of the cultures. Serum BDG analysis and Candida PCR could be used as complementary diagnostic techniques to detect IC in VLBW neonates. Copyright © 2017 Ramos et al.

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO).

PubMed

Ylisaukko-Oja, Tero; Aaltonen, Jaakko; Nuutinen, Heikki; Blomster, Timo; Jussila, Airi; Pajala, Markku; Salminen, Kimmo; Moilanen, Veikko; Hakala, Kalle; Kellokumpu, Mikko; Toljamo, Kari; Rautiainen, Henna; Kuisma, Juha; Peräaho, Markku; Molander, Pauliina; Silvennoinen, Jouni; Liukkonen, Ville; Henricson, Hans; Tillonen, Jyrki; Esterinen, Mirva; Nielsen, Christian; Hirsi, Eija; Lääne, Margus; Suhonen, Ulla-Maija; Vihriälä, Ilkka; Mäkelä, Petri; Puhto, Mika; Punkkinen, Jari; Sulonen, Hannu; Herrala, Sauli; Jokelainen, Jari; Tamminen, Klaus; Sipponen, Taina

2018-02-01

The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients. This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation. A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6. Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Reduction of gastrointestinal symptoms in Parkinson's disease after a switch from oral therapy to rotigotine transdermal patch: a non-interventional prospective multicenter trial.

PubMed

Woitalla, Dirk; Kassubek, Jan; Timmermann, Lars; Lauterbach, Thomas; Berkels, Reinhard; Grieger, Frank; Müller, Thomas

2015-03-01

Gastrointestinal (GI) symptoms are common among patients with Parkinson's disease (PD), due to both the disease itself and anti-PD drugs. We hypothesized that transdermal drug administration may result in fewer GI problems. This prospective observational study (ClinicalTrials.gov: NCT01159691) investigated effect of switching to rotigotine transdermal patch from oral anti-PD medications in patients with PD and existing GI symptoms. Patients were enrolled if their physician was planning to switch them to rotigotine because of GI symptoms experienced while receiving oral anti-PD medications. Effectiveness assessments included a visual analog scale (VAS) measuring intensity of GI symptoms from 0 (no disorder) to 100 mm (extremely severe disorder), a questionnaire on the frequency and intensity of six individual GI complaints (heartburn, bloating, nausea, vomiting, abdominal pain, diarrhea), each rated 0-12 for a sum score of 0-72, and patient satisfaction regarding GI symptoms over approximately 6 weeks after switching. Of 75 patients who received rotigotine, 58 had follow-up data available for final analysis. Intensity of GI complaints improved numerically on both the VAS (47.5 ± 24.4 mm [n = 65] at baseline, 19.7 ± 23.3 mm [n = 58] after around 6 weeks) and the sum score of GI complaints (11.2 ± 9.0 at baseline, 2.1 ± 4.4 [n = 58] after around 6 weeks). Fifty of 58 patients were "satisfied" or "very satisfied" regarding GI symptoms over around 6 weeks following switch to the patch. This study suggests that a switch from oral anti-PD medications to rotigotine transdermal patch may improve existing GI symptoms among patients with PD. Additional controlled studies are needed to confirm this finding. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical and Demographic Features of Vertigo: Findings from the REVERT Registry

PubMed Central

Agus, Sam; Benecke, Heike; Thum, Cornelia; Strupp, Michael

2013-01-01

Introduction: Despite being a common disease, data on vertigo management in a real-world setting are scarce. Aims: To provide information on the vertigo and its management in a real-world setting. Methods: Data were collected from 4,294 patients with vertigo in 13 countries over 28 months via a multi-national, non-interventional observational study (the so-called REVERT registry). Data included medical history and details of anti-vertigo therapy. “Clinical global impression” (CGI) of severity (CGI-S) was assessed at baseline (V1) and then at 6 months follow-up (V2) along with CGI change (CGI-C). All variables were analyzed descriptively. Results: The majority of patients were female, >40 years of age, and almost half had co-morbid cardio-vascular disease. Diagnoses were split into four categories: 37.2% “other vertigo of peripheral vestibular origin,” 26.9% benign paroxysmal positional vertigo (BPPV), 20.5% “peripheral vestibular vertigo of unknown origin,” and 15.4% Ménière’s disease (MD). Betahistine was the most commonly prescribed therapy prior to and after enrollment, and was followed by piracetam, ginkgo biloba, and diuretics. MD had the highest proportion of betahistine treated patients. Almost half of patients were “moderately ill” at V1 based on CGI-S. At V2, patient distribution moved toward “less severe illness” (91.0% improved). The greatest improvements were in the more severely ill, and those with BPPV or “other vertigo of peripheral origin.” Conclusion: There was a reduction in illness severity over the course of the study, some of which is likely to be due to pharmacological intervention. Further studies are needed to confirm these results. PMID:23675366

Real-life efficacy and safety of omalizumab in Portuguese patients with persistent uncontrolled asthma.

PubMed

Pereira Barbosa, M; Bugalho de Almeida, A; Pereira, C; Chen, C-W; Georgiou, P; Peachey, G

2015-01-01

The real life effectiveness, safety and the use of omalizumab for Portuguese patients with uncontrolled persistent allergic asthma are not sufficiently well known. The objective of this report was to make an evaluation, in a post-marketing, non-interventional, observational registry, of the Portuguese population included in the eXpeRience study. The methods used in this report are the same as the global eXpeRience ones, applied to a Portuguese sub-population. Patients with uncontrolled allergic asthma who had started omalizumab within the previous 15 weeks were enrolled and received omalizumab add-on therapy for 24 months. The physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms and control (ACT score), quality of life (mini-AQLQ score), exacerbations, and serious adverse events (SAE) were reported. Of the 943 patients recruited in the eXpeRience registry, 62 patients were from Portugal. 62.1% of them were observed to be responders with good/excellent GETE assessment at Week 16. Clinically meaningful improvements in asthma control (ACT score) and quality of life (mini-AQLQ score) were observed with omalizumab therapy at Months 12 (mean change: +7.7 [n=35]; +2.1 [n=20], respectively) and 24 (mean change: +7.0 [n=26]; +2.7 [n=13], respectively). Asthma symptoms and rescue medication usage were reduced to ≤1 day/week at Month 24 from a baseline of ≥3.5 days/week. The proportion of patients with no clinically significant exacerbations increased from 6.5% during pre-treatment (n=62) to 50% at Month 12 (n=54) and 60% at Month 24 (n=45). The findings from the Portugal subpopulation of eXpeRience registry confirm that omalizumab add-on therapy is efficacious and well tolerated in the management of uncontrolled persistent allergic asthma. Another pertinent issue is the fact that the Portuguese subpopulation response is similar to the international population average of the study. Copyright © 2014 Sociedade Portuguesa de Pneumologia. Published by Elsevier España, S.L.U. All rights reserved.

Evaluating Por Nuestra Salud: A Feasibility Study.

PubMed

Marshall, Brenda; Gonzales, Gustavo; Kernan, William

2016-01-01

This feasibility study evaluated the impact of a culturally consistent diabetes educational program, led by a Latino pastor, on Latino community diabetes knowledge levels. Latino adults were recruited from two churches serving Latino populations, one identified as intervention, the other as nonintervention. Both churches received the American Diabetes Association's booklets on diabetes education, "Four Steps to Control Your Diabetes for Life." The intervention group also received weekly reviews of the booklet's information from the church pastor, who was educated about diabetes by a Latino family nurse practitioner. Pre- and postintervention levels of diabetes knowledge were measured using the Diabetes Knowledge Questionnaire. Mean changes in the Diabetes Knowledge Questionnaire (DKQ-24) survey from pretest to posttest indicated a significant increase in knowledge in both groups. Only the grades for the participants from the pastor-led group, however, moved from failure in knowledge to high levels of passing. One hundred percent of intervention group participants reported having read the literature. This pilot study supports the feasibility of a local Latino pastor, as a culturally consistent diabetes educator, to increase Latino parishioner's knowledge of diabetes. © 2015 Society for Public Health Education.

Visuospatial training improves elementary students' mathematics performance.

PubMed

Lowrie, Tom; Logan, Tracy; Ramful, Ajay

2017-06-01

Although spatial ability and mathematics performance are highly correlated, there is scant research on the extent to which spatial ability training can improve mathematics performance. This study evaluated the efficacy of a visuospatial intervention programme within classrooms to determine the effect on students' (1) spatial reasoning and (2) mathematics performance as a result of the intervention. The study involved grade six students (ages 10-12) in eight classes. There were five intervention classes (n = 120) and three non-intervention control classes (n = 66). A specifically designed 10-week spatial reasoning programme was developed collaboratively with the participating teachers, with the intervention replacing the standard mathematics curriculum. The five classroom teachers in the intervention programme presented 20 hr of activities aimed at enhancing students' spatial visualization, mental rotation, and spatial orientation skills. The spatial reasoning programme led to improvements in both spatial ability and mathematics performance relative to the control group who received standard mathematics instruction. Our study is the first to show that a classroom-based spatial reasoning intervention improves elementary school students' mathematics performance. © 2017 The British Psychological Society.

Clinical experience with biphasic insulin aspart in people with type 2 diabetes: Results from the Libya cohort of the A1chieve study.

PubMed

Hajjaji, Issam M; Sherif, Ibrahim; Elazrag, Aisha; Jaber, Suhair; Chakkarwar, Praful N; Eltabal, Salem

2013-11-01

The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled in biphasic insulin aspart sub group from Libya. A total of 179 patients were enrolled in the biphasic insulin aspart subgroup. All the patients were prior insulin users. At baseline glycaemic control was poor (mean HbA1c: 9.3%). After 24 weeks of treatment there was an improvement in HbA1c (-0.9%). Hypoglycaemic events reduced from 7.2 events/patient-year to 3.7 events/patient-year in 24 weeks. SADRs did not occur in any of the study patients. Starting or switching to biphasic insulin aspart was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

PubMed Central

Ayres, J G; Frost, C D; Holmes, W F; Williams, D R R; Ward, S M

1998-01-01

Objective To evaluate the safety of a non-chlorofluorocarbon metered dose salbutamol inhaler. Design This was a postmarketing surveillance study, conducted under formal guidelines for company sponsored safety assessment of marketed medicines (SAMM). A non-randomised, non-interventional, observational design compared patients prescribed metered doses of salbutamol delivered by inhalers using either hydrofluoroalkane or chlorofluorocarbon as the propellant. Follow up was three months. Setting 646 general practices throughout the United Kingdom. Subjects 6614 patients with obstructive airways disease (1667 patient years of exposure). Main outcome measures Proportions of patients who were: admitted to hospital for respiratory diseases, reported adverse side effects, or withdrew because of adverse affects. Results There were no significant differences between the hydrofluoroalkane (HFA 134a) and chlorofluorocarbon inhaler groups in relation to the proportions of patients admitted to hospital for respiratory diseases (odds ratio 0.75; 95% confidence interval 0.51 to 1.08) or the proportions who reported adverse events (1.01; 0.88 to 1.17). However, more patients using the hydrofluoroalkane inhaler than the chlorofluorocarbon inhaler withdrew because of adverse events (3.8% and 0.9% respectively). Conclusion The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies. Key messagesCredibility of postmarketing surveillance studies is expected to increase after the introduction of guidelines covering their conduct The study design successfully fulfilled the requirements of these guidelines in terms of the number, rate, and geographical spread of patients recruitedSafety of salbutamol inhalers using hydrofluoroalkane and chlorofluorocarbon as propellants is similarImportant differences in study design/conduct and outcome between a postmarketing surveillance study and a randomised clinical trial merit further consideration. PMID:9756813

A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study.

PubMed

Runge, Uwe; Arnold, Stephan; Brandt, Christian; Reinhardt, Fritjof; Kühn, Frank; Isensee, Kathleen; Ramirez, Francisco; Dedeken, Peter; Lauterbach, Thomas; Noack-Rink, Matthias; Mayer, Thomas

2015-12-01

Evidence for the efficacy and safety of adjunctive lacosamide in the treatment of partial-onset seizures (POS) was gained during placebo-controlled clinical trials in patients with treatment-resistant seizures who were taking one to three concomitant antiepileptic drugs (AEDs). The VITOBA study (NCT01098162) evaluated the effectiveness and tolerability of adjunctive lacosamide added to one baseline AED in real-world clinical practice. We conducted a 6-month observational study at 112 sites across Germany. Adult patients (≥ 16 years) with POS received lacosamide adjunctive to only one baseline AED. Seizure frequency reduction at the end of the observation period was compared with a 3-month retrospective baseline period. Five hundred seventy-one patients received lacosamide at least once (Safety Set [SS]); 520 provided evaluable seizure records (Full Analysis Set [FAS]); and 499 took in-label dosages of lacosamide (up to 400 mg) and were evaluated for effectiveness (modified FAS). Median baseline seizure frequency was 2.0 per 28 days: 47.1% of patients (235/499, mFAS) took a concomitant sodium channel-blocking (SCB) AED; 38.1% (190/499) had only one lifetime AED; and 18.4% (92/499) were aged ≥ 65 years (mFAS). At the final visit, 72.5% (358/494) of patients showed a ≥ 50% reduction in seizure frequency from baseline, 63.8% (315/494) showed a ≥ 75% reduction, and 45.5% (225/494) were seizure-free. Seizure freedom rates were higher in patients aged ≥ 65 years (56.7%) compared with patients aged <65 years (43.1%), in patients with ≤ 5 years epilepsy duration (52.5%) versus >5 years duration (41.0%), and when added to first monotherapy (60.5%) rather than as a later therapy option. Treatment-emergent adverse events (TEAEs) were reported by 48.5% (277/571) of patients (SS), with a profile similar to that observed in pivotal trials; 466 of patients (81.6%, SS) continued lacosamide therapy after the trial. These results suggest that lacosamide use, added to one concomitant AED, was effective at improving seizure control and was well tolerated in patients treated in routine clinical practice. © 2015 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.

Observational Prospective study to esTIMAte the rates of outcomes in patients undergoing PCI with drug-eluting stent implantation who take statins -follow-up (OPTIMA II).

PubMed

Karpov, Yu; Logunova, N; Tomilova, D; Buza, V; Khomitskaya, Yu

2017-02-01

The OPTIMA II study sought to evaluate rates of major adverse cardiac and cerebrovascular events (MACCEs) during the long-term follow-up of chronic statin users who underwent percutaneous coronary intervention (PCI) with implantation of a drug-eluting stent (DES). OPTIMA II was a non-interventional, observational study conducted at a single center in the Russian Federation. Included patients were aged ≥18 years with stable angina who had received long-term (≥1 month) statin therapy prior to elective PCI with DES implantation and who had participated in the original OPTIMA study. Patients received treatment for stable angina after PCI as per routine study site clinical practice. Study data were collected from patient medical records and a routine visit 4 years after PCI. NCT02099565. Rate of MACCEs 4 years after PCI. Overall, 543 patients agreed to participate in the study (90.2% of patients in the original OPTIMA study). The mean (± standard deviation [SD]) duration of follow-up from the date of PCI to data collection was 4.42 ± 0.58 (range: 0.28-5.56) years. The frequency of MACCEs (including data in patients who died) was 30.8% (95% confidence interval: 27.0-34.7); half of MACCEs occurred in the first year of follow-up. After PCI, the majority of patients had no clinical signs of angina. Overall, 24.3% of patients discontinued statin intake in the 4 years after PCI. Only 7.7% of patients achieved a low-density lipoprotein (LDL) cholesterol goal of <1.8 mmol/L. Key limitations of this study related to its observational nature; for example, the sample size was small, the clinical results were derived from outpatients and hospitalized medical records, only one follow-up visit was performed at the end of the study (after 4 years' follow-up), only depersonalized medical information was made available for statistical analysis, and adherence to statin treatment was evaluated on the basis of patient questionnaire. Long-term follow-up of patients who underwent PCI with DES implantation demonstrated MACCEs in nearly one-third of patients, which is comparable to data from other studies. PCI was associated with relief from angina or minimal angina frequency, but compliance with statin therapy and the achievement of LDL cholesterol targets 4 years after PCI were suboptimal.

Suboptimal control of lipid levels: results from the non-interventional Centralized Pan-Russian Survey of the Undertreatment of Hypercholesterolemia II (CEPHEUS II).

PubMed

Boytsov, Sergey; Logunova, Natalia; Khomitskaya, Yunona

2017-12-16

Elevated levels of low-density lipoprotein cholesterol (LDL-C) and glycosylated hemoglobin (HbA1c) are risk factors for cardiovascular complications. This study evaluated LDL-C goal attainment in Russian clinical practice among patients with moderate to very high cardiovascular risk. The study also assessed LDL-C goal attainment in patients prescribed lipid-lowering therapy for primary compared with secondary cardiovascular disease (CVD) prevention, predictors of LDL-C goal attainment, and the proportion of individuals with diabetes mellitus who achieved HbA1c < 7%. The Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia in Russia II (CEPHEUS II) was a multicenter, non-interventional, cross-sectional study conducted in the Russian Federation from September 2014 to November 2015. Participants were aged ≥ 18 years, were receiving a stable dose of lipid-lowering medication and had a moderate to very high cardiovascular risk. The primary variable was the proportion of patients reaching LDL-C goals established by the Fifth Joint European Task Force guidelines. Secondary analyses used McNemar and χ 2 tests. Data from 2703 patients were analyzed; 91.2% had a very high cardiovascular risk and 24.0% had been diagnosed with diabetes mellitus. Overall, 17.4% of patients (95% confidence interval [CI] 15.9-18.8%) achieved LDL-C goals. Investigators estimated this proportion at 21.8% (95% CI 20.3-23.4%). LDL-C goals were achieved by more patients in the primary CVD prevention subgroup than in the secondary CVD prevention subgroup (19.7% vs 16.1%, p = 0.017). Patient-related factors associated with a decreased likelihood of achieving LDL-C goals included having ischemic heart disease or a family history of premature coronary heart disease, forgetting to take hypercholesterolemia treatment or considering it acceptable to miss prescribed doses more than once per week, and dissatisfaction with or concern about lipid-lowering therapy. Overall, 367/593 (61.9%) patients with diabetes mellitus and interpretable HbA1c results achieved HbA1c < 7%. Hypercholesterolemia management is suboptimal in patients with moderate to very high cardiovascular risk in Russian clinical practice. Substantial opportunity remains to improve treatment target attainment and reduce the risk of cardiovascular complications. Lipid-modifying strategies may need to be intensified to reduce CVD risk in this setting. Trial registration ClinicalTrials.gov: NCT02230241 (registered 26 August 2014).

The Effects of Consultation on Individualized Education Program Outcomes for Young Children With Autism: The Collaborative Model for Promoting Competence and Success

PubMed Central

Ruble, Lisa A.; Dalrymple, Nancy J.; McGrew, John H.

2011-01-01

The effects of a teacher consultation intervention were examined—namely, the collaborative model for promoting competence and success (COMPASS), which was designed to improve objectives of individualized education programs for children with autism. The intervention consists of an initial parent–teacher consultation, followed by four teacher consultations across the school year. Thirty-five teachers and a randomly selected child with autism (M age = 6.1 years) from each classroom participated. Compared to the nonintervention teacher–child dyads, the intervention teacher–child dyads showed improvements in individualized education program objectives, with a large effect size (d = 1.51). PMID:21691449

Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

PubMed

Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

2017-05-01

To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

Antianginal Efficacy of Ivabradine/Metoprolol Combination in Patients With Stable Angina.

PubMed

Zarifis, John; Kallistratos, Manolis; Katsivas, Apostolos

2016-12-01

Medical treatment is the main clinical strategy for controlling patients with chronic stable angina and improving their quality of life (QoL). Ivabradine treatment on top of metoprolol decreases angina symptoms and improves QoL in patients with stable angina and coronary artery disease (CAD). This is a post hoc analysis (636 CAD patients given ivabradine/metoprolol free combination) of a prospective, noninterventional study that included 2403 patients with CAD and stable angina. Data were recorded at baseline at 1 and 4 months after inclusion. Patient QoL was assessed using the EQ-5D questionnaire. From baseline to study completion; ivabradine administration on top of metoprolol decreased heart rate (HR) from 80.8 ± 9.6 to 64.2 ± 6.2 bpm (P < 0.001). Mean number of angina attacks decreased from 2.0 ± 2.0/wk to 0.2 ± 0.6/wk (P < 0.001), whereas nitroglycerin consumption decreased from 1.4 ± 1.9 times/wk to 0.1 ± 0.4 times/wk (P < 0.001). The percentage of patients in Canadian Cardiovascular Society angina class III to IV decreased from 15.4% to 1.9% (P < 0.001). The improvement of symptoms and angina class led to a significant 14.7-point increase in EQ-5D questionnaire score (P < 0.001). Patients with increased HR showed greater improvement (P = 0.001). Adherence to treatment during the entire trial was high (98%). Ivabradine combined with metoprolol significantly decreased angina symptoms and use of nitroglycerin in patients with stable angina and CAD, leading to improved QoL. The benefits observed with this combination explain the high rate of adherence to treatment. © 2016 Wiley Periodicals, Inc.

Nutritional Education Needs in Relation to Ramadan Fasting and Its Complications in Tehran, Iran.

PubMed

Shadman, Zhaleh; Akhoundan, Mahdieh; Poorsoltan, Nooshin; Khoshniat Nikoo, Mohsen; Larijani, Bagher; Akhgar Zhand, Camelia; Soleymanzadeh, Mozhdeh; Alsadat Seyed Rohani, Zahra; Jamshidi, Zahra

2016-08-01

Ramadan fasting is associated with some lifestyle changes. A lack of nutritional needs knowledge or the improper performance of fasting, particularly in relation to time, type and amount of food intake, can cause disorders such as indigestion, bloating, constipation, headaches and other clinical problems. To investigate the general knowledge regarding dietary factors associated with Ramadan fasting and its related complications. This prospective, non-interventional, observational study was conducted from April to July, 2012 to coincide with the month before and the month of Ramadan. The initial participants were 600 fasting and 588 non-fasting people (aged 18 - 65 years, BMI 18.5 - 40 kg/m 2 ) chosen by random cluster sampling in Tehran, Iran. A questionnaire of Ramadan fasting nutritional knowledge was developed and validated in a pilot study. The Likert scale was used two weeks before Ramadan and during the third and fourth weeks of Ramadan to estimate Ramadan-related complications. Seven-day, 24 - hour food recalls were used to assess food intakes. The lowest level of general knowledge was identified in the context of foods associated with hunger (22.1%) and hypoglycemia (24.8%) and the highest level of general knowledge was identified in reference to unsuitable foods for Sahar (91.4%). During Ramadan, all attributed complications increased in fasting subjects (P < 0.001). High calorie, carbohydrate, fat and protein intakes in the Ramadan diet were associated with some gastrointestinal and sleep complications (P < 0.05). Despite the relatively high level of knowledge in the context of the general principles of a diet to prevent Ramadan-related complications, practical training in regard to the amounts of nutrients associated with Ramadan-related complications is both necessary and recommended.

National audit of critical care resources in South Africa - nursing profile.

PubMed

Scribante, Juan; Bhagwanjee, Sats

2007-12-01

(i) To determine the profile and number of nurses working in South African intensive care units (ICUs) and high care units (HCUs); (ii) to determine the number of beds in ICU and HCUs in South Africa; and (iii) to determine the ratio of nurses to ICU/HC beds. A descriptive, non-interventive, observational study design was used. An audit of all public and private sector ICU and HCUs in South Africa was undertaken. A 100% was sample obtained; 74.8% of the ICU nursing managers were ICU-trained nurses with an average of 12.8 years of ICU experience. Only 25.6% of nurses working in ICU were ICU trained. The majority were registered nurses (49.2%), while 21.4% were semi-professional nurses. Private sector nurses represented 50.3% of all nurses. Some 42.8% of the professional nurses had 0 - 5 years of experience and 28.7% had 5 - 10 years. The groups 10 - 15 and 15 - 20 years represented 16.1% and 6.6% respectively. Only 5.7% nurses had 20 and more years' experience. In the units that used agency staff the ratio of permanent to agency nursing staff for the month of June 2003 was 64.5% versus 35.5%. In total there are 4,168 ICU and HC beds in South Africa that are serviced by 4,584 professional nurses. The nurse:bed ratio is 1.1 nurses per ICU/HC bed. This study demonstrates that ICU nursing in South Africa faces the challenge of an acute shortage of trained and experienced nurses. Our nurses are tired, often not healthy, and are plagued by discontent and low morale.

Comparison of reminder methods in selected adolescents with records in an immunization registry.

PubMed

Morris, Jessica; Wang, Wendy; Wang, Lawrence; Peddecord, K Michael; Sawyer, Mark H

2015-05-01

The aim of this study was to assess the effectiveness and cost efficiency of three reminder/recall methods for improving adolescent vaccination rates using the San Diego Immunization Registry. Parents of 5,050 adolescents whose records indicated they lacked one or more adolescent vaccines were identified from the San Diego Immunization Registry and contacted by telephone. Based on their preference, consenting participants were enrolled to receive either postal mail (n = 282), e-mail (n = 963), or text (n = 552) reminders for vaccination. The intervention groups were sent a series of up to three reminders. The vaccination completion rate was compared between the intervention groups and two control groups-the enrollment phone call-only group who declined to participate and a no contact group-using logistic regression. The participants who received any reminder were more likely (24.6% vs. 12.4%; p < .001) to become up-to-date (UTD) than those in the enrollment phone call-only group. At the conclusion of the study observation, UTD status was reached by 32.1% of text message recipients, 23.0% of postcard recipients, and 20.8% of e-mail recipients compared to 12.4% for the enrollment phone call recipients. Only 9.7% of nonintervention adolescents became UTD. All three reminder interventions were effective in improving adolescent vaccination rates. Although postal mail reminders were preferred by most participants, text messaging and e-mail were the more effective reminder methods. Text messaging and e-mail as reminder methods for receiving vaccinations should be considered for use to boost vaccination completion among adolescents. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Clinical course of 63 patients with neonatal onset urea cycle disorders in the years 2001-2013.

PubMed

Unsinn, Caroline; Das, Anibh; Valayannopoulos, Vassili; Thimm, Eva; Beblo, Skadi; Burlina, Alberto; Konstantopoulou, Vassiliki; Mayorandan, Sebene; de Lonlay, Pascale; Rennecke, Jörg; Derbinski, Jens; Hoffmann, Georg F; Häberle, Johannes

2016-08-19

Urea cycle disorders (UCDs) are rare inherited metabolic defects of ammonia detoxification. In about half of patients presenting with a UCD, the first symptoms appear within a few days after birth. These neonatal onset patients generally have a severe defect of urea cycle function and their survival and outcome prognoses are often limited. To understand better the current situation of neonatal onset in UCDs, we have performed a multicentre, retrospective, non-interventional case series study focussing on the most severe UCDs, namely defects of carbamoyl phosphate synthetase 1 (CPS1), ornithine transcarbamylase (OTC), and argininosuccinate synthetase (ASS). Data of 63 patients were collected (27 patients with ASS deficiency, 23 patients with OTC deficiency, and 12 patients with CPS1 deficiency, one patient definite diagnosis not documented). The majority of patients (43/63, 68 %) had an initial ammonia concentration exceeding 500 μmol/L (normal < 100), of which most (26/43, 60.5 %) were also encephalopathic and were treated with hemodialysis. In patients surviving the initial crisis, recurrence of hyperammonemic events within the first 1.5 years of life occurred frequently (mean 3.6 events, range 0-20). Of all patients, 16 (25.4 %) died during or immediately after the neonatal period. We observed in this cohort of neonatal onset UCD patients a high rate of initial life-threatening hyperammonemia and a high risk of recurrence of severe hyperammonemic crises. These corresponded to a high mortality rate during the entire study period (30.2 %) despite the fact that patients were treated in leading European metabolic centers. This underlines the need to critically re-evaluate the current treatment strategies in these patients.

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study.

PubMed

Trojano, Maria; Vila, Carlos

2015-01-01

The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries. This interim analysis reports on MOVE 2 patients from Italy. Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%). In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients. © 2015 S. Karger AG, Basel.

Retrospective cohort study of all deaths among infants born between 22 and 27 completed weeks of gestation in Switzerland over a 3-year period.

PubMed

Berger, T M; Steurer, M A; Bucher, H U; Fauchère, J C; Adams, M; Pfister, R E; Baumann-Hölzle, R; Bassler, D

2017-06-15

The aim of this research is to assess causes and circumstances of deaths in extremely low gestational age neonates (ELGANs) born in Switzerland over a 3-year period. Population-based, retrospective cohort study. All nine level III perinatal centres (neonatal intensive care units (NICUs) and affiliated obstetrical services) in Switzerland. ELGANs with a gestational age (GA) <28 weeks who died between 1 July 2012 and 30 June 2015. A total of 594 deaths were recorded with 280 (47%) stillbirths and 314 (53%) deaths after live birth. Of the latter, 185 (59%) occurred in the delivery room and 129 (41%) following admission to an NICU. Most liveborn infants dying in the delivery room had a GA ≤24 weeks and died following primary non-intervention. In contrast, NICU deaths occurred following unrestricted life support regardless of GA. End-of-life decision-making and redirection of care were based on medical futility and anticipated poor quality of life in 69% and 28% of patients, respectively. Most infants were extubated before death (87%). In Switzerland, most deaths among infants born at less than 24 weeks of gestation occurred in the delivery room. In contrast, most deaths of ELGANs with a GA ≥24 weeks were observed following unrestricted provisional intensive care, end-of-life decision-making and redirection of care in the NICU regardless of the degree of immaturity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Fertility and combined oral contraceptives - unintended pregnancies and planned pregnancies following oral contraceptive use - results from the INAS-SCORE study.

PubMed

Barnett, Clare; Hagemann, Christine; Dinger, Jürgen; Do Minh, Thai; Heinemann, Klaas

2017-02-01

To estimate the real-use contraceptive effectiveness of the combined oral contraceptive containing dienogest and estradiol valerate (DNG/EV) and whether DNG/EV compared to other combined oral contraceptives (oCOC) has a negative effect on return to fertility. Transatlantic, prospective, non-interventional cohort study conducted in the USA and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). In a planned secondary analysis, pregnancy outcomes were investigated including contraceptive effectiveness and pregnancy following contraceptive cessation. The influence of age, parity and OC-type were assessed. 50,203 COC users were followed for 105,761 woman-years (WY). There were 677 unintended pregnancies reported: 451 in the USA and 226 in Europe. The contraceptive failure rate in Europe was 0.5 events/100 WY (95% CI: 0.4-0.5) and in the USA 1.9 events/100 WY (95% CI: 1.7-2.1). Differences in compliance (1.3 pregnancies/100 WY) accounted for 90% of the geographical difference seen between Europe and the USA. DNG/EV showed lower contraceptive failure rates compared to the comparators; 0.9% DNG/EV, 2.1% oCOC and 2.8% LNG after 4 years. Overall, 1167 (2.3%) of women stopped contraceptive use with the intention of becoming pregnant with 89% conceiving within 2 years. No significant differences were seen between groups after adjusting for age. DNG/EV is associated with similar contraceptive effectiveness in typical-use settings when compared to oCOC and LNG. There was no difference observed between cohorts in fertility following OC use.

The Burden and Impact of Vertigo: Findings from the REVERT Patient Registry

PubMed Central

Benecke, Heike; Agus, Sam; Kuessner, Daniel; Goodall, Gordon; Strupp, Michael

2013-01-01

Objective: Despite the high prevalence of vertigo globally and an acknowledged, but under-reported, effect on an individual’s wellbeing, few studies have evaluated the burden on healthcare systems and society. This study was aimed to quantitatively determine the impact of vertigo on healthcare resource use and work productivity. Methods: The economic burden of vertigo was assessed through a multi-country, non-interventional, observational registry of vertigo patients: the Registry to Evaluate the Burden of Disease in Vertigo. Patients included were those with a new diagnosis of Meniere’s disease, benign paroxysmal positional vertigo, other vertigo of peripheral vestibular origin, or peripheral vestibular vertigo of unknown origin. Results: A total of 4,294 patients at 618 centers in 13 countries were included during the registry. Of the 4,105 patients analyzed, only half were in employment. Among this working patient population, 69.8% had reduced their workload, 63.3% had lost working days, and 4.6% had changed and 5.7% had quit their jobs, due to vertigo symptoms. Use of healthcare services among patients was high. In the 3 months preceding Visit 1, patients used emergency services 0.4 ± 0.9 times, primary care consultations 1.6 ± 1.8 times, and specialist consultations 1.4 ± 2.0 times (all mean ± SD). A mean of 2.0 ± 5.4 days/patient was also spent in hospital due to vertigo. Conclusion: In addition to the negative impact on the patient from a humanistic perspective, vertigo has considerable impact on work productivity and healthcare resource use. PMID:24106487

A pilot study to investigate the effects of combined dehumidification and HEPA filtration on dew point and airborne mold spore counts in day care centers.

PubMed

Bernstein, J A; Levin, L; Crandall, M S; Perez, A; Lanphear, B

2005-12-01

Meteorological factors such as relative humidity directly correlate with airborne fungal levels outdoors and indoors. While dehumidification alone is effective at reducing moisture necessary for mold growth, it is inadequate as a single intervention as it does not remove viable and non-viable fungal spores that are potentially allergenic. The purpose of this pilot study was to investigate whether dehumidification in combination with high-efficiency particulate arrestance (HEPA) filtration is effective at reducing airborne mold spore levels in day care centers. Two day care centers within a 2-mile radius of each other were selected. Day care center A was 2 years old with eight rooms while day care center B was 15 years old with six rooms. A high efficiency Santa Fe dehumidification unit equipped with a HEPA filter was installed in half the rooms (intervention) of each day care facility. Electronic HOBO data loggers continuously measured outdoor and indoor room dew point and temperature every 2 h throughout the study. Dew point and airborne fungal spore measurements from selected rooms with controlled air conditions were analyzed by comparing baseline measurements to those obtained at subsequent time periods over 1 year. Regression models accounted for correlations between measurements in the same room over time. Intervention resulted in a lowered average dew point from baseline by 8.8 degrees C compared with a decrease of 7.1 degrees C in non-intervention rooms across all time periods in both facilities (P<0.001). Fungal analyses demonstrated lower baseline (P=0.06) and follow-up means in intervention rooms (P<0.05), however the change from baseline to end of follow-up differed between intervention and non-intervention rooms in the two facilities. Log transformation was applied to approximate normality of fungal measurements. Dehumidification with HEPA filtration was effective at controlling indoor dew point in both facilities and at reducing airborne culturable fungal spore levels in one of the two facilities. These preliminary results provide a scientific rationale for using this intervention in future studies designed to investigate the impact of indoor mold exposure on health outcomes. Poor indoor air quality is a recognized cause or contributing factor to health effects. Dampness and humidity have been linked to upper and lower respiratory symptoms in children and adults. This study indicates that reducing indoor relative humidity and airborne mold spore levels using high-efficiency dehumidification units equipped with HEPA filtration is feasible even in work facilities such as day care centers where traffic in and out of the building is difficult to regulate. Clinicians should emphasize to their patients the importance of dehumidification and HEPA filtration to improve indoor air quality in the home and workplace.

A French national breast and thyroid cancer screening programme for survivors of childhood, adolescent and young adult (CAYA) cancers - DeNaCaPST programme.

PubMed

Demoor-Goldschmidt, Charlotte; Drui, Delphine; Doutriaux, Isabelle; Michel, Gérard; Auquier, Pascal; Dumas, Agnès; Berger, Claire; Bernier, Valérie; Bohrer, Sandrine; Bondiau, Pierre-Yves; Filhon, Bruno; Fresneau, Brice; Freycon, Claire; Stefan, Dinu; Helfre, Sylvie; Jackson, Angela; Kerr, Christine; Laprie, Anne; Leseur, Julie; Mahé, Marc-André; Oudot, Caroline; Pluchard, Claire; Proust, Stéphanie; Sudour-Bonnange, Hélène; Vigneron, Céline; Lassau, Nathalie; Schlumberger, Martin; Conter, Cécile Faure; de Vathaire, Florent

2017-05-12

Survival of childhood, adolescent and young adult (CAYA) cancers has increased with progress in the management of the treatments and has reached more than 80% at 5 years. Nevertheless, these survivors are at great risk of second cancers and non-malignant co-morbidities in later life. DeNaCaPST is a non-interventional study whose aim is to organize a national screening for thyroid cancer and breast cancer in survivors of CAYA cancers. It will study the compliance with international recommendations, with the aim, regarding a breast screening programme, of offering for every woman living in France, at equal risk, an equal screening. DeNaCaPST trial is coordinated by the INSERM 1018 unit in cooperation with the LEA (French Childhood Cancer Survivor Study for Leukaemia) study's coordinators, the long term follow up committee and the paediatric radiation committee of the SFCE (French Society of Childhood Cancers). A total of 35 centres spread across metropolitan France and la Reunion will participate. FCCSS (French Childhood Cancer Survivor Study), LEA and central registry will be interrogated to identify eligible patients. To participate, centers agreed to perform a complete "long-term follow-up consultations" according to good clinical practice and the guidelines of the SFCE (French Society of Children Cancers). As survival has greatly improved in childhood cancers, detection of therapy-related malignancies has become a priority even if new radiation techniques will lead to better protection for organs at risk. International guidelines have been put in place because of the evidence for increased lifetime risk of breast and thyroid cancer. DeNaCaPST is based on these international recommendations but it is important to recognize that they are based on expert consensus opinion and are supported by neither nonrandomized observational studies nor prospective randomized trials in this specific population. Over-diagnosis is a phenomenon inherent in any screening program and therefore such programs must be evaluated.

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

PubMed

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

2015-06-01

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

The EXPAND study: Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation.

