Increasing clinical relevance in oral radiology: Benefits and challenges when implementing digital assessment.

PubMed

de Lange, T; Møystad, A; Torgersen, G R

2018-02-13

The aims of the study were to investigate benefits and challenges in implementing a digital examination and study the clinical relevance of the digital examination in relation to clinical training and practice. The study was based on semi-structured focus-group interviews from two distinct student populations (2016 and 2017) in a bachelor programme in dental hygiene. In addition, conversational data from a plenary discussion from the whole second student population (2017) were collected and analysed. The data were approached on basis of content analysis. A benefit experienced in the digital examination was the ease in typing and editing answers on the computer. This suggests an increased effectiveness in computer-based compared to analogue examinations. An additional advantage was the experienced relevance of the examination related to the clinic. This finding refers not only to the digital presentations of images, but also to the entire setting in the clinic and dental practice. The limitations reported by the students were non-optimal viewing conditions for presenting radiographic images and difficulties in obtaining an overview of the assignments compared to paper-based examinations due to the linear digital examination format. The last finding on lacking overview revealed an influence on student performances which should be taken seriously in designing digital examinations. In conclusion, the digital layout increases efficiency and clinical relevance of examinations to a certain extent. Obstacles were found in limitations related to image presentation and lack of overview of the examination. The latter challenge raises questions related to developing suitable assessment software. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical benefit and preservation of flavonols in dark chocolate manufacturing.

PubMed

McShea, Andrew; Ramiro-Puig, Emma; Munro, Sandra B; Casadesus, Gemma; Castell, Margarida; Smith, Mark A

2008-11-01

The consumption of high-cacao-content chocolate has been associated with positive health benefits ascribed to flavanol [corrected] antioxidants derived from the ground, fermented cocoa seeds of Theobroma cacao. However, flavanols [corrected] impart a bitter, astringent flavor to foodstuffs, frequently masked in chocolates and confections by aggressive processing and adulteration with other flavors. Recent reports have implied that not all varieties of dark chocolate are created equally, and significant caveats exist regarding its potential health benefits. It is perhaps not surprising that extensive processing, dilution, and the addition of flavor modifiers may improve the palatability of chocolate, but could have negative nutritional and clinical benefits. This article examines the chemical composition of chocolate and the clinical data associated with the consumption of flavonoid-rich cocoa. We review the steps in chocolate manufacturing that directly affect the antioxidant levels in chocolate products, and the caveats associated with claims of health benefits from the consumption of dark chocolate.

Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials.

PubMed

Altman, Roy D; Devji, Tahira; Bhandari, Mohit; Fierlinger, Anke; Niazi, Faizan; Christensen, Robin

2016-10-01

Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA. MEDLINE and Embase databases were searched for articles published up to and including August 14th, 2014. Two reviewers assessed the eligibility of potential reports and the risk of bias of included trials. We analyzed short (≤3 months) and long-term (6-12 months) pain reduction of the saline arm of included trials using standardized mean differences (SMDs; estimated assuming a null effect in a comparator group) that were combined and weighted using a random effects model. Treatment-related adverse events (AEs) were tabulated and presented using descriptive statistics. From 40 randomized controlled trials (RCTs) eligible for inclusion only 38 provided sufficient data to be included in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P < 0.001; I(2) = 50%). Long-term knee pain was significantly decreased following IA injection with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P < 0.001) with a substantial degree of inconsistency (I(2) = 74%). Overall, 29 of the included trials reported on adverse events, none of which found any serious treatment-related AEs following IA injection with saline. Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

PubMed

Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

2017-01-01

The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P < 0.001]. Among the 226 RCTs for which the ESMO-MCBS could be applied, 31% (70/226) were designed to detect an effect size that could meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs. © The Author 2016. 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.

A Comparative Analysis of Mandated Benefit Laws, 1949–2002

PubMed Central

Laugesen, Miriam J; Paul, Rebecca R; Luft, Harold S; Aubry, Wade; Ganiats, Theodore G

2006-01-01

Objective To understand and compare the trends in mandated benefits laws in the United States. Data Sources/Study Setting Mandated benefit laws enacted in 50 states and the District of Columbia for the period 1949–2002 were compiled from multiple published compendia. Study Design Laws that require private insurers and health plans to cover particular services, types of diseases, or care by specific providers in 50 states and the District of Columbia are compared for the period 1949–2002. Legislation is compared by year, by average and total frequency, by state, by type (provider, health care service, or preventive), and according to whether it requires coverage or an offer of coverage. Data Collection/Extraction Method Data from published tables were entered into a spreadsheet and analyzed using statistical software. Principal Findings A total of 1,471 laws mandated coverage for 76 types of providers and services. The most common type of mandated coverage is for specific health care services (670 laws for 34 different services), followed by laws for services offered by specific professionals and other providers (507 mandated benefits laws for 25 types of providers), and coverage for specific preventive services (295 laws for 17 benefits). On average, a mandated benefit law has been adopted or significantly revised by 19 states, and each state has approximately 29 mandates. Only two benefits (minimum maternity stay and breast reconstruction) are mandated in all 51 jurisdictions and these were also federally mandated benefits. The mean number of total mandated benefit laws adopted or significantly revised per year was 17 per year in the 1970s, 36 per year in the 1980s, 59 per year in the 1990s, and 76 per year between 2000 and 2002. Since 1990, mandate adoption increased substantially, with around 55 percent of all mandated benefit laws enacted between 1990 and 2002. Conclusions There was a large increase in the number of mandated benefits laws during the managed

Exploring the Use of Cost-Benefit Analysis to Compare Pharmaceutical Treatments for Menorrhagia.

PubMed

Sanghera, Sabina; Frew, Emma; Gupta, Janesh Kumar; Kai, Joe; Roberts, Tracy Elizabeth

2015-09-01

The extra-welfarist theoretical framework tends to focus on health-related quality of life, whilst the welfarist framework captures a wider notion of well-being. EQ-5D and SF-6D are commonly used to value outcomes in chronic conditions with episodic symptoms, such as heavy menstrual bleeding (clinically termed menorrhagia). Because of their narrow-health focus and the condition's periodic nature these measures may be unsuitable. A viable alternative measure is willingness to pay (WTP) from the welfarist framework. We explore the use of WTP in a preliminary cost-benefit analysis comparing pharmaceutical treatments for menorrhagia. A cost-benefit analysis was carried out based on an outcome of WTP. The analysis is based in the UK primary care setting over a 24-month time period, with a partial societal perspective. Ninety-nine women completed a WTP exercise from the ex-ante (pre-treatment/condition) perspective. Maximum average WTP values were elicited for two pharmaceutical treatments, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral treatment. Cost data were offset against WTP and the net present value derived for treatment. Qualitative information explaining the WTP values was also collected. Oral treatment was indicated to be the most cost-beneficial intervention costing £107 less than LNG-IUS and generating £7 more benefits. The mean incremental net present value for oral treatment compared with LNG-IUS was £113. The use of the WTP approach was acceptable as very few protests and non-responses were observed. The preliminary cost-benefit analysis results recommend oral treatment as the first-line treatment for menorrhagia. The WTP approach is a feasible alternative to the conventional EQ-5D/SF-6D approaches and offers advantages by capturing benefits beyond health, which is particularly relevant in menorrhagia.

Clinical Practice Informs Secure Messaging Benefits and Best Practices.

PubMed

Haun, Jolie N; Hathaway, Wendy; Chavez, Margeaux; Antinori, Nicole; Vetter, Brian; Miller, Brian K; Martin, Tracey L; Kendziora, Lisa; Nazi, Kim M; Melillo, Christine

2017-10-01

Background Clinical care team members in Department of Veterans' Affairs (VA) facilities nationwide are working to integrate the use of Secure Messaging (SM) into care delivery and identify innovative uses. Identifying best practices for proactive use of SM is a key factor in its successful implementation and sustained use by VA clinical care team members and veterans. Objectives A collaborative project solicited input from VA clinical care teams about their local practices using SM to provide access to proactive patient-centered care for veterans and enhance workflow. Methods This project implemented a single-item cross-sectional qualitative electronic survey via internal e-mail to local coordinators in all 23 Veterans Integrated Service Networks (VISNs). Content analysis was used to manage descriptive data responses. Descriptive statistics described sample characteristics. Results VA clinical care team members across 15 of 23 VISNs responded to the questionnaire. Content analysis of 171 responses produced two global domains: (1) benefits of SM and (2) SM best practices. Benefits of SM use emphasize enhanced and efficient communication and increased access to care. Care team members incorporate SM into their daily clinical practices, using it to provide services before, during, and after clinical encounters as a best practice. SM users suggest improvements in veteran care, clinical team workflow, and efficient use of health resources. Clinical team members invested in the successful implementation of SM integrate SM into their daily practices to provide meaningful and useful veteran-centered care and improve workflow. Conclusion VA clinical care team members can use SM proactively to create an integrated SM culture. With adequate knowledge and motivation to proactively use this technology, all clinical team members within the VA system can replicate best practices shared by other clinical care teams to generate meaningful and useful interactions with SM

Percutaneous endoscopic gastrostomy: confirming the clinical benefits far beyond anthropometry.

PubMed

Cúrdia, Gonçalves T; Marinho, Carla; Magalhães, Joana; Barbosa, Mara; Monteiro, Sara; Dias de Castro, Francisca; Boal Carvalho, Pedro; Rosa, Bruno; Figueiredo, Lília; Cotter, José

2017-09-01

The real benefit of gastrostomy is still a matter of debate. We aimed to prospectively evaluate the global impact of percutaneous endoscopic gastrostomy (PEG) in patients followed at a specialized multidisciplinary clinic, namely, the impact on the need for healthcare resources, anthropometric measures, pressure ulcers prevention and healing, and nutritional and hydration status. From the 201 patients who underwent PEG between May 2011 and September 2014, 60 were included in a prospective study. Anthropometric, clinical, and laboratorial variables were collected and compared before and after PEG. Follow-up duration, mortality, and number of emergency department visits or hospital admissions were also assessed. Thirty-three (55.0%) patients were women and the median age was 79 years. The main indications for PEG were dementia (43.3%) and poststroke dysphagia (30.0%). Four months following PEG, significant decreases in the tricipital skinfold (P=0.002) and brachial perimeter (P=0.003) were found. A decrease in the mean number of hospitalizations (1.4 vs. 0.3; P<0.001) and visits to emergency department (2.2 vs. 1.1; P=0.003) was noted in the next 6 months after PEG compared with the previous semester. In 53.8% of patients with pressure ulcers, complete healing was observed after PEG. PEG was associated with increases in hemoglobin (P=0.024), lymphocytes (P=0.041), cholesterol (P=0.008), transferrin (P<0.001), albumin (P<0.001), and total proteins (P<0.001), and a decrease in serum sodium (P=0.001). Anthropometric values may not translate the early benefits of a gastrostomy. PEG decreases the need for hospital health care, facilitates healing of pressure ulcers, and induces biochemical changes that may reflect better nutrition and hydration.

Antibiotics in aggressive periodontitis, is there a clinical benefit?

PubMed

Rajendra, Anjana; Spivakovsky, Silvia

2016-12-01

Data sourcesMedline, Embase and CENTRAL databases were searched up to December 2014. Unpublished data were sought by searching a database listing unpublished studies OpenGray [http://www.opengrey.eu/], formerly OpenSIGLE.Study selectionRandomised clinical trials assessing treatment of patients with AgP comparing scaling and root planing (SRP) alone with SRP plus a single antibiotic or a combination of drugs with a minimum of three months follow-up were considered. Studies specifically designed to evaluate smokers or subjects with diabetes mellitus and HIV/AIDS were not included.Data extraction and synthesisTwo researchers independently screened titles, abstracts and full texts of the search results. The studies, which fulfilled inclusion criteria, underwent validity assessment and data extraction using a specifically designed form. The quality of included studies was assessed using the Cochranes collaboration tool for risk of bias. Only two of the 11 included trials were considered at a low risk of bias. The data extracted from ten studies was analysed by pair-wise meta-analyses and the data extracted from five studies was included in Bayesian network meta-analyses pooled estimates. The six studies evaluated in the pairwise meta-analyses were excluded in the pooled estimates because four studies included patients with advanced disease only and one study did not present average data for pocket depth (PD) and clinical attachment level (CAL) and another one for using a different mechanical treatment.ResultsFourteen studies reporting 11 randomised clinical trials with a total of 388 patients were included in the review. Nine of 11 studies reported a statistically significant greater gain in full mouth mean clinical attachment (CA) and reduction in probing depth (PD) when a systemic antibiotic was used. From those studies the calculated mean difference for CA gained was 1.08 mm (p < 0.0001) and for PD reduction was 1.05 mm (p< 0.00001) for SRP + Metronidazole (Mtz). For

Liver Cirrhosis in Patients With Atrial Fibrillation: Would Oral Anticoagulation Have a Net Clinical Benefit for Stroke Prevention?

PubMed

Kuo, Ling; Chao, Tze-Fan; Liu, Chia-Jen; Lin, Yenn-Jiang; Chang, Shih-Lin; Lo, Li-Wei; Hu, Yu-Feng; Tuan, Ta-Chuan; Liao, Jo-Nan; Chung, Fa-Po; Chen, Tzeng-Ji; Lip, Gregory Y H; Chen, Shih-Ann

2017-06-23

Patients with liver cirrhosis have been excluded from randomized clinical trials of oral anticoagulation therapy for stroke prevention in atrial fibrillation. We hypothesized that patients with liver cirrhosis would have a positive net clinical benefit for oral anticoagulation when used for stroke prevention in atrial fibrillation. This study used the National Health Insurance Research Database in Taiwan. Among 289 559 atrial fibrillation patients aged ≥20 years, there were 10 336 with liver cirrhosis, and 9056 of them having a CHA 2 DS 2 -VASc score ≥2 were divided into 3 groups, that is, no treatment, antiplatelet therapy, and warfarin. Patients with liver cirrhosis had a higher risk of ischemic stroke (hazard ratio=1.10, P =0.046) and intracranial hemorrhage (hazard ratio=1.20, P =0.043) compared with those without. Among patients with liver cirrhosis, patients taking antiplatelet therapy had a similar risk of ischemic stroke (hazard ratio=1.02, 95%CI=0.88-1.18) compared to those without antithrombotic therapies, but the risk was significantly lowered among warfarin users (hazard ratio=0.76, 95%CI=0.58-0.99). For intracranial hemorrhage, there were no significant differences between those untreated and those taking antiplatelet therapy or warfarin. The use of warfarin was associated with a positive net clinical benefit compared with being untreated or receiving only antiplatelet therapy. For atrial fibrillation patients with liver cirrhosis in the current analysis of an observational study, warfarin use was associated with a lower risk of ischemic stroke and a positive net clinical benefit compared with nontreatment, and thus, thromboprophylaxis should be considered for such patients. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Comprehensive cancer-gene panels can be used to estimate mutational load and predict clinical benefit to PD-1 blockade in clinical practice.

PubMed

Campesato, Luís Felipe; Barroso-Sousa, Romualdo; Jimenez, Leandro; Correa, Bruna R; Sabbaga, Jorge; Hoff, Paulo M; Reis, Luiz F L; Galante, Pedro Alexandre F; Camargo, Anamaria A

2015-10-27

Cancer gene panels (CGPs) are already used in clinical practice to match tumor's genetic profile with available targeted therapies. We aimed to determine if CGPs could also be applied to estimate tumor mutational load and predict clinical benefit to PD-1 and CTLA-4 checkpoint blockade therapy. Whole-exome sequencing (WES) mutation data obtained from melanoma and non-small cell lung cancer (NSCLC) patients published by Snyder et al. 2014 and Rizvi et al. 2015, respectively, were used to select nonsynonymous somatic mutations occurring in genes included in the Foundation Medicine Panel (FM-CGP) and in our own Institutional Panel (HSL-CGP). CGP-mutational load was calculated for each patient using both panels and was associated with clinical outcomes as defined and reported in the original articles. Higher CGP-mutational load was observed in NSCLC patients presenting durable clinical benefit (DCB) to PD-1 blockade (FM-CGP P=0.03, HSL-CGP P=0.01). We also observed that 69% of patients with high CGP-mutational load experienced DCB to PD-1 blockade, as compared to 20% of patients with low CGP-mutational load (FM-CGP and HSL-CGP P=0.01). Noteworthy, predictive accuracy of CGP-mutational load for DCB was not statistically different from that estimated by WES sequencing (P=0.73). Moreover, a high CGP-mutational load was significantly associated with progression-free survival (PFS) in patients treated with PD-1 blockade (FM-CGP P=0.005, HR 0.27, 95% IC 0.105 to 0.669; HSL-CGP P=0.008, HR 0.29, 95% IC 0.116 to 0.719). Similar associations between CGP-mutational load and clinical benefit to CTLA-4 blockade were not observed. In summary, our data reveals that CGPs can be used to estimate mutational load and to predict clinical benefit to PD-1 blockade, with similar accuracy to that reported using WES.

Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

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

Tabibian, Art A., E-mail: art.tabibian@gmail.com; Powers, Adam; Dolormente, Keith

In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample.more » The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from −4.7 to +3.0 and the average absolute performance results ranged from −6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.« less

Model for investigating the benefits of clinical supervision in psychiatric nursing: a survey study.

PubMed

Gonge, Henrik; Buus, Niels

2011-04-01

The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample was 136 nursing staff members in permanent employment on nine general psychiatric wards and at four community mental health centres at a Danish psychiatric university hospital. Data were collected by means of a set of questionnaires. Participation in clinical supervision was associated with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses indicated that certain individual and workplace factors were related to subscales of the MCSS, as well as some of the benefits. The study supported the suggested model, but methodological limitations apply. © 2011 The Authors. International Journal of Mental Health Nursing © 2011 Australian College of Mental Health Nurses Inc.

Clinically localized prostate cancer in 2017: A review of comparative effectiveness.

PubMed

Lavery, Hugh J; Cooperberg, Matthew R

2017-02-01

Introducing the topic of comparative effectiveness for prostate cancer treatments with a reminder of the disease's heterogeneity risks tautology. However, the profound variation both in this cancer's biology and its clinical course is increasingly widely recognized, while management alternatives for clinically localized prostate cancer have exploded. Available options now include active surveillance, multiple surgical approaches to prostatectomy, various forms of external-beam and interstitial radiation, and a growing list of energy ablative technologies. Each treatment option has its own efficacy rate as well as its own set of complications, side effects and financial costs. Difficulties comparing these options, together with the high prevalence of the disease, led the Institute of Medicine to include localized prostate cancer among the top 25 priority conditions for future comparative effectiveness research. The sheer volume of possible treatment options, with their individual risks and benefits, can be confusing for patients and clinicians to research, understand and explain. To help clinicians navigate these treatment options, we have assembled this Urologic Oncology Seminar on the comparative effectiveness of treatments for clinically localized prostate cancer. The articles focus on high quality evidence-based medicine and most have included useful tables summarizing seminal trials and available resources. Copyright © 2017 Elsevier Inc. All rights reserved.

Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products.

PubMed

Wen, Shihua; Zhang, Lanju; Yang, Bo

2014-07-01

The Problem formulation, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk attitude, and Linked decisions (PrOACT-URL) framework and multiple criteria decision analysis (MCDA) have been recommended by the European Medicines Agency for structured benefit-risk assessment of medicinal products undergoing regulatory review. The objective of this article was to provide solutions to incorporate the uncertainty from clinical data into the MCDA model when evaluating the overall benefit-risk profiles among different treatment options. Two statistical approaches, the δ-method approach and the Monte-Carlo approach, were proposed to construct the confidence interval of the overall benefit-risk score from the MCDA model as well as other probabilistic measures for comparing the benefit-risk profiles between treatment options. Both approaches can incorporate the correlation structure between clinical parameters (criteria) in the MCDA model and are straightforward to implement. The two proposed approaches were applied to a case study to evaluate the benefit-risk profile of an add-on therapy for rheumatoid arthritis (drug X) relative to placebo. It demonstrated a straightforward way to quantify the impact of the uncertainty from clinical data to the benefit-risk assessment and enabled statistical inference on evaluating the overall benefit-risk profiles among different treatment options. The δ-method approach provides a closed form to quantify the variability of the overall benefit-risk score in the MCDA model, whereas the Monte-Carlo approach is more computationally intensive but can yield its true sampling distribution for statistical inference. The obtained confidence intervals and other probabilistic measures from the two approaches enhance the benefit-risk decision making of medicinal products. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences

PubMed Central

Sarli, Cathy C.; Suiter, Amy M.; Carothers, Bobbi J.; Combs, Todd B.; Allen, Jae L.; Beers, Courtney E.; Evanoff, Bradley A.

2017-01-01

Abstract We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in‐house expert panel feedback. Three case studies illustrate the feasibility and face validity of the TSBM for identification of clinical and community health impacts that result from translational science activities. Future plans for the TSBM include further pilot testing and a resource library that will be freely available for evaluators, translational scientists, and academic institutions who wish to implement the TSBM framework in their own evaluation efforts. PMID:28887873

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

Key clinical benefits of neuroimaging at 7T.

PubMed

Trattnig, Siegfried; Springer, Elisabeth; Bogner, Wolfgang; Hangel, Gilbert; Strasser, Bernhard; Dymerska, Barbara; Cardoso, Pedro Lima; Robinson, Simon Daniel

2018-03-01

The growing interest in ultra-high field MRI, with more than 35.000 MR examinations already performed at 7T, is related to improved clinical results with regard to morphological as well as functional and metabolic capabilities. Since the signal-to-noise ratio increases with the field strength of the MR scanner, the most evident application at 7T is to gain higher spatial resolution in the brain compared to 3T. Of specific clinical interest for neuro applications is the cerebral cortex at 7T, for the detection of changes in cortical structure, like the visualization of cortical microinfarcts and cortical plaques in Multiple Sclerosis. In imaging of the hippocampus, even subfields of the internal hippocampal anatomy and pathology may be visualized with excellent spatial resolution. Using Susceptibility Weighted Imaging, the plaque-vessel relationship and iron accumulations in Multiple Sclerosis can be visualized, which may provide a prognostic factor of disease. Vascular imaging is a highly promising field for 7T which is dealt with in a separate dedicated article in this special issue. The static and dynamic blood oxygenation level-dependent contrast also increases with the field strength, which significantly improves the accuracy of pre-surgical evaluation of vital brain areas before tumor removal. Improvement in acquisition and hardware technology have also resulted in an increasing number of MR spectroscopic imaging studies in patients at 7T. More recent parallel imaging and short-TR acquisition approaches have overcome the limitations of scan time and spatial resolution, thereby allowing imaging matrix sizes of up to 128×128. The benefits of these acquisition approaches for investigation of brain tumors and Multiple Sclerosis have been shown recently. Together, these possibilities demonstrate the feasibility and advantages of conducting routine diagnostic imaging and clinical research at 7T. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights

Cost-benefit of a clinical services integrated with a decentralized unit dose system.

PubMed

Warrian, K; Irvine-Meek, J

1988-06-01

Clinical pharmacy services are believed to be beneficial to patient care and to have the potential to reduce drug costs. This study was designed to apply cost-benefit analysis techniques to selected clinical pharmacy services provided by staff pharmacists assigned to a mobile decentralized unit-dose drug distribution system. Pharmacists' interventions were identified and recorded by the pharmacists and the investigator over an eight-week period. Interventions, to which a monetary value could be assigned, included non-formulary drug use, drug regimen adjustments, and the duration of drug therapy. A total of 543 interventions were recorded or observed. Of these, 174 (32 percent) fit the criteria for inclusion in the study. Those interventions accepted by physicians (87 percent) were assigned a dollar value and tabulated. Costs to provide the service were the pharmacists' salaries. Benefit to cost ratios of 1.08 and 1.59 demonstrated that the benefits accrued from selected clinical pharmacy services exceeded the costs to the hospital.

Clinical, Ergonomic, and Economic Outcomes With Multichamber Bags Compared With (Hospital) Pharmacy Compounded Bags and Multibottle Systems: A Systematic Literature Review.

PubMed

Alfonso, Jorge Emilio; Berlana, David; Ukleja, Andrew; Boullata, Joseph

2017-09-01

Multichamber bags (MCBs) may offer potential clinical, ergonomic, and economic advantages compared with (hospital) pharmacy compounded bags (COBs) and multibottle systems (MBSs). A systematic literature review was performed to identify and assess the available evidence regarding advantages of MCBs compared with COBs and MBSs. Medline, Embase, the Cochrane Databases, and EconLit were searched for articles reporting clinical, ergonomic, and economic outcomes for MCBs compared with COBs or MBSs. The search was limited to studies conducted in hospitalized patients >2 years of age that were published in English between January 1990 and November 2014. The Population Intervention Comparison Outcomes Study Design (PICOS) framework was used for the analysis. From 1307 unique citations, 74 potentially relevant publications were identified; review of references identified 2 additional publications. Among the 76 publications, 18 published studies met the inclusion criteria. Most were retrospective in design. Ten studies reported clinical outcomes, including 1 prospective randomized trial and multiple retrospective analyses that reported a lower risk of bloodstream infection for MCBs compared with other delivery systems. Sixteen studies reported ergonomic and/or economic outcomes; most reported a potential cost benefit for MCBs, with consistent reports of reduced time and labor compared with other systems. The largest cost benefit was observed in studies evaluating total hospitalization costs. The systematic literature review identified evidence of potential clinical, ergonomic, and economic benefits for MCBs compared with COBs and MBSs; however, methodological factors limited evidence quality. More prospective studies are required to corroborate existing evidence.

Economic and clinical benefit of collagenase ointment compared to a hydrogel dressing for pressure ulcer debridement in a long-term care setting.

PubMed

Waycaster, Curtis; Milne, Catherine

2013-06-01

The purpose of this study is to determine the cost-effectiveness of collagenase ointment relative to autolysis with a hydrogel dressing when debriding necrotic pressure ulcers in a long-term care setting. A Markov decision process model with 2 states (necrotic nonviable wound bed transitioning to a granulated viable wound bed) was developed using data derived from a prospective, randomized, 6-week, single-center trial of 27 institutionalized subjects with pressure ulcers that were ≥ 85% necrotic nonviable tissue. Direct medical costs from the payer perspective included study treatments, wound treatment supplies, and nursing time. Clinical benefit was measured as "granulation days" and was derived from the time-dependent debridement rates of the alternative products. The average cost per patient for 42 days of pressure ulcer care was $1,817 in 2012 for the collagenase group and $1,611 for the hydrogel group. Days spent with a granulated wound were 3.6 times higher for collagenase (23.4 vs 6.5) than with the hydrogel. The estimated cost per granulation day was > 3.2 times higher for hydrogel ($249) vs collagenase ($78). In this economic analysis based on a randomized, controlled clinical trial, collagenase ointment resulted in a faster time to complete debridement and was more cost-effective than hydrogel autolysis for pressure ulcers in a long-term care setting. Even though collagenase ointment has a higher acquisition cost than hydrogel, the clinical benefit offsets the initial cost difference, resulting in lower cost per granulation day to the nursing home over the course of the 42-day analysis.

Comparative benefit of malaria chemoprophylaxis modelled in United Kingdom travellers.

PubMed

Toovey, Stephen; Nieforth, Keith; Smith, Patrick; Schlagenhauf, Patricia; Adamcova, Miriam; Tatt, Iain; Tomianovic, Danitza; Schnetzler, Gabriel

2014-01-01

Chemoprophylaxis against falciparum malaria is recommended for travellers from non-endemic countries to malarious destinations, but debate continues on benefit, especially with regard to mefloquine. Quantification of benefit for travellers from the United Kingdom (UK) was modelled to assist clinical and public health decision making. The model was constructed utilising: World Tourism Organization data showing total number of arrivals from the UK in countries with moderate or high malaria risk; data from a retrospective UK Clinical Practice Research Datalink (CPRD) drug utilisation study; additional information on chemoprophylaxis, case fatality and tolerability were derived from the travel medicine literature. Chemoprophylaxis with the following agents was considered: atovaquone-proguanil (AP), chloroquine with and without proguanil (C ± P), doxycycline (Dx), mefloquine (Mq). The model was validated for the most recent year with temporally matched datasets for UK travel destinations and imported malaria (2007) against UK Health Protection Agency data on imported malaria. The median (mean) duration of chemoprophylaxis for each agent in weeks (CPRD) was: AP 3.3 (3.5), C ± P 9 (12.1), Dx 8 (10.3), Mq 9 (12.3): the maximum duration of use of all regimens was 52 weeks. The model correctly predicted falciparum malaria deaths and gave a robust estimate of total cases--model: 5 deaths from 1118 cases; UK Health Protection Agency: 5 deaths from 1153 cases. The number needed to take chemoprophylaxis (NNP) to prevent a case of malaria considered against the 'background' reported incidence in non-users of chemoprophylaxis deemed in need of chemoprophylaxis was: C ± P 272, Dx 269, Mq 260, AP 252; the NNP to prevent a UK traveller malaria death was: C ± P 62613, Dx 61923, Mq 59973, AP 58059; increasing the 'background' rate by 50% yielded NNPs of: C ± P 176, Dx 175, Mq 171, AP 168. The impact of substituting atovaquone-proguanil for all mefloquine usage resulted in a 2

Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma.

PubMed

Jones, Robin L; Katz, Daniela; Loggers, Elizabeth T; Davidson, Darin; Rodler, Eve T; Pollack, Seth M

2017-08-29

Chondrosarcoma is the most common bone sarcoma in adults. Conventional chondrosarcoma, the commonest histological subtype, is largely resistant to anthracycline-based chemotherapy. There have been anecdotal reports of durable clinical benefit with antiangiogenic agents in this disease. A retrospective search of patients treated at three sarcoma referral centers was performed to identify patients with advanced chondrosarcoma treated with antiangiogenic agents. The aim of this study was to evaluate the efficacy and safety of antiangiogenic agents in advanced chondrosarcoma. Ten patients were identified; seven with conventional, one each with clear cell, extraskeletal mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma. The median progression-free survival for patients with conventional and clear cell sarcoma was 22.6 months. Median overall survival has not been met. Antiangiogenic therapy was well tolerated in this series of patients. Our retrospective data suggest that antiangiogenic therapy can provide prolonged clinical benefit in advanced chondrosarcoma patients. Further prospective trials are required to precisely define the role of this class of agent in advanced chondrosarcoma.

Evidence based exercise - clinical benefits of high intensity interval training.

PubMed

Shiraev, Tim; Barclay, Gabriella

2012-12-01

Aerobic exercise has a marked impact on cardiovascular disease risk. Benefits include improved serum lipid profiles, blood pressure and inflammatory markers as well as reduced risk of stroke, acute coronary syndrome and overall cardiovascular mortality. Most exercise programs prescribed for fat reduction involve continuous, moderate aerobic exercise, as per Australian Heart Foundation clinical guidelines. This article describes the benefits of exercise for patients with cardiovascular and metabolic disease and details the numerous benefits of high intensity interval training (HIIT) in particular. Aerobic exercise has numerous benefits for high-risk populations and such benefits, especially weight loss, are amplified with HIIT. High intensity interval training involves repeatedly exercising at a high intensity for 30 seconds to several minutes, separated by 1-5 minutes of recovery (either no or low intensity exercise). HIT is associated with increased patient compliance and improved cardiovascular and metabolic outcomes and is suitable for implementation in both healthy and 'at risk' populations. Importantly, as some types of exercise are contraindicated in certain patient populations and HIIT is a complex concept for those unfamiliar to exercise, some patients may require specific assessment or instruction before commencing a HIIT program.

Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.

PubMed

Vivot, A; Jacot, J; Zeitoun, J-D; Ravaud, P; Crequit, P; Porcher, R

2017-05-01

Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems. The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit. Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients. © 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.

Clinical and economic benefits of fidaxomicin compared to vancomycin for Clostridium difficile infection.

PubMed

Gallagher, Jason C; Reilly, Joseph P; Navalkele, Bhagyashri; Downham, Gemma; Haynes, Kevin; Trivedi, Manish

2015-11-01

We studied the clinical and economic impact of a protocol encouraging the use of fidaxomicin as a first-line drug for treatment of Clostridium difficile infection (CDI) in patients hospitalized during a 2-year period. This study evaluated patients who received oral vancomycin or fidaxomicin for the treatment of CDI during a 2-year period. All included patients were eligible for administration of fidaxomicin via a protocol that encouraged its use for selected patients. The primary clinical endpoint was 90-day readmission with a diagnosis of CDI. Hospital charges and insurance reimbursements for readmissions were calculated along with the cost of CDI therapy to estimate the financial impact of the choice of therapy. Recurrences were seen in 10/49 (20.4%) fidaxomicin patients and 19/46 (41.3%) vancomycin patients (P = 0.027). In a multivariate analysis that included determinations of severity of CDI, serum creatinine increases, and concomitant antibiotic use, only fidaxomicin was significantly associated with decreased recurrence (adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.12 to 0.93). The total lengths of stay of readmitted patients were 183 days for vancomycin and 87 days for fidaxomicin, with costs of $454,800 and $196,200, respectively. Readmissions for CDI were reimbursed on the basis of the severity of CDI, totaling $151,136 for vancomycin and $107,176 for fidaxomicin. Fidaxomicin drug costs totaled $62,112, and vancomycin drug costs were $6,646. We calculated that the hospital lost an average of $3,286 per fidaxomicin-treated patient and $6,333 per vancomycin-treated patient, thus saving $3,047 per patient with fidaxomicin. Fidaxomicin use for CDI treatment prevented readmission and decreased hospital costs compared to use of oral vancomycin. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Clinical benefit of metaphase I oocytes

PubMed Central

Vanhoutte, Leen; De Sutter, Petra; Van der Elst, Josiane; Dhont, Marc

2005-01-01

Background We studied the benefit of using in vitro matured metaphase I (MI) oocytes for ICSI in patients with a maximum of 6 mature metaphase II (MII) oocytes at retrieval. Methods In 2004, 187 ICSI cycles were selected in which maximum 6 MII oocytes and at least one MI oocyte were retrieved. MI oocytes were put in culture to mature until the moment of ICSI, which was performed between 2 to 11 hours after oocyte retrieval (day 0). In exceptional cases, when the patient did not have any mature oocyte at the scheduled time of ICSI, MI oocytes were left to mature overnight and were injected between 19 to 26 hours after retrieval (day 1). Embryos from MI oocytes were chosen for transfer only when no other good quality embryos from MII oocytes were available. Outcome parameters were time period of in vitro maturation (IVM), IVM and fertilization rates, embryo development, clinical pregnancy rates, implantation rates and total MI oocyte utilization rate. Results The overall IVM rate was 43%. IVM oocytes had lower fertilization rates compared to in vivo matured sibling oocytes (52% versus 68%, P < 0.05). The proportion of poor quality embryos was significantly higher in IVM derived oocytes. One pregnancy and live birth was obtained out of 13 transfers of embryos exclusively derived from IVM oocytes. This baby originated from an oocyte that was injected after 22 hrs of IVM. Conclusion Fertilization of in vitro matured MI oocytes can result in normal embryos and pregnancy, making IVM worthwhile, particularly when few MII oocytes are obtained at retrieval. PMID:16356175

Clinical benefit of ertapenem compared to flomoxef for the treatment of cefotaxime-resistant Enterobacteriaceae bacteremia.

PubMed

Lee, Chen-Hsiang; Chen, I-Ling; Li, Chia-Chin; Chien, Chun-Chih

2018-01-01

Cefotaxime-resistant Enterobacteriaceae (CE) infections are intractable, with limited treatment options. Though carbapenems are frequently prescribed for CE infections, the emergence of carbapenem-resistant Enterobacteriaceae is of huge concern. Flomoxef is effective against CE in vitro, and some clinical data on its demonstrated effectiveness against CE bloodstream infections (BSIs) exists. We conducted a retrospective study on adults with BSI caused by flomoxef-susceptible CE to investigate the efficacy of flomoxef compared with that of ertapenem. The outcome was evaluated with propensity score-based matching and logistic regression analysis. Demographic and clinical characteristics of patients treated with flomoxef (n = 58) or ertapenem (n = 188) were compared. In the multivariate analysis, severe sepsis (adjusted odds ratio [AOR] = 3.84; 95% confidence interval [CI], 1.16-12.78; p = 0.03), high BSI mortality score (AOR = 5.59; 95% CI, 2.37-13.21; p < 0.01), ultimately or rapidly fatal comorbidity (AOR = 10.60; 95% CI, 3.43-32.75; p < 0.01), and pneumonia (AOR = 10.11; 95% CI, 3.43-29.81; p < 0.01) were independently associated with 28-day mortality. Using propensity scores, 58 flomoxef-treated patients were matched to 116 ertapenem-treated patients. There were no intergroup differences in BSI severity, comorbidity, or BSI sources. The 28-day mortality rates (20.7% vs 13.8%, p = 0.28) did not differ significantly. However, hospitalization length was shorter in the ertapenem group (10.2 ± 8.5 vs. 14.6 ± 9.4 days, p < 0.01). Although similar outcomes were observed between the groups, ertapenem therapy was associated with a shorter hospitalization time in adults after CE BSI.

Comparing climate policy co-benefits in the United States and China

NASA Astrophysics Data System (ADS)

Selin, N. E.; Li, M.; Saari, R.; Zhang, D.; Karplus, V. J.; Li, C. T.; Thompson, T. M.; Mulvaney, K. M.; Rausch, S.

2016-12-01

We use modeling approaches that integrate atmospheric chemistry, economic analysis, and health impacts calculations to evaluate and compare the co-benefits of greenhouse gas reduction policies for the U.S. and China. Climate policies can have a variety of co-benefits for air quality, in particular on the concentrations of health-damaging pollutants O3 and PM2.5 as well as toxic pollutants such as mercury. Co-benefits. Controlling CO2 sources such as power plants and vehicles can lead to concomitant reductions in other pollutants such as SO2, NOx, and Hg. Here, we present and discuss our evaluations of co-benefits in the U.S. and China, at both national and regional (state/provincial) scales. In particular, we assess how policy design, stringency, and energy system characteristics affect projected co-benefits and their valuation for human health. We find that at the national scale in both the U.S. and China, monetized co-benefits can offset the costs of carbon policies. U.S. co-benefits exhibit diminishing returns to projected increases in policy stringency, while Chinese co-benefits show different behavior. The magnitude of health-related co-benefits is sensitive to the economic valuation methodology, and to the choice of health impact function, with China-specific functions yielding substantially less co-benefit than those typically used in the U.S. In both cases, we see overall national-scale co-benefits but substantial regional variation at sub-national scales, illustrating the benefits of coupled atmospheric-economic analysis.

Decision theory and the evaluation of risks and benefits of clinical trials.

PubMed

Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

2012-12-01

Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. Copyright © 2012 Elsevier Ltd. All rights reserved.

Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom.

PubMed

Fluyau, Dimy; Revadigar, Neelambika

2017-01-01

Kratom ( Mitragyna speciosa ) is a tropical tree with a long history of traditional use in parts of Africa and Southeast Asia. Kratom is also known as Thom, Thang, and Biak. Its leaves and the teas brewed from them have long been used by people in that region to manage pain and opioid withdrawal and to stave off fatigue. Kratom is actually consumed throughout the world for its stimulant effects and as an opioid substitute (in form of tea, chewed, smoked, or ingested in capsules). Some case reports have associated kratom exposure with psychosis, seizures, intrahepatic cholestasis, other medical conditions, and deaths. The clinical manifestations of kratom effects are not well defined and the clinical studies are limited. Data research suggest that both stimulant and sedative dose-dependent effects do exist, in addition to antinociceptive, antidepressant activity, anxiolytic-like effects, and anorectic effects, but a growing concern for the drug's effects and safety of use has resulted in national and international attention primarily due to an increase in hospital visits and deaths in several countries that are believed to have been caused by extracts of the plant. There is a dearth of double blind controlled studies. In this study, we aim to use existing literature to clarify both benefits and risks of kratom as well as its diagnosis evaluation as kratom misuse is an emerging trend in the Western world. Literature review using databases such as Embase, Medline, PubMed, Cochrane Library, and Mendeley from 2007 to 2017 were evaluated by all authors to analyze current state on benefits, risks, and diagnosis evaluation of kratom ( M. speciosa ). Data analysis suggested that kratom possesses some benefits such as stimulant and sedative effects as wells as antinociceptive effects. It seems to inhibit pro-inflammatory mediator release and vascular permeability and can enhance immunity. In addition, it may be an antidepressant and anorectic. However, kratom can cause

Clinical benefit of ertapenem compared to flomoxef for the treatment of cefotaxime-resistant Enterobacteriaceae bacteremia

PubMed Central

Lee, Chen-Hsiang; Chen, I-Ling; Li, Chia-Chin; Chien, Chun-Chih

2018-01-01

Objectives Cefotaxime-resistant Enterobacteriaceae (CE) infections are intractable, with limited treatment options. Though carbapenems are frequently prescribed for CE infections, the emergence of carbapenem-resistant Enterobacteriaceae is of huge concern. Flomoxef is effective against CE in vitro, and some clinical data on its demonstrated effectiveness against CE bloodstream infections (BSIs) exists. Patients and methods We conducted a retrospective study on adults with BSI caused by flomoxef-susceptible CE to investigate the efficacy of flomoxef compared with that of ertapenem. The outcome was evaluated with propensity score-based matching and logistic regression analysis. Results Demographic and clinical characteristics of patients treated with flomoxef (n = 58) or ertapenem (n = 188) were compared. In the multivariate analysis, severe sepsis (adjusted odds ratio [AOR] = 3.84; 95% confidence interval [CI], 1.16–12.78; p = 0.03), high BSI mortality score (AOR = 5.59; 95% CI, 2.37–13.21; p < 0.01), ultimately or rapidly fatal comorbidity (AOR = 10.60; 95% CI, 3.43–32.75; p < 0.01), and pneumonia (AOR = 10.11; 95% CI, 3.43–29.81; p < 0.01) were independently associated with 28-day mortality. Using propensity scores, 58 flomoxef-treated patients were matched to 116 ertapenem-treated patients. There were no intergroup differences in BSI severity, comorbidity, or BSI sources. The 28-day mortality rates (20.7% vs 13.8%, p = 0.28) did not differ significantly. However, hospitalization length was shorter in the ertapenem group (10.2 ± 8.5 vs. 14.6 ± 9.4 days, p < 0.01). Conclusion Although similar outcomes were observed between the groups, ertapenem therapy was associated with a shorter hospitalization time in adults after CE BSI. PMID:29503575

Doing Qualitative Comparative Research on Teaching: Challenges and Benefits of Working with Grounded Theory

ERIC Educational Resources Information Center

Rupp, Claudia

2016-01-01

The last decades have seen the completion of an increasing number of qualitative comparative research projects on teaching. Challenges and benefits which might arise from a qualitative international comparative research design have been considered. However, very little has been published on challenges and benefits which may arise from using…

Comparing the Value of Nonprofit Hospitals’ Tax Exemption to Their Community Benefits

PubMed Central

Herring, Bradley; Gaskin, Darrell; Zare, Hossein; Anderson, Gerard

2018-01-01

The tax-exempt status of nonprofit hospitals has received increased attention from policymakers interested in examining the value they provide instead of paying taxes. We use 2012 data from the Internal Revenue Service (IRS) Form 990, Centers for Medicare and Medicaid Services (CMS) Hospital Cost Reports, and American Hospital Association’s (AHA) Annual Survey to compare the value of community benefits with the tax exemption. We contrast nonprofit’s total community benefits to what for-profits provide and distinguish between charity and other community benefits. We find that the value of the tax exemption averages 5.9% of total expenses, while total community benefits average 7.6% of expenses, incremental nonprofit community benefits beyond those provided by for-profits average 5.7% of expenses, and incremental charity alone average 1.7% of expenses. The incremental community benefit exceeds the tax exemption for only 62% of nonprofits. Policymakers should be aware that the tax exemption is a rather blunt instrument, with many nonprofits benefiting greatly from it while providing relatively few community benefits. PMID:29436247

Comparing the Value of Nonprofit Hospitals' Tax Exemption to Their Community Benefits.

PubMed

Herring, Bradley; Gaskin, Darrell; Zare, Hossein; Anderson, Gerard

2018-01-01

The tax-exempt status of nonprofit hospitals has received increased attention from policymakers interested in examining the value they provide instead of paying taxes. We use 2012 data from the Internal Revenue Service (IRS) Form 990, Centers for Medicare and Medicaid Services (CMS) Hospital Cost Reports, and American Hospital Association's (AHA) Annual Survey to compare the value of community benefits with the tax exemption. We contrast nonprofit's total community benefits to what for-profits provide and distinguish between charity and other community benefits. We find that the value of the tax exemption averages 5.9% of total expenses, while total community benefits average 7.6% of expenses, incremental nonprofit community benefits beyond those provided by for-profits average 5.7% of expenses, and incremental charity alone average 1.7% of expenses. The incremental community benefit exceeds the tax exemption for only 62% of nonprofits. Policymakers should be aware that the tax exemption is a rather blunt instrument, with many nonprofits benefiting greatly from it while providing relatively few community benefits.

Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe

PubMed Central

2013-01-01

Background HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. Methods The analysis was performed using a model constructed in Microsoft®Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. Results Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. Conclusions In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental

Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe.

PubMed

Marty, Rémi; Roze, Stéphane; Bresse, Xavier; Largeron, Nathalie; Smith-Palmer, Jayne

2013-01-08

HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. The analysis was performed using a model constructed in Microsoft(®)Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental benefits of adding boys vaccination

Effectiveness of an on-site health clinic at a self-insured university: a cost-benefit analysis.

PubMed

McCaskill, Sherrie P; Schwartz, Lisa A; Derouin, Anne L; Pegram, Angela H

2014-04-01

This study assessed the impact and cost-effectiveness of an on-site health clinic at a self-insured university. Health care costs and number of claims filed to primary care providers were trended before and after the clinic was established to determine savings. A retrospective chart review of all full-time, insured employees treated for upper respiratory tract infections (URIs) during a 1-year study period was conducted. On-site clinic costs for the treatment of URIs were compared to costs at outside community providers for similar care. Community cost norms for the treatment of URIs were provided by Primary Physicians Care, the administrator of insurance claims for the University. A cost-benefit analysis compared the cost of services on-site versus similar services at an outside community provider. Based on the results of this study, the University's on-site health care services were determined to be more cost-effective than similar off-site health care services for the treatment of URIs. [Workplace Health Saf 2014;62(4):162-169.]. Copyright 2014, SLACK Incorporated.

Dose Adjustment for Normal Eating (DAFNE) in routine clinical practice: who benefits?

PubMed

Keen, A J A; Duncan, E; McKillop-Smith, A; Evans, N D; Gold, A E

2012-05-01

To explore the effectiveness of Dose Adjustment for Normal Eating in routine clinical practice in the UK. Participants were 124 adults with Type 1 diabetes who had completed a Dose Adjustment for Normal Eating course. Data were collected before the course and again 1 year later on a variety of biological, psychological and social measures. There were a range of significant benefits consistent with Dose Adjustment for Normal Eating aims, including: better control among those with baseline HbA(1c) ≥ 81 mmol/mol (9.6%) (z = -2.8, P = 0.004); reduced number of participants reporting severe hypoglycaemia (χ² = 4.27, P = 0.039); total eradication of diabetic ketoacidosis (χ² = 4.17, P = 0.041) and lower diabetes-related distress (z = -4.5, P < 0.001). The most deprived of the clinic population were significantly under-represented (χ² = 17.8, P = 0.001) and the levels of clinical depression were unusually low. These results indicate that Dose Adjustment for Normal Eating delivered in routine clinical practice is associated with a range of benefits and that certain clinical and psychosocial characteristics are associated with better outcomes. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

PubMed

Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

2011-04-01

The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); p<0.001. The use of DES was safe regardless of the risk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

Who reaps the benefits, who bears the risks? Comparative optimism, comparative utility, and regulatory preferences for mobile phone technology.

PubMed

White, Mathew P; Eiser, J Richard; Harris, Peter R; Pahl, Sabine

2007-06-01

Although the issue of risk target (e.g., self, others, children) is widely acknowledged in risk perception research, its importance appears underappreciated. To date, most research has been satisfied with demonstrating comparative optimism, i.e., lower perceived risk for the self than others, and exploring its moderators, such as perceived controllability and personal exposure. Much less research has investigated how the issue of target may affect benefit perceptions or key outcomes such as stated preferences for hazard regulation. The current research investigated these issues using data from a public survey of attitudes toward mobile phone technology (N= 1,320). First, results demonstrated comparative optimism for this hazard, and also found moderating effects of both controllability and personal exposure. Second, there was evidence of comparative utility, i.e., users believed that the benefits from mobile phone technology are greater for the self than others. Third, and most important for policy, preferences for handset regulation were best predicted by perceptions of the risks to others but perceived benefits for the self. Results suggest a closer awareness of target can improve prediction of stated preferences for hazard regulation and that it would be profitable for future research to pay more attention to the issue of target for both risk and benefit perceptions.

[3D imaging benefits in clinical pratice of orthodontics].

PubMed

Frèrejouand, Emmanuel

2016-12-01

3D imaging possibilities raised up in the last few years in the orthodontic field. In 2016, it can be used for diagnosis improvement and treatment planning by using digital set up combined to CBCT. It is relevant for orthodontic mechanic updating by creating visible or invisible customised appliances. It forms the basis of numerous scientific researches. The author explains the progress 3D imaging brings to diagnosis and clinics but also highlights the requirements it creates. The daily use of these processes in orthodontic clinical practices needs to be regulated regarding the benefit/risk ratio and the patient satisfaction. The command of the digital work flow created by these technics requires habits modifications from the orthodontist and his staff. © EDP Sciences, SFODF, 2016.

Clinical and economic benefits of extended treatment with apixaban for the treatment and prevention of recurrent venous thromboembolism in Canada.

PubMed

Quon, Peter; Le, Hoa H; Raymond, Vincent; Mtibaa, Mondher; Moshyk, Andriy

2016-06-01

Background and objective Venous thromboembolism (VTE) is associated with long-term clinical and economic burden. Clinical guidelines generally recommend at least 3 months of anticoagulation, but, in clinical practice, concerns over bleeding risk often limit extended treatment. Apixaban was studied for extended VTE treatment in the AMPLIFY-EXT trial, demonstrating superiority to placebo in VTE reduction without increasing risk of major bleeding. This study assessed the long-term clinical and economic benefits of extending treatment with apixaban when clinical equipoise exists compared to standard of care with enoxaparin/warfarin and other novel oral anti-coagulants (NOACs) for the treatment and prevention of recurrent VTE in Canada. Methods A Markov model was developed to follow patients with VTE over their lifetimes. Efficacy and safety for apixaban and enoxaparin/warfarin were based on AMPLIFY and AMPLIFY-EXT, while relative efficacy to other NOACs was synthesized by network meta-analysis (NMA). Dosages for NOACs and enoxaparin/warfarin were based on their respective trials and were given up to 18 months and up to 6 months, followed by no treatment, respectively. Patient quality adjusted life years (QALYs) were based on published studies, and costs for resource utilization were from a Ministry of Health perspective, expressed as 2014 CAD ($). Results Extended treatment with apixaban compared to enoxaparin/warfarin resulted in fewer recurrent VTEs, VTE-related deaths, and bleeding events, but at slightly increased cost. The incremental cost-effectiveness ratio was $4828 per QALY gained. Compared to other NOACs, apixaban had the fewest bleeding events, similar recurrent VTE events, and the lowest overall cost, which was driven by the strong bleeding profile. In scenario analyses of acute and lifetime treatments, apixaban was cost-effective against all strategies. Conclusions Extended treatment with apixaban can offer substantial clinical benefits and is a cost

Assessing the overall benefit of a medication: cumulative benefit of secukinumab over time in patients with moderate-to-severe plaque psoriasis.

PubMed

Armstrong, April W; Feldman, Steven R; Korman, Neil J; Meng, Xiangyi; Guana, Adriana; Nyirady, Judit; Herrera, Vivian; Zhao, Yang

2017-05-01

Conventional measurements for assessing psoriasis treatment effects capture improvements at fixed, pre-specified timepoints, failing to account for cumulative clinical benefit over time. Explore the innovative concept of "cumulative clinical benefit" by examining the effect of secukinumab over 52 weeks in moderate-to-severe psoriasis patients. Cumulative clinical benefit was determined as the area-under-the-curve of the percentage of responders over 52 weeks (AUC 0-52 wks ), using pooled data from two phase III trials for patients receiving secukinumab (300 or 150 mg) or etanercept. Normalized cumulative benefit with secukinumab 300 mg, secukinumab 150 mg, and etanercept was 74.2%, 63.2%, and 50.5%, respectively, for PASI 75; 58.0%, 42.5%, and 29.5%, respectively, for PASI 90; 32.3%, 18.8%, and 8.7%, respectively, for PASI 100; and 58.3%, 47.9%, and 38.3%, respectively, for DLQI 0/1. 52-week PASI 75 clinical benefit ratios for secukinumab 300 and 150 mg versus etanercept were 1.47 and 1.25, respectively; the ratio of the two secukinumab doses was 1.17, favoring 300 mg. Post hoc analysis. Cumulative clinical benefit estimated by AUC 0-52 wks is a novel measure for comparing psoriasis treatments. Secukinumab 300 mg provides greater cumulative clinical benefit than secukinumab 150 mg; both provide greater cumulative benefit than etanercept.