PubMed

Shimokawa, Hiroaki; Yamashita, Takeshi; Uchiyama, Shinichiro; Kitazono, Takanari; Shimizu, Wataru; Ikeda, Takanori; Kamouchi, Masahiro; Kaikita, Koichi; Fukuda, Koji; Origasa, Hideki; Sakuma, Ichiro; Saku, Keijiro; Okumura, Yasuo; Nakamura, Yuichiro; Morimoto, Hideo; Matsumoto, Naoki; Tsuchida, Akihito; Ako, Junya; Sugishita, Nobuyoshi; Shimizu, Shogo; Atarashi, Hirotsugu; Inoue, Hiroshi

2018-05-01

The EXPAND study examined the real-world efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism (SE) in Japanese patients with non-valvular atrial fibrillation (NVAF). This multicenter, prospective, non-interventional, observational, cohort study was conducted at 684 medical centers in Japan. A total of 7141 NVAF patients ≥20 years of age (mean, 71.6 ± 9.4 years) who were being or about to be treated with rivaroxaban (10 mg/day, 43.5%; 15 mg/day, 56.5%) were followed for an average of 897.1 (±206.8) days with a high follow-up rate (99.65%). The mean CHADS 2 score at baseline was 2.1 (1.3) (0-1, 37%; 2, 29%; ≥3, 34%). The total incidence rate of symptomatic stroke and SE (primary efficacy endpoint) was 1.0%/year, and 0.5%, 0.9%, and 1.7%/year for those with CHADS 2 scores of 0-1, 2, and ≥3, respectively. Cumulative incidence rates for major bleeding (primary safety endpoint) and non-major bleeding (secondary safety endpoint) were 1.2%/year and 4.9%/year, respectively. Differences were noted between new and current users only for major bleeding event rate (1.7% vs. 1.1%/year, P = 0.0024). Comparisons with previous studies suggested that rivaroxaban is effective and safe for low-risk patients (0-1 CHADS 2 ), as shown for warfarin in the XANTUS international prospective post-marketing study. The EXPAND study demonstrated that low dosages of rivaroxaban for Japanese NVAF patients in real-world clinical practice, including those with CHADS 2 scores 0-1, resulted in low rates of stroke and SE, and major and non-major bleeding. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

It's a matter of trust: policing domestic violence in Hong Kong.

PubMed

Leung, Lai-ching

2014-01-01

This article aims to examine the intervention approach of the police in handling domestic violence and the reasons behind the inactive response of police to domestic violence situations in Hong Kong. The study adopted a qualitative approach to data collection that included 20 in-depth interviews to survivors and 2 interviews to police officers. Findings of this study show that the police are likely to adopt a non-intervention or mediation approach rather than arrest approach because of their distrust of abused women. The police have different reactions in responding to domestic violence issues namely (1) stereotyping the victims, (2) cynical interpretation of women's motivation in reporting, and (3) disbelieve the problem is solvable. All these reactions are associated with the trust of the police that hold on domestic violence issues stems from the dominant patriarchy ideology. The beliefs of police are shaped by the male-dominated police occupational culture, which is characterized by sexism and suspicion. Such beliefs coupled with traditional family values and the dependency discourses prevalent in society have concealed the truth and reality of domestic violence.

Influence knowledge and behavior of TB medical personnels’ concordance principle based communications skill at primary healthcare, Medan, Indonesia

NASA Astrophysics Data System (ADS)

Wahyuni, A. S.; Soeroso, N. N.; Alona, I.; Yunanda, Y.; Siregar, I.

2018-03-01

Concordance behavior of TB management is a form of collaboration among doctors, personnel, and patients in treating TB. Approvalamong them could be achieved if credibility and policy occur. This study is aimed to analyze the influence of TB medical personnel’s concordance behaviour principle to patient obedience at primary health care in Medan.The design of this study was quasi experimental, focusing on interventional primary health care, which is those who applied concordance behaviour principle to non-interventionalprimary health care. The population is TB patients, starting from 18 years old, TB category I with positive Acid Fast Bacilli Smear Test (AFBST), and taking TB regimens at Medan. Seventy- four patients were selected to be samples. They had undergone interview based on validated concordance principle, knowledge, behavior, and treatment. Data were analyzed using chi- square. The percentage of knowledge, behavior of TB patient to the treatment is higher on interventional primary health care than noninterventional ones. Treatment awareness based on concordance principle is expected to planish DOTS-based TB programs.

Impact of Intensive Summer Reading Intervention for Children With Reading Disabilities and Difficulties in Early Elementary School.

PubMed

Christodoulou, Joanna A; Cyr, Abigail; Murtagh, Jack; Chang, Patricia; Lin, Jiayi; Guarino, Anthony J; Hook, Pamela; Gabrieli, John D E

Efficacy of an intensive reading intervention implemented during the nonacademic summer was evaluated in children with reading disabilities or difficulties (RD). Students (ages 6-9) were randomly assigned to receive Lindamood-Bell's Seeing Stars program ( n = 23) as an intervention or to a waiting-list control group ( n = 24). Analysis of pre- and posttesting revealed significant interactions in favor of the intervention group for untimed word and pseudoword reading, timed pseudoword reading, oral reading fluency, and symbol imagery. The interactions mostly reflected (a) significant declines in the nonintervention group from pre- to posttesting, and (2) no decline in the intervention group. The current study offers direct evidence for widening differences in reading abilities between students with RD who do and do not receive intensive summer reading instruction. Intervention implications for RD children are discussed, especially in relation to the relevance of summer intervention to prevent further decline in struggling early readers.

Effects of improved access to transportation on emergency obstetric care outcomes in Uganda.

PubMed

Mucunguzi, Stephen; Wamani, Henry; Lochoro, Peter; Tylleskar, Thorkild

2014-09-01

Reduction in maternal mortality has not been appreciable in most low-income countries. Improved access to transport for mothers is one way to improve maternal health. This study evaluated a free-of-charge 24-hour ambulance and communication services intervention in Oyam district using 'Caesarean section rate' (CSR) and compared with the neighbouring non-intervention district. Ecological data were collected retrospectively from maternity/theatre registers in October 2010 for 3 years pre and 3 years intervention period. The average CSR in the intervention district increased from 0.57% before the intervention to 1.21% (p = 0.022) during the intervention, while there was no change in the neighbouring district (0.51% to 0.58%, p = 0.512). Hospital deliveries increased by over 50% per year with a slight reduction in the average hospital stillbirths per 1000 hospital births in the intervention district (46.6 to 37.5, p = 0.253). Reliable communication and transport services increased access to and utilization of maternal health services, particularly caesarean delivery services.

The immediate effect of neuromuscular joint facilitation on the rotation of the tibia during walking.

PubMed

Li, Desheng; Huang, Qiuchen; Huo, Ming; Hiiragi, Yukinobu; Maruyama, Hitoshi

2017-01-01

[Purpose] The aim of this study was to investigate the change in tibial rotation during walking among young adults after neuromuscular joint facilitation therapy. [Subjects and Methods] The subjects were twelve healthy young people (6 males, 6 females). A neuromuscular joint facilitation intervention and nonintervention were performed. The interventions were performed one after the other, separated by a 1-week interval. The order of the interventions was completely randomized. The rotation of the tibia during walking was evaluated before and after treatment. [Results] The neuromuscular joint facilitation group demonstrated increased lateral rotation of the tibia in the overall gait cycle and stance phase, and decreased medial rotation of the tibia in the overall gait cycle, stance phase, and swing phase after the neuromuscular joint facilitation intervention. In the control group, there were no significant differences. [Conclusion] These results suggest neuromuscular joint facilitation intervention has an immediate effect on the rotational function of the knee.

Evaluation of a peer-led drug abuse risk reduction project for runaway/homeless youths.

PubMed

Fors, S W; Jarvis, S

1995-01-01

The purpose of this study was to evaluate the Drug Prevention in Youth risk reduction program that was implemented in shelters for runaway/homeless youths in the Southeastern United States. The program focuses on knowledge, attitudes and skills that can help this group of high risk young people minimize the serious negative consequences of drug abuse. An evaluation strategy was developed so comparisons could be made between peer-led, adult-led and non-intervention groups. Dependent samples t tests and least squares ANCOVAS were used to measure pretest-posttest differences both within and between groups. Results indicate that the peer-led groups were more successful than the other two groups, and that program effects were the most powerful with the youngest group of shelter clients. Process evaluation revealed important factors related to group leader training and group management. It is concluded that well-trained and motivated peer/near peer leaders have particularly valuable contributions to make with regard to drug abuse risk reduction for shelter clients.

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

PubMed Central

2010-01-01

Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC) for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP), visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP) population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population), the primary reasons for switching were inadequate IOP reduction (78.2%) and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible). In all, 1317 (56.3%) subjects completed the study, and 1028 (44.0%) were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P < 0.05 for change at all time points). By investigator assessments, optic disc parameters and visual field were stable over 24 months, and there was no relationship between IOP reduction over 24 months and development of a visual field defect. More than 90% of physicians rated latanoprost/timolol FC as "very good" or "good" for efficacy (PP population), tolerability, and compliance. The FC was safe and well tolerated. No change in iris color was reported by most subjects (83.1%) at month 24. Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up. PMID:20825668

Predictors of remission in the treatment of major depressive disorder: real-world evidence from a 6-month prospective observational study

PubMed Central

Novick, Diego; Hong, Jihyung; Montgomery, William; Dueñas, Héctor; Gado, Magdy; Haro, Josep Maria

2015-01-01

Background This study examined potential predictors of remission among patients treated for major depressive disorder (MDD) in a naturalistic clinical setting, mostly in the Middle East, East Asia, and Mexico. Methods Data for this post hoc analysis were taken from a 6-month prospective, noninterventional, observational study that involved 1,549 MDD patients without sexual dysfunction at baseline in 12 countries worldwide. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Depression-related pain was measured using the pain-related items of the Somatic Symptom Inventory. Remission was defined as a QIDS-SR16 score ≤5. Generalized estimating equation regression models were used to examine baseline factors associated with remission during follow-up. Results Being from East Asia (odds ratio [OR] 0.48 versus Mexico; P<0.001), a higher level of depression severity at baseline (OR 0.77, P=0.003, for Clinical Global Impression of Severity; OR 0.92, P<0.001, for QIDS-SR16), more previous MDD episodes (OR 0.92, P=0.007), previous treatments/therapies for depression (OR 0.78, P=0.030), and having any significant psychiatric and medical comorbidity at baseline (OR 0.60, P<0.001) were negatively associated with remission, whereas being male (OR 1.29, P=0.026) and treatment with duloxetine (OR 2.38 versus selective serotonin reuptake inhibitors, P<0.001) were positively associated with remission. However, the association between Somatic Symptom Inventory pain scores and remission no longer appeared to be significant in this multiple regression (P=0.580), (P=0.008 in descriptive statistics), although it remained significant in a subgroup of patients treated with selective serotonin reuptake inhibitors (OR 0.97, P=0.023), but not in those treated with duloxetine (P=0.182). Conclusion These findings are largely consistent with previous reports from the USA and Europe. They also highlight the potential mediating role of treatment with duloxetine on the negative relationship between depression-related pain and outcomes of depression. PMID:25653529

Predictors of remission in the treatment of major depressive disorder: real-world evidence from a 6-month prospective observational study.

PubMed

Novick, Diego; Hong, Jihyung; Montgomery, William; Dueñas, Héctor; Gado, Magdy; Haro, Josep Maria

2015-01-01

This study examined potential predictors of remission among patients treated for major depressive disorder (MDD) in a naturalistic clinical setting, mostly in the Middle East, East Asia, and Mexico. Data for this post hoc analysis were taken from a 6-month prospective, noninterventional, observational study that involved 1,549 MDD patients without sexual dysfunction at baseline in 12 countries worldwide. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Depression-related pain was measured using the pain-related items of the Somatic Symptom Inventory. Remission was defined as a QIDS-SR16 score ≤5. Generalized estimating equation regression models were used to examine baseline factors associated with remission during follow-up. Being from East Asia (odds ratio [OR] 0.48 versus Mexico; P<0.001), a higher level of depression severity at baseline (OR 0.77, P=0.003, for Clinical Global Impression of Severity; OR 0.92, P<0.001, for QIDS-SR16), more previous MDD episodes (OR 0.92, P=0.007), previous treatments/therapies for depression (OR 0.78, P=0.030), and having any significant psychiatric and medical comorbidity at baseline (OR 0.60, P<0.001) were negatively associated with remission, whereas being male (OR 1.29, P=0.026) and treatment with duloxetine (OR 2.38 versus selective serotonin reuptake inhibitors, P<0.001) were positively associated with remission. However, the association between Somatic Symptom Inventory pain scores and remission no longer appeared to be significant in this multiple regression (P=0.580), (P=0.008 in descriptive statistics), although it remained significant in a subgroup of patients treated with selective serotonin reuptake inhibitors (OR 0.97, P=0.023), but not in those treated with duloxetine (P=0.182). These findings are largely consistent with previous reports from the USA and Europe. They also highlight the potential mediating role of treatment with duloxetine on the negative relationship between depression-related pain and outcomes of depression.

Influence of patient training on persistence, compliance, and tolerability of different dosing frequency regimens of bisphosphonate therapy: An observational study in Turkish patients with postmenopausal osteoporosis.

PubMed

Akarırmak, Ülkü; Koçyiğit, Hikmet; Eskiyurt, Nurten; Esmaeilzadeh, Sina; Kuru, Ömer; Yalçinkaya, Ebru Yılmaz; Peker, Özlen; Ekim, Ayşe Aydemir; Özgirgin, Neşe; Çalış, Mustafa; Rezvani, Aylin; Çevikol, Alev; Eyigör, Sibel; Şendur, Ömer Faruk; İrdesel, Jale

2016-08-01

In our study, we aimed to evaluate the influence of training on compliance and persistence with bisphosphonate treatment given on a weekly vs. monthly basis in postmenopausal osteoporosis patients. A total of 979 patients with postmenopausal osteoporosis (mean age: 63.2 ± 7.2 years) were included in this national, multicenter, prospective non-interventional observational cohort registry study. Patients were randomized into training (n = 492, 50.3%, mean age: 63.4 ± 7.2 years) and control (n = 487, 49.7%, mean age: 63.0 ± 7.1 years) groups. Patients in each intervention group were given weekly (44.9% and 44.6% for training and control subjects, respectively) or monthly (55.1% and 55.4%, respectively) bisphosphonate regimens. After the initial visit, patients were followed up at three-month intervals throughout 12 months of treatment for evaluation of persistence, compliance and adverse events. On average, 79.4% of the patients were persistent with the treatment with a mean of 350.4 days of duration during the 12-month follow-up period. The mean compliance in the compliant and fully compliant group remained at an average of 86.6%. No significant difference was detected between the training and control groups in terms of compliance and persistence. Significantly longer persistence (360.0 ± 89.0 vs. 345.0 ± 108.0 days; p = 0.035), higher percentage of persistent patients (83.4% vs. 74.2%; p = 0.012) and higher compliance rates (88.8% vs. 83.3%; p = 0.002) were noted in monthly regimen patients in comparison to those given weekly regimen. Our findings revealed remarkably high rates for persistence and compliance with bisphosphonate treatment in postmenopausal osteoporosis, with no impact of training on compliance and persistence rates. Longer persistence and better compliance rates were achieved with the monthly bisphosphonate regimen when compared to the weekly regimen. Copyright © 2016 Turkish Association of Orthopaedics and Traumatology. Production and hosting by Elsevier B.V. All rights reserved.

The effectiveness of pharmaceutical interventions for obesity: weight loss with orlistat and sibutramine in a United Kingdom population-based cohort.

PubMed

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

2015-06-01

Drug treatments for obesity have proven efficacy from randomized trials, but their effectiveness in routine clinical practice is unknown. We assessed the effects on weight and body mass index (BMI) of orlistat and sibutramine when delivered in routine primary care. We used United Kingdom data from the Clinical Practice Research Datalink to estimate the effects of orlistat or sibutramine on weight and BMI over 3 years following treatment initiation. For comparison, we matched each patient with up to five obese patients receiving neither drug. Mixed effects linear regression with splines was used to model change in weight and BMI. Mean change with 95% confidence intervals (CI) was estimated. We identified 100 701 patients receiving orlistat, 15 355 receiving sibutramine and 508 140 non-intervention patients, with body mass index of 37.2, 36.6 and 33.2 kg m(-2) , respectively. Patients receiving orlistat lost, on average, 0.94 kg month(-1) (0.93 to 0.95) over the first 4 months. Weight gain then occurred, although weight remained slightly below baseline at 3 years. Patients receiving sibutramine lost, 1.28 kg month(-1) (1.26 to 1.30) over the first 4 months, but by 3 years had exceeded baseline weight. Non-intervention patients had slight increases in weight throughout the 3 year period, with gains ranging between 0.01 and 0.06 kg month(-1) . Orlistat and sibutramine had early effects on weight loss, not sustained over 3 years. As new treatments for obesity are approved, their effectiveness should be measured in routine clinical practice, as effectiveness may be considerably less than seen in randomized trials. © 2015 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society.

Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS)

PubMed Central

Peerson, Janet M.; Becquey, Elodie; Abbeddou, Souheila; Ouédraogo, Césaire T.; Somé, Jérôme W.; Yakes Jimenez, Elizabeth; Ouédraogo, Jean-Bosco; Vosti, Stephen A.; Rouamba, Noël; Brown, Kenneth H.

2017-01-01

Background Of two community-based trials among young children in neighboring health districts of Burkina Faso, one found that small-quantity lipid-based nutrient supplements (LNS) increased child growth compared with a non-intervention control group, but zinc supplementation did not in the second study. Objectives We explored whether the disparate growth outcomes were associated with differences in intervention components, household demographic variables, and/or children’s morbidity. Methods Children in the LNS study received 20g LNS daily containing different amounts of zinc (LNS). Children in the zinc supplementation study received different zinc supplementation regimens (Z-Suppl). Children in both studies were visited weekly for morbidity surveillance. Free malaria and diarrhea treatment was provided by the field worker in the LNS study, and by a village-based community-health worker in the zinc study. Anthropometric assessments were repeated every 13–16 weeks. For the present analyses, study intervals of the two studies were matched by child age and month of enrollment. The changes in length-for-age z-score (LAZ) per interval were compared between LNS and Z-Suppl groups using mixed model ANOVA or ANCOVA. Covariates were added to the model in blocks, and adjusted differences between group means were estimated. Results Mean ages at enrollment of LNS (n = 1716) and Z-Suppl (n = 1720) were 9.4±0.4 and 10.1±2.7 months, respectively. The age-adjusted change in mean LAZ per interval declined less with LNS (-0.07±0.44) versus Z-Suppl (-0.21±0.43; p<0.0001). There was a significant group by interval interaction with the greatest difference found in 9–12 month old children (p<0.0001). Adjusting for demographic characteristics and morbidity did not reduce the observed differences by type of intervention, even though the morbidity burden was greater in the LNS group. Conclusions Greater average physical growth in children who received LNS could not be explained by known cross-trial differences in baseline characteristics or morbidity burden, implying that the observed difference in growth response was partly due to LNS. PMID:28771493

Treatment of premenstrual syndrome with a phytopharmaceutical formulation containing Vitex agnus castus.

PubMed

Loch, E G; Selle, H; Boblitz, N

2000-04-01

A multicentric noninterventional trial (open study without control) to investigate the efficacy and tolerance of a drug in a large number of patients under routine medical conditions was performed for a new solid preparation from an extract of the fruit of Vitex agnus castus (VAC, Vitex, chaste tree, Chasteberry) in 1634 patients suffering from premenstrual syndrome (PMS). A specific questionnaire was developed for determining the effect of Vitex on psychic and somatic complaints, on the four characteristic PMS symptom complexes depression, anxiety, craving, and hyperhydration (DACH), and on single groups of symptoms. After a treatment period of three menstrual cycles 93% of patients reported a decrease in the number of symptoms or even cessation of PMS complaints. To a certain extent, this effect was observed within all symptom complexes and correlated with the global assessment of therapeutic efficacy. Whereas 85% of physicians rated it as good or very good, 81% of patients assessed their status after treatment as very much or much better. Analysis of frequency and severity of mastodynia as the predominant symptom revealed that complaints still present after 3 months of therapy were mostly less severe. Ninety-four percent of patients assessed the tolerance of Vitex treatment as good or very good. Adverse drug reactions were suspected by physicians in 1.2% of patients, but there were no serious adverse drug reactions. Hence, the risk/benefit ratio of the new Vitex preparation can be rated as very good, with significant efficacy for all aspects of the multifaceted and inhomogeneous clinical picture of PMS, with a safety profile comparable to other Vitex preparations.

Physiogenomic analysis of the Puerto Rican population

PubMed Central

Ruaño, Gualberto; Duconge, Jorge; Windemuth, Andreas; Cadilla, Carmen L; Kocherla, Mohan; Villagra, David; Renta, Jessica; Holford, Theodore; Santiago-Borrero, Pedro J

2009-01-01

Aims Admixture in the population of the island of Puerto Rico is of general interest with regards to pharmacogenetics to develop comprehensive strategies for personalized healthcare in Latin Americans. This research was aimed at determining the frequencies of SNPs in key physiological, pharmacological and biochemical genes to infer population structure and ancestry in the Puerto Rican population. Materials & methods A noninterventional, cross-sectional, retrospective study design was implemented following a controlled, stratified-by-region, random sampling protocol. The sample was based on birthrates in each region of the island of Puerto Rico, according to the 2004 National Birth Registry. Genomic DNA samples from 100 newborns were obtained from the Puerto Rico Newborn Screening Program in dried-blood spot cards. Genotyping using a physiogenomic array was performed for 332 SNPs from 196 cardiometabolic and neuroendocrine genes. Population structure was examined using a Bayesian clustering approach as well as by allelic dissimilarity as a measure of allele sharing. Results The Puerto Rican sample was found to be broadly heterogeneous. We observed three main clusters in the population, which we hypothesize to reflect the historical admixture in the Puerto Rican population from Amerindian, African and European ancestors. We present evidence for this interpretation by comparing allele frequencies for the three clusters with those for the same SNPs available from the International HapMap project for Asian, African and European populations. Conclusion Our results demonstrate that population analysis can be performed with a physiogenomic array of cardiometabolic and neuroendocrine genes to facilitate the translation of genome diversity into personalized medicine. PMID:19374515

AHEAD. Advate in HaEmophilia A outcome Database.

PubMed

Oldenburg, J; Kurnik, K; Huth-Kühne, A; Zimmermann, R; Abraham, I; Klamroth, R

2010-11-01

The clinical picture of haemophilia A patients is often characterised by recurrent bleedings, in particular joint bleeds. Thus far, long-term data on the outcome of haemophilia A patients are scarce as regards the development of target joints, joint replacement, lost days from school or work due to bleedings, and the quality of life, as most previous studies were limited to the aspects of safety and efficacy. The Baxter-initiated AHEAD (Advate in HaEmophilia A outcome Database) study is a multi-centre, prospective, non-interventional observational study of haemophilia A patients. All patients with a residual FVIII activity of £5% who are being treated with ADVATE are eligible. There are no limitations in terms of patient age or treatment regimen. AHEAD is scientifically supported by a renowned interdisciplinary steering board and is intended to yield data on 500 patients in up to 30 haemophilia centres, collected during a period of four years. The large patient population has been chosen in order to ensure a valid database. The objective of the study is to record haemophilia-related arthropathies, which will be defined based on imaging techniques (e. g. MRI, X-ray, ultrasound) and the judgment of the attending physician. In addition, extensive data will be collected on joint replacement surgeries, pseudotumour development, bleeding-related pain, quality of life (age-related questionnaires: Haem-A-QoL, Haemo-QoL, SF10, SF12v2), risk factors (diabetes mellitus, arterial hypertension, nicotine abuse), blood group, gene mutation, physical activity, and on the efficacy and safety of Advate. The patient data will be entered into an electronic CRF system at the centres. Plausibility checks during data entry, regular monitoring visits, and the option of auditing all serve to ensure a high data quality for AHEAD. The first patient was enrolled in the study in early June 2010; recruitment is planned to continue until the end of 2011. The Ethics Committee of the University of Bonn has given its favorable opinion.

Office and ambulatory blood pressure control with a fixed-dose combination of candesartan and hydrochlorothiazide in previously uncontrolled hypertensive patients: results of CHILI CU Soon

PubMed Central

Mengden, Thomas; Hübner, Reinhold; Bramlage, Peter

2011-01-01

Background Fixed-dose combinations of candesartan 32 mg and hydrochlorothiazide (HCTZ) have been shown to be effective in clinical trials. Upon market entry we conducted a noninterventional study to document the safety and effectiveness of this fixed-dose combination in an unselected population in primary care and to compare blood pressure (BP) values obtained during office measurement (OBPM) with ambulatory blood pressure measurement (ABPM). Methods CHILI CU Soon was a prospective, noninterventional, noncontrolled, open-label, multicenter study with a follow-up of at least 10 weeks. High-risk patients aged ≥18 years with previously uncontrolled hypertension were started on candesartan 32 mg in a fixed-dose combination with either 12.5 mg or 25 mg HCTZ. OBPM and ABPM reduction and adverse events were documented. Results A total of 4131 patients (52.8% male) with a mean age of 63.0 ± 11.0 years were included. BP was 162.1 ± 14.8/94.7 ± 9.2 mmHg during office visits at baseline. After 10 weeks of candesartan 32 mg/12.5 mg or 25 mg HCTZ, mean BP had lowered to 131.7 ± 10.5/80.0 ± 6.6 mmHg (P < 0.0001 for both comparisons). BP reduction was comparable irrespective of prior or concomitant medication. In patients for whom physicians regarded an ABPM to be necessary (because of suspected noncontrol over 24 hours), ABP at baseline was 158.2/93.7 mmHg during the day and 141.8/85.2 mmHg during the night. At the last visit, BP had significantly reduced to 133.6/80.0 mmHg and 121.0/72.3 mmHg, respectively, resulting in 20.8% being normotensive over 24 hours (<130/80 mmHg). The correlation between OBPM and ABPM was good (r = 0.589 for systolic BP and r = 0.389 for diastolic BP during the day). Of those who were normotensive upon OBPM, 35.1% had high ABPM during the day, 49.3% were nondippers, and 3.4% were inverted dippers. Forty-nine adverse events (1.19%) were reported, of which seven (0.17%) were regarded as serious. Conclusion Candesartan 32 mg in a fixed-dose combination with either 12.5 mg or 25 mg HCTZ is safe and effective for further BP lowering irrespective of prior antihypertensive drug class not being able to control BP. PMID:22241950

Evaluation of a program to improve diabetes care through intensified care management activities and diabetes medication copayment reduction.

PubMed

Kogut, Stephen J; Johnson, Scott; Higgins, Tara; Quilliam, Brian

2012-05-01

Medication copayment reduction can be integrated with disease management programs to incentivize patient engagement in chronic care management. While disease management programs in diabetes have been evaluated across a range of settings and designs, less is known regarding the effectiveness of copayment reduction as a component of disease management. To evaluate the short-term results of a diabetes-focused disease management program that included copayment reduction, care coordination, and patient goal setting, focusing on rates of evidence-based care processes and all-cause pharmacy and health care costs. Blue Cross Blue Shield of Rhode Island offered large employer groups the opportunity to participate in a diabetes disease management initiative that featured reduced copayments (from $7/$25/$40 for generic, tier 2, and tier 3 drugs, respectively, to $0 for generic and $0-$2 for brand drugs) for diabetes-related medications. In return for the copayment reduction, participants agreed to the following: (a) participate in care coordination with a case manager, (b) have an annual physical examination, (c) have a hemoglobin A1c blood test at least twice annually, and (d) have a low-density lipoprotein cholesterol (LDL-C) test at least once annually. Patients received personalized support provided by a registered nurse and dietician, disease-related education provided by nurses, and intensified case management services, including working with a health coach to establish healthy behavioral change goals. All study subjects were aged 18 years or older and had at least 1 ICD-9-CM code for diabetes and at least 1 claim for an antidiabetic drug during a 12-month measurement period, which was each subject's most recent 12-month period of continuous enrollment from January 1, 2008, through May 31, 2010. Administrative claims data were used to determine the percentage of intervention (participating) and nonintervention (nonparticipating) subjects from among all of the plan's employer groups who received at least once-yearly monitoring of A1c, high-density lipoprotein cholesterol (HDL-C), and LDL-C; medical attention (or drug therapy) for nephropathy; and an eye examination. We conducted multivariate logistic regression analyses to assess the effect of the intervention and other patient characteristics and comorbidities on rates of performance of these care processes, aggregating the 5 processes of care into an "all or none" single composite outcome. We also developed a propensity score-weighted model to attempt to adjust for differences between the intervention and nonintervention groups resulting from the nonrandomized study design. Additionally, we quantified average plan payments to providers less patient copayments (i.e., net plan cost) per patient per year (PPPY) for the 12-month follow-up period and compared these costs for the intervention versus nonintervention groups. The study sample consisted of 9,698 patients with diabetes; 649 (6.7%) of whom participated in the intervention. 9,049 (93.3%) patients were identified by the insurer as patients with diabetes receiving usual care. Patients in the intervention and nonintervention groups were similarly likely to have all 5 recommended processes of care performed (40.1% vs. 38.9%, respectively, P = 0.543). Younger patients received all 5 recommended care processes less frequently than older patients (30.5%, 38.0%, and 47.0% for ages 18-48 years, 49-59 years, and 60 years or older, respectively, P < 0.001); in adjusted analyses, patients aged 60 years or older were approximately twice as likely to receive all 5 care processes compared with patients aged 18-48 years (odds ratio [OR] = 1.97, 95% CI = 1.75-2.21). Users of oral antidiabetic monotherapy were least likely to have these processes of care performed compared with users of multiple oral therapies (OR = 1.23, 95% CI = 1.11-1.36) and insulin (OR = 1.59, 95% CI = 1.41-1.78). PPPY prescription drug costs incurred by the plan were greater for intervention than comparison patients (means [SDs] of $3,139 [$3,426] vs. $2,854 [$3,938], respectively, P < 0.001); and the generic-dispensing ratio was slightly lower (means [SDs] of 62.1% [22.4%] and 65.4% [23.0%], respectively, P < 0.001). There were no significant differences between the intervention and comparison groups in mean [SD] PPPY all-cause medical care costs ($7,475 [$17,601] vs. $8,577 [$22,972], respectively, P = 0.213) or total all-cause costs ($10,613 [$18,590] vs. $11,431 [$24,060], P = 0.666). Patients participating in this incentive program featuring diabetes medication copayment reduction and disease management components did not receive recommended care any more or less frequently than other enrolled members with diabetes. Younger patients and those utilizing oral antidiabetic monotherapy as their drug regimens were less likely to have the recommended processes of care performed. While prescription drug expenditures incurred by the plan were greater for intervention patients, between-group differences in total costs for medications and all-cause medical care were not statistically significant. Further follow-up is required to determine the success of this program over the longer term in promoting quality of care and achieving cost reductions and improved health outcomes.

Achieving symptomatic remission in out-patients with schizophrenia--a naturalistic study with quetiapine.

PubMed

Wobrock, T; Köhler, J; Klein, P; Falkai, P

2009-08-01

Symptomatic remission was defined as a score of mild or less on each of eight key schizophrenia symptoms on the Positive and Negative Syndrome Scale (PANSS-8). To evaluate the symptomatic remission criterion in clinical practice and to determine predictors for achieving symptomatic remission, a 12-week non-interventional study (NIS) with quetiapine was conducted in Germany. For the comparison of patients with and without symptomatic remission, sociodemographic and clinical variables of 693 patients were analyzed by logistic regression for their predictive value to achieve remission. Four hundred and four patients (58.3%) achieved symptomatic remission after 12 weeks' treatment with quetiapine. Remission was significantly predicted by a low degree of PANSS-8 total score, PANSS single items blunted affect (N1), social withdrawal (N4), lack of spontaneity (N6), mannerism and posturing (G5), and low disease severity (CGI-S) at baseline. Predictors of non-remission were older age, diagnosis of schizophrenic residuum, multiple previous episodes, longer duration of current episode, presence of concomitant diseases, and alcohol abuse. This study demonstrated that the majority of schizophrenia out-patients achieved symptomatic remission after 12 weeks treatment and confirms the importance of managing negative symptoms in order to achieve disease remission.

Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt - results from the GUARD study.

PubMed

Shelbaya, Salah; Rakha, Sameh

2017-05-01

The GUARD study evaluated the effectiveness, safety, and tolerability of vildagliptin treatment with or without metformin in patients with type 2 diabetes mellitus (T2DM) in real-life settings. Here we present the results of the GUARD study for the patient subset from Egypt. This was a 24 ± 6 weeks, prospective, non-interventional study that enrolled adult patients with T2DM receiving vildagliptin or vildagliptin + metformin combination therapy as per local prescribing information. The primary effectiveness endpoint was change in HbA1c levels from baseline to week 24 ± 6 endpoint. Safety was assessed by reporting of adverse events and serious adverse events (SAEs). Of 2786 patients enrolled from Egypt, 655 received vildagliptin and 2131 received vildagliptin + metformin. Overall, at baseline, mean (± standard deviation [SD]) age was 49.5 ± 9.49 years, BMI was 31.5 ± 4.85 kg/m 2 , HbA1c was 8.4 ± 0.86%, and duration of T2DM was 2.3 ± 3.78 years. At week 24, significant reductions in mean (±SD) HbA1c were observed in the vildagliptin (-1.47 ± 0.79%) and vildagliptin + metformin (-1.62 ± 0.82%) groups (both p < 0.0001) from baseline HbA1c of 8.1% and 8.4%, respectively. At week 24, 67.5% patients in the vildagliptin group and 60.5% in the vildagliptin + metformin group achieved HbA1c ≤7.0%. Treatment with vildagliptin (± metformin) was well tolerated, with a low incidence of hypoglycemia in both groups (vildagliptin, 0.5%; vildagliptin + metformin, 0.6%). No SAEs or deaths were reported in the vildagliptin group; however, 0.2% of patients experienced SAEs and one death (accidental death) was reported in the vildagliptin + metformin group. In a real-world setting, vildagliptin, with or without metformin, resulted in significant reductions in HbA1c and was well tolerated in patients with T2DM from Egypt. Limitations of the study include non-randomization and the open-label, observational nature of the study.

Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial.

PubMed

Reichardt, Peter; Demetri, George D; Gelderblom, Hans; Rutkowski, Piotr; Im, Seock-Ah; Gupta, Sudeep; Kang, Yoon-Koo; Schöffski, Patrick; Schuette, Jochen; Soulières, Denis; Blay, Jean-Yves; Goldstein, David; Fly, Kolette; Huang, Xin; Corsaro, Massimo; Lechuga, Maria Jose; Martini, Jean-Francois; Heinrich, Michael C

2016-01-15

Several small studies indicated that the genotype of KIT or platelet-derived growth factor receptor-α (PDGFRA) contributes in part to the level of clinical effectiveness of sunitinib in gastrointestinal stromal tumor (GIST) patients. This study aimed to correlate KIT and PDGFRA mutational status with clinical outcome metrics (progression-free survival [PFS], overall survival [OS], objective response rate [ORR]) in a larger international patient population. This is a non-interventional, retrospective analysis in patients with imatinib-resistant or intolerant GIST who were treated in a worldwide, open-label treatment-use study (Study 1036; NCT00094029) in which sunitinib was administered at a starting dose of 50 mg/day on a 4-week-on, 2-week-off schedule. Molecular status was obtained in local laboratories with tumor samples obtained either pre-imatinib, post-imatinib/pre-sunitinib, or post-sunitinib treatment, and all available data were used in the analyses regardless of collection time. The primary analysis compared PFS in patients with primary KIT exon 11 versus exon 9 mutations (using a 2-sided log-rank test) and secondary analyses compared OS (using the same test) and ORR (using a 2-sided Pearson χ(2) test) in the same molecular subgroups. Of the 1124 sunitinib-treated patients in the treatment-use study, 230 (20%) were included in this analysis, and baseline characteristics were similar between the two study populations. Median PFS was 7.1 months. A significantly better PFS was observed in patients with a primary mutation in KIT exon 9 (n = 42) compared to those with a primary mutation in exon 11 (n = 143; hazard ratio = 0.59; 95 % confidence interval, 0.39-0.89; P = 0.011), with median PFS times of 12.3 and 7.0 months, respectively. Similarly, longer OS and higher ORR were observed in patients with a primary KIT mutation in exon 9 versus exon 11. The data available were limited to investigate the effects of additional KIT or PDGFRA mutations on the efficacy of sunitinib treatment. This large retrospective analysis confirms the prognostic significance of KIT mutation status in patients with GIST. This analysis also confirms the effectiveness of sunitinib as a post-imatinib therapy, regardless of mutational status. NCT01459757.

Efficacy and safety of eslicarbazepine acetate monotherapy for partial-onset seizures: Experience from a multicenter, observational study.

PubMed

Toledano, Rafael; Jovel, Camilo Espinosa; Jiménez-Huete, Adolfo; Bayarri, Pau Giner; Campos, Dulce; Gomariz, Elena López; Giráldez, Beatriz González; García-Morales, Irene; Falip, Mercé; Agredano, Paula Martínez; Palao, Susana; Prior, María José Aguilar Amat; Pascual, María Rosa Querol; Navacerrada, Francisco José; González, Francisco Javier López; Ojeda, Joaquín; Sáez, Aránzazu Alfaro; Bermejo, Pedro Emilio; Gil-Nagel, Antonio

2017-08-01

Eslicarbazepine acetate (ESL, Aptiom™) is a once-daily anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). Historical-controlled trials investigating the use of ESL as monotherapy have demonstrated a favorable efficacy and tolerability profile in patients with POS. This prospective, non-interventional study recruited POS patients in 17 hospitals in Spain. After a 3-month baseline period, ESL therapy was initiated as 400mg QD and up-titrated to an optimal maintenance dose based on clinical response and tolerance. The incidence of seizures was assessed via seizure calendars and the nature and severity of adverse events (AEs) were also recorded. A total of 117 patients (aged 9-87years) enrolled in the study and were treated with ESL at either 400mg/day (3.4% patients), 800mg/day (61% patients), 1200mg/day (27.1% patients) or 1600mg/day (8.5% patients). At 3months, 82.0% (n=72) of patients achieved a ≥50% reduction in seizure frequency, compared to 79.7% (n=67) of patients at 6months and 83.0% (n=49) at 12months. Patients who suffered secondary generalized tonic-clonic (SGTC) seizures had seizure-free rates of 71% (n=27), 69.6% (n=29), and 72.7% (n=16) at 3, 6, and 12months, respectively. Overall, 18 patients (15.3%) reported AEs of instability and dizziness (n=9), somnolence (n=3), mild hyponatremia (n=3), headache (n=1), hypertriglyceridemia (n=1), and allergic reaction (n=1), which caused ESL discontinuation of ESL treatment. ESL is effective and well tolerated as monotherapy for patients with POS, which supports previous findings. Early use is supported by its frequent use as monotherapy in this study and lack of severe side effects. Copyright © 2017 Elsevier Inc. All rights reserved.

Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients.

PubMed

Nabieva, N; Kellner, S; Fehm, T; Häberle, L; de Waal, J; Rezai, M; Baier, B; Baake, G; Kolberg, H-C; Guggenberger, M; Warm, M; Harbeck, N; Wuerstlein, R; Deuker, J-U; Dall, P; Richter, B; Wachsmann, G; Brucker, C; Siebers, J W; Fersis, N; Kuhn, T; Wolf, C; Vollert, H-W; Breitbach, G-P; Janni, W; Landthaler, R; Kohls, A; Rezek, D; Noesselt, T; Fischer, G; Henschen, S; Praetz, T; Heyl, V; Kühn, T; Krauss, T; Thomssen, C; Hohn, A; Tesch, H; Mundhenke, C; Hein, A; Rauh, C; Bayer, C M; Jacob, A; Schmidt, K; Belleville, E; Brucker, S Y; Kümmel, S; Beckmann, M W; Wallwiener, D; Hadji, P; Fasching, P A

2018-01-01

Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole. The EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT. Out of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit). These results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evaluation of Stepping Stones as a tool for changing knowledge, attitudes and behaviours associated with gender, relationships and HIV risk in Karnataka, India

PubMed Central

2011-01-01

Background Stepping Stones training aims to help individuals explore sexual relationships and recognize gender inequalities, the structural drivers of the HIV epidemic, in order to understand risk behaviours and to seek solutions to factors that increase HIV vulnerability. Despite earlier studies suggesting the success of Stepping Stones, little data exist to show diffusion to trainees' social networks or the wider community. Methods A mixed-methods evaluation of this approach was undertaken using in-depth interviews of trainees and friends, and polling booth surveys in 20 villages where Stepping Stones training took place and in another 20 villages with no Stepping Stones intervention. Results The interview respondents and their friends reported significant changes in their relationships after training, and benefit from discussion of gender, sexuality, condom use and HIV vulnerability issues. However, though diffusion of this knowledge at the level of personal contacts was strong, the evaluation revealed that diffusion to the community level was limited. Conclusions The qualitative part of this study reflects other studies in different settings, in that SS participants gained immensely from the training. Wider behaviour change is a challenging goal that many programmes fail to attain, with most interventions too limited in scope and intensity to produce larger community effects. This may have contributed to the fact that we observed few differences between interventions and non-intervention villages in this study. However, it is also possible that we had excessive expectations of individual change at the community level, and that it might have been more appropriate to have had broader community level rather than individual behavioural change indicators. We suggest that SS could be enhanced by efforts to better engage existing community opinion leaders, to empower and train participants as community change agents, and to support the development of village-level action plans that combat sexual stereotyping and risky behaviours that lead to unhealthy sexual relationships. PMID:21702965

Automated, computer-guided PASI measurements by digital image analysis versus conventional physicians' PASI calculations: study protocol for a comparative, single-centre, observational study.

PubMed

Fink, Christine; Uhlmann, Lorenz; Klose, Christina; Haenssle, Holger A

2018-05-17

Reliable and accurate assessment of severity in psoriasis is very important in order to meet indication criteria for initiation of systemic treatment or to evaluate treatment efficacy. The most acknowledged tool for measuring the extent of psoriatic skin changes is the Psoriasis Area and Severity Index (PASI). However, the calculation of PASI can be tedious and subjective and high intraobserver and interobserver variability is an important concern. Therefore, there is a great need for a standardised and objective method that guarantees a reproducible PASI calculation. Within this study we will investigate the precision and reproducibility of automated, computer-guided PASI measurements in comparison to trained physicians to address these limitations. Non-interventional analyses of PASI calculations by either physicians in a prospective versus retrospective setting or an automated computer-guided algorithm in 120 patients with plaque psoriasis. All retrospective PASI calculations by physicians or by the computer algorithm are based on total body digital images. The primary objective of this study is comparison of automated computer-guided PASI measurements by means of digital image analysis versus conventional, prospective or retrospective physicians' PASI assessments. Secondary endpoints include (1) the assessment of physicians' interobserver variance in PASI calculations, (2) the assessment of physicians' intraobserver variance in PASI assessments of the same patients' images after a time interval of at least 4 weeks, (3) the assessment of the deviation between physicians' prospective versus retrospective PASI calculations, and (4) the reproducibility of automated computer-guided PASI measurements by assessment of two sets of total body digital images of the same patients taken at one time point. Ethical approval was provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg (ethics approval number S-379/2016). DRKS00011818; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluation of stepping stones as a tool for changing knowledge, attitudes and behaviours associated with gender, relationships and HIV risk in Karnataka, India.

PubMed

Bradley, Janet E; Bhattacharjee, Parinita; Ramesh, Banadakoppa M; Girish, Meghna; Das, Arup K

2011-06-24

Stepping Stones training aims to help individuals explore sexual relationships and recognize gender inequalities, the structural drivers of the HIV epidemic, in order to understand risk behaviours and to seek solutions to factors that increase HIV vulnerability. Despite earlier studies suggesting the success of Stepping Stones, little data exist to show diffusion to trainees' social networks or the wider community. A mixed-methods evaluation of this approach was undertaken using in-depth interviews of trainees and friends, and polling booth surveys in 20 villages where Stepping Stones training took place and in another 20 villages with no Stepping Stones intervention. The interview respondents and their friends reported significant changes in their relationships after training, and benefit from discussion of gender, sexuality, condom use and HIV vulnerability issues. However, though diffusion of this knowledge at the level of personal contacts was strong, the evaluation revealed that diffusion to the community level was limited. The qualitative part of this study reflects other studies in different settings, in that SS participants gained immensely from the training. Wider behaviour change is a challenging goal that many programmes fail to attain, with most interventions too limited in scope and intensity to produce larger community effects. This may have contributed to the fact that we observed few differences between interventions and non-intervention villages in this study. However, it is also possible that we had excessive expectations of individual change at the community level, and that it might have been more appropriate to have had broader community level rather than individual behavioural change indicators. We suggest that SS could be enhanced by efforts to better engage existing community opinion leaders, to empower and train participants as community change agents, and to support the development of village-level action plans that combat sexual stereotyping and risky behaviours that lead to unhealthy sexual relationships.

Systematic Review of Inspiratory Muscle Training After Cerebrovascular Accident.

PubMed

Martín-Valero, Rocío; De La Casa Almeida, Maria; Casuso-Holgado, Maria Jesus; Heredia-Madrazo, Alfonso

2015-11-01

This systematic review examines levels of evidence and recommendation grades of various therapeutic interventions of inspiratory muscle training in people who have had a stroke. Benefits from different levels of force and resistance in respiratory muscles are shown in this population. This review was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) directives and was completed in November 2014. The search limits were studies published in English between 2004 and 2014. Relevant studies were searched for in MEDLINE, PEDro, OAIster, Scopus, PsycINFO, Web of Knowledge, CINAHL, SPORTDiscus, DOAJ, Cochrane, Embase, Academic Search Complete, Fuente Académica, and MedicLatina. Initially, 20 articles were identified. After analyzing all primary documents, 14 studies were excluded. Only 6 studies were relevant to this review. Three different types of interventions were found (maximum inspiratory training, controlled training, and nonintervention) in 3 different groups. One specific study compared 3 inspiratory muscle training groups with a group of breathing exercises (diaphragmatic exercises with pursed lips) and a control group. Future long-term studies with larger sample sizes are needed. It is necessary to apply respiratory muscle training as a service of the national health system and to consider its inclusion in the conventional neurological program. Copyright © 2015 by Daedalus Enterprises.

Findings from a prospective cohort study evaluating the effects of International Health Advisors' work on recently settled migrants' health.

PubMed

Lecerof, Susanne Sundell; Stafström, Martin; Emmelin, Maria; Westerling, Ragnar; Östergen, Per-Olof

2017-04-28

Several interventions have been carried out to tackle health inequalities between migrant groups, especially refugees, and native-born European populations. These initiatives are often address language or cultural barriers. One of them is the International Health Advisors (IHA) in Sweden; a peer education intervention aimed at providing health information for recently settled migrants. It is known that social determinants, such as educational level and access to social capital, affect health. Social determinants may also affect how health information is received and transformed into practice. The aims of this study was to a) assess the impact of the IHA on recently settled migrants' self-reported health status, and received health information; b) determine the moderating role of educational level and social capital; and c) critically discuss the outcomes and suggest implications for health promotion practice. The study was designed as a prospective cohort study. A postal questionnaire translated to Arabic was sent to recently settled Iraqi migrants in eight counties in Sweden, in May 2008 and May 2010. Two of the counties were exposed to the intervention, and six were used as references. The proportion of individuals who reported that they had received information on healthy diet and physical exercise was higher in the intervention group than in the non-intervention group (OR 2.31, 95% CI 1.02-5.22), after adjustments. Low social participation was negatively associated with deteriorated or unchanged health needs (OR 0.47, 95% CI 0.24-0.92). No other statistically significant differences in health outcomes could be observed between the groups. No signs of effect modification on this association by social capital or educational level could be found. Health information provided by the IHA increased self-reported level of knowledge on healthy diet and physical exercise. The interpretation of the observed negative association between low social participation and deteriorated or unchanged health needs is that participation was limited to one's own social group, and therefore had limited positive influence on health seeking behaviour. The lack of measurable improvements in health status could be explained by limitations in the study, in the theoretical assumptions underlying the intervention, and in the implementation of the intervention. Further research is needed to understand success factors in health promoting interventions among recently settled migrants better.

Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark.

PubMed

Ronit, Andreas; Haissman, Judith; Kirkegaard-Klitbo, Ditte Marie; Kristensen, Thomas Skårup; Lebech, Anne-Mette; Benfield, Thomas; Gerstoft, Jan; Ullum, Henrik; Køber, Lars; Kjær, Andreas; Kofoed, Klaus; Vestbo, Jørgen; Nordestgaard, Børge; Lundgren, Jens; Nielsen, Susanne Dam

2016-11-26

Modern combination antiretroviral therapy (cART) has improved survival for people living with HIV (PLWHIV). Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity. The Copenhagen comorbidity in HIV-infection (COCOMO) study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS), a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT) angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC), urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases. As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic, clinical and pathophysiological characteristics of comorbidity in PLWHIV may help inform development of new guidelines and enable us to move forward to a more personalized HIV care. ClinicalTrials.gov: NCT02382822 .

Single-site Baseline and Short-term Outcomes of Clinical Characteristics and Life Quality Evaluation of Chinese Wet Age-related Macular Degeneration Patients in Routine Clinical Practice

PubMed Central

Wang, Li-Li; Liu, Wen-Jia; Liu, Hai-Yun; Xu, Xun

2015-01-01

Background: Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss among the older population. In China, treatment of age-related ocular diseases is becoming a priority in eye care services. This study was to investigate the clinical characteristics and quality of life of Chinese patients with wet AMD and current treatment types, to evaluate short-term gains in different treatments, and to investigate associations between visual function and vision-related quality of life (VRQoL). Methods: A prospective, observational, noninterventional study was conducted. Basic data were collected from patients with clinical diagnoses of wet AMD before clinical assessments at baseline. VRQoL was measured with the Chinese version of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). Correlations of the NEI VFQ-25 subscale scores with best-corrected visual acuity (BCVA) and between-group differences were analyzed. Results: A total of 80 wet AMD patients were enrolled, with the mean age of 68.40 years. About one-quarter of wet AMD patients received intravitreal (IVT) ranibizumab treatment, and 67% of them were treated on a pro re nata basis. The visual acuity of patients treated with IVT ranibizumab at month 3 after treatment was significantly increased, whereas patients treated with traditional Chinese medicine achieved no significant improvement. Cronbach's α for the NEI VFQ-25 subscales ranged from 0.697 to 0.843. Eight subscale and overall composite scores were moderately correlated with the BCVA of the better-seeing eye. Significant differences in the overall NEI VFQ-25 scores and other subscales were observed between patients with BCVA in the better-seeing eye of less than 50 letters and the others. Conclusions: Patients treated with IVT ranibizumab experienced better vision improvement at short-term follow-up. The Chinese version of the NEI VFQ-25 is a valid and reliable tool for assessing the VRQoL of Chinese wet AMD patients. PMID:25947396

Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.

PubMed

Rosales, R; Abou Jaoude, E; Al-Arouj, M; Fawwad, A; Orabi, A; Shah, P; DiTommaso, S; Vaz, J; Latif, Z A

2015-06-01

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24 weeks of treatment with vildagliptin with or without metformin. Of 19 331 patients analysed, 3511 received vildagliptin and 15 820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p < 0.0001). Significant reductions in HbA1c from baseline were consistently reported regardless of patient age, body mass index (BMI) or baseline HbA1c. Weight and BMI were also significantly reduced from baseline. Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice. © 2015 John Wiley & Sons Ltd.

Tolerability and efficacy of deferasirox in patients with transfusional iron overload: results from a German 2-year non-interventional study.

PubMed

Nolte, Florian; Nückel, Holger; Schmidt, Burkhard; Geer, Thomas; Rubanov, Oleg; Hebart, Holger; Jarisch, Andrea; Albrecht, Stefan; Johr, Christiane; Schumann, Christiane; Hofmann, Wolf-Karsten

2018-05-14

Iron overload (IOL) due to repetitive transfusions of packed red blood cells (pRBC) has a major impact on morbidity and mortality in patients with inherited bone marrow failure syndromes and hemoglobinopathies such as thalassemia and sickle cell disease. However, whether IOL influences the outcome of elderly patients with myeloid malignancies is not yet clear. Moreover, clinical trials have reported high drop-out rates during treatment with the oral iron chelator deferasirox (DFX). Here we report the results of a 2-year prospective observational study that aimed at describing the routine use of DFX in patients with hematological malignancies with regard to safety, efficacy and handling of the drug in a routine setting. A total of 406 patients were included. 58% of the patients were male. Most of the patients had myelodysplastic syndromes (MDS) (68%) and myeloproliferative neoplasms (MPN) (14%). Median time from first transfusion to study enrollment was 1.1 years (0-25.5 years) and most patients were chelation naive (91%) at enrollment. With regard to transfusion burden, most of the patients were moderately or mildly transfusion-dependent with 53% receiving 2-4 and 27% receiving less than 2 units of pRBC per month. Serum ferritin decreased from a mean of 2305 μg/l (± 1449 μg/l) to a mean of 1910 μg/l (± 1529 μg/l) at 24 months. There was no substantial change in transfusion-dependence during the observation period. Dose adjustments were reported in 48% of the patients with dose-escalation strategies being the most frequent reason for dosage increases (49%). The median observation time was 355 days (5-1080 days). Median duration of exposure to DFX was 322 days (2-1078 days). Two-hundred and ninety (72%) patients discontinued the trial prematurely after a median time of 235 days (1-808 days). Death (29%) and adverse events (23%) were the main reasons for discontinuation. Eleven percent of the patients discontinued treatment due to sufficient decrease in serum ferritin. Most frequent adverse events were decrease in creatinine clearance (22%), increase in serum creatinine (18%) and diarrhea (16%). This descriptive trial confirms the efficacy of DFX in decreasing the serum ferritin. Moreover, the high drop-out rates seen in prospective trials are recapitulated in this study, which can be attributed to adverse events in a substantial proportion of patients.

Medical resource utilization for administration of trastuzumab in a New Zealand oncology outpatient setting: a time and motion study

PubMed Central

North, Richard T; Harvey, Vernon J; Cox, Levonne C; Ryan, Stuart N

2015-01-01

Background In New Zealand, trastuzumab is standard therapy for human epidermal growth factor receptor-2 (HER2)-positive early and metastatic breast cancer. Given the requirement for ongoing adjuvant or maintenance treatment and intravenous (IV) delivery, such a regimen consumes considerable health care resources. The development of a subcutaneous (SC) trastuzumab formulation with a short administration time offers the potential to reduce hospital expenditure. The aim of this study was to determine medical resource utilization associated with administration of trastuzumab SC injection via handheld syringe vs trastuzumab IV infusion in patients with HER2-positive breast cancer in New Zealand. Methods This noninterventional, descriptive study was conducted at the outpatient oncology centers at Auckland City and Tauranga Hospitals. Trained observers recorded times associated with health care professional (HCP) tasks and consumables use associated with preparation and administration of trastuzumab IV or SC in women with early or metastatic breast cancer. The cost for each formulation was calculated as the mean cost of HCP time (based on Pharmaceutical Management Agency hourly rates) plus the mean cost of consumables used. Results Use of trastuzumab SC vs IV reduced mean chair time by 36.95 minutes and total nurse time by 6.12 minutes; there was a 20.45-minute reduction in pharmacist time when the SC formulation was used. After adding consumable costs, the overall estimated saving with trastuzumab SC vs IV was $76.94 (New Zealand dollars) per patient per cycle. Conclusions Compared with trastuzumab IV infusion, administration of trastuzumab via SC injection reduced time spent in the clinic and decreased HCP resources and consumables needed to administer treatment. These reductions could contribute to a decrease in health care costs and an improvement in the efficiency of HER2-positive breast cancer treatment delivery. PMID:26251623

Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice.

PubMed

Yoshizawa, K; Kawai, K; Fujie, M; Suzuki, J; Ogawa, Y; Yajima, T; Yokomori, J

2015-11-01

To evaluate the overall safety profile and clinical effectiveness of tramadol hydrochloride/acetaminophen (TA) combination tablets in Japanese patients with chronic noncancer pain unrelieved by non-opioid drugs for up to 12 weeks in real-world practice. This survey was a multicenter, prospective, longitudinal registry on the use of TA as a newly initiated pain treatment for chronic noncancer pain incurable by non-opioid analgesics that was conducted under the Good Post Marketing Study Practice regulation controlled by the Japan Ministry of Health, Labor and Welfare. Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period. A total of 1316 patients were registered. ADRs were reported in 259 patients (20.5%); most events were nonserious (99.4%), including nausea (n = 87 [6.9%]), constipation (n = 63 [5.0%]), dizziness and somnolence (n = 29 [2.3%] each), and vomiting (n = 21 [1.7%]). No event related to drug dependence or respiratory depression was reported. In addition, 82.8% of patients showed acceptable effectiveness based on PGI at Week 4. Numerical rating scale for intensity of pain and EQ-5D utility scores were improved by -2.7 (SD 2.3) and 0.16 (SD 0.20) at Week 4, respectively, and the improvement was maintained until Week 12. This is a first report to evaluate the risk-benefit profile of TA in Japanese real-world practice using large size registry data. It is suggested that the favorable risk-benefit balance of TA was confirmed for patients with chronic noncancer pain unrelieved by non-opioid drugs in real-world practice. Limitations of this study were those inherent to open-label and non-interventional study designs. This registry survey is registered at umin.ac.jp (identifier: UMIN000015901).

Treatment of hepatitis C virus infection in patients with cirrhosis and predictive value of model for end-stage liver disease: Analysis of data from the Hepa-C registry.

PubMed

Fernández Carrillo, Carlos; Lens, Sabela; Llop, Elba; Pascasio, Juan Manuel; Crespo, Javier; Arenas, Juan; Fernández, Inmaculada; Baliellas, Carme; Carrión, José Antonio; de la Mata, Manuel; Buti, Maria; Castells, Lluís; Albillos, Agustín; Romero, Manuel; Turnes, Juan; Pons, Clara; Moreno-Planas, José María; Moreno-Palomares, José Javier; Fernández-Rodriguez, Conrado; García-Samaniego, Javier; Prieto, Martín; Fernández Bermejo, Miguel; Salmerón, Javier; Badia, Ester; Salcedo, Magdalena; Herrero, José Ignacio; Granados, Rafael; Blé, Michel; Mariño, Zoe; Calleja, José Luis

2017-06-01

Direct-acting antiviral agents (DAAs) are highly effective and well tolerated in patients with chronic hepatitis C virus infection, including those with compensated cirrhosis. However, fewer data are available in patients with more advanced liver disease. Our retrospective, noninterventional, national, multicenter study in patients from the Spanish Hepa-C registry investigated the effectiveness and safety of interferon-free DAA regimens in patients with advanced liver disease, including those with decompensated cirrhosis, in routine practice (all currently approved regimens were registered). Patients transplanted during treatment or within 12 weeks of completing treatment were excluded. Among 843 patients with cirrhosis (Child-Turcotte-Pugh [CTP] class A, n = 564; CTP class B/C, n = 175), 90% achieved sustained virologic response 12 weeks after treatment (SVR12). Significant differences in SVR12 and relapse rates were observed between CTP class A and CTP class B/C patients (94% versus 78%, and 4% versus 14%, respectively; both P < 0.001). Serious adverse events (SAEs) were more common in CTP class B/C versus CTP class A patients (50% versus 12%, respectively; P < 0.001). Incident decompensation was the most common serious adverse event (7% overall). Death rate during the study period was 16/843 (2%), significantly higher among CTP class B/C versus CTP class A patients (6.4% versus 0.9%; P < 0.001). Baseline Model for End-Stage Liver Disease (MELD) score alone (cut-off 18) was the best predictor of survival. Patients with decompensated cirrhosis receiving DAAs present lower response rates and experience more SAEs. In this setting, a MELD score ≥18 may help clinicians to identify those patients with a higher risk of complications and to individualize treatment decisions. (Hepatology 2017;65:1810-1822). © 2017 by the American Association for the Study of Liver Diseases.

Results of a real-world study on vortioxetine in patients with major depressive disorder in South East Asia (REVIDA).

PubMed

Chin, Cheuk Ngen; Zain, Azhar; Hemrungrojn, Solaphat; Ung, Eng Khean; Kwansanit, Patanon; Au Yong, Koon Choong; Chong, Marvin Swee Woon; Inpa, Chalowat; Yen, Teck Hoe; Yeoh, Boon Beng David; Tay, Liam Kai; Bernardo, Carmina; Lim, Lionel Chee-Chong; Yap, Chin Hong; Fones, Calvin; Nayak, Ashwini; Nelleman, Lars

2018-06-14

The REVIDA study aimed to assess the evolution of major depression symptoms in South East Asian (SEA) patients treated with vortioxetine for major depression in real-world clinical practice. This non-interventional study was conducted from August 2016 to April 2017. A total of 138 patients (aged 18-65 years) with an active episode of major depression were recruited from Malaysia, Philippines, Singapore and Thailand. Vortioxetine was initiated on the first visit and patients were followed for 3 months. Depression severity was assessed using the PHQ-9 questionnaire (patient assessed) and CGI-S scale (physician assessed); cognitive function was assessed with the PDQ-D questionnaire; work productivity and activity impairment (WPAI) was assessed with the WPAI questionnaire. At baseline, 89.9% of patients were moderately to severely depressed (PHQ-9 score ≥10). During the 3 month treatment period, mean ± SD PHQ-9 score decreased from 18.7 ± 5.7 to 5.0 ± 5.3, mean ± SD CGI-S score decreased from 4.4 ± 0.7 to 2.2 ± 1.1 and mean ± SD PDQ-D score decreased from 42.1 ± 18.8 to 13.4 ± 13.0. By Month 3, response and remission rates reached 80.8% and 59.0%, respectively. Work productivity loss decreased from 73.6% to 30.5%, while activity impairment decreased from 71.5% to 24.6%. Positive correlations were observed between PHQ-9, PDQ-D, and WPAI work productivity loss and activity impairment. By Month 3, 82.0% of patients were either not depressed or only mildly depressed (PHQ-9 score ≤9). In real-world clinical settings, vortioxetine was effective in reducing depression severity and improving cognitive function and work productivity in SEA patients with major depression.

A systematic review of global cultural variations in knowledge, attitudes and health responses to tuberculosis stigma.

PubMed

Chang, S-H; Cataldo, J K

2014-02-01

Tuberculosis (TB) related stigma is associated with lack of treatment adherence. Individual perceptions of stigma differ by societal context. Limited data are available on variations of TB stigma worldwide. To describe the influence of TB stigma on knowledge, attitudes and responses to TB and to identify similarities and differences across countries. Systematic review of international descriptive studies. A total of 1268 studies were identified from PubMed/Medline, Web of Science, Cochrane, PsycINFO and Cumulative Index to Nursing and Allied Health Literature database searches. Eighty-three studies from 35 countries met the inclusion criteria for English, peer-reviewed, original and non-interventional studies. Variation and similarities in the influence of TB stigma on knowledge, attitudes and responses to TB across countries were identified. Stigma antecedents included negative attitudes and misperceptions regarding the causes of TB and the association with the human immunodeficiency virus. Decisions about illness disclosure and choices between traditional healers and public or private providers were influenced by TB stigma. Sex-influenced perceptions and management of TB and public health responses contributed to TB stigma. Our findings confirm cultural variations with respect to TB and the potential for stigma. Cultural variations should be considered in the development of interventions aimed at reducing stigma and improving treatment adherence.

Creating Well-Being: Increased Creativity and proNGF Decrease following Quadrato Motor Training

PubMed Central

Verdone, Loredana; Pesce, Caterina; Tocci, Nicoletta; Caserta, Micaela; Ben-Soussan, Tal Dotan

2015-01-01

Mind-body practices (MBP) are known to induce electrophysiological and morphological changes, whereas reports related to changes of neurotrophins are surprisingly scarce. Consequently, in the current paper, we focused on the Quadrato motor training (QMT), a newly developed whole-body movement-based MBP, which has been reported to enhance creativity. Here we report the effects of 4 weeks of daily QMT on creativity and proNGF level in two interrelated studies. In Study A, we examined the effects of QMT compared with a walking training (WT) in healthy adults, utilizing the alternate uses task. In contrast with the WT, QMT resulted in increased creativity. In addition, the change in creativity negatively correlated with the change in proNGF levels. In Study B, we examined QMT effects on creativity and additional metacognitive functions in children, using a nonintervention group as control. Similar to Study A, following QMT, we found a negative correlation of proNGF with creativity, as well as working memory updating and planning ability. Together, the current results point to the relationship between increased creativity and decreased proNGF following MBP. Thus, the current research emphasizes the importance of widening the scope of examination of “MBP in motion” in relation to metacognition and well-being. PMID:26137470

Creating Well-Being: Increased Creativity and proNGF Decrease following Quadrato Motor Training.

PubMed

Venditti, Sabrina; Verdone, Loredana; Pesce, Caterina; Tocci, Nicoletta; Caserta, Micaela; Ben-Soussan, Tal Dotan

2015-01-01

Mind-body practices (MBP) are known to induce electrophysiological and morphological changes, whereas reports related to changes of neurotrophins are surprisingly scarce. Consequently, in the current paper, we focused on the Quadrato motor training (QMT), a newly developed whole-body movement-based MBP, which has been reported to enhance creativity. Here we report the effects of 4 weeks of daily QMT on creativity and proNGF level in two interrelated studies. In Study A, we examined the effects of QMT compared with a walking training (WT) in healthy adults, utilizing the alternate uses task. In contrast with the WT, QMT resulted in increased creativity. In addition, the change in creativity negatively correlated with the change in proNGF levels. In Study B, we examined QMT effects on creativity and additional metacognitive functions in children, using a nonintervention group as control. Similar to Study A, following QMT, we found a negative correlation of proNGF with creativity, as well as working memory updating and planning ability. Together, the current results point to the relationship between increased creativity and decreased proNGF following MBP. Thus, the current research emphasizes the importance of widening the scope of examination of "MBP in motion" in relation to metacognition and well-being.

A balanced intervention ladder: promoting autonomy through public health action.

PubMed

Griffiths, P E; West, C

2015-08-01

The widely cited Nuffield Council on Bioethics 'Intervention Ladder' structurally embodies the assumption that personal autonomy is maximized by non-intervention. Consequently, the Intervention Ladder encourages an extreme 'negative liberty' view of autonomy. Yet there are several alternative accounts of autonomy that are both arguably superior as accounts of autonomy and better suited to the issues facing public health ethics. We propose to replace the one-sided ladder, which has any intervention coming at a cost to autonomy, with a two-sided 'Balanced Intervention Ladder,' where intervention can either enhance or diminish autonomy. We show that not only the alternative, richer accounts of autonomy but even Mill's classic version of negative liberty puts some interventions on the positive side of the ladder. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Medical resource utilisation and cost of care for women seeking treatment for urinary incontinence in an outpatient setting. Examples from three countries participating in the PURE study.

PubMed

Papanicolaou, Sotiria; Pons, Montserrat Espuna; Hampel, Christian; Monz, Brigitta; Quail, Deborah; Schulenburg, Matthias Graf von der; Wagg, Adrian; Sykes, David

2005-11-30

To describe the medical resource use and direct costs of treatment for women with urinary incontinence (UI) in European countries. PURE is a non-interventional, observational study of patients seeking treatment for UI in an outpatient setting. Investigators being either general practitioners (GPs) and/or specialists, i.e. urologists and gynaecologists, in 14 European countries participated in PURE. The results for medical resource use and cost of treatment in Germany, Spain and the UK/Ireland recorded retrospectively at the enrolment visit for the preceding 12 months are presented here. Treatment-seeking women aged over 18 years who were under treatment or seeking treatment for UI, and who presented within the normal course of care for UI were enrolled in the 6 months study. Information on the incontinence resource use was gathered on standard data collection forms. The direct medical costs were calculated by attaching the unit costs from the perspective of the relevant health insurance in each country to the country-specific resource use. Furthermore, the contribution of patients to the costs of pads, or any treatment for UI was assessed. Variation in medical resource use and cost of treatment between the three countries was observed, reflective of the differences in the healthcare systems and whether specialists and/or GPs provided the care. We found that women in Spain and Germany are more likely to have consulted a specialist for their UI symptoms, which had implications for utilisation of diagnostic procedures. Conservative treatment, particularly pelvis floor muscle exercises, was more common in patients in the UK/Ireland treated in primary care by GPs. In all three countries most of the women had used protective pads, which more than half the patients paying for them out-of-pocket, despite potential healthcare reimbursement schemes. Mean total UI-related costs per year ranged from 359 in the UK/Ireland for patients predominantly treated in the GP setting to 515 in Germany and 655 in Spain for patients treated by specialists and GPs. Our study provides an estimation of resource use and costs associated with UI in treatment-seeking European women, exemplified here in three countries.

Estimation of direct medical cost related to the management of chronic hepatitis C and its complications in South Korea.

PubMed

Kim, Do Young; Yoon, Ki Tae; Kim, Won; Lee, Jung Il; Hong, Sung Hwi; Lee, Danbi; Jang, Jeong Won; Choi, Jong Won; Kim, Ilsu; Paik, Yong Han

2016-07-01

This study aimed to estimate the direct medical costs of managing chronic hepatitis C (CHC) and its complications based on health-care resources in South Korea. The study design was multicenter, retrospective, non-interventional, and observational. Between September 2013 and April 2014, health-care resource data from patients chronically infected with hepatitis C virus, regardless of genotype, were collected from 8 institutions, including data related to outpatient management, emergency care, and hospitalization. The observation period was between January 2011 and December 2012. The disease state was classified as CHC, compensated cirrhosis (CC), decompensated cirrhosis (DC), or hepatocellular carcinoma (HCC). A total of 445 patients were recruited and mean age was 60.1 ± 12.3 years. Among 155 patients with reported outcomes of antiviral therapy, 107 (69%) had sustained virologic response (SVR). The rate of patients who did not receive antiviral therapy was 52.8% (n = 235). The distribution of disease state was CHC in 307 patients (69.0%), CC in 75 (16.9%), HCC in 45 (10.1%), and DC in 18 (4.0%). All direct medical costs, whether reimbursed or nonreimbursed by the National Health Insurance System, were included. After excluding patients whose observational period was <1 month for each disease status, the mean costs per month increased as disease state progressed (CHC: 77 ± 80 USD; CC: 98 ± 94 USD; DC: 512 ± 1115 USD; HCC: 504 ± 717 USD). The mean total costs per person were 3590 ± 8783 USD, and approximately 72% of patients were reimbursed. When 44 patients with an observation period <1 month were excluded, the mean medical costs per month for patients with CHC who achieved SVR (n = 69) were significantly lower than for those (n = 215) who did not (42 ± 16 vs 79 ± 83 USD, P < 0.001). The cost also tended to be lower for patients with CC with SVR (n = 8) than for those without SVR (n = 70; 48 ± 20 vs 95 ± 96 USD, P = 0.177). The cost of antiviral therapy (pegylated interferon and ribavirin) corresponded to 19.0% of total medical costs and 53.7% of prescription/pharmacy. The direct medical costs increased as disease state progressed from CHC to cirrhosis or HCC. The achievement of SVR by antiviral therapy would decrease the costs.

Estimation of direct medical cost related to the management of chronic hepatitis C and its complications in South Korea

PubMed Central

Kim, Do Young; Yoon, Ki Tae; Kim, Won; Lee, Jung Il; Hong, Sung Hwi; Lee, Danbi; Jang, Jeong Won; Choi, Jong Won; Kim, Ilsu; Paik, Yong Han

2016-01-01

Abstract Background: This study aimed to estimate the direct medical costs of managing chronic hepatitis C (CHC) and its complications based on health-care resources in South Korea. Methods: The study design was multicenter, retrospective, non-interventional, and observational. Between September 2013 and April 2014, health-care resource data from patients chronically infected with hepatitis C virus, regardless of genotype, were collected from 8 institutions, including data related to outpatient management, emergency care, and hospitalization. The observation period was between January 2011 and December 2012. The disease state was classified as CHC, compensated cirrhosis (CC), decompensated cirrhosis (DC), or hepatocellular carcinoma (HCC). Results: A total of 445 patients were recruited and mean age was 60.1 ± 12.3 years. Among 155 patients with reported outcomes of antiviral therapy, 107 (69%) had sustained virologic response (SVR). The rate of patients who did not receive antiviral therapy was 52.8% (n = 235). The distribution of disease state was CHC in 307 patients (69.0%), CC in 75 (16.9%), HCC in 45 (10.1%), and DC in 18 (4.0%). All direct medical costs, whether reimbursed or nonreimbursed by the National Health Insurance System, were included. After excluding patients whose observational period was <1 month for each disease status, the mean costs per month increased as disease state progressed (CHC: 77 ± 80 USD; CC: 98 ± 94 USD; DC: 512 ± 1115 USD; HCC: 504 ± 717 USD). The mean total costs per person were 3590 ± 8783 USD, and approximately 72% of patients were reimbursed. When 44 patients with an observation period <1 month were excluded, the mean medical costs per month for patients with CHC who achieved SVR (n = 69) were significantly lower than for those (n = 215) who did not (42 ± 16 vs 79 ± 83 USD, P < 0.001). The cost also tended to be lower for patients with CC with SVR (n = 8) than for those without SVR (n = 70; 48 ± 20 vs 95 ± 96 USD, P = 0.177). The cost of antiviral therapy (pegylated interferon and ribavirin) corresponded to 19.0% of total medical costs and 53.7% of prescription/pharmacy. Conclusion: The direct medical costs increased as disease state progressed from CHC to cirrhosis or HCC. The achievement of SVR by antiviral therapy would decrease the costs. PMID:27472670

The asthma ePrompt: a novel electronic solution for chronic disease management.

PubMed

Lim, Kaiser G; Rank, Matthew A; Cabanela, Rosa L; Furst, Joseph W; Rohrer, James E; Liesinger, Juliette; Muller, Lisa; Wagie, Amy E; Naessens, James M

2012-03-01

This study tested the ability of an electronic prompt to promote an asthma assessment during primary care visits. We performed a prospective study of all eligible adult patients with previously diagnosed asthma in three geographically distinct ambulatory family medicine clinics within a 4-month period. The usual clinic visit process was performed at two geographically distinct control sites (n = 75 and n = 55 patients, respectively). The intervention group site (n = 64) had an electronic flag embedded in the Patient Check-in Locator field which prompted the distribution of a self-administered Asthma Management Questionnaire (AMQ) in the waiting room. The primary outcome measure was a documented asthma severity assessment. The front desk distributed the AMQ successfully in 100% of possible opportunities and the AMQ was completed by 84% of patients. Providers in the intervention group were significantly more likely than providers in the two non-intervention groups to document asthma severity in the medical record during a non-asthma ambulatory clinic visit (63.3% vs. 18.7% vs. 3.6%; p < .001). The provision of standardized asthma information triggered by an electronic prompt at the time of check-in effectively initiates an asthma assessment during the primary care visits.