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

PubMed

Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

2016-01-01

The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical benefit of systemic treatment in patients with advanced pancreatic and gastrointestinal neuroendocrine tumours according to ESMO-MCBS and ASCO framework.

PubMed

de Hosson, L D; van Veenendaal, L M; Schuller, Y; Zandee, W T; de Herder, W W; Tesselaar, M E T; Klümpen, H J; Walenkamp, A M E

2017-12-01

Assessment of clinical benefit of systemic treatments of rare diseases including gastroenteropancreatic neuroendocrine tumours (GEP-NET) is challenging. Recently several tools have been developed to grade the clinical benefit of cancer drugs. The European Society for Medical Oncology (ESMO) has developed the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). The American Society of Clinical Oncology (ASCO) has developed and revised the ASCO framework consisting of the Net Health Benefit (NHB) score juxtaposed against the costs of the treatment. In this review, we graded systemic treatments for GEP-NET patients with both frameworks. The electronic databases (PubMed and EMBASE) were searched for papers reporting comparative trials, conducted in adult GEP-NET patients in the English language. Papers were assessed according to the ESMO-MCBS and the NHB part of the ASCO revised Framework (NHB-ASCO-F) by four independent assessors, and discrepancies were discussed. The search yielded 32 trials of which 6 were eligible for grading with the ESMO-MCBS resulting in scores of 2 or 3. Eight trials were eligible for grading with the NHB-ASCO-F, resulting in scores between 37.6 and 57.4. Trials that were not primary assessable by the tools were analysed separately. Consensus between assessors was reached in 68% of trials with the ESMO-MCBS and in 23% of trials with the NHB-ASCO-F. The currently used systemic treatments for GEP-NET patients had low scores according to the NHB-ASCO-F and none could be graded as meaningful clinical beneficial according to the ESMO-MCBS. Despite the low incidence, the heterogeneous patient population and relatively long natural course of NET, future studies on new treatment modalities should aim for high clinical benefit outcomes. © 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.

Escitalopram—translating molecular properties into clinical benefit: reviewing the evidence in major depression

PubMed Central

Leonard, Brian; Taylor, David

2010-01-01

The majority of currently marketed drugs contain a mixture of enantiomers; however, recent evidence suggests that individual enantiomers can have pharmacological properties that differ importantly from enantiomer mixtures. Escitalopram, the S-enantiomer of citalopram, displays markedly different pharmacological activity to the R-enantiomer. This review aims to evaluate whether these differences confer any significant clinical advantage for escitalopram over either citalopram or other frequently used antidepressants. Searches were conducted using PubMed and EMBASE (up to January 2009). Abstracts of the retrieved studies were reviewed independently by both authors for inclusion. Only those studies relating to depression or major depressive disorder were included. The search identified over 250 citations, of which 21 studies and 18 pooled or meta-analyses studies were deemed suitable for inclusion. These studies reveal that escitalopram has some efficacy advantage over citalopram and paroxetine, but no consistent advantage over other selective serotonin reuptake inhibitors. Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents. This review suggests that the mechanistic advantages of escitalopram over citalopram translate into clinical efficacy advantages. Escitalopram may have a favourable benefit-risk ratio compared with citalopram and possibly with several other antidepressant agents. PMID:20147575

An early evaluation of clinical and economic costs and benefits of implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England.

PubMed

Turner, Katherine M E; Round, Jeff; Horner, Patrick; Macleod, John; Goldenberg, Simon; Deol, Arminder; Adams, Elisabeth J

2014-03-01

To estimate the costs and benefits of clinical pathways incorporating a point of care (POC) nucleic acid amplification test (NAAT) for chlamydia and gonorrhoea in genitourinary medicine (GUM) clinics compared with standard off-site laboratory testing. We simulated 1.2 million GUM clinic attendees in England. A simulation in Microsoft Excel was developed to compare existing standard pathways of management for chlamydia and gonorrhoea with a POC NAAT. We conducted scenario analyses to evaluate the robustness of the model findings. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included the number of inappropriate treatments, complications and transmissions averted. The baseline cost of using the point of POC NAAT was £103.9 million compared with £115.6 million for standard care. The POC NAAT was also associated with a small increase of 46 quality adjusted life years, making the new test both more effective and cheaper. Over 95 000 inappropriate treatments might be avoided by using a POC NAAT. Patients receive diagnosis and treatment on the same day as testing, which may also prevent 189 cases of pelvic inflammatory disease and 17 561 onward transmissions annually. Replacing standard laboratory tests for chlamydia and gonorrhoea with a POC test could be cost saving and patients would benefit from more accurate diagnosis and less unnecessary treatment. Overtreatment currently accounts for about a tenth of the reported treatments for chlamydia and gonorrhoea and POC NAATs would effectively eliminate the need for presumptive treatment.

A Framework for Analysis of Research Risks and Benefits to Participants in Standard of Care Pragmatic Clinical Trials

PubMed Central

Chen, Stephanie C; Kim, Scott Y H

2016-01-01

Background/Aims Standard of care pragmatic clinical trials (SCPCTs) that compare treatments already in use could improve care and reduce cost but there is considerable debate about the research risks of SCPCTs and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate. Methods We developed a formal risk-benefit analysis framework for SCPCTs and then applied it to key provisions of the U.S. federal regulations. Results Our formal framework for SCPCT risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a SCPCT, the allocation ratios of treatments inside and outside a SCPCT, and the significance of some participants receiving a different treatment inside a SCPCT than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to SCPCTs. Conclusions Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of SCPCTs and can be used to clarify the implications for informed consent. PMID:27365010

Hydroxyurea therapy requires HbF induction for clinical benefit in a sickle cell mouse model

PubMed Central

Lebensburger, Jeffrey D.; Pestina, Tamara I.; Ware, Russell E.; Boyd, Kelli L.; Persons, Derek A.

2010-01-01

Hydroxyurea has proven clinical efficacy in patients with sickle cell disease. Potential mechanisms for the beneficial effects include fetal hemoglobin induction and the reduction of cell adhesive properties, inflammation and hypercoagulability. Using a murine model of sickle cell disease in which fetal hemoglobin induction does not occur, we evaluated whether hydroxyurea administration would still yield improvements in hematologic parameters and reduce end-organ damage. Animals given a maximally tolerated dose of hydroxyurea that resulted in significant reductions in the neutrophil and platelet counts showed no improvement in hemolytic anemia and end-organ damage compared to control mice. In contrast, animals having high levels of fetal hemoglobin due to gene transfer with a γ-globin lentiviral vector showed correction of anemia and organ damage. These data suggest that induction of fetal hemoglobin by hydroxyurea is an essential mechanism for its clinical benefits. PMID:20378564

Estimated Cost-Effectiveness, Cost Benefit, and Risk Reduction Associated with an Endocrinologist-Pharmacist Diabetes Intense Medical Management "Tune-Up" Clinic.

PubMed

Hirsch, Jan D; Bounthavong, Mark; Arjmand, Anisa; Ha, David R; Cadiz, Christine L; Zimmerman, Andrew; Ourth, Heather; Morreale, Anthony P; Edelman, Steven V; Morello, Candis M

2017-03-01

In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients. To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames. Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years. Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level

Clinical evidence inputs to comparative effectiveness research could impact the development of novel treatments.

PubMed

Eber, Michael R; Goldman, Dana P; Lakdawalla, Darius N; Philipson, Tomas J; Pritchard, Daryl; Huesch, Marco; Summers, Nicholas; Linthicum, Mark T; Sullivan, Jeff; Dubois, Robert W

2015-05-07

This study aims to analyze the impacts of a range of clinical evidence generation scenarios associated with comparative effectiveness research (CER) on pharmaceutical innovation. We used the Global Pharmaceutical Policy Model to project the effect of changes in pharmaceutical producer costs, revenues and timings on drug innovation and health for the age 55+ populations in the USA and Europe through year 2060 using three clinical scenarios. Changes in producer incentives from widespread CER evidence generation and use had varied but often large predicted impacts on simulated outcomes in 2060. Effect on the number of new drug introductions ranged from a 81.1% reduction to a 45.5% increase, and the effect on population-level life expectancy ranged from a 15.6% reduction to a 11.4% increase compared to baseline estimates. The uncertainty surrounding the consequences of increased clinical evidence generation and use on innovation calls for a carefully measured approach to CER implementation, balancing near-term benefits to spending and health with long-term implications for innovation.

The clinical benefit and safety of current and future assisted reproductive technology.

PubMed

Brown, Rachel; Harper, Joyce

2012-08-01

Since the first birth by IVF was achieved in 1978, the techniques involved in assisted reproductive technology have grown at an enormous rate. However, new technology has rarely been robustly validated before clinical use and developing scientific understanding of the available techniques has done little to alter their use. Furthermore, there are inconsistencies in the available clinical studies and endpoints. The benefits of some technologies already established for routine use are currently dubious and there are clear ethical concerns with providing them to patients when their scientific basis is not clear. As the uptake of assisted reproductive technology increases and newer technologies continue to push the boundaries of science, it is important to consider the clinical benefits and safety of all assisted reproductive technologies. This review will discuss aspects of some of the more recent techniques, including sperm DNA-damage tests, intracytoplasmic morphologically selected sperm injection, amino acid and metabolomics profiling, preimplantation genetic screening and time-lapse imaging, and those that may have substantial impacts on the field of reproductive medicine in the future including artificial gametes, ovarian transplantation and gene therapy. Copyright © 2012 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.

PubMed

Banerjee, Amitava; Lane, Deirdre A; Torp-Pedersen, Christian; Lip, Gregory Y H

2012-03-01

The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS(2)=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA(2)DS(2)-VASc=1, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS(2) score≥1 or CHA(2)DS(2)-VASc≥2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit than warfarin. In the absence of head-to-head trials for these new OACs, our analysis may help inform decision making processes when all these new OACs become available to clinicians for stroke prevention in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin.

The m-Health revolution: Exploring perceived benefits of WhatsApp use in clinical practice.

PubMed

Ganasegeran, Kurubaran; Renganathan, Pukunan; Rashid, Abdul; Al-Dubai, Sami Abdo Radman

2017-01-01

The dawn of m-Health facilitates new horizons of professional communication through WhatsApp, allowing health professionals to interact fast and efficiently for effective patient management. This preliminary study aimed to investigate perceived benefits, if any, of WhatsApp use across general medical and emergency teams during clinical practice in Malaysia. A cross-sectional study was conducted in a universal sample of 307 health professionals comprising of nurses, medical assistants, medical residents, medical officers and physicians across medical and casualty departments in a Malaysian public hospital. The self-administered questionnaire consisted of items on socio-demographics, WhatsApp usage characteristics and the type of communication events during clinical practice. The majority of respondents (68.4%) perceived WhatsApp as beneficial during clinical practice. In multivariate analysis, perceived benefits was significantly higher amongst the clinical management group (aOR=2.6, 95% CI 1.5-4.6, p=0.001), those using WhatsApp for >12months (aOR=1.7, 95% CI 1.0-3.0, p=0.047), those receiving response ≤15min to a new communication (aOR=1.9, 95% CI 1.1-3.2, p=0.017), and frequent information giving events (aOR=2.4, 95% CI 1.2-4.8, p=0.016). Perceived benefits of WhatsApp use in clinical practice was significantly associated with usage characteristics and type of communication events. This study lays the foundation for quality improvement innovations in patient management delivered through m-Health technology. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Benefits and challenges of international clinical education from a US-based physiotherapist faculty perspective.

PubMed

Pechak, Celia; Black, Jill D

2013-12-01

The influence of internationalization on physiotherapist education in at least North American-based programmes has become more apparent. Faculty and students have been involved in various international activities. One category of activities includes international clinical education (ICE), where students earn clinical education credit for their learning activities at international sites. Although this educational strategy appears to be increasingly used in at least the United States and Canada, the related literature is limited in scope. The purpose of this portion of the present study was to investigate the benefits and challenges of ICE for US-based students, US-based physiotherapy programmes and international partners from the perspective of US-based faculty sending students for clinical education internationally. Content analysis was used for this qualitative study. Fifteen US-based faculty members who had experience in sending physiotherapist students for ICE were recruited. The primary researcher conducted semi-structured phone interviews, averaging approximately 60 minutes in length. The primary and secondary researchers completed data analysis using NVivo 8 software (QSR International Inc., Cambridge, MA). Benefits of ICE to the students included exposure to alternate health systems, broadening of student perspectives and clinical competence. Challenges consisted of funding and possible language barrier. Increased visibility, expanded global perspective and faculty collaborations were benefits to the programme. Ensuring a quality learning experience was the greatest programme challenge. Benefits to the international site included education and faculty collaborations/exchanges; challenges were language, student clinical preparation and unfamiliarity with the student evaluation tool. Because the sample was limited to 15 US-based faculty members, the results may not be relevant to all programmes inside or outside of the United States. Additionally, the study

Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review.

PubMed

Bervoets, Diederik C; Luijsterburg, Pim A J; Alessie, Jeroen J N; Buijs, Martijn J; Verhagen, Arianne P

2015-07-01

Is massage therapy effective for people with musculoskeletal disorders compared to any other treatment or no treatment? Systematic review of randomised clinical trials. People with musculoskeletal disorders. Massage therapy (manual manipulation of the soft tissues) as a stand-alone intervention. The primary outcomes were pain and function. The 26 eligible randomised trials involved 2565 participants. The mean sample size was 95 participants (range 16 to 579) per study; 10 studies were considered to be at low risk of bias. Overall, low-to-moderate-level evidence indicated that massage reduces pain in the short term compared to no treatment in people with shoulder pain and osteoarthritis of the knee, but not in those with low back pain or neck pain. Furthermore, low-to-moderate-level evidence indicated that massage improves function in the short term compared to no treatment in people with low back pain, knee arthritis or shoulder pain. Low-to-very-low-level evidence from single studies indicated no clear benefits of massage over acupuncture, joint mobilisation, manipulation or relaxation therapy in people with fibromyalgia, low back pain and general musculoskeletal pain. Massage therapy, as a stand-alone treatment, reduces pain and improves function compared to no treatment in some musculoskeletal conditions. When massage is compared to another active treatment, no clear benefit was evident. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Challenges in the Clinical Application of the American Society of Clinical Oncology Value Framework: A Medicare Cost-Benefit Analysis in Chronic Lymphocytic Leukemia.

PubMed

Seymour, Erlene K; Schiffer, Charles A; de Souza, Jonas A

2017-12-01

The ASCO Value Framework calculates the value of cancer therapies. Given costly novel therapeutics for chronic lymphocytic leukemia, we used the framework to compare net health benefit (NHB) and cost within Medicare of all regimens listed in the National Comprehensive Cancer Network (NCCN) guidelines. The current NCCN guidelines for chronic lymphocytic leukemia were reviewed. All referenced studies were screened, and only randomized controlled prospective trials were included. The revised ASCO Value Framework was used to calculate NHB. Medicare drug pricing was used to calculate the cost of therapies. Forty-nine studies were screened. The following observations were made: only 10 studies (20%) could be evaluated; when comparing regimens studied against the same control arm, ranking NHB scores were comparable to their preference in guidelines; NHB scores varied depending on which variables were used, and there were no clinically validated thresholds for low or high values; treatment-related deaths were not weighted in the toxicity scores; and six of the 10 studies used less potent control arms, ranked as the least-preferred NCCN-recommended regimens. The ASCO Value Framework is an important initial step to quantify value of therapies. Essential limitations include the lack of clinically relevant validated thresholds for NHB scores and lack of incorporation of grade 5 toxicities/treatment-related mortality into its methodology. To optimize its application for clinical practice, we urge investigators/sponsors to incorporate and report the required variables to calculate the NHB of regimens and encourage trials with stronger comparator arms to properly quantify the relative value of therapies.

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. The first part (current issue) of this 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (next issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972618

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 2

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. In this 2-part series, the first part (previous issue) described the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (current issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972619

Accountable care organizations: benefits and barriers as perceived by Rural Health Clinic management.

PubMed

Ortiz, Judith; Bushy, Angeline; Zhou, Yue; Zhang, Hong

2013-01-01

Rural Health Clinics (RHCs) have served the primary healthcare needs of the medically underserved in US rural areas for more than 30 years. As a new model of healthcare delivery, the Accountable Care Organization (ACO) offers potential opportunities for addressing the healthcare needs of rural populations, yet little is known about how the ACO model will meet the needs of RHCs. This article reports on the results of a survey, focus groups, and phone interviews with RHC management personnel on the subject of benefits of and barriers to RHC participation in ACOs. Survey research, focus groups, and phone interviews were used to gather and analyze the opinions of RHCs' management about the benefits of and barriers to ACO participation. The study population consisted of all 2011 RHCs in Region 4 (Southeastern USA; as designated by the Department of Health and Human Services). California RHCs were used for comparison. Themes and concepts for the survey questionnaire were developed from recent literature. The survey data were analyzed in two stages: (1) analyses of the characteristics of the RHCs and their responses; and (2) bivariate analyses of several relationships using a variety of statistics including analysis of variance, Pearson's χ² and likelihood χ². Relationships were examined between the RHCs' willingness to join ACOs and the respondent clinic's classification (as provider-based or independent). In addition, willingness to join ACOs among Region 4 RHCs was compared with those in California. Finally, in order to gain a broader understanding of the results of the survey, focus groups and phone interviews were conducted with RHC personnel. It was found that the ACO model is generally unfamiliar to RHCs. Approximately 48% of the survey respondents reported having little knowledge of ACOs; the focus group participants and interviewees likewise reported a lack of knowledge. Among respondents who were knowledgeable about ACOs, the most frequently citied

Benefits, Barriers, and Motivators to Training Dietetic Interns in Clinical Settings: A Comparison between Preceptors and Nonpreceptors.

PubMed

AbuSabha, Rayane; Muller, Colette; MacLasco, Jacqueline; George, Mary; Houghton, Erica; Helm, Alison

2018-03-01

The shortage of supervised practice sites in dietetics is associated with fewer numbers of preceptors available to supervise interns, especially in the clinical setting. To identify clinical dietitians' perceived benefits and challenges of training dietetic interns and to determine key motivators that would entice nonpreceptors to volunteer for the role. Registered dietitian nutritionists working in clinical settings completed a semi-structured, audiotaped interview followed by a brief questionnaire. Clinical dietitians working in hospitals, long-term care facilities, and outpatient clinics (n=100) participated: 54 preceptors and 46 nonpreceptors. Qualitative analysis was conducted using an iterative process to identify and code common themes. T tests were used to compare mean differences between the opinions of preceptors and nonpreceptors. Preceptors had approximately 5 more years of experience (mean=14.27±12.09 years) than nonpreceptors (mean=8.83±9.72 years) (P< 0.01). Furthermore, preceptors reported twice as many benefits to mentoring interns (mean=6.7 mentions/participant) as nonpreceptors (mean=3.4 mentions/participant), including knowledge gains and staying current. Lack of time was consistently noted as a barrier in interviews and rated as the greatest barrier in the survey. Both groups rated receiving continuing professional education units (CPEUs) for precepting as the greatest potential motivator for taking on interns. Incentive programs should be developed to entice nonpreceptors to take on interns. These programs should include extensive training on the preceptor role and how to alleviate the burden of time spent supervising interns and should provide a significant number of CPEUs to make the added workload worthwhile. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Minimal Clinically Important Difference and Substantial Clinical Benefit After Revision Hip Arthroscopy.

PubMed

Nwachukwu, Benedict U; Chang, Brenda; Rotter, Ben-Zion; Kelly, Bryan T; Ranawat, Anil S; Nawabi, Danyal H

2018-06-01

To define minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in revision hip arthroscopy. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS), and the international Hip Outcome Tool (iHOT-33) were administered to revision hip arthroscopy patients. At 1 year postoperatively, patients graded their hip function based on anchor responses. SCB was defined as both a net change and an absolute value. Receiver operating characteristic analysis with area under the curve was used to confirm psychometric values. A distribution-based method was used for MCID. Forty-nine patients were included with a mean age of 29.7 (±8.6) years. The most common indication for revision hip arthroscopy was residual femoroacetabular impingement (FAI; N = 34; 69.4%) followed by capsular management (N = 8; 16.3%). At 1-year follow-up, 34 patients reported feeling improved. Outcome score change corresponding to MCID and SCB net change for the mHHS, HOS Activities of Daily Living (ADL), HOS Sports, and iHOT-33 was 7.9/23.1, 7.9/16.2, 13.1/25.0, and 12.8/25.5, respectively. A higher proportion of patients with residual FAI achieved MCID compared with patients with other diagnoses. On the preoperative HOS ADL, HOS Sports, and iHOT-33, patients scoring below 67.7 (0.78), 55.6 (0.81), and 35.7 (0.73) were significantly more likely to achieve SCB postoperatively. Thirty-four patients (73.9%) were classified as receiving physical function improvement, and on the HOS Sports, MCID was achieved by 65% whereas 43% met the SCB criteria. MCID values ranged from 7.9 on the mHHS and the HOS ADL to 13.1 on the HOS Sports. SCB net change ranged from 16.2 on the HOS ADL to 25.2 on the iHOT-33, whereas absolute SCB ranged from 82.4 on the iHOT-33 to 84.7 on the mHHS. Residual FAI and capsular management were the most common indications for revision surgery with patients who underwent surgery for the former found to be most likely to achieve clinically significant

76 FR 1620 - Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-11

... a surrogate endpoint that is reasonably likely to predict clinical benefit or based on a clinical endpoint other than survival or irreversible morbidity. Approval of PROAMATINE was based on trials... surrogate endpoints are ``subject to the requirement that the applicant study the drug further to verify and...

The ESMO-Magnitude of Clinical Benefit Scale for novel oncology drugs: correspondence with three years of reimbursement decisions in Israel.

PubMed

Hammerman, Ariel; Greenberg-Dotan, Sari; Feldhamer, Ilan; Birnbaum, Yair; Cherny, Nathan I

2018-02-01

The European Society for Medical Oncology published in 2015 its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for cancer medicines. Our objective was to evaluate the association between Israel's national reimbursement decisions regarding novel cancer drugs, prior to the availability of ESMO-MCBS, and the later published ESMO-MCBS scores. ESMO-MCBS scores were obtained retrospectively for the cancer drugs that were candidates for reimbursement in Israel in 2013-2015 and were categorized to 'highest benefit' (ESMO-MCBS 4-5 or A) 'medium benefit' (3 or B) and 'lowest benefit' (0-2 or C). The reimbursement decisions were accessed and compared with the categorized ESMO scores. ESMO-MCBS score was available for 19/22 drugs approved for reimbursement and 15/16 non-approved drugs. 58% of the approved drugs gained a 'highest benefit' score and 37% were 'medium benefit'. 87% of the non-approved drugs had 'lowest benefit' scores. Median score for approved drugs was 4 vs. 1 for the non-approved (p < 0.05). The Israeli decisions regarding reimbursement of novel cancer drugs, demonstrated concordance with ESMO-MCBS scores. Incorporation of ESMO-MCBS data in reimbursement deliberations could assist in framing the appropriate use of the limited resources to deliver effective and affordable cancer care.

Comparing Benefit Estimation Techniques: Residential Flood Hazard Reduction Benefits in Roanoke, Virginia

DTIC Science & Technology

1998-03-01

benefit estimation techniques used to monetize the value of flood hazard reduction in the City of Roanoke. Each method was then used to estimate...behavior. This framework justifies interpreting people’s choices to infer and then monetize their preferences. If individuals have well-ordered and...Journal of Agricultural Economics. 68 (1986) 2: 280-290. Soule, Don M. and Claude M. Vaughn, "Flood Protection Benefits as Reflected in Property

Cooperating Teacher Compensation and Benefits: Comparing 1957-1958 and 2012-2013

ERIC Educational Resources Information Center

Fives, Helenrose; Mills, Tammy M.; Dacey, Charity M.

2016-01-01

We offer a comparative investigation of the compensation and benefits afforded to cooperating teachers (CTs) by teacher education programs (TEPs) in 1957-1958 and 2012-2013. This investigation replicates and extends a description of the compensation practices of 20 U.S. TEPs published by VanWinkle in 1959. Data for the present investigation came…

Transdiagnostic Internet-delivered cognitive behaviour therapy in Canada: An open trial comparing results of a specialized online clinic and nonspecialized community clinics.

PubMed

Hadjistavropoulos, H D; Nugent, M M; Alberts, N M; Staples, L; Dear, B F; Titov, N

2016-08-01

Effects of Internet-delivered cognitive behaviour therapy (ICBT) for anxiety and depression are not well understood when delivered in non-specialized as compared to specialized clinic settings. This open trial (n=458 patients) examined the benefits of transdiagnostic-ICBT when delivered in Canada by therapists (registered providers or graduate students) working in either a specialized online clinic or one of eight nonspecialized community clinics. Symptoms of depression and anxiety were assessed at pre-treatment, post-treatment and at 3-month follow-up. Completion rates and satisfaction were high. Significant and large reductions (effect sizes 1.17-1.31) were found on symptom measures. Completion rates, satisfaction levels and outcomes did not differ whether ICBT was delivered by therapists working in a specialized online clinic or nonspecialized community clinics. Differences were also not found between registered providers and graduate students, or therapists trained in psychology or another discipline. The findings support the public health potential of ICBT. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Benefits, pitfalls and risks of phytotherapy in clinical practice in otorhinolaryngology.

PubMed

Laccourreye, O; Werner, A; Laccourreye, L; Bonfils, P

2017-04-01

To elucidate the benefits, pitfalls and risks of phytotherapy in the clinical practice of otorhinolaryngology. The PubMed and Cochrane databases were searched using the following keywords: phytotherapy, phytomedicine, herbs, otology, rhinology, laryngology, otitis, rhinitis, laryngitis and otorhinolaryngology. Seventy-two articles (18 prospective randomized studies, 4 Cochrane analyses, 4 meta-analysis and 15 reviews of the literature) devoted to clinical studies were analyzed. Articles devoted to in vitro or animal studies, biochemical analyses or case reports (including fewer than 10 patients) and articles dealing with honey, aromatherapy or minerals were excluded. Per os ginkgo biloba has no indications in tinnitus, presbycusis or anosmia following viral rhinitis. Traditional Asian medicine has no proven benefit in sudden deafness or laryngeal papillomatosis. Per os mistletoe extracts associated to conventional treatment for head and neck squamous cell carcinoma does not increase 5-year survival. Extracts of various herbs, notably echinacea, eucalyptus, petasites hybridus, pelargonium sidoides, rosemary, spirulina and thyme, show superiority over placebo for rhinosinusitis and allergic rhinitis, as does gingko biloba for selected vertigo. There have been encouraging preliminary results for intratumoral injection of mistletoe in head and neck carcinoma and acupoint herbal patching for allergic rhinitis. Herb intake should be screened for in case of certain unexplained symptoms such as epistaxis, headache or dizziness, or signs suggesting allergy. Phytotherapy should be interrupted ahead of surgery and/or chemotherapy. Scientific proof of the benefit of phytotherapy in otorhinolaryngology remains to be established but, given its widespread use and the reported data, knowledge of this form of treatment needs to be developed. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Benefit of Preemptive Pharmacogenetic Information on Clinical Outcome.

PubMed

Roden, Dan M; Van Driest, Sara L; Mosley, Jonathan D; Wells, Quinn S; Robinson, Jamie R; Denny, Joshua C; Peterson, Josh F

2018-05-01

The development of new knowledge around the genetic determinants of variable drug action has naturally raised the question of how this new knowledge can be used to improve the outcome of drug therapy. Two broad approaches have been taken: a point-of-care approach in which genotyping for specific variant(s) is undertaken at the time of drug prescription, and a preemptive approach in which multiple genetic variants are typed in an individual patient and the information archived for later use when a drug with a "pharmacogenetic story" is prescribed. This review addresses the current state of implementation, the rationale for these approaches, and barriers that must be overcome. Benefits to pharmacogenetic testing are only now being defined and will be discussed. © 2018 American Society for Clinical Pharmacology and Therapeutics.

Treatment of painful bone metastases in prostate and breast cancer patients with the therapeutic radiopharmaceutical rhenium-188-HEDP. Clinical benefit in a real-world study.

PubMed

Lange, Rogier; Overbeek, Floor; de Klerk, John M H; Pasker-de Jong, Pieternel C M; van den Berk, Alexandra M; Ter Heine, Rob; Rodenburg, Cees J; Kooistra, Anko; Hendrikse, N Harry; Bloemendal, Haiko J

2016-09-26

Rhenium-188-HEDP ((188)Re-HEDP) is an effective radiopharmaceutical for the palliative treatment of osteoblastic bone metastases. However, only limited data on its routine use are available and its effect on quality of life (QoL) has not been studied. Therefore, we evaluated the clinical benefit of (188)Re-HEDP in routine clinical care. Prostate or breast cancer patients with painful bone metastases receiving (188)Re-HEDP as a routine clinical procedure were eligible for evaluation. Clinical benefit was assessed in terms of efficacy and toxicity. Pain palliation and QoL were monitored using the visual analogue scale (VAS), corrected for opioid intake, and the EORTC QLQ-C30 Global health status/QoL-scale. Thrombocyte and leukocyte nadirs were used to assess haematological toxicity. 45 and 47 patients were evaluable for pain palliation and QoL, respectively. After a single injection of (188)Re-HEDP, the overall pain response rate was 69% and mean VAS-scores decreased relevantly and significantly (p < 0.05). Repeated treatment resulted in similar pain response. The overall QoL response rate was 68% and mean Global health status/QoL-scores increased relevantly and significantly. Haematological side effects were mild and transient. The clinically relevant response on pain and quality of life and the limited adverse events prove clinical benefit of treatment with (188)Re-HEDP and support its use in routine clinical care. Its effectiveness appears comparable to that of external beam radiotherapy.

Which research is needed to support clinical decision-making on integrative medicine?- Can comparative effectiveness research close the gap?

PubMed

Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Bm, Berman

2012-10-01

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of the best care options. This evidence, more generalizable than the evidence generated by traditional randomized controlled trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on comparative effectiveness is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

Tribal Benefits Counseling Program: Expanding Health Care Opportunities for Tribal Members

PubMed Central

Friedsam, Donna; Haug, Gretchen; Rust, Mike; Lake, Amy

2003-01-01

American Indian tribal clinics hired benefits counselors to increase the number of patients with public and private insurance coverage, expand the range of health care options available to tribal members, and increase third-party revenues for tribal clinics. Benefits counselors received intensive training, technical assistance, and evaluation over a 2-year period. Six tribal clinics participated in the full training program, including follow-up, process evaluation, and outcomes reporting. Participating tribal sites experienced a 78% increase in Medicaid enrollment among pregnant women and children, compared with a 26% enrollment increase statewide during the same period. Trained benefits counselors on-site at tribal clinics can substantially increase third-party insurance coverage among patients. PMID:14534213

[Which research is needed to support clinical decision-making on integrative medicine? Can comparative effectiveness research close the gap?].

PubMed

Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Berman, Brian M

2013-08-01

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications

Comparative Cost-effectiveness of Strategies to Prevent Postoperative Clinical Recurrence of Crohn's Disease

PubMed Central

Doherty, Glen A.; Miksad, Rebecca A.; Cheifetz, Adam S.; Moss, Alan C.

2012-01-01

Background A number of treatments have been shown to reduce the risk of postoperative recurrence of Crohn's disease (CD). The optimal strategy is unknown. The aim was to evaluate the comparative cost-effectiveness of postoperative strategies to prevent clinical recurrence of CD. Methods Three prophylactic strategies were compared to “no prophylaxis”; mesalamine, azathioprine (AZA) / 6-mercaptopurine (6-MP), and infliximab. The probability of clinical recurrence, endoscopic recurrence, and therapy discontinuation due to adverse drug reactions (ADRs) were extracted from randomized controlled trials (RCTs). Quality-of-life scores and treatment costs were derived from published data. The primary model evaluated quality-adjusted life years (QALYs) and cost-effectiveness at 1 year after surgery. Sensitivity analysis assessed the impact of a range of recurrence rates on cost-effectiveness. An exploratory analysis evaluated cost-effectiveness outcomes 5 years after surgery. Results A strategy of “no prophylaxis” was the least expensive one at 1 and 5 years after surgery. Compared to this approach, AZA/6-MP had the most favorable incremental cost-effectiveness ratio (ICER) ($299,188/QALY gained), and yielded the highest net health benefits of the medication strategies at 1 year. Sensitivity analysis determined that the ICER of AZA/6-MP was preferable to mesalamine up to a recurrence rate of 52%, but mesalamine dominated at higher rates. In the 5-year exploratory analysis, mesalamine had the most favorable ICER over 5 years ($244,177/QALY gained). Conclusions Compared to no prophylactic treatment, AZA/6-MP has the most favorable ICER in the prevention of clinical recurrence of postoperative CD up to 1 year. At 5 years, mesalamine had the most favorable ICER in this model. PMID:21905173

Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

PubMed

Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

2016-02-16

Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

Five-Year Follow-up of Knee Joint Distraction: Clinical Benefit and Cartilaginous Tissue Repair in an Open Uncontrolled Prospective Study.

PubMed

van der Woude, Jan-Ton A D; Wiegant, Karen; van Roermund, Peter M; Intema, Femke; Custers, Roel J H; Eckstein, Felix; van Laar, Jaap M; Mastbergen, Simon C; Lafeber, Floris P J G

2017-07-01

Objective In end-stage knee osteoarthritis, total knee arthroplasty (TKA) may finally become inevitable. At a relatively young age, this comes with the risk of future revision surgery. Therefore, in these cases, joint preserving surgery such as knee joint distraction (KJD) is preferred. Here we present 5-year follow-up data of KJD. Design Patients ( n = 20; age <60 years) with conservative therapy resistant tibiofemoral osteoarthritis considered for TKA were treated. Clinical evaluation was performed by questionnaires. Change in cartilage thickness was quantified on radiographs and magnetic resonance images (MRI). The 5-year changes after KJD were evaluated and compared with the natural progression of osteoarthritis using Osteoarthritis Initiative data. Results Five-years posttreatment, patients still reported clinical improvement from baseline: ΔWOMAC (Western Ontario and McMaster Universities Arthritis Index) +21.1 points (95% CI +8.9 to +33.3; P = 0.002), ΔVAS (visual analogue scale score) pain -27.6 mm (95%CI -13.3 to -42.0; P < 0.001), and minimum radiographic joint space width (JSW) of the most affected compartment (MAC) remained increased as well: Δ +0.43 mm (95% CI +0.02 to +0.84; P = 0.040). Improvement of mean JSW (x-ray) and mean cartilage thickness (MRI) of the MAC, were not statistically different from baseline anymore (Δ +0.26 mm; P = 0.370, and Δ +0.23 mm; P = 0.177). Multivariable linear regression analysis indicated that KJD treatment was associated with significantly less progression in mean and min JSW (x-ray) and mean cartilage thickness (MRI) compared with natural progression (all Ps <0.001). Conclusions KJD treatment results in prolonged clinical benefit, potentially explained by an initial boost of cartilaginous tissue repair that provides a long-term tissue structure benefit as compared to natural progression. Level of evidence, II.

Representing clinical guidelines in UMl: a comparative study.

PubMed

Hederman, Lucy; Smutek, Daniel; Wade, Vincent; Knape, Thomas

2002-01-01

Clinical guidelines can be represented using models, such as GLIF, specifically designed for healthcare guidelines. This paper demonstrates that they can also be modelled using a mainstream business modelling language such as UML. The paper presents a guideline in GLIF and as UML activity diagrams, and then presents a mapping of GLIF primitives to UML. The potential benefits of using a mainstream modelling language are outlined. These include availability of advanced modelling tools, transfer between modelling tools, and automation via business workflow technology.

Survival benefit of liver resection for Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.

PubMed

Kim, H; Ahn, S W; Hong, S K; Yoon, K C; Kim, H-S; Choi, Y R; Lee, H W; Yi, N-J; Lee, K-W; Suh, K-S

2017-07-01

Although transarterial chemoembolization is recommended as the standard treatment for Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma (BCLC-B HCC), other treatments including liver resection have been used. This study aimed to determine the survival benefit of treatment strategies including resection for BCLC-B HCC compared with non-surgical treatments. The nationwide multicentre database of the Korean Liver Cancer Association was reviewed. Patients with BCLC-B HCC who underwent liver resection as a first or second treatment within 2 years of diagnosis and patients who received non-surgical treatment were selected randomly. Survival outcomes of propensity score-matched groups were compared. Among 887 randomly selected patients with BCLC-B HCC, 83 underwent liver resection as first or second treatment and 597 had non-surgical treatment. After propensity score matching, the two groups were well balanced (80 patients in each group). Overall median survival in the resection group was better than that for patients receiving non-surgical treatment (50·9 versus 22·1 months respectively; P < 0·001). The 1-, 2-, 3- and 5-year overall survival rates in the resection group were 90, 88, 75 and 63 per cent, compared with 79, 48, 35 and 22 per cent in the no-surgery group (P < 0·001). In multivariable analysis, non-surgical treatment only (hazard ratio (HR) 3·35, 95 per cent c.i. 2·16 to 5·19; P < 0·001), albumin level below 3·5 g/dl (HR 1·96, 1·22 to 3·15; P = 0·005) and largest tumour size greater than 5·0 cm (HR 1·81, 1·20 to 2·75; P = 0·005) were independent predictors of worse overall survival. Treatment strategies that include liver resection offer a survival benefit compared with non-surgical treatments for potentially resectable BCLC-B HCC. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our

Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

PubMed

Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

2017-10-05

As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

The clinical and occupational effectiveness of condition management for Incapacity Benefit recipients.

PubMed

Kellett, Stephen; Bickerstaffe, Darren; Purdie, Fiona; Dyke, Andrew; Filer, Sarah; Lomax, Victoria; Tomlinson, Hayley

2011-06-01

OBJECTIVES. The aim of the Condition Management Programme (CMP) is to help Incapacity Benefit recipients manage their health conditions more effectively and return to work. This paper seeks to examine the clinical and employment outcomes from a group-based and mixed-condition CMP. DESIGN. In a prospective cohort design, measures of employment status and psychological well-being were taken at three time points; pre-CMP, post-CMP, and at 3-month follow-up. METHOD. Participants (N= 2,064) with a variety of physical and mental health conditions voluntarily attended a seven session cognitive-behaviourally informed psychoeducational group intervention. The psychological measures used were the Clinical Outcomes in Routine Evaluation - Outcome Measure, Work and Social Adjustment Scale, Self-Efficacy Scale, and the Intrinsic Motivation Scale. The employment status of participants was also measured at the three time points of the evaluation. RESULTS. Following CMP, 50% of participants experienced a reliable improvement in psychological well-being and 26% had either taken some steps towards work or returned to work at follow-up. Participants with a mental health condition were more likely to experience a reliable improvement in psychological well-being compared to those with physical health conditions. CONCLUSIONS. The results suggest that participation in CMP may be helpful in facilitating more effective self-management of the health conditions contributing to unemployment. The results have implications for whether formal employment assistance should be available in mental health services. ©2010 The British Psychological Society.

Clinical and economic benefit of enzymatic debridement of pressure ulcers compared to autolytic debridement with a hydrogel dressing.

PubMed

Waycaster, Curtis; Milne, Catherine T

2013-07-01

The purpose of this study was to determine the cost-effectiveness of enzymatic debridement using collagenase relative to autolytic debridement with a hydrogel dressing for the treatment of pressure ulcers. A 3-stage Markov model was used to determine the expected costs and outcomes of wound care for collagenase and hydrogel dressings. Outcome data used in the analysis were taken from a randomized clinical trial that directly compared collagenase and hydrogel dressings. The primary outcome in the clinical trial was the proportion of patients achieving a closed epithelialized wound. Transition probabilities for the Markov states were estimated from the clinical trial. A 1-year time horizon was used to determine the expected number of closed wound days and the expected costs for the two alternative debridement therapies. Resource utilization was based on the wound care treatment regimen used in the clinical trial. Resource costs were derived from standard cost references and medical supply wholesalers. The economic perspective taken was that of the long-term care facility. No cost discounting was performed due to the short time horizon of the analysis. A deterministic sensitivity analysis was conducted to analyze economic uncertainty. The number of expected wound days for the collagenase and hydrogel cohorts are estimated at 48 and 147, respectively. The expected direct cost per patient for pressure ulcer care was $2003 for collagenase and $5480 for hydrogel debridement. The number of closed wound days was 1.5-times higher for collagenase (317 vs 218 days) than with the hydrogel. The estimated cost/closed wound day was 4-times higher for the hydrogel ($25) vs collagenase ($6). In this Markov model based on a randomized trial of pressure ulcer care in a long-term care setting collagenase debridement was economically dominant over autolytic debridement, yielding better outcomes at a lower total cost. Since it was a single institution study with a small sample size, the

Evaluating the risks of clinical research: direct comparative analysis.

PubMed

Rid, Annette; Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S; Wendler, David

2014-09-01

Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. This study employed a conceptual and normative analysis, and use of an illustrative example. Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

The urgent need to improve the tools to assess clinical benefit and value of cancer treatment.

PubMed

Sobrero, Alberto; Puccini, Alberto; Bregni, Giacomo; Bruzzi, Paolo

2017-09-01

There are several controversies in the assessment of the benefit, value and sustainability of cancer drugs. First, there is a surprising disagreement on the impact of drugs on the overall outcome of cancer treatment. Second, raising the bar of efficacy in clinical trials is claimed by many, but at the same time, being conservative appears justified as well, given the overall benefit of multiple incremental gains, typically observed in advanced solid tumours. Third, sustainability of cancer drug cost is a prohibitive challenge, but no major successful action has been taken so far. The reason for these controversies can be understood using concepts borrowed from psychological and cognitive sciences: each stakeholder has different perspectives generated by different availability biases; this implies different priorities, leading people to think, choose and act differently. Providing an 'objective' assessment of the benefit and value of a cancer drug makes sense only if the perspective adopted is clearly identified. The American Society of Clinical Oncology (ASCO) scale fits the patients' perspective by helping individual patients to choose the most valuable therapeutic option for their condition. Conversely, the European Society for Medical Oncology (ESMO) scale has a public health perspective: ranking the clinical benefit of oncologic drugs to identify those agents that should be available in every EU country. Because this scale is being adopted for reimbursement purposes in several European regions, the current major methodological problems of the scale should urgently be corrected to avoid unwanted societal consequences. Copyright © 2017 Elsevier Ltd. All rights reserved.

Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

PubMed

Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

2016-02-01

We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial.

PubMed

Myint, Ma Wai Wai; Wu, Jenny; Wong, Euann; Chan, Suk Ping; To, Tze Shing Jess; Chau, Mei Wa Rosanna; Ting, Kwai Hing; Fung, Pui Man; Au, Kit Sing Derrick

2013-01-01

malnutrition is an important risk factor for poor outcome in patients recovering after hip fracture surgery. This study aimed to investigate the clinical, nutritional and rehabilitation effects of an oral nutritional supplementation (ONS) in an inpatient rehabilitation setting. this was an observer-blinded randomised controlled trial of elderly post-surgical proximal femoral fracture patients. A ready-to-use oral liquid nutritional supplementation (18-24 g protein and 500 kcal per day) in addition to hospital diet was compared with hospital diet only. Both groups received usual rehabilitation therapy and oral calcium and vitamin D supplements. Outcomes were compared at discharge from rehabilitation and after 4 weeks of discharge. The primary outcome parameters were the serum albumin level, the body mass index (BMI), the functional independence measure (FIM) and the elderly mobility scale (EMS). Secondary outcome parameters were frequency of complications, inpatient length of stay, mortality and acute hospital use within 6 months after discharge. a total of 126 patients were recruited, 65 in the supplementation arm and 61 in the control arm. There was a significant difference in change in BMI with a decrease of 0.25 and 0.03 kg/m(2) in the ONS group and 0.72 and 0.49 kg/m(2) in the control group at hospital discharge and follow-up, respectively (P = 0.012). The length of stay in rehabilitation ward was shortened by 3.80 (SE = 1.81, P = 0.04) days favouring the ONS group. The total number of infection episodes was also reduced significantly. No difference was observed in the rate of change of the serum albumin level, the FIM and the EMS. clinical and nutritional benefits were seen in this trial but rehabilitation benefits could not be demonstrated.

Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy.

PubMed

Feres, Magda; Gursky, Lauren Christine; Faveri, Marcelo; Tsuzuki, Claudia Ota; Figueiredo, Luciene Cristina

2009-10-01

To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical [professional plaque control (PPC)] or chemical [chlorhexidine rinsing (CHX)] control of supragingival plaque in the treatment of chronic periodontitis. Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and were continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analysed for 38 bacterial species by checkerboard DNA-DNA hybridization. The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing.

Analysis of the antibacterial activity and plaque control benefit of colgate total dentifrice via clinical evaluation and real-time polymerase chain reaction.

PubMed

Xu, Tao; Deshmukh, Meenal; Barnes, Virginia Monsul; Trivedi, Harsh M; Du-Thumm, Laurence; Richter, Rose; Cummins, Diane

2005-01-01

This study analyzed, from a combined clinical and molecular biologic perspective, the antibacterial and antiplaque efficacy of Colgate Total dentifrice (CTD). A single-blind crossover study design utilized 11 healthy human subjects. After a one-week washout period, subjects donated dental plaque, received a dental prophylaxis, and subsequently brushed with a test product. Twenty-four hours postbrushing, dental plaque was collected and a clinical plaque score determined. Dental plaque was submitted for Real-time Polymerase Chain Reaction (Real-time PCR) analysis. The same procedure was repeated in accordance with a crossover design for the use of the second test product. Following a one-week washout, a plaque donation, prophylaxis, and brushing with the test product ensued for each subject. Twenty-four hours post-brushing, the subjects returned for a plaque score and plaque donation. Twenty-four hours after brushing, dental plaque coverage increased 17.88% +/- 8.27% with CTD, compared to 30.42% +/- 9.97% with Colgate Cavity Protection (CCP; p = 0.005). Real-time PCR found plaque collected 24 hours after brushing with CTD exhibited, on average, fewer representative periodontal pathogens (Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Tannerella forsythensis, and Porphyromonas gingivalis) and fewer early colonizers (Actinomyces naeslundii) than plaque collected before brushing, whereas CCP showed a moderate effect on oral bacteria. The study provides clinical and molecular biological evidence to substantiate the antibacterial and plaque control benefits of Colgate Total, and suggests the value of combining a molecular biological method with clinical research to corroborate clinical benefits.

Which Benefits Are Mentioned Most Often in Drug Development Publications?

PubMed

Strüver, Vanessa

2017-01-01

The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general. Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results. Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words benefit and clinical research . The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results. The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically

Fiber supplements and clinically proven health benefits: How to recognize and recommend an effective fiber therapy

PubMed Central

Lambeau, Kellen V.

2017-01-01

Abstract Background Only 5% of adults consume the recommended level of dietary fiber. Fiber supplements appear to be a convenient and concentrated source of fiber, but most do not provide the health benefits associated with dietary fiber. Purpose This review will summarize the physical effects of isolated fibers in small and large intestines, which drive clinically meaningful health benefits. Data sources A comprehensive literature review was conducted (Scopus and PubMed) without limits to year of publication (latest date included: October 31, 2016). Conclusions The physical effects of fiber in the small intestine drive metabolic health effects (e.g., cholesterol lowering, improved glycemic control), and efficacy is a function of the viscosity of gel‐forming fibers (e.g., psyllium, β‐glucan). In the large intestine, fiber can provide a laxative effect if (a) it resists fermentation to remain intact throughout the large intestine, and (b) it increases percentage of water content to soften/bulk stool (e.g., wheat bran and psyllium). Implications for practice It is important for nurse practitioners to understand the underlying mechanisms that drive specific fiber‐related health benefits, and which fiber supplements have rigorous clinical data to support a recommendation. Clinical pearl For most fiber‐related beneficial effects, “Fiber needs to gel to keep your patients well.” PMID:28252255

Honey in wound care: effects, clinical application and patient benefit.

PubMed

Lay-flurrie, Karen

The use of honey in wound management has enjoyed a resurgence. This is largely due to the growing clinical problem of antibiotic-resistant bacteria and the combined difficulties for the practitioner in managing chronic wound types, such as burns, leg ulcers or surgical wounds, that may become infected, for example, with methicillin-resistant Staphylococcus aureus or Pseudomonas. The associated costs of treating such wounds are escalating as a result. While the use of honey as a wound dressing has been recognized, at least since Egyptian times circa 2000 BC, it is only more recently, due to the development and licensing of modern honey wound dressings, that such dressings have become more widely available and used in wound management. This article focuses on the use of honey in the treatment of infected wounds and burns. It will examine the effects of honey at the wound bed and its clinical applications, along with the current dressings available. Also discussed are the practical considerations, if, like any wound dressing, honey is to be used safely, appropriately and for the benefit of the patient.

Net clinical benefit of dabigatran vs. warfarin in venous thromboembolism: analyses from RE-COVER®, RE-COVER™ II, and RE-MEDY™.

PubMed

Feuring, Martin; Schulman, Sam; Eriksson, Henry; Kakkar, Ajay J; Schellong, Sebastian; Hantel, Stefan; Schueler, Elke; Kreuzer, Jörg; Goldhaber, Samuel Z

2017-05-01

The direct oral anticoagulants, e.g., dabigatran etexilate (DE), are effective and well tolerated treatments for venous thromboembolism (VTE). Net clinical benefit (NCB) is a useful concept in weighing potential benefits against potential harm of comparator drugs. The NCB of DE vs. warfarin in VTE treatment was compared. Post-hoc analyses were performed on pooled data from the 6-month RE-COVER® and RE-COVER™ II trials, and data from the RE-MEDY™ trial (up to 36 months), to compare the NCB of DE (150 mg twice daily) and warfarin [target international normalized ratio (INR) 2.0-3.0]. Patients (≥18 years old) had symptomatic proximal deep vein thrombosis and/or pulmonary embolism. NCB was the composite of cardiovascular endpoints (non-fatal events of recurrent VTE, myocardial infarction, stroke or systemic embolism), all-cause death, and bleeding outcomes, all weighted equally. A broad definition of NCB included major bleeding events (MBE) and clinically relevant non-major bleeding events as bleeding outcomes, while a narrow definition included just MBE. The pooled dataset totalled 5107 patients from RE-COVER/RE-COVER II and 2856 patients from RE-MEDY. When NCB was narrowly defined, NCB was similar between DE and warfarin. When broadly defined, NCB was superior with DE vs. warfarin [RE-COVER/RE-COVER II, hazard ratio (HR) 0.80; 95% confidence interval (CI), 0.68-0.95 and RE-MEDY, HR 0.73; 95% CI 0.59-0.91]. These findings were unaffected by warfarin time in therapeutic range. The NCB of DE was similar or superior to warfarin, depending on the NCB definition used, regardless of the quality of INR control.

[Experiences with power-injectable port systems: complications, patient satisfaction and clinical benefit].

PubMed

Chang, D-H; Kabbasch, C; Bovenschulte, H; Libicher, M; Maintz, D; Bangard, C

2013-05-01

Evaluation of complications, patient satisfaction and clinical benefit of port systems with authorization for high pressure injection of contrast agent during CT/MR examinations. Ultrasound-guided insertions of central venous port catheters were performed through the lateral subclavian vein at a university teaching hospital. The radiological information system (HIS/RIS) was used to evaluate technical success and complication rates. Assessment of patient satisfaction and clinical benefit was carried out by a questionnaire during a telephone call 6 months after implantation of the port system. A total of 195 port systems in 193 patients were implanted. The catheter remained in place for a mean duration of 169 days (overall 29,210 catheter days). The technical success rate was 99.5 % and the overall complication rate was 17.4 % (24/138; 0.82 per 1000 catheter days). Follow-up revealed 13 early port explantations (9 %). Most of the patients reported high satisfaction in general (satisfied/very satisfied: 94 %). 34/209 contrast-enhanced CT/MRT scans (16 %) were performed using the port for contrast media injection. There were no complications during or after administration of contrast agent via the port system. The Powerport system is a safe alternative for peripheral i. v. contrast media injection during CT/MR scans, but has been infrequently used. Most patients reported high overall satisfaction with the port system. © Georg Thieme Verlag KG Stuttgart · New York.

Feasibility testing of smart tablet questionnaires compared to paper questionnaires in an amputee rehabilitation clinic.

PubMed

Payne, Michael; Janzen, Shannon; Earl, Eric; Deathe, Barry; Viana, Ricardo

2017-08-01

Capturing the variability that exists among patients attending an amputee clinic using standardized paper-based questionnaires is time-consuming and may not be practical for routine clinical use. Electronic questionnaires are a potential solution; however, the benefits are dependent on the feasibility and acceptance of this mode of data collection among patients. To determine the feasibility and patient preference/comfort in using a tablet-based questionnaire for data collection in an outpatient amputee rehabilitation clinic compared to a traditional paper-based questionnaire. Observational study. In all, 48 patients with major extremity amputations completed both tablet and paper questionnaires related to their amputation and prosthetic use. Both trials were timed; patients then completed a semi-structured questionnaire about their experience. In all, 20.5% of patients needed hands-on assistance completing the paper questionnaire compared to 20.8% for the tablet. The majority of participants (52.1%) indicated a preference for the tablet questionnaire; 64.6% of patients felt the tablet collected a more complete and accurate representation of their status and needs. In all, 70.8% of participants described themselves as comfortable using the tablet. Despite comorbidities, patients with amputations demonstrated excellent acceptance of the electronic tablet-based questionnaire. Tablet questionnaires have significant potential advantages over paper questionnaires and should be further explored. Clinical relevance A custom electronic questionnaire was found to be beneficial for routine clinic use and was well received by patients in an amputee rehabilitation clinic. Development of such questionnaires can provide an efficient mechanism to collect meaningful data that can be used for individual patient care and program quality improvement initiatives.