Rapid Assessment of Ecosystem Services Provided by Two Mineral Extraction Sites Restored for Nature Conservation in an Agricultural Landscape in Eastern England

PubMed Central

Blaen, Phillip J.; Jia, Li; Peh, Kelvin S.-H.; Field, Rob H.; Balmford, Andrew; MacDonald, Michael A.; Bradbury, Richard B.

2015-01-01

Despite growing recognition that mineral sites restored for nature conservation can enhance local biodiversity, the wider societal benefits provided by this type of restoration relative to alternative options are not well understood. This study addresses this research gap by quantifying differences in ecosystem services provision under two common mineral site after-uses: nature conservation and agriculture. Using a combination of site-specific primary field data, benefits transfer and modelling, we show that for our sites restoration for nature conservation provides a more diverse array of ecosystem services than would be delivered under an agricultural restoration scenario. We also explore the effects of addressing different conservation targets, which we find alter the provision of ecosystem services on a service-specific basis. Highly species-focused intervention areas are associated with increased carbon storage and livestock grazing provision, whereas non-intervention areas are important for carbon sequestration, fishing, recreation and flood risk mitigation. The results of this study highlight the wider societal importance of restored mineral sites and may help conservation managers and planners to develop future restoration strategies that provide benefits for both biodiversity and human well-being. PMID:25894293

Rapid assessment of ecosystem services provided by two mineral extraction sites restored for nature conservation in an agricultural landscape in eastern England.

PubMed

Blaen, Phillip J; Jia, Li; Peh, Kelvin S-H; Field, Rob H; Balmford, Andrew; MacDonald, Michael A; Bradbury, Richard B

2015-01-01

Despite growing recognition that mineral sites restored for nature conservation can enhance local biodiversity, the wider societal benefits provided by this type of restoration relative to alternative options are not well understood. This study addresses this research gap by quantifying differences in ecosystem services provision under two common mineral site after-uses: nature conservation and agriculture. Using a combination of site-specific primary field data, benefits transfer and modelling, we show that for our sites restoration for nature conservation provides a more diverse array of ecosystem services than would be delivered under an agricultural restoration scenario. We also explore the effects of addressing different conservation targets, which we find alter the provision of ecosystem services on a service-specific basis. Highly species-focused intervention areas are associated with increased carbon storage and livestock grazing provision, whereas non-intervention areas are important for carbon sequestration, fishing, recreation and flood risk mitigation. The results of this study highlight the wider societal importance of restored mineral sites and may help conservation managers and planners to develop future restoration strategies that provide benefits for both biodiversity and human well-being.

Carbohydrates as a cerebral metabolic fuel.

PubMed

Evans, M; Amiel, S A

1998-03-01

The human brain is an extremely active metabolic organ with little endogenous stores of energy. It is thus dependent on circulating glucose to fuel metabolism and support cognitive functioning. However there is growing evidence that the human brain is able to utilise other non-glucose fuels during times of glucose lack. We review the evidence for the potential of the human brain to use the alternate fuels lactate and beta-hydroxybutyrate, and some recent studies examining the ability of regions of brain to use non-glucose lipid fuels. The human brain does not seem to have the ability to use the gluconeogenic precursor alanine to any significant degree. Regionality within the brain can be examined in vivo by the use of positron emission tomography, which offers the exciting prospect of studying human brain metabolism in vivo using a simple and non-interventional technique. Increased understanding of the brain's metabolism, the way in which hypoglycaemia is recognised and the manner in which this can be altered in the syndrome of hypoglycaemia unawareness and deficient counterregulation will help develop further strategies to prevent the clinical problems associated with hypoglycaemia in insulin-dependent diabetic adults and children.

Feasibility of in utero telemetric fetal ECG monitoring in a lamb model.

PubMed

Hermans, Bart; Lewi, Liesbeth; Jani, Jacques; De Buck, Frederik; Deprest, Jan; Puers, Robert

2008-01-01

If fetal ECG (fECG) devices could be miniaturized sufficiently, one could consider their implantation at the time of fetal surgery to allow permanent monitoring of the fetus and timely intervention in the viable period. We set up an experiment to evaluate the feasibility of in utero direct fECG monitoring and telemetric transmission using a small implantable device in a lamb model. A 2-lead miniature ECG sensor (volume 1.9 cm(3); weight 3.9 g) was subcutaneously implanted in 2 fetal lambs at 122 days gestation (range 119-125; term 145 days). The ECG sensor can continuously register and transmit fECG. The signal is captured by an external receiving antenna taped to the maternal abdominal wall. We developed dedicated software running on a commercial laptop for on-line analysis of the transmitted fECG signal. This was a noninterventional study, i.e. daily readings of the fECG signal were done without clinical consequences to the observations. fECG could be successfully registered, transmitted by telemetry and analyzed from the moment of implantation till term birth in one case (24 days). In the second case, unexplained in utero fetal death occurred 12 days after implantation. In this subject, agonal fECG changes were recorded. An implanted miniature (<2 ml) ECG sensor can be used to retrieve, process and transmit continuously a qualitative fECG signal in third-trimester fetal lambs. The telemetric signal could be picked up by an external antenna located within a 20-cm range. In this experiment, this was achieved through taping the external receiver to the maternal abdomen. Any acquired signal could be transmitted to a commercially available laptop that could perform on-line analysis of the signal. (c) 2008 S. Karger AG, Basel.

Glycemic Control Over 5 Years in 4,900 People With Type 2 Diabetes

PubMed Central

Best, James D.; Drury, Paul L.; Davis, Timothy M.E.; Taskinen, Marja-Riitta; Kesäniemi, Y. Antero; Scott, Russell; Pardy, Christopher; Voysey, Merryn; Keech, Anthony C.

2012-01-01

OBJECTIVE Glycemic control in type 2 diabetes generally worsens over time, requiring intensification of therapy. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial provided the opportunity to observe glycemic control in a real-world setting. We assessed the adequacy of metformin, sulfonylureas, and insulin to maintain glycemic control and their effects on weight. RESEARCH DESIGN AND METHODS Diabetes control was measured at baseline and yearly for a median of 5 years in the 4,900 patients from the nonintervention arm of this study allocated to placebo. RESULTS Median HbA1c was 6.9% at baseline and increased by an average of 0.22% over 5 years (P < 0.001). Median weight was 86.3 kg at baseline and decreased by 0.4 kg over 5 years (P = 0.002). Baseline therapy was lifestyle measures only in 27%, oral agents without insulin in 59%, and insulin in 14% (7% also taking oral agents). Over 5 years, insulin use increased to 32% (21% also taking oral agents). Use of oral agents remained similar at 56%. Only 2% of patients at baseline and 4% after 5 years were taking oral agents other than metformin or sulfonylureas. Initiation of insulin therapy in 855 patients produced a sustained reduction of HbA1c from a median of 8.2 to 7.7%, with a weight gain of 4.6 kg over 5 years. CONCLUSIONS With intensification of traditional therapies, glycemic control deteriorated very little over 5 years in a large cohort of type 2 diabetes. However, the requirement for insulin therapy doubled, at the expense of significant weight gain and risk of hypoglycemia. PMID:22432105

Analysis of contemporary HIV/AIDS health care costs in Germany

PubMed Central

Treskova, Marina; Kuhlmann, Alexander; Bogner, Johannes; Hower, Martin; Heiken, Hans; Stellbrink, Hans-Jürgen; Mahlich, Jörg; von der Schulenburg, Johann-Matthias Graf; Stoll, Matthias

2016-01-01

Abstract To analyze contemporary costs of HIV health care and the cost distribution across lines of combination antiretroviral therapy (cART). To identify variations in expenditures with patient characteristics and to identify main cost determinants. To compute cost ratios between patients with varying characteristics. Empirical data on costs are collected in Germany within a 2-year prospective observational noninterventional multicenter study. The database contains information for 1154 HIV-infected patients from 8 medical centers. Means and standard deviations of the total costs are estimated for each cost fraction and across cART lines and regimens. The costs are regressed against various patient characteristics using a generalized linear model. Relative costs are calculated using the resultant coefficients. The average annual total costs (SD) per patient are €22,231.03 (8786.13) with a maximum of €83,970. cART medication is the major cost fraction (83.8%) with a mean of €18,688.62 (5289.48). The major cost-driving factors are cART regimen, CD4-T cell count, cART drug resistance, and concomitant diseases. Viral load, pathology tests, and demographics have no significant impact. Standard non-nucleoside reverse transcriptase inhibitor-based regimens induce 28% lower total costs compared with standard PI/r regimens. Resistance to 3 or more antiretroviral classes induces a significant increase in costs. HIV treatment in Germany continues to be expensive. Majority of costs are attributable to cART. Main cost determinants are CD4-T cells count, comorbidity, genotypic antiviral resistance, and therapy regimen. Combinations of characteristics associated with higher expenditures enhance the increasing effect on the costs and induce high cost cases. PMID:27367993

Strong Communities for Children: Results of a multi-year community-based initiative to protect children from harm.

PubMed

McDonell, James R; Ben-Arieh, Asher; Melton, Gary B

2015-03-01

This article reports the evaluation results from Strong Communities for Children, a multi-year comprehensive community-based initiative to prevent child maltreatment and improve children's safety. The outcome study consisted of a survey of a random sample of caregivers of children under age 10 in the Strong Communities service area and a set of comparison communities matched at the block group level on demography. Survey data were collected in two waves 4 years apart. Data were collected on (a) perceptions of the neighborhood and neighbors (e.g., neighboring, collective efficacy), (b) perceptions of neighbors' parenting practices, (c) parental attitudes and beliefs (e.g., parental stress; parental efficacy), and (d) self-reported parenting practices. The survey data were supplemented by data on substantiated reported rates of child abuse and neglect per 1,000 children and ICD-9 coded child injuries suggesting child abuse and neglect per 1,000 children. Compared to the non-intervention sample across time, the Strong Communities samples showed significant changes in the expected direction for social support, collective efficacy, child safety in the home, observed parenting practices, parental stress, parental efficacy, self-reported parenting practices, rates of officially substantiated child maltreatment, and rates of ICD-9 coded child injuries suggesting child maltreatment. These promising results, obtained through multiple methods of evaluation, confirm that a community mobilization strategy can shift norms of parents' care for their children and neighbors' support for one another, so that young children are safer at home and in the community. Replications should be undertaken and evaluated in other communities under diverse auspices. Copyright © 2014 Elsevier Ltd. All rights reserved.

Exposure to foods' non-taste sensory properties. A nursery intervention to increase children's willingness to try fruit and vegetables.

PubMed

Dazeley, Paul; Houston-Price, Carmel

2015-01-01

Activities that engage young children with the sensory properties of foods are popular with nursery schools, despite the lack of evidence for their efficacy in increasing children's consumption of healthy foods. This study provides the first empirical exploration of the effectiveness of a non-taste sensory activity program in a nursery school setting. Ninety-two children aged between 12 and 36 months were allocated either to an intervention group, who took part in looking, listening, feeling and smelling activities with unusual fruits and vegetables every day for 4 weeks, or to a non-intervention control group. In a subsequent mealtime taste test, children touched and tasted more of the vegetables to which they had been familiarized in their playtime activities than of a matched set of non-exposed foods. The results demonstrate that hands-on activities with unfamiliar fruits and vegetables can enhance children's willingness to taste these foods, and confirm the potential for such activities to support healthy eating initiatives. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Parenting and childhood obesity research: a quantitative content analysis of published research 2009-2015.

PubMed

Gicevic, S; Aftosmes-Tobio, A; Manganello, J A; Ganter, C; Simon, C L; Newlan, S; Davison, K K

2016-08-01

A quantitative content analysis of research on parenting and childhood obesity was conducted to describe the recent literature and to identify gaps to address in future research. Studies were identified from multiple databases and screened according to an a priori defined protocol. Eligible studies included non-intervention studies, published in English (January 2009-December 2015) that focused on parenting and childhood obesity and included parent participants. Studies eligible for inclusion (N = 667) focused on diet (57%), physical activity (23%) and sedentary behaviours (12%). The vast majority of studies used quantitative methods (80%) and a cross-sectional design (86%). Few studies focused exclusively on fathers (1%) or included non-residential (1%), non-biological (4%), indigenous (1%), immigrant (7%), ethnic/racial minority (15%) or low-socioeconomic status (19%) parents. While results illustrate that parenting in the context of childhood obesity is a robust, global and multidisciplinary area of inquiry, it is also evident that the vast majority of studies are conducted among Caucasian, female, biological caregivers living in westernized countries. Expansion of study foci and design is recommended to capture a wider range of caregiver types and obesity-related parenting constructs, improve the validity and generalizability of findings and inform the development of culture-specific childhood obesity prevention interventions and policies. © 2016 World Obesity. © 2016 World Obesity.

Trends of fruit and vegetable availability in neighbourhoods in Albany, NY, USA, 2003-2012.

PubMed

Hosler, Akiko S; Kammer, Jamie R

2015-02-01

To investigate a 9-year trend of fresh fruit and vegetable availability and factors associated with the net availability change in two contrasting neighbourhoods. Longitudinal design. Data were collected in 2003, 2009 and 2012 through in-store observations. Fresh fruit and vegetable availability was presented by weight-adjusted counts of stores having designated varieties per 10 000 population. A low-income minority neighbourhood and an adjacent middle-income racially mixed neighbourhood in Albany, NY, USA. These neighbourhoods became sites of fresh produce interventions after baseline data were collected. A total of 111, 128 and 146 eligible food stores in respective years. Fresh fruit availability (two or more varieties) increased in both neighbourhoods. Inventory expansion of existing stores and the convenience store intervention contributed to the significant increase (P for trend=0·04) of fresh fruit availability in the minority neighbourhood. Although not statistically significant (P>0·05), the availability of two or more dark-coloured fresh vegetables also increased in the mixed neighbourhood, but declined slightly in the minority neighbourhood. The secular (non-intervention) fresh vegetable availability rate ratio by neighbourhood reached 3·0 in 2012 (P<0·01). The net decline of fresh vegetable availability in the minority neighbourhood was primarily attributed to inventory reduction of existing stores. Longitudinal observations revealed narrowed neighbourhood disparities of fresh fruit availability and widened gaps of fresh vegetable availability. Inventory shifts of existing stores impacted the net availability change more profoundly than store opening or closing in the minority neighbourhood. Findings support increasing the programme capacity of the convenience store intervention to address the fresh vegetable disparity.

Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.

PubMed

Lammerich, Andreas; Balcke, Peter; Bias, Peter; Mangold, Simone; Wiesholzer, Martin

2016-02-01

The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia. In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or end-stage renal disease and receiving epoetin theta were followed up for 6 months. Data on reportable adverse events (RAEs) (cardiac disorders, cardiac failure, myocardial infarction, and ischemic stroke and respective subterms), epoetin theta dosage, and Hb concentrations were collected. A post hoc exploratory analysis assessed the incidences of RAEs according to tertiles for individual mean Hb concentration (≤10.7, >10.7-11.47, and >11.47 g/dL for low, intermediate, and high, respectively) and mean weekly epoetin theta dosage (≤62, >62-125, and >125 IU/kg/wk for low, intermediate, and high). Data from 1039 patients were included (577 men, 462 women; mean age, 68.7 years). A total of 101 RAEs were documented in 89 patients (8.6%), for an event rate of 0.1985/person-year. Sixty-four patients (6.1%) died; none of the deaths was considered related to epoetin theta use. The incidence of RAEs was lowest at intermediate Hb concentrations (6.2%) compared with low (11.3%) and high (7.8%) Hb concentrations. The incidence of ischemic stroke was 1.5% at high Hb concentrations versus 0.6% at both the low and intermediate Hb concentrations. The incidence of any RAE was greater in the high-dose group (10.1%) than in the intermediate-dose (8.0%) and low-dose (7.6%) groups. The risk for any cardiovascular RAE or ischemic stroke was greatest in the high-dose/high-Hb group (13.3%), followed by high dose/low Hb (12.6%) and low dose/low Hb (12.1%). The risks for RAEs were lowest at high dose/intermediate Hb (3.8%) and low dose/intermediate Hb (5.3%). The event rate of adverse drug reactions other than the predefined RAEs was 0.0161/person-year. No cases of pure red cell aplasia were reported. The findings from the present study suggest that, for maintaining the optimal target Hb concentration (10-12 g/dL according to the current summary of product characteristics for epoetin theta; 10-11.5 g/dL according to the current guideline from Kidney Disease Improving Global Outcomes) in anemic adults with CKD, the lowest approved, effective dose epoetin theta should be used. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Assessing the performance of maternity care in Europe: a critical exploration of tools and indicators.

PubMed

Escuriet, Ramón; White, Joanna; Beeckman, Katrien; Frith, Lucy; Leon-Larios, Fatima; Loytved, Christine; Luyben, Ans; Sinclair, Marlene; van Teijlingen, Edwin

2015-11-02

This paper critically reviews published tools and indicators currently used to measure maternity care performance within Europe, focusing particularly on whether and how current approaches enable systematic appraisal of processes of minimal (or non-) intervention in support of physiological or "normal birth". The work formed part of COST Actions IS0907: "Childbirth Cultures, Concerns, and Consequences: Creating a dynamic EU framework for optimal maternity care" (2011-2014) and IS1405: Building Intrapartum Research Through Health - an interdisciplinary whole system approach to understanding and contextualising physiological labour and birth (BIRTH) (2014-). The Actions included the sharing of country experiences with the aim of promoting salutogenic approaches to maternity care. A structured literature search was conducted of material published between 2005 and 2013, incorporating research databases, published documents in english in peer-reviewed international journals and indicator databases which measured aspects of health care at a national and pan-national level. Given its emergence from two COST Actions the work, inevitably, focused on Europe, but findings may be relevant to other countries and regions. A total of 388 indicators were identified, as well as seven tools specifically designed for capturing aspects of maternity care. Intrapartum care was the most frequently measured feature, through the application of process and outcome indicators. Postnatal and neonatal care of mother and baby were the least appraised areas. An over-riding focus on the quantification of technical intervention and adverse or undesirable outcomes was identified. Vaginal birth (no instruments) was occasionally cited as an indicator; besides this measurement few of the 388 indicators were found to be assessing non-intervention or "good" or positive outcomes more generally. The tools and indicators identified largely enable measurement of technical interventions and undesirable health (or pathological medical) outcomes. A physiological birth generally necessitates few, or no, interventions, yet most of the indicators presently applied fail to capture (a) this phenomenon, and (b) the relationship between different forms and processes of care, mode of birth and good or positive outcomes. A need was identified for indicators which capture non-intervention, reflecting the reality that most births are low-risk, requiring few, if any, technical medical procedures.

Fetal nasal bone length in the second trimester: comparison between population groups from different ethnic origins.

PubMed

Papasozomenou, Panayiota; Athanasiadis, Apostolos P; Zafrakas, Menelaos; Panteris, Eleftherios; Loufopoulos, Aristoteles; Assimakopoulos, Efstratios; Tarlatzis, Basil C

2016-03-01

To compare normal ranges of ultrasonographically measured fetal nasal bone length in the second trimester between different ethnic groups. A prospective, non-interventional study in order to establish normal ranges of fetal nasal bone length in the second trimester in a Greek population was conducted in 1220 singleton fetuses between 18 completed weeks and 23 weeks and 6 days of gestation. A literature search followed in order to identify similar studies in different population groups. Fetal nasal bone length mean values and percentiles from different population groups were compared. Analysis of measurements in the Greek population showed a linear association, i.e., increasing nasal bone length with increasing gestational age from 5.73 mm at 18 weeks to 7.63 mm at 23 weeks. Eleven studies establishing normal ranges of fetal nasal bone length in the second trimester were identified. Comparison of fetal nasal bone length mean values between the 12 population groups showed statistically significant differences (P<0.0001). Normal ranges of fetal nasal bone length in the second trimester vary significantly between different ethnic groups. Hence, distinct ethnic nomograms of fetal nasal bone length in the second trimester should be used in a given population rather than an international model.

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Reasons to love life. Effects of a suicide-awareness campaign on the utilization of a telephone emergency line in Austria.

PubMed

Till, Benedikt; Sonneck, Gernot; Baldauf, Gerhard; Steiner, Elise; Niederkrotenthaler, Thomas

2013-01-01

A suicide awareness campaign was initiated in the Austrian federal state of Styria to increase help-seeking behavior in the population. Billboards were shown throughout Styria depicting joyful everyday-life situations with a focus on social and family connectedness, and promoting the Telephone Emergency Service, a crisis hotline. The present study investigated the impact of this campaign on the utilization of the crisis hotline and on suicide rates. Phone calls and suicide rates in the study region 3 months before the campaign were compared with rates 3 months after the campaign. The changes were contrasted with the characteristics of phone calls and the suicide rate in a comparable control region. There were significantly more phone calls in the study region after the awareness campaign compared to the control region, which was similar to seasonal trends in nonintervention years, and there was no increase of suicide-related phone calls. The proportion of suicide-related phone calls referring to family problems decreased after the initiation of the campaign. Suicide rates did not change. The campaign may have had some minor immediate impact on the utilization of the Telephone Emergency Service, but it did not seem to motivate suicidal individuals, especially those with family problems, to call.

Teleexercise for Persons With Spinal Cord Injury: A Mixed-Methods Feasibility Case Series.

PubMed

Lai, Byron; Rimmer, James; Barstow, Beth; Jovanov, Emil; Bickel, C Scott

2016-07-14

Spinal cord injury (SCI) results in significant loss of function below the level of injury, often leading to restricted participation in community exercise programs. To overcome commonly experienced barriers to these programs, innovations in technology hold promise for remotely delivering safe and effective bouts of exercise in the home. To test the feasibility of a remotely delivered home exercise program for individuals with SCI as determined by (1) implementation of the intervention in the home; (2) exploration of the potential intervention effects on aerobic fitness, physical activity behavior, and subjective well-being; and (3) acceptability of the program through participant self-report. Four adults with SCI (mean age 43.5 [SD 5.3] years; 3 males, 1 female; postinjury 25.8 [SD 4.3] years) completed a mixed-methods sequential design with two phases: an 8-week intervention followed by a 3-week nonintervention period. The intervention was a remotely delivered aerobic exercise training program (30-45 minutes, 3 times per week). Instrumentation included an upper body ergometer, tablet, physiological monitor, and custom application that delivered video feed to a remote trainer and monitored and recorded exercise data in real time. Implementation outcomes included adherence, rescheduled sessions, minutes of moderate exercise, and successful recording of exercise data. Pre/post-outcomes included aerobic capacity (VO 2 peak), the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD), the Satisfaction with Life Scale (SWLS), and the Quality of Life Index modified for spinal cord injury (QLI-SCI). Acceptability was determined by participant perceptions of the program features and impact, assessed via qualitative interview at the end of the nonintervention phase. Participants completed all 24 intervention sessions with 100% adherence. Out of 96 scheduled training sessions for the four participants, only 8 (8%) were makeup sessions. The teleexercise system successfully recorded 85% of all exercise data. The exercise program was well tolerated by all participants. All participants described positive outcomes as a result of the intervention and stated that teleexercise circumvented commonly reported barriers to exercise participation. There were no reported adverse events and no dropouts. A teleexercise system can be a safe and feasible option to deliver home-based exercise for persons with SCI. Participants responded favorably to the intervention and valued teleexercise for its ability to overcome common barriers to exercise. Study results are promising but warrant further investigation in a larger sample. ©Byron Lai, James Rimmer, Beth Barstow, Emil Jovanov, C Scott Bickel. Originally published in JMIR Rehabilitation and Assistive Technology (http://rehab.jmir.org), 14.07.2016.

Teleexercise for Persons With Spinal Cord Injury: A Mixed-Methods Feasibility Case Series

PubMed Central

Lai, Byron; Rimmer, James; Barstow, Beth; Jovanov, Emil

2016-01-01

Background Spinal cord injury (SCI) results in significant loss of function below the level of injury, often leading to restricted participation in community exercise programs. To overcome commonly experienced barriers to these programs, innovations in technology hold promise for remotely delivering safe and effective bouts of exercise in the home. Objective To test the feasibility of a remotely delivered home exercise program for individuals with SCI as determined by (1) implementation of the intervention in the home; (2) exploration of the potential intervention effects on aerobic fitness, physical activity behavior, and subjective well-being; and (3) acceptability of the program through participant self-report. Methods Four adults with SCI (mean age 43.5 [SD 5.3] years; 3 males, 1 female; postinjury 25.8 [SD 4.3] years) completed a mixed-methods sequential design with two phases: an 8-week intervention followed by a 3-week nonintervention period. The intervention was a remotely delivered aerobic exercise training program (30-45 minutes, 3 times per week). Instrumentation included an upper body ergometer, tablet, physiological monitor, and custom application that delivered video feed to a remote trainer and monitored and recorded exercise data in real time. Implementation outcomes included adherence, rescheduled sessions, minutes of moderate exercise, and successful recording of exercise data. Pre/post-outcomes included aerobic capacity (VO2 peak), the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD), the Satisfaction with Life Scale (SWLS), and the Quality of Life Index modified for spinal cord injury (QLI-SCI). Acceptability was determined by participant perceptions of the program features and impact, assessed via qualitative interview at the end of the nonintervention phase. Results Participants completed all 24 intervention sessions with 100% adherence. Out of 96 scheduled training sessions for the four participants, only 8 (8%) were makeup sessions. The teleexercise system successfully recorded 85% of all exercise data. The exercise program was well tolerated by all participants. All participants described positive outcomes as a result of the intervention and stated that teleexercise circumvented commonly reported barriers to exercise participation. There were no reported adverse events and no dropouts. Conclusion A teleexercise system can be a safe and feasible option to deliver home-based exercise for persons with SCI. Participants responded favorably to the intervention and valued teleexercise for its ability to overcome common barriers to exercise. Study results are promising but warrant further investigation in a larger sample. PMID:28582252

Nutritional status in older persons according to healthcare setting: A systematic review and meta-analysis of prevalence data using MNA®.

PubMed

Cereda, Emanuele; Pedrolli, Carlo; Klersy, Catherine; Bonardi, Chiara; Quarleri, Lara; Cappello, Silvia; Turri, Annalisa; Rondanelli, Mariangela; Caccialanza, Riccardo

2016-12-01

Old persons are more likely to suffer from malnutrition, which may result in higher dependency in activities of daily living. We aimed to provide a quantitative synthesis of prevalence data on malnutrition and its risk as assessed by the Mini Nutritional Assessment across different healthcare settings. The association between nutritional status and setting-related level of dependence was also investigated. Non-interventional studies published as full-text articles in English up to 31th December 2014 were searched for in PubMed and by reviewing references of eligible articles. Meta-analysis and meta-regression of potential sources of heterogeneity were conducted. A total of 240 studies/795 citations - providing 258 setting-specific prevalence estimates (113,967 subjects) - fulfilled inclusion criteria for meta-analysis. Prevalence of malnutrition differed significantly across the healthcare settings considered: community, 3.1% (95%CI, 2.3-3.8); outpatients, 6.0% (95%CI, 4.6-7.5); home-care services, 8.7% (95%CI, 5.8-11.7); hospital, 22.0% (95%CI, 18.9-22.5); nursing homes, 17.5% (95%CI, 14.3-20.6); long-term care, 28.7% (95%CI, 21.4-36.0); rehabilitation/sub-acute care, 29.4% (95%CI, 21.7-36.9). For every setting significant heterogeneity in individual study results was observed (I 2 ≥80%, P < 0.001) and meta-regression showed that study quality was the most important determinant. Finally, meta-regression of all the studies included showed that both malnutrition and its risk were directly associated with the setting-related level of dependence (P < 0.001). However, despite multiple adjustments, residual heterogeneity remained high. We provided updated estimates of malnutrition and its risk in different healthcare settings. Although the level of dependence appears to be an important determinant, heterogeneity in individual study results remained substantially unexplained. The cause-effect relationship between nutritional status and level of dependence deserves further investigation. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Observational study of patients with gastroenteropancreatic and bronchial neuroendocrine tumors in Argentina: Results from the large database of a multidisciplinary group clinical multicenter study

PubMed Central

O’CONNOR, JUAN MANUEL; MARMISSOLLE, FABIANA; BESTANI, CLAUDIA; PESCE, VERONICA; BELLI, SUSANA; DOMINICHINI, ENZO; MENDEZ, GUILLERMO; PRICE, PAOLA; GIACOMI, NORA; PAIROLA, ALEJANDRO; LORIA, FERNANDO SÁNCHEZ; HUERTAS, EDUARDO; MARTIN, CLAUDIO; PATANE, KARINA; POLERI, CLAUDIA; ROSENBERG, MOISES; CABANNE, ANA; KUJARUK, MIRTA; CAINO, ANALIA; ZAMORA, VICTOR; MARIANI, JAVIER; DIOCA, MARIANO; PARMA, PATRICIA; PODESTA, GUSTAVO; ANDRIANI, OSCAR; GONDOLESI, GABRIEL; ROCA, ENRIQUE

2014-01-01

Neuroendocrine tumors (NET) include a spectrum of malignancies arising from neuroendocrine cells throughout the body. The objective of this clinical investigation of retrospectively and prospectively collected data was to describe the prevalence, demographic data, clinical symptoms and methods of diagnosis of NET and the treatment and long-term follow-up of patients with NET. Data were provided by the participating centers and assessed for consistency by internal reviewers. All the cases were centrally evaluated (when necessary) by the pathologists in our group. The tissue samples were reviewed by hematoxylin and eosin and immunohistochemical staining techniques to confirm the diagnosis of NET. In total, 532 cases were documented: 461 gastroenteropancreatic-NET (GEP-NET) and 71 bronchial NET (BNET). All the tumors were immunohistochemically defined according to the World Health Organization (WHO) and European Neuroendocrine Tumor Society criteria. The most common initial symptoms in GEP-NET were abdominal pain, diarrhea, bowel obstruction, flushing, gastrointestinal bleeding and weight loss. The most common tumor types were carcinoid (58.0%), non-functional pancreatic tumor (23.0%), metastatic NET of unknown primary (16.0%) and functional pancreatic tumor (3.0%). Of the BNET, 89.0% were typical and 11.0% atypical carcinoids. Of the patients with GEP-NET, 59.2% had distant metastasis at diagnosis. The locations of the primary tumors in GEP-NET were the small bowel (26.9%), pancreas (25.2%), colon-rectum (12.4%), appendix (7.6%), stomach (6.9%), esophagus (2.8%), duodenum (2.0%) and unknown primary (16.3%). The histological subtypes based on the WHO classification were well-differentiated NET (20.1%), well-differentiated neuroendocrine carcinomas (66.5%) and poorly differentiated neuroendocrine carcinomas (10.3%). Overall, 67.3% of the patients underwent surgery, 41.2% with curative intent and 26.1% for palliative purposes. The 5-year survival rates were 65.1% (95% confidence interval, 58.0–71.4%) in GEP-NET and 100.0% in typical carcinoid of the lung. This observational, non-interventional, longitudinal study aimed to accumulate relevant information regarding the epidemiology, clinical presentation and current practices in the treatment of NET patients in Argentina, providing insight into regional differences and patterns of care in this heterogeneous disease. PMID:25054030

Caregivers' and physicians' attitudes to rotigotine transdermal patch versus oral Parkinson's disease medication: an observational study.

PubMed

Sieb, Jörn Peter; Themann, Peter; Warnecke, Tobias; Lauterbach, Thomas; Berkels, Reinhard; Grieger, Frank; Lorenzl, Stefan

2015-05-01

To provide real-world data on caregiver and physician perceptions of the advantages and disadvantages of rotigotine transdermal patch (Neupro * ) versus oral Parkinson's Disease (PD) medication. Cross-sectional, non-interventional study in routine clinical practice in Germany (NCT01330290). Patients had PD with documented need for care, and had received rotigotine transdermal patch as add-on to oral PD treatment for ≥1 month. Caregivers/nurses and physicians assessed rotigotine transdermal patch versus oral PD medications using questionnaires. Specific questions regarding the possible benefits of transdermal application were asked and comprised questions on: swallowing dysfunction, nausea/vomiting, monitoring therapy, once daily application, application independently from meals, application to sleeping patients, caregiving efforts (caregivers only) and clinical aspects (physicians only). Each question was assessed on a 5 point scale ranging from -2 (major disadvantage) to 2 (major advantage) compared with oral treatment. Primary outcomes were mean total scores of all questions for caregivers/nurses and physicians who provided responses for ≥4 questions. As there are no validated tools to assess physician/caregiver preference in the PD setting, there is no reference against which the current findings can be compared; this study serves to pilot the questionnaires. Questionnaire responses from 128 caregivers/nurses and 41 physicians were documented for 147 patients. One hundred (68%) patients had a caregiving family member; 40 (27%) were cared for by a nurse. Mean PD duration was 8.2 (SD 6.3) years; 136 (93%) patients were taking levodopa. Mean total score of caregivers'/nurses' questionnaires was 1.32 (SD 0.67) and of physicians' questionnaires was 1.46 (0.32) indicating a perceived advantage of rotigotine transdermal patch over oral PD therapy. Mean scores for individual questions were in the range 1.03-1.54 for caregivers/nurses and 1.15-1.87 for physicians. When given a choice about rationale to prescribe, physicians cited pharmaceutical form (patch) in 139 (95%) cases and active agent (rotigotine) in 89 (61%) cases. Caregivers/nurses and physicians perceived advantages with rotigotine transdermal patch compared to an oral PD medication as add-on therapy in patients with PD; advantages were observed in aspects of medical treatment as well as in everyday situations of caregiving of PD patients.

Impact of recurrent Clostridium difficile infection: hospitalization and patient quality of life.

PubMed

Wilcox, Mark H; Ahir, Harblas; Coia, John E; Dodgson, Andrew; Hopkins, Susan; Llewelyn, Martin J; Settle, Chris; Mclain-Smith, Susan; Marcella, Stephen W

2017-09-01

Data quantifying outcomes of recurrent Clostridium difficile infection (rCDI) are lacking. We sought to determine the UK hospital resource use and health-related quality of life (HRQoL) associated with rCDI hospitalizations. A non-interventional study in six UK acute hospitals collected retrospective clinical and resource use data from medical records of 64 adults hospitalized for rCDI and 64 matched inpatient controls with a first episode only (f)CDI. Patients were observed from the index event (date rCDI/fCDI confirmed) for 28 days (or death, if sooner); UK-specific reference costs were applied. HRQoL was assessed prospectively in a separate cohort of 30 patients hospitalized with CDI, who completed the EQ-5D-3L questionnaire during their illness. The median total management cost (post-index) was £7539 and £6294 for rCDI and fCDI, respectively (cost difference, P = 0.075); median length of stay was 21 days and 15.5 days, respectively (P = 0.269). The median cost difference between matched rCDI and fCDI cases was £689 (IQR=£1873-£3954). Subgroup analysis demonstrated the highest median costs (£8542/patient) in severe rCDI cases. CDI management costs were driven primarily by hospital length of stay, which accounted for >85% of costs in both groups. Mean EQ-5D index values were 46% lower in CDI patients compared with UK population values (0.42 and 0.78, respectively); EQ visual analogue scale scores were 38% lower (47.82 and 77.3, respectively). CDI has considerable impact on patients and healthcare resources. This multicentre study provides a contemporaneous estimate of the real-world UK costs associated with rCDI management, which are substantial and comparable to fCDI costs. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Attention-Deficit/Hyperactivity Disorder Medication Treatment Impact on Response to Growth Hormone Therapy: Results from the ANSWER Program, a Non-Interventional Study.

PubMed

Rose, Susan R; Reeves, Grafton; Gut, Robert; Germak, John

2015-12-01

To examine whether attention-deficit/hyperactivity disorder (ADHD) stimulant medication modified the linear growth response to growth hormone (GH) treatment in children enrolled in the American Norditropin Studies: Web-Enabled Research Program. Short, GH treatment-naive children with or without GH deficiency (GHD) received GH therapy. A subset also received ADHD stimulant medication (n = 1190), and others did not (n = 7230). Linear mixed models (adjusted means) examined height SDS (HSDS) and body mass index (BMI) SDS from baseline through year 4. Analyses were repeated with ADHD groups matched for baseline age, height, weight, BMI, and sex. Groups with and without GHD were compared between ADHD groups. Adjusted change in HSDS for the group receiving ADHD stimulant medication was slightly lower than that for patients not receiving stimulant medication at years 1 to 4 (P < .05). However, adjusted change in HSDS was similar between children receiving and not receiving ADHD stimulant medication when matched for baseline measurements. At year 4, 86.7% of patients receiving ADHD stimulant medication, 86.8% of total patients not receiving ADHD stimulant medication, and 84.6% of matched group patients not receiving ADHD stimulant medication achieved HSDS >-2. Year 4 adjusted change in BMI SDS was greater in the patients receiving ADHD stimulant medication compared with both groups not receiving ADHD stimulant medication (P < .05). Patients with GHD showed comparable differences in adjusted change in BMI SDS among the ADHD groups at year 4, whereas patients without GHD showed no significant differences. ADHD medication did not affect the linear growth response of children treated with GH when those receiving or not receiving ADHD stimulant medication were matched for baseline measurements. Underlying reasons for the observed greater increase in BMI in patients with GHD concomitantly treated with ADHD medication remain to be elucidated. ClinicalTrials.gov: NCT01009905. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Remission, response, and relapse rates in patients with acute schizophrenia treated with olanzapine monotherapy or other atypical antipsychotic monotherapy: 12-month prospective observational study

PubMed Central

Takahashi, Michihiro; Nakahara, Naohiro; Fujikoshi, Shinji; Iyo, Masaomi

2015-01-01

Purpose To compare the rates of antipsychotic response, remission, and relapse in patients with schizophrenia treated with olanzapine or other antipsychotics in usual clinical care in Japan. Patients and methods This analysis of a 12-month, prospective, noninterventional study examined outcomes for 1,089 inpatients and outpatients with schizophrenia who initiated antipsychotic monotherapy. All treatment decisions, including medication choice, were left to the discretion of the treating physician. The rates of treatment response, relapse, and 6-month sustained remission were compared between olanzapine monotherapy (OLZ) and other anti-psychotic monotherapy (OAN), and between OLZ and other atypical antipsychotic monotherapy (OAT). Visit-wise comparisons of treatment response and remission were examined using repeated-measures logistic regressions. Propensity scores were used to control for potential baseline differences between groups. Results Response rates were higher for OLZ patients and relapse rates were consistently lower for OLZ patients, however the differences were not statistically significant. Rates of 6-month sustained remission were significantly higher for OLZ than OAN patients (P=0.032) and for OLZ than OAT patients (P=0.041). An exploratory analysis of OLZ and OAN comparison found outpatients treated with OLZ or OAN had similar sustained remission rates (OLZ: 22.2%, OAN: 22.8%), while inpatients treated with OLZ had significantly higher sustained remission rates than inpatients treated with OAN (OLZ: 17.1%, OAN: 6.6%, odds ratio [95% confidence interval] =3.54 [2.00–6.25]). Conclusion In usual care in Japan, treating the acute symptoms of schizophrenia with olanzapine was not found to be significantly different for response and relapse rates; however, treatment with olanzapine was found to have significantly greater sustained remission rates than treatment with other antipsychotics. In the inpatient setting, where patients tend to be more severe and difficult to manage, olanzapine treatment may lead to higher sustained remission rates than other antipsychotics. PMID:27774031

Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry.