Comparison of methods of evaluating hearing benefit of middle ear surgery.

PubMed

Toner, J G; Smyth, G D

1993-01-01

The objective of this paper is to compare two methods of predicting the level of subjective patient benefit following reconstructive middle ear surgery. This should have always been an important consideration in advising patients regarding surgery, but assumes even more relevance in these days of clinical audit and cost benefit analysis. The two methods studied were the '15/30 dB rule of thumb' (Smyth and Patterson, 1985) and the 'Glasgow plot' (Browning et al., 1991). The predictions of benefit for each of the two methods were compared to the assessment of actual benefits by the patient post-operatively. The results of this comparison in 153 patients were analysed, the rule of thumb was found to be somewhat more sensitive in predicting patient benefit.

Cost-benefit analysis of childhood asthma management through school-based clinic programs.

PubMed

Tai, Teresa; Bame, Sherry I

2011-04-01

Asthma is a leading chronic illness among American children. School-based health clinics (SBHCs) reduced expensive ER visits and hospitalizations through better healthcare access and monitoring in select case studies. The purpose of this study was to examine the cost-benefit of SBHC programs in managing childhood asthma nationwide for reduction in medical costs of ER, hospital and outpatient physician care and savings in opportunity social costs of lowing absenteeism and work loss and of future earnings due to premature deaths. Eight public data sources were used to compare costs of delivering primary and preventive care for childhood asthma in the US via SBHC programs, including direct medical and indirect opportunity costs for children and their parents. The costs of nurse staffing for a nationwide SBHC program were estimated at $4.55 billion compared to the estimated medical savings of $1.69 billion, including ER, hospital, and outpatient care. In contrast, estimated total savings for opportunity costs of work loss and premature death were $23.13 billion. Medical savings alone would not offset the expense of implementing a SBHC program for prevention and monitoring childhood asthma. However, even modest estimates of reducing opportunity costs of parents' work loss would be far greater than the expense of this program. Although SBHC programs would not be expected to affect the increasing prevalence of childhood asthma, these programs would be designed to reduce the severity of asthma condition with ongoing monitoring, disease prevention and patient compliance.

Do benefits accrue from longer rotations for students in Rural Clinical Schools?

PubMed

Denz-Penhey, Harriet; Shannon, Susan; Murdoch, Campbell J; Newbury, Jonathon W

2005-01-01

The Australian Government has provided funding for Rural Clinical Schools (RCS) to provide substantial rural clinical experience to medical students. The strategy aims to acculturate students into rural living with the intended long-term outcome of increasing the availability and viability of rural health services. When evaluators from two of the Rural Clinical Schools discussed findings and insights relating to rural rotations from their in-depth evaluation studies of their respective schools they found a range of similarities. This article is a collaboration that articulates parallel findings from evaluations over 2 years, using three different approaches to students' placements across the two RCS: (1) students based long term in one centre (with only a few days away at a time); (2) students based long term in one centre with short-term rotations of 3-6 weeks away from home base; and (3) week rotations without a home base. The two RCS, as part of their initial establishment, put comprehensive internal evaluation processes in place, including the employment of dedicated evaluators extant from the teaching and assessment of the rural medical curriculum. Data were collected and analysed according to standard education evaluation procedures. Home-base preference: most students preferred having a home base in one centre and having as little time as possible away from that centre, while recognising that sometimes the requirement to go and learn elsewhere was useful. The reasons for this were three-fold: academic, clinical and social. Academic benefits: students enjoyed the excellence of teaching and learning opportunities in their rural sites and did not want their discipline of learning interrupted by what they perceived as unnecessary change. Students with a home base used their learning opportunities qualitatively differently from those students who had 6 week rotations. Their learning became self-directed and students sought opportunities to extend and consolidate

Comparative Effectiveness Research in Pediatric Respiratory Disease: Promise and Pitfalls.

PubMed

Ramos, Kathleen J; Somayaji, Ranjani; Nichols, David P; Goss, Christopher H

2018-02-01

Comparative effectiveness research (CER) has become increasing central to clinical research in medicine. CER seeks to conduct clinical trials that compare different commonly used interventions in real-world settings (pragmatic clinical trials) and use a multitude of sources of evidence (including registries and cohort studies) to inform clinical decision making. CER also ensures that stakeholders (patients, families, care providers, insurers) have a voice in the research process by integrating formal stakeholder engagement as part of the research. This innovative approach to clinical research has distinct benefits and pitfalls. This review first defines what CER is and then describes some of its benefits and then pitfalls. The focus is on the role of CER in pediatrics.

Quantitative Assessment of the Safety Benefits Associated with Increasing Clinical Peanut Thresholds Through Immunotherapy.

PubMed

Baumert, Joseph L; Taylor, Steve L; Koppelman, Stef J

Peanut immunotherapy studies are conducted with the aim to decrease the sensitivity of patients to peanut exposure with the outcome evaluated by testing the threshold for allergic response in a double-blind placebo-controlled food challenge. The clinical relevance of increasing this threshold is not well characterized. We aimed to quantify the clinical benefit of an increased threshold for peanut-allergic patients. Quantitative risk assessment was performed by matching modeled exposure to peanut protein with individual threshold levels. Exposure was modeled by pairing US consumption data for various food product categories with potential contamination levels of peanut that have been demonstrated to be present on occasion in such food products. Cookies, ice cream, doughnuts/snack cakes, and snack chip mixes were considered in the risk assessment. Increasing the baseline threshold before immunotherapy from 100 mg or less peanut protein to 300 mg peanut protein postimmunotherapy reduces the risk of experiencing an allergic reaction by more than 95% for all 4 food product categories that may contain trace levels of peanut residue. Further increase in the threshold to 1000 mg of peanut protein had an additional quantitative benefit in risk reduction for all patients reacting to 300 mg or less at baseline. We conclude that achieving thresholds of 300 mg and 1000 mg of peanut protein by peanut immunotherapy is clinically relevant, and that the risk for peanut-allergic patients who have achieved this increased threshold to experience an allergic reaction is reduced in a clinically meaningful way. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A systematic review on clinical benefits of continuous administration of beta-lactam antibiotics.

PubMed

Roberts, Jason A; Webb, Steven; Paterson, David; Ho, Kwok M; Lipman, Jeffrey

2009-06-01

The clinical benefits of extended infusion or continuous infusion of beta-lactam antibiotics remain controversial. We systematically reviewed the literature to determine whether any clinical benefits exist for administration of beta-lactam antibiotics by extended or continuous infusion. PubMed (January 1950 to November 2007), EMBASE (1966 to November 2007), and the Cochrane Controlled Trial Register were searched (updated November 2007). Randomized controlled trials (RCTs) were meta-analyzed, and observational studies were described by two unblinded reviewers. A total of 846 patients from eligible prospective randomized controlled studies were included in the meta-analysis. Two observational studies were deemed appropriate for description. A meta-analysis of prospective RCTs was undertaken using Review Manager. Among a total of 59 potentially relevant studies, 14 RCTs involving a total of 846 patients from nine countries were deemed appropriate for meta-analysis. The use of continuous infusion of a beta-lactam antibiotic was not associated with an improvement in clinical cure (n = 755 patients; odds ratio: 1.04, 95% confidence interval: 0.74-1.46, p = 0.83, I = 0%) or mortality (n = 541 patients; odds ratio: 1.00, 95% confidence interval: 0.48-2.06, p = 1.00, I = 14.8%). All RCTs except one used a higher antibiotic dose in the bolus administration group. Two observational studies, not pooled because they did not meet the a priori criteria for meta-analysis, showed that beta-lactam administration by extended or continuous infusion was associated with an improvement in clinical cure. The difference in the results between the meta-analysis results and the observational studies could be explained by the bias created by a higher dose of antibiotic in the bolus group in the RCTs and because many of the RCTs only recruited patients with a low acuity of illness. The limited data available suggest that continuous infusion of beta-lactam antibiotics leads to the same

Colleges Grapple with New Provision of U.S. Tax Code that Requires Comparable Benefits for All Employees.

ERIC Educational Resources Information Center

Mooney, Carolyn J.

1988-01-01

The provision, known as Section 89 of the Internal Revenue Code, that requires employers to make sure that their health and insurance benefits do not discriminate against low-paid employees, is discussed. The process of comparing employee benefits and a lack of federal guidance has complicated matters. (MLW)

Comparative effectiveness research in clinical practice.

PubMed

Lawrence, William F; Chang, Stephanie; Kane, Robert L; Wilt, Timothy J

2014-08-01

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

Evaluating the Risks of Clinical Research: Direct Comparative Analysis

PubMed Central

Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David

2014-01-01

Abstract Objectives: Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed “risks of daily life” standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the “risks of daily life” standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Conclusions: Direct comparative analysis is a systematic method for applying the “risks of daily life” standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about

Incidental Findings in Imaging Research: Evaluating Incidence, Benefit and Burden

PubMed Central

Orme, Nicholas M.; Fletcher, Joel G.; Siddiki, Hassan A.; Harmsen, W. Scott; O’Byrne, Megan M.; Port, John D.; Tremaine, William J.; Pitot, Henry C.; McFarland, Beth; Robinson, Marguerite E.; Koenig, Barabara A.; King, Bernard F.; Wolf, Susan M.

2013-01-01

Context Little information exists concerning the frequency of clinically significant incidental findings (IFs) identified in the course of imaging research across a broad spectrum of imaging modalities and body regions. Objective To estimate the frequency with which research imaging IFs generate further clinical action, and the medical benefit/burden of identifying these IFs. Design, Setting, and Participants Retrospective review of subjects undergoing a research imaging exam that was interpreted by a radiologist for IFs in the first quarter of 2004, with 3-year clinical follow-up. An expert panel reviewed IFs generating clinical action to determine medical benefit/burden based on predefined criteria. Main Outcome Measures Frequency of (1) IFs that generated further clinical action by modality, body part, age, gender, and (2) IFs resulting in clear medical benefit or burden. Results 1376 patients underwent 1426 research imaging studies. 40% (567/1426) of exams had at least one IF (1055 total). Risk of an IF increased significantly by age (OR=1.5; [1.4–1.7=95% C.I.] per decade increase). Abdominopelvic CT generated more IFs than other exams (OR=18.9 compared with ultrasound; 9.2% with subsequent clinical action), with CT Thorax and MR brain next (OR=11.9 and 5.9; 2.8% and 2.2% with action, respectively). Overall 6.2% of exams (35/567) with an IF generated clinical action, resulting in clear medical benefit in 1.1% (6/567) and clear medical burden in 0.5% (3/567). In most instances, medical benefit/burden was unclear (4.6%; 26/567). Conclusions The frequency of IFs in imaging research exams varies significantly by imaging modality, body region and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a substantial number of cases and subsequent clinical action to address them in much smaller number. Such clinical action can result in medical

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

PubMed

Isbary, Georg; Staab, Thomas R; Amelung, Volker E; Dintsios, Charalabos-Markos; Iking-Konert, Christof; Nesurini, Sonja Mariotti; Walter, Miriam; Ruof, Jörg

2018-06-01

In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects. To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA). For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications. Eleven of 21 benefit assessments included crossover trials. Significant intergroup differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without crossover. For 6 of 11 medicines with crossover, these were demonstrated before crossover. Treatment effects generally worsened with increasing proportions of crossover. The EMA requested additional data more frequently if crossover was performed, particularly if no OS data were available before crossover. The G-BA granted a considerable benefit to 73% of medicines with crossover and 40% of those without. Evidence levels were intermediate for 50% and 75%, respectively. None of the medicines received the highest evidence level. In G-BA appraisals, oncology medicines with crossover received better additional benefit ratings, but were assigned lower evidence levels, than those without. The five medicines with crossover after progression were assigned lower evidence levels than the six medicines with crossover after demonstration of superior OS, indicating that the way in which crossover is implemented may be one factor influencing the assignment of evidence levels by the G-BA. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care.

PubMed

Kelly, Ronan J; Smith, Thomas J

2014-03-01

Cancer costs continue to increase alarmingly despite much debate about how they can be reduced. The oncology community needs to take greater responsibility for our own practice patterns, especially when using expensive tests and treatments with marginal value: we cannot continue to accept novel therapeutics with very small benefits for exorbitant prices. Patients, payers, and pharmaceutical communities should be constructively engaged to communicate medically and economically possible goals, and eventually, to reduce use and costs. Diagnostic tests and treatments should have to show true value to be added to existing protocols. In this article, we discuss three key drivers of costs: end-of-life care patterns, medical imaging, and drugs. We propose health-care models that have the potential to decrease costs and discuss solutions to maintain clinical benefit at an affordable price. Copyright © 2014 Elsevier Ltd. All rights reserved.

Two Different Percutaneous Bone-Anchored Hearing Aid Abutment Systems: Comparative Clinical Study.

PubMed

Polat, Beldan; İşeri, Mete; Orhan, Kadir Serkan; Yılmazer, Ayça Başkadem; Enver, Necati; Ceylan, Didem; Kara, Ahmet; Güldiken, Yahya; Çomoğlu, Şenol

2016-04-01

To compare two different percutaneous bone-anchored hearing aid (BAHA) abutment systems regarding operation time, scar healing, quality of life, implant stability, audiologic results, and complications. The study involves a prospective multi-center clinical evaluation. Thirty-two consecutive patients who had undergone BAHA surgery from January 2011 to January 2013 in two tertiary centers were included in the study. The Glasgow Inventory Benefit Score was used to assess the patients at least 6 months after surgery. The operation time and complications were recorded. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Holger's classification was used to evaluate skin reactions. The mean length of the operation was 39.2±4 min for standard abutment and 18.3±5.7 min for hydroxyapatite-coated abutment. ISQ scores were significantly better for standard abutment in all tests. The mean total Glasgow Inventory Benefit Score was 39.3±19 for the standard abutment and 46.3±24.5 for the hydroxyapatite-coated abutment groups, but there was no statistical significance between the two groups. There was no difference in audiological improvement between the two groups after surgery. Hydroxyapatite-coated abutment provided a shorter operation time that was significantly different from standard abutment. There were no significant differences between standard abutment and hydroxyapatite-coated abutment regarding audiologic improvement, quality of life, loading time, and complications.

Can emergency medicine research benefit from adaptive design clinical trials?

PubMed

Flight, Laura; Julious, Steven A; Goodacre, Steve

2017-04-01

Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. 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/.

Genetic Risk, Coronary Heart Disease Events, and the Clinical Benefit of Statin Therapy

PubMed Central

Smith, JG; Chasman, DI; Caulfield, M; Devlin, JJ; Nordio, F; Hyde, C; Cannon, CP; Sacks, F; Poulter, N; Sever, P; Ridker, PM; Braunwald, E; Melander, O

2015-01-01

Background Genetic variants have been associated with the risk of coronary heart disease (CHD). We tested whether a composite of these variants could identify the risk of both incident as well as recurrent CHD events and distinguish individuals who derived greater clinical benefit from statin therapy. Methods A community-based cohort and four randomized controlled trials of both primary (JUPITER and ASCOT) and secondary (CARE and PROVE IT-TIMI 22) prevention with statin therapy totaling 48,421 individuals and 3,477 events were included in these analyses. We examined the association of a genetic risk score based on 27 genetic variants with incident or recurrent CHD, adjusting for established clinical predictors. We then investigated the relative and absolute risk reductions in CHD events with statin therapy stratified by genetic risk. Data from studies were combined using meta-analysis. Findings When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient of risk for incident or recurrent CHD was demonstrated with the multivariable-adjusted HRs (95% CI) for CHD for the intermediate and high genetic risk categories vs. low genetic risk category being 1.32 (1.20-1.46, P<0.0001) and 1.71 (1.54-1.91, P<0.0001), respectively. In terms of the benefit of statin therapy in the four randomized trials, there was a significant gradient of increasing relative risk reduction across the low, intermediate, and high genetic risk categories (13%, 29%, and 48%, P=0.0277). Similarly, greater absolute risk reductions were seen in those individuals in higher genetic risk categories (P=0.0101), resulting in an approximate three-fold gradient in the number needed to treat (NNT) in the primary prevention trials. Specifically, in the primary prevention trials, the NNT to prevent one MACE over 10 years for the low, intermediate, and high GRS individuals was 66, 42, and 25 in JUPITER and 57, 47, and 20

Clinical Benefit of Valvular Surgery in Patients with Chronic Kidney Disease.

PubMed

Chen, Yan; Au, Wing-Kuk; Chan, Daniel; Sit, Ko-Yung; Zhen, Zhe; Ho, Kar-Lai; Wong, Debbie; Ho, Lai-Ming; Yap, Desmond; Lam, Yui-Ming; Lau, Chu-Pak; Tse, Hung-Fat; Chan, Tak-Mao; Yiu, Kai-Hang

2018-06-20

Concomitant chronic kidney disease (CKD) is common in patients with significant valvular heart disease (VHD). This study sought to evaluate the clinical benefit of valvular surgery in patients with concomitant CKD.We evaluated 349 patients with significant VHD who were referred for surgery. Patients were divided into those with CKD stage ≥ 3 (CKD patients; n = 88) and those with CKD stage 1 or 2 (no CKD patients; n = 261). 63 patients did not receive surgery, of which 20 patients had CKD and 43 had no CKD. Mortality and change in eGFR were assessed after a median follow-up of 21 months.In the whole study population, 25% of the patients had CKD and these patients had higher mortality than those with no CKD. The annual mortality rates of patients with CKD who did and did not undergo surgery were 7.9% and 28.0%, respectively. In patients with no CKD, the annual mortality rates of those who did and did not undergo surgery were 1.8% and 2.3%, respectively. Importantly, surgery was associated with significant survival benefit in patients with CKD (log-rank test, P < 0.01), but was neutral in patients with no CKD. Multivariable analysis confirmed the survival benefit of valvular surgery in all patients, which was most significant in patients with CKD. Furthermore, eGFR was preserved in patients who underwent valvular surgery but declined significantly in those who did not.CKD is common in patients with significant VHD and, if left untreated surgically, these patients exhibit a high mortality.

Safeguarding the future of independent, academic clinical cancer research in Europe for the benefit of patients.

PubMed

Negrouk, Anastassia; Lacombe, Denis; Cardoso, Fatima; Morin, Franck; Carrasco, Eva; Maurel, Joan; Maibach, Rudolf; Aranda, Enrique; Marais, Richard; Stahel, Rolf A

2017-01-01

Cancer is a complex disease that is constantly evolving. It is now the most common cause of death in Europe after cardiovascular diseases. There are inequalities among European countries, potentially unsustainable healthcare systems impacting quality of cancer care and increasing number of patients with cancer with rare conditions. Clinical and translational research are the backbone in establishing scientific advances as novel treatments and advancing progress to the benefit of patients. Commercially sponsored clinical trials are responsible for developing new medicines that can treat various disease areas, including cancer. It is important to note, however, that these clinical trials only assess the viability of compounds that are chosen by a commercial entity that funds the entire process. By their design and focus, these trials need to fulfil commercial interests and market expectations, which do not always coincide with patients' needs. As soon or even before novel treatments and compounds obtain formal market authorisation, academia will take these existing and new medicines to further conduct research in order to optimise their use, develop new combinations and with a strong focus on the patients and their needs. Established standard of care most commonly relies on clinical cancer research stemming from non-commercial entities, cooperative groups or academic clinical research. This article provides a consensus on the definition of academic research, illustrates its added value and suggests and calls to European Union institutions to support this type of research for the benefit of patients.

The European Society for Medical Oncology 'Magnitude of Clinical Benefit Scale' field-tested in infrequent tumour entities: an extended analysis of its feasibility at the Medical University of Vienna.

PubMed

Kiesewetter, Barbara; Raderer, Markus; Prager, Gerald W; Fuereder, Thorsten; Marosi, Christine; Preusser, Matthias; Krainer, Michael; Locker, Gottfried J; Brodowicz, Thomas; Zielinski, Christoph C

2017-01-01

The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a new tool to quantify the clinical benefit that may be anticipated from a novel anticancer treatment. We present here an analysis on the feasibility of the ESMO-MCBS in less frequent tumour entities. This study evaluates the practicability of the ESMO-MCBS for metastatic neuroendocrine tumours (NETs), soft tissue sarcomas, glioblastoma, thyroid cancer, pancreatic cancer, head/neck cancer, urothelial cancer and ovarian cancer at the Medical University Vienna. A three-step approach including data acquisition, assessment of ESMO-MCBS scores and evaluation of results with a focus on clinical feasibility was applied. In NET and thyroid cancer, all analysed trials were very comparable in design and efficacy, and the ESMO-MCBS scores appeared to be consistent with the clinical benefit seen in practice. For pancreatic cancer, it was more difficult to compare first-line trials due to diverging populations included in the respective studies. Concerning soft tissue sarcomas, the ESMO-MCBS was applicable for gastrointestinal stromal tumours(GIST) and 'non-GIST' soft tissue sarcoma with respect to data deriving from randomised studies. However, due to the heterogeneity of the disease itself and a limited number of controlled trials, limitations are noted. In ovarian cancer, the ESMO-MCBS supported the use of bevacizumab in high-risk patients. To date, there are only limited data for glioblastoma, head/neck cancer and urothelial cancer but whenever randomised trials were available, the ESMO-MCBS rating supported clinical decisions. Interestingly, nivolumab for salvage treatment of head/neck cancer rated extremely high. The ESMO-MCBS scores supported our common treatment strategies and highlight the potential of new immunomodulatory drugs. Our results encourage further development of the ESMO-MCBS.

Clinical trial to compare tinnitus masking and tinnitus retraining therapy.

PubMed

Henry, J A; Schechter, M A; Zaugg, T L; Griest, S; Jastreboff, P J; Vernon, J A; Kaelin, C; Meikle, M B; Lyons, K S; Stewart, B J

2006-12-01

Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a 'moderate' and 'big' problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a 'very big' problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

Comparing employee health benefits in the public and private sectors, 1997.

PubMed

Long, S H; Marquis, M S

1999-01-01

Data from the 1997 Robert Wood Johnson Foundation Employer Health Insurance Survey provide new information comparing public- and private-sector employee health benefits. The federal government is ahead of other employers in adopting managed competition principles using financial incentives and consumer information to promote choosing efficient plans. Federal employees experience a $200 annual compensation gap relative to those in the private sector, but it is partly explained by advantage in purchasing power. In contrast, state and local governments make higher payments toward health insurance than private-sector employers do. Their premiums are equivalent, but they pay a greater share of the total cost.

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

PubMed

Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet

2018-01-01

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Enclosed nests may provide greater thermal than nest predation benefits compared with open nests across latitudes

USGS Publications Warehouse

Martin, Thomas E.; Boyce, Andy J.; Fierro-Calderon, Karolina; Mitchell, Adam E.; Armstad, Connor E.; Mouton, James C.; Bin Soudi, Evertius E.

2017-01-01

Nest structure is thought to provide benefits that have fitness consequences for several taxa. Traditionally, reduced nest predation has been considered the primary benefit underlying evolution of nest structure, whereas thermal benefits have been considered a secondary or even non-existent factor. Yet, the relative roles of these factors on nest structures remain largely unexplored.Enclosed nests have a constructed or natural roof connected to sides that allow a restricted opening or tube entrance that provides cover in all directions except the entrance, whereas open nests are cups or platforms that are open above. We show that construction of enclosed nests is more common among songbirds (Passeriformes) in tropical and southern hemisphere regions than in north temperate regions. This geographic pattern may reflect selection from predation risk, under long-standing assumptions that nest predation rates are higher in southern regions and that enclosed nests reduce predation risk compared with open cup nests. We therefore compared nest predation rates between enclosed vs. open nests in 114 songbird species that do not nest in tree holes among five communities of coexisting birds, and for 205 non-hole-nesting species from the literature, across northern temperate, tropical, and southern hemisphere regions.Among coexisting species, enclosed nests had lower nest predation rates than open nests in two south temperate sites, but not in either of two tropical sites or a north temperate site. Nest predation did not differ between nest types at any latitude based on literature data. Among 319 species from both our field studies and the literature, enclosed nests did not show consistent benefits of reduced predation and, in fact, predation was not consistently higher in the tropics, contrary to long-standing perspectives.Thermal benefits of enclosed nests were indicated based on three indirect results. First, species that built enclosed nests were smaller than species using

Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program.

PubMed

Havrdova, Eva; Cohen, Jeffrey A; Horakova, Dana; Kovarova, Ivana; Meluzinova, Eva

2017-01-01

The introduction of high-efficacy therapies for relapsing-remitting multiple sclerosis has driven re-evaluation of treatment goals and benefit:risk considerations in treatment choice. In the alemtuzumab Phase II and III clinical trials, patients treated with alemtuzumab 12 mg versus subcutaneous interferon beta-1a demonstrated significantly reduced annualized relapse rates and improved magnetic resonance imaging outcomes, and were significantly more likely to achieve no evidence of disease activity and reduction in brain volume loss. In two of the studies, alemtuzumab-treated patients had a significantly reduced risk of 6-month confirmed disease worsening, compared with subcutaneous interferon beta-1a. Benefits were maintained throughout 5 years, with a majority of patients receiving no alemtuzumab retreatment or other disease-modifying therapy. Trial results support alemtuzumab's manageable, consistent safety profile in relapsing-remitting multiple sclerosis. Infusion-associated reactions, the most frequent adverse events (AEs), can be minimized by corticosteroid pretreatment, monitoring, and symptomatic management. Other AEs include infections and autoimmune events. Oral anti-herpes prophylaxis should be initiated on the first day of each alemtuzumab treatment course and continued according to local guidelines. Overall cancer risk was lower in the alemtuzumab clinical trials than in a reference population; however, continuing surveillance will determine if alemtuzumab may be associated with certain malignancies such as thyroid papillary carcinoma and melanoma, which are currently identified as potential risks. The post-approval risk management strategy includes a safety monitoring program. Autoimmune AEs (thyroid events, immune thrombocytopenia, nephropathies) can be detected in a timely manner with the monitoring program, which includes physician and patient education about the signs and symptoms, monthly renal and hematologic monitoring, and quarterly thyroid

Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory.

PubMed

Mednick, Sara C; Cai, Denise J; Kanady, Jennifer; Drummond, Sean P A

2008-11-03

Caffeine, the world's most common psychoactive substance, is used by approximately 90% of North Americans everyday. Little is known, however, about its benefits for memory. Napping has been shown to increase alertness and promote learning on some memory tasks. We directly compared caffeine (200mg) with napping (60-90min) and placebo on three distinct memory processes: declarative verbal memory, procedural motor skills, and perceptual learning. In the verbal task, recall and recognition for unassociated words were tested after a 7h retention period (with a between-session nap or drug intervention). A second, different, word list was administered post-intervention and memory was tested after a 20min retention period. The non-declarative tasks (finger tapping task (FTT) and texture discrimination task (TDT)) were trained before the intervention and then retested afterwards. Naps enhanced recall of words after a 7h and 20min retention interval relative to both caffeine and placebo. Caffeine significantly impaired motor learning compared to placebo and naps. Napping produced robust perceptual learning compared with placebo; however, naps and caffeine were not significantly different. These findings provide evidence of the limited benefits of caffeine for memory improvement compared with napping. We hypothesize that impairment from caffeine may be restricted to tasks that contain explicit information; whereas strictly implicit learning is less compromised.

Comparing the benefits of Caffeine, Naps and Placebo on Verbal, Motor and Perceptual Memory

PubMed Central

Mednick, Sara C.; Cai, Denise J.; Kanady, Jennifer; Drummond, Sean P.A.

2008-01-01

Caffeine, the world’s most common psychoactive substance, is used by approximately 90% of North Americans everyday. Little is known, however, about its benefits for memory. Napping has been shown to increase alertness and promote learning on some memory tasks. We directly compared caffeine (200mg) with napping (60–90 minutes) and placebo on three distinct memory processes: declarative verbal memory, procedural motor skills, and perceptual learning. In the verbal task, recall and recognition for unassociated words were tested after a 7hr retention period (with a between-session nap or drug intervention). A second, different, word list was administered post-intervention and memory was tested after a 20min retention period. The non-declarative tasks (finger tapping task and texture discrimination task) were trained before the intervention and then retested afterwards. Naps enhanced recall of words after a 7hr and 20min retention interval relative to both caffeine and placebo. Caffeine significantly impaired motor learning compared to placebo and naps. Napping produced robust perceptual learning compared with placebo; however, naps and caffeine were not significantly different. These findings provide evidence of the limited benefits of caffeine for memory improvement compared with napping. We hypothesize that impairment from caffeine may be restricted to tasks that contain explicit information; whereas strictly implicit learning is less compromised. PMID:18554731

A comparative review of clinical governance arrangements in the UK.

PubMed

Pridmore, Julia Ann; Gammon, John

This article provides a comparative review of the interpretation and implementation of clinical governance frameworks within the four home countries of the UK--England, Northern Ireland, Scotland and Wales. Clinical governance has become one of most significant and important concepts in modern health care. The article considers the policy background and the many definitions of clinical governance, but specifically compares the various strategic and operational approaches to delivery of clinical governance in different parts of the UK. It is suggested that these variations in approach, by each of the four UK countries, can lead to confusion for healthcare professionals in trying to understand, implement and monitor elements of clinical governance in practice.

Differential pharmacology and benefit/risk of azilsartan compared to other sartans.

PubMed

Kurtz, Theodore W; Kajiya, Takashi

2012-01-01

Azilsartan, an angiotensin II type 1 (AT(1)) receptor blocker (ARB), was recently approved by regulatory authorities for treatment of hypertension and is the 8th ARB to join the clinical market. This article discusses the medical reasons for introducing a new AT(1) receptor blocker and reviews the experimental and clinical studies that have compared the functional properties of azilsartan to those of other ARBs. The main question addressed is: Does azilsartan have distinguishing features that should motivate choosing it over any of the other sartans for use in clinical practice? Based on studies conducted to date in hypertensive patients without serious comorbidities, azilsartan appears to be characterized by a superior ability to control 24-hour systolic blood pressure (BP) relative to other widely used ARBs including valsartan, olmesartan, and candesartan, and presumably others as well (eg, losartan). Compared to these other ARBs, azilsartan may increase the BP target control and response rate by an absolute value of 8%-10%. Greater antihypertensive effects of azilsartan might be due in part to its unusually potent and persistent ability to inhibit binding of angiotensin II to AT(1) receptors. Preclinical studies have indicated that azilsartan may also have potentially beneficial effects on cellular mechanisms of cardiometabolic disease and insulin sensitizing activity that could involve more than just blockade of AT(1) receptors and/or reduction in BP. However, the clinical relevance of these additional actions is unknown. Given that the general ability of antihypertensive drugs to protect against target organ damage is largely mediated by their ability to decrease BP, the enhanced antihypertensive effects of azilsartan should serve to justify clinical interest in this ARB relative to other molecules in the class that have a lower capacity to reduce BP.

Differential pharmacology and benefit/risk of azilsartan compared to other sartans

PubMed Central

Kurtz, Theodore W; Kajiya, Takashi

2012-01-01

Azilsartan, an angiotensin II type 1 (AT1) receptor blocker (ARB), was recently approved by regulatory authorities for treatment of hypertension and is the 8th ARB to join the clinical market. This article discusses the medical reasons for introducing a new AT1 receptor blocker and reviews the experimental and clinical studies that have compared the functional properties of azilsartan to those of other ARBs. The main question addressed is: Does azilsartan have distinguishing features that should motivate choosing it over any of the other sartans for use in clinical practice? Based on studies conducted to date in hypertensive patients without serious comorbidities, azilsartan appears to be characterized by a superior ability to control 24-hour systolic blood pressure (BP) relative to other widely used ARBs including valsartan, olmesartan, and candesartan, and presumably others as well (eg, losartan). Compared to these other ARBs, azilsartan may increase the BP target control and response rate by an absolute value of 8%–10%. Greater antihypertensive effects of azilsartan might be due in part to its unusually potent and persistent ability to inhibit binding of angiotensin II to AT1 receptors. Preclinical studies have indicated that azilsartan may also have potentially beneficial effects on cellular mechanisms of cardiometabolic disease and insulin sensitizing activity that could involve more than just blockade of AT1 receptors and/or reduction in BP. However, the clinical relevance of these additional actions is unknown. Given that the general ability of antihypertensive drugs to protect against target organ damage is largely mediated by their ability to decrease BP, the enhanced antihypertensive effects of azilsartan should serve to justify clinical interest in this ARB relative to other molecules in the class that have a lower capacity to reduce BP. PMID:22399858

"They put you on your toes": Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting.

PubMed

Davies, Robyn; Hanna, Elizabeth; Cott, Cheryl

2011-01-01

To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff.

Using the weighted area under the net benefit curve for decision curve analysis.

PubMed

Talluri, Rajesh; Shete, Sanjay

2016-07-18

Risk prediction models have been proposed for various diseases and are being improved as new predictors are identified. A major challenge is to determine whether the newly discovered predictors improve risk prediction. Decision curve analysis has been proposed as an alternative to the area under the curve and net reclassification index to evaluate the performance of prediction models in clinical scenarios. The decision curve computed using the net benefit can evaluate the predictive performance of risk models at a given or range of threshold probabilities. However, when the decision curves for 2 competing models cross in the range of interest, it is difficult to identify the best model as there is no readily available summary measure for evaluating the predictive performance. The key deterrent for using simple measures such as the area under the net benefit curve is the assumption that the threshold probabilities are uniformly distributed among patients. We propose a novel measure for performing decision curve analysis. The approach estimates the distribution of threshold probabilities without the need of additional data. Using the estimated distribution of threshold probabilities, the weighted area under the net benefit curve serves as the summary measure to compare risk prediction models in a range of interest. We compared 3 different approaches, the standard method, the area under the net benefit curve, and the weighted area under the net benefit curve. Type 1 error and power comparisons demonstrate that the weighted area under the net benefit curve has higher power compared to the other methods. Several simulation studies are presented to demonstrate the improvement in model comparison using the weighted area under the net benefit curve compared to the standard method. The proposed measure improves decision curve analysis by using the weighted area under the curve and thereby improves the power of the decision curve analysis to compare risk prediction models in

[Benefits of using rapid HIV testing at the PMU-FLON walk-in clinic in Lausanne].

PubMed

Gilgien, W; Aubert, J; Bischoff, T; Herzig, L; Perdrix, J

2012-05-16

Lab tests are frequently used in primary care to guide patient care. This is particularly the case when a severe disorder, or one that will affect patients' initial care, needs to be excluded rapidly. At the PMU-FLON walk-in clinic the use of HIV testing as recommended by the Swiss Office of Public Health was hampered by the delay in obtaining test results. This led us to introduce rapid HIV testing which provides results within 30 minutes. Following the first 250 tests the authors discuss the results as well as the benefits of rapid HIV testing in an urban walk-in clinic.

A Novel Glycinate-based Body Wash: Clinical Investigation Into Ultra-mildness, Effective Conditioning, and Improved Consumer Benefits.

PubMed

Regan, Jamie; Mollica, Leonel-Maximo; Ananthapadmanabhan, K P

2013-06-01

To assess the properties of a novel body wash containing the mild surfactant glycinate. Biochemical and clinical assays. Research laboratories and clinical sites in the United States and Canada. Women 18 to 65 years of age (cleansing efficacy); male and female subjects 26 to 63 years of age with mild or moderate dryness and erythema (leg-controlled application test); subjects 5 to 65 years of age with mild-to-moderate eczema (eczema compatibility); and women 18 to 64 years of age (home use). Assessments across studies included colorimetric dye exclusion to assess skin damage potential (corneosurfametry), efficacy of cosmetic product removal from skin, change from baseline in visual dryness, change from baseline in Eczema Area and Severity Index, and self-perceived eczema attributes and self-reported product preference. The glycinate-based cleanser demonstrated mildness to skin components when evaluated in a corneosurfametry assay. Short-term use under exaggerated wash conditions in subjects with dryness scores <3 and erythema scores <2 (both on a 0-6 scale) indicated an initial reduction in visual dryness. In subjects with eczema, normal use resulted in significant improvements (p<0.05) at Week 4 compared with baseline in skin dryness (change from baseline = -0.73), rash (-0.56), itch (-0.927), tightness (-0.585), and all eczema (-0.756). The glycinate-based body wash removed 56 percent of a long-lasting cosmetic foundation from skin compared with less than 30 percent removed by two competitive products tested. The glycinate-based body wash was preferred over a competitive mild cleansing product overall. The patented glycinate-containing body wash demonstrated better product mildness and patient-preferred attributes and clinical benefits.

Comparative responsiveness and minimal clinically important differences for idiopathic ulnar impaction syndrome.

PubMed

Kim, Jae Kwang; Park, Eun Soo

2013-05-01

Patient-reported questionnaires have been widely used to predict symptom severity and functional disability in musculoskeletal disease. Importantly, questionnaires can detect clinical changes in patients; however, this impact has not been determined for ulnar impaction syndrome. We asked (1) which of Patient-Rated Wrist Evaluation (PRWE), DASH, and other physical measures was more responsive to clinical improvements, and (2) what was the minimal clinically important difference for the PRWE and DASH after ulnar shortening osteotomy for idiopathic ulnar impaction syndrome. All patients who underwent ulnar shortening osteotomy between March 2008 and February 2011 for idiopathic ulnar impaction syndrome were enrolled in this study. All patients completed the PRWE and DASH questionnaires, and all were evaluated for grip strength and wrist ROM, preoperatively and 12 months postoperatively. We compared the effect sizes observed by each of these instruments. Effect size is calculated by dividing the mean change in a score of each instrument during a specified interval by the standard deviation of the baseline score. In addition, patient-perceived overall improvement was used as the anchor to determine the minimal clinically important differences on the PRWE and DASH 12 months after surgery. The average score of each item except for wrist flexion and supination improved after surgery. The PRWE was more sensitive than the DASH or than physical measurements in detecting clinical changes. The effect sizes and standardized response means of the outcome measures were as follows: PRWE (1.51, 1.64), DASH (1.12, 1.24), grip strength (0.59, 0.68), wrist pronation (0.33, 0.41), and wrist extension (0.28, 0.36). Patient-perceived overall improvement and score changes of the PRWE and DASH correlated significantly. Minimal clinically important differences were 17 points (of a possible 100) for the PRWE and 13.5 for the DASH (also of 100), and minimal detectable changes were 7.7 points

Comparative audit of clinical research in pediatric neurology.

PubMed

Al-Futaisi, Amna; Shevell, Michael

2004-11-01

Clinical research involves direct observation or data collection on human subjects. This study was conducted to evaluate the profile of pediatric neurology clinical research over a decade. Trends in pediatric neurology clinical research were documented through a systematic comparative review of articles published in selected journals. Eleven journals (five pediatric neurology, three general neurology, three general pediatrics) were systematically reviewed for articles involving a majority of human subjects less than 18 years of age for the years 1990 and 2000. Three hundred thirty-five clinical research articles in pediatric neurology were identified in the 11 journals for 1990 and 398 for 2000, a 19% increase. A statistically significant increase in analytic design (21.8% vs 39.5%; P = .01), statistical support (6% vs 16.6%; P < .0001), and multidisciplinary team (69.9% vs 87%; P = .003) was observed. In terms of specific study design, a significant decline in case reports (34.3% vs 10.3%; P < .0001) and an increase in case-control studies (11.3% vs 22.9%; P = .02) were evident over the 10-year interval. This comparative audit revealed that there has been a discernible change in the methodology profile of clinical research in child neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

Fiber supplements and clinically proven health benefits: How to recognize and recommend an effective fiber therapy.

PubMed

Lambeau, Kellen V; McRorie, Johnson W

2017-04-01

Only 5% of adults consume the recommended level of dietary fiber. Fiber supplements appear to be a convenient and concentrated source of fiber, but most do not provide the health benefits associated with dietary fiber. This review will summarize the physical effects of isolated fibers in small and large intestines, which drive clinically meaningful health benefits. A comprehensive literature review was conducted (Scopus and PubMed) without limits to year of publication (latest date included: October 31, 2016). The physical effects of fiber in the small intestine drive metabolic health effects (e.g., cholesterol lowering, improved glycemic control), and efficacy is a function of the viscosity of gel-forming fibers (e.g., psyllium, β-glucan). In the large intestine, fiber can provide a laxative effect if (a) it resists fermentation to remain intact throughout the large intestine, and (b) it increases percentage of water content to soften/bulk stool (e.g., wheat bran and psyllium). It is important for nurse practitioners to understand the underlying mechanisms that drive specific fiber-related health benefits, and which fiber supplements have rigorous clinical data to support a recommendation. For most fiber-related beneficial effects, "Fiber needs to gel to keep your patients well." ©2017 The Authors. Journal of the American Association of Nurse Practitioners published by Wiley Periodicals, Inc. on behalf of American Association of Nurse Practitioners.

Is there really a clinical benefit of using minimized extracorporeal circulation for coronary artery bypass grafting?

PubMed

Schöttler, J; Lutter, G; Böning, A; Soltau, D; Bein, B; Caliebe, D; Haake, N; Schoeneich, F; Cremer, J

2008-03-01

Minimized extracorporeal circulation is intended to reduce the negative effects associated with cardiopulmonary bypass. This prospective study was performed to evaluate whether minimized extracorporeal circulation has a clinical benefit for coronary artery surgery patients compared to standard extracorporeal circulation. Sixty patients were randomized into two study groups: 30 patients underwent coronary artery bypass grafting using minimized extracorporeal circulation and 30 patients were operated using standard extracorporeal circulation. Baseline characteristics, intraoperative details, postoperative data, perioperative blood chemistry determinations of hematocrit, platelets, muscle-brain fraction of the creatine kinase, cardiac troponin T and colloid osmotic pressure as measurements of intrathoracic blood volume index and extravascular lung water index were compared. Baseline characteristics and intraoperative details of both groups were similar. Patients who underwent minimized extracorporeal circulation showed more short-term dependency on norepinephrine ( P < 0.01). Their maximal postoperative muscle-brain fraction of the creatine kinase was lower ( P < 0.05) and their hematocrit on arrival in the intensive care unit was higher ( P < 0.01). No other significant differences were found. In both collectives, values for hematocrit ( P < 0.001), platelets ( P < 0.001), colloid osmotic pressure ( P < 0.001) and intrathoracic blood volume index ( P < 0.05) decreased, while the extravascular lung water index did not change significantly during cardiopulmonary bypass. A clinical advantage of minimized over standard extracorporeal circulation was not found. Furthermore, a higher number of patients in the minimized extracorporeal circulation group required postoperative norepinephrine infusions for hemodynamic stabilization. In summary, the presumed superiority of minimized extracorporeal circulation for coronary artery bypass grafting in standard patients could not be

Circulating tumor DNA evaluated by Next-Generation Sequencing is predictive of tumor response and prolonged clinical benefit with nivolumab in advanced non-small cell lung cancer.

PubMed

Giroux Leprieur, Etienne; Herbretau, Guillaume; Dumenil, Coraline; Julie, Catherine; Giraud, Violaine; Labrune, Sylvie; Dumoulin, Jennifer; Tisserand, Julie; Emile, Jean-François; Blons, Hélène; Chinet, Thierry

2018-01-01

Nivolumab is an anti-PD1 antibody, given in second-line or later treatment in advanced non-small cell lung cancer (NSCLC). The objective of this study was to describe the predictive value of circulating tumor DNA (ctDNA) on the efficacy of nivolumab in advanced NSCLC. We prospectively included all consecutive patients with advanced NSCLC treated with nivolumab in our Department between June 2015 and October 2016. Plasma samples were obtained before the first injection of nivolumab and at the first tumor evaluation with nivolumab. ctDNA was analyzed by Next-Generation Sequencing (NGS), and the predominant somatic mutation was followed for each patient and correlated with tumor response, clinical benefit (administration of nivolumab for more than 6 months), and progression-free survival (PFS). Of 23 patients, 15 had evaluable NGS results at both times of analysis. ctDNA concentration at the first tumor evaluation and ctDNA change correlated with tumor response, clinical benefit and PFS. ROC curve analyses showed good diagnostic performances for tumor response and clinical benefit, both for ctDNA concentration at the first tumor evaluation (tumor response: positive predictive value (PPV) at 100.0% and negative predictive value (NPV) at 71.0%; clinical benefit: PPV at 83.3% and NPV 77.8%) and the ctDNA change (tumor response: PPV 100.0% and NPV 62.5%; clinical benefit: PPV 100.0% and NPV 80.0%). Patients without ctDNA concentration increase >9% at 2 months had a long-term benefit of nivolumab. In conclusion, NGS analysis of ctDNA allows the early detection of tumor response and long-term clinical benefit with nivolumab in NSCLC.

Cost-benefit of hospitalization compared with outpatient care for pregnant women with pregestational and gestational diabetes or with mild hyperglycemia, in Brazil.

PubMed

Cavassini, Ana Claudia Molina; Lima, Silvana Andréa Molina; Calderon, Iracema Mattos Paranhos; Rudge, Marilza Vieira Cunha

2012-01-01

Pregnancies complicated by diabetes are associated with increased numbers of maternal and neonatal complications. Hospital costs increase according to the type of care provided. This study aimed to estimate the cost-benefit relationship and social profitability ratio of hospitalization, compared with outpatient care, for pregnant women with diabetes or mild hyperglycemia. This was a prospective observational quantitative study conducted at a university hospital. It included all pregnant women with pregestational or gestational diabetes, or mild hyperglycemia, who did not develop clinical intercurrences during pregnancy and who delivered at the Botucatu Medical School Hospital (Hospital das Clínicas, Faculdade de Medicina de Botucatu, HC-FMB) of Universidade Estadual de São Paulo (Unesp). Thirty pregnant women treated with diet were followed as outpatients, and twenty treated with diet plus insulin were managed through frequent short hospitalizations. Direct costs (personnel, materials and tests) and indirect costs (general expenses) were ascertained from data in the patients' records and the hospital's absorption costing system. The cost-benefit was then calculated. Successful treatment of pregnant women with diabetes avoided expenditure of US$ 1,517.97 and US$ 1,127.43 for patients treated with inpatient and outpatient care, respectively. The cost-benefit of inpatient care was US$ 143,719.16, and outpatient care, US$ 253,267.22, with social profitability of 1.87 and 5.35, respectively. Decision-tree analysis confirmed that successful treatment avoided costs at the hospital. Cost-benefit analysis showed that outpatient management was economically more advantageous than hospitalization. The social profitability of both treatments was greater than one, thus demonstrating that both types of care for diabetic pregnant women had positive benefits.

The European Society for Medical Oncology Magnitude of Clinical Benefit Scale in daily practice: a single institution, real-life experience at the Medical University of Vienna.

PubMed

Kiesewetter, Barbara; Raderer, Markus; Steger, Günther G; Bartsch, Rupert; Pirker, Robert; Zöchbauer-Müller, Sabine; Prager, Gerald; Krainer, Michael; Preusser, Matthias; Schmidinger, Manuela; Zielinski, Christoph C

2016-01-01

The European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) has been designed to stratify the therapeutic benefit of a certain drug registered for the treatment of cancer. However, though internally validated, this tool has not yet been evaluated for its feasibility in the daily practice of a major center of medical oncology. The practicability of the MCBS for advanced oncological diseases at the Clinical Division of Oncology, Medical University of Vienna, which constitutes one of the largest oncological centres in Europe, was analysed in a three-step approach. First, retrospectively collected data were analysed to gain an overview of treatments in regular use. Second, data were scored by using the MCBS. Third, the ensuing results were evaluated within corresponding programme directorships to assess feasibility in a real-life clinical context. In the majority of tumour entities, the MCBS results reported earlier are consistent with daily clinical practice. Thus, in metastatic breast cancer or advanced lung cancer, there was a high level of clinical benefit for first-line treatment standards, and these results reflected well real-life experience. However, analyses based on the first version of the MCBS are limited if it comes to salvage treatment in tumour entities in which optimal sequencing of potential treatment options is of major importance, as in metastatic colorectal or renal cell cancer. In contrast to this, it is remarkable that certain novel therapies such as nivolumab assessed for heavily pretreated advanced renal cancer reached the highest level of clinical benefit due to prolongation in survival and a favourable toxicity profile. The MCBS clearly underlines the potential benefit of these compounds. The MCBS is an excellent tool for daily clinical practice of a tertiary referral centre. It supports treatment decisions based on the clinical benefit to be expected from a novel approach such as immunotherapy in as yet

Influence of clinical outcome and outcome period definitions on estimates of absolute clinical and economic benefits of influenza vaccination in community dwelling elderly persons.

PubMed

Nichol, K L; Nordin, J; Mullooly, J

2006-03-06

Studies assessing the clinical and economic benefits of vaccination in the elderly have used different clinical outcomes (e.g. hospitalizations for pneumonia or influenza versus hospitalizations for respiratory and cardiovascular causes) and different outcome periods (e.g. peak versus total influenza season) on which to base estimates of clinical effectiveness and cost effectiveness. We explored the implications of these varying approaches by comparing two health economic analysis models of influenza vaccination of community-dwelling elderly persons. We developed computerized models using clinical data from 3 large US HMOs for the 1998-1999 and 1999-2000 influenza seasons. The primary health economic model used a broad definition of clinical events and outcome period and included hospitalizations for all respiratory and cardiovascular events that occurred during the entire influenza season. The alternative model used more restrictive definitions and included pneumonia or influenza hospitalizations occurring during the peak influenza season. The results of Monte Carlo simulation showed that, with the more inclusive primary model, influenza vaccination resulted in net medical care cost savings due to fewer respiratory or cardiovascular hospitalizations of Dollars 71/person vaccinated (5th-95th percentile Dollars 32-118) and net savings of Dollars 809/year of life saved (5th-95th percentile Dollars 331-1450). In contrast, the alternate model found costs of Dollars 3.50/person vaccinated (5th-95th percentile Dollars -11 to 5) and net costs of Dollars 91/year of life saved (5th-95th percentile Dollars -309 to 126). Our findings confirm that influenza vaccination of the elderly is most likely cost saving and supports policies and programs that advocate routine immunization of all persons 65 and older. They also highlight how different outcome definitions can influence the results of health economic analyses.

The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

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

Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be; Van den Bergh, Laura; Al-Mamgani, Abrahim

2012-03-01

Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including themore » most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions

Outcomes at 7 years post-transplant in black vs nonblack kidney transplant recipients administered belatacept or cyclosporine in BENEFIT and BENEFIT-EXT.

PubMed

Florman, Sander; Vincenti, Flavio; Durrbach, Antoine; Abouljoud, Marwan; Bresnahan, Barbara; Garcia, Valter Duro; Mulloy, Laura; Rice, Kim; Rostaing, Lionel; Zayas, Carlos; Calderon, Kellie; Meier-Kriesche, Ulf; Polinsky, Martin; Yang, Lingfeng; Medina Pestana, Jose; Larsen, Christian P

2018-04-01

Clinical outcomes are generally worse for black vs nonblack renal allograft recipients. In BENEFIT and BENEFIT-EXT, recipients were randomized to belatacept more intense-based, belatacept less intense-based, or cyclosporine-based immunosuppression. At year 7, belatacept was associated with superior graft survival vs cyclosporine in BENEFIT (recipients of living or standard criteria deceased donor kidneys); belatacept was associated with similar graft survival vs cyclosporine in BENEFIT-EXT (recipients of extended criteria donor kidneys). In both studies, renal function was superior for belatacept-treated vs cyclosporine-treated patients. Seven-year outcomes were examined by race post hoc in each study. The effect of race and treatment on time to death or graft loss was compared using Cox regression. The interaction between treatment and race was also considered. Glomerular filtration rate (GFR) was estimated from months 1 to 84 using a repeated-measures model. In total, 8.3% (55/666) and 13.1% (71/543) of patients in BENEFIT and BENEFIT-EXT, respectively, were black. Time to death or graft loss was similar in blacks and nonblacks. For both subgroups, estimated mean GFR increased over 7 years for belatacept, but declined for cyclosporine. Outcomes were similar in belatacept-treated black and nonblack patients. Due to the small number of black patients, these results must be interpreted with caution. © 2018 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature.

PubMed

Narayana, D B Anantha; Durg, Sharanbasappa; Manohar, P Ram; Mahapatra, Anita; Aramya, A R

2017-02-02

Chyawanprash (CP), a traditional immune booster recipe, has a long history of ethnic origin, development, household preparation and usage. There are even mythological stories about the origin of this recipe including its nomenclature. In the last six decades, CP, because of entrepreneurial actions of some research Vaidyas (traditional doctors) has grown to industrial production and marketing in packed forms to a large number of consumers/patients like any food or health care product. Currently, CP has acquired a large accepted user base in India and in a few countries out-side India. Authoritative texts, recognized by the Drugs and Cosmetics Act of India, describe CP as an immunity enhancer and strength giver meant for improving lung functions in diseases with compromised immunity. This review focuses on published clinical efficacy and safety studies of CP for correlation with health benefits as documented in the authoritative texts, and also briefs on its recipes and processes. Authoritative texts were searched for recipes, processes, and other technical details of CP. Labels of marketing CP products (Indian) were studied for the health claims. Electronic search for studies of CP on efficacy and safety data were performed in PubMed/MEDLINE and DHARA (Digital Helpline for Ayurveda Research Articles), and Ayurvedic books were also searched for clinical studies. The documented clinical studies from electronic databases and Ayurvedic books evidenced that individuals who consume CP regularly for a definite period of time showed improvement in overall health status and immunity. However, most of the clinical studies in this review are of smaller sample size and short duration. Further, limitation to access and review significant data on traditional products like CP in electronic databases was noted. Randomized controlled trials of high quality with larger sample size and longer follow-up are needed to have significant evidence on the clinical use of CP as immunity

Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

PubMed

Evans, Scott R; Pennello, Gene; Pantoja-Galicia, Norberto; Jiang, Hongyu; Hujer, Andrea M; Hujer, Kristine M; Manca, Claudia; Hill, Carol; Jacobs, Michael R; Chen, Liang; Patel, Robin; Kreiswirth, Barry N; Bonomo, Robert A

2016-09-15

The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk trade-offs of diagnostics that assist in medical decision making. Benefit-Risk Evaluation of Diagnostics: A Framework (BED-FRAME) is a strategy for pragmatic evaluation of diagnostics designed to supplement traditional approaches. BED-FRAME evaluates diagnostic yield and addresses 2 key issues: (1) that diagnostic yield depends on prevalence, and (2) that different diagnostic errors carry different clinical consequences. As such, evaluating and comparing diagnostics depends on prevalence and the relative importance of potential errors. BED-FRAME provides a tool for communicating the expected clinical impact of diagnostic application and the expected trade-offs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision making. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Children with dyslexia show a reduced processing benefit from bimodal speech information compared to their typically developing peers.

PubMed

Schaadt, Gesa; van der Meer, Elke; Pannekamp, Ann; Oberecker, Regine; Männel, Claudia

2018-01-17

During information processing, individuals benefit from bimodally presented input, as has been demonstrated for speech perception (i.e., printed letters and speech sounds) or the perception of emotional expressions (i.e., facial expression and voice tuning). While typically developing individuals show this bimodal benefit, school children with dyslexia do not. Currently, it is unknown whether the bimodal processing deficit in dyslexia also occurs for visual-auditory speech processing that is independent of reading and spelling acquisition (i.e., no letter-sound knowledge is required). Here, we tested school children with and without spelling problems on their bimodal perception of video-recorded mouth movements pronouncing syllables. We analyzed the event-related potential Mismatch Response (MMR) to visual-auditory speech information and compared this response to the MMR to monomodal speech information (i.e., auditory-only, visual-only). We found a reduced MMR with later onset to visual-auditory speech information in children with spelling problems compared to children without spelling problems. Moreover, when comparing bimodal and monomodal speech perception, we found that children without spelling problems showed significantly larger responses in the visual-auditory experiment compared to the visual-only response, whereas children with spelling problems did not. Our results suggest that children with dyslexia exhibit general difficulties in bimodal speech perception independently of letter-speech sound knowledge, as apparent in altered bimodal speech perception and lacking benefit from bimodal information. This general deficit in children with dyslexia may underlie the previously reported reduced bimodal benefit for letter-speech sound combinations and similar findings in emotion perception. Copyright © 2018 Elsevier Ltd. All rights reserved.

What is the benefit of using amniotic membrane in oral surgery? A comprehensive review of clinical studies.

PubMed

Fénelon, M; Catros, S; Fricain, J C

2018-06-01

Since its first use for the reconstruction of tissue defects in the oral cavity in 1985, human amniotic membrane (hAM) has been widely studied in the field of oral surgery. Despite the growing number of publications in this field, there is no systematic review or meta-analysis concerning its clinical applications, outcome assessments, and relevance in oral surgery. The aim of this review is to provide a thorough understanding of the potential use of hAM for soft and hard tissue reconstruction in the oral cavity. A systematic electronic and a manual literature search of the MEDLINE-PubMed database and Scopus database was completed. Patient, Intervention, Comparison and Outcomes (PICO) technique was used to select the relevant articles to meet the objective. Studies using hAM for oral reconstruction, and conducted on human subjects, were included in this survey. A total of 17 articles were analyzed. Five areas of interest were identified as potential clinical application: periodontal surgery, cleft palate and tumor reconstruction, prosthodontics and peri-implant surgery. Overall, periodontal surgery was the only discipline to assess the efficacy of hAM with randomized clinical trials. The wide variability of preservation methods of hAM and the lack of objective measurements were observed in this study. hAM is already used in the field of oral surgery. Despite this, there is weak clinical evidence demonstrating convincingly the benefit of hAM in this area compared to standard surgery. Several studies now suggest the interest of hAM for periodontal tissue repair. Due to its biological and mechanical properties, hAM seems to be a promising treatment for wound healing in various areas of oral reconstruction. However, further randomized clinical trials are needed to confirm these preliminary results.

Clinical and economic impact of mirabegron compared with antimuscarinics for the treatment of overactive bladder in Canada.

PubMed

Hakimi, Zalmai; Nazir, Jameel; McCrea, Charles; Berling, Malin; Fatoye, Francis; Ramos, Barbara; Wagg, Adrian

2017-06-01

The β 3 -adrenoceptor agonist, mirabegron, and antimuscarinic agents provide similar efficacy for the treatment of overactive bladder (OAB), but mirabegron appears to be associated with better persistence, perhaps due to an absence of anticholinergic side-effects. This study estimated the expected costs associated with the management of OAB in Canada from a societal perspective by utilizing real-world evidence. An economic model with monthly cycles and a 1-year time horizon was developed to depict a treatment pathway for a hypothetical cohort of 100 patients with OAB. At model entry, patients receive mirabegron or an antimuscarinic. Patients who do not persist may switch treatment, undergo a minimally invasive procedure, or remain symptomatic (uncontrolled). The model includes direct costs (e.g. physician visits) and indirect costs (e.g. lost productivity). A one-way univariate sensitivity analysis assessed a ±20% variation in each of the key model inputs. At 1 year, a greater proportion of patients persisted on treatment with mirabegron compared with antimuscarinics (33% vs 15-23%), and a smaller proportion switched treatment (17% vs 20-22%). The number of healthcare visits (292 vs 299-304), pads used (74,098 vs 77,878-81,669), and work hours lost (4,497 vs 5,372-6,249) were all lower for mirabegron vs antimuscarinics. The estimated total annual cost of treatment per patient with mirabegron was $2,127.46 Canadian dollars (CAD) ($5.82 CAD/day) compared with $2,150.20-$2,496.69 CAD ($5.89-$6.84 CAD/day) for antimuscarinics. The one-way sensitivity analysis indicated the results are robust. Improved persistence observed in routine clinical practice with mirabegron appears to translate into benefits of reduced healthcare resource use, and lower direct and indirect costs of treatment compared with antimuscarinics. Overall, these data suggest that mirabegron may offer clinical and economic benefits for the management of patients with OAB in Canada.

Benefit and outcome of using temozolomide-based chemoradiotherapy followed by temozolomide alone for glioblastoma in clinical practice.

PubMed

Salma, Svetlana; Djan, Igor; Bjelan, Mladen; Vulekovic, Petar; Novakovic, Mico; Vidovic, Vladimir; Lucic, Milos

2017-01-01

Temozolomide (TEM), an oral alkylating agent, has shown promising activity in the last 10 years in the treatment of glioblastoma multiforme (GBM). Our goal was to show the benefit of concomitant therapy involving 3D conformal radiotherapy and temozolomide in clinical practice. This was a retrospective/prospective study and included a total of 113 patients with GBM diagnosis. Forty- seven patients received postoperative radiotherapy and 66 received concomitant temozolomide plus 3D conformal radiotherapy. The mean overall survival of patients who received postoperative radiotherapy alone was 9.93±6.475 months, compared to statistically longer overall survival in the group of patients who received radiotherapy plus temozolomide (13.89±8.049 months) (p=0.006). The latter group was divided into two subgroups, one consisting of patients who received 6 complete cycles of temozolomide, and a second with patients who received incomplete treatment. Statistically significant longer overall survival was registered in the first subgroup compared to the second (p=0.006). The concomitant usage of temozolomide and radiotherapy was beneficial, and statistically significant difference among groups and subgroups was observed regarding overall survival.

Ontario Universities Benefits Survey, 1989-90. Part I: Benefits Excluding Pensions.

ERIC Educational Resources Information Center

Council of Ontario Universities, Toronto.

The report compares benefits offered to employees of 17 universities in Ontario, Canada. The report, which is entirely in tabular form, presentation of universities' responses to general benefits questions, such as the administration of insurance plans, communication of benefits to employees, proposed changes in benefits, provision of accidental…

A comparative analysis of clinical outcomes and disposable costs of different catheter ablation methods for the treatment of atrioventricular nodal reentrant tachycardia

PubMed Central

Berman, Adam E; Rivner, Harold; Chalkley, Robin; Heboyan, Vahé

2017-01-01

Background Catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) is a commonly performed electrophysiology (EP) procedure. Few data exist comparing conventional (CONV) versus novel ablation strategies from both clinical and direct cost perspectives. We sought to investigate the disposable costs and clinical outcomes associated with three different ablation methodologies used in the ablation of AVNRT. Methods We performed a retrospective review of AVNRT ablations performed at Augusta University Medical Center from 2006 to 2014. A total of 183 patients were identified. Three different ablation techniques were compared: CONV manual radiofrequency (RF) (n=60), remote magnetic navigation (RMN)-guided RF (n=67), and cryoablation (CRYO) (n=56). Results Baseline demographics did not differ between the three groups except for a higher prevalence of cardiomyopathy in the RMN group (p<0.01). The clinical end point of interest was recurrent AVNRT following the index ablation procedure. A significantly higher number of recurrent AVNRT cases occurred in the CRYO group as compared to CONV and RMN (p=0.003; OR =7.75) groups. Cost-benefit analysis showed both CONV and RMN to be dominant compared to CRYO. Cost-minimization analysis demonstrated the least expensive ablation method to be CONV (mean disposable catheter cost = CONV US$2340; CRYO US$3515; RMN US$5190). Despite comparable clinical outcomes, the incremental cost of RMN over CONV averaged US$3094 per procedure. Conclusion AVNRT ablation using either CONV or RMN techniques is equally effective and associated with lower AVNRT recurrence rates than CRYO. CONV ablation carries significant disposable cost savings as compared to RMN, despite similar efficacy. PMID:29138585

A comparative analysis of clinical outcomes and disposable costs of different catheter ablation methods for the treatment of atrioventricular nodal reentrant tachycardia.

PubMed

Berman, Adam E; Rivner, Harold; Chalkley, Robin; Heboyan, Vahé

2017-01-01

Catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) is a commonly performed electrophysiology (EP) procedure. Few data exist comparing conventional (CONV) versus novel ablation strategies from both clinical and direct cost perspectives. We sought to investigate the disposable costs and clinical outcomes associated with three different ablation methodologies used in the ablation of AVNRT. We performed a retrospective review of AVNRT ablations performed at Augusta University Medical Center from 2006 to 2014. A total of 183 patients were identified. Three different ablation techniques were compared: CONV manual radiofrequency (RF) (n=60), remote magnetic navigation (RMN)-guided RF (n=67), and cryoablation (CRYO) (n=56). Baseline demographics did not differ between the three groups except for a higher prevalence of cardiomyopathy in the RMN group ( p <0.01). The clinical end point of interest was recurrent AVNRT following the index ablation procedure. A significantly higher number of recurrent AVNRT cases occurred in the CRYO group as compared to CONV and RMN ( p =0.003; OR =7.75) groups. Cost-benefit analysis showed both CONV and RMN to be dominant compared to CRYO. Cost-minimization analysis demonstrated the least expensive ablation method to be CONV (mean disposable catheter cost = CONV US$2340; CRYO US$3515; RMN US$5190). Despite comparable clinical outcomes, the incremental cost of RMN over CONV averaged US$3094 per procedure. AVNRT ablation using either CONV or RMN techniques is equally effective and associated with lower AVNRT recurrence rates than CRYO. CONV ablation carries significant disposable cost savings as compared to RMN, despite similar efficacy.

Expectations of Benefit in Early-Phase Clinical Trials: Implications for Assessing the Adequacy of Informed Consent

PubMed Central

Weinfurt, Kevin P.; Seils, Damon M.; Tzeng, Janice P.; Compton, Kate L.; Sulmasy, Daniel P.; Astrow, Alan B.; Solarino, Nicholas A.; Schulman, Kevin A.; Meropol, Neal J.

2009-01-01

Background Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented. Such concern is based on assumptions about what patients mean when they respond to questions about likelihood of benefit. Methods Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, we randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency-type, belief-type, and vague. In semistructured interviews, we queried participants about how they understood and answered the question. Participants then answered and discussed one of the other questions. Results Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P = .02). The most common justifications involved positive attitude (n = 27 [60%]) and references to physical health (n = 23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower (< 50%) expectations (n = 3 [27%]). Conclusions The wording of questions about likelihood of benefit shapes the expectations that patients express. Also, patients who express high expectations may not do so to communicate understanding, but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding in this context. PMID:18378940

Travel cost demand model based river recreation benefit estimates with on-site and household surveys: Comparative results and a correction procedure

NASA Astrophysics Data System (ADS)

Loomis, John

2003-04-01

Past recreation studies have noted that on-site or visitor intercept surveys are subject to over-sampling of avid users (i.e., endogenous stratification) and have offered econometric solutions to correct for this. However, past papers do not estimate the empirical magnitude of the bias in benefit estimates with a real data set, nor do they compare the corrected estimates to benefit estimates derived from a population sample. This paper empirically examines the magnitude of the recreation benefits per trip bias by comparing estimates from an on-site river visitor intercept survey to a household survey. The difference in average benefits is quite large, with the on-site visitor survey yielding 24 per day trip, while the household survey yields 9.67 per day trip. A simple econometric correction for endogenous stratification in our count data model lowers the benefit estimate to $9.60 per day trip, a mean value nearly identical and not statistically different from the household survey estimate.

“They put you on your toes”: Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting

PubMed Central

Hanna, Elizabeth; Cott, Cheryl

2011-01-01

ABSTRACT Purpose: To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. Method: In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Results: Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Conclusions: Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff. PMID:22379263

Is the Juice Worth the Squeeze? Costs and Benefits of Multiple Human Annotators for Clinical Text De-identification.

PubMed

Carrell, David S; Cronkite, David J; Malin, Bradley A; Aberdeen, John S; Hirschman, Lynette

2016-08-05

Clinical text contains valuable information but must be de-identified before it can be used for secondary purposes. Accurate annotation of personally identifiable information (PII) is essential to the development of automated de-identification systems and to manual redaction of PII. Yet the accuracy of annotations may vary considerably across individual annotators and annotation is costly. As such, the marginal benefit of incorporating additional annotators has not been well characterized. This study models the costs and benefits of incorporating increasing numbers of independent human annotators to identify the instances of PII in a corpus. We used a corpus with gold standard annotations to evaluate the performance of teams of annotators of increasing size. Four annotators independently identified PII in a 100-document corpus consisting of randomly selected clinical notes from Family Practice clinics in a large integrated health care system. These annotations were pooled and validated to generate a gold standard corpus for evaluation. Recall rates for all PII types ranged from 0.90 to 0.98 for individual annotators to 0.998 to 1.0 for teams of three, when meas-ured against the gold standard. Median cost per PII instance discovered during corpus annotation ranged from $ 0.71 for an individual annotator to $ 377 for annotations discovered only by a fourth annotator. Incorporating a second annotator into a PII annotation process reduces unredacted PII and improves the quality of annotations to 0.99 recall, yielding clear benefit at reasonable cost; the cost advantages of annotation teams larger than two diminish rapidly.

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance in clinical research. Therefore also clinical trialists have to involve health economic aspects more frequently. However, whereas they are quite familiar with classical effect measures in clinical trials, the corresponding parameters in health economic evaluation of therapeutic and diagnostic procedures are still not this common. The concepts of incremental cost effectiveness ratios (ICERs) and incremental net health benefit (INHB) will be illustrated and contrasted along the cost effectiveness evaluation of cataract surgery with monofocal and multifocal intraocular lenses. ICERs relate the costs of a treatment to its clinical benefit in terms of a ratio expression (indexed as Euro per clinical benefit unit). Therefore ICERs can be directly compared to a pre-specified willingness to pay (WTP) benchmark, which represents the maximum costs, health insurers would invest to achieve one clinical benefit unit. INHBs estimate a treatment's net clinical benefit after accounting for its cost increase versus an established therapeutic standard. Resource allocation rules can be formulated by means of both effect measures. Both the ICER and the INHB approach enable the definition of directional resource allocation rules. The allocation decisions arising from these rules are identical, as long as the willingness to pay benchmark is fixed in advance. Therefore both strategies crucially call for a priori determination of both the underlying clinical benefit endpoint (such as gain in vision lines after cataract surgery or gain in quality-adjusted life years) and the corresponding willingness to pay benchmark. The use of incremental cost effectiveness and net health benefit estimates provides a rationale for health economic allocation discussions and founding decisions. It implies the same requirements on trial protocols as yet established for clinical trials, that is the a priori

[Challenges for clinical trials in oncology within the scope of early benefit assessment of drugs].

PubMed

Lange, Stefan

2015-01-01

Until May 31, 2015 the German Institute for Quality and Efficiency in Health Care (IQWiG) conducted 108 assessments for various diseases on the basis of 103 dossiers within the scope of the early benefit assessment of drugs pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). 29 of these assessments (28 dossiers) referred to advanced stages of oncologic (including neoplastic-hematologic) diseases. In 21 of these 29 assessments (72%), IQWiG found an added benefit for at least one subpopulation or subgroup, compared to 33% with non-oncologic diseases. For oncologic diseases, the extent of benefit was classified as "major" in six assessments (21%), compared to 5% for non-oncologic disorders. In contrast, the conclusions of the oncologic studies were less certain: only one assessment provided proof (of an added benefit); for non-oncologic diseases, this was the case in eight assessments. A distinctive methodological feature of the available oncologic studies is that, as a rule, treatment switching was planned in the event of progression (normally on the basis of imaging or laboratory findings) and that shortly afterwards the follow-up of important endpoints (adverse events and patient-reported outcomes) was normally discontinued. In particular, the pre-specified option in the study protocol allowing the control group to switch treatment to the experimental intervention after progression ("protocol-permitted treatment switches") makes it extremely difficult to interpret the results beyond the outcome "progression" (or progression-free survival). This treatment switching is mostly justified by reference to ethical necessity. This, however, alleges that the experimental intervention (i. e., the new drug) is superior to the control intervention, which means that circular reasoning is unavoidable. But despite this, oncologic studies are better than their reputation. Hence, so far the results of the early benefit assessment of new drugs (regarding

Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease.

PubMed

Nordanstig, J; Pettersson, M; Morgan, M; Falkenberg, M; Kumlien, C

2017-09-01

Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation. This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation. A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients. The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following

[Beta lactam antibiotics and the question of dose regimen for severe infection. Prolonged infusion theoretically appealing--yet no evidence of clinical benefit].

PubMed

Leander, Gunilla; Eliasson, Erik; Hanberger, Håkan; Giske, Christian

2015-03-24

Patients with severe sepsis/septic shock have a high mortality. Beta-lactam antibiotics are normally first line treatment. This antimicrobial class has been associated with time-dependent efficacy. It is therefore plausible that administration as prolonged infusion will increase the therapeutic effect, as compared to short term bolus injections, which is the most common practice today. We have reviewed 14 randomized controlled studies to investigate whether prolonged infusion provides lower mortality and/or increased clinical cure. In summary, convincing advantages with prolonged infusion could not be found, however randomized studies are heterogeneous, and it cannot be excluded that some subgroups of critically ill patients could benefit from such treatment.

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Exploring the use of the medicinal leech: a clinical risk-benefit analysis.

PubMed

de Chalain, T M

1996-04-01

The medicinal leech, Hirudo medicinalis, has been used with increasing frequency for salvage of compromised pedicled flaps and microvascular free-tissue transfers. The data pertaining to 18 cases in which flap salvage with leeches was attempted were reviewed and contrasted with the data from 108 published cases from other centers. A further analysis isolated and examined 19 cases in which infection, secondary to leech utilization, supervened. Results suggested that successful salvage of tissue with leeches occurs in 70 to 80 percent of cases. In contrast, the infection rate of most series is between 7 and 20 percent and, when a clinically significant infection occurs, the flap salvage rate drops to 30 percent or less. In addition to infection, the risks of leech therapy include blood loss, which may require replacement transfusion, loss of leeches into body orifices and spaces, allergic reactions, and adverse psychological responses. Clinical indications and contraindications, and strategies to reduce the risks of leech usage, are discussed. Conclusions are that leeches are best used early, and in accordance with an accepted institutional protocol. For each case, the potential risks and benefits must be rigorously assessed and honestly applied.

[Aconitum in treatment of rheumatoid arthritis: benefit-risk assessment].

PubMed

Zhang, Xiao-Meng; Jin, Yong-Nan; Zhang, Bing; Li, Ning

2018-01-01

Rheumatoid arthritis (RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events (ADR/ADE) due to the long-time medication. Thus, it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum, a kind of toxic traditional Chinese herbs, is an important complement therapy for RA, with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines (TCM) and Western medicines (WM), this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not, which was carried out by the method of multi-criteria decision analysis model. RevMan 5.2 software was used to separately analyze the results of every index of 21 random clinical trials (RCTs) of Aconitum exclusive use in the treatment of RA, and 49 RCTs of Aconitum combined use with WM. The merged results indicated that as compared with the conventional therapy of WM, no matter the exclusive use or the combined use of Aconitum could improve the efficacy and decrease the incidence of ADR/ADEs. Based on the benefit-risk assessment decision tree of RA treatment, Hiview 3 software and Crystal Ball Monte Carlo simulation were used to calculate the benefit value, risk value and benefit-risk value of Aconitum exclusive use and the combined use of Aconitum with WM. The results showed that the combination therapy had significantly better benefits than Aconitum exclusive using, difference value was 15, (95%CI[9.72, 20.25]), but the risk of combined use was higher difference value=23, （95%CI[15.57, 30.55]）. In comprehensive consideration of the benefit and risk, the total benefit-risk value of using Aconitum alone was 58, while that of the combination therapy was 55, and the probability of the former superior to the latter was 81.07%. The study showed that Aconitum was the

Optimizing clinical benefit with targeted treatment in mRCC: "Tumor growth rate" as an alternative clinical endpoint.

PubMed

Milella, Michele

2016-06-01

Tumor growth rate (TGR), usually defined as the ratio between the slope of tumor growth before the initiation of treatment and the slope of tumor growth during treatment, between the nadir and disease progression, is a measure of the rate at which tumor volume increases over time. In patients with metastatic renal cell carcinoma (mRCC), TGR has emerged as a reliable alternative parameter to allow a quantitative and dynamic evaluation of tumor response. This review presents evidence on the correlation between TGR and treatment outcomes and discusses the potential role of this tool within the treatment scenario of mRCC. Current evidence, albeit of retrospective nature, suggests that TGR might represent a useful tool to assess whether treatment is altering the course of the disease, and has shown to be significantly associated with progression-free survival and overall survival. Therefore, TGR may represent a valuable endpoint for clinical trials evaluating new molecularly targeted therapies. Most importantly, incorporation of TGR in the assessment of individual patients undergoing targeted therapies may help clinicians decide if a given agent is no longer able to control disease growth and whether continuing therapy beyond RECIST progression may still produce clinical benefit. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Benefits of donor human milk for preterm infants: current evidence.

PubMed

Bertino, Enrico; Giuliani, Francesca; Occhi, Luciana; Coscia, Alessandra; Tonetto, Paola; Marchino, Federica; Fabris, Claudio

2009-10-01

It's undoubted that optimum nutrition for term infants is breastfeeding, exclusive for the first six months, then followed by a complementary diet and carried on, if possible, for the first year of life or even more. During the last decades several data confirmed the great advantages of fresh mother's milk use also for feeding very low and extremely low birthweight preterm infants. When mother's milk is unavailable or in short supply, pasteurized donor breast milk is widely used in neonatal intensive care units. Pasteurization partially affects nutritional and immunological properties of breast milk, however it is known that pasteurized milk maintains some biological properties and clinical benefits. The substantial benefits of mother's own milk feeding of preterm infants are supported by strong evidence. However, there is increasing evidence also on specific benefits of donor breast milk. Future research is needed to compare formula vs. nutrient fortified donor breast milk, to compare formula and DM as supplements to maternal milk rather than as sole diet and to compare effects of different methods of heat treatments on donor human milk quality.

Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node-positive prostate cancer patients: External validation on a multi-institutional database.

PubMed

Bianchi, Lorenzo; Schiavina, Riccardo; Borghesi, Marco; Bianchi, Federico Mineo; Briganti, Alberto; Carini, Marco; Terrone, Carlo; Mottrie, Alex; Gacci, Mauro; Gontero, Paolo; Imbimbo, Ciro; Marchioro, Giansilvio; Milanese, Giulio; Mirone, Vincenzo; Montorsi, Francesco; Morgia, Giuseppe; Novara, Giacomo; Porreca, Angelo; Volpe, Alessandro; Brunocilla, Eugenio

2018-04-06

To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer-specific mortality-free survival after surgery in pN1 prostate cancer patients through an external validation. We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram-derived probability cut-off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice. External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1-73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer-specific mortality-free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none. In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery. © 2018 The Japanese Urological Association.

Comparing shame in clinical and nonclinical populations: Preliminary findings.

PubMed

Dyer, Kevin F W; Dorahy, Martin J; Corry, Mary; Black, Rebecca; Matheson, Laura; Coles, Holly; Curran, David; Seager, Lenaire; Middleton, Warwick

2017-03-01

To conduct a preliminary study comparing different trauma and clinical populations on types of shame coping style and levels of state shame and guilt. A mixed independent groups/correlational design was employed. Participants were recruited by convenience sampling of 3 clinical populations-complex trauma (n = 65), dissociative identity disorder (DID; n = 20), and general mental health (n = 41)-and a control group of healthy volunteers (n = 125). All participants were given (a) the Compass of Shame Scale, which measures the four common shame coping behaviors/styles of "withdrawal," "attack self," "attack other," and "avoidance," and (b) the State Shame and Guilt Scale, which assesses state shame, guilt, and pride. The DID group exhibited significantly higher levels of "attack self," "withdrawal," and "avoidance" relative to the other groups. The complex trauma and general mental health groups did not differ on any shame variable. All three clinical groups had significantly greater levels of the "withdrawal" coping style and significantly impaired shame/guilt/pride relative to the healthy volunteers. "Attack self" emerged as a significant predictor of increased state shame in the complex trauma, general mental health, and healthy volunteer groups, whereas "withdrawal" was the sole predictor of state shame in the DID group. DID emerged as having a different profile of shame processes compared to the other clinical groups, whereas the complex trauma and general mental health groups had comparable shame levels and variable relationships. These differential profiles of shame coping and state shame are discussed with reference to assessment and treatment. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Exploring the teaching and learning of clinical reasoning, risks, and benefits of cervical spine manipulation.

PubMed

Yamamoto, Katie; Condotta, Luca; Haldane, Chloe; Jaffrani, Sahar; Johnstone, Victoria; Jachyra, Patrick; Gibson, Barbara E; Yeung, Euson

2018-02-01

The aim of this study was to examine how risks and benefits of cervical spine manipulation (CSM) were framed and discussed in the context of mentorship and their impact on the perception of safe practice of CSM in clinical physiotherapy settings. A multi-method qualitative approach was employed, including a document analysis of established educational guidelines, observations of mentoring sessions, and individual face-to-face interviews with five mentees in the process of learning CSM, and four mentors with Orthopedic Manual Physical Therapy (OMPT) certification. Results demonstrated that participants' clinical decision-making processes to perform CSM were primarily oriented to the mitigation of risk. Achieving proficiency in the "science" of clinical reasoning and the "art" of "feel" related to mastering technical skills were viewed as means to mitigating risk and enhancing confidence to use CSM safely in clinical practice. While the "art" of technical skill mastery was of high importance to mentees and considered important to developing competency in performing CSM, it was discussed as distinct from their clinical reasoning processes. Thus, promoting a more balanced and integrated use of the "art" and "science" of safe practice for CSM in OMPT training may result in greater confidence and judicious use of CSM by physiotherapists.

POSTSURGICAL RECURRENT CUSHING DISEASE: CLINICAL BENEFIT OF EARLY INTERVENTION IN PATIENTS WITH NORMAL URINARY FREE CORTISOL.

PubMed

Carroll, Ty B; Javorsky, Bradley R; Findling, James W

2016-10-01

To assess the performance of biochemical markers in the detection of recurrent Cushing disease (CD), as well as the potential benefit of early intervention in recurrent CD patients with elevated late-night salivary cortisol (LNSC) and normal urinary free cortisol (UFC). The design was a single-center, retrospective chart review. Patients treated by the authors from 2008-2013 were included. Recurrence was defined by postsurgical remission of CD with subsequent abnormal LNSC, UFC, or dexamethasone suppression test (DST). We identified 15 patients with postsurgical recurrent CD after initial remission; all but one underwent testing with LNSC, DST, and UFC. Although 12 of 15 patients had normal UFC at time of recurrence, DST was abnormal in 11 of 15, and all 14 patients with LNSC results had ≥1 elevated measurement. Nine patients (7 with normal UFC) showed radiologic evidence of a pituitary tumor at time of recurrence. Among the 14 patients with available follow-up data, 12 have demonstrated significant improvement since receiving treatment. Five patients underwent repeat pituitary surgery and 4 achieved clinical and biochemical remission. Eight patients received mifepristone or cabergoline, and 6 showed clinical and/or biochemical improvement. Three patients (2 with prior mifepristone) underwent bilateral adrenalectomy and 2 demonstrated significant clinical improvements. LNSC is more sensitive than UFC or DST for detection of CD recurrence. Prompt intervention when LNSC is elevated, despite normal UFC, may yield significant clinical benefit for many patients with CD. Early treatment for patients with recurrent CD should be prospectively evaluated, utilizing LNSC elevation as an early biochemical marker. ACTH = adrenocorticotropic hormone CD = Cushing disease CS = Cushing syndrome CV = coefficient of variation DST = dexamethasone suppression test IPSS = inferior petrosal sinus sampling LNSC = late-night salivary cortisol QoL = quality of life TSS = transsphenoidal

Risk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors.

PubMed

Tang, Gong; Cuzick, Jack; Costantino, Joseph P; Dowsett, Mitch; Forbes, John F; Crager, Michael; Mamounas, Eleftherios P; Shak, Steven; Wolmark, Norman

2011-11-20

The 21-gene breast cancer assay recurrence score (RS) is widely used for assessing recurrence risk and predicting chemotherapy benefit in patients with estrogen receptor (ER) -positive breast cancer. Pathologic and clinical factors such as tumor size, grade, and patient age also provide independent prognostic utility. We developed a formal integration of these measures and evaluated its prognostic and predictive value. From the National Surgical Adjuvant Breast and Bowel (NSABP) B-14 and translational research cohort of the Arimidex, Tamoxifen Alone or in Combination (TransATAC) studies, we included patients who received hormonal monotherapy, had ER-positive tumors, and RS and traditional clinicopathologic factors assessed (647 and 1,088, respectively). Individual patient risk assessments from separate Cox models were combined using meta-analysis to form an RS-pathology-clinical (RSPC) assessment of distant recurrence risk. Risk assessments by RS and RSPC were compared in node-negative (N0) patients. RSPC was compared with RS for predicting chemotherapy benefit in NSABP B-20. RSPC had significantly more prognostic value for distant recurrence than did RS (P < .001) and showed better separation of risk in the study population. RSPC classified fewer patients as intermediate risk (17.8% v 26.7%, P < .001) and more patients as lower risk (63.8% v 54.2%, P < .001) than did RS among 1,444 N0 ER-positive patients. In B-20, the interaction of RSPC with chemotherapy was not statistically significant (P = .10), in contrast to the previously reported significant interaction of RS with chemotherapy (P = .037). RSPC refines the assessment of distant recurrence risk and reduces the number of patients classified as intermediate risk. Adding clinicopathologic measures did not seem to enhance the value of RS alone nor the individual biology RS identifies in predicting chemotherapy benefit.

Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors

PubMed Central

Tang, Gong; Cuzick, Jack; Costantino, Joseph P.; Dowsett, Mitch; Forbes, John F.; Crager, Michael; Mamounas, Eleftherios P.; Shak, Steven; Wolmark, Norman

2011-01-01

Purpose The 21-gene breast cancer assay recurrence score (RS) is widely used for assessing recurrence risk and predicting chemotherapy benefit in patients with estrogen receptor (ER) –positive breast cancer. Pathologic and clinical factors such as tumor size, grade, and patient age also provide independent prognostic utility. We developed a formal integration of these measures and evaluated its prognostic and predictive value. Patients and Methods From the National Surgical Adjuvant Breast and Bowel (NSABP) B-14 and translational research cohort of the Arimidex, Tamoxifen Alone or in Combination (TransATAC) studies, we included patients who received hormonal monotherapy, had ER-positive tumors, and RS and traditional clinicopathologic factors assessed (647 and 1,088, respectively). Individual patient risk assessments from separate Cox models were combined using meta-analysis to form an RS-pathology-clinical (RSPC) assessment of distant recurrence risk. Risk assessments by RS and RSPC were compared in node-negative (N0) patients. RSPC was compared with RS for predicting chemotherapy benefit in NSABP B-20. Results RSPC had significantly more prognostic value for distant recurrence than did RS (P < .001) and showed better separation of risk in the study population. RSPC classified fewer patients as intermediate risk (17.8% v 26.7%, P < .001) and more patients as lower risk (63.8% v 54.2%, P < .001) than did RS among 1,444 N0 ER-positive patients. In B-20, the interaction of RSPC with chemotherapy was not statistically significant (P = .10), in contrast to the previously reported significant interaction of RS with chemotherapy (P = .037). Conclusion RSPC refines the assessment of distant recurrence risk and reduces the number of patients classified as intermediate risk. Adding clinicopathologic measures did not seem to enhance the value of RS alone nor the individual biology RS identifies in predicting chemotherapy benefit. PMID:22010013

[Comparative evaluation of clinical and economic efficiency of paliperidone in various dosage forms used in patients with schizophrenia].

PubMed

D'yakov, I N; Zyryanov, S K

To evaluate clinical and economic efficacy of schizophrenia treatment with three forms of paliperidone (peroral form, intramuscular injections once a month and once in three month). Pharmacoeconomic analysis based on the results of earlier foreign randomized clinical studies on paliperidone in treatment of schizophrenia was carried out. Indirect comparison of different medication forms of paliperidone compared to placebo was performed. The analysis of costs was based on a Markov model built for the study. Two categories of costs: costs of pharmacological treatment with paliperidone and costs of disease exacerbation due to the violation of treatment regimen were considered. To assess pharmacoeconomic efficacy of paliperidone, a cost-benefit analysis with calculation of cost utility ratio (CUR) and incremental cost utility ratio (ICUR) was used. In view of the influence on the budget, all forms of paliperidone have similar pharmacoeconomic efficacy with the advantage of prolonged release injectable (depot) forms that increase patient's adherence to treatment. As a result, CUR of injectable forms was lower compared to that of the peroral form by 11,1 and 46,3% of month and 3-month forms, respectively. ICUR for paliperidone used once in 3 month (trevicta) was more effective compared to paliperidone used monthly (xeplion). It has been concluded that paliperidone for prolonged release injections used once in 3 month is most pharmacoeconomically effective.

"Meaningful use" of EHR in dental school clinics: how to benefit from the U.S. HITECH Act's financial and quality improvement incentives.

PubMed

Kalenderian, Elsbeth; Walji, Muhammad; Ramoni, Rachel B

2013-04-01

Through the 2009 HITECH (Health Information Technology for Economic and Clinical Health) Act, the U.S. government committed $27 billion to incentivize the adoption and "meaningful use" of certified electronic health records (EHRs) by providers, including dentists. Given their patient profiles, dental school clinics are in a position to benefit from this time-delimited commitment to support the adoption and use of certified EHR technology under the Medicaid-based incentive. The benefits are not merely financial: rather, the meaningful use objectives and clinical quality measures can drive quality improvement initiatives within dental practices and help develop a community of medical and dental professionals focused on quality. This article describes how dentists can qualify as eligible providers and the set of activities that must be undertaken and attested to in order to obtain this incentive. Two case studies describe the approaches that can be used to meet the Medicaid threshold necessary to be eligible for the incentive. Dentists can and have successfully applied for meaningful use incentive payments. Given the diverse set of patients who are treated at dental schools, these dental practices are among those most likely to benefit from the incentive programs.

Depression and Anxiety During Pregnancy: Evaluating the Literature in Support of Clinical Risk-Benefit Decision-Making.

PubMed

Dalke, Katharine Baratz; Wenzel, Amy; Kim, Deborah R

2016-06-01

Depression and anxiety during pregnancy are common, and patients and providers are faced with complex decisions regarding various treatment modalities. A structured discussion of the risks and benefits of options with the patient and her support team is recommended to facilitate the decision-making process. This clinically focused review, with emphasis on the last 3 years of published study data, evaluates the major risk categories of medication treatments, namely pregnancy loss, physical malformations, growth impairment, behavioral teratogenicity, and neonatal toxicity. Nonpharmacological treatment options, including neuromodulation and psychotherapy, are also briefly reviewed. Specific recommendations, drawn from the literature and the authors' clinical experience, are also offered to help guide the clinician in decision-making.

Prospective, comparative cohort studies and their contribution to the benefit assessments of therapeutic options: heart failure treatment with and without Hawthorn special extract WS 1442.

PubMed

Habs, M

2004-08-01

In addition to testing a drug for its efficacy, pharmacological quality and safety, current policies are increasingly demanding evaluations of the therapeutic benefits provided by a drug in general practice with "non-selected" patients and increasingly restrictive economic considerations. One of the trials which addresses this task is the WISO cohort study (Efficacy and socio-economic relevance of treatment of chronic heart failure stage NYHA II with Crataegus extract WS 1442). It compares two different therapeutic strategies in the treatment of heart failure stage NYHA II, i.e. a conventional medication and a therapy which also includes hawthorn special extract WS 1442 (Crataegutt novo 450) in addition to chemical-synthetic drugs. In contrast to clinical trials, the patients in cohort studies are expressly not randomised and the physician in charge independently chooses the administered treatment. This comparative, non-interventional observation provides well-founded evidence of the "real-world effectiveness" of the tested preparation. 952 patients with heart failure (NYHA II) were enrolled in the study by 217 general practitioners. 588 patients received Crataegus special extract WS 1442 (Crataegutt novo 450) either as an add-on therapy or as a monotherapy (Crataegus cohort) and 364 patients received therapy without hawthorn (comparative cohort). These two groups had the same indication (heart failure NYHA II) but were significantly different regarding gender, age and concomitant cardiovascular disease. Basically, in view of the free choice of therapy made by the physician in charge, such differences are to be expected in comparative observational studies. A sufficient degree of patient comparability was provided by means of the matched-pairs technique, which replaced the randomisation procedure normally used in clinical studies. After 2 years, 130 patient pairs generated by this technique could be included in the interim assessment. The clinical symptoms with

Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience.

PubMed

Kim, Yoshiharu; Asukai, Nozomu; Konishi, Takako; Kato, Hiroshi; Hirotsune, Hideto; Maeda, Masaharu; Inoue, Hirotaka; Narita, Hiroyasu; Iwasaki, Masaru

2008-12-01

The present study was a 52-week, non-comparative, open-label study of flexible dose paroxetine (20-40 mg) in 52 Japanese post-traumatic stress disorder (PTSD) patients in order to obtain clinical experience regarding efficacy and safety in regular clinical practice. Efficacy was measured using the Clinician-Administered PTSD Scale One Week Symptom Status Version (CAPS-SX). The mean change from baseline in CAPS-SX total score was -19.1, -22.8 and -32.3 at weeks 4, 12 and 52, respectively, and that in the Clinical Global Impression (CGI) Severity of Illness score was -1.1 at week 12 and -1.7 at week 52. A total of 46.9% were CGI responders at week 12, while 67.3% were improved on the CGI at week 52. Of 52 subjects who entered into the drug treatment, 25 completed the study. Only one patient withdrew from the study due to lack of efficacy. In patients who were rated as 'moderately ill' or less at baseline, the proportion of CGI responders at end-point was higher at a dose of 20 mg/day than at higher doses, whereas in patients rated as 'markedly ill' or more, it was higher at 30 and 40 mg/day, suggesting that severely ill patients could benefit from higher doses. Paroxetine appeared generally tolerated in short- and long-term use, and the safety profile in this study was consistent with international trials and other Japanese populations (i.e. patients suffering from depression, panic disorder or obsessive-compulsive disorder). Although the study was not conducted in double-blind fashion, the current findings suggest that paroxetine may contribute to clinically meaningful improvement that is maintained during long-term use and is generally well tolerated.

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

PubMed Central

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F.; Mt-Isa, Shahrul; Luo, Sheng

2018-01-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. PMID:29505866

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

PubMed

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F; Mt-Isa, Shahrul; Luo, Sheng

2018-04-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. Copyright © 2018 Elsevier Inc. All rights reserved.

Insurance Benefit Preferences of the Low-income Uninsured

PubMed Central

Danis, Marion; Biddle, Andrea K; Goold, Susan Dorr

2002-01-01

OBJECTIVE A frequently cited obstacle to universal insurance is the lack of consensus about what benefits to offer in an affordable insurance package. This study was conducted to assess the feasibility of providing uninsured patients the opportunity to define their own benefit package within cost constraints. DESIGN Structured group exercises SETTING Community setting PARTICIPANTS Uninsured individuals recruited from clinical and community settings in central North Carolina. MEASUREMENTS Insurance choices were measured using a simulation exercise, CHAT (Choosing Healthplans All Together). Participants designed managed care plans, individually and as groups, by selecting from 15 service categories having varied levels of restriction (e.g., formulary, copayments) within the constraints of a fixed monthly premium comparable to the typical per member/per month managed care premium paid by U.S. employers. MAIN RESULTS Two hundred thirty-four individuals who were predominantly male (70%), African American (55%), and socioeconomically disadvantaged (53% earned <$15,000 annually) participated in 22 groups and were able to design health benefit packages individually and in groups. All 22 groups chose to cover hospitalization, pharmacy, dental, and specialty care, and 21 groups chose primary care and mental health. Although individuals' choices differed from their groups' selections, 86% of participants were willing to abide by group choices. CONCLUSIONS Groups of low-income uninsured individuals are able to identify acceptable benefit packages that are comparable in cost but differ in benefit design from managed care contracts offered to many U.S. employees today. PMID:11841528

Can Repeat Injection Provide Clinical Benefit in Patients with Lumbosacral Diseases When First Epidural Injection Results Only in Partial Response?

PubMed

Lee, Jung Hwan; Lee, Sang-Ho

2016-02-01

Epidural steroid injection (ESI) is known to be an effective treatment for lower back or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after a single ESI, there has been little evidence supporting the usefulness of repeat injections in cumulative clinical pain reduction. The purpose of this study was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than that provided by intermittent injection performed only when pain was aggravated. An Institutional Review Board (IRB)-approved retrospective chart review. Spine hospital. Two hundred and four patients who had underwent transforaminal ESI (TFESI) for treatment of lower back and radicular pain due to HIVD or SS and could be followed-up for one year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (NRS = 3 after first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 96) comprised partial responders who did not receive a repeat injection at the prescribed interval, but received repeat injections only for aggravation of pain. Various clinical data including total number of injections during one year, duration of NRS < 3 during one year (NRS < 3 duration), and time interval until aggravation of pain required additional injections after repeat injection in group A, or after first injection in group B (time to reinjection), were assessed. These data were compared between groups A and B in terms of total population, HIVD, and SS. In the whole population, the mean time to reinjection was 6.09 ± 3.02 months in group A and 3.69 ± 2.07 months in group B. The NRS < 3 duration was 9.72 ± 2.86 months and 6.2 ± 2.61 months in groups A and B

Barriers and benefits associated with nurses information seeking related to patient education needs on clinical nursing units.

PubMed

Jones, Josette; Schilling, Katherine; Pesut, Daniel

2011-01-01

The purpose of this study was to answer the following two questions: What are clinical nurses' rationales for their approaches to finding patient educational materials on the web? What are perceived barriers and benefits associated with the use of web-based information resources for patient education in the context of nursing clinical practice?Over 179 individual data units were analyzed to understand clinical nurses' rationales for their approaches to find patient educational materials on the web. Rationales were defined as those underlying catalysts or activators leading to an information need. Analyses found that the primary reasons why clinical nurses conducted web-based information searches included direct patient requests ( 9 requests), colleague requests (6 requests), building patient materials collections (4), patients' family requests (3), routine teaching (1), personal development (1), or staff development (1). From these data, four broad themes emerged: professional reasons, personal reasons, technology reasons, and organization reasons for selecting information resources. Content analysis identified 306 individual data units representing either 'benefits' (178 units) or 'barriers' (128) to the nurses' use of web resources for on-unit patient care. Inter-rater reliability was assessed and found to be excellent (r = 0.943 to 0.961). The primary themes that emerged as barriers to the used of web-based resources included: 1) time requirements to perform a search, 2) nurses' experience and knowledge about the resources or required technology, 3) specific characteristics of individuals electronic information resources, and 4) organizational procedures and policies. Three primary themes that represented the benefits of using web-based resources were also identified: 1) past experiences and knowledge of a specific resource or the required technologies, 2) availability and accessibility on the unit, and 3) specific characteristics of individual information tool

Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

PubMed

Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

2015-02-01

A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." Copyright © 2015. Published by Elsevier Inc.

Comparing ECT data of two different inpatient clinics: propofol or thiopental?

PubMed

Yazici, Esra; Bosgelmez, Sukriye; Tas, Halil Ibrahim; Karabulut, Umit; Yazici, Ahmet Bulent; Yildiz, Mustafa; Kirpinar, Ismet

2013-10-01

This study compares the data of (modified) electroconvulsive theraphy (ECT) applications from two different inpatient clinics in Turkey: Kocaeli Derince Training and Research Hospital (Clinic-I) and Kocaeli University (Clinic-II). Recorded files of patients from the two clinics were compared in terms of ECT indications, number and duration of seizures, and anesthetic agents used (propofol vs. thiopental). ECT applications occurring between January 2011 and January 2013 were included in the study. A total of 86 patients (9.5% of the inpatients) received ECT in Clinic-I and 103 patients (21.1% of the inpatients) in Clinic-II during the period studied. The yearly ECT rate (treated person rate per 10,000 per year) was 0.59/10,000 for Kocaeli (Turkey) as a whole. The overall number of ECT applications was 539 in Clinic-I and 999 in Clinic-II, and the average number of ECT sessions for each patient was 6.4 ± 2.33 in Clinic-I and 9.69 ± 4.66 in Clinic-II. The majority of indications were depressive disorders and insufficient response to medicine. Patients in the clinic which utilized thiopental as the anesthetic agent experienced more cardiovascular and respiratory side effects than the one which used propofol. The number of ECT sessions required was greater for patients with schizoaffective disorder than for others. The administration of ECT was considered to be a reliable method of treatment in these clinics. With respect to specific anesthetic agents, propofol was found to have less hemodynamic side effects and shorter seizure durations than thiopental.

Comparative genomic analysis of Mycobacterium tuberculosis clinical isolates.

PubMed

Liu, Fei; Hu, Yongfei; Wang, Qi; Li, Hong Min; Gao, George F; Liu, Cui Hua; Zhu, Baoli

2014-06-13

Due to excessive antibiotic use, drug-resistant Mycobacterium tuberculosis has become a serious public health threat and a major obstacle to disease control in many countries. To better understand the evolution of drug-resistant M. tuberculosis strains, we performed whole genome sequencing for 7 M. tuberculosis clinical isolates with different antibiotic resistance profiles and conducted comparative genomic analysis of gene variations among them. We observed that all 7 M. tuberculosis clinical isolates with different levels of drug resistance harbored similar numbers of SNPs, ranging from 1409-1464. The numbers of insertion/deletions (Indels) identified in the 7 isolates were also similar, ranging from 56 to 101. A total of 39 types of mutations were identified in drug resistance-associated loci, including 14 previously reported ones and 25 newly identified ones. Sixteen of the identified large Indels spanned PE-PPE-PGRS genes, which represents a major source of antigenic variability. Aside from SNPs and Indels, a CRISPR locus with varied spacers was observed in all 7 clinical isolates, suggesting that they might play an important role in plasticity of the M. tuberculosis genome. The nucleotide diversity (Л value) and selection intensity (dN/dS value) of the whole genome sequences of the 7 isolates were similar. The dN/dS values were less than 1 for all 7 isolates (range from 0.608885 to 0.637365), supporting the notion that M. tuberculosis genomes undergo purifying selection. The Л values and dN/dS values were comparable between drug-susceptible and drug-resistant strains. In this study, we show that clinical M. tuberculosis isolates exhibit distinct variations in terms of the distribution of SNP, Indels, CRISPR-cas locus, as well as the nucleotide diversity and selection intensity, but there are no generalizable differences between drug-susceptible and drug-resistant isolates on the genomic scale. Our study provides evidence strengthening the notion that

A Model for Assessing the Clinical and Economic Benefits of Bone-forming Agents for Reducing Fractures in Postmenopausal Women at High, Near-term Risk of Osteoporotic Fracture.

PubMed

O'Hanlon, Claire E; Parthan, Anju; Kruse, Morgan; Cartier, Shannon; Stollenwerk, Bjorn; Jiang, Yawen; Caloyeras, John P; Crittenden, Daria B; Barron, Richard

2017-07-01

The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment. Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab. The alternative bone-forming agent profiles were defined by using assumptions regarding the onset and total magnitude of protection against fractures with teriparatide. The model cohort comprised 70-year-old female patients with T scores below -2.5 and a previous vertebral fracture. Outcomes included clinical fractures, direct costs, and quality-adjusted life years. The simulated treatment strategies were compared by calculating their incremental "value" (net monetary benefit). Improvements in the onset and magnitude of fracture protection (vs the teriparatide reference case) produced a net monetary benefit of $17,000,000 per 10,000 treated patients during the (1.5-year) bone-forming agent treatment period and $80,000,000 over a lifetime horizon that included 3.5 years of maintenance treatment with denosumab. Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A Method for Making Cross-Comparable Estimates of the Benefits of Decision Support Technologies for Air Traffic Management

NASA Technical Reports Server (NTRS)

Lee, David; Long, Dou; Etheridge, Mel; Plugge, Joana; Johnson, Jesse; Kostiuk, Peter

1998-01-01

We present a general method for making cross comparable estimates of the benefits of NASA-developed decision support technologies for air traffic management, and we apply a specific implementation of the method to estimate benefits of three decision support tools (DSTs) under development in NASA's advanced Air Transportation Technologies Program: Active Final Approach Spacing Tool (A-FAST), Expedite Departure Path (EDP), and Conflict Probe and Trial Planning Tool (CPTP). The report also reviews data about the present operation of the national airspace system (NAS) to identify opportunities for DST's to reduce delays and inefficiencies.

[Assessment of actual benefits of new drugs by the Transparency Committee].

PubMed

Le Jeunne, C

2008-01-01

When a drug has been granted a marketing authorization, if the pharmaceutical company wants it to be covered by the National Health Insurance, the company has to submit a file with all the studies concerning the drug, especially drug-drug comparative studies, to be assessed by the Transparency Committee. Drugs are assessed on two criteria: actual or expected benefit (AB) and improvement in actual benefit (IAB). Actual benefit mainly takes into account the severity of the disease concerned, the level of efficacy relative to known side effects (risk-benefit ratio), and the place the drug is intended to take in the therapeutic strategy. At the end of the assessment, AB is considered as important, moderate, poor or insufficient (to justify inclusion of the drug on the list of products to be reimbursed). After actual benefit is determined, improvement of actual benefit is assessed, comparing the estimated benefit of this drug with one of drugs with the same indication that is already reimbursed, to assess whether this drug will improve the patient's disease. This can be assessed by direct comparison (two drugs compared in the same clinical trial) or by indirect comparison (separate studies with the same design). There are four levels of added value, from I (major improvement) to IV (minor improvement). Level V represents no improvement. This second assessment is always relative to another drug. It never provides an absolute score. However, IAB is very important for pharmaceutical companies, because it is a fundamental criterion to determine the price of the drug, which is discussed with the Economic Committee of Health Products in a final phase. Actual benefit and improvement in actual benefit are allocated for each indication of a drug.

Humidification during laparoscopic surgery: overview of the clinical benefits of using humidified gas during laparoscopic surgery.