PubMed

Gonzalez-Ruiz, Armando; Gargalianos-Kakolyris, Panayiotis; Timerman, Artur; Sarma, Jayanta; José González Ramallo, Víctor; Bouylout, Kamel; Trostmann, Uwe; Pathan, Rashidkhan; Hamed, Kamal

2015-06-01

The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections. Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter, observational registry. The real-world data were collected across 18 countries (Europe, Latin America, and Asia) for patients who had received at least one dose of daptomycin between January 2006 and April 2012. Two-year follow-up data were collected until 2014 for patients with endocarditis, intracardiac/intravascular device infection, osteomyelitis, or orthopedic device infection. A total of 6075 patients were enrolled. The most common primary infections were complicated skin and soft tissue infection (31.7%) and bacteremia (20.7%). Staphylococcus aureus was the most frequently reported pathogen (42.9%; methicillin-resistant S. aureus [MRSA], 23.2%), followed by Staphylococcus epidermidis and other coagulase-negative staphylococci (CoNS, 28.5%). The most commonly prescribed dose of daptomycin was 6 mg/kg/day (43.6%), and the median duration of therapy was 11 (range 1-300) days. Overall clinical success rate was 80.5%, and was similar whether daptomycin was used as first-line (82.9%) or second-line (79.2%) therapy. Clinical success rates were high in patients with S. aureus (83.9%; MRSA 83.0%) and CoNS (including S. epidermidis, 82.5%) infections. The majority of patients with endocarditis or intracardiac/intravascular device infection (86.7%) or osteomyelitis/orthopedic device infection (85.9%) had a sustained response during the 2-year follow-up period. There were no new or unexpected safety findings. Results from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections. This study was funded by Novartis Pharma AG.

Intervention for the bereaved: gender differences in the efficacy of two counselling programmes.

PubMed

Schut, H A; Stroebe, M S; van den Bout, J; de Keijser, J

1997-02-01

This article describes an investigation of emotion-focused versus problem-focused intervention for widowers (N = 23) and widowers (N = 23) who were suffering elevated levels of distress 11 months after their loss. They were randomly assigned to an intervention condition and improvement (on the General Health Questionnaire) was compared with non-intervention controls (N = 59). Two alternative hypotheses were considered: (1) men, since they focus less on their emotions, would benefit from problem-focused counselling, while women, focusing more on their emotions, would benefit from emotion-focused intervention; (2) each gender, having been comparatively unsuccessful in coping through these usual strategies, would benefit more from intervention directed towards the less familiar strategy. Results supported the second hypothesis: widowers benefited more from emotion-focused, widows from problem-focused interventions. Implications for supporting widows and widowers are discussed.

Liquid biopsy: A potential and promising diagnostic tool for advanced stage non-small cell lung cancer patients.

PubMed

Doval, D C; Deshpande, R; Dhabhar, B; Babu, K G; Prabhash, K; Chopra, R; Sripada, P V; Deshmukh, C; Suryavanshi, M

2017-12-01

More than 50% of non-small cell lung cancer (NSCLC) cases harbor an actionable mutation, and molecular testing at different intervals can help in personalized and targeted treatment. Core tissue biopsy and needle biopsy done at the time of diagnosis/disease progression are interventional, time-consuming and can affect the patients adversely. Noninterventional biomarker testing by liquid biopsy promises to revolutionize advanced stage cancer screening. The present report was formulated based on an expert panel meeting of renowned oncologists who gave their opinions for minimally invasive liquid biopsy to detect targetable molecular biomarkers in advanced NSCLC cases. An exhaustive literature search was done to support their recommendations. Clinical utility of minimally invasive liquid biopsy, for detection of molecular biomarkers in advanced stage NSCLC patients, was broadly discussed by the key opinion leaders.

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

PubMed

Talwalkar, P G; Gupta, Vishal; Kovil, Rajiv

2013-11-01

The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Mumbai, India. A total of 2112 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 1561), insulin detemir (n = 313), insulin aspart (n = 144), basal insulin plus insulin aspart (n = 53) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.7%) and insulin user (mean HbA1c: 9.2%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.4%, insulin users: -1.8%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

The Comorbidity Between Internet Gaming Disorder and Depression: Interrelationship and Neural Mechanisms

PubMed Central

Liu, Lu; Yao, Yuan-Wei; Li, Chiang-shan R.; Zhang, Jin-Tao; Xia, Cui-Cui; Lan, Jing; Ma, Shan-Shan; Zhou, Nan; Fang, Xiao-Yi

2018-01-01

Internet gaming disorder (IGD) is characterized by cognitive and emotional deficits. Previous studies have reported the co-occurrence of IGD and depression. However, extant brain imaging research has largely focused on cognitive deficits in IGD. Few studies have addressed the comorbidity between IGD and depression symptoms and underlying neural mechanisms. Here, we systematically investigated this issue by combining a longitudinal survey study, a cross-sectional resting-state functional connectivity (rsFC) study and an intervention study. Autoregressive cross-lagged modeling on a longitudinal dataset of college students showed that IGD severity and depression are reciprocally predictive. At the neural level, individuals with IGD exhibited enhanced rsFC between the left amygdala and right dorsolateral prefrontal cortex (DLPFC), inferior frontal and precentral gyrus, compared with control participants, and the amygdala-frontoparietal connectivity at the baseline negatively predicted reduction in depression symptoms following a psychotherapy intervention. Further, following the intervention, individuals with IGD showed decreased connectivity between the left amygdala and left middle frontal and precentral gyrus, as compared with the non-intervention group. These findings together suggest that IGD may be closely associated with depression; aberrant rsFC between emotion and executive control networks may underlie depression and represent a therapeutic target in individuals with IGD. Registry name: The behavioral and brain mechanism of IGD; URL: https://www.clinicaltrials.gov/ct2/show/NCT02550405; Registration number: NCT02550405. PMID:29740358

Cytomegalovirus and Epstein-Barr Virus DNA Kinetics in Whole Blood and Plasma of Allogeneic Hematopoietic Stem Cell Transplantation Recipients.

PubMed

Lazzarotto, Tiziana; Chiereghin, Angela; Piralla, Antonio; Piccirilli, Giulia; Girello, Alessia; Campanini, Giulia; Gabrielli, Liliana; Costa, Cristina; Prete, Arcangelo; Bonifazi, Francesca; Busca, Alessandro; Cairoli, Roberto; Colombo, Anna Amelia; Zecca, Marco; Sidoti, Francesca; Bianco, Gabriele; Paba, Pierpaolo; Perno, Carlo Federico; Cavallo, Rossana; Baldanti, Fausto

2018-03-12

Currently, no consensus has been reached on the optimal blood compartment to be used for surveillance of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) DNAemia. Although several comparative studies have been performed correlating CMV and EBV DNA loads in whole blood (WB) versus plasma, to our knowledge, no studies to date have analyzed the kinetics of both viruses in the 2 blood compartments. In this retrospective noninterventional multicenter cohort study, the kinetics of CMV and EBV DNA in 121 hematopoietic stem cell transplantation (HSCT) recipients were investigated by analyzing in parallel 569 and 351 paired samples from 80 and 58 sequential episodes of CMV and EBV DNAemia, respectively. Unlike previous studies, this study used a single automated molecular method that was CE-marked and Food and Drug Administration-approved for use in quantifying CMV and EBV DNA in both plasma and WB. Furthermore, the complete viral replication kinetics of all episodes (including both the ascending and the descending phases of the active infection) was examined in each patient. The previously observed overall correlation between CMV DNA levels in WB and plasma was confirmed (Spearman's ρ = .85; P < .001). However, although WB and plasma CMV DNAemia reached peak levels simultaneously, in the ascending phase, the median CMV DNA levels in plasma were approximately 1 log10 lower than WB. Furthermore, in patients who received preemptive therapy, CMV DNA showed a delayed decrease in plasma compared with WB. A lower correlation between EBV DNA levels in plasma versus WB was found (Spearman's ρ = .61; P < .001). EBV DNA kinetics was not consistent in the 2 blood compartments, mostly due to the lower positivity in plasma. Indeed, in 19% of episodes, EBV DNA was negative at the time of the EBV DNA peak in WB. Our results suggest a preferential use of WB for surveillance of CMV and EBV infection in HSCT recipients. Copyright © 2018 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Hypoglycaemia with oral antidiabetic drugs: results from prescription-event monitoring cohorts of rosiglitazone, pioglitazone, nateglinide and repaglinide.

PubMed

Vlckova, Veronika; Cornelius, Victoria; Kasliwal, Rachna; Wilton, Lynda; Shakir, Saad A W

2009-01-01

Hypoglycaemia is an acute complication associated with intensive treatment of patients with diabetes mellitus. This complication poses a major challenge in diabetes management. Furthermore, severe hypoglycaemia may be life threatening. Although hypoglycaemia is more often associated with insulin treatment, oral hypoglycaemic agents have the potential to trigger hypoglycaemia. The aim of this study was to quantify the incidence of hypoglycaemic events and to describe the pattern of these incident events during the first 9 months of treatment with four oral antidiabetic drugs, rosiglitazone, pioglitazone, nateglinide and repaglinide, prescribed in general practice in England. We used data collected for prescription-event monitoring (PEM) studies of rosiglitazone, pioglitazone, nateglinide and repaglinide. PEM is an observational, non-interventional, incept cohort study. Observation time for each patient and incidence rate (IR) per 1000 patient-years of treatment for hypoglycaemia was calculated for each drug cohort. Smoothed hazard estimates were plotted over time. Case/non-case analysis was performed to describe and compare patients who had at least one hypoglycaemic event in the first 9 months of treatment with those who did not. The total number of patients included in the analysis was 14,373, 12,768, 4,549 and 5,727 in rosiglitazone, pioglitazone, nateglinide and repaglinide cohorts, respectively. From these, 276 patients experienced at least one episode of hypoglycaemia. The IR was between 50% and 100% higher in patients receiving treatment with meglitinides compared with those treated with the thiazolidinediones (TZDs) [IR = 9.94, 9.64, 15.71 and 20.32 per 1,000 patient-years for rosiglitazone, pioglitazone, nateglinide and repaglinide, respectively]. The plot of the hazard function and the estimated shape parameter from the Weibull regression model showed that pioglitazone, nateglinide and repaglinide had non-constant (decreasing) hazards over time, whereas the hazard for rosiglitazone-treated patients was approximately constant over time. Nateglinide and repaglinide had similar shape hazard function, indicating a significantly higher number of hypoglycaemic episodes shortly after starting treatment. For women treated with TZDs, hypoglycaemia was reported more frequently than for men. This analysis shows that the frequency of reported hypoglycaemia within the study cohorts was relatively low. The rates of hypoglycaemia were not equal between drug classes. Treatment with nateglinide or repaglinide was characterized by a higher incidence of hypoglycaemia at the beginning of treatment. Further investigation is necessary to assess whether women treated with TZDs are more prone to hypoglycaemia than men. Findings from this study should be taken into account with other clinical and pharmacoepidemiological studies.

A community-randomised controlled trial promoting waterless hand sanitizer and handwashing with soap, Dhaka, Bangladesh.

PubMed

Luby, Stephen P; Kadir, Mohammad Abdul; Yushuf Sharker, M A; Yeasmin, Farzana; Unicomb, Leanne; Sirajul Islam, M

2010-12-01

To pilot two intensive hand hygiene promotion interventions, one using soap and one using a waterless hand sanitizer, in low-income housing compounds in Dhaka, Bangladesh and assess subsequent changes in handwashing behaviour and hand microbiology. Fieldworkers randomized 30 housing compounds: 10 received handwashing promotion with free soap, 10 received handwashing promotion with free waterless hand sanitizer and 10 were non-intervention controls. Fieldworkers assessed handwashing behaviour by structured observation and collected hand rinse specimens. At baseline, compound residents washed their hands with soap 26% of the time after defecation and 30% after cleaning a child's anus but <1% at other times. Compared with baseline, residents of soap intervention compounds were much more likely to wash their hands with soap after faecal contact (85-91%), before preparing food (26%) and before eating (26%). Compounds that received waterless hand sanitizer cleansed their hands more commonly than control compounds that used soap (10.4%vs. 2.3%), but less commonly than soap intervention compounds used soap (25%). Post-intervention hand rinse samples from soap and sanitizer compounds had lower concentrations of faecal indicator bacteria compared with baseline and control compounds. Waterless hand sanitizer was readily adopted by this low-income community and reduced hand contamination but did not improve the frequency of handwashing compared with soap. Future deployments of waterless hand sanitizers may improve hand hygiene more effectively by targeting settings where soap and water is unavailable. © 2010 Blackwell Publishing Ltd.

[Statin associated myopathy in clinical practice. Results of DAMA study].

PubMed

Millán, Jesús; Pedro-Botet, Juan; Climent, Elisenda; Millán, Joaquín; Rius, Joan

Muscle symptoms, with or without elevation of creatin kinase are one of the main adverse effects of statin therapy, a fact that sometimes limits their use. The aim of this study was to evaluate the clinical characteristics of patients treated with statins who have complained muscle symptoms and to identify possible predictive factors. A cross-sectional one-visit, non-interventional, national multicenter study including patients of both sexes over 18 years of age referred for past or present muscle symptoms associated with statin therapy was conducted. 3,845 patients were recruited from a one-day record from 2,001 physicians. Myalgia was present in 78.2% of patients included in the study, myositis in 19.3%, and rhabdomyolysis in 2.5%. Patients reported muscle pain in 77.5% of statin-treated individuals, general weakness 42.7%, and cramps 28.1%. Kidney failure, intense physical exercise, alcohol consumption (>30g/d in men and 20g/d in women) and abdominal obesity were the clinical situations associated with statin myopathy. Myalgia followed by myositis are the most frequent statin-related side effects. It should be recommended control environmental factors such as intense exercise and alcohol intake as well as abdominal obesity and renal function of the patient treated with statins. Copyright © 2016 Sociedad Española de Arteriosclerosis. Publicado por Elsevier España, S.L.U. All rights reserved.

A systematic review of physiological reactivity to stimuli in autism.

PubMed

Lydon, Sinéad; Healy, Olive; Reed, Phil; Mulhern, Teresa; Hughes, Brian M; Goodwin, Matthew S

2016-12-01

The prevalence of abnormal behavioural responses to a variety of stimuli among individuals with autism has led researchers to examine whether physiological reactivity (PR) is typical in this population. This article reviewed studies assessing PR to sensory, social and emotional, and stressor stimuli in individuals with autism. Systematic searches of electronic databases identified 57 studies that met our inclusion criteria. Studies were analysed to determine: (a) participant characteristics; (b) physiological measures used; (c) PR to sensory, social and emotional or stressor stimuli; (d) the relation between PR and behavioural or psychological variables and (e) baseline physiological activity. A novel measure of methodological quality suitable for use with non-randomized, non-interventional, psychophysiological studies was also developed and applied. Individuals with autism were found to respond differently than typically developing controls in 78.6%, 66.7% and 71.4% of sensory, social and emotional, and stressor stimulus classes, respectively. However, this extant literature is characterized by variable and inconsistent findings, which do not appear to be accounted for by varying methodological quality, making it difficult to determine what specific factors differentiate individuals with autism who present with atypical PR from those who do not. Despite this uncertainty, individual differences in PR are clearly present in autism, suggesting additional research is needed to determine the variables relating to PR among those with ASD and to examine the possible existence of physiological subtype responders in the population.

Teaching beyond the walls: A mixed method study of prospective elementary teacher's belief systems about science instruction

NASA Astrophysics Data System (ADS)

Asim, Sumreen

This mixed method study investigated K-6 teacher candidates' beliefs about informal science instruction prior to and after their experiences in a 15-week science methods course and in comparison to a non-intervention group. The study is predicated by the literature that supports the extent to which teachers' beliefs influence their instructional practices. The intervention integrated the six strands of learning science in informal science education (NRC, 2009) and exposed candidates to out-of-school-time environments (NRC, 2010). Participants included 17 candidates in the intervention and 75 in the comparison group. All were undergraduate K-6 teacher candidates at one university enrolled in different sections of a required science methods course. All the participants completed the Beliefs about Science Teaching (BAT) survey. Reflective journals, drawings, interviews, and microteaching protocols were collected from participants in the intervention. There was no statistically significant difference in pre or post BAT scores of the two groups; However, there was a statistically significant interaction effect for the intervention group over time. Analysis of the qualitative data revealed that the intervention candidates displayed awareness of each of the six strands of learning science in informal environments and commitment to out-of-school-time learning of science. This study supports current reform efforts favoring integration of informal science instructional strategies in science methods courses of elementary teacher education programs.

Arrival in the labour ward in second stage of labour--any prognostic significance?

PubMed

Nkyekyer, K

1998-05-01

A comparative descriptive study was carried out to determine whether, in uncomplicated term pregnancies with the foetus in vertex presentation, there were any differences in maternal or foetal outcome between women who arrived in the labour ward in second stage of labour and those who arrived in early active phase. There were two hundred and seventeen women each in the study and comparison groups. There were no significant differences between the two groups as regards age, parity, marital status and level of education. Women in the comparison group were better antenatal clinic attendants. Those in the study group were more likely to have indicated that they had problems with transportation. They also had considerably shorter labours and all achieved spontaneous vaginal deliveries; a significant proportion (10.6%) of the comparison group had interventional deliveries. The incidence of episiotomies, lower genital tract injuries, manual removal of placenta and postpartum haemorrhage after vaginal delivery were not different between the two groups. Babies born to mothers in the study group were significantly lighter, by about 170 gms, and had a lower incidence of low one-minute Apgar scores. There were no significant differences in the rates of admission to the neonatal intensive care unit or in early neonatal deaths. Arrival in the labour ward in second stage of labour prognosticates non-interventional delivery without any increased risk of adverse outcome to the mother or her baby.

Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review.

PubMed

Santos, Thiago R T; Oliveira, Bárbara A; Ocarino, Juliana M; Holt, Kenneth G; Fonseca, Sérgio T

2015-01-01

Patellofemoral pain syndrome (PFPS) is characterized by anterior knee pain, which may limit the performance of functional activities. The influence of hip joint motion on the development of this syndrome has already been documented in the literature. In this regard, studies have investigated the effectiveness of hip muscle strengthening in patients with PFPS. The aims of this systematic review were (1) to summarize the literature related to the effects of hip muscle strengthening on pain intensity, muscle strength, and function in individuals with PFPS and (2) to evaluate the methodological quality of the selected studies. A search for randomized controlled clinical trials was conducted using the following databases: Google Scholar, MEDLINE, PEDro, LILACS, and SciELO. The selected studies had to distinguish the effects of hip muscle strengthening in a group of patients with PFPS, as compared to non-intervention or other kinds of intervention, and had to investigate the following outcomes: pain, muscle strength, and function. The methodological quality of the selected studies was analyzed by means of the PEDro scale. Seven studies were selected. These studies demonstrated that hip muscle strengthening was effective in reducing pain. However, the studies disagreed regarding the treatments' ability to improve muscle strength. Improvement in functional capabilities after hip muscle strengthening was found in five studies. Hip muscle strengthening is effective in reducing the intensity of pain and improving functional capabilities in patients with PFPS, despite the lack of evidence for its ability to increase muscle strength.

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data.

PubMed

Linetzky, Bruno; Curtis, Brad; Frechtel, Gustavo; Montenegro, Renan; Escalante Pulido, Miguel; Stempa, Oded; de Lana, Janaina Martins; Gagliardino, Juan José

2016-01-01

Poor glycemic control in patients with type 2 diabetes is commonly recorded worldwide; Latin America (LA) is not an exception. Barriers to intensifying insulin therapy and which barriers are most likely to negatively impact outcomes are not completely known. The objective was to identify barriers to insulin progression in individuals with type 2 diabetes mellitus (T2DM) in LA countries (Mexico, Brazil, and Argentina). MOSAIc is a multinational, non-interventional, prospective, observational study aiming to identify the patient-, physician-, and healthcare-based factors affecting insulin intensification. Eligible patients were ≥18 years, had T2DM, and were treated with insulin for ≥3 months with/without oral antidiabetic drugs (OADs). Demographic, clinical, and psychosocial data were collected at baseline and regular intervals during the 24-month follow-up period. This paper however, focuses on baseline data analysis. The association between glycated hemoglobin (HbA1c) and selected covariates was assessed. A trend toward a higher level of HbA1c was observed in the LA versus non-LA population (8.40 ± 2.79 versus 8.18 ± 2.28; p ≤ 0.069). Significant differences were observed in clinical parameters, treatment patterns, and patient-reported outcomes in LA compared with the rest of the cohorts and between Mexico, Brazil, and Argentina. Higher number of insulin injections and lower number of OADs were used, whereas a lower level of knowledge and a higher level of diabetes-related distress were reported in LA. Covariates associated with HbA1c levels included age (-0.0129; p < 0.0001), number of OADs (0.0835; p = 0.0264), higher education level (-0.2261; p = 0.0101), healthy diet (-0.0555; p = 0.0083), self-monitoring blood glucose (-0.0512; p = 0.0033), hurried communication style in the process of care (0.1295; p = 0.0208), number of insulin injections (0.1616; p = 0.0088), adherence (-0.1939; p ≤ 0.0104), and not filling insulin prescription due to associated cost (0.2651; p = 0.0198). MOSAIc baseline data showed that insulin intensification in LA is not optimal and identified several conditions that significantly affect attaining appropriate HbA1c values. Tailored public health strategies, including education, should be developed to overcome such barriers. Trial Registration NCT01400971.

Behavioral antecedents for handwashing in a low-income urban setting in Bangladesh: an exploratory study.

PubMed

Rahman, Musarrat J; Nizame, Fosiul A; Unicomb, Leanne; Luby, Stephen P; Winch, Peter J

2017-05-05

Health programs commonly promote handwashing by drawing attention to potential fecal contamination in the environment. The underlying assumption is that the thought of fecal contamination will result in disgust, and motivate people to wash their hands with soap. However, this has not proven sufficient to achieve high rates of handwashing with soap at key times. We argue that handwashing with soap is influenced by broader range of antecedents, many unrelated to fecal contamination, that indicate to people when and where to wash their hands. This exploratory study aimed to identify and characterize this broader range of handwashing antecedents for use in future handwashing promotion efforts. First, an initial list of behavioral antecedents was elicited through unstructured interviews, focus group discussions and observation with residents, from a low-income community in Dhaka, Bangladesh, who were also recipients of a handwashing intervention. Then, photographs representing three categories of behavioral antecedents were taken: activities of daily living, visual or tactile sensations, and handwashing-related hardware and activities. Finally, the research team conducted ranking exercises with a new set of participants, from the same area, to assess the perceived importance of each antecedent illustrated by the photographs. The research team probed about perceptions regarding how and why that particular antecedent, represented by the photograph, influences handwashing behavior. After coming out of the bathroom and dirt (moyla) on hands were the two antecedents that ranked highest. In all the categories, intervention-related antecedents (three key times for handwashing which included handwashing after coming out of the bathroom, after cleaning a child's anus and before food preparation; intervention provided items that included handwashing station, soapy water bottle, handwashing reminders from posters and community health provider visits) that were being promoted actively in this community were perceived favorably in the qualitative responses, but did not consistently rank higher than non-intervention items. However, many other antecedents were reported to influence when and where people wash their hands: cutting greasy fish, starting a meal, contact with oil and fat stuck to dishes, oil and lice from hair, sweat, unwashed vegetables, reminders from son and daughter or observing others wash hands, and observing the sunset. Beyond well-recognized antecedents related to fecal contact and dirt on hands, we identified a broader set of antecedents not reported in the literature. Adopting a handwashing promotional strategy to highlight existing antecedents that people themselves have identified as important can help inform the content of an intervention that is more relatable and effective in increasing handwashing practices.

Assessment of asthma control: the SERENA study.

PubMed

Corrado, Antonio; Renda, Teresa; Polese, Guido; Rossi, Andrea

2013-11-01

Several studies suggest that many asthmatic subjects have uncontrolled asthma. The control of asthma is now considered the major goal of therapy. to ascertain the level of asthma control, by Asthma Control Test (ACT), in "real-life" clinical practice and the potential risk factors for uncontrolled disease in patients treated with inhaled corticosteroids (ICS) and long-acting beta-adrenergic agonists (LABA). SERENA is a multi-centre, cross-sectional, 6-month observational, non-interventional study carried out in 16 Pulmonary Units in Italy. Asthmatic outpatients aged over 18, undergoing treatment with ICS at medium-high daily doses associated with LABA, were enrolled. The patients were divided in 3 subgroups according to the level of asthma control by ACT score (25:controlled; 20-24:partly controlled; <20: uncontrolled). Out of a total of 548 patients, 396 met the inclusion criteria. Only 9.1% of patients had asthma controlled, while partly controlled and uncontrolled asthma accounted for 39.6% and 51.3% respectively. The mean age was 54.5 ± 15.8 and the mean duration of asthma was 16.1 ± 14.1 years. There were more females than males (63% vs 37%) and females had highest prevalence of uncontrolled asthma (63.1%). The mean values of FEV1% predicted were lower in the uncontrolled group (p < 0.001). The percentage of patients with at least 1 exacerbation, unscheduled visit and/or admissions was lower in controlled (22.2%, 8.3%, 8.3%) than in partly controlled (50%, 38.6%, 9.2%) and uncontrolled (83.2%, 66.2%, 27.8%) groups (p < 0.0001). The multivariate ordinal logistic regression analysis identified female sex, FEV1 and exacerbations as the strongest independent factors associated with the uncontrolled disease. This study highlights the importance in clinical practice of a periodic assessment by a validated asthma control instrument and exacerbations/health care contacts during previous year. Clinicians should be aware that a significant proportion of patients can have uncontrolled asthma, despite regular pharmacological treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy.

PubMed

Maa, April Y; Feuer, William J; Davis, C Quentin; Pillow, Ensa K; Brown, Tara D; Caywood, Rachel M; Chasan, Joel E; Fransen, Stephen R

2016-04-01

To evaluate the performance of the RETeval device, a handheld instrument using flicker electroretinography (ERG) and pupillography on undilated subjects with diabetes, to detect vision-threatening diabetic retinopathy (VTDR). Performance was measured using a cross-sectional, single armed, non-interventional, multi-site study with Early Treatment Diabetic Retinopathy Study 7-standard field, stereo, color fundus photography as the gold standard. The 468 subjects were randomized to a calibration phase (80%), whose ERG and pupillary waveforms were used to formulate an equation correlating with the presence of VTDR, and a validation phase (20%), used to independently validate that equation. The primary outcome was the prevalence-corrected area under the receiver operating characteristic (ROC) curve for the detection of VTDR. The area under the ROC curve was 0.86 for VTDR. With a sensitivity of 83%, the specificity was 78% and the negative predictive value was 99%. The average testing time was 2.3 min. With a VTDR prevalence similar to that in the U.S., the RETeval device will identify about 75% of the population as not having VTDR with 99% accuracy. The device is simple to use, does not require pupil dilation, and has a short testing time. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

The Effect of Curanderismo on Chronic Non-malignant Pain: A Case Report.

PubMed

Kennedy, Laura; Gonzales, Erin; Corbin, Lisa

2016-01-01

This case study describes the effects of the use of curanderismo, an indigenous healing modality combining techniques in massage, sound, and aromatherapy, on a patient with chronic pain. Despite being a commonly used health practice in certain populations, little is reported in the medical literature about the use of curanderismo. Case report as part of a larger randomized trial of curanderismo for chronic pain. Setting was a community-based hospital affiliated primary care clinic. An adult patient with chronic, opioid dependent back pain following an injury, and subsequent spinal fusion was treated. Intervention was the patient received 33 curanderismo treatment sessions over 10 months in addition to ongoing conventional treatment at a community-based chronic pain management clinic. Main outcomes measures were self-reported assessments of pain, functional ability, mood, insomnia, and narcotic usage. Secondary outcome measure was qualitative interview. Although there was no change in quantitative self-reported pain measures, the patient reported improved function, mood, and sleep as well as decreased narcotic usage. Curanderismo, in addition to conventional pain management, improved patient reported symptoms and functional ability, led to healthy lifestyle changes, and decreased narcotic usage. Controlled studies are needed to confirm the benefit of curanderismo as safe, non-interventional, and cost-effective adjunct for chronic pain management. Copyright © 2016 Elsevier Inc. All rights reserved.

New strategies for the treatment of colic: modifying the parent/infant interaction.

PubMed

Dihigo, S K

1998-01-01

The purpose of this study was to validate the effectiveness of behavior modification in treating colicky infants. Colic was defined as a self-limiting condition in infants less than 4 months of age with a complex of physical behaviors and inconsolable crying (> 2 hours a day for 3 days). It was hypothesized that when parents are given specific instructions about how to respond quickly and appropriately to their infant's cues (modification of the parent/infant interaction), the amount of crying by the infant decreases. A quasi-experimental design with an untreated control group and a pretest and posttest was used for the study. Twenty-three infants were randomly assigned to intervention, nonintervention, and control groups. Crying diaries kept by the parents were used to obtain quantitative measurements of crying before and after intervention. The Nursing Child Assessment Feeding Scale (NCAFS) was used to measure parent/infant interaction. Crying was significantly reduced from 3.79 hours per day to 1.12 hours per day (F = 46.00, df = 2, P < .05) among infants whose parents received interventions of individualized counseling and education. Caregivers of colicky infants in the intervention group scored lower on the NCAFS (F = 5.59, df = 2, P < .05). Findings support previous research suggesting that crying can be reduced by modifying parental responses to the infant.

Outcomes of an Interdisciplinary Transitional Care Quality Improvement Project on Self-Management and Health Care Use in Patients With Heart Failure.

PubMed

Hoover, Carrie; Plamann, Joy; Beckel, Jean

2017-01-01

Heart failure (HF) accounts for most U.S. Medicare hospital admissions. The purpose of the current study was to evaluate the effectiveness of a care transitions quality improvement (QI) intervention on self-management and readmission rates in older adults with HF. A quasi-experimental, descriptive study was conducted with 66 patients with HF in three medical units in a 489-bed Midwestern acute care hospital. The intervention included a nurse coach visit and follow up, pharmacy medication education and reconciliation, and HF clinic referral. Outcomes were assessed within 48 hours of admission and 30 days after discharge using the Self-Care of Heart Failure Index and medical record review. Following implementation, readmission rates decreased from 24% to 13%. Participants demonstrated a greater improvement in use of self-management strategies to control symptoms than the non-intervention group (p < 0.02) and more readily identified their symptoms of HF (p < 0.04). The evolution of population health, with increasing numbers of older adults living at home with complex chronic conditions, will require establishment of active partnerships among pharmacists, physicians, nurse specialists, home care nurses, and patients. [Journal of Gerontological Nursing, 43(1), 23-31.]. Copyright 2016, SLACK Incorporated.

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

PubMed Central

Blouza, Samira; Jamoussi, Henda

2013-01-01

Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Northern Tunisia. Results: A total of 443 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 137), insulin detemir (n = 243), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 39) and other insulin combinations (n = 13). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.2%) and insulin user (mean HbA1c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: −2.1%, insulin users: −0.9%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia. PMID:24404473

Treatment continuation of four long-acting antipsychotic medications in the Netherlands and Belgium: A retrospective database study

PubMed Central

Sermon, Jan; Geerts, Paul; Denee, Tom R.; De Vos, Cedric; Malfait, Bart; Lamotte, Mark; Mulder, Cornelis L.

2017-01-01

Achieving greater continuation of treatment is a key element to improve treatment outcomes in schizophrenia patients. However, reported treatment continuation can differ markedly depending on the study design. In a retrospective setting, treatment continuation remains overall poor among patients using antipsychotics. This study aimed to document the difference in treatment continuation between four long-acting injectable antipsychotics based on the QuintilesIMS LRx databases, national, longitudinal, panel based prescription databases of retail pharmacies, in the Netherlands and Belgium. Paliperidone palmitate once monthly, risperidone microspheres, haloperidol decanoate, and olanzapine pamoate were studied. This study demonstrated significantly higher treatment continuation of paliperidone palmitate once monthly compared to risperidone microspheres (p-value<0,01) and haloperidol decanoate (p-value<0,01) in both countries, a significantly higher treatment continuation of paliperidone palmitate once monthly compared to olanzapine pamoate in the Netherlands (p-value<0,01), and a general trend towards better treatment continuation versus olanzapine pamoate in Belgium. Analysing the subgroup of patients without previous exposure to long-acting antipsychotic treatment revealed the positive impact of previous exposure on treatment continuation with a subsequent long acting treatment. Additionally, the probability of restarting the index therapy was higher among patients treated with paliperidone palmitate once monthly compared to patients treated with risperidone microspheres and haloperidol decanoate. The data source used and the methodology defined ensured for the first time a comparison of treatment continuation in a non-interventional study design for the four long-acting injectable antipsychotics studied. PMID:28614404

Effect of dietary patterns differing in carbohydrate and fat content on blood lipid and glucose profiles based on weight-loss success of breast-cancer survivors.

PubMed

Thompson, Henry J; Sedlacek, Scot M; Paul, Devchand; Wolfe, Pamela; McGinley, John N; Playdon, Mary C; Daeninck, Elizabeth A; Bartels, Sara N; Wisthoff, Mark R

2012-01-06

Healthy body weight is an important factor for prevention of breast cancer recurrence. Yet, weight loss and weight gain are not currently included in clinical-practice guidelines for posttreatment of breast cancer. The work reported addresses one of the questions that must be considered in recommending weight loss to patients: does it matter what diet plan is used, a question of particular importance because breast cancer treatment can increase risk for cardiovascular disease. Women who completed treatment for breast cancer were enrolled in a nonrandomized, controlled study investigating effects of weight loss achieved by using two dietary patterns at the extremes of macronutrient composition, although both diet arms were equivalent in protein: high fat, low carbohydrate versus low fat, high carbohydrate. A nonintervention group served as the control arm; women were assigned to intervention arms based on dietary preferences. During the 6-month weight-loss program, which was menu and recipe defined, participants had monthly clinical visits at which anthropometric data were collected and fasting blood was obtained for safety monitoring for plasma lipid profiles and fasting glucose. Results from 142 participants are reported. Adverse effects on fasting blood lipids or glucose were not observed in either dietary arm. A decrease in fasting glucose was observed with progressive weight loss and was greater in participants who lost more weight, but the effect was not statistically significant, even though it was observed across both diet groups (P = 0.21). Beneficial effects of weight loss on cholesterol (4.7%; P = 0.001), triglycerides (21.8%; P = 0.01), and low-density lipoprotein (LDL) cholesterol (5.8%; P = 0.06) were observed in both groups. For cholesterol (P = 0.07) and LDL cholesterol (P = 0.13), greater reduction trends were seen on the low-fat diet pattern; whereas, for triglycerides (P = 0.01) and high-density lipoprotein (HDL) cholesterol (P = 0.08), a decrease or increase, respectively, was greater on the low-carbohydrate diet pattern. Because an individual's dietary preferences can affect dietary adherence and weight-loss success, the lack of evidence of a negative effect of dietary pattern on biomarkers associated with cardiovascular risk is an important consideration in the development of breast cancer practice guidelines for physicians who recommend that their patients lose weight. Whether dietary pattern affects biomarkers that predict long-term survival is a primary question in this ongoing clinical trial.

Multicenter intervention program to increase adherence to hand hygiene recommendations and glove use and to reduce the incidence of antimicrobial resistance.