PubMed

Binda, Maria Mercedes

2015-11-01

The peritoneum is the serous membrane that covers the abdominal cavity and most of the intra-abdominal organs. It is a very delicate layer highly susceptible to damage and it is not designed to cope with variable conditions such as the dry and cold carbon dioxide (CO2) during laparoscopic surgery. The aim of this review was to evaluate the effects caused by insufflating dry and cold gas into the abdominal cavity after laparoscopic surgery. A literature search using the Pubmed was carried out. Articles identified focused on the key issues of laparoscopy, peritoneum, morphology, pneumoperitoneum, humidity, body temperature, pain, recovery time, post-operative adhesions and lens fogging. Insufflating dry and cold CO2 into the abdomen causes peritoneal damage, post-operative pain, hypothermia and post-operative adhesions. Using humidified and warm gas prevents pain after surgery. With regard to hypothermia due to desiccation, it can be fully prevented using humidified and warm gas. Results relating to the patient recovery are still controversial. The use of humidified and warm insufflation gas offers a significant clinical benefit to the patient, creating a more physiologic peritoneal environment and reducing the post-operative pain and hypothermia. In animal models, although humidified and warm gas reduces post-operative adhesions, humidified gas at 32 °C reduced them even more. It is clear that humidified gas should be used during laparoscopic surgery; however, a question remains unanswered: to achieve even greater clinical benefit to the patient, at what temperature should the humidified gas be when insufflated into the abdomen? More clinical trials should be performed to resolve this query.

IgE-based Immunotherapy of Cancer -A Comparative Oncology Approach

PubMed Central

Singer, Josef; Jensen-Jarolim, Erika

2014-01-01

Antibody-based immunotherapies are important therapy options in human oncology. Although human humoral specific immunity is constituted of five different immunoglobulin classes, currently only IgG-based immunotherapies have proceeded to clinical application. This review, however, discusses the benefits and difficulties of IgE-based immunotherapy of cancer, with special emphasis on how to translate promising preclinical results into clinical studies. Pursuing the “Comparative Oncology” approach, novel drug candidates are investigated in clinical trials with veterinary cancer patients, most often dogs. By this strategy drug development could be speeded up, animal experiments could be reduced and novel therapy options could be introduced benefitting humans as well as man’s best friend. PMID:25264496

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

PubMed

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

[Benefits of nursing care service in the assisted reproduction clinic to self-cycle-management and self-efficiency of infertility patients].

PubMed

Li, Xiao-Qin; Sun, Chao-Feng; Guo, Mei

2017-06-01

To investigate the benefits of nursing care service in the assisted reproduction clinic to self-cycle-management and self-efficiency of the outpatients with infertility. We randomly divided 600 females preliminarily diagnosed with infertility into a control and an experimental group, 288 in the former and 285 in the latter group excluding those whose husbands had azoospermia. For the women patients of the experimental group, we conducted nursing care intervention concerning related knowledge, skills, diet, excise, medication, and psychology, by one-to-one consultation, individualized or group communication, establishing files, telephone follow-up, and wechat guidance. After 3 months of intervention, we compared the compliance of medical visits, effectiveness of cycle management, sense of self-efficiency, satisfaction, and anxiety score between the two groups of patients. In comparison with the controls, the patients of the experimental group showed significantly better knowledge about assisted reproduction and higher effectiveness of self-cycle-management, self-efficiency, and satisfaction (P <0.05), but a markedly lower degree of anxiety (P <0.05). Nursing care service in the assisted reproduction clinic can improve the compliance of medical visits, effectiveness of self-cycle-management, self-efficiency, and satisfaction and reduce the anxiety of the patients.

Korean Cancer Patients' Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate.

PubMed

Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

2017-10-01

The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p < 0.001). Heavily treated patients and patients with previous experience regarding CTs also showed a higher willingness to participate (p < 0.001). The perceived benefit of CTs was higher in the group willing to participate (p=0.026). The patient's level of awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

PubMed Central

Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

PubMed

Crossley, George H; Chen, Jane; Choucair, Wassim; Cohen, Todd J; Gohn, Douglas C; Johnson, W Ben; Kennedy, Eleanor E; Mongeon, Luc R; Serwer, Gerald A; Qiao, Hongyan; Wilkoff, Bruce L

2009-11-24

The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

Comparative effectiveness research and its utility in In-clinic practice

PubMed Central

Dang, Amit; Kaur, Kirandeep

2016-01-01

One of the important components of patient-centered healthcare is comparative effectiveness research (CER), which aims at generating evidence from the real-life setting. The primary purpose of CER is to provide comparative information to the healthcare providers, patients, and policy makers about the standard of care available. This involves research on clinical questions unanswered by the explanatory trials during the regulatory approval process. Main methods of CER involve randomized controlled trials and observational methods. The limitations of these two methods have been overcome with the help of new statistical methods. After the evidence generation, it is equally important to communicate the results to all the interested organizations. CER is beginning to have its impact in the clinical practice as its results become part of the clinical practice guidelines. CER will have far-reaching scientific and financial impact. CER will make both the treating physician and the patient equally responsible for the treatment offered. PMID:26955571

Claims to the benefits of clinical supervision: A critique of the policy development process and outcomes in New South Wales, Australia.

PubMed

White, Edward

2017-02-01

The historical development of clinical supervision has been variously interpreted in the international literature. Creditable evidence has accumulated, particularly over the past two decades, to show that clinical supervision has a positive demonstrable effect on supervisees. However, comparatively little research evidence has entered the public domain on any effect that clinical supervision might have on other nominated outcomes. In Australia, developments in clinical supervision were recently prompted by initiatives at national and state levels. Since 2010, lead agencies for these have sought feedback from professional bodies and organizations on a number of inter-related draft policy documents. The present article tracked changes over time between the draft and final versions of these documents in New South Wales, and reviewed the original sources of literature cited within them. The strength of evidence upon which the final published versions were reportedly predicated was scrutinized. Upon examination, claims to the wider benefits of clinical supervision were found to be unconvincingly supported, not least because the examples selected by the agencies from the international literature and cited in their respective documents were either silent, parsimonious, or contradictory. Many claims remain at the level of folklore/hypothetical propositions, therefore, and stay worthy of rigorous empirical testing and faithful public reporting. Such investigations have been acknowledged as notoriously difficult to conduct. The present article identified noteworthy examples in the contemporary literature that signpost robust ways forward for empirical outcomes-orientated research, the findings from which might strengthen the evidence base of future policy documents. © 2017 Australian College of Mental Health Nurses Inc.

Minimum income protection and European integration: trends and levels of minimum benefits in comparative perspective, 1990-2005.

PubMed

Nelson, Kenneth

2008-01-01

This article draws attention to the Europeanization of social policy and the development of minimum income protection in a large number of welfare democracies. The empirical analyses are based on unique institutional and comparative data on benefit levels from the Social Assistance and Minimum Income Protection Interim Dataset. There is some evidence of convergence in benefit levels among the European countries in the new millennium, but there is no clear proof of universal ambitions to fight poverty or of the existence of a single European social model. There are still welfare front-runners and those who lag behind in this regard, not only among industrial welfare democracies in general but also in Europe.

[Benefit-risk assessment of vaccination strategies].

PubMed

Hanslik, Thomas; Boëlle, Pierre Yves

2007-04-01

This article summarises the various stages of the risk/benefit assessment of vaccination strategies. Establishing the awaited effectiveness of a vaccination strategy supposes to have an epidemiologic description of the disease to be prevented. The effectiveness of the vaccine strategy will be thus expressed in numbers of cases, hospitalizations or deaths avoided. The effectiveness can be direct, expressed as the reduction of the incidence of the infectious disease in the vaccinated subjects compared to unvaccinated subjects. It can also be indirect, the unvaccinated persons being protected by the suspension in circulation of the pathogenic agent, consecutive to the implementation of the vaccination campaign. The risks of vaccination related to the adverse effects detected during the clinical trials preceding marketing are well quantified, but other risks can occur after marketing: e.g., serious and unexpected adverse effects detected by vaccinovigilance systems, or risk of increase in the age of cases if the vaccination coverage is insufficient. The medico-economic evaluation forms a part of the risks/benefit assessment, by positioning the vaccine strategy comparatively with other interventions for health. Epidemiologic and vaccinovigilance informations must be updated very regularly, which underlines the need for having an operational and reliable real time monitoring system to accompany the vaccination strategies. Lastly, in the context of uncertainty which often accompanies the risks/benefit assessments, it is important that an adapted communication towards the public and the doctors is planned.

Identifying appropriate reference data models for comparative effectiveness research (CER) studies based on data from clinical information systems.

PubMed

Ogunyemi, Omolola I; Meeker, Daniella; Kim, Hyeon-Eui; Ashish, Naveen; Farzaneh, Seena; Boxwala, Aziz

2013-08-01

The need for a common format for electronic exchange of clinical data prompted federal endorsement of applicable standards. However, despite obvious similarities, a consensus standard has not yet been selected in the comparative effectiveness research (CER) community. Using qualitative metrics for data retrieval and information loss across a variety of CER topic areas, we compare several existing models from a representative sample of organizations associated with clinical research: the Observational Medical Outcomes Partnership (OMOP), Biomedical Research Integrated Domain Group, the Clinical Data Interchange Standards Consortium, and the US Food and Drug Administration. While the models examined captured a majority of the data elements that are useful for CER studies, data elements related to insurance benefit design and plans were most detailed in OMOP's CDM version 4.0. Standardized vocabularies that facilitate semantic interoperability were included in the OMOP and US Food and Drug Administration Mini-Sentinel data models, but are left to the discretion of the end-user in Biomedical Research Integrated Domain Group and Analysis Data Model, limiting reuse opportunities. Among the challenges we encountered was the need to model data specific to a local setting. This was handled by extending the standard data models. We found that the Common Data Model from the OMOP met the broadest complement of CER objectives. Minimal information loss occurred in mapping data from institution-specific data warehouses onto the data models from the standards we assessed. However, to support certain scenarios, we found a need to enhance existing data dictionaries with local, institution-specific information.

Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF.

PubMed

Uchiyama, Shinichiro; Hori, Masatsugu; Matsumoto, Masayasu; Tanahashi, Norio; Momomura, Shin-Ichi; Goto, Shinya; Izumi, Tohru; Koretsune, Yukihiro; Kajikawa, Mariko; Kato, Masaharu; Ueda, Hitoshi; Iekushi, Kazuma; Yamanaka, Satoshi; Tajiri, Masahiro

2014-01-01

The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF. Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1.5. Second, the composite end point of major bleeding events and secondary efficacy end points (stroke, noncentral nervous system systemic embolism, myocardial infarction and death) to ascertain the NCB were established. Subgroup analysis by CHADS2 score or creatinine clearance was also performed. The adjusted NCB, which was given a weight of 1.5 for ICH, was nominally significant in favor of rivaroxaban therapy (difference in incidence rate -2.13; 95% confidence interval [CI]: -.26 to -3.99). Furthermore, the event rate of the composite end point tended to be lower in patients treated with rivaroxaban than in those treated with warfarin (rivaroxaban: 4.97% per year, warfarin: 6.11% per year; difference in incidence rate: -1.14; 95% CI: -3.40 to 1.12). The event rate of the composite end point tended to be consistently low in patients treated with rivaroxaban in the subanalysis by CHADS2 score and renal function. Analysis of the NCB supports that rivaroxaban therapy provides clinical benefit for Japanese patients with AF. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

The benefits and challenges of using computer-assisted symptom assessments in oncology clinics: results of a qualitative assessment.

PubMed

Mark, Tami L; Johnson, Gina; Fortner, Barry; Ryan, Katheryn

2008-10-01

Developed for clinical use in oncology settings, the Patient Assessment, Care & Education (PACE) System is a computer technology tool designed to address the under-identification and treatment of chemotherapy-related symptoms. This system includes general core questions together with the Patient Care Monitor (PCM), a validated questionnaire that assesses patient-reported problems, six symptom burden indices, and one global quality of life index. The system automatically scores the PCM and generates a written report. The objective of this study was to assess the manner in which clinicians use this system and identify the benefits and challenges that oncology clinics may face when adopting this system. The study was part of a larger evaluation of the system that included standardized surveys and chart review. Sixteen providers (physicians, nurses, and physician assistants) at 13 community oncology clinics participated in a 30-minute interview. Responses were coded according to common phrases or concepts. Clinicians indicated that they use the system mainly for symptom assessment or review of systems. The most common benefits identified included the improved ability to identify under-reported symptoms, enhanced communication with patients; increased efficiency; and its ability to highlight patients' most bothersome symptoms. Challenges included patient burden from the frequent need to answer the questionnaires, issues with the wording and formatting of the screening questionnaire, and technical difficulties. In sum, these interviews suggest that electronic symptom assessments offer potential advantages in terms improving the integration of routine assessment of patients' symptoms and health-related quality of life into the daily flow of an oncology clinic. The approach should receive additional research and development attention.

Contractualist reasoning, HIV cure clinical trials, and the moral (ir)relevance of the risk/benefit ratio

PubMed Central

Kumar, Rahul

2017-01-01

Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality. PMID:27590492

Colchicine in Pericardial Disease: from the Underlying Biology and Clinical Benefits to the Drug-Drug Interactions in Cardiovascular Medicine.

PubMed

Schenone, Aldo L; Menon, Venu

2018-06-14

This is an in-depth review on the mechanism of action, clinical utility, and drug-drug interactions of colchicine in the management of pericardial disease. Recent evidence about therapeutic targets on pericarditis has demonstrated that NALP3 inflammasome blockade is the cornerstone in the clinical benefits of colchicine. Such benefits extend from acute and recurrent pericarditis to transient constriction and post-pericardiotomy syndrome. Despite the increased utilization of colchicine in cardiovascular medicine, safety concerns remains unsolved regarding the long-term use of colchicine in the cardiac patient. Moreover, recent evidence has demonstrated that numerous cardiovascular medications, ranging from antihypertensive medication to antiarrhythmics, are known to interact with the CYP3A4 and/or P-gp system increasing the toxicity potential of colchicine. The use of adjunctive colchicine in the management of inflammatory pericardial diseases is standard of care in current practice. It is advised that a careful medication reconciliation with emphasis on pharmacokinetic is completed before prescribing colchicine in order to avoid harmful interaction by finding an alternative regimen or adjusting colchicine dosing.

Decision curve analysis assessing the clinical benefit of NMP22 in the detection of bladder cancer: secondary analysis of a prospective trial.

PubMed

Barbieri, Christopher E; Cha, Eugene K; Chromecki, Thomas F; Dunning, Allison; Lotan, Yair; Svatek, Robert S; Scherr, Douglas S; Karakiewicz, Pierre I; Sun, Maxine; Mazumdar, Madhu; Shariat, Shahrokh F

2012-03-01

• To employ decision curve analysis to determine the impact of nuclear matrix protein 22 (NMP22) on clinical decision making in the detection of bladder cancer using data from a prospective trial. • The study included 1303 patients at risk for bladder cancer who underwent cystoscopy, urine cytology and measurement of urinary NMP22 levels. • We constructed several prediction models to estimate risk of bladder cancer. The base model was generated using patient characteristics (age, gender, race, smoking and haematuria); cytology and NMP22 were added to the base model to determine effects on predictive accuracy. • Clinical net benefit was calculated by summing the benefits and subtracting the harms and weighting these by the threshold probability at which a patient or clinician would opt for cystoscopy. • In all, 72 patients were found to have bladder cancer (5.5%). In univariate analyses, NMP22 was the strongest predictor of bladder cancer presence (predictive accuracy 71.3%), followed by age (67.5%) and cytology (64.3%). • In multivariable prediction models, NMP22 improved the predictive accuracy of the base model by 8.2% (area under the curve 70.2-78.4%) and of the base model plus cytology by 4.2% (area under the curve 75.9-80.1%). • Decision curve analysis revealed that adding NMP22 to other models increased clinical benefit, particularly at higher threshold probabilities. • NMP22 is a strong, independent predictor of bladder cancer. • Addition of NMP22 improves the accuracy of standard predictors by a statistically and clinically significant margin. • Decision curve analysis suggests that integration of NMP22 into clinical decision making helps avoid unnecessary cystoscopies, with minimal increased risk of missing a cancer. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

Durable Clinical Benefit in Metastatic Renal Cell Carcinoma Patients Who Discontinue PD-1/PD-L1 Therapy for Immune-Related Adverse Events.

PubMed

Martini, Dylan J; Hamieh, Lana; McKay, Rana R; Harshman, Lauren C; Brandao, Raphael; Norton, Craig K; Steinharter, John A; Krajewski, Katherine M; Gao, Xin; Schutz, Fabio A; McGregor, Bradley; Bossé, Dominick; Lalani, Aly-Khan A; De Velasco, Guillermo; Michaelson, M Dror; McDermott, David F; Choueiri, Toni K

2018-04-01

The current standard of care for treatment of metastatic renal cell carcinoma (mRCC) patients is PD-1/PD-L1 inhibitors until progression or toxicity. Here, we characterize the clinical outcomes for 19 mRCC patients who experienced an initial clinical response (any degree of tumor shrinkage), but after immune-related adverse events (irAE) discontinued all systemic therapy. Clinical baseline characteristics, outcomes, and survival data were collected. The primary endpoint was time to progression from the date of treatment cessation (TTP). Most patients had clear cell histology and received anti-PD-1/PD-L1 therapy as second-line or later treatment. Median time on PD-1/PD-L1 therapy was 5.5 months (range, 0.7-46.5) and median TTP was 18.4 months (95% CI, 4.7-54.3) per Kaplan-Meier estimation. The irAEs included arthropathies, ophthalmopathies, myositis, pneumonitis, and diarrhea. We demonstrate that 68.4% of patients ( n = 13) experienced durable clinical benefit off treatment (TTP of at least 6 months), with 36% ( n = 7) of patients remaining off subsequent treatment for over a year after their last dose of anti-PD-1/PD-L1. Three patients with tumor growth found in a follow-up visit, underwent subsequent surgical intervention, and remain off systemic treatment. Nine patients (47.4%) have ongoing irAEs. Our results show that patients who benefitted clinically from anti-PD-1/PD-L1 therapy can experience sustained beneficial responses, not needing further therapies after the initial discontinuation of treatment due to irAEs. Investigation of biomarkers indicating sustained benefit to checkpoint blockers are needed. Cancer Immunol Res; 6(4); 402-8. ©2018 AACR . ©2018 American Association for Cancer Research.

Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate

PubMed Central

Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

2017-01-01

Purpose The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. Materials and Methods From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. Results A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p < 0.001). Heavily treated patients and patients with previous experience regarding CTs also showed a higher willingness to participate (p < 0.001). The perceived benefit of CTs was higher in the group willing to participate (p=0.026). Conclusion The patient’s level of awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary. PMID:28392549

Toward a Framework for Benefit-Risk Assessment in Diagnostic Imaging: Identifying Scenario-specific Criteria.

PubMed

Agapova, Maria; Bresnahan, Brian W; Linnau, Ken F; Garrison, Louis P; Higashi, Mitchell; Kessler, Larry; Devine, Beth

2017-05-01

Diagnostic imaging has many effects and there is no common definition of value in diagnostic radiology. As benefit-risk trade-offs are rarely made explicit, it is not clear which framework is used in clinical guideline development. We describe initial steps toward the creation of a benefit-risk framework for diagnostic radiology. We performed a literature search and an online survey of physicians to identify and collect benefit-risk criteria (BRC) relevant to diagnostic imaging tests. We operationalized a process for selection of BRC with the use of four clinical use case scenarios that vary by diagnostic alternatives and clinical indication. Respondent BRC selections were compared across clinical scenarios and between radiologists and nonradiologists. Thirty-six BRC were identified and organized into three domains: (1) those that account for differences attributable only to the test or device (n = 17); (2) those that account for clinical management and provider experiences (n = 12); and (3) those that capture patient experience (n = 7). Forty-eight survey participants selected 22 criteria from the initial list in the survey (9-11 per case). Engaging ordering physicians increased the number of criteria selected in each of the four clinical scenarios presented. We developed a process for standardizing selection of BRC in guideline development. These results suggest that a process relying on elements of comparative effectiveness and the use of standardized BRC may ensure consistent examination of differences among alternatives by way of making explicit implicit trade-offs that otherwise enter the decision-making space and detract from consistency and transparency. These findings also highlight the need for multidisciplinary teams that include input from ordering physicians. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

PubMed

Park, Ki Byung; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Kim, Me-Riong; Lee, Jun-Hwan; Shin, Kyung-Min; Shin, Byung-Cheul; Cho, Jae-Heung; Ha, In-Hyuk

2017-04-15

.: Prospective observational 1-year study. .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. 3.

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

8D.04: CLINICAL BENEFITS OF ADMINISTERING SUPER-SELECTIVE SEGMENTAL ADRENAL VENOUS SAMPLING AND PERFORMING ADRENAL SPARING SURGERY IN THE PATIENTS WITH PRIMARY ALDOSTERONISM.

PubMed

Satoh, F; Morimoto, R; Ono, Y; Iwakura, Y; Omata, K; Kudo, M; Satani, N; Ota, H; Seiji, K; Takase, K; Nakamura, Y; Sasano, H; Ito, S

2015-06-01

Adrenal venous sampling (AVS) has been well known to play pivotal roles in clinical differential diagnosis of unilateral aldosterone producing adenoma (APA) from bilateral idiopathic hyperaldosteronism (IHA). However, it is also true that a central vein AVS or c-AVS which collects the blood from right and left central adrenal veins can by no means discriminate bilateral APA from BHA. There have been no published studies reporting the reliable clinical differential diagnosis between bilateral APA and IHA, especially IHA cases with bilateral non-functioning adenomas (NFA), which has been considered practically impossible in clinical differential diagnosis. As an attempt to this clinical dilemma, segmental AVS (S-AVS), which could evaluate segmental effluents from adrenal tributary veins, has been recently developed. We have performed S-AVS in these patients above following C-AVS, via the insertion of a microcatheter in up to three intra-adrenal first-degree tributary veins on bilateral adrenals. S-AVS did enable us to evaluate the intra-adrenal localization of corticosteroidogenesis. These data did indicate that S-AVS should be performed in the PA patients who had increased aldosterone levels in bilateral central vein and demonstrated space occupying lesions in the bilateral adrenals in order to avoid bilateral adrenalectomy or long lasting medical treatment toward persistent PA. In addition to the situations above, we have administere S-AVS to the following patients; those who had clinically suspected APA but not sufficiently high lateralization indexes according to the results of C-AVS, very young ones with higher clinical probability of recurrence and those who could benefit from partial adrenalectomy by demonstrating the sites of specific steroidogenesis. However, it is also entirely true that S-AVS is more expensive, time-consuming and labor-intensive compared to C-AVS.(Figure is included in full-text article.)The angiography during S-AVS (A, B), the coronal CT

Benefit-based tree valuation

Treesearch

E.G. McPherson

2007-01-01

Benefit-based tree valuation provides alternative estimates of the fair and reasonable value of trees while illustrating the relative contribution of different benefit types. This study compared estimates of tree value obtained using cost- and benefit-based approaches. The cost-based approach used the Council of Landscape and Tree Appraisers trunk formula method, and...

Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan.

PubMed

Shen, Li-Jiuan; Chou, Hua; Huang, Chih-Fen; Chou, Guann-Miaw; Chan, Wing Kai; Wu, Fe-Lin Lin

2011-07-01

Concerns exist regarding the additional cost of patient care when patients are enrolled in clinical trials at hospitals. To assess the avoidance of drug costs by conducting sponsored clinical trials, a retrospective analysis evaluating drug cost avoidance in all sponsored clinical trials was conducted in 2008 at the most prominent medical center in Taiwan. The National Health Insurance (NHI) reimbursement prices of either the investigated drugs or the standardized drug therapy for each specific disease were used to calculate the cost avoidance. Drug cost avoidance from sponsored clinical trials per year, per trial, per patient, in different therapeutic areas, and in different phases was analyzed. Three quarters of the cost avoidance in drug expenditures from 194 sponsored clinical trials were estimated. All cost values are in US Dollars. Around $11.2 million was avoided at the center in 2008. The average value of cost avoidance was $58,000/trial-year or $3,900/participant-year. The early-phase trials and phase III trials accounted for 25% and 56% of all trials, respectively, while they constituted 32% and 49% of the total costs avoided, respectively. The most frequently conducted and highest cost-avoiding trials were those for antineoplastic agents, especially targeted therapy which accounted for 85% of the total cost avoidance of anti-cancer trials. This study demonstrates the profoundly positive economic impact on the healthcare system in Taiwan by sponsored clinical trials. To understand the trend of economic benefits of the trials on pharmaceutical expenditure, it would be important to analyze the cost avoidance of trials regularly in an institution. Copyright © 2011 Elsevier Inc. All rights reserved.

Survival Benefit of Japanese Extended Lymphadenectomy for Clinically Node-Negative and Node-Positive Colorectal Cancers.

PubMed

Ouchi, Akira; Komori, Koji; Kimura, Kenya; Kinoshita, Takashi; Shimizu, Yasuhiro; Nagino, Masato

2018-02-01

The impact of extended lymphadenectomy for colorectal cancer is still not sufficiently clear. The aim of the present study was to evaluate the survival benefit of extended lymphadenectomy compared with nonextended lymphadenectomy for clinically node-negative and node-positive colorectal cancers. The present study was a retrospective cohort study that used prospectively collected data and a propensity score matching method. The present study was conducted at a single specialized colorectal surgery department. Of the 1314 patients who underwent radical resection with nonextended or extended lymphadenectomy between 1988 and 2007, we included 711 and 603 patients in the cN0 and cN1/2 series. Propensity score matching was applied, and 141 and 63 pairs were extracted from the cN0 and cN1/2 series. Disease-free survival, cancer-specific survival, and overall survival of the 2 groups were calculated and compared. In the cN0 series, no differences were observed in the long-term outcomes between the nonextended and extended groups. In the cN1/2 series, the disease-free survival, cancer-specific survival and overall survival were significantly higher (log rank, p = 0.04, p = 0.02, and p = 0.01, respectively), and the frequency of local recurrence was significantly lower (p = 0.04) in the extended group. The present study was limited by its nonrandomized retrospective design. Extended lymphadenectomy demonstrated a good inhibitory effect on the local recurrence rate and led to improved disease-free survival, cancer-specific survival, and overall survival of patients in the cN1/2 series. See Video Abstract at http://links.lww.com/DCR/A517.

Evaluation and justification of clinical pharmacy services.

PubMed

Anderson, Scott V; Schumock, Glen T

2009-12-01

Pharmacy managers often must justify clinical pharmacy services (CPSs). This can be done by generalizing evidence from the literature or by conducting local evaluations. In either case, it is important that the clinical, humanistic or economic benefits of CPSs are considered, and limitations of the studies recognized. The basic model for the evaluation of CPSs includes the consideration of costs and outcomes, as well as the inclusion of a comparator group. Recent systematic reviews and individual studies provide good evidence regarding the value of CPSs, and are discussed here. Benefit-to-cost ratios of selected CPSs are also provided. While much of the evidence for CPSs has been conducted in the hospital setting, in the future, CPS expansion will occur in ambulatory care settings and will be benefited by healthcare reform efforts.

Net Efficacy Adjusted for Risk (NEAR): A Simple Procedure for Measuring Risk:Benefit Balance

PubMed Central

Boada, José N.; Boada, Carlos; García-Sáiz, Mar; García, Marcelino; Fernández, Eduardo; Gómez, Eugenio

2008-01-01

Background Although several mathematical models have been proposed to assess the risk:benefit of drugs in one measure, their use in practice has been rather limited. Our objective was to design a simple, easily applicable model. In this respect, measuring the proportion of patients who respond favorably to treatment without being affected by adverse drug reactions (ADR) could be a suitable endpoint. However, remarkably few published clinical trials report the data required to calculate this proportion. As an approach to the problem, we calculated the expected proportion of this type of patients. Methodology/Principal Findings Theoretically, responders without ADR may be obtained by multiplying the total number of responders by the total number of subjects that did not suffer ADR, and dividing the product by the total number of subjects studied. When two drugs are studied, the same calculation may be repeated for the second drug. Then, by constructing a 2×2 table with the expected frequencies of responders with and without ADR, and non-responders with and without ADR, the odds ratio and relative risk with their confidence intervals may be easily calculated and graphically represented on a logarithmic scale. Such measures represent “net efficacy adjusted for risk” (NEAR). We assayed the model with results extracted from several published clinical trials or meta-analyses. On comparing our results with those originally reported by the authors, marked differences were found in some cases, with ADR arising as a relevant factor to balance the clinical benefit obtained. The particular features of the adverse reaction that must be weighed against benefit is discussed in the paper. Conclusion NEAR representing overall risk-benefit may contribute to improving knowledge of drug clinical usefulness. As most published clinical trials tend to overestimate benefits and underestimate toxicity, our measure represents an effort to change this trend. PMID:18974868

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

PubMed

Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial.

PubMed

Rouchy, R C; Moreau-Gaudry, A; Chipon, E; Aubry, S; Pazart, L; Lapuyade, B; Durand, M; Hajjam, M; Pottier, S; Renard, B; Logier, R; Orry, X; Cherifi, A; Quehen, E; Kervio, G; Favelle, O; Patat, F; De Kerviler, E; Hughes, C; Medici, M; Ghelfi, J; Mounier, A; Bricault, I

2017-07-06

Interventional radiology includes a range of minimally invasive image-guided diagnostic and therapeutic procedures that have become routine clinical practice. Each procedure involves a percutaneous needle insertion, often guided using computed tomography (CT) because of its availability and usability. However, procedures remain complicated, in particular when an obstacle must be avoided, meaning that an oblique trajectory is required. Navigation systems track the operator's instruments, meaning the position and progression of the instruments are visualised in real time on the patient's images. A novel electromagnetic navigation system for CT-guided interventional procedures (IMACTIS-CT®) has been developed, and a previous clinical trial demonstrated improved needle placement accuracy in navigation-assisted procedures. In the present trial, we are evaluating the clinical benefit of the navigation system during the needle insertion step of CT-guided procedures in the thoraco-abdominal region. This study is designed as an open, multicentre, prospective, randomised, controlled interventional clinical trial and is structured as a standard two-arm, parallel-design, individually randomised trial. A maximum of 500 patients will be enrolled. In the experimental arm (navigation system), the procedures are carried out using navigation assistance, and in the active comparator arm (CT), the procedures are carried out with conventional CT guidance. The randomisation is stratified by centre and by the expected difficulty of the procedure. The primary outcome of the trial is a combined criterion to assess the safety (number of serious adverse events), efficacy (number of targets reached) and performance (number of control scans acquired) of navigation-assisted, CT-guided procedures as evaluated by a blinded radiologist and confirmed by an expert committee in case of discordance. The secondary outcomes are (1) the duration of the procedure, (2) the satisfaction of the operator and

Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

PubMed

Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

2014-06-01

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.

The harm-benefit tradeoff in "bad deal" trials.

PubMed

Nycum, Gillian; Reid, Lynette

2007-12-01

This paper examines the nature of the harm-benefit tradeoff in early clinical research for interventions that involve remote possibility of direct benefit and likelihood of direct harms to research participants with fatal prognoses, by drawing on the example of gene transfer trials for glioblastoma multiforme. We argue that the appeal made by the component approach to clinical equipoise fails to account fully for the nature of the harm-benefit tradeoff-individual harm for social benefit-that would be required to justify such research. An analysis of what we label "collateral affective benefits," such as the experience of hope or exercise of altruism, shows that the existence of these motivations reinforces rather than mitigates the necessity of justification by reference to social benefit. Evaluations of social benefit must be taken seriously in the research ethics review process to avoid the exploitation of research participants' motivations of hope or altruism and to avoid the possibility of inadvertent exploitation of high-risk research participants and the harms that would associate with such exploitation.

A framework for quantifying net benefits of alternative prognostic models.

PubMed

Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

2012-01-30

New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd.

A framework for quantifying net benefits of alternative prognostic models‡

PubMed Central

Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

2012-01-01

New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd. PMID:21905066

Benefits of a transfer clinic in adolescent and young adult kidney transplant patients.

PubMed

McQuillan, Rory F; Toulany, Alene; Kaufman, Miriam; Schiff, Jeffrey R

2015-01-01

Adolescent and young adult kidney transplant recipients have worse graft outcomes than older and younger age groups. Difficulties in the process of transition, defined as the purposeful, planned movement of adolescents with chronic health conditions from child to adult-centered health care systems, may contribute to this. Improving the process of transition may improve adherence post-transfer to adult care services. The purpose of this study is to investigate whether a kidney transplant transfer clinic for adolescent and young adult kidney transplant recipients transitioning from pediatric to adult care improves adherence post-transfer. We developed a joint kidney transplant transfer clinic between a pediatric kidney transplant program, adult kidney transplant program, and adolescent medicine at two academic health centers. The transfer clinic facilitated communication between the adult and pediatric transplant teams, a face-to-face meeting of the patient with the adult team, and a meeting with the adolescent medicine physician. We compared the outcomes of 16 kidney transplant recipients transferred before the clinic was established with 16 patients who attended the clinic. The primary outcome was a composite measure of non-adherence. Non-adherence was defined as either self-reported medication non-adherence or displaying two of the following three characteristics: non-attendance at clinic, non-attendance for blood work appointments, or undetectable calcineurin inhibitor levels within 1 year post-transfer. The two groups were similar at baseline, with non-adherence identified in 43.75 % of patients. Non-adherent behavior in the year post-transfer, which included missing clinic visits, missing regular blood tests, and undetectable calcineurin inhibitor levels, was significantly lower in the cohort which attended the transfer clinic (18.8 versus 62.5 %, p = 0.03). The median change in estimated glomerular filtration rate (eGFR) in the year following transfer

Performance specifications and six sigma theory: Clinical chemistry and industry compared.

PubMed

Oosterhuis, W P; Severens, M J M J

2018-04-11

Analytical performance specifications are crucial in test development and quality control. Although consensus has been reached on the use of biological variation to derive these specifications, no consensus has been reached which model should be preferred. The Six Sigma concept is widely applied in industry for quality specifications of products and can well be compared with Six Sigma models in clinical chemistry. However, the models for measurement specifications differ considerably between both fields: where the sigma metric is used in clinical chemistry, in industry the Number of Distinct Categories is used instead. In this study the models in both fields are compared and discussed. Copyright © 2018. Published by Elsevier Inc.

Multiplex molecular testing for management of infectious gastroenteritis in a hospital setting: a comparative diagnostic and clinical utility study.

PubMed

Halligan, E; Edgeworth, J; Bisnauthsing, K; Bible, J; Cliff, P; Aarons, E; Klein, J; Patel, A; Goldenberg, S

2014-08-01

Laboratory diagnosis and clinical management of inpatients with diarrhoea is complex and time consuming. Tests are often requested sequentially and undertaken in different laboratories. This causes prolonged unnecessary presumptive isolation of patients, because most cases are non-infectious. A molecular multiplex test (Luminex(®) Gastrointestinal Pathogen Panel (GPP)) was compared with conventional testing over 8 months to determine diagnostic accuracy, turnaround times, laboratory costs, use of isolation facilities and user acceptability. A total of 262 (12%) patients had a pathogen detected by conventional methods compared with 483 (22.1%) by GPP. Most additional cases were detected in patients developing symptoms in the first 4 days of admission. Additional cases were detected because of presumed improved diagnostic sensitivity but also because clinicians had not requested the correct pathogen. Turnaround time (41.8 h) was faster than bacterial culture (66.5 h) and parasite investigation (66.5 h) but slower than conventional testing for Clostridium difficile (17.3 h) and viruses (27 h). The test could allow simplified requesting by clinicians and a consolidated laboratory workflow, reducing the overall number of specimens received by the laboratory. A total of 154 isolation days were saved at an estimated cost of £30 800. Consumables and labour were estimated at £150 641 compared with £63 431 for conventional testing. Multiplex molecular testing using a panel of targets allowed enhanced detection and a consolidated laboratory workflow. This is likely to be of greater benefit to cases that present within the first 4 days of hospital admission. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Spontaneous Swallow Frequency Compared with Clinical Screening in the Identification of Dysphagia in Acute Stroke

PubMed Central

Crary, Michael A.; Carnaby, Giselle D.; Sia, Isaac

2017-01-01

Background The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. Methods In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Results Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Conclusions Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. PMID:25088166

Cost and Economic Benefit of Clinical Decision Support Systems (CDSS) for Cardiovascular Disease Prevention: A Community Guide Systematic Review

PubMed Central

Jacob, Verughese; Thota, Anilkrishna B.; Chattopadhyay, Sajal K.; Njie, Gibril J.; Proia, Krista K.; Hopkins, David P.; Ross, Murray N.; Pronk, Nicolaas P.; Clymer, John M.

2017-01-01

Objective This review evaluates costs and benefits associated with acquiring, implementing, and operating clinical decision support systems (CDSS) to prevent cardiovascular disease (CVD). Materials and Methods Methods developed for The Community Guide were used to review CDSS literature covering the period from January 1976 to October 2015. Twenty-one studies were identified for inclusion. Results It was difficult to draw a meaningful estimate for the cost of acquiring and operating CDSS to prevent CVD from the available studies (n=12) due to considerable heterogeneity. Several studies (n=11) indicated healthcare costs were averted by using CDSS but many were partial assessments that did not consider all components of healthcare. Four cost-benefit studies reached conflicting conclusions about the net benefit of CDSS based on incomplete assessments of costs and benefits. Three cost-utility studies indicated inconsistent conclusions regarding cost-effectiveness based on a conservative $50,000 threshold. Discussion Intervention costs were not negligible but specific estimates were not derived because of the heterogeneity of implementation and reporting metrics. Expected economic benefits from averted healthcare cost could not be determined with confidence because many studies did not fully account for all components of healthcare. Conclusion We were unable to conclude whether CDSS for CVD prevention is either cost-beneficial or cost effective. Several evidence gaps are identified, most prominently the lack of information about major drivers of cost and benefit; the lack of standard metrics for the cost of CDSS; and not allowing for useful life of CDSS that generally extends beyond one accounting period. PMID:28049635

Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials.

PubMed

Mega, J L; Stitziel, N O; Smith, J G; Chasman, D I; Caulfield, M; Devlin, J J; Nordio, F; Hyde, C; Cannon, C P; Sacks, F; Poulter, N; Sever, P; Ridker, P M; Braunwald, E; Melander, O; Kathiresan, S; Sabatine, M S

2015-06-06

Genetic variants have been associated with the risk of coronary heart disease. In this study, we tested whether or not a composite of these variants could ascertain the risk of both incident and recurrent coronary heart disease events and identify those individuals who derive greater clinical benefit from statin therapy. A community-based cohort study (the Malmo Diet and Cancer Study) and four randomised controlled trials of both primary prevention (JUPITER and ASCOT) and secondary prevention (CARE and PROVE IT-TIMI 22) with statin therapy, comprising a total of 48,421 individuals and 3477 events, were included in these analyses. We studied the association of a genetic risk score based on 27 genetic variants with incident or recurrent coronary heart disease, adjusting for traditional clinical risk factors. We then investigated the relative and absolute risk reductions in coronary heart disease events with statin therapy stratified by genetic risk. We combined data from the different studies using a meta-analysis. When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient in risk for incident or recurrent coronary heart disease was shown. Compared with the low genetic risk category, the multivariable-adjusted hazard ratio for coronary heart disease for the intermediate genetic risk category was 1·34 (95% CI 1·22-1·47, p<0·0001) and that for the high genetic risk category was 1·72 (1·55-1·92, p<0·0001). In terms of the benefit of statin therapy in the four randomised trials, we noted a significant gradient (p=0·0277) of increasing relative risk reductions across the low (13%), intermediate (29%), and high (48%) genetic risk categories. Similarly, we noted greater absolute risk reductions in those individuals in higher genetic risk categories (p=0·0101), resulting in a roughly threefold decrease in the number needed to treat to prevent one coronary heart disease

Perceived benefits of the use of learning contracts to guide clinical education in respiratory care students.

PubMed

Rye, Kathy Jones-Boggs

2008-11-01

The benefits of contract learning have been identified in the literature as increased individualization to meet the student's individual needs, promotion of learner independence, and development of lifelong learning behaviors among students. I used an "action research" approach to implement the contract-learning method into a clinical course. Clinical learning contracts were designed to provide students with the opportunity to focus on any identified areas of unsatisfactory or desired practice. The learning contract specified how the learner would acquire the knowledge and attitudes relevant to their selected learning experience. The learning contract was used as a learning tool and as evidence of the student's development in the clinical experience. Twenty-four senior respiratory therapy students in the College of Health Related Professions, University of Arkansas for Medical Sciences, prepared and used learning contracts during their Clinical Practicum IV. After they had completed the clinical practicum and received their grades, I surveyed the students about their experience with the learning-contract method. The surveys were administered anonymously. Twenty-one students (88%) returned the surveys. The respondents were overall quite optimistic regarding learning contracts. They generally agreed that they could use the learning contract with confidence and that there is an increase in student autonomy and motivation in scholarship with a learning contract. The median agree/disagree ratings on the survey ranged from 1 (strongly agree) to 2 (agree). Contract learning is favorable to students' knowledge and skill acquisition and can be incorporated into clinical education of respiratory care students.

Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a community guide systematic review.

PubMed

Jacob, Verughese; Thota, Anilkrishna B; Chattopadhyay, Sajal K; Njie, Gibril J; Proia, Krista K; Hopkins, David P; Ross, Murray N; Pronk, Nicolaas P; Clymer, John M

2017-05-01

This review evaluates costs and benefits associated with acquiring, implementing, and operating clinical decision support systems (CDSSs) to prevent cardiovascular disease (CVD). Methods developed for the Community Guide were used to review CDSS literature covering the period from January 1976 to October 2015. Twenty-one studies were identified for inclusion. It was difficult to draw a meaningful estimate for the cost of acquiring and operating CDSSs to prevent CVD from the available studies ( n  = 12) due to considerable heterogeneity. Several studies ( n  = 11) indicated that health care costs were averted by using CDSSs but many were partial assessments that did not consider all components of health care. Four cost-benefit studies reached conflicting conclusions about the net benefit of CDSSs based on incomplete assessments of costs and benefits. Three cost-utility studies indicated inconsistent conclusions regarding cost-effectiveness based on a conservative $50,000 threshold. Intervention costs were not negligible, but specific estimates were not derived because of the heterogeneity of implementation and reporting metrics. Expected economic benefits from averted health care cost could not be determined with confidence because many studies did not fully account for all components of health care. We were unable to conclude whether CDSSs for CVD prevention is either cost-beneficial or cost-effective. Several evidence gaps are identified, most prominently a lack of information about major drivers of cost and benefit, a lack of standard metrics for the cost of CDSSs, and not allowing for useful life of a CDSS that generally extends beyond one accounting period. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

The economic costs of routine INR monitoring in infants and children--examining point-of-care devices used within the home setting compared to traditional anticoagulation clinic monitoring.

PubMed

Gaw, James R; Crowley, Steven; Monagle, Paul; Jones, Sophie; Newall, Fiona

2013-07-01

The use of point-of-care (POC) devices within the home for routine INR monitoring has demonstrated reliability, safety and effectiveness in the management of infants and children requiring long-term warfarin therapy. However, a comprehensive cost-analysis of using this method of management, compared to attending anticoagulation clinics has not been reported. The aim of this study was to compare the estimated societal costs of attending anticoagulation clinics for routine INR monitoring to using a POC test in the home. This study used a comparative before-and-after design that included 60 infants and children managed via the Haematology department at a tertiary paediatric centre. Each participant was exposed to both modes of management at various times for a period of ≥3 months. A questionnaire, consisting of 25 questions was sent to families to complete and return. Data collected included: the frequency of monitoring, mode of travel to and from clinics, total time consumed, and primary carer's income level. The home monitoring cohort saved a total of 1 hour 19 minutes per INR test compared to attending anticoagulation clinics and had a cost saving to society of $66.83 (AUD) per INR test compared to traditional care; incorporating health sector costs, travel expenses and lost time. The traditional model of care requires a considerable investment of time per test from both child and carer. Home INR monitoring in infants and children provides greater societal economic benefits compared to traditional models. Copyright © 2013 Elsevier Ltd. All rights reserved.

Can repeat injection provide clinical benefit in patients with cervical disc herniation and stenosis when the first epidural injection results only in partial response?

PubMed

Lee, Jung Hwan; Lee, Sang-Ho

2016-07-01

Epidural steroid injection (ESI) is known to be an effective treatment for neck or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after single ESI, there has been little evidence supporting the usefulness of this procedure. The purpose of this study, therefore, was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than intermittent ESI performed only when pain was aggravated. One hundred eighty-four patients who underwent transforaminal ESI (TFESI) for treatment of axial neck and radicular arm pain due to HIVD or SS and could be followed up for 1 year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (numeric rating scale (NRS) ≥ 3 after the first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 76) comprised partial responders who did not receive repeat injection at the prescribed interval, but received intermittent injections only for aggravation of pain. Various clinical data were assessed, including total number of injections during 1 year, NRS duration of <3 during 1 year (NRS < 3 duration), and time interval until pain was increased to require additional injections after repeat injection in Group A, or after first injection in Group B (time to reinjection). Groups A and B were compared in terms of total population, HIVD, and SS. In the whole population, HIVD subgroup, and SS subgroup, patients in Group A required significantly fewer injections to obtain satisfactory pain relief during the 1-year follow-up period. Group A showed a significantly longer time to reinjection and longer NRS < 3 than Group B did. Repeat TFESI conducted at 2- to 3-week intervals

Potential explanations for control group benefit.

PubMed

Nichols, Linda O; Martindale-Adams, Jennifer L; Burns, Robert; Graney, Marshall J; Zuber, Jeffrey K; Kennedy, Sarah E

2012-10-01

Estimating effectiveness of clinical interventions depends on detecting differences between the responses of intervention and control groups. The outcome, intervention, and moderating factors all may influence the between group change. The absence of a clinically or statistically meaningful difference may also result from control group improvement due to nonspecific factors such as participants' perception of attention, positive regard, expectations, desire to please, and therapeutic alliance with the care provider. We examined perceived benefit and sources of benefit for control caregivers who participated in the CONNECT randomized controlled trial of a dementia caregiving intervention. After the final scheduled data collection in CONNECT, control group participants were asked whether they believed they benefited from study participation. Those who reported benefit were asked to describe the benefit received. Data were analyzed qualitatively. Of 60 available control caregivers, 82% reported a perceived benefit from study participation in five areas: getting information about dementia and caregiving; having someone to talk to and feeling supported; receiving understanding and validation of feelings; knowledge that others were in similar situations; and perceived appreciation of own abilities. Control caregivers who reported benefit were less burdened and depressed and spent less time on duty at baseline than those who did not report benefit. From caregivers' responses, we have identified the assessment battery, both content and time spent in data collection, as a possible mechanism of action for benefit. Study limitations include the better baseline characteristics of the control caregivers who reported benefit, the sample size of benefit control caregivers, the possibility of perceptions of benefit being a function of social desirability, and the lack of a similar question about benefit being asked of intervention caregivers. These findings suggest that the

Comparing clinical and social-personality conceptualizations of narcissism.

PubMed

Miller, Joshua D; Campbell, W Keith

2008-06-01

There is a lack of consensus surrounding the conceptualization of narcissism. The present study compared two measures of narcissism-one used in clinical settings (Personality Diagnostic Questionnaire, PDQ-4+; Hyler, 1994) and one used in social-personality research (Narcissistic Personality Inventory, NPI; Raskin & Terry, 1988)-across two samples. Sample 1 (N=271) was composed of undergraduates, whereas Sample 2 (N=211) was composed of parents of the Sample 1 participants. The scales were significantly interrelated but manifested divergent relations with general personality traits, personality disorders (including expert prototypal ratings of narcissism), recollections of parenting received, and psychological distress and self-esteem. PDQ-4 narcissism captured an emotionally unstable, negative-affect-laden, and introverted variant of narcissism; NPI narcissism captured an emotionally resilient, extraverted form. The clinical and social-personality conceptualizations of narcissism primarily share a tendency to use an antagonistic interpersonal style. Implications for the DSM-V are discussed.

Ecosystem Services in Conservation Planning: Targeted Benefits vs. Co-Benefits or Costs?

PubMed Central

Chan, Kai M. A.; Hoshizaki, Lara; Klinkenberg, Brian

2011-01-01

There is growing support for characterizing ecosystem services in order to link conservation and human well-being. However, few studies have explicitly included ecosystem services within systematic conservation planning, and those that have follow two fundamentally different approaches: ecosystem services as intrinsically-important targeted benefits vs. substitutable co-benefits. We present a first comparison of these two approaches in a case study in the Central Interior of British Columbia. We calculated and mapped economic values for carbon storage, timber production, and recreational angling using a geographical information system (GIS). These ‘marginal’ values represent the difference in service-provision between conservation and managed forestry as land uses. We compared two approaches to including ecosystem services in the site-selection software Marxan: as Targeted Benefits, and as Co-Benefits/Costs (in Marxan's cost function); we also compared these approaches with a Hybrid approach (carbon and angling as targeted benefits, timber as an opportunity cost). For this analysis, the Co-Benefit/Cost approach yielded a less costly reserve network than the Hybrid approach (1.6% cheaper). Including timber harvest as an opportunity cost in the cost function resulted in a reserve network that achieved targets equivalently, but at 15% lower total cost. We found counter-intuitive results for conservation: conservation-compatible services (carbon, angling) were positively correlated with each other and biodiversity, whereas the conservation-incompatible service (timber) was negatively correlated with all other networks. Our findings suggest that including ecosystem services within a conservation plan may be most cost-effective when they are represented as substitutable co-benefits/costs, rather than as targeted benefits. By explicitly valuing the costs and benefits associated with services, we may be able to achieve meaningful biodiversity conservation at lower cost

Fitting recommendations and clinical benefit associated with use of the NAL-NL2 hearing-aid prescription in Nucleus cochlear implant recipients.

PubMed

English, Ruth; Plant, Kerrie; Maciejczyk, Michael; Cowan, Robert

2016-01-01

For a group of cochlear implant recipients, who use hearing aids in the contralateral ear, the benefit of NAL-NL2 relative to a recipients' own prescription was assessed. Whether there was a preferred frequency response and/or gain deviation from NAL-NL2 was then investigated. Speech recognition and self-reported ratings of benefit were examined for the recipients' own prescription compared to the NAL-NL2 prescription, in the bimodal and hearing-aid alone conditions. Paired-comparison of hearing-aid frequency response was conducted with default NAL-NL2 and two variants, a low frequency boost or cut. Using a loudness balancing procedure, the hearing-aid gain required to achieve equal loudness between the devices was measured. Sixteen adults with post-lingual hearing loss. A 22% increase in group median word score in quiet with use of NAL-NL2 in the hearing-aid alone condition. In the bimodal condition there was no improvement with NAL-NL2. Default NAL-NL2 frequency response was preferred by 67% of participants. For 56% of participants, the preferred gain to achieve loudness balance across bimodal devices was within 5-dB of prescribed values. The NAL-NL2 prescription provides a high level of clinical performance, and an acceptable frequency response and gain for most participants.

Rejuvenation of allogenic red cells: benefits and risks.

PubMed

Aujla, H; Woźniak, M; Kumar, T; Murphy, G J

2018-06-04

To review preclinical and clinical studies that have evaluated the effects of red cell rejuvenation in vivo and in vitro and to assess the potential risks and benefits from their clinical use. A systematic review and narrative synthesis of the intervention of red cell rejuvenation using a red cell processing solution containing inosine, pyruvate, phosphate and adenine. Outcomes of interest in vitro were changes in red cell characteristics including adenosine triphosphate (ATP), 2,3-diphosphoglycerate (2,3-DPG), deformability and the accumulation of oxidized lipids and other reactive species in the red cell supernatant. Outcomes in vivo were 24-h post-transfusion survival and the effects on oxygen delivery, organ function and inflammation in transfused recipients. The literature search identified 49 studies evaluating rejuvenated red cells. In vitro rejuvenation restored cellular properties including 2,3-DPG and ATP to levels similar to freshly donated red cells. In experimental models, in vivo transfusion of rejuvenated red cells improved oxygen delivery and myocardial, renal and pulmonary function when compared to stored red cells. In humans, in vivo 24-h survival of rejuvenated red cells exceeded 75%. In clinical studies, rejuvenated red cells were found to be safe, with no reported adverse effects. In one adult cardiac surgery trial, transfusion of rejuvenated red cells resulted in improved myocardial performance. Transfusion of rejuvenated red cells reduces organ injury attributable to the red cell storage lesion without adverse effects in experimental studies in vivo. The clinical benefits of this intervention remain uncertain. © 2018 International Society of Blood Transfusion.

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

PubMed

Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

2014-09-01

The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants.

PubMed

Demmelmair, Hans; Prell, Christine; Timby, Niklas; Lönnerdal, Bo

2017-07-28

The provision of essential and non-essential amino acids for breast-fed infants is the major function of milk proteins. In addition, breast-fed infants might benefit from bioactivities of milk proteins, which are exhibited in the intestine during the digestive phase and by absorption of intact proteins or derived peptides. For lactoferrin, osteopontin and milk fat globule membrane proteins/lipids, which have not until recently been included in substantial amounts in infant formulas, in vitro experiments and animal models provide a convincing base of evidence for bioactivities, which contribute to the protection of the infant from pathogens, improve nutrient absorption, support the development of the immune system and provide components for optimal neurodevelopment. Technologies have become available to obtain these compounds from cow´s milk and the bovine compounds also exhibit bioactivities in humans. Randomized clinical trials with experimental infant formulas incorporating lactoferrin, osteopontin, or milk fat globule membranes have already provided some evidence for clinical benefits. This review aims to compare findings from laboratory and animal experiments with outcomes of clinical studies. There is good justification from basic science and there are promising results from clinical studies for beneficial effects of lactoferrin, osteopontin and the milk fat globule membrane complex of proteins and lipids. Further studies should ideally be adequately powered to investigate effects on clinically relevant endpoints in healthy term infants.

Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants

PubMed Central

Prell, Christine; Timby, Niklas; Lönnerdal, Bo

2017-01-01

The provision of essential and non-essential amino acids for breast-fed infants is the major function of milk proteins. In addition, breast-fed infants might benefit from bioactivities of milk proteins, which are exhibited in the intestine during the digestive phase and by absorption of intact proteins or derived peptides. For lactoferrin, osteopontin and milk fat globule membrane proteins/lipids, which have not until recently been included in substantial amounts in infant formulas, in vitro experiments and animal models provide a convincing base of evidence for bioactivities, which contribute to the protection of the infant from pathogens, improve nutrient absorption, support the development of the immune system and provide components for optimal neurodevelopment. Technologies have become available to obtain these compounds from cow´s milk and the bovine compounds also exhibit bioactivities in humans. Randomized clinical trials with experimental infant formulas incorporating lactoferrin, osteopontin, or milk fat globule membranes have already provided some evidence for clinical benefits. This review aims to compare findings from laboratory and animal experiments with outcomes of clinical studies. There is good justification from basic science and there are promising results from clinical studies for beneficial effects of lactoferrin, osteopontin and the milk fat globule membrane complex of proteins and lipids. Further studies should ideally be adequately powered to investigate effects on clinically relevant endpoints in healthy term infants. PMID:28788066

A STUDY OF FRINGE BENEFITS.

DTIC Science & Technology

Fringe benefits as a term was coined by the War Labor Board during World War II to describe the various indirect benefits which industry had devised...trends for the future. The appendix contains an analysis of comparative costs of fringe benefits in industry and the military services. (Author)

Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

PubMed

Weseler, Antje R; Ruijters, Erik J B; Drittij-Reijnders, Marie-José; Reesink, Koen D; Haenen, Guido R M M; Bast, Aalt

2011-01-01

Cardiovascular diseases are expanding to a major social-economic burden in the Western World and undermine man's deep desire for healthy ageing. Epidemiological studies suggest that flavanol-rich foods (e.g. grapes, wine, chocolate) sustain cardiovascular health. For an evidenced-based application, however, sound clinical data on their efficacy are strongly demanded. In a double-blind, randomized, placebo-controlled intervention study we supplemented 28 male smokers with 200 mg per day of monomeric and oligomeric flavanols (MOF) from grape seeds. At baseline, after 4 and 8 weeks we measured macro- and microvascular function and a cluster of systemic biomarkers for major pathological processes occurring in the vasculature: disturbances in lipid metabolism and cellular redox balance, and activation of inflammatory cells and platelets. In the MOF group serum total cholesterol and LDL decreased significantly (P ≤ 0.05) by 5% (n = 11) and 7% (n = 9), respectively in volunteers with elevated baseline levels. Additionally, after 8 weeks the ratio of glutathione to glutathione disulphide in erythrocytes rose from baseline by 22% (n = 15, P<0.05) in MOF supplemented subjects. We also observed that MOF supplementation exerts anti-inflammatory effects in blood towards ex vivo added bacterial endotoxin and significantly reduces expression of inflammatory genes in leukocytes. Conversely, alterations in macro- and microvascular function, platelet aggregation, plasma levels of nitric oxide surrogates, endothelin-1, C-reactive protein, fibrinogen, prostaglandin F2alpha, plasma antioxidant capacity and gene expression levels of antioxidant defense enzymes did not reach statistical significance after 8 weeks MOF supplementation. However, integrating all measured effects into a global, so-called vascular health index revealed a significant improvement of overall vascular health by MOF compared to placebo (P ≤ 0.05). Our integrative multi-biomarker approach unveiled the

Comparing the Costs and Benefits of Re-Accreditation Processes. AIR 2002 Forum Paper.

ERIC Educational Resources Information Center

Shibley, Lisa R.; Volkwein, J. Fredericks

This study examined the costs and benefits of reaccredidation processes at a public research university. A case study approach was used to examining the costs and benefits of reaccredidation activities by Middle States Association (MSA), American Assembly of Collegiate Schools of Business-International Association for Management Education (AACSB),…

Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

PubMed Central

Kimmelman, Jonathan; Henderson, Valerie C.

2015-01-01

Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

Review of nanomaterials in dentistry: interactions with the oral microenvironment, clinical applications, hazards, and benefits.

PubMed

Besinis, Alexandros; De Peralta, Tracy; Tredwin, Christopher J; Handy, Richard D

2015-03-24

Interest in the use of engineered nanomaterials (ENMs) as either nanomedicines or dental materials/devices in clinical dentistry is growing. This review aims to detail the ultrafine structure, chemical composition, and reactivity of dental tissues in the context of interactions with ENMs, including the saliva, pellicle layer, and oral biofilm; then describes the applications of ENMs in dentistry in context with beneficial clinical outcomes versus potential risks. The flow rate and quality of saliva are likely to influence the behavior of ENMs in the oral cavity, but how the protein corona formed on the ENMs will alter bioavailability, or interact with the structure and proteins of the pellicle layer, as well as microbes in the biofilm, remains unclear. The tooth enamel is a dense crystalline structure that is likely to act as a barrier to ENM penetration, but underlying dentinal tubules are not. Consequently, ENMs may be used to strengthen dentine or regenerate pulp tissue. ENMs have dental applications as antibacterials for infection control, as nanofillers to improve the mechanical and bioactive properties of restoration materials, and as novel coatings on dental implants. Dentifrices and some related personal care products are already available for oral health applications. Overall, the clinical benefits generally outweigh the hazards of using ENMs in the oral cavity, and the latter should not prevent the responsible innovation of nanotechnology in dentistry. However, the clinical safety regulations for dental materials have not been specifically updated for ENMs, and some guidance on occupational health for practitioners is also needed. Knowledge gaps for future research include the formation of protein corona in the oral cavity, ENM diffusion through clinically relevant biofilms, and mechanistic investigations on how ENMs strengthen the tooth structure.

Mental health service use: comparing people who served in the military or received Veterans' Affairs benefits and the general population.

PubMed

McGuire, Annabel; Dobson, Annette; Mewton, Louise; Varker, Tracey; Forbes, David; Wade, Darryl

2015-12-01

To compare the lifetime prevalence of affective, anxiety and substance use disorders and the use of mental health services between people who had served in the Australian Defence Force (ADF) or received Department of Veterans' Affairs (DVA) benefits and the general population. The 2007 National Survey of Mental Health and Wellbeing obtained data from a nationally representative household survey of 8,841 respondents. Fewer than 20% of men who had served in the ADF reported receiving benefits from DVA. ADF men were older and more likely to report poorer health than other men. They were 50% more likely to be diagnosed with any lifetime mental disorder, any affective disorder, depression, PTSD, any substance use and alcohol disorder. Almost 90% of women who received DVA benefits had not served in the ADF. DVA women were older, and more likely to report moderate/severe psychological distress and less life satisfaction than other women. There was no evidence of greater lifetime use of mental health services by ADF men or DVA women compared to the general population. Health care providers should ask their patients if they have connections with the military in order to better detect and treat potential mental health problems. © 2015 Public Health Association of Australia.

Is heterogeneity in stage 3 non-small cell lung cancer obscuring the potential benefits of dose-escalated concurrent chemo-radiotherapy in clinical trials?

PubMed

Hudson, Andrew; Chan, Clara; Woolf, David; McWilliam, Alan; Hiley, Crispin; O'Connor, James; Bayman, Neil; Blackhall, Fiona; Faivre-Finn, Corinne

2018-04-01

The current standard of care for the management of inoperable stage 3 non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy (cCRT) using radiotherapy dose-fractionation and chemotherapy regimens that were established 3 decades ago. In an attempt to improve the chances of long-term control from cCRT, dose-escalation of the radiotherapy dose was assessed in the RTOG 0617 randomised control study comparing the standard 60 Gy in 30 fractions with a high-dose arm receiving 74 Gy in 37 fractions. Following the publication of this trial the thoracic oncology community were surprised to learn that there was worse survival in the dose-escalated arm and that for now the standard of care must remain with the lower dose. In this article we review the RTOG 0617 paper with subsequent analyses and studies to explore why the use of dose-escalated cCRT in stage 3 NSCLC has not shown the benefits that were expected. The overarching theme of this opinion piece is how heterogeneity between stage 3 NSCLC cases in terms of patient, tumour, and clinical factors may obscure the potential benefits of dose-escalation by causing imbalances in the arms of studies such as RTOG 0617. We also examine recent advances in the staging, management, and technological delivery of radiotherapy in NSCLC and how these may be employed to optimise cCRT trials in the future and ensure that any potential benefits of dose-escalation can be detected. Copyright © 2018 Elsevier B.V. All rights reserved.

Age and perceived risks and benefits of preventive genomic screening.

PubMed

Waltz, Margaret; Cadigan, R Jean; Prince, Anya E R; Skinner, Debra; Henderson, Gail E

2017-12-07

PurposeAs genome sequencing moves from research to clinical practice, sequencing technologies focused on "medically actionable" targets are being promoted for preventive screening despite the dearth of systematic evidence of risks and benefits and of criteria for selection of screening subjects. This study investigates researchers' and research participants' perceptions of these issues within the context of a preventive genomic screening study, GeneScreen.MethodsWe recorded researcher deliberations regarding age eligibility criteria and the risks and benefits of screening, and conducted interviews with 50 GeneScreen participants about their motivations for joining and their perceptions of risks and benefits.ResultsResearchers made assumptions about who would want and benefit from screening based on age. After discussion, researchers opted not to have an upper age limit for enrollment. Participants of all ages perceived similar benefits, including prevention, treatment, and cascade testing, and similar risks, such as insurance discrimination and worry.ConclusionWhile clinical benefits of preventive genomic screening for older adults are debatable, our respondents perceived a range of benefits of screening in both clinical and research settings. Researchers and clinicians should carefully consider decisions about whether to exclude older adults and whether to provide information about benefits and risks across age groups.GENETICS in MEDICINE advance online publication, 7 December 2017; doi:10.1038/gim.2017.206.

Clinical Benefits of Rivastigmine in the Real World Dementia Clinics of the Okayama Rivastigmine Study (ORS).

PubMed

Matsuzono, Kosuke; Sato, Kota; Kono, Syoichiro; Hishikawa, Nozomi; Ohta, Yasuyuki; Yamashita, Toru; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

2015-01-01

Alzheimer's disease (AD) is one of the most important diseases in an aging society, but the clinical effects of rivastigmine have not been fully examined in real world domestic clinics. We performed the "Okayama Rivastigmine Study (ORS)" to retrospectively analyze the clinical effects of rivastigmine (n = 75) or donepezil (n = 71) on AD patients with seven dementia assessment batteries at the baseline, 3, 6, and 12 months. In addition, we divided the rivastigmine group into two subgroups at the baseline: the mild behavioral and psychological symptoms of dementia (BPSD) group (Abe's BPSD score (ABS) <6) and the severe BPSD group (6≤ABS). In these two subgroups, baseline scores and changes were also retrospectively analyzed until 12 months. Rivastigmine significantly improved the Mini-Mental State Examination score at 3 months (*p <  0.05 versus baseline) and at 6 months (*p <  0.05), the Frontal Assessment Battery (FAB) at 6 months (*p <  0.05), and ABS at 3 months (**p <  0.01) while donepezil only stabilized the three cognitive scores. On the other hand, the Geriatric Depression Scale and the Apathy Scale were stable until 12 months in both groups. Baseline BPSD severity-dependent analysis showed a small improvement of FAB at 6 months in the mild BPSD subgroup (*p <  0.05) and a great improvement of ABS at 3 months in the severe BPSD subgroup (**p <  0.01) in the rivastigmine group. Our present study showed that rivastigmine improved both cognitive and affective functions at 3 and 6 months, and suggested an advantage at 3 and 6 months compared to donepezil in real world dementia clinics.

A comparative assessment of the financial costs and carbon benefits of REDD+ strategies in Southeast Asia

NASA Astrophysics Data System (ADS)

Graham, Victoria; Laurance, Susan G.; Grech, Alana; McGregor, Andrew; Venter, Oscar

2016-11-01

REDD+ holds potential for mitigating emissions from tropical forest loss by providing financial incentives for carbon stored in forests, but its economic viability is under scrutiny. The primary narrative raised in the literature is that REDD+ will be of limited utility for reducing forest carbon loss in Southeast Asia, while the level of finance committed falls short of profits from alternative land-use activities in the region, including large-scale timber and oil palm operations. Here we assess the financial costs and carbon benefits of various REDD+ strategies deployed in the region. We find the cost of reducing emissions ranges from 9 to 75 per tonne of avoided carbon emissions. The strategies focused on reducing forest degradation and promoting forest regrowth are the most cost-effective ways of reducing emissions and used in over 60% of REDD+ projects. By comparing the financial costs and carbon benefits of a broader range of strategies than previously assessed, we highlight the variation between different strategies and draw attention to opportunities where REDD+ can achieve maximum carbon benefits cost-effectively. These findings have broad policy implications for Southeast Asia. Until carbon finance escalates, emissions reductions can be maximized from reforestation, reduced-impact logging and investing in improved management of protected areas. Targeting cost-efficient opportunities for REDD+ is important to improve the efficiency of national REDD+ policy, which in-turn fosters greater financial and political support for the scheme.

Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research

PubMed Central

Singh, Sonal

2013-01-01

Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values

Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research.

PubMed

Maruthur, Nisa M; Joy, Susan; Dolan, James; Segal, Jodi B; Shihab, Hasan M; Singh, Sonal

2013-01-01

Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.

Pellagra-like condition is xeroderma pigmentosum/Cockayne syndrome complex and niacin confers clinical benefit.

PubMed

Hijazi, H; Salih, M A; Hamad, M H A; Hassan, H H; Salih, S B M; Mohamed, K A; Mukhtar, M M; Karrar, Z A; Ansari, S; Ibrahim, N; Alkuraya, F S

2015-01-01

An extremely rare pellagra-like condition has been described, which was partially responsive to niacin and associated with a multisystem involvement. The condition was proposed to represent a novel autosomal recessive entity but the underlying mutation remained unknown for almost three decades. The objective of this study was to identify the causal mutation in the pellagra-like condition and investigate the mechanism by which niacin confers clinical benefit. Autozygosity mapping and exome sequencing were used to identify the causal mutation, and comet assay on patient fibroblasts before and after niacin treatment to assess its effect on DNA damage. We identified a single disease locus that harbors a novel mutation in ERCC5, thus confirming that the condition is in fact xeroderma pigmentosum/Cockayne syndrome (XP/CS) complex. Importantly, we also show that the previously described dermatological response to niacin is consistent with a dramatic protective effect against ultraviolet-induced DNA damage in patient fibroblasts conferred by niacin treatment. Our findings show the power of exome sequencing in reassigning previously described novel clinical entities, and suggest a mechanism for the dermatological response to niacin in patients with XP/CS complex. This raises interesting possibilities about the potential therapeutic use of niacin in XP. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Fanconi Anemia BRCA Pathway as a Predictor of Benefit from Bevacizumab in a Large Phase 3 Clinical Trial in Ovarian Cancer

DTIC Science & Technology

2014-12-01

1 AWARD NUMBER: W81XWH-13-1-0421 TITLE: The Fanconi Anemia BRCA Pathway as a Predictor of Benefit from Bevacizumab in a Large Phase III Clinical...DATES COVERED 30Sep2013 - 29Sep2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER W81XWH-13-1-0421 The Fanconi Anemia BRCA Pathway as a Predictor of...another upfront clinical trial GOG262. We found that germline or somatic mutations in the BRCA- Fanconi anemia pathway was significantly associated with

[Comparative analysis of modification of Misgav-Ladach and Pfannenstiel methods for cesarean section in the material of Fetal-Maternal Clinical Department PMMH-RI between 1994-1999].

PubMed

Pawłowicz, P; Wilczyński, J; Stachowiak, G

2000-04-01

Comparative analysis of own modification of Misgav-Ladach (mML) and Pfannenstiel methods for caesarean section in the material of Fetal-Maternal Medicine Clinical Department PMMH-RI between 1994-99. Study group consists of 242 patients. In all women from this group we performed caesarean section using Misgav-Ladach method. Among all patients from control group counting 285 women we performed caesarean section applying Pfannenstiel method. To analyse clinical postoperative course in both groups we took account several parameters. Statistical analysis revealed that most of clinical postoperative course parameters was significantly better values in the study group we performed caesarean section using Misgav-Ladach method. The benefits of Misgav-Ladach method, with less pain post-operatively and quicker recovery, are all a by-product of doing the least harm during surgery and removing every unnecessary step. This method is appealing for its simplicity, ease of execution and its time-saving advantage.

Effects of Subsidies and Prohibitions on Nutrition in a Food Benefit Program: A Randomized Clinical Trial.

PubMed

Harnack, Lisa; Oakes, J Michael; Elbel, Brian; Beatty, Timothy; Rydell, Sarah; French, Simone

2016-11-01

. A food benefit program that pairs incentives for purchasing more fruits and vegetables with restrictions on the purchase of less nutritious foods may reduce energy intake and improve the nutritional quality of the diet of participants compared with a program that does not include incentives or restrictions. clinicaltrials.gov Identifier: NCT02643576.

Contractualist reasoning, HIV cure clinical trials, and the moral (ir)relevance of the risk/benefit ratio.

PubMed

Kumar, Rahul

2017-02-01

Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality. 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/.

Early discharge of patients with pulmonary embolism in daily clinical practice: A prospective observational study comparing clinical gestalt and clinical rules.

PubMed

Vanni, Simone; Becattini, Cecilia; Nazerian, Peiman; Bova, Carlo; Stefanone, Valerio Teodoro; Cimini, Ludovica Anna; Viviani, Gabriele; Caviglioli, Cosimo; Sanna, Michela; Pepe, Giuseppe; Grifoni, Stefano

2018-05-08

To estimate the efficiency and safety of clinicians' gestalt in the identification of patients with pulmonary embolism (PE) candidates for early discharge and to compare the efficiency and safety of clinical gestalt with that of the Pulmonary Embolism Severity Index (PESI), the simplified PESI (sPESI) and the Hestia criteria (HC). Consecutive adult patients presenting to the emergency department of four Italian hospitals with confirmed diagnosis of PE were included. Data for PESI, sPESI and HC assessment were prospectively collected. Patients were managed according to the clinical gestalt of the attending physician, independent of the results of PESI, sPESI and HC. Efficiency was defined as the prevalence of candidates to early discharge. The primary safety measure was the incidence of a composite of venous thromboembolic recurrence, major haemorrhage or all-cause mortality within 30 days. Out of 547 included patients, 178 (32.5%) were judged to be at low risk and discharged within 48 h from presentation. HC identified a higher proportion (41.7%) whereas both PESI (24.1%) and sPESI (18.3%) identified a lower proportion of candidates for early discharge when compared to clinical gestalt (P < 0.01 for all). The incidence of the safety outcome was 2.8% in early-discharged patients according to clinical gestalt and 2.3%, 3.0% and 2.6% in candidates to early discharge according to PESI, sPESI and HC, without differences between strategies. In our cohort, clinical gestalt identified one-third of PE patients for early discharge. Among different strategies HC showed the highest efficiency sharing similar safety with the other strategies. Copyright © 2018 Elsevier Ltd. All rights reserved.

Benefits and drawbacks of electronic health record systems

PubMed Central

Menachemi, Nir; Collum, Taleah H

2011-01-01

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 that was signed into law as part of the “stimulus package” represents the largest US initiative to date that is designed to encourage widespread use of electronic health records (EHRs). In light of the changes anticipated from this policy initiative, the purpose of this paper is to review and summarize the literature on the benefits and drawbacks of EHR systems. Much of the literature has focused on key EHR functionalities, including clinical decision support systems, computerized order entry systems, and health information exchange. Our paper describes the potential benefits of EHRs that include clinical outcomes (eg, improved quality, reduced medical errors), organizational outcomes (eg, financial and operational benefits), and societal outcomes (eg, improved ability to conduct research, improved population health, reduced costs). Despite these benefits, studies in the literature highlight drawbacks associated with EHRs, which include the high upfront acquisition costs, ongoing maintenance costs, and disruptions to workflows that contribute to temporary losses in productivity that are the result of learning a new system. Moreover, EHRs are associated with potential perceived privacy concerns among patients, which are further addressed legislatively in the HITECH Act. Overall, experts and policymakers believe that significant benefits to patients and society can be realized when EHRs are widely adopted and used in a “meaningful” way. PMID:22312227

Cardiovascular Magnetic Resonance Imaging-Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study.

PubMed

Hegde, Vinayak A; Biederman, Robert Ww; Mikolich, J Ronald

2017-01-01

This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

PubMed Central

Hegde, Vinayak A; Biederman, Robert WW; Mikolich, J Ronald

2017-01-01

BACKGROUND This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. METHODS AND RESULTS Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. CONCLUSIONS Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner. PMID:28579858

To Compare PubMed Clinical Queries and UpToDate in Teaching Information Mastery to Clinical Residents: A Crossover Randomized Controlled Trial

PubMed Central

Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

2011-01-01

Purpose To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. Method A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Results Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (P<0.001). The median time to answer retrieval was 17 min (95% CI: 16 to 18) using UpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (P<0.001). The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001). Conclusions For first time users, using UpToDate compared to Pubmed Clinical Querries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient. PMID:21858142

To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

PubMed

Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

2011-01-01

To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (P<0.001). The median time to answer retrieval was 17 min (95% CI: 16 to 18) using UpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (P<0.001). The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001). For first time users, using UpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.

PubMed

Lowe, Nancy K; Neal, Jeremy L; Ryan-Wenger, Nancy A

2009-01-01

To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard. This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard. Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult. II.

Comparative Evaluation of American Cancer Society and American Lung Association Smoking Cessation Clinics.

ERIC Educational Resources Information Center

Lando, Harry A.; And Others

1990-01-01

Compared the effectiveness of the American Cancer Society's "FreshStart," the American Lung Association's "Freedom from Smoking," and a laboratory smoking cessation clinic. A one-year followup favored the more intensive laboratory and "Freedom from Smoking" clinics over the "FreshStart" method. (FMW)

The clinical and economic benefits of school-based quadrivalent HPV vaccination in Singapore.

PubMed

Tay, Sun Kuie; Hsu, Tun-Ying; Shcheprov, Andrei; Walia, Anuj; Kulkarni, Amit S

2017-05-01

To investigate the clinical and economic impacts of school-based administration of the quadrivalent HPV vaccine. A retrospective health-economic analysis was conducted using data collected in Singapore between 2004 and 2005. A dynamic transmission model was adapted for universal vaccination that provided 80% coverage among students aged 11-12 years. Strategy 1 involved only girls, with a 5-year catch-up vaccination to provide 50% coverage among those aged 13-17 years. Strategy 2 included both girls and boys with no catch-up vaccination. Outcomes included the predicted incidence of HPV-related disease over 100 years. Current coverage was assumed to be 5%. Strategy 1 would reduce cervical intraepithelial neoplasia grade 1 (CIN1) by 63.8%, cervical intraepithelial neoplasia grade 2-3 (CIN2-3) by 62.9%, cervical cancer by 50.9%, and genital warts by 78.0% (female individuals) and 73.6% (male individuals). Strategy 2 would reduce CIN1 by 64.0%, CIN2-3 by 63.1%, cervical cancer by 50.7%, and genital warts by 79.9% (female individuals) and 80.1% (male individuals). The incremental cost-effectiveness ratio was S$12 464 for strategy 1 and $27 837 for Strategy 2. These values decreased to $7477 and $22 574, respectively, if a two-dose regimen was adapted. School-based quadrivalent HPV vaccination offered clinical and economic benefits, and is cost-effective in Singapore. © 2017 International Federation of Gynecology and Obstetrics.

Local infiltration analgesia adds no clinical benefit in pain control to peripheral nerve blocks after total knee arthroplasty.

PubMed

Hinarejos, Pedro; Capurro, Bruno; Santiveri, Xavier; Ortiz, Pere; Leal, Joan; Pelfort, Xavier; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan C

2016-10-01

To evaluate the effect of the local infiltration of analgesics for pain after total knee arthroplasty in patients treated with femoral and sciatic peripheral nerve blocks. The secondary objective was to detect differences in analgesic consumption as well as blood loss after local infiltration of analgesics. Prospective randomized double-blinded study in patients who underwent a TKA for knee osteoarthritis under spinal anesthesia and treated with femoral and sciatic nerve blocks. This study compared 50 patients treated with local infiltration with ropivacaine, epinephrine, ketorolac and clonidine and 50 patients treated with a placebo with the same technique. The visual analogic score was registered postoperatively at 2, 6, 12, 24, 36, 48 and 72 h after surgery. Analgesic consumption was also registered. Both groups of patients were treated with the same surgical and rehabilitation protocols. A significant difference of one point was found in the visual analogic pain scores 12 h after surgery (0.6 ± 1.5 vs. 1.7 ± 2.3). There were no significant differences in the visual analogic pain scores evaluated at any other time between 2 and 72 h after surgery. No significant differences were found in the required doses of tramadol or morphine in the postoperative period. Postoperative hemoglobin and blood loss were also similar in both groups. Adding local infiltration of analgesics to peripheral nerve blocks after TKA surgery only provides minimal benefit for pain control. This benefit may be considered as non-clinically relevant. Moreover, the need for additional analgesics was the same in both groups. Therefore, the use of local infiltration of analgesics treatment in TKA surgery cannot be recommended if peripheral nerve blocks are used. I.

Monitoring worksite clinic performance using a cost-benefit tool.

PubMed

Tao, Xuguang; Chenoweth, David; Alfriend, Amy S; Baron, David M; Kirkland, Tracie W; Scherb, Jill; Bernacki, Edward J

2009-10-01

The purpose of this study was to explore the usefulness of continuously assessing the return on investment (ROI) of worksite medical clinics as a means of evaluating clinic performance. Visit data from January 1, 2007, to December 31, 2008, were collected from all the on-site clinics operated for the Pepsi Bottling Group. An average system-wide ROI was calculated from the time of each clinic's opening and throughout the study period. A multivariate linear regression model was used to determine the association of average ROI with penetration/utilization rate and plant size. A total of 26 on-site clinics were actively running as of December 2008. The average ROI at the time of start up was 0.4, which increased to 1.2 at approximately 4 months and 1.6 at the end of the first year of operation. Overall, it seems that the cost of operating a clinic becomes equal to the cost of similar care purchased in the community (ROI = 1) at approximately 3 months after a clinic's opening and flattens out at the end of the first year. The magnitude of the ROI was closely related to the number of visits (a function of the penetration/utilization rate) and the size of the plant population served. Serial monitoring of ROIs is a useful metric in assessing on-site clinic performance and quantifying the effect of new initiatives aimed at increasing a clinic's cost effectiveness.

Patient-perceived outcome after sialendoscopy using the glasgow benefit inventory.

PubMed

Ianovski, Ilia; Morton, Randall P; Ahmad, Zahoor

2014-04-01

Sialendoscopy is a technique for investigating and managing obstructive salivary disease that avoids risks associated with the more invasive sialoadenectomy and other open surgery techniques. To date, surgeon-based outcomes have been reported, but only one report of patient-oriented outcomes has appeared in the literature. The objective of this study was to review our experience after introducing sialendoscopy to New Zealand and report the patient-perceived benefit. A prospective observational study of all sialendoscopic procedures performed in the only sialendoscopy-practicing center in New Zealand between June 2010 and June 2012. Clinical and epidemiological data of all patients were recorded. Sialendoscopic findings, complications, and outcomes were noted. The Glasgow Benefit Inventory questionnaire was administered to the patients at their follow-up. Fifty-four patients underwent a total of 66 sialendoscopic procedures, involving 44 parotid and 22 submandibular glands. There was a complete symptom resolution in 54 procedures (82%). Sialolith removal was successful in 67% of cases, with postsialendoscopy symptom resolution in 86% of sialolithiasis cases. Symptoms resolved in 81% of cases with ductal stenosis. The overall mean Glasgow Benefit Inventory score was +31, which compares very favorably with other otolaryngology procedures. This study shows a substantial positive patient-perceived benefit of sialendoscopy for both sialolith- and stenosis-based pathology. The overall rate of symptom resolution is comparable to international literature. 4. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multicriteria decision analysis model in the development of combination therapy for overactive bladder.

PubMed

de Greef-van der Sandt, I; Newgreen, D; Schaddelee, M; Dorrepaal, C; Martina, R; Ridder, A; van Maanen, R

2016-04-01

A multicriteria decision analysis (MCDA) approach was developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of overactive bladder (OAB). The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. The MCDA model was developed using efficacy, safety, and tolerability attributes and the results of a phase II factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5+25 and 5+50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for phase III clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. © 2015 The American Society for Clinical Pharmacology and Therapeutics.

Future Directions for Cardiovascular Disease Comparative Effectiveness Research

PubMed Central

Hlatky, Mark A; Douglas, Pamela S; Cook, Nakela L; Wells, Barbara; Benjamin, Emelia J; Dickersin, Kay; Goff, David C; Hirsch, Alan T; Hylek, Elaine M; Peterson, Eric; Roger, Véronique L; Selby, Joseph V; Udelson, James E; Lauer, Michael S

2012-01-01

Comparative effectiveness research (CER) aims to provide decision-makers the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart Lung and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address eight clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. PMID:22796257

Comparing Differences in ADL Outcomes for the STOMP Intervention for Dementia in the Natural Home Environment Versus a Clinic Environment.

PubMed

Ciro, C A; Poole, J L; Skipper, B; Hershey, L A

2014-01-01

Few studies have examined structured rehabilitation techniques for improving activities of daily living in people with mild-moderate dementia. We sought to examine the advantages to delivering the Skill-building through Task-Oriented Motor Practice (STOMP) intervention in the home environment (versus the clinic), hypothesizing that ADL improvement would be significantly better, time to meeting goals would be faster and fewer displays of behavior would be noted. Compared results of two quasi-experimental studies of STOMP, one completed in the home, one completed previously in a clinic. Participants were English-speaking; community dwelling adults aged 50-90 diagnosed with mild-moderate dementia who could participate in an intensive rehabilitation program (5 days/week, 3 hours/day, for 2 weeks). Outcome measurements include examiner-observation of performance and proxy-report of performance and satisfaction with performance in patient-selected goals. No differences existed in the sociodemographic characteristics between the home and clinic groups where the groups were primarily white, married, had > high school education and had mild-moderate dementia. Results from the home group indicate that participants made significant improvement in ADL which was generally retained at the 90 day follow-up. These results were not significantly different than the clinic group. No significant advantages were noted for the home group in terms of time to meeting goals or exhibition of fewer behaviors. The STOMP intervention appeared to work equally as well in the home and in the clinic. Future studies should continue to examine the benefits of massed practice using high-dose regimens.

The comparability of solicited versus clinic subjects in alcohol treatment research.

PubMed

Pearlman, S; Zweben, A; Li, S

1989-05-01

The increasing use of media advertisements to recruit subjects in alcohol treatment research has raised concerns about the comparability of such solicited subjects and subjects drawn from more traditional clinic populations. This paper, based on a study that involved both solicited and clinic subjects, identifies differences between the two types of subjects in terms of sociodemographic variables; pre-treatment drinking and marital adjustment; several dimensions of 'self-definition'; and three outcome measures. These findings suggest that there may be significant differences between solicited and clinic subjects and that these differences should be taken into account in the design of studies utilizing solicited subjects in order to determine the generalizability of the results.

Characteristics of Effective Clinical Teachers in Simulated Clinical Experiences Compared to Traditional Clinical Experiences

ERIC Educational Resources Information Center

Sieh-Bliss, Selina

2014-01-01

While there is evidence in the literature measuring effective clinical teacher characteristics in traditional experiences, little is known of effective characteristics expected from clinical teachers during simulated clinical experiences. This study examined which clinical teaching behaviors and characteristics are perceived by nursing students'…

Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability.

PubMed

Hourd, Paul; Ginty, Patrick; Chandra, Amit; Williams, David J

2014-08-01

Manufacturing of more-than-minimally manipulated autologous cell therapies presents a number of unique challenges driven by complex supply logistics and the need to scale out production to multiple manufacturing sites or near the patient within hospital settings. The existing regulatory structure in Europe and the United States imposes a requirement to establish and maintain comparability between sites. Under a single market authorization, this is likely to become an unsurmountable burden beyond two or three sites. Unless alternative manufacturing approaches can be found to bridge the regulatory challenge of comparability, realizing a sustainable and investable business model for affordable autologous cell therapy supply is likely to be extremely demanding. Without a proactive approach by the regulators to close this "translational gap," these products may not progress down the development pipeline, threatening patient accessibility to an increasing number of clinician-led autologous cellular therapies that are already demonstrating patient benefits. We propose three prospective manufacturing models for the scale out/roll out of more-than-minimally manipulated clinically led autologous cell therapy products and test their prospects for addressing the challenge of product comparability with a selected expert reference panel of US and UK thought leaders. This paper presents the perspectives and insights of the panel and identifies where operational, technological and scientific improvements should be prioritized. The main purpose of this report is to solicit feedback and seek input from key stakeholders active in the field of autologous cell therapy in establishing a consensus-based manufacturing approach that may permit the roll out of clinically led autologous cell therapies. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Incomes and Outcomes: Social Security Disability Benefits in First-Episode Psychosis.

PubMed

Rosenheck, Robert A; Estroff, Sue E; Sint, Kyaw; Lin, Haiqun; Mueser, Kim T; Robinson, Delbert G; Schooler, Nina R; Marcy, Patricia; Kane, John M

2017-09-01

Social Security Administration (SSA) disability benefits are an important source of income for people with psychoses and confer eligibility for health insurance. The authors examined the impact of coordinated specialty care on receipt of such benefits in first-episode psychosis, along with the correlates and consequences of receiving them. The Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 34-site cluster-randomized trial, compared NAVIGATE, a coordinated specialty care program, to usual community care over 2 years. Receipt of SSA benefits and clinical outcomes were assessed at program entry and every 6 months for 2 years. Piecewise regression analysis was used to identify relative change in outcome trajectories after receipt of disability benefits. Among 399 RAISE-ETP participants, 36 (9%) were receiving SSA disability benefits at baseline; of the remainder, 124 (34.1%) obtained benefits during the 2-year study period. The NAVIGATE intervention improved quality of life, symptoms, and employment but did not significantly reduce the likelihood of receiving SSA disability benefits. Obtaining benefits was predicted by more severe psychotic symptoms and greater dysfunction and was followed by increased total income but fewer days of employment, reduced motivation (e.g., sense of purpose, greater anhedonia), and fewer days of intoxication. A 2-year coordinated specialty care intervention did not reduce receipt of SSA disability benefits. There were some advantages for those who obtained SSA disability benefits over the 2-year treatment period, but there were also some unintended adverse consequences. Providing income supports without impeding recovery remains an important policy challenge.

Incidental findings in imaging research: evaluating incidence, benefit, and burden.

PubMed

Orme, Nicholas M; Fletcher, Joel G; Siddiki, Hassan A; Harmsen, W Scott; O'Byrne, Megan M; Port, John D; Tremaine, William J; Pitot, Henry C; McFarland, Elizabeth G; Robinson, Marguerite E; Koenig, Barbara A; King, Bernard F; Wolf, Susan M

2010-09-27

Little information exists concerning the frequency and medical significance of incidental findings (IFs) in imaging research. Medical records of research participants undergoing a research imaging examination interpreted by a radiologist during January through March 2004 were reviewed, with 3-year clinical follow-up. An expert panel reviewed all IFs generating clinical action to determine medical benefit/burden on the basis of predefined criteria. The frequency of IFs that generated further clinical action was estimated by modality, body part, age, and sex, along with net medical benefit or burden. Of 1426 research imaging examinations, 567 (39.8%) had at least 1 IF (1055 total). Risk of an IF increased significantly by age (odds ratio [OR], 1.5; 95% confidence interval, 1.4-1.7 per decade increase). Abdominopelvic computed tomography generated more IFs than other examinations (OR, 18.9 vs ultrasonography; 9.2% with subsequent clinical action), with computed tomography of the thorax and magnetic resonance imaging of the head next (OR, 11.9 and 5.9; 2.8% and 2.2% with action, respectively). Of the 567 examinations with an IF, 35 (6.2%) generated clinical action, resulting in clear medical benefit in 1.1% (6 of 567) and clear medical burden in 0.5% (3 of 567). Medical benefit/burden was usually unclear (26 of 567 [4.6%]). Frequency of IFs in imaging research examinations varies significantly by imaging modality, body region, and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a high number of cases and subsequent clinical action to address them in a small but significant minority. Such clinical action can result in medical benefit to a small number of patients.

Number needed to benefit from information (NNBI): proposal from a mixed methods research study with practicing family physicians.

PubMed

Pluye, Pierre; Grad, Roland M; Johnson-Lafleur, Janique; Granikov, Vera; Shulha, Michael; Marlow, Bernard; Ricarte, Ivan Luiz Marques

2013-01-01

We wanted to describe family physicians' use of information from an electronic knowledge resource for answering clinical questions, and their perception of subsequent patient health outcomes; and to estimate the number needed to benefit from information (NNBI), defined as the number of patients for whom clinical information was retrieved for 1 to benefit. We undertook a mixed methods research study, combining quantitative longitudinal and qualitative research studies. Participants were 41 family physicians from primary care clinics across Canada. Physicians were given access to 1 electronic knowledge resource on handheld computer in 2008-2009. For the outcome assessment, participants rated their searches using a validated method. Rated searches were examined during interviews guided by log reports that included ratings. Cases were defined as clearly described searches where clinical information was used for a specific patient. For each case, interviewees described information-related patient health outcomes. For the mixed methods data analysis, quantitative and qualitative data were merged into clinical vignettes (each vignette describing a case). We then estimated the NNBI. In 715 of 1,193 searches for information conducted during an average of 86 days, the search objective was directly linked to a patient. Of those searches, 188 were considered to be cases. In 53 cases, participants associated the use of information with at least 1 patient health benefit. This finding suggested an NNBI of 14 (715/53). The NNBI may be used in further experimental research to compare electronic knowledge resources. A low NNBI can encourage clinicians to search for information more frequently. If all searches had benefits, the NNBI would be 1. In addition to patient benefits, learning and knowledge reinforcement outcomes are frequently reported.

An evaluation of costs and benefits of a vehicle periodic inspection scheme with six-monthly inspections compared to annual inspections.

PubMed

Keall, Michael D; Newstead, Stuart

2013-09-01

Although previous research suggests that safety benefits accrue from periodic vehicle inspection programmes, little consideration has been given to whether the benefits are sufficient to justify the often considerable costs of such schemes. Methodological barriers impede many attempts to evaluate the overall safety benefits of periodic vehicle inspection schemes, including this study, which did not attempt to evaluate the New Zealand warrant of fitness scheme as a whole. Instead, this study evaluated one aspect of the scheme: the effects of doubling the inspection frequency, from annual to biannual, when the vehicle reaches six years of age. In particular, reductions in safety-related vehicle faults were estimated together with the value of the safety benefits compared to the costs. When merged crash data, licensing data and roadworthiness inspection data were analysed, there were estimated to be improvements in injury crash involvement rates and prevalence of safety-related faults of respectively 8% (95% CI 0.4-15%) and 13.5% (95% CI 12.8-14.2%) associated with the increase from annual to 6-monthly inspections. The wide confidence interval for the drop in crash rate shows considerably statistical uncertainty about the precise size of the drop. Even assuming that this proportion of vehicle faults prevented by doubling the inspection frequency could be maintained over the vehicle age range 7-20 years, the safety benefits are very unlikely to exceed the additional costs of the 6-monthly inspections to the motorists, valued at $NZ 500 million annually excluding the overall costs of administering the scheme. The New Zealand warrant of fitness scheme as a whole cannot be robustly evaluated using the analysis approach used here, but the safety benefits would need to be substantial--yielding an unlikely 12% reduction in injury crashes--for benefits to equal costs. Copyright © 2013 Elsevier Ltd. All rights reserved.

Social participation and psychosocial outcomes of young adults with chronic physical conditions: Comparing recipients and non-recipients of disability benefits.

PubMed

Bal, Marjolijn I; Sattoe, Jane N T; Miedema, Harald S; van Staa, AnneLoes

2018-03-01

Little is known about any differences between young people with chronic physical conditions who do and do not apply for disability benefits in young adulthood for providing insights for future policy and rehabilitation care. We aimed to identify predictors during adolescence of receiving disability benefits in young adulthood and to compare recipients and non-recipients of benefits in social participation and psychosocial outcomes in young adulthood. Follow-up study of 18 to 25 year olds with various chronic conditions who at adolescent age completed a web-based survey (n=518; T0). The outcome was receiving disability benefits (yes or no). Associations with background characteristics, social participation, and impact of the chronic condition were explored with stepwise multivariate modelling, using T0 variables. Differences between recipients and non-recipients were explored using chi-square tests and t-tests. Receiving disability benefits in young adulthood was associated with greater extent of physical disability, receiving less special education, absenteeism at school/work, and low health-related quality of life during adolescence. In young adulthood, recipients of benefits reported higher perceived impact of the chronic condition on their school/work career and lower quality of life than non-recipients. Social participation varied across domains. This study provides important insights into the characteristics of a vulnerable subgroup of young people with chronic physical conditions. Disability benefit recipients experienced more impact of their chronic condition and reported a lower health-related quality of life over time than non-recipients. Rehabilitation professionals are encouraged to use patient-reported outcomes to address the lived experiences and screen the need for psychosocial support of this vulnerable subgroup of young people with chronic physical conditions. Copyright © 2018. Published by Elsevier Masson SAS.

34 CFR 76.654 - Benefits for private school students.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Benefits for private school students. 76.654 Section 76... Schools § 76.654 Benefits for private school students. (a) Comparable benefits. The program benefits that a subgrantee provides for students enrolled in private schools must be comparable in quality, scope...

34 CFR 76.654 - Benefits for private school students.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Benefits for private school students. 76.654 Section 76... Schools § 76.654 Benefits for private school students. (a) Comparable benefits. The program benefits that a subgrantee provides for students enrolled in private schools must be comparable in quality, scope...

Benefits of Exercise on the Executive Functions in People with Parkinson Disease: A Controlled Clinical Trial.

PubMed

de Oliveira, Renata Terra; Felippe, Lilian Assunção; Bucken Gobbi, Lilian Teresa; Barbieri, Fabio Augusto; Christofoletti, Gustavo

2017-05-01

We have made a 3-arm trial (group vs. individual exercise vs. no treatment) to test the effects of a 6-month exercise program upon the executive functions in participants with Parkinson disease. Twenty-four subjects were randomly allocated in 3 groups and undertook individualized exercises (G1, n = 8), group exercises (G2, n = 8), or monitoring (G3, n = 8). Executive functions were evaluated by means of the Wisconsin card sorting test and the Raven colored matrices, both assessed at the beginning of the program and after 6 months. The statistical analyses consisted of the application of repeated measurement tests, with a significant level of 5%. The findings showed similar behavior of groups in terms of the Wisconsin card sorting test (P = 0.792), reporting no benefit of the program on such instrument. Differently, Raven colored matrices evidenced a significant benefit provided by the intervention (P = 0.032). Compared with the control group, individuals from G1 had a substantial improvement on executive functions (P = 0.031) and from G2 had a trend of significance (P = 0.072). Findings of this study show that 6 months of exercise improved some aspects of executive functions when compared with control peers. Individual therapy seems to have a more prominent improvement than group therapy.

Correlation between vitiligo occurrence and clinical benefit in advanced melanoma patients treated with nivolumab: A multi-institutional retrospective study.

PubMed

Nakamura, Yasuhiro; Tanaka, Ryota; Asami, Yuri; Teramoto, Yukiko; Imamura, Taichi; Sato, Sayuri; Maruyama, Hiroshi; Fujisawa, Yasuhiro; Matsuya, Taisuke; Fujimoto, Manabu; Yamamoto, Akifumi

2017-02-01

Vitiligo is occasionally seen in melanoma patients. Although several studies indicate a correlation between vitiligo occurrence and clinical response in melanoma patients receiving immunotherapy, most studies have included heterogeneous patient and treatment settings. The aim of this study is to investigate the correlation between the occurrence of vitiligo and clinical benefit of nivolumab treatment in advanced melanoma patients. We retrospectively reviewed unresectable stage III or IV melanoma patients treated with nivolumab. Of 35 melanoma patients treated with nivolumab, 25.7% (9/35) developed vitiligo during treatment. The time from the start of nivolumab treatment to occurrence of vitiligo ranged 2-9 months (mean, 5.2). Of nine patients who developed vitiligo, two (22.2%) had a complete response to nivolumab and two (22.2%) had a partial response. The objective response rate was significantly higher in patients with vitiligo than in patients without vitiligo (4/9 [44.4%] vs 2/26 [7.7%]; P = 0.027). The mean time to vitiligo occurrence in patients achieving an objective response was significantly less than that in patients who showed no response (3.1 vs 6.8 months, P = 0.004). Vitiligo occurrence was significantly associated with prolonged progression-free and overall survival (hazard ratio, 0.24 and 0.16; 95% confidence interval, 0.11-0.55 and 0.03-0.79; P = 0.005, and 0.047, respectively). At the 20-week landmark analysis, however, vitiligo was not associated with a statistically significant overall survival benefit (P = 0.28). The occurrence of vitiligo during nivolumab treatment may be correlated with favorable clinical outcome. © 2016 Japanese Dermatological Association.

Benefit/Risk Assessment for Breast Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 Years or Older

PubMed Central

Freedman, Andrew N.; Yu, Binbing; Gail, Mitchell H.; Costantino, Joseph P.; Graubard, Barry I.; Vogel, Victor G.; Anderson, Garnet L.; McCaskill-Stevens, Worta

2011-01-01

Purpose The Study of Tamoxifen and Raloxifene (STAR) demonstrated that raloxifene was as effective as tamoxifen in reducing the risk of invasive breast cancer (IBC) in postmenopausal women and had lower risks of thromboembolic events, endometrial cancer, and cataracts but had a nonstatistically significant higher risk of noninvasive breast cancer. There is a need to summarize the risks and benefits of these agents. Patients and Methods Baseline incidence rates of IBC and other health outcomes, absent raloxifene and tamoxifen, were estimated from breast cancer chemoprevention trials; the Surveillance, Epidemiology and End Results Program; and the Women's Health Initiative. Effects of raloxifene and tamoxifen were estimated from STAR and the Breast Cancer Prevention Trial. We assigned weights to health outcomes to calculate the net benefit from raloxifene compared with placebo and tamoxifen compared with placebo. Results Risks and benefits of treatment with raloxifene or tamoxifen depend on age, race, breast cancer risk, and history of hysterectomy. Over a 5-year period, postmenopausal women with an intact uterus had a better benefit/risk index for raloxifene than for tamoxifen. For postmenopausal women without a uterus, the benefit/risk ratio was similar. The benefits and risks of raloxifene and tamoxifen are described in tables that can help identify groups of women for whom the benefits outweigh the risks. Conclusion We developed a benefit/risk index to quantify benefits from chemoprevention with tamoxifen or raloxifene. This index can complement clinical evaluation in deciding whether to initiate chemoprevention and in comparing the benefits and risks of raloxifene versus tamoxifen. PMID:21537036

Patient-perceived benefit of sialendoscopy as measured by the Glasgow Benefit Inventory.

PubMed

Meier, Bue A; Holst, René; Schousboe, Lars P

2015-08-01

Evaluate the patient-perceived effect of sialendoscopy on patients with obstructive symptoms from the salivary glands. Retrospectively identified cohort used for a prospective study of all consecutive patients at the Department of Otorhinolaryngology at Vejle Hospital, Vejle, Denmark, March 2009 to December 2013. By chart review we recorded the patient's age, gender, date of the sialendoscopy, type of gland, sialolithiasis, successful extraction of sialolithiasis, stenosis of salivary ducts, dilation, type of saliva, and surgeon. The follow-up was done by applying the Glasgow Benefit Inventory questionnaire by letter and telephone. There were 130 sialendoscopies performed on 116 patients. Of these, 24 patients were excluded due to subsequent surgery. Thus, 92 patients were eligible, of whom 80 responded, giving an 87% response rate. The Glasgow Benefit Inventory score had a predicted overall mean of 13.4 (95% confidence interval: 9.9 to 17.2). Significant positive outcomes by multiple regression were the presence of stones (P = 0.015) and examination of the parotid gland (P = 0.041). Overall, there is a significant patient-perceived benefit from sialendoscopy, which is comparable to the benefit from tonsillectomy. The benefit is significantly higher if stones are found than not and for examination of the parotid gland as compared to the submandibular gland. 4 © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

The Evidence for α-Linolenic Acid and Cardiovascular Disease Benefits: Comparisons with Eicosapentaenoic Acid and Docosahexaenoic Acid12

PubMed Central

Fleming, Jennifer A.; Kris-Etherton, Penny M.

2014-01-01

Our understanding of the cardiovascular disease (CVD) benefits of α-linolenic acid (ALA, 18:3n–3) has advanced markedly during the past decade. It is now evident that ALA benefits CVD risk. The expansion of the ALA evidence base has occurred in parallel with ongoing research on eicosapentaenoic acid (EPA, 20:5n–3) and docosahexaenoic acid (DHA, 22:6n–3) and CVD. The available evidence enables comparisons to be made for ALA vs. EPA + DHA for CVD risk reduction. The epidemiologic evidence suggests comparable benefits of plant-based and marine-derived n–3 (omega-3) PUFAs. The clinical trial evidence for ALA is not as extensive; however, there have been CVD event benefits reported. Those that have been reported for EPA + DHA are stronger because only EPA + DHA differed between the treatment and control groups, whereas in the ALA studies there were diet differences beyond ALA between the treatment and control groups. Despite this, the evidence suggests many comparable CVD benefits of ALA vs. EPA + DHA. Thus, we believe that it is time to revisit what the contemporary dietary recommendation should be for ALA to decrease the risk of CVD. Our perspective is that increasing dietary ALA will decrease CVD risk; however, randomized controlled clinical trials are necessary to confirm this and to determine what the recommendation should be. With a stronger evidence base, the nutrition community will be better positioned to revise the dietary recommendation for ALA for CVD risk reduction. PMID:25398754

Retroperitoneal tumour radiotherapy: clinical improvements using kilovoltage cone beam computed tomography.

PubMed

Juan-Senabre, Xavier J; Ferrer-Albiach, Carlos; Rodríguez-Cordón, Marta; Santos-Serra, Agustín; López-Tarjuelo, Juan; Calzada-Feliu, Salvador

2009-04-01

We present a clinical case of a patient diagnosed with a retroperitoneal sarcoma, which received preoperative treatment with daily verification via computed tomography obtained with kilovoltage cone beam. We compare the benefit of this treatment compared to other conventional treatment without image guiding, reporting quantitative results.

Employee use and perceived benefit of a complementary and alternative medicine wellness clinic at a major military hospital: evaluation of a pilot program.

PubMed

Duncan, Alaine D; Liechty, Janet M; Miller, Cathy; Chinoy, Gail; Ricciardi, Richard

2011-09-01

The objectives of this study were to examine the feasibility of a weekly on-site complementary and alternative medicine (CAM) wellness clinic for staff at a military hospital, and to describe employees' perceptions of program effectiveness. The study setting was the Restore & Renew(®) Wellness Clinic at a United States Department of Defense hospital. The subjects were hospital nurses, physicians, clinicians, support staff, and administrators. The walk-in wellness clinic was open 8:00 am-2:00 pm 1 day a week. Participants selected one or more modalities each visit: ear acupuncture, clinical acupressure, and Zero Balancing.(®) A self-report survey was done after each clinic visit to evaluate clinic features and perceived impact on stress-related symptoms, compassion for patients, sleep, and workplace or personal relationships. Surveys completed after first-time and repeat visits (n=2,756 surveys) indicated that most participants agreed or strongly agreed they felt more relaxed after sessions (97.9%), less stress (94.5%), more energy (84.3%), and less pain (78.8%). Ninety-seven percent (97%) would recommend it to a co-worker. Among surveys completed after five or more visits, more than half (59%-85%) strongly agreed experiencing increased compassion with patients, better sleep, improved mood, and more ease in relations with co-workers. Perceived benefits were sustained and enhanced by number of visits. The most frequently reported health habit changes were related to exercise, stress reduction, diet/nutrition, and weight loss. This evaluation suggests that a hospital-based wellness clinic based on CAM principles and modalities is feasible, well-utilized, and perceived by most participants to have positive health benefits related to stress reduction at work, improved mood and sleep, and lifestyle.

Comparative analyses of longevity and senescence reveal variable survival benefits of living in zoos across mammals.