PubMed

Trick, William E; Vernon, Michael O; Welbel, Sharon F; Demarais, Patricia; Hayden, Mary K; Weinstein, Robert A

2007-01-01

To determine whether a multimodal intervention could improve adherence to hand hygiene and glove use recommendations and decrease the incidence of antimicrobial resistance in different types of healthcare facilities. Prospective, observational study performed from October 1, 1999, through December 31, 2002. We monitored adherence to hand hygiene and glove use recommendations and the incidence of antimicrobial-resistant bacteria among isolates from clinical cultures. We evaluated trends in and predictors for adherence and preferential use of alcohol-based hand rubs, using multivariable analyses. Three intervention hospitals (a 660-bed acute and long-term care hospital, a 120-bed community hospital, and a 600-bed public teaching hospital) and a control hospital (a 700-bed university teaching hospital).Intervention. At the intervention hospitals, we introduced or increased the availability of alcohol-based hand rub, initiated an interactive education program, and developed a poster campaign; at the control hospital, we only increased the availability of alcohol-based hand rub. We observed 6,948 hand hygiene opportunities. The frequency of hand hygiene performance or glove use significantly increased during the study period at the intervention hospitals but not at the control hospital; the maximum quarterly frequency of hand hygiene performance or glove use at intervention hospitals (74%, 80%, and 77%) was higher than that at the control hospital (59%). By multivariable analysis, preferential use of alcohol-based hand rubs rather than soap and water for hand hygiene was more likely among workers at intervention hospitals compared with nonintervention hospitals (adjusted odds ratio, 4.6 [95% confidence interval, 3.3-6.4]) and more likely among physicians (adjusted odds ratio, 1.4 [95% confidence interval, 1.2-1.8]) than among nurses at intervention hospitals. A significantly reduced incidence of antimicrobial-resistant bacteria among isolates from clinical culture was found at a single intervention hospital, which had the greatest increase in the frequency of hand hygiene performance. During a 3-year period, a multimodal intervention program increased adherence to hand hygiene recommendations, especially to the use of alcohol-based hand rubs. In one hospital, a concomitant reduction was found in the incidence of antimicrobial-resistant bacteria among isolates from clinical cultures.

Universality of physicians' burnout syndrome as a result of experiencing difficulty in relationship with patients.

PubMed

Sablik, Zbigniew; Samborska-Sablik, Anna; Drożdż, Jarosław

2013-06-20

The aim of our work is to present the universality of burnout syndrome among physicians worldwide and to demonstrate selected aspects of the relationship between patients and doctors as a common factor predisposing to burnout. We looked up 20 original pieces of research from the Medline database published in the last 10 years to determine the prevalence of burnout among doctors in different countries. In all quoted works a remarkable percentage of doctors of interventional and non-interventional specialties suffered burnout. Because it is the relationship with patients that constitutes a key denominator for their work, in the discussion we have exposed an important aspect of it, destructive patient games, described on the basis of transactional analysis. Since universal burnout causes a deterioration of doctors' service, for the optimal good of the patient to survive preservation of the doctor's well-being in the patient-doctor relationship is needed everywhere.

Optic disc dysplasia in poland syndrome.

PubMed

Maxfield, Steven D; Strominger, Mitchell B

2014-06-01

To report optic disc dysplasia in a case of Poland syndrome. Non-interventional case report. A 2-year-old boy with Poland syndrome was referred for ophthalmic evaluation after abnormal optic discs were found on exam. Physical exam at birth revealed right-sided aplasia of the pectoralis major muscle, symbrachydactyly, hypoplastic scapula, and an abnormal third rib. On dilated examination the optic nerve heads were dysplastic. The findings included multiple cilioretinal vessels, situs inversus, inferotemporal excavation, and surrounding pigmentary disturbances. Only one case of optic disc anomaly has been reported in Poland syndrome and was described as morning glory syndrome. The optic discs in our patient do not fit well with other optic disc excavation syndromes but are most reminiscent of those in papillorenal syndrome. As both Poland syndrome and papillorenal syndrome share vascular dysfunction as a possible etiology, this case adds to the literature of vascular dysgenesis in Poland syndrome.

Sibling rivalry and the new baby: anticipatory guidance and management strategies.

PubMed

Sawicki, J A

1997-01-01

Sibling rivalry can be found in many families and frequently creates a stressful and challenging situation for parents. The arrival of a new baby often causes older siblings to feel displaced, frustrated, angry, and even unloved. Age, gender, personality and temperament, and parental behavior are factors that appear to influence the degree to which sibling rivalry occurs. Common reactions of older siblings to the birth of a new baby include aggression toward the newborn, behavioral regression, and attention seeking behavior, as well as independence and maturity. Anticipatory guidance is recommended to help parents adequately prepare their older child for the arrival of a new sibling. Strategies for managing sibling rivalry include open parent-child communication, equal treatment of siblings, non-intervention in sibling conflicts, distraction, and separation. Parents can minimize feelings of jealousy between siblings by providing a supportive, nurturing environment that allows each child to feel secure and loved.

Adaptive non-interventional heuristics for covariation detection in causal induction: model comparison and rational analysis.

PubMed

Hattori, Masasi; Oaksford, Mike

2007-09-10

In this article, 41 models of covariation detection from 2 × 2 contingency tables were evaluated against past data in the literature and against data from new experiments. A new model was also included based on a limiting case of the normative phi-coefficient under an extreme rarity assumption, which has been shown to be an important factor in covariation detection (McKenzie & Mikkelsen, 2007) and data selection (Hattori, 2002; Oaksford & Chater, 1994, 2003). The results were supportive of the new model. To investigate its explanatory adequacy, a rational analysis using two computer simulations was conducted. These simulations revealed the environmental conditions and the memory restrictions under which the new model best approximates the normative model of covariation detection in these tasks. They thus demonstrated the adaptive rationality of the new model. 2007 Cognitive Science Society, Inc.

Moral absolutism and ectopic pregnancy.

PubMed

Kaczor, C

2001-02-01

If one accepts a version of absolutism that excludes the intentional killing of any innocent human person from conception to natural death, ectopic pregnancy poses vexing difficulties. Given that the embryonic life almost certainly will die anyway, how can one retain one's moral principle and yet adequately respond to a situation that gravely threatens the life of the mother and her future fertility? The four options of treatment most often discussed in the literature are non-intervention, salpingectomy (removal of tube with embryo), salpingostomy (removal of embryo alone), and use of methotrexate (MXT). In this essay, I review these four options and introduce a fifth (the milking technique). In order to assess these options in terms of the absolutism mentioned, it will also be necessary to discuss various accounts of the intention/foresight distinction. I conclude that salpingectomy, salpingostomy, and the milking technique are compatible with absolutist presuppositions, but not the use of methotrexate.

Histopathological reporting of corneal pathology by a biomedical scientist: the Sheffield Experience.

PubMed

Meeney, A; Mudhar, H S

2013-02-01

The advanced specialist diploma in ophthalmic pathology was jointly ratified by the Royal College of Pathologists and the Institute of Biomedical Science in 2008. It results in extended roles for suitably qualified Biomedical Scientists (BMSs) in ophthalmic pathology specimen dissection and histological reporting of selected specimens, specifically non-neoplastic corneas. This study aimed to examine the reporting of corneal histology by a BMS training towards this diploma in comparison with a Consultant Ophthalmic Pathologist. This report covers a non-interventional, prospective examination of BMS's diagnostic skills. After 6 months training, 50 consecutive corneal cases were reported by the BMS and the same case reported by the consultant ophthalmic pathologist. The BMS's diagnosis was compared with the final consultant's diagnosis. This exercise was then repeated after 24 months of training. After 6 months, the BMS's diagnoses matched the consultant diagnoses in 44/50 (88%) cases. After 24 months, the BMS's diagnoses matched the consultant diagnoses in 48/50 (96%) of cases. The results indicate that BMS's reporting of corneal histology is a real and safe possibility. Furthermore, it indicated deficiencies in BMS's diagnostic skills to inform further training/knowledge acquisition.

Randomized trial of four noise-induced hearing loss and tinnitus prevention interventions for children.

PubMed

Martin, William Hal; Griest, Susan E; Sobel, Judith L; Howarth, Linda C

2013-02-01

To evaluate the effectiveness of four NIHL prevention interventions at improving knowledge, attitudes, and intended behaviors regarding sound exposure and appropriate use of hearing protective strategies in children. A randomized trial of the four interventions with a non-intervention comparison group. Questionnaires were completed prior to, immediately after, and three months after each intervention. Interventions included: (1) A classroom presentation by older-peer educators, (2) A classroom presentation by health professionals, (3). Exploration of a museum exhibition, and (4). Exploration of an internet-based virtual museum. A comparison group received no intervention. Fifty-three fourth grade classrooms (1120 students) participated in the study. All interventions produced significant improvements but the number of improvements decreased over time. In terms of effectiveness, the classroom programs were more effective than the internet-based virtual exhibit, which was more effective than the visit to the museum exhibition. Self-reported exposures indicated that as many as 94.5% of participants were at risk for NIHL. Interpersonal, interactive educational interventions such as the classroom program are more effective and have longer impact than self-directed learning experiences for NIHL and tinnitus prevention, however each may have an important role in promoting hearing health in elementary school students.

Factors Influencing Decision-Making for or against Adjuvant and Neoadjuvant Chemotherapy in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study

PubMed Central

Gaß, Paul; Fasching, Peter A.; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W.; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesselt, Thomas; Fischer, Gunnar; Henschen, Stephan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M.; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y.; Beckmann, Matthias W.; Wallwiener, Diethelm; Kümmel, Sherko; Löhberg, Christian R.

2016-01-01

Background Decision-making for or against neoadjuvant or adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive breast cancer does not follow any clear guidelines, and some patients may unnecessarily undergo chemotherapy and be exposed to the associated toxicity. The aim of this study was to identify the patient population for whom this issue may bear relevance. Methods Patients being treated with letrozole in the prospective multicenter noninterventional EvAluate-TM study were recruited. The percentage of patients receiving chemotherapy and factors associated with chemotherapy administration were identified. Results In all, 3,924 (37.4%) patients received chemotherapy before treatment with letrozole. Of these, 293 (20%) underwent neoadjuvant therapy. Younger age was predictive for both adjuvant and neoadjuvant therapy. Overall, decisions in favor of administering chemotherapy are more likely to be made in patients with a higher body mass index (BMI), and neoadjuvant chemotherapy is administered at a higher rate in women with a lower BMI. Concomitant medication influenced the overall decision-making regarding chemotherapy, irrespective of whether it was given on a neoadjuvant or adjuvant basis. Conclusion There is an ongoing debate as to whether all of the many patients who receive chemotherapy actually benefit from it. Neoadjuvant chemotherapy is frequently administered in this patient population, and this should encourage further research to resolve current clinical and research issues. PMID:27920623

Factors Influencing Decision-Making for or against Adjuvant and Neoadjuvant Chemotherapy in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study.

PubMed

Gaß, Paul; Fasching, Peter A; Fehm, Tanja; de Waal, Johann; Rezai, Mahdi; Baier, Bernd; Baake, Gerold; Kolberg, Hans-Christian; Guggenberger, Martin; Warm, Mathias; Harbeck, Nadia; Wuerstlein, Rachel; Deuker, Jörg-Uwe; Dall, Peter; Richter, Barbara; Wachsmann, Grischa; Brucker, Cosima; Siebers, Jan W; Fersis, Nikos; Kuhn, Thomas; Wolf, Christopher; Vollert, Hans-Walter; Breitbach, Georg-Peter; Janni, Wolfgang; Landthaler, Robert; Kohls, Andreas; Rezek, Daniela; Noesselt, Thomas; Fischer, Gunnar; Henschen, Stephan; Praetz, Thomas; Heyl, Volker; Kühn, Thorsten; Krauss, Thomas; Thomssen, Christoph; Hohn, Andre; Tesch, Hans; Mundhenke, Christoph; Hein, Alexander; Rauh, Claudia; Bayer, Christian M; Jacob, Adib; Schmidt, Katja; Belleville, Erik; Hadji, Peyman; Brucker, Sara Y; Beckmann, Matthias W; Wallwiener, Diethelm; Kümmel, Sherko; Löhberg, Christian R

2016-10-01

Decision-making for or against neoadjuvant or adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive breast cancer does not follow any clear guidelines, and some patients may unnecessarily undergo chemotherapy and be exposed to the associated toxicity. The aim of this study was to identify the patient population for whom this issue may bear relevance. Patients being treated with letrozole in the prospective multicenter noninterventional EvAluate-TM study were recruited. The percentage of patients receiving chemotherapy and factors associated with chemotherapy administration were identified. In all, 3,924 (37.4%) patients received chemotherapy before treatment with letrozole. Of these, 293 (20%) underwent neoadjuvant therapy. Younger age was predictive for both adjuvant and neoadjuvant therapy. Overall, decisions in favor of administering chemotherapy are more likely to be made in patients with a higher body mass index (BMI), and neoadjuvant chemotherapy is administered at a higher rate in women with a lower BMI. Concomitant medication influenced the overall decision-making regarding chemotherapy, irrespective of whether it was given on a neoadjuvant or adjuvant basis. There is an ongoing debate as to whether all of the many patients who receive chemotherapy actually benefit from it. Neoadjuvant chemotherapy is frequently administered in this patient population, and this should encourage further research to resolve current clinical and research issues.

Asthma-chronic obstructive pulmonary disease overlap syndrome in Poland. Findings of an epidemiological study.

PubMed

Brzostek, Dorota; Kokot, Marek

2014-12-01

Recent years have seen an increased interest in asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS). In 2012, Takeda Polska conducted a non-interventional epidemiological study aimed at identifying the typical phenotype of ACOS patients receiving pulmonary care. The study enrolled a total of 12,103 of smoking patients above 45 years of age (mean age: 61.5 years; mean duration of smoking: 28.4 pack-years). A total of 68.6% of patients represented the frequent-exacerbation phenotype (mean number of exacerbations during 12 months: 2.11), and 56.4% of patients from the group comprising 12,103 participants were hospitalized at least once during their lifetime due to a respiratory system disease (mean number: 3.82 ±3.76). The most commonly found asthma symptoms included paroxysmal dyspnoea with wheezing, and good response to inhaled steroids. The most frequently identified COPD-associated symptoms were: long-lasting reduction in forced expiratory volume in 1 s (FEV1) (< 80% after administering a bronchodilator) and chronic productive cough. Eighty-five percent of patients were diagnosed with concomitant diseases, predominantly arterial hypertension (62.9%) and metabolic diseases (metabolic syndrome, obesity, type 2 diabetes - 46.4% in total). A clinically severe course of ACOS and the presence of concomitant diseases should be regarded as factors justifying an individual selection of inhalation therapy which specifically takes into account anti-inflammatory treatment and patient safety.

Adherence predicts symptomatic and psychosocial remission in schizophrenia: Naturalistic study of patient integration in the community.

PubMed

Bernardo, Miguel; Cañas, Fernando; Herrera, Berta; García Dorado, Marta

Psychosocial functioning in patients with schizophrenia attended in daily practice is an understudied aspect. The aim of this study was to assess the relationship between symptomatic and psychosocial remission and adherence to treatment in schizophrenia. This cross-sectional, non-interventional, and multicenter study assessed symptomatic and psychosocial remission and community integration of 1,787 outpatients with schizophrenia attended in Spanish mental health services. Adherence to antipsychotic medication in the previous year was categorized as≥80% vs.<80%. Symptomatic remission was achieved in 28.5% of patients, and psychosocial remission in 26.1%. A total of 60.5% of patients were classified as adherent to antipsychotic treatment and 41% as adherent to non-pharmacological treatment. During the index visit, treatment was changed in 28.4% of patients, in 31.1% of them because of low adherence (8.8% of the total population). Adherent patients showed higher percentages of symptomatic and psychosocial remission than non-adherent patients (30.5 vs. 25.4%, P<.05; and 32 vs. 17%, P<.001, respectively). Only 3.5% of the patients showed an adequate level of community integration, which was also higher among adherent patients (73.0 vs. 60.1%, P<.05). Adherence to antipsychotic medication was associated with symptomatic and psychosocial remission as well as with community integration. Copyright © 2016 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

Five years audit for presence of toxic agents/drug of abuse at autopsy.

PubMed

Ali, S Muhammad Aijaz; Khalil, Inayatur-ur-Rehman; Saeed, Ahmed; Hussain, Zahid

2003-09-01

To know the frequency of fatal poisoning in Peshawar regarding the toxic agents mostly involved and yearwise percentage. To know the age group and the gender that is most vulnerable to fatal poisoning. Non-interventional (descriptive) type. This study was conducted over a period of five years (1997-2001) at Forensic Medicine Department, Khyber Medical College, Peshawar. The study included 3508 autopsies conducted at Khyber Medical College, Peshawar. Out of these, 52 cases were those caused by fatal poisoning. These were analyzed according to age, gender and the toxic agent involved. t-test was applied as the test of significance. Poisoning was the cause of death in 1.48% of the total autopsies conducted during the five years. Males were more involved than the females, 90.38 %. Suicidal poisoning was present in 17.30% of the total cases and accidental poisoning was found in 80.72% cases, while homicidal cases were 1.29% only. Diacetylmorphine (heroin) was the most commonly involved agent, 65.38 %, of the total cases. The incidence of poisoning was more during the third and fourth decades of life. Diacetylmorphine (heroin) was the main causative agent involved in young males due to accidental over- dosage. Accidental and suicidal deaths should not be considered as inevitable. More elaborative studies are required in this area of recent research to adopt appropriate and adequate measures to save precious lives.

Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants.

PubMed

Camm, A John; Fox, Keith A A

2018-01-01

Randomised controlled trials (RCTs) provide the reference standard for comparing the efficacy of one therapy or intervention with another. However, RCTs have restrictive inclusion and exclusion criteria; thus, they are not fully representative of an unselected real-world population. Real-world evidence (RWE) studies encompass a wide range of research methodologies and data sources and can be broadly categorised as non-interventional studies, patient registries, claims database studies, patient surveys and electronic health record studies. If appropriately designed, RWE studies include a patient population that is far more representative of unselected patient populations than those of RCTs, but they do not provide a robust basis for comparing treatment strategies. RWE studies can have very large sample sizes, can provide information on treatments in patient groups that are usually excluded from RCTs, are generally less expensive and quicker than RCTs, and can assess a broad range of outcomes. Limitations of RWE studies can include low internal validity, lack of quality control surrounding data collection and susceptibility to multiple sources of bias for comparing outcomes. RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions. RWE studies have been extensively applied in the postmarketing approval assessment of non-vitamin K antagonist oral anticoagulants since 2010. However, the benefits, costs, limitations and methodological challenges associated with the different types of RWE must be considered carefully when interpreting the findings.

Strengths and weaknesses of ‘real-world’ studies involving non-vitamin K antagonist oral anticoagulants

PubMed Central

Camm, A John; Fox, Keith A A

2018-01-01

Randomised controlled trials (RCTs) provide the reference standard for comparing the efficacy of one therapy or intervention with another. However, RCTs have restrictive inclusion and exclusion criteria; thus, they are not fully representative of an unselected real-world population. Real-world evidence (RWE) studies encompass a wide range of research methodologies and data sources and can be broadly categorised as non-interventional studies, patient registries, claims database studies, patient surveys and electronic health record studies. If appropriately designed, RWE studies include a patient population that is far more representative of unselected patient populations than those of RCTs, but they do not provide a robust basis for comparing treatment strategies. RWE studies can have very large sample sizes, can provide information on treatments in patient groups that are usually excluded from RCTs, are generally less expensive and quicker than RCTs, and can assess a broad range of outcomes. Limitations of RWE studies can include low internal validity, lack of quality control surrounding data collection and susceptibility to multiple sources of bias for comparing outcomes. RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions. RWE studies have been extensively applied in the postmarketing approval assessment of non-vitamin K antagonist oral anticoagulants since 2010. However, the benefits, costs, limitations and methodological challenges associated with the different types of RWE must be considered carefully when interpreting the findings. PMID:29713485

Immunogenicity and tolerability after two doses of non-adjuvanted, whole-virion pandemic influenza A (H1N1) vaccine in HIV-infected individuals.

PubMed

Lagler, Heimo; Grabmeier-Pfistershammer, Katharina; Touzeau-Römer, Veronique; Tobudic, Selma; Ramharter, Michael; Wenisch, Judith; Gualdoni, Guido Andrés; Redlberger-Fritz, Monika; Popow-Kraupp, Theresia; Rieger, Armin; Burgmann, Heinz

2012-01-01

During the influenza pandemic of 2009/10, the whole-virion, Vero-cell-derived, inactivated, pandemic influenza A (H1N1) vaccine Celvapan® (Baxter) was used in Austria. Celvapan® is adjuvant-free and was the only such vaccine at that time in Europe. The objective of this observational, non-interventional, prospective single-center study was to evaluate the immunogenicity and tolerability of two intramuscular doses of this novel vaccine in HIV-positive individuals. A standard hemagglutination inhibition (HAI) assay was used for evaluation of the seroconversion rate and seroprotection against the pandemic H1N1 strain. In addition, H1N1-specific IgG antibodies were measured using a recently developed ELISA and compared with the HAI results. Tolerability of vaccination was evaluated up to one month after the second dose. A total of 79 HIV-infected adults with an indication for H1N1 vaccination were evaluated. At baseline, 55 of the 79 participants had an HAI titer ≥1:40 and two patients showed a positive IgG ELISA. The seroconversion rate was 31% after the first vaccination, increasing to 41% after the second; the corresponding seroprotection rates were 92% and 83% respectively. ELISA IgG levels were positive in 25% after the first vaccination and in 37% after the second. Among the participants with baseline HAI titers <1:40, 63% seroconverted. Young age was clearly associated with lower HAI titers at baseline and with higher seroconversion rates, whereas none of the seven patients >60 years of age had a baseline HAI titer <1:40 or seroconverted after vaccination. The vaccine was well tolerated. The non-adjuvanted pandemic influenza A (H1N1) vaccine was well tolerated and induced a measurable immune response in a sample of HIV-infected individuals.

Immunogenicity and Tolerability after Two Doses of Non-Adjuvanted, Whole-Virion Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Individuals

PubMed Central

Lagler, Heimo; Grabmeier-Pfistershammer, Katharina; Touzeau-Römer, Veronique; Tobudic, Selma; Ramharter, Michael; Wenisch, Judith; Gualdoni, Guido Andrés; Redlberger-Fritz, Monika; Popow-Kraupp, Theresia; Rieger, Armin; Burgmann, Heinz

2012-01-01

Background During the influenza pandemic of 2009/10, the whole-virion, Vero-cell-derived, inactivated, pandemic influenza A (H1N1) vaccine Celvapan® (Baxter) was used in Austria. Celvapan® is adjuvant-free and was the only such vaccine at that time in Europe. The objective of this observational, non-interventional, prospective single-center study was to evaluate the immunogenicity and tolerability of two intramuscular doses of this novel vaccine in HIV-positive individuals. Methods and Findings A standard hemagglutination inhibition (HAI) assay was used for evaluation of the seroconversion rate and seroprotection against the pandemic H1N1 strain. In addition, H1N1-specific IgG antibodies were measured using a recently developed ELISA and compared with the HAI results. Tolerability of vaccination was evaluated up to one month after the second dose. A total of 79 HIV-infected adults with an indication for H1N1 vaccination were evaluated. At baseline, 55 of the 79 participants had an HAI titer ≥1∶40 and two patients showed a positive IgG ELISA. The seroconversion rate was 31% after the first vaccination, increasing to 41% after the second; the corresponding seroprotection rates were 92% and 83% respectively. ELISA IgG levels were positive in 25% after the first vaccination and in 37% after the second. Among the participants with baseline HAI titers <1∶40, 63% seroconverted. Young age was clearly associated with lower HAI titers at baseline and with higher seroconversion rates, whereas none of the seven patients >60 years of age had a baseline HAI titer <1∶40 or seroconverted after vaccination. The vaccine was well tolerated. Conclusion The non-adjuvanted pandemic influenza A (H1N1) vaccine was well tolerated and induced a measurable immune response in a sample of HIV-infected individuals. PMID:22629330

Insulin regimens and glycemic control in different parts of Europe over 4years after starting insulin in people with type 2 diabetes: Data from the CREDIT non-interventional study.

PubMed

Blonde, Lawrence; Marre, Michel; Vincent, Maya; Brette, Sandrine; Pilorget, Valerie; Danchin, Nicholas; Vespasiani, Giacomo; Home, Philip

2017-11-01

A number of insulin regimens are used in type 2 diabetes. This analysis aims to better understand the evolution of insulin therapy in different regions of Europe. Data from people starting any insulin were collected in eastern Europe (EEur: Croatia, Russia, Ukraine), northern Europe (NEur: Finland, Germany, UK) and southern Europe (SEur: France, Italy, Portugal, Spain). Retrospective data on starting insulin and prospective follow-up data were extracted from clinical records. At 4years, 1699 (76.0%) of 2236 eligible people had data. EEur participants were mostly female, younger and had shorter diabetes duration on starting insulin, yet had highest baseline HbA1c and more micro-/macrovascular disease. A majority (60%-64%) in all regions started on basal insulin alone, declining to 30%-38% at 4years, with most switching to basal+mealtime insulin regimen (24%-40%). Higher baseline (28%) and 4-year use (34%) of premix insulin was observed in NEur. Change in HbA1c (SD) ranged from -1.2 (2.1)% (-13 [23]mmol/mol) in NEur to -2.4 (2.0)% (-26 [22]mmol/mol) in EEur. Weight change ranged from +1.9 (8.3) kg in NEur to +3.2 (7.0) kg in SEur. Overall documented hypoglycemia ranged from 0.3 (1.3) to 1.3 (4.4) events/person/6-months (NEur vs. EEur, respectively) and was stable with time. Severe hypoglycemia rates remained low. When starting insulin, HbA1c and prevalence of complications were higher in EEur. Regional differences exist in choice of insulin regimens in Europe. However, people starting insulin improved and sustained their glycemic control regardless of regional differences or insulin regimens used. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Cardiometabolic risk after weight loss and subsequent weight regain in overweight and obese postmenopausal women.

PubMed

Beavers, Daniel P; Beavers, Kristen M; Lyles, Mary F; Nicklas, Barbara J

2013-06-01

Little is known about the effect of intentional weight loss and subsequent weight regain on cardiometabolic risk factors in older adults. The objective of this study was to determine how cardiometabolic risk factors change in the year following significant intentional weight loss in postmenopausal women, and if observed changes were affected by weight and fat regain. Eighty, overweight and obese, older women (age = 58.8±5.1 years) were followed through a 5-month weight loss intervention and a subsequent 12-month nonintervention period. Body weight/composition and cardiometabolic risk factors (blood pressure; total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; fasting glucose and insulin; and Homeostatic Model Assessment of Insulin Resistance) were analyzed at baseline, immediately postintervention, and 6- and 12-months postintervention. Average weight loss during the 5-month intervention was 11.4±4.1kg and 31.4% of lost weight was regained during the 12-month follow-up. On average, all risk factor variables were significantly improved with weight loss but regressed toward baseline values during the year subsequent to weight loss. Increases in total cholesterol, triglycerides, glucose, insulin, and Homeostatic Model Assessment of Insulin Resistance during the postintervention follow-up were significantly (p < .05) associated with weight and fat mass regain. Among women who regained weight, model-adjusted total cholesterol (205.8±4.0 vs 199.7±2.9mg/dL), low-density lipoprotein cholesterol (128.4±3.4 vs 122.7±2.4mg/dL), insulin (12.6±0.7 vs 11.4±0.7mg/dL), and Homeostatic Model Assessment of Insulin Resistance (55.8±3.5 vs 50.9±3.7mg/dL) were higher at follow-up compared with baseline. For postmenopausal women, even partial weight regain following intentional weight loss is associated with increased cardiometabolic risk. Conversely, maintenance of or continued weight loss is associated with sustained improvement in the cardiometabolic profile.

Using Technology to Enhance Discharge Teaching and Improve Coping for Patients After Stroke.

PubMed

Schneider, Melissa A; Howard, Katrina A

2017-06-01

A diagnosis of stroke is a life-changing event. Effective discharge teaching after a stroke is crucial for recovery, but the overload of information can be overwhelming for patients and caregivers. The purpose of this study was to examine differences in discharge readiness and postdischarge coping in patients admitted for stroke after the use of individualized postdischarge information/education provided via a technology package (including patient online portal access, e-mail/secure messaging) compared with current standard discharge teaching methods (verbal/written instructions). This study used a descriptive comparative design to evaluate the difference between the nonintervention group A and the intervention group B. Patients in group B received additional discharge information via secured e-mail messaging at postdischarge days 2, 6, and 10. Two validated tools, Readiness for Hospital Discharge Form and Post-Discharge Coping Difficulty Scale, were used. One hundred patients were recruited for the study, but the final number of complete data sets collected was 86-42 in group A and 44 in group B. There was no statistically significant difference between the groups in discharge readiness. There was a significant difference in coping scores between the 2 groups, with the technology group exhibiting higher coping. New technology affords new options to improve discharge readiness and contribute to positive patient coping after stroke. The researchers hope that this study will contribute to the growing body of evidence showing success using aspects of technology to enhance discharge teaching and follow-up after discharge.

Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review

PubMed Central

Santos, Thiago R. T.; Oliveira, Bárbara A.; Ocarino, Juliana M.; Holt, Kenneth G.; Fonseca, Sérgio T.

2015-01-01

Introduction: Patellofemoral pain syndrome (PFPS) is characterized by anterior knee pain, which may limit the performance of functional activities. The influence of hip joint motion on the development of this syndrome has already been documented in the literature. In this regard, studies have investigated the effectiveness of hip muscle strengthening in patients with PFPS. Objectives: The aims of this systematic review were (1) to summarize the literature related to the effects of hip muscle strengthening on pain intensity, muscle strength, and function in individuals with PFPS and (2) to evaluate the methodological quality of the selected studies. Method: A search for randomized controlled clinical trials was conducted using the following databases: Google Scholar, MEDLINE, PEDro, LILACS, and SciELO. The selected studies had to distinguish the effects of hip muscle strengthening in a group of patients with PFPS, as compared to non-intervention or other kinds of intervention, and had to investigate the following outcomes: pain, muscle strength, and function. The methodological quality of the selected studies was analyzed by means of the PEDro scale. Results: Seven studies were selected. These studies demonstrated that hip muscle strengthening was effective in reducing pain. However, the studies disagreed regarding the treatments' ability to improve muscle strength. Improvement in functional capabilities after hip muscle strengthening was found in five studies. Conclusion: Hip muscle strengthening is effective in reducing the intensity of pain and improving functional capabilities in patients with PFPS, despite the lack of evidence for its ability to increase muscle strength. PMID:26039034

Indirect Effects of the Fast Track Intervention on Conduct Disorder Symptoms and Callous-Unemotional Traits: Distinct Pathways Involving Discipline and Warmth

PubMed Central

Pasalich, Dave S.; Witkiewitz, Katie; McMahon, Robert J.; Pinderhughes, Ellen E.

2016-01-01

Little is known about intervening processes that explain how prevention programs improve particular youth antisocial outcomes. We examined whether parental harsh discipline and warmth in childhood differentially account for Fast Track intervention effects on conduct disorder (CD) symptoms and callous-unemotional (CU) traits in early adolescence. Participants included 891 high-risk kindergarteners (69% male; 51% African American) from urban and rural United States communities who were randomized into either the Fast Track intervention (n = 445) or non-intervention control (n = 446) groups. The 10-year intervention included parent management training and other services (e.g., social skills training, universal classroom curriculum) targeting various risk factors for the development of conduct problems. Harsh discipline (Grades 1 through 3) and warmth (Grades 1 and 2) were measured using parent responses to vignettes and direct observations of parent-child interaction, respectively. Parents reported on children’s CD symptoms in Grade 6 and CU traits in Grade 7. Results demonstrated indirect effects of the Fast Track intervention on reducing risk for youth antisocial outcomes. That is, Fast Track was associated with lower scores on harsh discipline, which in turn predicted decreased levels of CD symptoms. In addition, Fast Track was associated with higher scores on warmth, which in turn predicted reduced levels of CU traits. Our findings inform developmental and intervention models of youth antisocial behavior by providing evidence for the differential role of harsh discipline and warmth in accounting for indirect effects of Fast Track on CD symptoms versus CU traits, respectively. PMID:26242993

Is a project needed to prevent urinary tract infection in patients admitted to spanish ICUs?

PubMed

Álvarez Lerma, F; Olaechea Astigarraga, P; Nuvials, X; Gimeno, R; Catalán, M; Gracia Arnillas, M P; Seijas Betolaza, I; Palomar Martínez, M

2018-02-06

To analyze epidemiological data of catheter-associated urinary tract infection (CAUTI) in critically ill patients admitted to Spanish ICUs in order to assess the need of implementing a nationwide intervention program to reduce these infections. Non-intervention retrospective annual period prevalence analysis. Participating ICUs in the ENVIN-UCI multicenter registry between the years 2007-2016. Critically ill patients admitted to the ICU with catheter-associated urinary tract infection (CAUTI). Incidence rates per 1,000 catheter-days; urinary catheter utilization ratio; proportion of CAUTIs in relation to total health care-associated infections (HAIs). A total of 187,100 patients, 137,654 (73.6%) of whom had a urinary catheter in place during 1,215,673 days (84% of days of ICU stay) were included. In 4,539 (3.3%) patients with urinary catheter, 4,977 CAUTIs were diagnosed (3.6 episodes per 100 patients with urinary catheter). The CAUTI incidence rate showed a 19% decrease between 2007 and 2016 (4.69 to 3.8 episodes per 1,000 catheter-days), although a sustained urinary catheter utilization ratio was observed (0.84 [0.82-0.86]). The proportion of CAUTI increased from 23.3% to 31.9% of all HAIs controlled in the ICU. Although CAUTI rates have declined in recent years, these infections have become proportionally the first HAIs in the ICU. The urinary catheter utilization ratio remains high in Spanish ICUs. There is room for improvement, so that a CAUTI-ZERO project in our country could be useful. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Restraint use law enforcement intervention in Latino communities.

PubMed

Schaechter, Judy; Uhlhorn, Susan B

2011-11-01

Motor vehicle crashes are the leading cause of death for U.S. Latinos aged 1 to 35 years. Restraint use is an effective means of prevention of motor vehicle crash injury. Effective interventions to raise restraint use include the following: legislation, law enforcement, education, and equipment distribution. The effects of law enforcement interventions in Latino immigrant communities are understudied. We measured the community-level effect of a combined intervention that included warnings and citations phase enforcement in Latino communities. We designed and implemented in two of three Latino-majority communities a multicomponent intervention consisting of a community awareness campaign, restraint use education with equipment distribution, and a two-staged law enforcement intervention. Restraint use observations were conducted in all three communities at baseline, after the warnings phase and again after the citations phase of the intervention were completed. The combined intervention of community awareness, education, child passenger restraint distribution, and law enforcement focused on educational traffic stops with incentives and warnings was associated with a significant increase in both driver and child passenger restraint use in one intervention community, but only driver restraint increased to a level of significance in the other intervention community; significant increase was also noted among nonintervention drivers. The citations phase of the intervention did not result in a significant increase in restraint use and was complicated by interruptions due to unlicensed drivers. The combined effort of community awareness, education, equipment distribution and law enforcement intervention that included incentives and warnings may be effective at increasing seat belt use in Latino communities without the need for citations.

Indirect Effects of the Fast Track Intervention on Conduct Disorder Symptoms and Callous-Unemotional Traits: Distinct Pathways Involving Discipline and Warmth.

PubMed

Pasalich, Dave S; Witkiewitz, Katie; McMahon, Robert J; Pinderhughes, Ellen E

2016-04-01

Little is known about intervening processes that explain how prevention programs improve particular youth antisocial outcomes. We examined whether parental harsh discipline and warmth in childhood differentially account for Fast Track intervention effects on conduct disorder (CD) symptoms and callous-unemotional (CU) traits in early adolescence. Participants included 891 high-risk kindergarteners (69% male; 51% African American) from urban and rural United States communities who were randomized into either the Fast Track intervention (n = 445) or non-intervention control (n = 446) groups. The 10-year intervention included parent management training and other services (e.g., social skills training, universal classroom curriculum) targeting various risk factors for the development of conduct problems. Harsh discipline (Grades 1 to 3) and warmth (Grades 1 and 2) were measured using parent responses to vignettes and direct observations of parent-child interaction, respectively. Parents reported on children's CD symptoms in Grade 6 and CU traits in Grade 7. Results demonstrated indirect effects of the Fast Track intervention on reducing risk for youth antisocial outcomes. That is, Fast Track was associated with lower scores on harsh discipline, which in turn predicted decreased levels of CD symptoms. In addition, Fast Track was associated with higher scores on warmth, which in turn predicted reduced levels of CU traits. Our findings inform developmental and intervention models of youth antisocial behavior by providing evidence for the differential role of harsh discipline and warmth in accounting for indirect effects of Fast Track on CD symptoms versus CU traits, respectively.

Circulating Cell-Free DNA Differentiates Severity of Inflammation.

PubMed

Frank, Mayu O

2016-10-01

As the U.S. population ages, the incidence of chronic disease will rise. Chronic diseases have been linked to chronic inflammation. The purpose of this review is to summarize the literature on cell-free DNA (cfDNA) in relation to inflammation. PubMed, EMBASE, and Web of Science were searched. Inclusion criteria were noninterventional studies on acute and chronic inflammation, autoimmunity, and infection published in English after 2000, conducted in humans using the fluorescence method of quantifying DNA. Of the 442 articles retrieved, 83 were identified for full-text review and 13 remained after application of inclusion criteria. Of the reviewed studies, three involved acute inflammation, six involved chronic inflammation, and four involved infection. Healthy controls with interpretable results were included in six studies, three of which used the Quant-iT high-sensitivity DNA kit and found cfDNA quantities near 800 ng/ml, while the other three used other fluorescence methods and found quantities below 100 ng/ml. All 13 studies compared groups, and all but 1 found statistically significant differences between them. Among studies using the Quant-iT reagent, levels were higher in infection than in chronic inflammation. Among studies that used other reagents, levels increased from chronic to acute inflammation to severe infection. CfDNA levels were associated with mortality and with clinical outcomes in acute inflammation and infection. Most studies assessed cfDNA's correlation with other inflammation biomarkers and found inconclusive results. There appears to be an association between inflammation and cfDNA. Further research is necessary before cfDNA can be used clinically as a measure of inflammation. © The Author(s) 2016.