PubMed

Tidière, Morgane; Gaillard, Jean-Michel; Berger, Vérane; Müller, Dennis W H; Bingaman Lackey, Laurie; Gimenez, Olivier; Clauss, Marcus; Lemaître, Jean-François

2016-11-07

While it is commonly believed that animals live longer in zoos than in the wild, this assumption has rarely been tested. We compared four survival metrics (longevity, baseline mortality, onset of senescence and rate of senescence) between both sexes of free-ranging and zoo populations of more than 50 mammal species. We found that mammals from zoo populations generally lived longer than their wild counterparts (84% of species). The effect was most notable in species with a faster pace of life (i.e. a short life span, high reproductive rate and high mortality in the wild) because zoos evidently offer protection against a number of relevant conditions like predation, intraspecific competition and diseases. Species with a slower pace of life (i.e. a long life span, low reproduction rate and low mortality in the wild) benefit less from captivity in terms of longevity; in such species, there is probably less potential for a reduction in mortality. These findings provide a first general explanation about the different magnitude of zoo environment benefits among mammalian species, and thereby highlight the effort that is needed to improve captive conditions for slow-living species that are particularly susceptible to extinction in the wild.

Clinical and Cost Effectiveness of Apixaban Compared to Aspirin in Patients with Atrial Fibrillation: An Australian Perspective.

PubMed

Ademi, Zanfina; Pasupathi, Kumar; Liew, Danny

2017-06-01

To determine the clinical and cost effectiveness of apixaban compared to aspirin in the prevention of thromboembolic events for patients with atrial fibrillation for whom vitamin K antagonist (VKA) therapy (warfarin) has been considered unsuitable. A previously published Markov model with yearly cycles was updated. Information from the Apixaban Versus Acetylsalicylic acid to prevent Stroke in Atrial Fibrillation (AVERROES) trial in combination with other population data was used to simulate the costs and effects of apixaban compared to aspirin over 10 years. The model comprised five health states. Costs from an Australian healthcare perspective were estimated from published sources for the year 2015. The main outcome of interest was number needed to treat (NNT), number needed to harm (NNH), the incremental cost-effectiveness ratio (ICER) [cost per quality-adjusted life-year (QALY) gained, and cost per year of life saved (YoLS)]. Costs and benefits were discounted at 5.0 % per annum. For each patient followed up over 10 years, NNT to prevent one additional event (thromboembolic event, death) for apixaban compared to aspirin was 4.6 and 11.8, respectively. NNH was 35.9 for non-fatal major bleeding. The model predicted that compared to aspirin, apixaban would lead to 0.33 YoLS (discounted) and 0.29 QALYs gained (discounted), at an incremental cost of AUD$1996 (discounted). This resulted in ICERs of AUD$6011 per YoLS and AUD$6929 per QALY gained. In the sensitivity analyses, ICERs were most sensitive to efficacy measures derived from the AVERROES study, and time frame. Compared to aspirin, apixaban is likely to be cost effective in preventing thromboembolic disease among VKA unsuitable patients with atrial fibrillation.

The comparative clinical efficacy of pyrophosphate/triclosan, copolymer/triclosan and zinc citrate/triclosan dentifrices for the reduction of supragingival calculus formation.

PubMed

Fairbrother, K J; Kowolik, M J; Curzon, M E; Müller, I; McKeown, S; Hill, C M; Hannigan, C; Bartizek, R D; White, D J

1997-01-01

Three triclosan-containing "multi-benefit" dentifrices were compared for clinical efficacy in reducing supragingival calculus formation following a dental prophylaxis. A total of 544 subjects completed a double-blind parallel-group clinical study using the Volpe-Manhold Index (VMI) to record severity and occurrence of supragingival calculus. The study design included a pre-test period where the calculus formation rate was measured in subjects brushing with a placebo dentifrice. Following a prophylaxis, subjects were stratified for age, gender and VMI scores and assigned to one of four treatments: 1) a dentifrice containing 5.0% soluble pyrophosphate/0.145% fluoride as NaF/silica abrasive/0.28% triclosan (hereafter PPi/TCS-comparable to Crest Complete dentifrice, Procter & Gamble, UK); 2) a commercial dentifrice containing 2.0% Gantrez acid copolymer/ 0.145% fluoride as NaF/silica abrasive/0.30% triclosan (hereafter Gan/TCS-Colgate Total dentifrice, Colgate-Palmolive Company, UK); 3) a commercial dentifrice containing 0.5% zinc citrate trihydrate/0.15% fluoride as sodium monofluorophosphate/silica abrasive/0.20% triclosan (hereafter Zn/TCS-Mentadent P dentifrice, Unilever, UK); and 4) a control dentifrice comprised of 0.145% fluoride as NaF/silica abrasive (hereafter Control). Subjects were instructed to use their assigned dentifrice at least twice per day and to brush as they do normally. Supragingival calculus formation was assesed at two and four months using site-specific and whole-mouth VMI indices for both calculus severity and occurrence. Following four months of use, the PPi/TCS dentifrice provided statistically significant reductions in calculus severity (22-23%) and occurrence (15%) as compared with the Control dentifrice. The Zn/TCS dentifrice also provided significant reductions in calculus severity (17-19%) and occurrence (12-13%) as compared with the Control. The Gan/TCS produced no statistically significant reductions in calculus formation (occurrence

Knowledge Gaps of the Health Benefits of Beans among Low-Income Women.

PubMed

Palmer, Shelly M; Winham, Donna M; Hradek, Christine

2018-01-01

We determined knowledge of the health benefits of consuming beans, and assessed if awareness varied by acculturation status among Hispanic and non-Hispanic low-income women. We used a self-administered survey with Iowa women aged 18-65 years who were eligible to receive income-based services through 2 healthcare clinics, a WIC clinic, and Extension Outreach. Chi-square and ANOVA were used to compare bean health benefit knowledge, demographics, health-risk factors, nutrition information seeking, and self-efficacy by acculturation categories. Of the 158 women who completed the survey, 58% were Hispanic, with a mean age of 36 years. In terms of acculturation, 24% were Hispanic-dominant, 30% bicultural, and 46% English dominant. Over 50% of all respondents did not know bean consumption lowered cholesterol, aided blood glucose control, or reduced some cancer risks. Responses for 5 of 7 knowledge statements differed significantly by acculturation. Hispanic-dominant and bicultural women reported significantly better health, higher bean consumption, and less cigarette smoking than English-dominant women. Bicultural and English-dominant women were more likely to use the Internet for nutrition information. There are knowledge gaps about the health benefits of bean consumption among low-income women. Nutrition education to improve their knowledge may lead to increased bean consumption, reducing health disparities and improving nutrition.

Clinical benefit in Fabry patients given enzyme replacement therapy--a case series.

PubMed

Guffon, N; Fouilhoux, A

2004-01-01

Fabry disease is a rare lysosomal storage disorder resulting from deficient activity of alpha-galactosidase A and subsequent pathological accumulation of glycosphingolipids throughout the body. Traditionally, Fabry disease was managed symptomatically, but the introduction of enzyme replacement therapies (ERTs) (agalsidase beta (Fabrazyme); agalsidase alfa (Replagal)) has transformed treatment of this disorder. Clinical studies of both compounds have demonstrated clearance of glycosphingolipds from key tissues. To explore whether substrate clearance translates into clinical benefit, a retrospective survey of 17 patients (mean age 34.7 years) treated with agalsidase beta (1 mg/kg every 2 weeks) was undertaken, using an eight-item retrospective questionnaire developed specifically to assess the effect of ERT on the symptoms of Fabry disease. Pain severity, heat tolerance, physical activity, fatigue and psychological status were scored using a 10-point visual analogue scale (e.g. for pain severity: 1=none, 10=strong). Answers to all other questions were quantitative. Changes in mean scores were 4.69 to 2.25 (p =0.012) for pain severity; 4.38 to 2.21 (p =0.019) for number of pain crises per month; 8.69 to 2.98 (p =0.097) for duration of pain crises in hours; 2.76 to 5.76 (p =0.002) for heat tolerance; 3.28 to 2.51 (p =0.058) for bowel movements per day; 2.47 to 4.47 (p =0.007) for frequency of physical activity; 5.53 to 3.71 (p =0.046) for fatigue, and 5.82 to 8.12 (p =0.005) for psychological status. All patients improved in at least one aspect, although the degree of improvement across patients and aspects varied widely; reasons for this remain unclear. Despite the inherent bias involved in retrospective questionnaires, we believe that the findings are encouraging. A prospective version of the questionnaire is currently under validation.

"To screen or not to screen": Comparing the health and economic benefits of early peanut introduction strategies in five countries.

PubMed

Shaker, M; Stukus, D; Chan, E S; Fleischer, D M; Spergel, J M; Greenhawt, M

2018-03-30

Early peanut introduction (EPI) in the first year of life is associated with reduced risk of developing peanut allergy in children with either severe eczema and/or egg allergy. However, EPI recommendations differ among countries with formal guidelines. Using simulation and Markov modeling over a 20-year horizon to attempt to explore optimal EPI strategies applied to the US population, we compared high-risk infant-specific IgE peanut screening (US/Canadian) with the Australiasian Society for Clinical Immunology and Allergy (Australia/New Zealand) (ASCIA) and the United Kingdom Department of Health (UKDOH)-published EPI approaches. Screening peanut skin testing of all children with early-onset eczema and/or egg allergy before in-office peanut introduction was dominated by a no screening approach, in terms of number of cases of peanut allergy prevented, quality-adjusted life years (QALY), and healthcare costs, although screening resulted in a slightly lower rate of allergic reactions to peanut per patient in high-risk children. Considering costs of peanut allergy in high-risk children, the per-patient cost of early introduction without screening over the model horizon was $6556.69 (95%CI, $6512.76-$6600.62), compared with a cost of $7576.32 (95%CI, $7531.38-$7621.26) for skin test screening prior to introduction. From a US societal perspective, screening prior to introduction cost $654 115 322 and resulted in 3208 additional peanut allergy diagnoses. Both screening and nonscreening approaches dominated deliberately delayed peanut introduction. A no-screening approach for EPI has superior health and economic benefits in terms of number of peanut allergy cases prevented, QALY, and total healthcare costs compared to screening and in-office peanut introduction. © 2018 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Cost benefit analysis: applications and future opportunities.

DOT National Transportation Integrated Search

2016-06-01

Cost Benefit Analysis (CBA or Benefit Cost Analysis BCA) is an evaluation tool that state transportation agencies can : use to compare infrastructure project options across transportation modes and gauge if the discounted value of benefits : exce...

Problems and Benefits Reported by Stroke Family Caregivers: Results from a Prospective Epidemiological Study

PubMed Central

Haley, William E.; Allen, Jessica Y.; Grant, Joan S.; Clay, Olivio J.; Perkins, Martinique; Roth, David L.

2009-01-01

Background and Purpose Stroke symptoms can be very stressful for family caregivers, but most knowledge about the prevalence and stressfulness of stroke-related patient problems is derived from convenience samples. In addition, little is known about perceived benefits of the stroke caregiving experience. The purpose of this study was to determine the prevalence and stressfulness of stroke-related problems, and perceived benefits of caregiving, as reported by an epidemiologically-derived sample of caregivers of stroke survivors. Methods Stroke survivors (N=75) from a prospective epidemiological study of stroke, the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, and their family caregivers were followed. Caregivers were given a comprehensive telephone interview 8 to 12 months after the stroke, using measures of stroke patient problems, caregiver appraisals of the stressfulness of these problems, and perceived benefits of caregiving. Results Caregivers rated patient problems with mood (depression, loneliness and anxiety), memory, and physical care (bowel control), as the most stressful, but reported prevalence of these problems was lower than those reported previously in studies using clinical samples. Caregivers also reported many benefits from caregiving, with over 90% reporting that caregiving enabled them to appreciate life more. Conclusions Epidemiologically based studies of stroke caregiving provide a unique picture of caregiver strains and benefits compared with clinical studies, which tend to over-represent more impaired patients. Support for caregivers should include interventions to aid their coping with highly stressful mood, physical care, and cognitive problems of stroke patients, but should also attend to perceived benefits of caregiving. PMID:19407230

Benefits of information technology-enabled diabetes management.

PubMed

Bu, Davis; Pan, Eric; Walker, Janice; Adler-Milstein, Julia; Kendrick, David; Hook, Julie M; Cusack, Caitlin M; Bates, David W; Middleton, Blackford

2007-05-01

To determine the financial and clinical benefits of implementing information technology (IT)-enabled disease management systems. A computer model was created to project the impact of IT-enabled disease management on care processes, clinical outcomes, and medical costs for patients with type 2 diabetes aged >25 years in the U.S. Several ITs were modeled (e.g., diabetes registries, computerized decision support, remote monitoring, patient self-management systems, and payer-based systems). Estimates of care process improvements were derived from published literature. Simulations projected outcomes for both payer and provider organizations, scaled to the national level. The primary outcome was medical cost savings, in 2004 U.S. dollars discounted at 5%. Secondary measures include reduction of cardiovascular, cerebrovascular, neuropathy, nephropathy, and retinopathy clinical outcomes. All forms of IT-enabled disease management improved the health of patients with diabetes and reduced health care expenditures. Over 10 years, diabetes registries saved $14.5 billion, computerized decision support saved $10.7 billion, payer-centered technologies saved $7.10 billion, remote monitoring saved $326 million, self-management saved $285 million, and integrated provider-patient systems saved $16.9 billion. IT-enabled diabetes management has the potential to improve care processes, delay diabetes complications, and save health care dollars. Of existing systems, provider-centered technologies such as diabetes registries currently show the most potential for benefit. Fully integrated provider-patient systems would have even greater potential for benefit. These benefits must be weighed against the implementation costs.

Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain.

PubMed

Standaert, Christopher J; Friedly, Janna; Erwin, Mark W; Lee, Michael J; Rechtine, Glenn; Henrikson, Nora B; Norvell, Daniel C

2011-10-01

Systematic review. We sought to answer the following clinical questions: (1) Is structured exercise more effective in the treatment of chronic low back pain (LBP) than spinal manipulative therapy (SMT)? (2) Is structured exercise more effective in the treatment of chronic LBP than acupuncture? (3) Is SMT more effective in the treatment of chronic LBP than acupuncture? (4) Do certain subgroups respond more favorably to specific treatments? (5) Are any of these treatments more cost-effective than the others? Exercise, SMT, and acupuncture are widely used interventions in the treatment of chronic LBP. There is evidence that all of these approaches may offer some benefit for patients with chronic LBP when compared with usual care or no treatment. The relative benefits or cost-effectiveness of any one of these treatments when compared with the others are less well-defined, and it is difficult to identify specific subgroups of those with chronic LBP who may preferentially respond to a particular treatment modality. A systematic review of the literature was performed to identify randomized controlled trials comparing a structured exercise program, SMT, or acupuncture with one another in patients with chronic LBP. Two studies were identified comparing the use of structured exercise with SMT that met our inclusion criteria. Although these studies utilized different approaches for the exercise and SMT treatment groups, patients in both groups improved in terms of pain and function in both studies. Using random-effects modeling, there was no difference between the exercise and SMT groups when the data from these studies were pooled. We identified no studies meeting our inclusion criteria that compared acupuncture with either structured exercise or SMT or that addressed the relative cost-effectiveness of these approaches in the treatment of patients with chronic LBP. The studies identified indicate that structured exercise and SMT appear to offer equivalent benefits in terms

Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

PubMed

Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

2017-04-01

Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in

Comparative prediction of nonepileptic events using MMPI-2 clinical scales, Harris Lingoes subscales, and restructured clinical scales.

PubMed

Yamout, Karim Z; Heinrichs, Robin J; Baade, Lyle E; Soetaert, Dana K; Liow, Kore K

2017-03-01

The Minnesota Multiphasic Personality Inventory-2 (MMPI-2) is a psychological testing tool used to measure psychological and personality constructs. The MMPI-2 has proven helpful in identifying individuals with nonepileptic events/nonepileptic seizures. However, the MMPI-2 has had some updates that enhanced its original scales. The aim of this article was to test the utility of updated MMPI-2 scales in predicting the likelihood of non-epileptic seizures in individuals admitted to an EEG video monitoring unit. We compared sensitivity, specificity, and likelihood ratios of traditional MMPI-2 Clinical Scales against more homogenous MMPI-2 Harris-Lingoes subscales and the newer Restructured Clinical (RC) scales. Our results showed that the Restructured Scales did not show significant improvement over the original Clinical scales. However, one Harris-Lingoes subscale (HL4 of Clinical Scale 3) did show improved predictive utility over the original Clinical scales as well as over the newer Restructured Clinical scales. Our study suggests that the predictive utility of the MMPI-2 can be improved using already existing scales. This is particularly useful for those practitioners who are not invested in switching over to the newly developed MMPI-2 Restructured Form (MMPI-2 RF). Copyright © 2016 Elsevier Inc. All rights reserved.

Benefits and work-schedule options in hospital pharmacy practice.

PubMed

Gaither, C A; Mason, N A; Diokno, D A; Hoffman, E J

1994-03-15

Hospital pharmacy directors were surveyed to determine whether their departments offered specific family-related benefits and work-schedule options and how their attitudes about these options compared with those of female hospital pharmacists. Questionnaires were mailed to 300 randomly selected hospital pharmacy directors to collect the following information: vacancy rates and male:female ratios in hospital pharmacy positions, which of 13 selected benefits and work-schedule options were offered, barriers that prevented the other options from being offered, and attitudes about the listed options. The options included in the survey were selected because they represent ways of balancing home and work (e.g., maternity leave, job sharing, day care). The pharmacy directors' responses were compared with those from a similar survey of female hospital pharmacists. The usable response rate was 50.3%. Position vacancy rates ranged from 5.5% for directors to 35.8% for clinical supervisors. All full-time positions had an even distribution of men and women except for director and assistant or associate director positions. Of 13 options, only maternity leave, part-time schedules, and flexible schedules were offered by more than half of the hospitals. These three were also the only listed options that the respondents considered important in recruiting and retaining pharmacists. Barriers to offering other options included the perception that current benefits and work-schedule options were adequate, lack of staff coverage, lack of funds, and the perception that some positions are not compatible with alternative schedules. Respondents' ratings of the importance of the listed benefits and work-schedule options were significantly lower than ratings given by female hospital pharmacists in a separate survey.(ABSTRACT TRUNCATED AT 250 WORDS)

Re-Orientation of Clinical Research in Traumatic Brain Injury: Report of an International Workshop on Comparative Effectiveness Research

PubMed Central

Menon, David K.; Lingsma, Hester F.; Pineda, Jose A.; Sandel, M. Elizabeth; Manley, Geoffrey T.

2012-01-01

Abstract During the National Neurotrauma Symposium 2010, the DG Research of the European Commission and the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) organized a workshop on comparative effectiveness research (CER) in traumatic brain injury (TBI). This workshop reviewed existing approaches to improve outcomes of TBI patients. It had two main outcomes: First, it initiated a process of re-orientation of clinical research in TBI. Second, it provided ideas for a potential collaboration between the European Commission and the NIH/NINDS to stimulate research in TBI. Advances in provision of care for TBI patients have resulted from observational studies, guideline development, and meta-analyses of individual patient data. In contrast, randomized controlled trials have not led to any identifiable major advances. Rigorous protocols and tightly selected populations constrain generalizability. The workshop addressed additional research approaches, summarized the greatest unmet needs, and highlighted priorities for future research. The collection of high-quality clinical databases, associated with systems biology and CER, offers substantial opportunities. Systems biology aims to identify multiple factors contributing to a disease and addresses complex interactions. Effectiveness research aims to measure benefits and risks of systems of care and interventions in ordinary settings and broader populations. These approaches have great potential for TBI research. Although not new, they still need to be introduced to and accepted by TBI researchers as instruments for clinical research. As with therapeutic targets in individual patient management, so it is with research tools: one size does not fit all. PMID:21545277

Measuring the individual benefit of a medical or behavioral treatment using generalized linear mixed-effects models.

PubMed

Diaz, Francisco J

2016-10-15

We propose statistical definitions of the individual benefit of a medical or behavioral treatment and of the severity of a chronic illness. These definitions are used to develop a graphical method that can be used by statisticians and clinicians in the data analysis of clinical trials from the perspective of personalized medicine. The method focuses on assessing and comparing individual effects of treatments rather than average effects and can be used with continuous and discrete responses, including dichotomous and count responses. The method is based on new developments in generalized linear mixed-effects models, which are introduced in this article. To illustrate, analyses of data from the Sequenced Treatment Alternatives to Relieve Depression clinical trial of sequences of treatments for depression and data from a clinical trial of respiratory treatments are presented. The estimation of individual benefits is also explained. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Number Needed to Benefit From Information (NNBI): Proposal From a Mixed Methods Research Study With Practicing Family Physicians

PubMed Central

Pluye, Pierre; Grad, Roland M.; Johnson-Lafleur, Janique; Granikov, Vera; Shulha, Michael; Marlow, Bernard; Ricarte, Ivan Luiz Marques

2013-01-01

PURPOSE We wanted to describe family physicians’ use of information from an electronic knowledge resource for answering clinical questions, and their perception of subsequent patient health outcomes; and to estimate the number needed to benefit from information (NNBI), defined as the number of patients for whom clinical information was retrieved for 1 to benefit. METHODS We undertook a mixed methods research study, combining quantitative longitudinal and qualitative research studies. Participants were 41 family physicians from primary care clinics across Canada. Physicians were given access to 1 electronic knowledge resource on handheld computer in 2008–2009. For the outcome assessment, participants rated their searches using a validated method. Rated searches were examined during interviews guided by log reports that included ratings. Cases were defined as clearly described searches where clinical information was used for a specific patient. For each case, interviewees described information-related patient health outcomes. For the mixed methods data analysis, quantitative and qualitative data were merged into clinical vignettes (each vignette describing a case). We then estimated the NNBI. RESULTS In 715 of 1,193 searches for information conducted during an average of 86 days, the search objective was directly linked to a patient. Of those searches, 188 were considered to be cases. In 53 cases, participants associated the use of information with at least 1 patient health benefit. This finding suggested an NNBI of 14 (715/53). CONCLUSION The NNBI may be used in further experimental research to compare electronic knowledge resources. A low NNBI can encourage clinicians to search for information more frequently. If all searches had benefits, the NNBI would be 1. In addition to patient benefits, learning and knowledge reinforcement outcomes are frequently reported. PMID:24218380

Comparative effectiveness research in hand surgery.

PubMed

Johnson, Shepard P; Chung, Kevin C

2014-08-01

Comparative effectiveness research (CER) is a concept initiated by the Institute of Medicine and financially supported by the federal government. The primary objective of CER is to improve decision making in medicine. This research is intended to evaluate the effectiveness, benefits, and harmful effects of alternative interventions. CER studies are commonly large, simple, observational, and conducted using electronic databases. To date, there is little comparative effectiveness evidence within hand surgery to guide therapeutic decisions. To draw conclusions on effectiveness through electronic health records, databases must contain clinical information and outcomes relevant to hand surgery interventions, such as patient-related outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical assessment, gross examination, frozen section of ovarian masses: do patients benefit?

PubMed

Ghaemmaghami, Fatemah; Fakour, Fereshteh; Karimi Zarchi, Mojgan; Behtash, Nadereh; Modares Gilani, Mitra; Mousavi, Azamsadat; Shariat, Mamak

2008-09-01

The overall risk of malignancy in ovarian neoplasm is 13% in premenopausal women and 45% in postmenopausal women. Differentiating benign and malignant disease with frozen section is possible during operation; however, information on patients' history, physical examination, paraclinical criteria (tumour markers, imaging) and gross examination of tumour can also be helpful in planing the surgery. This study was conducted on 150 women who underwent laparotomy due to adnexal mass between April 2003 and October 2005 at Vali-e-Asr Hospital, Tehran, Iran. Sensitivity and specificity of clinical assessment (history, tumour marker and imaging), gross examination and frozen section were calculated. Based on our findings frozen section had the highest sensitivity for diagnosing malignant tumour comparing with other methods of diagnosis (88.9%). Sensitivity was 71.3% for preoperative clinical examination, 83% for ultrasonography, 89.8% for CT scan, 70% for CA125 and 84.1% for gross examination, likewise the highest specificity was seen for frozen section (93.5%). This data confirm that frozen section diagnosis is a reliable method for the surgical management of patients with an ovarian mass, but history of disease, Para clinical criteria and gross examination can help to surgeon to perform on appropriate operation in the areas where frozen section is not possible.

Population genetics and benefit sharing.

PubMed

Knoppers, B M

2000-01-01

The majority of international or national guidelines, specific to human genetics concentrate on actual or potential clinical applications. In contrast, the Ethics Committee of the Human Genome Organisation (HUGO) attempts to provide guidance to the bench scientists engaged in fundamental research in genomics prior to any clinical applications. Often confused as constituting the Human Genome Project (HGP) itself, HUGO's (Human Genome Organization) ultimate goal is to assist in the worldwide collaboration underpinning the HGP. It is an international organisation with 1,229 members in approximately 60 countries. The Ethics Committee is one of HUGO's six international advisory committees. Composed of experts from a number of countries and disciplines, the HUGO Ethics Committee promotes discussion and understanding of social, legal, and ethical issues as they relate to the conduct of, and knowledge derived from, the Genome Initiative. Currently, it has 13 members from 11 difference countries. It has produced statements on the conduct of genetic research, on cloning, and, has most recently presented a 'Statement on Benefit-Sharing', April 11, 2000. The Intellectual Property Committee of HUGO has been active in the controversial area of patenting. The issue of benefit-sharing is one that has its source in the mandate of both committees. How to avoid both commodification of the person through payment for access to DNA and biopiracy with no return to benefits to the families or community? While patents are a legitimate form of recognition for innovation, there seems to be no therapeutic exception to some of its stringent rules and the 'morality' exclusion has lain dormant. The HUGO 'Statement on Benefit-Sharing' examines the issues of defining community, common heritage, distributive justice and solidarity before arriving at its conclusions in benefit-sharing. This communication reviews some of these issues.

How a modified approach to dental coding can benefit personal and professional development with improved clinical outcomes.

PubMed

Lam, Raymond; Kruger, Estie; Tennant, Marc

2014-12-01

One disadvantage of the remarkable achievements in dentistry is that treatment options have never been more varied or confusing. This has made the concept of Evidenced Based Dentistry more applicable to modern dental practice. Despite merit in the concept whereby clinical decisions are guided by scientific evidence, there are problems with establishing a scientific base. This is no more challenging than in modern dentistry where the gap between rapidly developing products/procedures and its evidence base are widening. Furthermore, the burden of oral disease continues to remain high at the population level. These problems have prompted new approaches to enhancing research. The aim of this paper is to outline how a modified approach to dental coding may benefit clinical and population level research. Using publically assessable data obtained from the Australian Chronic Disease Dental Scheme and item codes contained within the Australian Schedule of Dental Services and Glossary, a suggested approach to dental informatics is illustrated. A selection of item codes have been selected and expanded with the addition of suffixes. These suffixes provided circumstantial information that will assist in assessing clinical outcomes such as success rates and prognosis. The use of item codes in administering the CDDS yielded a large database of item codes. These codes are amenable to dental informatics which has been shown to enhance research at both the clinical and population level. This is a cost effective method to supplement existing research methods. Copyright © 2014 Elsevier Inc. All rights reserved.

Does benefit justify research with children?

PubMed

Binik, Ariella

2018-01-01

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these 'benefit arguments'. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non-medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. © 2017 The Authors. Bioethics Published by John Wiley & Sons Ltd.

Does benefit justify research with children?

PubMed Central

2017-01-01

Abstract The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non‐medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. PMID:28885727

The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure.

PubMed

Hendry, J; Chin, A; Swan, I R C; Akeroyd, M A; Browning, G G

2016-06-01

The Glasgow Benefit Inventory (GBI) is a validated, generic patient-recorded outcome measure widely used in otolaryngology to report change in quality of life post-intervention. To date, no systematic review has made (i) a quality assessment of reporting of Glasgow Benefit Inventory outcomes; (ii) a comparison between Glasgow Benefit Inventory outcomes for different interventions and objectives; (iii) an evaluation of subscales in describing the area of benefit; (iv) commented on its value in clinical practice and research. Systematic review. 'Glasgow Benefit Inventory' and 'GBI' were used as keywords to search for published, unpublished and ongoing trials in PubMed, EMBASE, CINAHL and Google in addition to an ISI citation search for the original validating Glasgow Benefit Inventory paper between 1996 and January 2015. Papers were assessed for study type and quality graded by a predesigned scale, by two authors independently. Papers with sufficient quality Glasgow Benefit Inventory data were identified for statistical comparisons. Papers with <50% follow-up were excluded. A total of 118 eligible papers were identified for inclusion. A national audit paper (n = 4325) showed that the Glasgow Benefit Inventory gave a range of scores across the specialty, being greater for surgical intervention than medical intervention or 'reassurance'. Fourteen papers compared one form of surgery versus another form of surgery. In all but one study, there was no difference between the Glasgow Benefit Inventory scores (or of any other outcome). The most likely reason was lack of power. Two papers took an epidemiological approach and used the Glasgow Benefit Inventory scores to predict benefit. One was for tonsillectomy where duration of sore throat episodes and days with fever were identified on multivariate analysis to predict benefit albeit the precision was low. However, the traditional factor of number of episodes of sore throat was not predictive. The other was surgery for

The Rapid Benefit Indicators (RBI) Approach: A Process for Assessing the Social Benefits of Ecological Restoration

EPA Science Inventory

Environmental managers face difficult decisions about allocating resources to the most beneficial projects. Focusing solely on ecological outcomes can lead to missed opportunities to provide social benefits, yet few methods exist to easily compare the social benefits of ecologica...

Working Lives Project: A Ten-Year Comparative Analysis of Work Benefit and Skill Trajectories of Trade and Bachelor Graduates. Overview

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2010

2010-01-01

This study compared the work benefit and skill trajectories of a cohort of trade (vocational education) and bachelor (higher education) graduates of RMIT University in the first ten years of their working lives. It found that there are a number of key similarities and differences between the two groups in terms of further learning and occupational…

Clinical outcomes of CO2-less single-port video-assisted thoracoscopic thymectomy versus open thymectomy: comparative study.

PubMed

Aragón, Javier; Pérez Méndez, Itzell; Gutiérrez Pérez, Alexia

2016-01-01

Although video-assisted thoracoscopic surgery (VATS) for thymic disorders has been introduced, its oncological outcome and benefits over others open approaches remains unclear. Single-port VATS thymectomy using a flexible port and CO 2 has been described. However, VATS thymectomy is possible by a single incision of 3 cm without CO 2 insufflation or special port device avoiding objections related to CO 2 insufflation and allowing instruments to move more freely making procedure easier and cheaper. Our institutional experience in open and CO 2 -less VATS single-port thymectomy was retrospectively reviewed to evaluate compared to sternotomy, the clinical and oncological outcomes with this novel approach. A retrospective review consisting of 84 patients who underwent thymectomy because different thymic disorders especially thymoma was performed. Eighteen patients underwent CO 2 -less VATS single port thymectomy, while 66 underwent thymectomy through open sternotomy. Many clinical factors associated with the surgical and clinical outcomes, including tumor recurrence and clinical remission, were recorded. Non major postoperative complications were observed in any group. The median operative time and postoperative hospital stay of CO 2 -less VATS single port thymectomy were 95 min and 1 day, respectively and 120 min and 7 days for open sternotomy. The thymoma was the most common thymic disorder with 7 patients (38%) in VATS group and 28 patients (42.4%) for the open approach. The median lesion size was 2.6 cm in the VATS group and 3.2 cm in the open approach. No thymoma recurrence in patients undergoing VATS was observed during the follow-up time, while in the open surgery group 14.28% recurrence was observed, distributed as follows: loco-regional 75% and 25% at distance; free disease period of these patients was 8.3 months. Thymectomy associated with myasthenia gravis (MG) was observed in 6 (33%) patients in the VATS group and 32 (48%) patients for sternotomy; our

Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

PubMed

Plemmons, Christina; Clark, Michele; Feng, Du

2018-03-01

Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (p<0.001) had significantly larger increases in clinical self-efficacy compared to students participating in the traditional model. These findings support the use of dedicated education unit and blended clinical partnerships as effective alternatives to the traditional model to promote both clinical self-efficacy and team process among entry

Selection of first-line therapy in multiple sclerosis using risk-benefit decision analysis.

PubMed

Bargiela, David; Bianchi, Matthew T; Westover, M Brandon; Chibnik, Lori B; Healy, Brian C; De Jager, Philip L; Xia, Zongqi

2017-02-14

To integrate long-term measures of disease-modifying drug efficacy and risk to guide selection of first-line treatment of multiple sclerosis. We created a Markov decision model to evaluate disability worsening and progressive multifocal leukoencephalopathy (PML) risk in patients receiving natalizumab (NTZ), fingolimod (FGL), or glatiramer acetate (GA) over 30 years. Leveraging publicly available data, we integrated treatment utility, disability worsening, and risk of PML into quality-adjusted life-years (QALYs). We performed sensitivity analyses varying PML risk, mortality and morbidity, and relative risk of disease worsening across clinically relevant ranges. Over the entire reported range of NTZ-associated PML risk, NTZ as first-line therapy is predicted to provide a greater net benefit (15.06 QALYs) than FGL (13.99 QALYs) or GA (12.71 QALYs) treatment over 30 years, after accounting for loss of QALYs due to PML or death (resulting from all causes). NTZ treatment is associated with delayed worsening to an Expanded Disability Status Scale score ≥6.0 vs FGL or GA (22.7, 17.0, and 12.4 years, respectively). Compared to untreated patients, NTZ-treated patients have a greater relative risk of death in the early years of treatment that varies according to PML risk profile. NTZ as a first-line treatment is associated with the highest net benefit across full ranges of PML risk, mortality, and morbidity compared to FGL or GA. Integrated modeling of long-term treatment risks and benefits informs stratified clinical decision-making and can support patient counseling on selection of first-line treatment options. © 2017 American Academy of Neurology.

Comparative analyses of longevity and senescence reveal variable survival benefits of living in zoos across mammals

PubMed Central

Tidière, Morgane; Gaillard, Jean-Michel; Berger, Vérane; Müller, Dennis W. H.; Bingaman Lackey, Laurie; Gimenez, Olivier; Clauss, Marcus; Lemaître, Jean-François

2016-01-01

While it is commonly believed that animals live longer in zoos than in the wild, this assumption has rarely been tested. We compared four survival metrics (longevity, baseline mortality, onset of senescence and rate of senescence) between both sexes of free-ranging and zoo populations of more than 50 mammal species. We found that mammals from zoo populations generally lived longer than their wild counterparts (84% of species). The effect was most notable in species with a faster pace of life (i.e. a short life span, high reproductive rate and high mortality in the wild) because zoos evidently offer protection against a number of relevant conditions like predation, intraspecific competition and diseases. Species with a slower pace of life (i.e. a long life span, low reproduction rate and low mortality in the wild) benefit less from captivity in terms of longevity; in such species, there is probably less potential for a reduction in mortality. These findings provide a first general explanation about the different magnitude of zoo environment benefits among mammalian species, and thereby highlight the effort that is needed to improve captive conditions for slow-living species that are particularly susceptible to extinction in the wild. PMID:27819303

Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

PubMed

Hróbjartsson, A; Gøtzsche, P C

2001-05-24

Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits

A comparative analysis of quality management standards for contract research organisations in clinical trials.

PubMed

Murray, Elizabeth; McAdam, Rodney

2007-01-01

This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

Clinical versus actuarial judgment.

PubMed

Dawes, R M; Faust, D; Meehl, P E

1989-03-31

Professionals are frequently consulted to diagnose and predict human behavior; optimal treatment and planning often hinge on the consultant's judgmental accuracy. The consultant may rely on one of two contrasting approaches to decision-making--the clinical and actuarial methods. Research comparing these two approaches shows the actuarial method to be superior. Factors underlying the greater accuracy of actuarial methods, sources of resistance to the scientific findings, and the benefits of increased reliance on actuarial approaches are discussed.

VALUING BENEFITS FROM WATER QUALITY IMPROVEMENTS USING KUHN TUCKER MODEL - A COMPARATIVE ANALYSIS ON UTILITY FUNCTIONAL FORMS-

NASA Astrophysics Data System (ADS)

Okuyama, Tadahiro

Kuhn-Tucker model, which has studied in recent years, is a benefit valuation technique using the revealed-preference data, and the feature is to treatvarious patterns of corner solutions flexibly. It is widely known for the benefit calculation using the revealed-preference data that a value of a benefit changes depending on a functional form. However, there are little studies which examine relationship between utility functions and values of benefits in Kuhn-Tucker model. The purpose of this study is to analysis an influence of the functional form to the value of a benefit. Six types of utility functions are employed for benefit calculations. The data of the recreational activity of 26 beaches of Miyagi Prefecture were employed. Calculation results indicated that Phaneuf and Siderelis (2003) and Whitehead et al.(2010)'s functional forms are useful for benefit calculations.

The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial.

PubMed

Rodríguez, P C; Prada, D M; Moreno, E; Aira, L E; Molinero, C; López, A M; Gómez, J A; Hernández, I M; Martínez, J P; Reyes, Y; Milera, J M; Hernández, M V; Torres, R; Avila, Y; Barrese, Y; Viada, C; Montero, E; Hernández, P

2018-02-01

Itolizumab is a humanized anti-CD6 monoclonal antibody (mAb) that has previously shown encouraging results, in terms of safety and positive clinical effects, in a 6-week monotherapy clinical trial conducted in rheumatoid arthritis (RA) patients. The current Phase I study evaluated the safety and clinical response for a longer treatment of 12 itolizumab intravenous doses in subjects with active RA despite previous disease-modifying anti-rheumatic drug (DMARD) therapy. Twenty-one subjects were enrolled into four dosage groups (0·1, 0·2, 0·4 and 0·8 mg/kg). Efficacy end-points including American College of Rheumatology (ACR)20, ACR50 and ACR70 response rates and disease activity score in 28 joints (DAS28) were monitored at baseline and at specific time-points during a 10-week follow-up period. Itolizumab was well tolerated up to the highest tested dose. No related serious adverse events were reported and most adverse events were mild. Remarkably, itolizumab treatment did not produce lymphopenia and, therefore, was not associated with infections. All patients achieved a clinical response (ACR20) at least once during the study. Eleven subjects (55%) achieved at least a 20% improvement in ACR just 1 week after the first itolizumab administration. The clinical response was observed from the beginning of the treatment and was sustained during 24 weeks. The efficacy profile of this 12-week treatment was similar to that of the previous study (6-week treatment). These results reinforce the safety profile of itolizumab and provide further evidence on the clinical benefit from the use of this anti-CD6 mAb in RA patients. © 2017 British Society for Immunology.

Benefit sharing: an exploration on the contextual discourse of a changing concept

PubMed Central

2013-01-01

Background The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept. Discussion We examine the discourse on benefit sharing within three main spheres; namely: common heritage of humankind, access and use of genetic resources according to the Convention on Biological Diversity (CBD), and international clinical research. Benefit sharing has change from a concept that is enshrined in a legally binding regulation in the contexts of common heritage of humankind and CBD to a non-binding regulation in international clinical research. Nonetheless, there are more ethical justifications that accentuate benefit sharing in international clinical research than in the contexts of common heritage of humankind and the CBD. Summary There is a need to develop a legal framework in order to strengthen the advocacy and decisiveness of benefit sharing practice in international health research. Based on this legal framework, research sponsors would be required to provide a minimum set of possible benefits to participants and communities in research. Such legal framework on benefit sharing will encourage research collaboration with local communities; and dispel mistrust between research sponsors and host communities. However, more research is needed—drawing from other international legal frameworks, to understand how such a legal framework on benefit sharing can be successfully formulated in international health research. PMID:24028325

The benefits of remote microphone technology for adults with cochlear implants.

PubMed

Fitzpatrick, Elizabeth M; Séguin, Christiane; Schramm, David R; Armstrong, Shelly; Chénier, Josée

2009-10-01

Cochlear implantation has become a standard practice for adults with severe to profound hearing loss who demonstrate limited benefit from hearing aids. Despite the substantial auditory benefits provided by cochlear implants, many adults experience difficulty understanding speech in noisy environments and in other challenging listening conditions such as television. Remote microphone technology may provide some benefit in these situations; however, little is known about whether these systems are effective in improving speech understanding in difficult acoustic environments for this population. This study was undertaken with adult cochlear implant recipients to assess the potential benefits of remote microphone technology. The objectives were to examine the measurable and perceived benefit of remote microphone devices during television viewing and to assess the benefits of a frequency-modulated system for speech understanding in noise. Fifteen adult unilateral cochlear implant users were fit with remote microphone devices in a clinical environment. The study used a combination of direct measurements and patient perceptions to assess speech understanding with and without remote microphone technology. The direct measures involved a within-subject repeated-measures design. Direct measures of patients' speech understanding during television viewing were collected using their cochlear implant alone and with their implant device coupled to an assistive listening device. Questionnaires were administered to document patients' perceptions of benefits during the television-listening tasks. Speech recognition tests of open-set sentences in noise with and without remote microphone technology were also administered. Participants showed improved speech understanding for television listening when using remote microphone devices coupled to their cochlear implant compared with a cochlear implant alone. This benefit was documented both when listening to news and talk show recordings

Comparative study of balloon and metal olive dilators for endoscopic management of benign anastomotic rectal strictures: clinical and cost-effectiveness outcomes.

PubMed

Xinopoulos, Dimitrios; Kypreos, Dimitrios; Bassioukas, Stefanos P; Korkolis, Dimitrios; Mavridis, Konstantinos; Scorilas, Andreas; Dimitroulopoulos, Dimitrios; Loukou, Argyro; Paraskevas, Emmanouel

2011-03-01

Postoperative anastomotic strictures frequently complicate colorectal resection. Currently, various endoscopic techniques are being employed in their management, but the establishment of an optimal therapeutic strategy is still pending. The purpose of our study is to compare through-the-scope (TTS) balloon dilators versus Eder-Puestow metal olive dilators in the treatment of postoperative benign rectal strictures, considering the clinical outcome and cost-effectiveness of each method. A total of 39 patients with benign anastomotic rectal stenosis were retrospectively studied. In group A, 15 patients underwent dilation with Eder-Puestow metal olives, while in group B 19 patients were treated by means of TTS balloon dilators. The technical and clinical success of dilation, complications, number of repeated sessions required, disease-free time intervals, and the overall cost of each procedure were evaluated. Dilations were technically successful in all patients. No major complications occurred in either group. The number of dilations needed, rate of stricture recurrence, and duration of stenosis-free time intervals were not statistically significantly different between the two groups. Both methods proved more effective in older patients, given the greater number of dilations required in younger patients of both groups and higher frequency of stricture relapse in younger balloon-dilated patients (median 64.00 years) compared with older ones (median 75.00 years) (p = 0.001). An indisputable advantage of the Eder-Puestow technique, compared with TTS balloon dilators, is the low cost of equipment (median 22.30 compared with 680 , respectively; p < 0.001). Endoscopic dilation of postoperative benign rectal strictures is equally effective and safe, especially in older patients, when performed by Eder-Puestow bougies or TTS balloon dilators. However, metal olivary tips seem to surpass balloon dilators when considering the obvious economical benefits of the

Trust, Benefit, Satisfaction, and Burden

PubMed Central

Corbie-Smith, Giselle; Ammerman, Alice S; Katz, Mira L; St. George, Diane Marie M; Blumenthal, Connie; Washington, Chanetta; Weathers, Benita; Keyserling, Thomas C; Switzer, Boyd

2003-01-01

BACKGROUND Community-based participatory research (CBPR) approaches that actively engage communities in a study are assumed to lead to relevant findings, trusting relationships, and greater satisfaction with the research process. OBJECTIVE To examine community members' perceptions of trust, benefit, satisfaction, and burden associated with their participation. DESIGN, SETTING, AND PARTICIPANTS A randomized controlled trial tested a cancer prevention intervention in members of African-American churches. Data were collected at baseline and 1-year follow-up. MEASUREMENTS Subscales measured perception of trust in the research project and the project team, benefit from involvement with the project, satisfaction with the project and the team, and perception of burden associated with participation. MAIN RESULTS Overall, we found high levels of trust, perceived benefit, and satisfaction, and low perceived burden among community members in Partnership to Reach African Americans to Increase Smart Eating. In bivariate analyses, participants in the intervention group reported more perceived benefit and trust (P < .05). Participants in smaller churches reported more benefit, satisfaction and trust, while participants from churches without recent health activities perceived greater benefit, greater satisfaction, and lower burden with the project and the team (P < .05). Participants whose pastors had less educational attainment noted higher benefit and satisfaction; those whose pastors were making personal lifestyle changes noted higher benefit and satisfaction, but also reported higher burden (P < .05). CONCLUSIONS A randomized clinical trial designed with a CBPR approach was associated with high levels of trust and a perceived benefit of satisfaction with the research process. Understanding variations in responses to a research partnership will be helpful in guiding the design and implementation of future CBPR efforts. PMID:12848836

The development of clinical reasoning and interprofessional behaviors: service-learning at a student-run free clinic.

PubMed

Seif, Gretchen; Coker-Bolt, Patty; Kraft, Sara; Gonsalves, Wanda; Simpson, Kit; Johnson, Emily

2014-11-01

This article examines the benefits of a student run free clinic (SRFC) as a service learning experience for students in medicine, pharmacy, occupational therapy, physical therapy and physician assistant programs. We hypothesized that students who participate in an interprofessional service learning course and volunteer at a SRFC would demonstrate significant increases in perceptions and attitudes for working in interprofessional health care teams and clinical reasoning skills compared to students who did not participate. Three assessments were administered to an experimental and control group of pre-clinical students from medical, occupational therapy, physical therapy, pharmacy and physician assistant programs before and after participation in an interprofessional service-learning course and volunteering at the SRFC. The tools were the Interdisciplinary Education Perception Scale (IEPS), Readiness for Interprofessional Learning Scale (RIPLS) and the Self-Assessment of Clinical Reflection and Reasoning (SACRR). Students who completed the course had improvements in interprofessional perceptions and attitudes (p = 0.03) and perceptions of clinical reasoning skills when compared to the control group (p = 0.002). This study is novel as it examined students' perceptions of interprofessional attitudes and clinical reasoning following participation in an interprofessional service-learning course and participation in a SRFC.

Novel cancer immunotherapy agents with survival benefit: recent successes and next steps

PubMed Central

Sharma, Padmanee; Wagner, Klaus; Wolchok, Jedd D.; Allison, James P.

2012-01-01

The US Food and Drug Administration (FDA) recently approved two novel immunotherapy agents, sipuleucel-T and ipilimumab, which showed a survival benefit for patients with metastatic prostate cancer and melanoma, respectively. The mechanisms by which these agents provide clinical benefit are not completely understood. However, knowledge of these mechanisms will be crucial for probing human immune responses and tumour biology in order to understand what distinguishes responders from non-responders. The following next steps are necessary: first, the development of immune-monitoring strategies for the identification of relevant biomarkers; second, the establishment of guidelines for the assessment of clinical end points; and third, the evaluation of combination therapy strategies to improve clinical benefit. PMID:22020206

Benefit Sharing in a Global Context: Working Towards Solutions for Implementation.

PubMed

Hurst, Daniel J

2017-08-01

Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is "benefit sharing," and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice. © 2016 John Wiley & Sons Ltd.

More than a score: a qualitative study of ancillary benefits of performance measurement.

PubMed

Powell, Adam A; White, Katie M; Partin, Melissa R; Halek, Krysten; Hysong, Sylvia J; Zarling, Edwin; Kirsh, Susan R; Bloomfield, Hanna E

2014-08-01

Prior research has examined clinical effects of performance measurement systems. To the extent that non-clinical effects have been researched, the focus has been on negative unintended consequences. Yet, these same systems may also have ancillary benefits for patients and providers--that is, benefits that extend beyond improvements on clinical measures. The purpose of this study is to identify and describe potential ancillary benefits of performance measures as perceived by primary care staff and facility leaders in a large US healthcare system. In-person individual semistructured interviews were conducted with 59 primary care staff and facility leaders at four Veterans Health Administration facilities. Transcribed interviews were coded and organised into thematic categories. Interviewed staff observed that local performance measurement implementation practices can result in increased patient knowledge and motivation. These effects on patients can lead to improved performance scores and additional ancillary benefits. Performance measurement implementation can also directly result in ancillary benefits for the patients and providers. Patients may experience greater satisfaction with care and psychosocial benefits associated with increased provider-patient communication. Ancillary benefits of performance measurement for providers include increased pride in individual or organisational performance and greater confidence that one's practice is grounded in evidence-based medicine. A comprehensive understanding of the effects of performance measurement systems needs to incorporate ancillary benefits as well as effects on clinical performance scores and negative unintended consequences. Although clinical performance has been the focus of most evaluations of performance measurement to date, both patient care and provider satisfaction may improve more rapidly if all three categories of effects are considered when designing and evaluating performance measurement systems

Estimating individual benefits of medical or behavioral treatments in severely ill patients.

PubMed

Diaz, Francisco J

2017-01-01

There is a need for statistical methods appropriate for the analysis of clinical trials from a personalized-medicine viewpoint as opposed to the common statistical practice that simply examines average treatment effects. This article proposes an approach to quantifying, reporting and analyzing individual benefits of medical or behavioral treatments to severely ill patients with chronic conditions, using data from clinical trials. The approach is a new development of a published framework for measuring the severity of a chronic disease and the benefits treatments provide to individuals, which utilizes regression models with random coefficients. Here, a patient is considered to be severely ill if the patient's basal severity is close to one. This allows the derivation of a very flexible family of probability distributions of individual benefits that depend on treatment duration and the covariates included in the regression model. Our approach may enrich the statistical analysis of clinical trials of severely ill patients because it allows investigating the probability distribution of individual benefits in the patient population and the variables that influence it, and we can also measure the benefits achieved in specific patients including new patients. We illustrate our approach using data from a clinical trial of the anti-depressant imipramine.

Low BRAF and NRAS expression levels are associated with clinical benefit from DTIC therapy and prognosis in metastatic melanoma.

PubMed

Birkeland, Einar; Busch, Christian; Berge, Elisabet Ognedal; Geisler, Jürgen; Jönsson, Göran; Lillehaug, Johan Richard; Knappskog, Stian; Lønning, Per Eystein

2013-10-01

Metastatic melanoma is characterized by a poor response to chemotherapy. Furthermore, there is a lack of established predictive and prognostic markers. In this single institution study, we correlated mutation status and expression levels of BRAF and NRAS to dacarbazine (DTIC) treatment response as well as progression-free and overall survival in a cohort of 85 patients diagnosed with advanced melanoma. Neither BRAF nor NRAS mutation status correlated to treatment response. However, patients with tumors harboring NRAS mutations had a shorter overall survival (p < 0.001) compared to patients with tumors wild-type for NRAS. Patients having a clinical benefit (objective response or stable disease at 3 months) on DTIC therapy had lower BRAF and NRAS expression levels compared to patients progressing on therapy (p = 0.037 and 0.003, respectively). For BRAF expression, this association was stronger among patients with tumors wild-type for BRAF (p = 0.005). Further, low BRAF as well as NRAS expression levels were associated with a longer progression-free survival in the total population (p = 0.004 and <0.001, respectively). Contrasting low NRAS expression levels, which were associated with improved overall survival in the total population (p = 0.01), low BRAF levels were associated with improved overall survival only among patients with tumors wild-type for BRAF (p = 0.013). These findings indicate that BRAF and NRAS expression levels may influence responses to DTIC as well as prognosis in patients with advanced melanoma.

Cost benefit of privatizing wall barrier.

DOT National Transportation Integrated Search

2007-08-01

This project began as an attempt to perform a formal comparative cost benefit analysis of privatized wall barrier purchase/management and NMDOT wall barrier purchase/management in order to answer the question "What are the costs and benefits of priva...

The proposed 'concordance-statistic for benefit' provided a useful metric when modeling heterogeneous treatment effects.

PubMed

van Klaveren, David; Steyerberg, Ewout W; Serruys, Patrick W; Kent, David M

2018-02-01

Clinical prediction models that support treatment decisions are usually evaluated for their ability to predict the risk of an outcome rather than treatment benefit-the difference between outcome risk with vs. without therapy. We aimed to define performance metrics for a model's ability to predict treatment benefit. We analyzed data of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) trial and of three recombinant tissue plasminogen activator trials. We assessed alternative prediction models with a conventional risk concordance-statistic (c-statistic) and a novel c-statistic for benefit. We defined observed treatment benefit by the outcomes in pairs of patients matched on predicted benefit but discordant for treatment assignment. The 'c-for-benefit' represents the probability that from two randomly chosen matched patient pairs with unequal observed benefit, the pair with greater observed benefit also has a higher predicted benefit. Compared to a model without treatment interactions, the SYNTAX score II had improved ability to discriminate treatment benefit (c-for-benefit 0.590 vs. 0.552), despite having similar risk discrimination (c-statistic 0.725 vs. 0.719). However, for the simplified stroke-thrombolytic predictive instrument (TPI) vs. the original stroke-TPI, the c-for-benefit (0.584 vs. 0.578) was similar. The proposed methodology has the potential to measure a model's ability to predict treatment benefit not captured with conventional performance metrics. Copyright © 2017 Elsevier Inc. All rights reserved.