A systematic review of oral herpetic viral infections in cancer patients: commonly used outcome measures and interventions.

PubMed

Elad, Sharon; Ranna, Vinisha; Ariyawardana, Anura; Correa, Maria Elvira Pizzigatti; Tilly, Vanessa; Nair, Raj G; Rouleau, Tanya; Logan, Richard M; Pinto, Andres; Charette, Veronica; Saunders, Debbie P; Jensen, Siri Beier

2017-02-01

To review the literature for outcome measures for oral viral infections in cancer patients. A secondary aim was to update the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of oral viral infections in cancer patients. Databases were searched for articles published in the English language, 1981-2013. Studies that met the eligibility criteria were reviewed systematically. The data about the outcome measures were classified according to the aim of the study: prevention, treatment, or non-interventional. The results of interventional studies were compared to the 2010 MASCC/ISOO publication. Multiple clinical and laboratory tests were used to measure oral viral infections, with great variability between studies. Most of the studies were about Herpes Simplex Virus (HSV). The outcome measure that was most commonly used was the presence of HSV infection diagnosed based on a combination of suggestive clinical presentation with a positive laboratory result. HSV culture was the most commonly reported laboratory outcome measure. Acyclovir and valacyclovir were consistently reported to be efficacious in the management of oral herpetic infections. No new data on the quality of life and economic aspects was found. Considering the variability in outcome measures reported to assess oral herpetic infections the researcher should select carefully the appropriate measures based on the objective of the study. Acyclovir and valacyclovir are effective in the management of oral herpetic infections in patients receiving treatment for cancer. Studies on newer anti-viral drugs may be useful to address the issue of anti-viral resistance.

A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial.

PubMed

Mitchell, Marion L; Kean, Susanne; Rattray, Janice E; Hull, Alastair M; Davis, Chelsea; Murfield, Jenny E; Aitken, Leanne M

2017-06-01

Family members could play an important role in preventing and reducing the development of delirium in Intensive Care Units (ICU) patients. This study sought to assess the feasibility of design and recruitment, and acceptability for family members and nurses of a family delivered intervention to reduce delirium in ICU patients. A single centre randomised controlled trial in an Australian medical/surgical ICU was conducted. Sixty-one family members were randomised (29 in intervention and 32 in non-intervention group). Following instructions, the intervention comprised the family members providing orientation or memory clues (family photographs, orientation to surroundings) to their relative each day. In addition, family members conducted sensory checks (vision and hearing with glasses and hearing aids); and therapeutic or cognitive stimulation (discussing family life, reminiscing) daily. Eleven ICU nurses were interviewed to gain insight into the feasibility and acceptability of implementing the intervention from their perspective. Recruitment rate was 28% of eligible patients (recruited n=90, attrition n=1). Following instruction by the research nurse the family member delivered the intervention which was assessed to be feasible and acceptable by family members and nurses. Protocol adherence could be improved with alternative data collection methods. Nurses considered the activities acceptable. The study was able to recruit, randomise and retain family member participants. Further strategies are required to assess intervention fidelity and improve data collection. Copyright © 2017 Elsevier Ltd. All rights reserved.

Severity of statin-induced adverse effects on muscle and associated conditions: data from the DAMA study.

PubMed

Pedro-Botet, Juan; Millán Núñez-Cortés, Jesús; Chillarón, Juan J; Flores-Le Roux, Juana A; Rius, Joan

2016-12-01

Statins are generally well tolerated, but muscular adverse effects appear to be the most common obstacle limiting their use. Our objective was to describe the severity of muscle injury (myalgia, myositis and rhabdomyolysis) and associated conditions related to statin therapy that may be clinically significant. A cross-sectional one-visit, non-interventional, national multicenter study including patients of both sexes over 18 years of age referred for past or present muscle symptoms associated with statin therapy was conducted. Clinical, biochemical and drug therapy characteristics were obtained at the initial evaluation. 3,845 patients were recruited from a one-day record from 2,001 physicians. Myalgia was present in 78.2% of patients, myositis in 19.3% and rhabdomyolysis in 2.5%. The prevalence of different comorbidities such as diabetes, hypertension, atrial fibrillation, and coronary heart disease increased as the severity of myopathy rose. High-intensity statin therapy was used in 33.4% of patients. Concomitant drugs metabolized by the CYP450 3A4 pathway were taken by 9.3% of patients, and statins with this metabolic route by 75%. Independent variables associated with myositis or rhabdomyolysis compared with myalgia alone in the multivariate model were excessive alcohol consumption and pravastatin therapy. Myalgia was the most common muscle adverse effect associated with statin therapy. Excessive alcohol consumption and pravastatin were independently associated with myositis or rhabdomyolysis.

Cyst acquisition rate for Giardia lamblia in backcountry travelers to Desolation Wilderness, Lake Tahoe

USGS Publications Warehouse

Zell, S.C.; Sorenson, S.K.

1993-01-01

The objective of this study was to determine the incidence of Giardia lamblia acquisition in back-country travelers to a wilderness area, provide longitudinal follow-up on the incidence of symptomatic gastrointestinal illness and relate such information to concentrations of Giardia cysts in water samples from a high-use area. A prospective cohort non-interventional study of 41 healthy adult backcountry travelers from age 19 to 71 years in Desolation Wilderness, Lake Tahoe Basin was carried out. The incidence of Giardia cyst acquisition in backcountry travelers was only 5.7% (95% CI 0.17–20.2%). Mild, self-limiting gastrointestinal illness occurred in 16.7% of subjects (95% CI 4.9%–34.50%), none of whom demonstrated G. lamblia infection. Water sampling from three popular stream sites revealed cyst contamination to be generally at low levels with cyst concentrations in the single digit range for every 100 gallons filtered. G. lamblia contamination of water occurs, but at low levels. Acquisition of this parasite may be infrequent in backcountry recreationalists. Symptomatic gastrointestinal illness following wilderness travel can be due to other etiologies. Our findings may not be representative of all wilderness areas, but suggest that in the absence of documented G. lamblia infection, persons symptomatic following travel may suffer a self-limiting gastrointestinal illness. In such circumstances, empiric therapy for giardiasis is tempting but difficult to justify.

Assessment of the impact of phenylketonuria and its treatment on quality of life of patients and parents from seven European countries.

PubMed

Bosch, Annet M; Burlina, Alberto; Cunningham, Amy; Bettiol, Esther; Moreau-Stucker, Flavie; Koledova, Ekaterina; Benmedjahed, Khadra; Regnault, Antoine

2015-06-18

The strict and demanding dietary treatment and mild cognitive abnormalities seen in PKU treated from a young age can be expected to affect the health-related quality of life (HRQoL) of patients and their families. Our aim was to describe the HRQoL of patients with PKU from a large international study, using generic HRQoL measures and an innovative PKU-specific HRQoL questionnaire (PKU-QOL). Analyses were exploratory, performed post-hoc on data collected primarily to validate the PKU-QOL. A multicentre, prospective, non-interventional, observational study conducted in France, Germany, Italy, The Netherlands, Spain, Turkey and the UK. Patients diagnosed with PKU aged ≥9 years old and treated with a Phe-restricted diet and/or Phe-free amino acid protein supplements and/or pharmacological therapy were included in the study; parents of at least one patient with PKU aged <18 years were also included. HRQoL was assessed by generic measures (Pediatric Quality-of-Life Inventory; Medical Outcome Survey 36 item Short Form; Child Health Questionnaire 28 item Parent Form) and the newly developed PKU-QOL. Mean generic domain scores were interpreted using published reference values from the general population. PKU-QOL domain scores were described overall and in different subgroups of patients defined according to severity of PKU, overall assessment of patient's health status by the investigator and treatment with tetrahydrobiopterin (BH4). Data from 559 subjects were analysed: 306 patients (92 children, 110 adolescents, 104 adults) and 253 parents. Mean domain scores of generic measures in the study were comparable to the general population. The highest PKU-QOL impact scores (indicating greater impact) were for emotional impact of PKU, anxiety about blood Phe levels, guilt regarding poor adherence to dietary restrictions or Phe-free amino acid supplement intake and anxiety regarding blood Phe levels during pregnancy. Patients with mild/moderate PKU and those receiving BH4 reported lower practical and emotional impacts of the diet and Phe-free amino acid supplement intake. Patients with PKU showed good HRQoL in the study, both with the generic and PKU-specific measures. Negative impacts of PKU on a patient's life, including the emotional impact of PKU and its management, was delineated by the PKU-QOLs across all age groups.

The effect of preoperative suggestions on perioperative dreams and dream recalls after administration of different general anesthetic combinations: a randomized trial in maxillofacial surgery.

PubMed

Gyulaházi, Judit; Varga, Katalin; Iglói, Endre; Redl, Pál; Kormos, János; Fülesdi, Béla

2015-01-01

Images evoked immediately before the induction of anesthesia with the help of suggestions may influence dreaming during anesthesia.The aim of the study was to assess the incidence of evoked dreams and dream recalls by employing suggestions before induction of anesthesia while administering different general anesthetic combinations. This is a single center, prospective randomized including 270 adult patients scheduled for maxillofacial surgical interventions. Patients were assigned to control, suggestion and dreamfilm groups according to the psychological method used. According to the anesthetic protocol there were also three subgroups: etomidate & sevoflurane, propofol & sevoflurane, propofol & propofol groups. Primary outcome measure was the incidence of postoperative dreams in the non-intervention group and in the three groups receiving different psychological interventions. Secondary endpoint was to test the effect of perioperative suggestions and dreamfilm-formation training on the occurrance of dreams and recallable dreams in different general anesthesiological techniques. Dream incidence rates measured in the control group did not differ significantly (etomidate & sevoflurane: 40%, propofol & sevoflurane: 26%, propofol & propofol: 39%). A significant increase could be observed in the incidence rate of dreams between the control and suggestion groups in the propofol & sevoflurane (26%-52%) group (p = 0.023). There was a significant difference in the incidence of dreams between the control and dreamfilm subgroup in the propofol & sevoflurane (26% vs. 57%), and in the propofol & propofol group (39% vs.70%) (p = 0.010, and p = 0.009, respectively). Similar to this, there was a significant difference in dream incidence between the dreamfilm and the suggestion subgroups (44% vs. 70%) in the propofol & propofol group (p = 0.019). Propofol as an induction agent contributed most to dream formation and recalls (χ2-test p value: 0.005). The content of images and dreams evoked using suggestions showed great agreement using all three anesthetic protocols. The psychological method influenced dreaming during anesthesia. The increase of the incidence rate of dreams was dependent on the anesthetic agent used, especially the induction agent. The study was registered in ClinicalTrials.gov. Identifier: NCT01839201.

Cohesive Polydensified Matrix® hyaluronic acid volumizer injected for cheek augmentation has additional positive effect on nasolabial folds.

PubMed

Gauglitz, Gerd; Steckmeier, Stephanie; Pötschke, Julian; Schwaiger, Hannah

2017-01-01

Cohesive Polydensified Matrix ® hyaluronic acid (CPM-HA) volumizer has been used successfully for several years to reverse biometric volume loss during facial aging. This observational study explored the additive effect on nasolabial folds when CPM-HA volumizer is injected into the neighboring cheek area. In this open-label, prospective, postmarketing noninterventional study, 18 adult patients seeking esthetic enhancement of the lateral cheek hollows and cheekbone area were injected with CPM-HA volumizer integrated with lidocaine (CPM-HA-VL) in the upper or lower cheek area. Safety and performance of CPM-HA-VL up to 12 months after injection with follow-up visits at week 4 and month 3, 6, and 12 were assessed. The primary endpoint was improvement of cheek fullness on the validated Merz Aesthetics Scales. Additionally, changes in nasolabial folds were quantified using a phaseshift rapid in vivo measurement of skin optical three-dimensional (3D) in vivo measurement device. Patients (94.4% female, median age 52 years, age range 39-69 years) were injected with a mean volume of 2.5±1.1 mL CPM-HA-VL per side. Immediately after injection, mean severity for upper and lower cheek fullness assessed on the validated MAS improved from 2.5±0.6 and 2.8±0.5, respectively, to 1.0±0.0, and remained unchanged through month 12. Improvement in relation to baseline was attested on the Global Aesthetics Improvement Scale for all assessments. Compared with baseline, the following assessments offered a statistical significance in the reduction of wrinkle depth of nasolabial folds (maximum depth reduction by 30.4% at 3 months) according to optical 3D in vivo measurements. Pain during injection was minimal and abated within 30 minutes. Treatment was well tolerated and led to great patient satisfaction. CPM-HA-VL injected into the upper and lower cheeks led to long-lasting satisfactory cosmetic results in cheek augmentation as well as in reducing depth of nasolabial folds adjacent to the injection site.

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries

PubMed Central

De Cock, Erwin; Kritikou, Persefoni; Sandoval, Mariana; Tao, Sunning; Wiesner, Christof; Carella, Angelo Michele; Ngoh, Charles; Waterboer, Tim

2016-01-01

Background Rituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings. Methods This non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient’s first year of treatment (11 rituximab sessions). Results Mean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27–58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1–5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53–91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1–5.5 eight-hour days. Conclusions Compared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units. Trial Registration ClinicalTrials.gov NCT01200758 PMID:27362533

Costs and health resources utilization following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain: a post hoc analysis.

PubMed

Navarro, Ana; Saldaña, María T; Pérez, Concepción; Masramón, Xavier; Rejas, Javier

2012-06-01

To analyze the changes in pain severity and associated costs resulting from resource utilization and reduced productivity in patients with gabapentin-refractory peripheral neuropathic pain who switched to pregabalin therapy in primary care settings in Spain. This is a post hoc analysis of a 12-week, multicentre, noninterventional cost-of-illness study. Patients were included in the study if they were over 18 years of age and had a diagnosis of chronic, treatment-refractory peripheral neuropathic pain. The analysis included all pregabalin-naïve patients who had previously shown an inadequate response to gabapentin and switched to pregabalin. Severity of pain before and after treatment with pregabalin, alone or as an add-on therapy, was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ) and its related visual analogue scale (VA). Healthcare resource utilization, productivity (including lost-workday equivalents [LWDE]), and related costs were assessed at baseline and after pregabalin treatment. A total of 174 patients switched to pregabalin had significant and clinically relevant reductions in pain severity (mean [SD] change on SF-MPQ VA scale, -31.9 [22.1]; P < 0.05 vs. baseline; effect size, 1.87). Reduction in pain was similar with both pregabalin monotherapy and add-on therapy. Significant reductions in healthcare resource utilization (concomitant drug use [in pregabalin add-on group], ancillary tests, and unscheduled medical visits) were observed at the end of trial. Additionally, there were substantial improvements in productivity, including a reduction in the number of LWDE following pregabalin treatment (-18.9 [26.0]; P < 0.0001). These changes correlated with substantial reductions in both direct (-652.9 ± 1622.4 €; P < 0.0001) and indirect healthcare costs (-851.6 [1259.6] €; P < 0.0001). The cost of care in patients with gabapentin-refractory peripheral neuropathic pain appeared to be significantly reduced after switching to pregabalin treatment, alone or in combination with other analgesic drugs, in a real-life setting. © 2011 The Authors. Pain Practice © 2011 World Institute of Pain.

[Nutritional content of foods offered and consumed in a Spanish university canteen].

PubMed

Fernández Torres, Ángela; Moreno-Rojas, Rafael; Cámara Martos, Fernando

2014-09-12

The prime objective of our work was to study the eating habits at lunchtime of staff and students at a University of "hidden due to confidentiality"of Spain. The second one was to attempt to reduce the energy consumption of cholesterol and fat in the diet of those groups. The study was made between 2010 and 2012 in the main canteen serving food at this university, focusing on food intake at lunch, the main meal of the day, containing between 35 and 40% of the total calories ingested throughout the day. A total of 9530 observations were made, each one corresponding to the nutritional valuation of food eaten (a complete lunch) per person, by students, teachers and service personnel. The study was carried out in 5 intervention stages and a previous non-intervention one to establish the habitual food intake of these groups. In each stage the nutritional information supplied to canteen users was increased to that in the final stage a modification of the price of the menus served was made. The food choices freely made by the groups were converted into the amount of nutrients by means of a prior nutritional evaluation of the dishes offered via their calculation using the database Nutriplato. This permitted the evaluation of 29 nutrients which, taking the user data observed, were converted into % of contribution to the RDA (per each population group), which produced a standardization of the data, permitting a subsequent statistical study by the GLM (SPSS v15) procedure to assess the effect of the different factors contemplated. The following were taken into account as classification factors (independent variables): sex, age group and level of body fat, as well as the intervention stage. The dependent variables were: energy, protein, lipid, carbohydrate, fiber, Ca, Mg, P, Na, K, Fe, Cu, Zn, Mn, I, Se, vitamins: B1, B2, B3, B5, B6, B8, B9, B12, C, A, D, E and cholesterol. The mean energy and cholesterol intake was significantly reduced in the individuals investigated in the last two intervention stages. Moreover, those last two stages were statistically differentiated, the last one being that which presented the lowest intake of those nutrients. As positive collateral effects, although this was not a priority objective in the study, a greater statistically significant intake of vitamin D, B9, dietetic fiber, and calcium and a lower intake of sodium with respect to the initial stages were noted. Our conclusions go in two directions: the positive effect of the nutritional information and the need to complement that information with economic measures that encourage still further food changes in population groups whose purchasing power is not very great. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Work Site-Based Environmental Interventions to Reduce Sedentary Behavior: A Systematic Review.

PubMed

Hutcheson, Amanda K; Piazza, Andrew J; Knowlden, Adam P

2018-01-01

The purpose of this investigation was to systematically review work site-based, environmental interventions to reduce sedentary behavior following preferred reporting items for systematic reviews and meta-analyses guidelines. Data were extracted from Medical Literature Analysis and Retrieval System Online, Cochrane Central Register of Controlled Trials, and Web of Science between January 2005 and December 2015. Inclusion criteria were work site interventions, published in peer-reviewed journals, employing environmental modalities, targeting sedentary behavior, and using any quantitative design. Exclusion criteria were noninterventions and non-English publications. Data extracted included study design, population, intervention dosage, intervention activities, evaluation measures, and intervention effects. Data were tabulated quantitatively and synthesized qualitatively. A total of 15 articles were identified for review and 14 reported statistically significant decreases in sedentary behavior. The majority of studies employed a randomized controlled trial design (n = 7), used inclinometers to measure sedentary behavior (n = 9), recruited predominantly female samples (n = 15), and utilized sit-to-stand desks as the primary intervention modality (n = 10). The mean methodological quality score was 6.2 out of 10. Environmental work site interventions to reduce sedentary behavior show promise because work sites often have more control over environmental factors. Limitations of this intervention stream include inconsistent measurement of sedentary behavior, absence of theoretical frameworks to guide program development, and absence of long-term evaluation. Future studies should include clear reporting of intervention strategies and explicit operationalization of theoretical constructs.

Characterization of Chinese body skin through in vivo instrument assessments, visual evaluations, and questionnaire: influences of body area, inter-generation, season, sex, and skin care habits.

PubMed

Li, Xi; Galzote, Carlos; Yan, Xiuyuan; Li, Li; Wang, Xi

2014-02-01

The varying influence of multiple factors (e.g., aging, sex, season, skin care habits) on skin structure and function necessitates study within ethnic groups to fully characterize their skin. Men and women aged 40-50 years (n = 43) and their consanguineous same-sex children, aged 18-25 years (n = 43), living in Chengdu, China were enrolled in this single center, non-interventional study. Volunteers attended two study visits (summer, 2010 and winter, 2011) at which dermatologists measured transepidermal water loss (TEWL), skin hydration, sebum secretion, fine lines/roughness, melanin/erythema, temperature, and color, and clinically graded participants' skin. Participants answered a questionnaire, indicating their perceived skin type/condition. Data were analyzed using t-test/anova or Friedman/Wilcoxon test. Objective measurements demonstrated statistically significant inter-generational differences in skin condition, with aged skin more wrinkled at most sites, having reduced oil/colder facial and décolletage skin, darker/more erythematous skin in exposed areas, and less hydrated/rougher heel skin; similarities were detected in skin melanin, erythema, and TEWL. There were also statistically significant differences between seasons and sexes. The intersection between instrument measurements and subjective perceptions of skin revealed notable differences. Objective measurements and their intersection with subjective perceptions demonstrate the influences of inter-generation, season, sex, and living habits on Chinese body skin. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Women's political participation and health: a health capability study in rural India.

PubMed

Feldman, Candace H; Darmstadt, Gary L; Kumar, Vishwajeet; Ruger, Jennifer Prah

2015-02-01

Understanding the relationship between women's political participation and health has eluded researchers and cannot be adequately studied using traditional epidemiological or social scientific methodologies. We employed a health capability framework to understand dimensions of health agency to illuminate how local political economies affect health. Exploiting a cluster-randomized controlled trial of a community-based behavior change management intervention in northern India, we conducted a qualitative study with semistructured, in-depth focus groups in both intervention and nonintervention villages. We presented scenarios to each group regarding the limitations and motivations involved in women's political participation and health. Thematic analysis focused on four domains of health agency -- participation, autonomy, self-efficacy, and health systems -- relevant for understanding the relationship between political participation and health. Elder women demonstrated the greatest sense of self-efficacy and as a group cited the largest number of successful health advocacy efforts. Participation in an associated community-based neonatal intervention had varying effects, showing some differences in self-efficacy, but only rare improvements in participation, autonomy, or health system functioning. Better understanding of cultural norms surrounding autonomy, the local infrastructure and health system, and male and female perceptions of political participation and self-efficacy are needed to improve women's health agency. For a community-based participatory health intervention to improve health capability effectively, explicit strategies focused on health agency should be as central as health indicators. Copyright © 2015 by Duke University Press.

Prospective multi-center study for quantification of chemotherapies and CTX-related direct medication costs avoided by use of biomarkers uPA and PAI-1 in primary breast cancer.

PubMed

Jacobs, Volker R; Augustin, Doris; Wischnik, Arthur; Kiechle, Marion; Höss, Cornelia; Steinkohl, Oliver; Rack, Brigitte; Kapitza, Thomas; Krase, Peter

2013-08-01

Biomarkers uPA/PAI-1 as recommended by ASCO and AGO are used in primary breast cancer to avoid unnecessary CTX in medium risk-recurrence patients. This study verified how many CTX cycles and CTX-related direct medication costs can be avoided by uPA/PAI-1 testing. A prospective, non-interventional, multi-center study was performed among six Certified Breast Centers to analyze application of uPA/PAI-1 and consecutive decision-making. CTX avoided were identified and direct costs for CTX, CTX-related concomitant medication and febrile neutropenia (FN) prophylaxis with G-CSF calculated. In n = 93 breast cancers n = 35 CTX (37.6%) with 210 CTX cycles were avoided according to uPA/PAI-1 test result. uPA/PAI-1 testing saved direct medication costs for CTX of 177,453 €, CTX-related concomitant medication of 27,482 € and FN prophylaxis of 20,599 €, overall 225,534 €. At test costs at 287.50 € uPA/PAI-1 testing resulted in additional costs of 26,737.50 €. uPA/PAI-1 has proven to be cost-effective at a return-on-investment ratio of 8.4:1. Indirect cost savings further increase this ROI. These results support decision-making for cost-effective diagnostics and therapy in breast cancer. Copyright © 2013 Elsevier Ltd. All rights reserved.

Implementation and impact of an audit and feedback antimicrobial stewardship intervention in the orthopaedics department of a tertiary-care hospital: a controlled interrupted time series study.

PubMed

Tavares, Margarida; Carvalho, Ana Cláudia; Almeida, José Pedro; Andrade, Paulo; São-Simão, Ricardo; Soares, Pedro; Alves, Carlos; Pinto, Rui; Fontanet, Arnaud; Watier, Laurence

2018-06-01

A prospective audit and feedback antimicrobial stewardship intervention conducted in the Orthopaedics Department of a university hospital in Portugal was evaluated by comparing an interrupted time series in the intervention group with a non-intervention (control) group. Monthly antibiotic use (except cefazolin) was measured as the World Health Organization's Anatomical Therapeutic Chemical defined daily doses (ATC-DDD) from January 2012 to September 2016, excluding the 6-month phase of intervention implementation starting on 1 January 2015. Compared with the control group, the intervention group had a monthly decrease in the use of fluoroquinolones by 2.3 DDD/1000 patient-days [95% confidence interval (CI) -3.97 to -0.63]. An increase in the use of penicillins by 103.3 DDD/1000 patient-days (95% CI 47.42 to 159.10) was associated with intervention implementation, followed by a decrease during the intervention period (slope = -5.2, 95% CI -8.56 to -1.82). In the challenging scenario of treatment of osteoarticular and prosthetic joint infections, an audit and feedback intervention reduced antibiotic exposure and spectrum. Copyright © 2018 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

Demographic characteristics and clinical predictors of patients discharged from university hospital-affiliated pain clinic due to breach in narcotic use contract.

PubMed

Chakrabortty, Shushovan; Gupta, Deepak; Rustom, David; Berry, Hussein; Rai, Ajit

2014-01-01

The current retrospective study was completed with the aim to identify demographic characteristics and clinical predictors (if any) of the patients discharged from our pain clinic due to breach in narcotic use contract (BNUC). Retrospective patient charts' review and data audit. University hospital-affiliated pain clinic in the United States. All patient charts in our pain clinic for a 2-year period (2011-2012). The patients with BNUC were delineated from the patients who had not been discharged from our pain clinic. Pain characteristics, pain management, and substance abuse status were compared in each patient with BNUC between the time of admission and the time of discharge. The patients with BNUC discharges showed significant variability for the discharging factors among the pain physicians within a single pain clinic model with this variability being dependent on their years of experience and their proactive interventional pain management. The patients with BNUC in our pain clinic setting were primarily middle-aged, obese, unmarried males with nondocumented stable occupational history who were receiving only noninterventional pain management. Substance abuse, doctor shopping, and potential diversion were the top three documented reasons for BNUC discharges. In 2011-2012, our pain clinic discharged 1-in-16 patients due to breach in narcotic use contract.

Management of bladder dysfunction in Wolfram syndrome with Mitrofanoff appendicovesicostomy: long-term follow-up.

PubMed

Mozafarpour, Sarah; Kajbafzadeh, Abdol-Mohammad; Mojtahed, Ali; Mojtahed, Mohammad; Mahboubi, Hossein; Shalileh, Keivan

2015-07-01

To present the long-term outcomes of appendicovesicostomy using the Mitrofanoff principle for end-stage Wolfram bladder dysfunction as an alternative to clean intermittent self-catheterization (CIC) per urethra mainly following blindness. Twelve Wolfram patients presenting with bilateral hydroureteronephrosis and advanced bladder dysfunction were included in this study. All patients were managed initially by CIC per urethra. All of these patients became blind during follow-up and were unable to perform urethral CIC independently. Out of these patients, six patients agreed to proceed to appendicovesicostomy. Appendicovesicostomy urinary diversion using the Mitrofanoff principle was performed in these six blind patients. The rest of the patients stopped CIC or performed CIC irregularly. Severe hydroureteronephrosis and large bladders were found in all patients prior to intervention. All patients were able to conduct CIC independently through the stoma and maintained overnight bladder free drainage. In all patients with urinary diversion and CIC, the hydroureteronephrosis was reduced and renal function returned to normal. However, the non-intervention group ended with different degrees of progressive renal failure with three mortalities during the follow-up. We suggest appendicovesicostomy as a safe and lifesaving procedure for long-term management of bladder dysfunction in Wolfram syndrome particularly after progression to blindness. Copyright © 2015 Elsevier Inc. All rights reserved.

Early alterations in soleus GLUT-4, glucose transport, and glycogen in voluntary running rats

NASA Technical Reports Server (NTRS)

Henriksen, Erik J.; Halseth, Amy E.

1994-01-01

Voluntary wheel running (WR) by juvenile female rats was used as a noninterventional model of soleus muscle functional overload to study the regulation of insulin-stimulated glucose transport activity by the glucose transporter (GLUT-4 isoform) protein level and glycogen concentration. Soleus total protein content was significantly greater (+18%;P greater than 0.05) than in age-matched controls after 1 wk of WR, and this hypertrophic response continued in weeks 2-4 (+24-32%). GLUT-4 protein was 39% greater than in controls in 1-wk WR soleus, and this adaptation was accompanied by a similar increase in in vitro insulin-stimulated glucose transport activity(+29%). After 2 and 4 wk of WR, however, insulin-stimulated glucose transport activity had returned to control levels, despite a continued elevation (+25-28%) of GLUT-4 protein. At these two time points, glycogen concentration was significantly enhanced in WR soleus (+21-42%), which coincided with significant reductions in glycogen synthase activity ratios (-23 to-41%). These results indicate that, in this model of soleus muscle functional overload, the GLUT-4 protein level may initially regulate insulin-stimulated glucose transport activity in the absence of changes in other modifying factors. However,this regulation of glucose transport activity by GLUT-4 protein may be subsequently overridden by elevated glycogen concentration.

Relationship between gender role attitude and fertility rate in women referring to health centers in Mashhad in 2013.

PubMed

Golmakani, Nahid; Fazeli, Elham; Taghipour, Ali; Shakeri, Mohammad Taghi

2015-01-01

Fertility rate apparently is a non-interventional behavior, but in practice, it is influenced by social values and norms in which culture and traditional beliefs play a significant role. In this regard, some studies have shown that gender roles can be associated with reproductive behaviors. With regard to the importance of annual reduction of population growth rate and its outcomes, the present study was performed to determine the relationship between gender role attitude and fertility rate in women referring to Mashhad health centers in 2013. The present study is an analytical cross-sectional and multistage sampling study performed on 712 women. Data were collected by a questionnaire consisting of two sections: Personal information and gender role attitude questionnaire that contained two dimensions, i.e. gender stereotypes and gender egalitarianism. Its validity was determined by content validity and its reliability by internal consistency (r = 0.77). Data were analyzed by SPSS software version 16. Initial analysis of the data indicated that there was a significant relationship between acceptance of gender stereotypes (P = 0.008) and gender egalitarianism (P < 0.001), and fertility. There was also a direct association between acceptance of gender stereotypes and fertility rate (r = 0.13) and an indirect association between egalitarianism and fertility rate (r = -0.15). The results of the present study indicate that there is an association between gender role attitude and fertility. Paying attention to women's attitude is very important for successful planning in the improvement of fertility rate and population policy.

Determinants of health insurance ownership among South African women.

PubMed

Kirigia, Joses M; Sambo, Luis G; Nganda, Benjamin; Mwabu, Germano M; Chatora, Rufaro; Mwase, Takondwa

2005-02-28

Studies conducted in developed countries using economic models show that individual- and household- level variables are important determinants of health insurance ownership. There is however a dearth of such studies in sub-Saharan Africa. The objective of this study was to examine the relationship between health insurance ownership and the demographic, economic and educational characteristics of South African women. The analysis was based on data from a cross-sectional national household sample derived from the South African Health Inequalities Survey (SANHIS). The study subjects consisted of 3,489 women, aged between 16 and 64 years. It was a non-interventional, qualitative response econometric study. The outcome measure was the probability of a respondent's ownership of a health insurance policy. The chi2 test for goodness of fit indicated satisfactory prediction of the estimated logit model. The coefficients of the covariates for area of residence, income, education, environment rating, age, smoking and marital status were positive, and all statistically significant at p < or = 0.05. Women who had standard 10 education and above (secondary), high incomes and lived in affluent provinces and permanent accommodations, had a higher likelihood of being insured. Poverty reduction programmes aimed at increasing women's incomes in poor provinces; improving living environment (e.g. potable water supplies, sanitation, electricity and housing) for women in urban informal settlements; enhancing women's access to education; reducing unemployment among women; and increasing effective coverage of family planning services, will empower South African women to reach a higher standard of living and in doing so increase their economic access to health insurance policies and the associated health services.

[Prevalence of dermatomycoses in professional football players : A study based on data of German Bundesliga fitness check-ups (2013-2015) compared to data of the general population].

PubMed

Buder, V; Augustin, M; Schäfer, I; Welsch, G; Catala-Lehnen, P; Herberger, K

2018-05-01

The prevention, early diagnosis and treatment of onychomycosis is of great importance for professional athletes to avoid physical limitations by complications. So far, there is only little data on the prevalence of dermatomycosis in professional athletes. The aim of the study was to detect the prevalence of dermatomycosis in professional football players compared to the general population. The prospective, non-interventional, controlled study on the prevalence of dermatomycosis in professional football players was carried out on football players of a German Bundesliga team compared with a previously studied, equivalently aged German working population. A questionnaire survey, a dermatological check-up and a microbiological detection of pathogens in cases of suspicion were performed. Data of 84 football players (n = 45 in 2013; n = 39 in 2015) were compared to data of n = 8186 male employees between 17 and 35 years of age. In the group of athletes, there were findings of 60.7% onychomycosis, 36.9% of tinea pedis and 17.8% of pityriasis versicolor. In the group of the age-equivalent general German working population the findings were: onychomycosis 3.3%, tinea pedis 3.2%, pityriasis versicolor 1.4%. Our study shows a clearly higher risk for fungal diseases of the skin especially on the feet of professional football players. The results show a necessity for elucidation within prevention and the establishment of an appropriate therapy of dermatomycosis for professional football players.

The CASE Programme Implemented Across the Primary and Secondary School Transition in Ireland

NASA Astrophysics Data System (ADS)

McCormack, Lorraine; Finlayson, Odilla E.; McCloughlin, Thomas J. J.

2014-11-01

In the Irish education system, there is little continuity between the primary and secondary education systems. The transfer between these systems is particularly problematic in the area of science. In order to alleviate some of these problems, as well as to enhance the cognitive development of students, the Cognitive Acceleration through Science Education programme was adapted for use and implemented across the primary-secondary school transition in Ireland. The programme was delivered in a variety of ways across the two levels, including the teacher and researcher teaching the programmes individually and team-teaching arrangements. The results on cognitive development measures showed that the students who were taught the programme in primary and secondary school made significant gains, when compared to the non-intervention group. There were also gains evident for students who only received one part of the programme (i.e. in either primary or secondary school). The greater gains, in terms of effect size, were evident at secondary school. The rationale, methodology and results are detailed in this paper.

Differential prognostic utility of NTproBNP and Cystatin C in patients with acute exacerbation of chronic pulmonary disease

PubMed Central

Pérez-Calvo, Juan I; Sánchez-Marteles, Marta; Ruiz-Ruiz, Francisco-José; Morales-Rull, José-Luis; Nieto-Rodríguez, José-Antonio

2010-01-01

Objectives To determine whether serum Cystatin C (CysC) and NTproBNP have prognostic value among patients with long-standing chronic lung disease. Design Prospective, observational, non-interventional study. Setting CysC and NTproBNP are prognostic markers in several cardiac conditions. In addition, CysC acts as an antiprotease following Cathepsin activation, which has been involved in the pathogenesis of chronic obstructive pulmonary disease. Participants Patients with a basal functional status of II-IV (NYHA), admitted for an acute exacerbation of chronic pulmonary diseases and no previous history of symptoms related to pulmonary hypertension or heart failure. Main outcome measures NTproBNP and CysC were determined at admission in 107 patients with acute exacerbation of chronic lung disease. During 12-month follow-up, mortality, new hospital admissions and prescription of diuretics were recorded. Results During follow-up there were eight patient deaths (7.5%). Mean NTproBNP among the deceased was 1510.20 pg/mL (95% CI 498.44–4628.55) vs 502.70 pg/mL (95% CI 395.44–645.48) among survivors (p = 0.01). Twenty-seven patients (25%) were prescribed loop diuretics. Mean concentration of CysC was 1.45 mg/dL (95% CI 1.21–1.69 mg/dL) vs 1.17 mg/dL (95% IC 1.09–1.25 mg/dL) in those not prescribed (p = 0.004). NTproBNP concentration was 837.14 pg/mL (95% CI 555.57–1274.10 pg/mL) in patients prescribed diuretics vs 473.42 pg/mL (95% CI 357.80–632.70 pg/mL) in those not prescribed (p = 0.03). Kaplan-Meier analysis revealed a significant difference between death and diuretic prescription during follow-up when cut-off value for NTproBNP was 550 pg/mL (p = 0.03 and p = 0.02, respectively). For 1.16mg/dL of CsysC, a significant difference was only observed in diuretic prescription (p = 0.007). Conclusions In patients with chronic respiratory diseases NTproBNP has predictive value in terms of mortality whereas CysC does not. However, it is still possible that both can contribute to the early identification of patients at risk of developing clinical ventricular dysfunction. PMID:21103136

Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study)

PubMed Central

Niven, Robert M; Saralaya, Dinesh; Chaudhuri, Rekha; Masoli, Matthew; Clifton, Ian; Mansur, Adel H; Hacking, Victoria; McLain-Smith, Susan; Menzies-Gow, Andrew

2016-01-01

Objective To describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS). Design A non-interventional, mixed methodology study, combining retrospective and prospective data collection for 12 months pre-omalizumab and post-omalizumab initiation, respectively. Setting Data were collected in 22 UK NHS centres, including specialist centres and district general hospitals in the UK. Participants 258 adult patients (aged ≥16 years; 65% women) with severe persistent allergic asthma treated with omalizumab were recruited, of whom 218 (84.5%) completed the study. Primary and secondary outcome measures The primary outcome measure was change in mean daily dose of oral corticosteroids (OCS) between the 12-month pre-omalizumab and post-omalizumab initiation periods. A priori secondary outcome measures included response to treatment, changes in OCS dosing, asthma exacerbations, lung function, employment/education, patient-reported outcomes and hospital resource utilisation. Results The response rate to omalizumab at 16 weeks was 82.4%. Comparing pre-omalizumab and post-omalizumab periods, the mean (95% CIs) daily dose of OCS decreased by 1.61 (−2.41 to −0.80) mg/patient/day (p<0.001) and hospital exacerbations decreased by 0.97 (−1.19 to −0.75) exacerbations/patient (p<0.001). Compared with baseline, lung function, assessed by percentage of forced expiratory volume in 1 s, improved by 4.5 (2.7 to 6.3)% at 16 weeks (p<0.001; maintained at 12 months) and patient quality of life (Asthma Quality of Life Questionnaire) improved by 1.38 (1.18 to 1.58) points at 16 weeks (p<0.001, maintained at 12 months). 21/162 patients with complete employment data gained employment and 6 patients lost employment in the 12-month post-omalizumab period. The mean number of A&E visits, inpatient hospitalisations, outpatient visits (excluding for omalizumab) and number of bed days/patient decreased significantly (p<0.001) in the 12-month post-omalizumab period. Conclusions These data support the beneficial effects of omalizumab on asthma-related outcomes, quality of life and resource utilisation in unselected patients treated in ‘real-world’ clinical practice. PMID:27507234

First-trimester screening for early and late preeclampsia using maternal characteristics, biomarkers, and estimated placental volume.

PubMed

Sonek, Jiri; Krantz, David; Carmichael, Jon; Downing, Cathy; Jessup, Karen; Haidar, Ziad; Ho, Shannon; Hallahan, Terrence; Kliman, Harvey J; McKenna, David

2018-01-01

Preeclampsia is a major cause of perinatal morbidity and mortality. First-trimester screening has been shown to be effective in selecting patients at an increased risk for preeclampsia in some studies. We sought to evaluate the feasibility of screening for preeclampsia in the first trimester based on maternal characteristics, medical history, biomarkers, and placental volume. This is a prospective observational nonintervention cohort study in an unselected US population. Patients who presented for an ultrasound examination between 11-13+6 weeks' gestation were included. The following parameters were assessed and were used to calculate the risk of preeclampsia: maternal characteristics (demographic, anthropometric, and medical history), maternal biomarkers (mean arterial pressure, uterine artery pulsatility index, placental growth factor, pregnancy-associated plasma protein A, and maternal serum alpha-fetoprotein), and estimated placental volume. After delivery, medical records were searched for the diagnosis of preeclampsia. Detection rates for early-onset preeclampsia (<34 weeks' gestation) and later-onset preeclampsia (≥34 weeks' gestation) for 5% and 10% false-positive rates using various combinations of markers were calculated. We screened 1288 patients of whom 1068 (82.99%) were available for analysis. In all, 46 (4.3%) developed preeclampsia, with 13 (1.22%) having early-onset preeclampsia and 33 (3.09%) having late-onset preeclampsia. Using maternal characteristics, serum biomarkers, and uterine artery pulsatility index, the detection rate of early-onset preeclampsia for either 5% or 10% false-positive rate was 85%. With the same protocol, the detection rates for preeclampsia with delivery <37 weeks were 52% and 60% for 5% and 10% false-positive rates, respectively. Based on maternal characteristics, the detection rates for late-onset preeclampsia were 15% and 48% for 5% and 10%, while for preeclampsia at ≥37 weeks' gestation the detection rates were 24% and 43%, respectively. The detection rates for late-onset preeclampsia and preeclampsia with delivery at >37 weeks' gestation were not improved by the addition of biomarkers. Screening for preeclampsia at 11-13+6 weeks' gestation using maternal characteristics and biomarkers is associated with a high detection rate for a low false-positive rate. Screening for late-onset preeclampsia yields a much poorer performance. In this study the utility of estimated placental volume and mean arterial pressure was limited but larger studies are needed to ultimately determine the effectiveness of these markers. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of Therapy Management and Patient Compliance in Postmenopausal Patients with Hormone Receptor-positive Breast Cancer Receiving Letrozole Treatment: The EvaluateTM Study

PubMed Central

Fasching, P. A.; Fehm, T.; Kellner, S.; de Waal, J.; Rezai, M.; Baier, B.; Baake, G.; Kolberg, H.-C.; Guggenberger, M.; Warm, M.; Harbeck, N.; Würstlein, R.; Deuker, J.-U.; Dall, P.; Richter, B.; Wachsmann, G.; Brucker, C.; Siebers, J. W.; Fersis, N.; Kuhn, T.; Wolf, C.; Vollert, H.-W.; Breitbach, G.-P.; Janni, W.; Landthaler, R.; Kohls, A.; Rezek, D.; Noesslet, T.; Fischer, G.; Henschen, S.; Praetz, T.; Heyl, V.; Kühn, T.; Krauß, T.; Thomssen, C.; Kümmel, S.; Hohn, A.; Tesch, H.; Mundhenke, C.; Hein, A.; Rauh, C.; Bayer, C. M.; Jacob, A.; Schmidt, K.; Belleville, E.; Hadji, P.; Wallwiener, D.; Grischke, E.-M.; Beckmann, M. W.; Brucker, S. Y.

2014-01-01

Introduction: The EvaluateTM study (Evaluation of therapy management and patient compliance in postmenopausal hormone receptor-positive breast cancer patients receiving letrozole treatment) is a prospective, non-interventional study for the assessment of therapy management and compliance in the routine care of postmenopausal women with invasive hormone receptor-positive breast cancer receiving letrozole. The parameters for inclusion in the study are presented and discussed here. Material and Methods: Between January 2008 and December 2009 a total of 5045 patients in 310 study centers were recruited to the EvaluateTM study. Inclusion criteria were hormone receptor-positive breast cancer and adjuvant treatment or metastasis. 373 patients were excluded from the analysis for various reasons. Results: A total of 4420 patients receiving adjuvant treatment and 252 patients with metastasis receiving palliative treatment were included in the study. For 4181 patients receiving adjuvant treatment, treatment with the aromatase inhibitor letrozole commenced immediately after surgery (upfront). Two hundred patients had initially received tamoxifen and started aromatase inhibitor treatment with letrozole at 1–5 years after diagnosis (switch), und 39 patients only commenced letrozole treatment 5–10 years after diagnosis (extended endocrine therapy). Patient and tumor characteristics were within expected ranges, as were comorbidities and concurrent medication. Conclusion: The data from the EvaluateTM study will offer a good overview of therapy management in the routine care of postmenopausal women with hormone receptor-positive breast cancer. Planned analyses will look at therapy compliance and patient satisfaction with how information is conveyed and the contents of the conveyed information. PMID:25568468

Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes.

PubMed

Khunti, Kamlesh; Alsifri, Saud; Aronson, Ronnie; Cigrovski Berković, Maja; Enters-Weijnen, Catherine; Forsén, Tom; Galstyan, Gagik; Geelhoed-Duijvestijn, Petronella; Goldfracht, Margalit; Gydesen, Helge; Kapur, Rahul; Lalic, Nebojsa; Ludvik, Bernhard; Moberg, Erik; Pedersen-Bjergaard, Ulrik; Ramachandran, Ambady

2017-08-01

Data on the impact of hypoglycaemia on patients' daily lives and diabetes self-management, particularly in developing countries, are lacking. The aim of this study was to assess fear of, and responses to, hypoglycaemia experienced by patients globally. This non-interventional, multicentre, 4-week prospective study using self-assessment questionnaires and patient diaries consisted of 27,585 patients, ≥18years, with type 1 diabetes (n=8022) or type 2 diabetes (n=19,563) treated with insulin for >12months, at 2004 sites in 24 countries worldwide. Increased blood glucose monitoring (69.7%) and seeking medical assistance (62.0%) were the most common responses in the 4weeks following hypoglycaemic events for patients with type 1 diabetes and type 2 diabetes, respectively. Approximately 44% of patients with type 1 diabetes or type 2 diabetes increased calorie intake in response to a hypoglycaemic episode. Following hypoglycaemia, 3.9% (type 1 diabetes) and 6.2% (type 2 diabetes) of patients took leave from work or study. Regional differences in fear of, and responses to, hypoglycaemia were evident - in particular, a lower level of hypoglycaemic fear and utilisation of healthcare resources in Northern Europe and Canada. Hypoglycaemia has a major impact on patients and their behaviour. These global data for the first time reveal regional variations in response to hypoglycaemia and highlight the importance of patient education and management strategies. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Effects of behavioral activation on default mode network connectivity in subthreshold depression: A preliminary resting-state fMRI study.

PubMed

Yokoyama, Satoshi; Okamoto, Yasumasa; Takagaki, Koki; Okada, Go; Takamura, Masahiro; Mori, Asako; Shiota, Syouichi; Ichikawa, Naho; Jinnin, Ran; Yamawaki, Shigeto

2018-02-01

Subthreshold depression is a risk factor for major depressive disorder, and it is known to have a negative impact on quality of life (QOL). Although behavioral activation, which is one type of cognitive behavioral therapy, is an effective psychological intervention for subthreshold depression, neural mechanisms of behavioral activation are unclear. Enhanced functional connectivity between default mode network (DMN) and the other regions has been demonstrated in participants with subthreshold depression. The purpose of this study was to examine the effects of behavioral activation on DMN abnormalities by using resting-state functional MRI (rs-fMRI). Participants with subthreshold depression (N =40) were randomly assigned to either an intervention group or a non-intervention group. They were scanned using rs-fMRI before and after the intervention. Independent component analysis indicated three subnetworks of the DMN. Analyzing intervention effects on functional connectivity of each subnetwork indicated that connectivity of the anterior DMN subnetwork with the dorsal anterior cingulate was reduced after the intervention. Moreover, this reduction was correlated with an increase in health-related QOL. We did not compare the findings with healthy participants. Further research should be conducted by including healthy controls to verify the results of this study. Mechanisms of behavioral activation might be related to enhanced ability to independently use the dACC and the DMN, which increases an attention control to positive external stimuli. This is the first study to investigate neural mechanisms of behavioral activation using rs-fMRI. Copyright © 2017 Elsevier B.V. All rights reserved.

Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients.

PubMed

Sankey, Christopher; Setnik, Beatrice; Harsanyi, Zoltan; Michalko, Ken; Yang, Zejiang; Geoffroy, Pierre

2016-01-01

Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT). The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use. The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada. Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period. This was a noninterventional study. The main outcome was the number of oxycodonepositive UDSs. The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted. The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.

The Clinical Profile of Patients with Psoriasis in Korea: A Nationwide Cross-Sectional Study (EPI-PSODE).

PubMed

Song, Hae Jun; Park, Chul Jong; Kim, Tae Yoon; Choe, Yong Beom; Lee, Seok-Jong; Kim, Nack In; Cho, Jae We; Jeon, Jie Hyun; Jang, Min Soo; Youn, Jai Il; Kim, Myung Hwa; Park, Joonsoo; Kim, Ki Ho; Kim, Byung Soo; Youn, Sang Woong; Lee, Joo-Heung; Lee, Min-Geol; Ahn, Sung Ku; Won, Young Ho; Yun, Seok Kweon; Shin, Bong Seok; Seo, Seong Jun; Lee, Ji Yeoun; Kim, Kwang Joong; Ro, Young Suck; Kim, Youngdoe; Yu, Dae Young; Choi, Jee-Ho

2017-08-01

Psoriasis is an immune-mediated, chronic inflammatory disease affecting multiple aspects of patients' lives. Its epidemiology varies regionally; however, nationwide epidemiologic data on psoriasis depicting profile of Korean patients has not been available to date. To understand nationwide epidemiologic characteristics and clinical features of adult patients with psoriasis visited university hospitals in Korea. This multicenter, non-interventional, cross-sectional study recruited 1,278 adult patients with psoriasis across 25 centers in Korea in 2013. Various clinical data including PASI, BSA, DLQI, SF-36 and PASE were collected. A total of 1,260 patients completed the study (male:female=1.47:1). The mean age was 47.0 years with a distribution mostly in the 50s (24.9%). Early onset (<40 years) of psoriasis accounted for 53.9% of patients. The mean disease duration was 109.2 months; mean body mass index was 23.9 kg/m 2 ; and 12.7% of patients had a family history of psoriasis. Plaque and guttate types of psoriasis accounted for 85.8% and 8.4%, respectively. Patients with PASI ≥10 accounted for 24.9%; patients with body surface area ≥10 were 45.9%. Patients with DLQI ≥6 accounted for 78.8%. Between PASI <10 and PASI ≥10 groups, significant difference was noted in age at diagnosis, disease duration, blood pressure, waist circumference of female, and treatment experiences with phototherapy, systemic agents, and biologics. This was the first nationwide epidemiologic study of patients with psoriasis in Korea and provides an overview of the epidemiologic characteristics and clinical profiles of this patient population.

Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis.

PubMed

Hengge, Ulrich R; Röschmann, Kristina; Candler, Henning

2017-01-01

Psoriasis is a frequent inflammatory skin disease affecting ~2%-3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon ® ) removes scales in a physical way without any pharmacological effect. To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions. Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score (psoriasis corporis) and the psoriasis scalp severity index score (psoriasis capitis) was performed and evaluated at baseline, after 3 and 7 days of treatment. Baseline scaling scores and redness scores were calculated for two target lesions of the scalp or the body on a 5-point scale each. For the primary efficacy variable scaling score, a statistically significant decrease was observed after treatment, with a relative reduction in scaling of 36.8% after 7 days of treatment within patients affected by psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for these patients and 4.33 days for patients suffering from psoriasis corporis. In conclusion, this trial demonstrated that the dimeticone-based medical device is a safe, well-tolerated, practicable, and efficient keratolytic compound, which can be well implemented in and recommended for standard therapy of psoriasis.

Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis

PubMed Central

Hengge, Ulrich R; Röschmann, Kristina; Candler, Henning

2017-01-01

Introduction Psoriasis is a frequent inflammatory skin disease affecting ~2%–3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon®) removes scales in a physical way without any pharmacological effect. Objective To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions. Methods Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score (psoriasis corporis) and the psoriasis scalp severity index score (psoriasis capitis) was performed and evaluated at baseline, after 3 and 7 days of treatment. Baseline scaling scores and redness scores were calculated for two target lesions of the scalp or the body on a 5-point scale each. Results For the primary efficacy variable scaling score, a statistically significant decrease was observed after treatment, with a relative reduction in scaling of 36.8% after 7 days of treatment within patients affected by psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for these patients and 4.33 days for patients suffering from psoriasis corporis. Conclusion In conclusion, this trial demonstrated that the dimeticone-based medical device is a safe, well-tolerated, practicable, and efficient keratolytic compound, which can be well implemented in and recommended for standard therapy of psoriasis. PMID:29387607

Patients' perception of DED and its relation with time to diagnosis and quality of life: an international and multilingual survey.

PubMed

Labetoulle, Marc; Rolando, Maurizio; Baudouin, Christophe; van Setten, Gysbert

2017-08-01

To improve understanding of patients' experience and perception of dry eye disease (DED) and its impact on quality of life (QoL). This survey was observational, non-interventional and cross-sectional. The survey was conducted online on 706 patients with DED from five European countries (France, Germany, Italy, Spain and the UK). All patients met the following inclusion criteria: 40 years or older with DED diagnosed by a healthcare professional (HCP), not wearing contact lenses and using tear substitutes daily for at least 6 months. The survey (performed in the five native languages) included 9 screening questions (inclusion criteria) and 26 complementary questions about patients' demography, disease history, DED diagnosis, use of relief treatments, perceptions of DED condition and its impact on QoL. Overall, 218 of 706 (31%) patients perceived DED as a 'disease' or even a 'handicap', and 468 of 706 (66%) as a 'discomfort'. High impact of DED on patients' QoL was associated with negative perception, delay in diagnosis, visits to more than one HCP before diagnosis and high frequency of treatment use. This survey also provided us with a list of language-specific keywords that patients used most frequently to spontaneously describe their condition. Findings showed that negative perception of DED, delayed diagnosis and high frequency of treatment use were inter-related, and that all have a negative impact on patients' QoL. The generated language-specific keywords used to describe DED could serve as the basis for a comprehensive QoL questionnaire to be used in clinical settings. 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/.

efficacy of dry extract of ivy leaves in the treatment of productive cough.

PubMed

Schönknecht, Karina; Fal, Andrzej M; Mastalerz-Migas, Agnieszka; Joachimiak, Monika; Doniec, Zbigniew

Introduction: Coughing is a physiological, spontaneous defense mechanism against irritants that stimulate respiratory mucosa. Productive cough should be not suppressed; instead, mucus-dissolving agents are recommended. One of the expectorants, which increases the excretion volume, is the herbal medicine derived from ivy leaves. The ivy extract contains triterpene saponins, which have secretory properties. The aim of this study was to determine the effectiveness and safety of the treatment with the medicinal product Hedussin®, containing dry ivy extract, in the therapy of productive cough in the course of the respiratory tract infection. Material and methods:This was a non-randomized, non-interventional, multicenter, open-label, post-authorization effectiveness study (PAES). The study group consisted of 464 patients aged 2-12 years with productive cough. The study was supported by a questionnaire that included: the type of cough etiological factor, Bronchitis Severity Score (BSS), temperature, and prescription of antibiotic therapy. Effectiveness and safety of the therapy with Hedussin® was assessed at the follow-up visit. Results and conclusion: Improvement in cough was reported in 93.3% subjects; improvement in chest pain on coughing was reported in 84.7%, in wheezing - in 90.0%, in dyspnoea - in 88.7%, and in auscultation changes - in 94.8%. In addition, decline or normalization of body temperature was found in 96.0% of subjects. No adverse drug reactions were reported in the study population. The non-antibiotic treated group showed similar proportions. The results of this study support the efficacy of Hedussin® prescribed for the treatment of productive cough in the course of respiratory tract infections. Hedussin® was well tolerated by sick children aged 2-12 years.

Short term (14 days) consumption of insoluble wheat bran fibre-containing breakfast cereals improves subjective digestive feelings, general wellbeing and bowel function in a dose dependent manner.

PubMed

Lawton, Clare L; Walton, Jenny; Hoyland, Alexa; Howarth, Elaine; Allan, Peter; Chesters, David; Dye, Louise

2013-04-22

This study investigated whether increasing insoluble (predominantly wheat bran) fibre over 14 days improves subjective digestive feelings, general wellbeing and bowel function. A single centre, multi-site, open, within subjects design with a 14 day non-intervention (baseline) monitoring period followed by a 14 day fibre consumption (intervention) period was performed. 153 low fibre consumers (<15 g/day AOAC 985.29) completed a daily symptom diary for 14 days after which they consumed one bowl of ready-to-eat breakfast cereal containing at least 5.4 g fibre (3.5 g from wheat bran) for 14 days and completed a daily symptom diary. Significant improvements were demonstrated in subjective perception of bowel function (e.g., ease of defecation) and digestive feelings (bloating, constipation, feeling sluggish and digestive discomfort). Significant improvements were also found in subjective perception of general wellbeing (feeling less fat, more mentally alert, slim, happy and energetic whilst experiencing less stress, mental and physical tiredness, difficulty concentrating and fewer headaches). In general, improvements in study outcomes increased with increasing cereal/fibre consumption. However, consuming an additional minimum 5.4 g of fibre (3.5 g wheat bran) per day was shown to deliver measurable and significant benefits for digestive health, comfort and wellbeing. Encouraging consumption of relatively small amounts of wheat bran could also provide an effective method of increasing overall fibre consumption.

Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer.

PubMed

Kim, Yeon Hee; Kim, Hwa Jung; Ahn, Seung Do; Seo, Yun Jeong; Kim, So Hee

2013-08-01

To investigate the effects of meditation on anxiety, depression, fatigue, and quality of life in women who are receiving radiation therapy for breast cancer. Randomized, non-program controlled, parallel intervention clinical trial. The ASAN Cancer Center located in Seoul, Korea. The subjects of this study included 102 female breast cancer patients who had undergone breast-conserving surgery; these female patients were randomized into equally assigned meditation control groups, with each group consisting of 51 patients. The test group received a total of 12 meditation therapy sessions during their 6-week radiation therapy period, and the control group underwent only a conventional radiation therapy. The tools used to evaluate the effects of meditation were Hospital Anxiety and Depression scale, Revised Piper Fatigue scale, and European Organization for Research and Treatment of Cancer-Quality of Life Core-30. The results were analyzed based on the principles of intention-to-treat analysis, and, as a corollary analysis, per-protocol analysis was conducted. The breast cancer patients who received meditation therapy compared with the non-intervention group saw improvements in reduction of anxiety (p=.032), fatigue (p=.030), and improvement in global quality of life (p=.028). Based on the results of this study, an affirmation can be made that meditation can be used as a non-invasive intervention treatment for improving fatigue, anxiety, quality of life, and emotional faculties of women with breast cancer. Copyright © 2013 Elsevier Ltd. All rights reserved.

Does Dexamethasone Helps in Meningococcal Sepsis?

PubMed

Tolaj, Ilir; Ramadani, Hamdi; Mehmeti, Murat; Gashi, Hatixhe; Kasumi, Arbana; Gashi, Visar; Jashari, Haki

2017-06-01

Prompt recognition and aggressive early treatment are the only effective measures against invasive meningococcal disease (IMD). Anti-inflammatory adjunctive treatment remains controversial and difficult to assess in patients with IMD. The purpose of this study was to evaluate the effect of dexamethasone (DXM) as adjunctive treatment in different clinical forms of IMD, and attempt to answer if DXM should be routinely used in the treatment of IMD. In this non-interventional clinical study (NIS), 39 patients with meningococcal septicaemia with or without of meningitis were included, and compared regarding the impact of dexamethasone (DXM), as an adjunctive treatment, on the outcome of IMD. SPSS statistics is used for statistical processing of data. Thirty (76.9%) patients with IMD had sepsis and meningitis, and 9 (23.1%) of them had sepsis alone. Dexamethasone was used in 24 (61.5%) cases, in both clinical groups. The overall mortality rate was 10.3%. Pneumonia was diagnosed in 6 patients (15.4%), arthritis in 3 of them (7.7%), and subdural effusion in one patient (2.6%). The data showed a significant statistical difference on the length of hospitalization, and WBC normalization in groups of patients treated with DXM. The use of DXM as adjunctive therapy in invasive meningococcal disease has a degree of proven benefits and no harmful effects. In fighting this very dangerous and complex infection, even a limited benefit is sufficient to recommend the use of DXM as adjunctive treatment in invasive meningococcal disease.

Does Dexamethasone Helps in Meningococcal Sepsis?

PubMed Central

Tolaj, Ilir; Ramadani, Hamdi; Mehmeti, Murat; Gashi, Hatixhe; Kasumi, Arbana; Gashi, Visar; Jashari, Haki

2017-01-01

Purpose: Prompt recognition and aggressive early treatment are the only effective measures against invasive meningococcal disease (IMD). Anti-inflammatory adjunctive treatment remains controversial and difficult to assess in patients with IMD. The purpose of this study was to evaluate the effect of dexamethasone (DXM) as adjunctive treatment in different clinical forms of IMD, and attempt to answer if DXM should be routinely used in the treatment of IMD. Methods: In this non-interventional clinical study (NIS), 39 patients with meningococcal septicaemia with or without of meningitis were included, and compared regarding the impact of dexamethasone (DXM), as an adjunctive treatment, on the outcome of IMD. SPSS statistics is used for statistical processing of data. Results: Thirty (76.9%) patients with IMD had sepsis and meningitis, and 9 (23.1%) of them had sepsis alone. Dexamethasone was used in 24 (61.5%) cases, in both clinical groups. The overall mortality rate was 10.3%. Pneumonia was diagnosed in 6 patients (15.4%), arthritis in 3 of them (7.7%), and subdural effusion in one patient (2.6%). The data showed a significant statistical difference on the length of hospitalization, and WBC normalization in groups of patients treated with DXM. Conclusion: The use of DXM as adjunctive therapy in invasive meningococcal disease has a degree of proven benefits and no harmful effects. In fighting this very dangerous and complex infection, even a limited benefit is sufficient to recommend the use of DXM as adjunctive treatment in invasive meningococcal disease. PMID:28974828

[Physical Exercise and Depression in the Elderly : A Systematic Review].

PubMed

Patiño Villada, Fredy Alonso; Arango Vélez, Elkin Fernando; Baena, Lucidia Zuleta

2013-06-01

The literature supports the benefits of exercise in people with depressive disorders, but there is controversy over these benefits in depressed elderly. To determine the effect of different types of exercise on depression in older adults using a systematic review of clinical trials. The Cochrane Library; PubMed-MEDLINE (1966-dic 2010); EMBASE (1980-dic 2010); LILACS (1986-dic 2010); SCIELO (1998-dic 2010); Register of Controlled Trials; manual search in other sources. Clinical trials with people >60 years with diagnosis of depression were included, without restriction by year of publication, language and sex, with exercise intervention structures, controlled with usual care (medication, psychotherapy, electric shock therapy), placebo or non-intervention. Three independent reviewers conducted the search, applied inclusion and exclusion criteria, assessed methodological quality and extracted data; discrepancies were resolved by consensus. The primary outcome was the score for depressive symptoms. A total of 11 studies (n=7195) were identified. In general, exercise produces an improvement in depression in older adults with more evidence in the short-term (3 months) and strength training at high intensity. Exercise is beneficial for older persons with depression, but studies that support this are of low methodological quality and heterogeneous, which makes it necessary to develop clinical trials to clarify the magnitude of the effect and the levels at which it is beneficial. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Design of a Mediterranean exchange list diet implemented by telephone counseling.

PubMed

Djuric, Zora; Vanloon, Glee; Radakovich, Katherine; Dilaura, Nora M; Heilbrun, Lance K; Sen, Ananda

2008-12-01

A Greek-Mediterranean dietary pattern has two distinct aspects that differ relative to average intakes in the United States: a high intake of monounsaturated fats and a high intake of fruit and vegetables. The purpose of the study was to develop and test an exchange list Greek-Mediterranean diet that could be used in future clinical trials of breast cancer prevention. A total of 69 women, ages 25 to 59 years, were randomized to either continue their own usual diet or follow an intervention diet for 6 months during 2004 through 2005. Intervention goals were to decrease usual fat intakes by about half and to replace those fats with olive oil and other high-monounsaturated fatty acid foods; increase fruit and vegetable intakes to 7 to 9 servings/day, depending on energy intake; and consume at least one serving per day each of culinary herbs and allium vegetables. Registered dietitians provided exchange goals and individualized telephone counseling, and diets were self-selected using a Mediterranean exchange list developed specifically for this study. Changes in diet were assessed by 7-day food records. Results demonstrated that counseling using the Mediterranean exchange list was effective for large dietary changes relative to the nonintervention group. Repeated measures analysis of variance indicated a statistically significant 48% increase in dietary monounsaturated fat with no appreciable change in total fat intake, and a significant increase in fruit and vegetable intake from 4.0 to 8.6 servings/day (P < 0.05).

[Exon-dependent Subgroup-analysis of the Non-interventional REASON-Study: PFS and OS in EGFR-mutated NSCLC Patients Treated with Gefitinib or Chemotherapy].

PubMed

Schuette, W; Dietel, M; Thomas, M; Eberhardt, W; Griesinger, F; Zirrgiebel, U; Radke, S; Schirmacher, P

2016-08-01

To analyze the influence of the localization of mutations in the epidermal growth factor receptor (EGFR) gene on progression-free (PFS) and overall survival (OS) in patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with gefitinib (gef) or chemotherapy (CT) under real world conditions within the REASON study. Subgroups of pts with mutations in exon 19 (n = 141), 18/20 (n = 43), and 21 (n = 104) were analyzed for PFS and OS according to gef or CT treatment and compared using the log-rank test. Pts with mutations in exon 19 and 18/20 treated with gef as first line therapy showed increased PFS and OS compared to CT. This increase was statistically significant in pts with exon 19 mutation (11.3 vs. 6.5 months), but was not found in pts with exon 21 mutation (9.1 vs. 9.3 months). Also, OS was significantly increased in patients with mutation in exon 19 treated with gef ever over all treatment lines compared to CT (21.8 vs. 10.6 months), whereas this was not found in pts with mutation in exon 21 (14.1 vs. 13.9 months). Localization and nature of EGFR mutations influences gefitinib treatment outcomes under routine conditions and should therefore be analyzed in detail. © Georg Thieme Verlag KG Stuttgart · New York.

A Paleolithic Diet with and without Combined Aerobic and Resistance Exercise Increases Functional Brain Responses and Hippocampal Volume in Subjects with Type 2 Diabetes

PubMed Central

Stomby, Andreas; Otten, Julia; Ryberg, Mats; Nyberg, Lars; Olsson, Tommy; Boraxbekk, Carl-Johan

2017-01-01

Type 2 diabetes is associated with impaired episodic memory functions and increased risk of different dementing disorders. Diet and exercise may potentially reverse these impairments. In this study, sedentary individuals with type 2 diabetes treated by lifestyle ± metformin were randomized to a Paleolithic diet (PD, n = 12) with and without high intensity exercise (PDEX, n = 12) for 12 weeks. Episodic memory function, associated functional brain responses and hippocampal gray matter volume was measured by magnetic resonance imaging. A matched, but not randomized, non-interventional group was included as a reference (n = 6). The PD included a high intake of unsaturated fatty acids and protein, and excluded the intake of dairy products, grains, refined sugar and salt. The exercise intervention consisted of 180 min of supervised aerobic and resistance exercise per week. Both interventions induced a significant weight loss, improved insulin sensitivity and increased peak oxygen uptake without any significant group differences. Furthermore, both interventions were associated with increased functional brain responses within the right anterior hippocampus, right inferior occipital gyrus and increased volume of the right posterior hippocampus. There were no changes in memory performance. We conclude that life-style modification may improve neuronal plasticity in brain areas linked to cognitive function in type 2 diabetes. Putative long-term effects on cognitive functions including decreased risk of dementing disorders await further studies. Clinical trials registration number: Clinicaltrials. gov NCT01513798. PMID:29255413

Short Term (14 Days) Consumption of Insoluble Wheat Bran Fibre-Containing Breakfast Cereals Improves Subjective Digestive Feelings, General Wellbeing and Bowel Function in a Dose Dependent Manner

PubMed Central

Lawton, Clare L.; Walton, Jenny; Hoyland, Alexa; Howarth, Elaine; Allan, Peter; Chesters, David; Dye, Louise

2013-01-01

This study investigated whether increasing insoluble (predominantly wheat bran) fibre over 14 days improves subjective digestive feelings, general wellbeing and bowel function. A single centre, multi-site, open, within subjects design with a 14 day non-intervention (baseline) monitoring period followed by a 14 day fibre consumption (intervention) period was performed. 153 low fibre consumers (<15 g/day AOAC 985.29) completed a daily symptom diary for 14 days after which they consumed one bowl of ready-to-eat breakfast cereal containing at least 5.4 g fibre (3.5 g from wheat bran) for 14 days and completed a daily symptom diary. Significant improvements were demonstrated in subjective perception of bowel function (e.g., ease of defecation) and digestive feelings (bloating, constipation, feeling sluggish and digestive discomfort). Significant improvements were also found in subjective perception of general wellbeing (feeling less fat, more mentally alert, slim, happy and energetic whilst experiencing less stress, mental and physical tiredness, difficulty concentrating and fewer headaches). In general, improvements in study outcomes increased with increasing cereal/fibre consumption. However, consuming an additional minimum 5.4 g of fibre (3.5 g wheat bran) per day was shown to deliver measurable and significant benefits for digestive health, comfort and wellbeing. Encouraging consumption of relatively small amounts of wheat bran could also provide an effective method of increasing overall fibre consumption. PMID:23609776

A Paleolithic Diet with and without Combined Aerobic and Resistance Exercise Increases Functional Brain Responses and Hippocampal Volume in Subjects with Type 2 Diabetes.

PubMed

Stomby, Andreas; Otten, Julia; Ryberg, Mats; Nyberg, Lars; Olsson, Tommy; Boraxbekk, Carl-Johan

2017-01-01

Type 2 diabetes is associated with impaired episodic memory functions and increased risk of different dementing disorders. Diet and exercise may potentially reverse these impairments. In this study, sedentary individuals with type 2 diabetes treated by lifestyle ± metformin were randomized to a Paleolithic diet (PD, n = 12) with and without high intensity exercise (PDEX, n = 12) for 12 weeks. Episodic memory function, associated functional brain responses and hippocampal gray matter volume was measured by magnetic resonance imaging. A matched, but not randomized, non-interventional group was included as a reference ( n = 6). The PD included a high intake of unsaturated fatty acids and protein, and excluded the intake of dairy products, grains, refined sugar and salt. The exercise intervention consisted of 180 min of supervised aerobic and resistance exercise per week. Both interventions induced a significant weight loss, improved insulin sensitivity and increased peak oxygen uptake without any significant group differences. Furthermore, both interventions were associated with increased functional brain responses within the right anterior hippocampus, right inferior occipital gyrus and increased volume of the right posterior hippocampus. There were no changes in memory performance. We conclude that life-style modification may improve neuronal plasticity in brain areas linked to cognitive function in type 2 diabetes. Putative long-term effects on cognitive functions including decreased risk of dementing disorders await further studies. Clinical trials registration number: Clinicaltrials. gov NCT01513798.

Text Messaging Improves Participation in Laboratory Testing in Adolescent Liver Transplant Patients.

PubMed

McKenzie, Rebecca B; Berquist, William E; Foley, Megan A; Park, K T; Windsheimer, Jered E; Litt, Iris F

In solid organ transplant patients, non-participation in all aspects of the medical regimen is a prevalent problem associated with adverse consequences particularly in the adolescent and young adult (AYA) age group. This study is the first to evaluate the feasibility, utility and impact of a text messaging (TM) intervention to improve participation in laboratory testing in adolescent liver transplant patients. AYA patients, aged 12 to 21 years, were recruited for a prospective pilot trial evaluating a TM intervention delivered over a 1-year period. The intervention involved automated TM reminders with feedback administered according to a prescribed laboratory testing frequency. Participation rate in laboratory testing after the intervention was compared to the year prior. Patient responses and feedback by text and survey were used to assess feasibility, acceptability and use of the intervention. Forty-two patients were recruited and 33 patients remained enrolled for the study duration. Recipients of the TM intervention demonstrated a significant improvement in participation rate in laboratory testing from 58% to 78% (P<.001). This rate was also significantly higher than in non-intervention controls (P=.003). There was a high acceptability, response rate and a significant correlation with reported versus actual completion of laboratory tests by TM. TM reminders significantly improved participation in laboratory testing in AYA liver transplant patients. The intervention demonstrated feasibility, acceptability, and use with a high proportion of patients who engaged in and perceived a benefit from using this technology.

The feasibility of measuring renal blood flow using transesophageal echocardiography in patients undergoing cardiac surgery.

PubMed

Yang, Ping-Liang; Wong, David T; Dai, Shuang-Bo; Song, Hai-Bo; Ye, Ling; Liu, Jin; Liu, Bin

2009-05-01

There is no reliable method to monitor renal blood flow intraoperatively. In this study, we evaluated the feasibility and reproducibility of left renal blood flow measurements using transesophageal echocardiography during cardiac surgery. In this prospective noninterventional study, left renal blood flow was measured with transesophageal echocardiography during three time points (pre-, intra-, and postcardiopulmonary bypass) in 60 patients undergoing cardiac surgery. Sonograms from 6 subjects were interpreted by 2 blinded independent assessors at the time of acquisition and 6 mo later. Interobserver and intraobserver reproducibility were quantified by calculating variability and intraclass correlation coefficients. Patients with Doppler angles of >30 degrees (20 of 60 subjects) were eliminated from renal blood flow measurements. Left renal blood flow was successfully measured and analyzed in 36 of 60 (60%) subjects. Both interobserver and intraobserver variability were <10%. Interobserver and intraobserver reproducibility in left renal blood flow measurements were good to excellent (intraclass correlation coefficients 0.604-0.999). Left renal arterial luminal diameter for the pre, intra, and postcardiopulmonary bypass phases, ranged from 3.8 to 4.1 mm, renal arterial velocity from 25 to 35 cm/s, and left renal blood flow from 192 to 299 mL/min. In patients undergoing cardiac surgery, it was feasible in 60% of the subjects to measure left renal blood flow using intraoperative transesophageal echocardiography. The interobserver and intraobserver reproducibility of renal blood flow measurements was good to excellent.

Real world data of 1473 patients treated with ulipristal acetate for uterine fibroids: Premya study results.

PubMed

Fernandez, Hervé; Schmidt, Torsten; Powell, Martin; Costa, Ana Patrícia Freitas; Arriagada, Pablo; Thaler, Christian

2017-01-01

To characterize and describe treatment with Ulipristal acetate (UPA) in a pre-operative setting and to evaluate the safety, effectiveness, and Health Related Quality of Life (HRQoL) outcomes in a population treated according to standard clinical practice in the EU. Multi-centre, prospective, non-interventional study (PREMYA) of patients diagnosed with moderate to severe symptoms of uterine fibroids and undergoing a pre-operative treatment with UPA (Esmya ® ) at 73 clinical practice sites within the EU. Patients were followed during UPA treatment and for 12 months after treatment discontinuation for a total of 15 months follow-up. Data was collected every 3 months in accordance with standard care visits. A total of 1568 women were enrolled, of whom 1473 were found to be eligible for data analysis. Only 38.8% of patients underwent surgery, of which the majority were of a conservative/minimally invasive nature. Physicians' assessments of patients' overall symptomatic change, as measured on the Clinical Global Impression-Improvement (CGI-I) scale, indicated that 60% of patients were much improved or very much improved at 3 months. Pain and quality of life after treatment cessation remain lower than baseline during the entire period of follow-up CONCLUSIONS: The majority of patients do not undergo surgery immediately after treatment cessation. Quality of life and pain are highly improved by Esmya ® treatment. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.