A Comparative Analysis of Drug-Induced Hepatotoxicity in Clinically Relevant Situations

PubMed Central

Thiel, Christoph; Cordes, Henrik; Fabbri, Lorenzo; Aschmann, Hélène Eloise; Baier, Vanessa; Atkinson, Francis; Blank, Lars Mathias; Kuepfer, Lars

2017-01-01

Drug-induced toxicity is a significant problem in clinical care. A key problem here is a general understanding of the molecular mechanisms accompanying the transition from desired drug effects to adverse events following administration of either therapeutic or toxic doses, in particular within a patient context. Here, a comparative toxicity analysis was performed for fifteen hepatotoxic drugs by evaluating toxic changes reflecting the transition from therapeutic drug responses to toxic reactions at the cellular level. By use of physiologically-based pharmacokinetic modeling, in vitro toxicity data were first contextualized to quantitatively describe time-resolved drug responses within a patient context. Comparatively studying toxic changes across the considered hepatotoxicants allowed the identification of subsets of drugs sharing similar perturbations on key cellular processes, functional classes of genes, and individual genes. The identified subsets of drugs were next analyzed with regard to drug-related characteristics and their physicochemical properties. Toxic changes were finally evaluated to predict both molecular biomarkers and potential drug-drug interactions. The results may facilitate the early diagnosis of adverse drug events in clinical application. PMID:28151932

Meta-Analysis Comparing Metoprolol and Carvedilol on Mortality Benefits in Patients With Acute Myocardial Infarction.

PubMed

Li, Jingen; Chen, Zhuo; Gao, Xiang; Zhang, He; Xiong, Wenjing; Ju, Jianqing; Xu, Hao

2017-11-01

Although carvedilol, a nonselective beta-blocker with alpha-adrenergic blocking and multiple ancillary activities, has been demonstrated to be superior to metoprolol in chronic heart failure, it remains unclear whether the superiority of carvedilol still exists in myocardial infarction (MI). Therefore, we performed a network meta-analysis of randomized controlled trials (RCTs) to compare the 2 drugs in patients with MI. All RCTs that compared either 2 of the following interventions, carvedilol, metoprolol, and placebo, for the treatment of MI were included. The Cochrane Collaboration Central Register of Controlled Trials, Embase, and PubMed were searched thoroughly for potential eligible studies. Finally, 12 RCTs involving 61,081 patients were included. Pooled results showed that compared with placebo, carvedilol and metoprolol significantly reduced composite cardiovascular events (risk ratio [RR] 0.63; 95% credible interval [CrI] 0.41, 0.85 for carvedilol; RR 0.78; 95% CrI 0.65, 0.93 for metoprolol) and re-infarction (RR 0.57; 95% CrI 0.37, 0.84 for carvedilol; RR 0.77; 95% CrI 0.62, 0.91 for metoprolol) in patients with MI. However, neither carvedilol nor metoprolol showed significant benefits on all-cause death, cardiovascular death, revascularization, and rehospitalization. Also, no obvious difference was found when comparing carvedilol and metoprolol on primary or secondary outcomes. In conclusion, there is insufficient evidence supporting the superiority of carvedilol over metoprolol for the treatment of MI. Further studies are needed to confirm our findings. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.

PubMed

Grob, J-J; Amonkar, M M; Martin-Algarra, S; Demidov, L V; Goodman, V; Grotzinger, K; Haney, P; Kämpgen, E; Karaszewska, B; Mauch, C; Miller, W H; Millward, M; Mirakhur, B; Rutkowski, P; Chiarion-Sileni, V; Swann, S; Hauschild, A

2014-07-01

In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial. The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks. This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient. ClinicalTrials.gov Identifier: NCT01227889. © The Author 2014. 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.

Evaluating a new paradigm for comparing surface disinfection in clinical practice.

PubMed

Carling, Philip C; Perkins, Jennifer; Ferguson, JoAnn; Thomasser, Anita

2014-11-01

Despite an increasing understanding of the importance of near-patient surfaces in the transmission of healthcare-associated pathogens, there remains a need to define the relative clinical effectiveness of disinfection interventions. A serial 2-phase evaluation of the clinical effectiveness of 2 surface disinfectants. A general acute care hospital. A unique system for quantifying bioburden reduction while monitoring the possible impact of differences in cleaning thoroughness was used to compare the clinical effectiveness of a traditional quaternary ammonium compound (QAC) and a novel peracetic acid/hydrogen peroxide disinfectant (ND) as part of terminal room cleaning. As a result of QAC cleaning, 93 (40%) of 237 cleaned surfaces confirmed by fluorescent marker (DAZO) removal were found to have complete removal of aerobic bioburden. During the ND phase of the study, bioburden was removed from 211 (77%) of 274 cleaned surfaces. Because there was no difference in the thoroughness of cleaning with either disinfectant (65.3% and 66.4%), the significant ([Formula: see text]) difference in bioburden reduction can be attributed to better cleaning efficacy with the ND. In the context of the study design, the ND was 1.93 times more effective in removing bacterial burden than the QAC ([Formula: see text]). Furthermore, the study design represents a new research paradigm in which 2 interventions can be compared by concomitantly and objectively analyzing both the product and process variables in a manner that can be used to define the relative effectiveness of all disinfection cleaning interventions.

T-wave alternans negative coronary patients with low ejection and benefit from defibrillator implantation

NASA Technical Reports Server (NTRS)

Hohnloser, S. H.; Ikeda, T.; Bloomfield, D. M.; Dabbous, O. H.; Cohen, R. J.

2003-01-01

In a trial of prophylactic implantation of a defibrillator, a mortality benefit was seen among patients with previous myocardial infarction and a left-ventricular ejection fraction of 0.30 or less. We identified 129 similar patients from two previously published clinical trials in which microvolt T-wave alternans testing was prospectively assessed. At 24 months of follow-up, no sudden cardiac death or cardiac arrest was seen among patients who tested T-wave alternans negative, compared with an event rate of 15.6% among the remaining patients. Testing of T-wave alternans seems to identify patients who are at low risk of ventricular tachyarrhythmic event and who may not benefit from defibrillator therapy.

Comparative Systems Analyses Reveal Molecular Signatures of Clinically tested Vaccine Adjuvants

NASA Astrophysics Data System (ADS)

Olafsdottir, Thorunn A.; Lindqvist, Madelene; Nookaew, Intawat; Andersen, Peter; Maertzdorf, Jeroen; Persson, Josefine; Christensen, Dennis; Zhang, Yuan; Anderson, Jenna; Khoomrung, Sakda; Sen, Partho; Agger, Else Marie; Coler, Rhea; Carter, Darrick; Meinke, Andreas; Rappuoli, Rino; Kaufmann, Stefan H. E.; Reed, Steven G.; Harandi, Ali M.

2016-12-01

A better understanding of the mechanisms of action of human adjuvants could inform a rational development of next generation vaccines for human use. Here, we exploited a genome wide transcriptomics analysis combined with a systems biology approach to determine the molecular signatures induced by four clinically tested vaccine adjuvants, namely CAF01, IC31, GLA-SE and Alum in mice. We report signature molecules, pathways, gene modules and networks, which are shared by or otherwise exclusive to these clinical-grade adjuvants in whole blood and draining lymph nodes of mice. Intriguingly, co-expression analysis revealed blood gene modules highly enriched for molecules with documented roles in T follicular helper (TFH) and germinal center (GC) responses. We could show that all adjuvants enhanced, although with different magnitude and kinetics, TFH and GC B cell responses in draining lymph nodes. These results represent, to our knowledge, the first comparative systems analysis of clinically tested vaccine adjuvants that may provide new insights into the mechanisms of action of human adjuvants.

[Assessing the benefits of digital health solutions in the societal reimbursement context].

PubMed

Albrecht, Urs-Vito; Kuhn, Bertolt; Land, Jörg; Amelung, Volker E; von Jan, Ute

2018-03-01

For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.

Review of the neurological benefits of phytocannabinoids.

PubMed

Maroon, Joseph; Bost, Jeff

2018-01-01

Numerous physical, psychological, and emotional benefits have been attributed to marijuana since its first reported use in 2,600 BC in a Chinese pharmacopoeia. The phytocannabinoids, cannabidiol (CBD), and delta-9-tetrahydrocannabinol (Δ9-THC) are the most studied extracts from cannabis sativa subspecies hemp and marijuana. CBD and Δ9-THC interact uniquely with the endocannabinoid system (ECS). Through direct and indirect actions, intrinsic endocannabinoids and plant-based phytocannabinoids modulate and influence a variety of physiological systems influenced by the ECS. In 1980, Cunha et al . reported anticonvulsant benefits in 7/8 subjects with medically uncontrolled epilepsy using marijuana extracts in a phase I clinical trial. Since then neurological applications have been the major focus of renewed research using medical marijuana and phytocannabinoid extracts. Recent neurological uses include adjunctive treatment for malignant brain tumors, Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuropathic pain, and the childhood seizure disorders Lennox-Gastaut and Dravet syndromes. In addition, psychiatric and mood disorders, such as schizophrenia, anxiety, depression, addiction, postconcussion syndrome, and posttraumatic stress disorders are being studied using phytocannabinoids. In this review we will provide animal and human research data on the current clinical neurological uses for CBD individually and in combination with Δ9-THC. We will emphasize the neuroprotective, antiinflammatory, and immunomodulatory benefits of phytocannabinoids and their applications in various clinical syndromes.

Review of the neurological benefits of phytocannabinoids

PubMed Central

Maroon, Joseph; Bost, Jeff

2018-01-01

Background: Numerous physical, psychological, and emotional benefits have been attributed to marijuana since its first reported use in 2,600 BC in a Chinese pharmacopoeia. The phytocannabinoids, cannabidiol (CBD), and delta-9-tetrahydrocannabinol (Δ9-THC) are the most studied extracts from cannabis sativa subspecies hemp and marijuana. CBD and Δ9-THC interact uniquely with the endocannabinoid system (ECS). Through direct and indirect actions, intrinsic endocannabinoids and plant-based phytocannabinoids modulate and influence a variety of physiological systems influenced by the ECS. Methods: In 1980, Cunha et al. reported anticonvulsant benefits in 7/8 subjects with medically uncontrolled epilepsy using marijuana extracts in a phase I clinical trial. Since then neurological applications have been the major focus of renewed research using medical marijuana and phytocannabinoid extracts. Results: Recent neurological uses include adjunctive treatment for malignant brain tumors, Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuropathic pain, and the childhood seizure disorders Lennox-Gastaut and Dravet syndromes. In addition, psychiatric and mood disorders, such as schizophrenia, anxiety, depression, addiction, postconcussion syndrome, and posttraumatic stress disorders are being studied using phytocannabinoids. Conclusions: In this review we will provide animal and human research data on the current clinical neurological uses for CBD individually and in combination with Δ9-THC. We will emphasize the neuroprotective, antiinflammatory, and immunomodulatory benefits of phytocannabinoids and their applications in various clinical syndromes. PMID:29770251

Modulating peroxisome proliferator–activated receptors for therapeutic benefit? Biology, clinical experience, and future prospects

PubMed Central

Rosenson, Robert S.; Wright, R. Scott; Farkouh, Michael; Plutzky, Jorge

2014-01-01

Clinical trials of cardiovascular disease (CVD) prevention in patients with type 2 diabetes mellitus primarily have been directed at the modification of a single major risk factor; however, in trials that enroll patients with and without diabetes, the absolute risk in CVD events remains higher in patients with diabetes. Efforts to reduce the macrovascular and microvascular residual risk have been directed toward a multifactorial CVD risk-factor modification; nonetheless, long-term complications remain high. Dual-peroxisome proliferator–activated receptor (PPAR) α/γ agonists may offer opportunities to lower macrovascular and microvascular complications of type 2 diabetes mellitus beyond the reductions achieved with conventional risk-factor modification. The information presented elucidates the differentiation of compound-specific vs class-effect properties of PPARs as the basis for future development of a new candidate molecule. Prior experience with thiazolidinediones, an approved class of PPARγ agonists, and glitazars, investigational class of dual-PPARα/γ agonists, also provides important lessons about the risks and benefits of targeting a nuclear receptor while revealing some of the future challenges for regulatory approval. PMID:23137497

Potential Benefits of Edible Berries in the Management of Aerodigestive and Gastrointestinal Tract Cancers: Preclinical and Clinical Evidence.

PubMed

Bishayee, Anupam; Haskell, Yennie; Do, Chau; Siveen, Kodappully Sivaraman; Mohandas, Nima; Sethi, Gautam; Stoner, Gary D

2016-07-26

Epidemiological reports as well as experimental studies have demonstrated the significant health benefits provided by regular berry consumption. Berries possess both prophylactic and therapeutic potential against several chronic illnesses, such as cardiovascular, neurodegenerative, and neoplastic diseases. Berries owe their health benefits to phytoconstituents, such as polyphenolic anthocyanins, ellagic acid, and a diverse array of phytochemicals bestowed with potent antioxidant and anti-inflammatory effects as well as the ability to engage a multitude of signaling pathways. This review highlights the principal chemical constituents present in berries and their primary molecular targets. The article presents and critically analyzes the chemopreventive and therapeutic potential of berry extracts, fractions, and bioactive components on various cancers of the gastrointestinal tract (GIT), including esophageal, stomach, intestinal, and colorectal cancers as well as cancers of the upper aerodigestive tract, such as oral cancer. The current status of clinical studies evaluating berry products in several aforementioned cancers is presented. Various emerging issues including dose-ranging and dosage forms, the role of synergy and the usage of combination therapy as well as other relevant areas essential for the development of berry phytoconstituents as mainstream chemopreventive and therapeutic agents against aerodigestive and GIT cancers are critically discussed.

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

Negative argininosuccinate synthetase expression in melanoma tumours may predict clinical benefit from arginine-depleting therapy with pegylated arginine deiminase

PubMed Central

Feun, L G; Marini, A; Walker, G; Elgart, G; Moffat, F; Rodgers, S E; Wu, C J; You, M; Wangpaichitr, M; Kuo, M T; Sisson, W; Jungbluth, A A; Bomalaski, J; Savaraj, N

2012-01-01

Background: Arginine-depleting therapy with pegylated arginine deiminase (ADI-PEG20) was reported to have activity in advanced melanoma in early phase I–II trial, and clinical trials are currently underway in other cancers. However, the optimal patient population who benefit from this treatment is unknown. Methods: Advanced melanoma patients with accessible tumours had biopsy performed before the start of treatment with ADI-PEG20 and at the time of progression or relapse when amenable to determine whether argininosuccinate synthetase (ASS) expression in tumour was predictive of response to ADI-PEG20. Results: Twenty-seven of thirty-eight patients treated had melanoma tumours assessable for ASS staining before treatment. Clinical benefit rate (CBR) and longer time to progression were associated with negative expression of tumour ASS. Only 1 of 10 patients with ASS-positive tumours (ASS+) had stable disease, whereas 4 of 17 (24%) had partial response and 5 had stable disease, when ASS expression was negative (ASS−), giving CBR rates of 52.9 vs 10%, P=0.041. Two responding patients with negative ASS expression before therapy had rebiopsy after tumour progression and the ASS expression became positive. The survival of ASS− patients receiving at least four doses at 320 IU m−2 was significantly better than the ASS+ group at 26.5 vs 8.5 months, P=0.024. Conclusion: ADI-PEG20 is safe and the drug is only efficacious in melanoma patients whose tumour has negative ASS expression. Argininosuccinate synthetase tumour positivity is associated with drug resistance and tumour progression. PMID:22472884

The population benefit of evidence-based radiotherapy: 5-Year local control and overall survival benefits.

PubMed

Hanna, T P; Shafiq, J; Delaney, G P; Vinod, S K; Thompson, S R; Barton, M B

2018-02-01

To describe the population benefit of radiotherapy in a high-income setting if evidence-based guidelines were routinely followed. Australian decision tree models were utilized. Radiotherapy alone (RT) benefit was defined as the absolute proportional benefit of radiotherapy compared with no treatment for radical indications, and of radiotherapy over surgery alone for adjuvant indications. Chemoradiotherapy (CRT) benefit was the absolute incremental benefit of concurrent chemoradiotherapy over RT. Five-year local control (LC) and overall survival (OS) benefits were measured. Citation databases were systematically queried for benefit data. Meta-analysis and sensitivity analysis were performed. 48% of all cancer patients have indications for radiotherapy, 34% curative and 14% palliative. RT provides 5-year LC benefit in 10.4% of all cancer patients (95% Confidence Interval 9.3, 11.8) and 5-year OS benefit in 2.4% (2.1, 2.7). CRT provides 5-year LC benefit in an additional 0.6% of all cancer patients (0.5, 0.6), and 5-year OS benefit for an additional 0.3% (0.2, 0.4). RT benefit was greatest for head and neck (LC 32%, OS 16%), and cervix (LC 33%, OS 18%). CRT LC benefit was greatest for rectum (6%) and OS for cervix (3%) and brain (3%). Sensitivity analysis confirmed a robust model. Radiotherapy provides significant 5-year LC and OS benefits as part of evidence-based cancer care. CRT provides modest additional benefits. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?

PubMed Central

Musgrove, John L.; Morris, Jason; Estrada, Carlos A.; Kraemer, Ryan R.

2016-01-01

Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms. PMID:27168884

Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?

PubMed

Musgrove, John L; Morris, Jason; Estrada, Carlos A; Kraemer, Ryan R

2016-05-01

Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms.

Benefits of plasma rich in growth factors (PRGF) in skin photodamage: clinical response and histological assessment.

PubMed

Díaz-Ley, B; Cuevast, J; Alonso-Castro, L; Calvo, M I; Ríos-Buceta, L; Orive, G; Anitua, E; Jaén, P

2015-01-01

Skin ageing is characterized by small and fine wrinkles, roughness, laxity, and pigmentation as a result of epidermal thinning, collagen degradation, dermal atrophy, and fewer fibroblasts. Plasma rich in growth factors (PRGF) is an autologous plasma preparation enriched in proteins obtained from patient's own blood aimed at accelerating tissue repair and regeneration. To evaluate the benefits of PRGF in skin photodamage, 10 healthy volunteers were treated with three consecutive intradermal injections of PRGF in the facial area. Clinical outcomes and histological analysis were performed. A statistically significant increase in the epidermis and papillary dermis thickness was seen after PRGF treatment (p < 0.001). Skin thickening was observed in all patients studied, being more intense in the group of patients with photodamage (p < 0.001). After PRGF treatment, a reduction of the average area fraction of solar elastosis was observed in patients with clinical and histological signs of skin photodamage (p < 0.05).No changeswere observed in the number of CD31, XIIIa factor, cKit, CD10, nor p53-positive cells. The improvement score after PRGF use was 0.75 (9/12) for the group of patients with signs of skin photodamage. Intradermal PRGF infiltration appears to be an effective treatment for the photodamaged skin. © 2015 Wiley Periodicals, Inc.

Balancing the risks and benefits of drinking water disinfection: disability adjusted life-years on the scale.

PubMed

Havelaar, A H; De Hollander, A E; Teunis, P F; Evers, E G; Van Kranen, H J; Versteegh, J F; Van Koten, J E; Slob, W

2000-04-01

To evaluate the applicability of disability adjusted life-years (DALYs) as a measure to compare positive and negative health effects of drinking water disinfection, we conducted a case study involving a hypothetical drinking water supply from surface water. This drinking water supply is typical in The Netherlands. We compared the reduction of the risk of infection with Cryptosporidium parvum by ozonation of water to the concomitant increase in risk of renal cell cancer arising from the production of bromate. We applied clinical, epidemiologic, and toxicologic data on morbidity and mortality to calculate the net health benefit in DALYs. We estimated the median risk of infection with C. parvum as 10(-3)/person-year. Ozonation reduces the median risk in the baseline approximately 7-fold, but bromate is produced in a concentration above current guideline levels. However, the health benefits of preventing gastroenteritis in the general population and premature death in patients with acquired immunodeficiency syndrome outweigh health losses by premature death from renal cell cancer by a factor of > 10. The net benefit is approximately 1 DALY/million person-years. The application of DALYs in principle allows us to more explicitly compare the public health risks and benefits of different management options. In practice, the application of DALYs may be hampered by the substantial degree of uncertainty, as is typical for risk assessment.

A Comparative Analysis of the Economic Benefits of Nonresident Students. AIR 1986 Annual Forum Paper.

ERIC Educational Resources Information Center

Smith, Edwin R.; Bissonnette, Kathleen K.

The economic contribution of nonresident college students to West Virginia's economy was examined. Comparisons were also made to the economic costs and benefits to the state of visitors to the state's parks system. The economic benefits of nonresident students on the West Virginia economy was estimated by summing the approximated effects of three…

Cardiovascular Benefits of Dark Chocolate?

PubMed

Higginbotham, Erin; Taub, Pam R

2015-12-01

The use of cacao for health benefits dates back at least 3000 years. Our understanding of cacao has evolved with modern science. It is now felt based on extensive research the main health benefits of cacao stem from epicatechin, a flavanol found in cacao. The process of manufacturing dark chocolate retains epicatechin, whereas milk chocolate does not contain significant amounts of epicatechin. Thus, most of the current research studies are focused on dark chocolate. Both epidemiological and clinical studies suggest a beneficial effect of dark chocolate on blood pressure, lipids, and inflammation. Proposed mechanisms underlying these benefits include enhanced nitric oxide bioavailability and improved mitochondrial structure/function. Ultimately, further studies of this promising compound are needed to elucidate its potential for prevention and treatment of cardiovascular and metabolic diseases as well as other diseases that have underlying mechanisms of mitochondrial dysfunction and nitric oxide deficiency.

Antiseptic mouth rinses: an update on comparative effectiveness, risks and recommendations.

PubMed

Osso, Diane; Kanani, Nehal

2013-02-01

Antiseptic mouth rinses are widely recommended and marketed to improve oral health. This article summarizes current studies on the comparative effectiveness of selected antiseptic mouth rinses in controlling plaque and gingivitis, as well as risks associated with daily exposure, including salivary flow rate, oral cancer and wear of composite restorations. Electronic database searches were conducted using Google Scholar and PubMed to identify articles comparing the effectiveness of 4 commercially marketed antiseptic mouth rinses differing in active ingredients (0.12% chlorhexidine gluconate, essential oils (menthol, thymol and eucalyptol) and methyl salicylate, 0.7% cetylpyridinium chloride and 20% aloe vera gel) for controlling plaque and gingivitis. Criteria for inclusion included controlled clinical trials and systematic reviews appearing in English language publications evaluating the comparative effectiveness of the mouth rinses in controlling plaque and gingivitis, as well as risks associated with daily usage. The majority of studies have shown mouth rinses containing chlorhexidine gluconate or essential oils and methyl salicylate provide clinically significant anti-gingivitis and anti-plaque benefits. Cetylpyridinium chloride has been found to provide only limited clinical benefits compared to inactive control mouth rinse. Inadequate evidence is available to evaluate the clinical effectiveness of aloe vera gel. Chlorhexidine, essential oils and cetylpyridinium have been found to be safe. However, limited data are available on the effects of the mouth rinse on wear patterns of dental restorations. Studies reviewed reported no significant difference in salivary flow rate related to alcohol based mouth rinse. Research supports the effectiveness of antiseptic mouth rinses in reducing plaque and gingivitis as an adjunct to home care. Insufficient evidence is available to support the claim that oral antiseptics can reduce the risk of developing periodontitis or the

The obstetrical and postpartum benefits of continuous support during childbirth.

PubMed

Scott, K D; Klaus, P H; Klaus, M H

1999-12-01

The purpose of this article is to review the evidence regarding the effectiveness of continuous support provided by a trained laywoman (doula) during childbirth on obstetrical and postpartum outcomes. Twelve individual randomized trials have compared obstetrical and postpartum outcomes between doula-supported women and women who did not receive doula support during childbirth. Three meta-analyses, which used different approaches, have been performed on the results of the clinical trials. Emotional and physical support significantly shortens labor and decreases the need for cesarean deliveries, forceps and vacuum extraction, oxytocin augmentation, and analgesia. Doula-supported mothers also rate childbirth as less difficult and painful than do women not supported by a doula. Labor support by fathers does not appear to produce similar obstetrical benefits. Eight of the 12 trials report early or late psychosocial benefits of doula support. Early benefits include reductions in state anxiety scores, positive feelings about the birth experience, and increased rates of breastfeeding initiation. Later postpartum benefits include decreased symptoms of depression, improved self-esteem, exclusive breastfeeding, and increased sensitivity of the mother to her child's needs. The results of these 12 trials strongly suggest that doula support is an essential component of childbirth. A thorough reorganization of current birth practices is in order to ensure that every woman has access to continuous emotional and physical support during labor.

Conceptual Framework for Conducting Cost Benefit Studies in Wisconsin VTAE and Cost Benefit Studies--VTAE Programs.

ERIC Educational Resources Information Center

Webb, Robert I.; And Others

The step-by-step cost benefit study, confined to measuring and comparing economic costs with economic benefits, is based on the 1971, 1972, and 1973 classes graduating from the Agribusiness-Machinery Partsman-Salesman Program at District One Technical Institute in Eau Claire, Wisconsin. Numerous tables throughout the report contain cost benefit…

Comparing the services and quality of private and public clinics in rural China.

PubMed

Meng, Q; Liu, X; Shi, J

2000-12-01

After 15 years eradication of the private health sector in Socialist China, private practice was restored in 1980 along with the market oriented economic reform. In recent years, however, debates on its pros and cons are increasing. Arguments against private practice have led to a ban on private practice in some rural counties. The arguments against private practice state that the service quality of private clinics tends to be lower than that of public ones; private clinics are less likely to provide preventive care; and private clinics are more likely to provide over-treatment. This paper presents the major findings from a study conducted in China, aiming at comparing private and public village health clinics in terms of quality of services, willingness to provide preventive care and over-prescription of drugs. While it was found that the quality of services was poor and a large proportion of patient expenditure was due to over-treatment for all village clinics, there was no difference between public and private clinics. Both private and public clinics were willing to provide preventive services if they were subsidized for the provision. This study finds no evidence that care provided by private clinics is inferior to that of public clinics.

Lack of adjunctive benefit of Er:YAG laser in non-surgical periodontal treatment: a randomized split-mouth clinical trial.

PubMed

Rotundo, Roberto; Nieri, Michele; Cairo, Francesco; Franceschi, Debora; Mervelt, Jana; Bonaccini, Daniele; Esposito, Marco; Pini-Prato, Giovanpaolo

2010-06-01

This split-mouth, randomized, clinical trial aimed to evaluate the efficacy of erbium-doped:yttrium-aluminium-garnet (Er:YAG) laser application in non-surgical periodontal treatment. A total of 27 patients underwent four modalities of non-surgical therapy: supragingival debridement; scaling and root planing (SRP)+Er:YAG laser; Er:YAG laser; and SRP. Each strategy was randomly assigned and performed in one of the four quadrants. Clinical outcomes were evaluated at 3 and 6 months. Subjective benefits of patients have been evaluated by means of questionnaires. Six months after therapy, Er:YAG laser showed no statistical difference in clinical attachment gain with respect to supragingival scaling [0.15 mm (95% CI -0.16; 0.46)], while SRP showed a greater attachment gain than the supragingival scaling [0.37 mm (95% CI 0.05; 0.68)]. No difference resulted between Er:YAG laser+SRP and SRP alone [0.05 mm (95% CI -0.25; 0.36)]. The adjunctive use of Er:YAG laser to conventional SRP did not reveal a more effective result than SRP alone. Furthermore, the sites treated with Er:YAG laser showed similar results of the sites treated with supragingival scaling.

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

PubMed Central

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. PMID:28740389

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity.

PubMed

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD.

Sleep benefit in Parkinson's disease: time to revive an enigma?

PubMed

van Gilst, Merel M; Louter, Maartje; Baumann, Christian R; Bloem, Bastiaan R; Overeem, Sebastiaan

2012-01-01

Some patients with Parkinson's disease (PD) reportedly experience 'sleep benefit': an improved motor functioning upon awaking in the morning. In this questionnaire study, 114 out of 243 consecutive outpatients with PD (46.9%) subjectively experienced sleep benefit. Among those patients that regularly took an afternoon nap, 33.7% experienced sleep benefit after the nap as well. Between patients with and without sleep benefit, there were no differences in demographic or clinical variables, including age, disease duration, dopaminergic treatment, and nocturnal sleep quality. Sleep benefit remains an intriguing but elusive phenomenon, which deserves renewed attention and further research.

The value of vendor-reported ambulatory EHR benefits data.

PubMed

Thompson, Douglas; Classen, David; Garrido, Terhilda; Bisordi, Joseph; Novogoratz, Scott; Zywiak, Walt

2007-04-01

Implementation of an electronic health record is expensive and labor-intensive. For this reason, providers often seek information about possible benefits to help them decide whether to implement an EHR. Our study found that a benefits database maintained by an ambulatory clinical systems vendor provided information that is useful, but that also has limitations.

Peer-Assisted Learning in the Athletic Training Clinical Setting

PubMed Central

Henning, Jolene M; Weidner, Thomas G; Jones, James

2006-01-01

Context: Athletic training educators often anecdotally suggest that athletic training students enhance their learning by teaching their peers. However, peer-assisted learning (PAL) has not been examined within athletic training education in order to provide evidence for its current use or as a pedagogic tool. Objective: To describe the prevalence of PAL in athletic training clinical education and to identify students' perceptions of PAL. Design: Descriptive. Setting: “The Athletic Training Student Seminar” at the National Athletic Trainers' Association 2002 Annual Meeting and Clinical Symposia. Patients or Other Participants: A convenience sample of 138 entry-level male and female athletic training students. Main Outcome Measure(s): Students' perceptions regarding the prevalence and benefits of and preferences for PAL were measured using the Athletic Training Peer-Assisted Learning Assessment Survey. The Survey is a self-report tool with 4 items regarding the prevalence of PAL and 7 items regarding perceived benefits and preferences. Results: A total of 66% of participants practiced a moderate to large amount of their clinical skills with other athletic training students. Sixty percent of students reported feeling less anxious when performing clinical skills on patients in front of other athletic training students than in front of their clinical instructors. Chi-square analysis revealed that 91% of students enrolled in Commission on Accreditation of Allied Health Education Programs–accredited athletic training education programs learned a minimal to small amount of clinical skills from their peers compared with 65% of students in Joint Review Committee on Educational Programs in Athletic Training–candidacy schools (χ2 3 = 14.57, P < .01). Multiple analysis of variance revealed significant interactions between sex and academic level on several items regarding benefits and preferences. Conclusions: According to athletic training students, PAL is occurring in

[Emotional climate and internal communication in a clinical management unit compared with two traditional hospital services].

PubMed

Alonso, E; Rubio, A; March, J C; Danet, A

2011-01-01

The aim of this study is to compare the emotional climate, quality of communication and performance indicators in a clinical management unit and two traditional hospital services. Quantitative study. questionnaire of 94 questions. 83 health professionals (63 responders) from the clinical management unit of breast pathology and the hospital services of medical oncology and radiation oncology. descriptive statistics, comparison of means, correlation and linear regression models. The clinical management unit reaches higher values compared with the hospital services about: performance indicators, emotional climate, internal communication and evaluation of the leadership. An important gap between existing and desired sources, channels, media and subjects of communication appear, in both clinical management unit and traditional services. The clinical management organization promotes better internal communication and interpersonal relations, leading to improved performance indicators. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Which Benefits of Research Participation Count as ‘Direct’?

PubMed Central

Friedman, Alexander; Robbins, Emily; Wendler, David

2010-01-01

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research. PMID:20497168

Clinical diagnosis of ventilator associated pneumonia revisited: comparative validation using immediate post-mortem lung biopsies.

PubMed

Fàbregas, N; Ewig, S; Torres, A; El-Ebiary, M; Ramirez, J; de La Bellacasa, J P; Bauer, T; Cabello, H

1999-10-01

A study was undertaken to assess the diagnostic value of different clinical criteria and the impact of microbiological testing on the accuracy of clinical diagnosis of suspected ventilator associated pneumonia (VAP). Twenty five deceased mechanically ventilated patients were studied prospectively. Immediately after death, multiple bilateral lung biopsy specimens (16 specimens/patient) were obtained for histological examination and quantitative lung cultures. The presence of both histological pneumonia and positive lung cultures was used as a reference test. The presence of infiltrates on the chest radiograph and two of three clinical criteria (leucocytosis, purulent secretions, fever) had a sensitivity of 69% and a specificity of 75%; the corresponding numbers for the clinical pulmonary infection score (CPIS) were 77% and 42%. Non-invasive as well as invasive sampling techniques had comparable values. The combination of all techniques achieved a sensitivity of 85% and a specificity of 50%, and these values remained virtually unchanged despite the presence of previous treatment with antibiotics. When microbiological results were added to clinical criteria, adequate diagnoses originating from microbiological results which might have corrected false positive and false negative clinical judgements (n = 5) were countered by a similar proportion of inadequate diagnoses (n = 6). Clinical criteria had reasonable diagnostic values. CPIS was not superior to conventional clinical criteria. Non-invasive and invasive sampling techniques had diagnostic values comparable to clinical criteria. An algorithm guiding antibiotic treatment exclusively by microbiological results does not increase the overall diagnostic accuracy and carries the risk of undertreatment.

A cost-benefit model comparing the California Milk Cell Test and Milk Electrical Resistance Test.

PubMed

Petzer, Inge-Marie; Karzis, Joanne; Meyer, Isabel A; van der Schans, Theodorus J

2013-04-24

The indirect effects of mastitis treatment are often overlooked in cost-benefit analyses, but it may be beneficial for the dairy industry to consider them. The cost of mastitis treatment may increase when the duration of intra-mammary infections are prolonged due to misdiagnosis of host-adapted mastitis. Laboratory diagnosis of mastitis can be costly and time consuming, therefore cow-side tests such as the California Milk Cell Test (CMCT) and Milk Electrical Resistance (MER) need to be utilised to their full potential. The aim of this study was to determine the relative benefit of using these two tests separately and in parallel. This was done using a partial-budget analysis and a cost-benefit model to estimate the benefits and costs of each respective test and the parallel combination thereof. Quarter milk samples (n= 1860) were taken from eight different dairy herds in South Africa. Milk samples were evaluated by means of the CMCT, hand-held MER meter and cyto-microbiological laboratory analysis. After determining the most appropriate cut-off points for the two cow-side tests, the sensitivity and specificity of the CMCT (Se= 1.00, Sp= 0.66), MER (Se= 0.92, Sp= 0.62) and the tests done in parallel (Se= 1.00, Sp= 0.87) were calculated. The input data that were used for partial-budget analysis and in the cost-benefit model were based on South African figures at the time of the study, and on literature. The total estimated financial benefit of correct diagnosis of host-adapted mastitis per cow for the CMCT, MER and the tests done in parallel was R898.73, R518.70 and R1064.67 respectively. This involved taking the expected benefit of a correct test result per cow, the expected cost of an error per cow and the cost of the test into account. The CMCT was shown to be 11%more beneficial than the MER test, whilst using the tests in parallel was shown to be the most beneficial method for evaluating the mastitis-control programme. Therefore, it is recommended that the

"It is not guaranteed that you will benefit": True but misleading?

PubMed

Kim, Scott Y H; Wilson, Renee; De Vries, Raymond; Kim, H Myra; Holloway, Robert G; Kieburtz, Karl

2015-08-01

Participants of early-phase intervention trials for serious conditions provide high estimates of likelihood of benefit, even when informed consent forms do not promise such benefits. However, some technically correct, negatively stated benefits statements—such as "it is not guaranteed that you will benefit"—could play a role in raising expectations of benefit because in ordinary English usage such statements denote a likely but not a certain-to-occur event. An experimental online survey of 584 English-speaking adults recruited online. They were randomized to receive one of two benefit statements ("not guaranteed" vs "some but very small chance"), using a hypothetical scenario of an early-phase clinical trial testing an intervention to treat amyotrophic lateral sclerosis. We assessed respondents' willingness to consider participating in the amyotrophic lateral sclerosis trial, their estimates of likelihood of benefit, and their explanations for those estimates. The two arms did not differ in willingness to consider participation in the amyotrophic lateral sclerosis trial. Those receiving "not guaranteed" benefit statement had higher estimates of benefit than those receiving "some but very small chance" statement (35.7% (standard deviation 20.2) vs 28.3% (standard deviation 22.0), p < 0.0001). A total of 43% of all respondents chose expressions of positive sentiment (hope and need to stay positive) as explanations of their estimates; these respondents' estimates of benefit were higher than others but similar between the two arms. The effect of benefit statements was greatest among those who chose "Those are just the facts" as the explanation for their estimate (31.0% (standard deviation 22.4%) in "not guaranteed" arm vs 18.9% (standard deviation 21.0%) in comparison arm, p = 0.008). The use of "not guaranteed" language in benefit statements, when compared to "small but very small chance" language, appeared to increase the perception of likelihood of

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

PubMed

Hey, Spencer Phillips; Kimmelman, Jonathan

2016-10-01

Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach - forecast analysis - that would enable direct and effective measure of the quality of risk/benefit estimation. We then consider some objections and limitations to the forecasting approach. © 2016 John Wiley & Sons Ltd.

Identifying who will benefit from non-invasive ventilation in amyotrophic lateral sclerosis/motor neurone disease in a clinical cohort.

PubMed

Berlowitz, David J; Howard, Mark E; Fiore, Julio F; Vander Hoorn, Stephen; O'Donoghue, Fergal J; Westlake, Justine; Smith, Anna; Beer, Fiona; Mathers, Susan; Talman, Paul

2016-03-01

Respiratory failure is associated with significant morbidity and is the predominant cause of death in motor neurone disease/amyotrophic lateral sclerosis (MND/ALS). This study aimed to determine the effect of non-invasive ventilatory (NIV) support on survival and pulmonary function decline across MND/ALS phenotypes. Cohort recruited via a specialist, multidisciplinary clinic. Patients were categorised into four clinical phenotypes (ALS, flail arm, flail leg and primary lateral sclerosis) according to site of presenting symptom and the pattern of upper versus lower motor neurone involvement. NIV was initiated according to current consensus practice guidelines. Between 1991 and 2011, 1198 patients diagnosed with ALS/MND were registered. 929 patients (77.5%) fulfilled the selection criteria and their data were analysed. Median tracheostomy free survival from symptom onset was 28 months in NIV-treated patients compared to 15 months in untreated (Univariate Cox regression HR=0.61 (0.51 to 0.73), p<0.001). The positive survival effect of NIV persisted when the model was adjusted for age, gender, riluzole and percutaneous endoscopic gastrostomy use (HR=0.72 (0.60 to 0.88, p=0.001). In contrast with the only randomised controlled trial, NIV statistically significantly increased survival by 19 months in those with ALS-bulbar onset (Univariate HR=0.50 (0.36 to 0.70), multivariate HR=0.59 (0.41 to 0.83)). These data confirm that NIV improves survival in MND/ALS. The overall magnitude of benefit is 13 months and was largest in those with ALS-bulbar disease. Future research should explore the optimal timing of NIV initiation within phenotypes in order to optimise respiratory function, quality of life and survival. 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/

Greater clinical benefit of more intensive oral antiplatelet therapy with prasugrel in patients with diabetes mellitus in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-Thrombolysis in Myocardial Infarction 38.

PubMed

Wiviott, Stephen D; Braunwald, Eugene; Angiolillo, Dominick J; Meisel, Simha; Dalby, Anthony J; Verheugt, Freek W A; Goodman, Shaun G; Corbalan, Ramon; Purdy, Drew A; Murphy, Sabina A; McCabe, Carolyn H; Antman, Elliott M

2008-10-14

Patients with diabetes mellitus (DM) are at high risk for recurrent cardiovascular events after acute coronary syndromes, in part because of increased platelet reactivity. The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38) showed an overall reduction in ischemic events with more intensive antiplatelet therapy with prasugrel than with clopidogrel but with more bleeding. We compared prasugrel with clopidogrel among subjects with DM in TRITON-TIMI 38. We classified 13 608 subjects on the basis of preexisting history of DM and further according to insulin use. Prespecified analyses of the primary (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and key secondary end points, including net clinical benefit (death, nonfatal myocardial infarction, nonfatal stroke, and nonfatal TIMI major bleeding) were compared by use of the log-rank test. We found that 3146 subjects had a preexisting history of DM, including 776 receiving insulin. The primary end point was reduced significantly with prasugrel among subjects without DM (9.2% versus 10.6%; hazard ratio [HR], 0.86; P=0.02) and with DM (12.2% versus 17.0%; HR, 0.70; P<0.001, P(interaction)=0.09). A benefit for prasugrel was observed among DM subjects on insulin (14.3% versus 22.2%; HR, 0.63; P=0.009) and those not on insulin (11.5% versus 15.3%; HR, 0.74; P=0.009). Myocardial infarction was reduced with prasugrel by 18% among subjects without DM (7.2% versus 8.7%; HR, 0.82; P=0.006) and by 40% among subjects with DM (8.2% versus 13.2%; HR, 0.60; P<0.001, P(interaction)=0.02). Although TIMI major hemorrhage was increased among subjects without DM on prasugrel (1.6% versus 2.4%; HR, 1.43; P=0.02), the rates were similar among subjects with DM for clopidogrel and prasugrel (2.6% versus 2.5%; HR, 1.06; P=0.81, P(interaction)=0.29). Net clinical benefit with prasugrel was greater for subjects

[Who benefits from the night clinic? - Value of a part-time treatment facility].

PubMed

Stutz, Constanze; Kawohl, Wolfram; Platz, Christoph; Warnke, Ingeborg; Jäger, Matthias

2017-12-01

The night clinic which is part of the psychiatric department of the University of Zurich is a part-time treatment option with psychiatric treatment and support in the evening. This study aimed to characterize the patients and detect different functions of the treatment setting. Data of 253 patients covering a six-year period from 2008 up to 2013 were retrospectively assessed using descriptive methods. Subgroups according to the situation before admission and after discharge were compared. Patients admitted from home differed considerably from those who were transferred from a psychiatric ward concerning sociodemographic and clinical factors. They were more frequently single, unemployed, received disability funds and suffered from a psychotic disorder. They were also more likely to be discharged in a supported housing condition. The night clinic serves as an alternative to full inpatient treatment for individuals who have work as well as a rehabilitative option for homeless patients with severe mental illness. It contributes to a reduction of avoidance of inpatients stays for those groups of patients.

Comparative efficacy of photo-activated disinfection and calcium hydroxide for disinfection of remaining carious dentin in deep cavities: a clinical study

PubMed Central

Sharma, Sidhartha; Shah, Naseem

2014-01-01

Objectives To comparatively evaluate the efficacy of photo-activated disinfection (PAD), calcium hydroxide (CH) and their combination on the treatment outcome of indirect pulp treatment (IPT). Materials and Methods Institutional ethical clearance and informed consent of the patients were taken. The study was also registered with clinical registry of India. Sixty permanent molars exhibiting deep occlusal carious lesion in patients with the age range of 18 - 22 yr were included. Clinical and radiographic evaluation and set inclusion and exclusion criteria's were followed. Gross caries excavation was accomplished. In group I (n = 20) PAD was applied for sixty seconds. In group II (n = 20), CH was applied to the remaining carious dentin, while in group III (n = 20), PAD application was followed by CH placement. The teeth were permanently restored. They were clinically and radiographically followed-up at 45 day, 6 mon and 12 mon. Relative density of the remaining affected dentin was measured by 'Radiovisiography (RVG) densitometric' analysis. Results Successful outcome with an increase in radiographic grey values were observed in all three groups. However, on inter-group comparison, this change was not significant (p > 0.05). Conclusions PAD and CH both have equal disinfection efficacy in the treatment of deep carious dentin. PAD alone is as effective for treatment of deep carious lesion as calcium hydroxide and hence can be used as an alternative to CH. They can be used independently in IPT, since combining both does not offer any additional therapeutic benefits. PMID:25110643

Comparative Benefit-Cost Analysis of the Abecedarian Program and Its Policy Implications

ERIC Educational Resources Information Center

Barnett, W. S.; Masse, Leonard N.

2007-01-01

Child care and education are to some extent joint products of preschool programs, but public policy and research frequently approach these two goals independently. We present a benefit-cost analysis of a preschool program that provided intensive education during full-day child care. Data were obtained from a randomized trial with longitudinal…

Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

PubMed

Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

2018-05-01

Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

Clinical Benefits of n-3 PUFA and ɤ-Linolenic Acid in Patients with Rheumatoid Arthritis.

PubMed

Veselinovic, Mirjana; Vasiljevic, Dragan; Vucic, Vesna; Arsic, Aleksandra; Petrovic, Snjezana; Tomic-Lucic, Aleksandra; Savic, Maja; Zivanovic, Sandra; Stojic, Vladislava; Jakovljevic, Vladimir

2017-03-25

(1) Background: Marine n -3 polyunsaturated fatty acids (PUFA) and ɤ-linolenic acid (GLA) are well-known anti-inflammatory agents that may help in the treatment of inflammatory disorders. Their effects were examined in patients with rheumatoid arthritis; (2) Methods: Sixty patients with active rheumatoid arthritis were involved in a prospective, randomized trial of a 12 week supplementation with fish oil (group I), fish oil with primrose evening oil (group II), or with no supplementation (group III). Clinical and laboratory evaluations were done at the beginning and at the end of the study; (3) Results: The Disease Activity Score 28 (DAS 28 score), number of tender joints and visual analogue scale (VAS) score decreased notably after supplementation in groups I and II ( p < 0.001). In plasma phospholipids the n -6/ n -3 fatty acids ratio declined from 15.47 ± 5.51 to 10.62 ± 5.07 ( p = 0.005), and from 18.15 ± 5.04 to 13.50 ± 4.81 ( p = 0.005) in groups I and II respectively. The combination of n -3 PUFA and GLA (group II) increased ɤ-linolenic acid (0.00 ± 0.00 to 0.13 ± 0.11, p < 0.001), which was undetectable in all groups before the treatments; (4) Conclusion: Daily supplementation with n -3 fatty acids alone or in combination with GLA exerted significant clinical benefits and certain changes in disease activity.

Survival benefit of neoadjuvant chemotherapy for resectable breast cancer: A meta-analysis.

PubMed

Chen, Yan; Shi, Xiu-E; Tian, Jin-Hui; Yang, Xu-Juan; Wang, Yong-Feng; Yang, Ke-Hu

2018-05-01

Neoadjuvant chemotherapy (NAC) increases breast conservation rates in patients with resectable breast cancer at the associated cost of higher locoregional recurrence rates; however, the magnitude of the survival benefits of NAC for these patients remains undefined. Therefore, we aimed to clarify the survival benefit of NAC versus postoperative chemotherapy by conducting an updated meta-analysis of randomized clinical trials (RCTs). The authors searched the Cochrane Library, PubMed, Embase, Web of Science, Chinese biomedical literature database, and Chinese Scientific Journals full-text database from their inception to December 2016. The authors identified relevant RCTs that compared NAC with postoperative chemotherapy in the treatment of operable breast cancer. The main endpoints were overall survival (OS) and recurrence-free survival (RFS). A total of 21 citations representing 16 unique studies were eligible. There were 787 deaths among 2794 patients assigned to NAC groups and 816 deaths among 2799 patients assigned to adjuvant chemotherapy groups. A meta-analysis of data indicated that there was no significant benefit in terms of OS ([hazard ratio [HR] = 1.03, 95% confidence interval [CI]: 0.94-1.13, P = .51) and RFS (HR = 1.01, 95% CI: 0.93-1.10, P = .80) between the NAC and postoperative chemotherapy groups. The pooled HR estimate for OS was not influenced by NAC cycles, the total number of chemotherapy cycles, administration of tamoxifen, administration of adjuvant chemotherapy, or type of NAC regimen. Subgroup analysis showed that the pooled HR estimate for RFS was influenced by anthracycline-containing regimens. Patients with a pathological complete response had superior survival outcomes compared with patients who had residual disease. The survival benefits for patients with operable breast cancer who received either NAC or adjuvant chemotherapy based on anthracycline regimens were comparable.

Specific barriers to the conduct of randomised clinical trials on medical devices.

PubMed

Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee; Eikermann, Michaela; Seidel, Doerthe; Koenen, Carsten; Jacobs, Esther; Pieper, Dawid; Laville, Martine; Pitel, Séverine; Martinho, Cecilia; Djurisic, Snezana; Demotes-Mainard, Jacques; Kubiak, Christine; Bertele, Vittorio; Jakobsen, Janus C; Garattini, Silvio; Gluud, Christian

2017-09-13

Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.

Health benefits of tai chi: What is the evidence?

PubMed

Huston, Patricia; McFarlane, Bruce

2016-11-01

To summarize the evidence on the health benefits of tai chi. A literature review was conducted on the benefits of tai chi for 25 specific conditions, as well as for general health and fitness, to update a 2014 review of systematic reviews. Systematic reviews and recent clinical trials were assessed and organized into 5 different groups: evidence of benefit as excellent, good, fair, or preliminary, or evidence of no direct benefit. During the past 45 years more than 500 trials and 120 systematic reviews have been published on the health benefits of tai chi. Systematic reviews of tai chi for specific conditions indicate excellent evidence of benefit for preventing falls, osteoarthritis, Parkinson disease, rehabilitation for chronic obstructive pulmonary disease, and improving cognitive capacity in older adults. There is good evidence of benefit for depression, cardiac and stroke rehabilitation, and dementia. There is fair evidence of benefit for improving quality of life for cancer patients, fibromyalgia, hypertension, and osteoporosis. Current evidence indicates no direct benefit for diabetes, rheumatoid arthritis, or chronic heart failure. Systematic reviews of general health and fitness benefits show excellent evidence of benefit for improving balance and aerobic capacity in those with poor fitness. There is good evidence for increased strength in the lower limbs. There is fair evidence for increased well-being and improved sleep. There were no studies that found tai chi worsened a condition. A recent systematic review on the safety of tai chi found adverse events were typically minor and primarily musculoskeletal; no intervention-related serious adverse events have been reported. There is abundant evidence on the health and fitness effects of tai chi. Based on this, physicians can now offer evidence-based recommendations to their patients, noting that tai chi is still an area of active research, and patients should continue to receive medical follow-up for any

Comparing clinical effects of marbofloxacin and gamithromycin in goat kids with pneumonia.

PubMed

Kacar, Yigit; Batmaz, Hasan; Yilmaz, Ozge E; Mecitoglu, Zafer

2018-06-20

The aim of this study was to compare the clinical efficacy of a single-dose of gamithromycin (GM) or marbofloxacin (MR) in kids with naturally occurring pneumonia. Thirty-six kids, aged 2-2.5 months, with body weight ranging from 12 kg to 18 kg were presented with clinical signs of pneumonia. The most prominent clinical findings were an increase in the respiratory rate, crackling lung sounds on auscultation, coughing, nasal discharge and an increased rectal temperature. Mannheimia haemolytica and Mycoplasma spp. colonies were isolated from microbiological examination of six transtracheal washes and lung tissues of one necropsied kid. The severity of pneumonia was evaluated by using cumulative clinical score (CCS). The CCS of the 36 kids used in the study were four and above. Kids were randomly divided into two equal groups; the GM group received a single subcutaneous dose of GM at a dosage of 6 mg/kg and the MR group received MR intramuscularly at a dosage of 8 mg/kg as a single-dose. No side effects related to the drugs were detected in either group. All 36 kids were clinically examined 3 weeks after the initiation of the treatment. Clinical signs in both groups were almost completely absent at the end of the study. A single administration of GM or MR was successfully used in the treatment of kids with pneumonia.

The use of clinical trials in comparative effectiveness research on mental health.

PubMed

Blanco, Carlos; Rafful, Claudia; Olfson, Mark

2013-08-01

A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods. Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical diagnosis of ventilator associated pneumonia revisited: comparative validation using immediate post-mortem lung biopsies

PubMed Central

Fabregas, N.; Ewig, S.; Torres, A.; El-Ebiary, M.; Ramirez, J.; de la Bellacasa, J. P.; Bauer, T.; Cabello, H.

1999-01-01

BACKGROUND—A study was undertaken to assess the diagnostic value of different clinical criteria and the impact of microbiological testing on the accuracy of clinical diagnosis of suspected ventilator associated pneumonia (VAP).
METHODS—Twenty five deceased mechanically ventilated patients were studied prospectively. Immediately after death, multiple bilateral lung biopsy specimens (16 specimens/patient) were obtained for histological examination and quantitative lung cultures. The presence of both histological pneumonia and positive lung cultures was used as a reference test.
RESULTS—The presence of infiltrates on the chest radiograph and two of three clinical criteria (leucocytosis, purulent secretions, fever) had a sensitivity of 69% and a specificity of 75%; the corresponding numbers for the clinical pulmonary infection score (CPIS) were 77% and 42%. Non-invasive as well as invasive sampling techniques had comparable values. The combination of all techniques achieved a sensitivity of 85% and a specificity of 50%, and these values remained virtually unchanged despite the presence of previous treatment with antibiotics. When microbiological results were added to clinical criteria, adequate diagnoses originating from microbiological results which might have corrected false positive and false negative clinical judgements (n = 5) were countered by a similar proportion of inadequate diagnoses (n =6).
CONCLUSIONS—Clinical criteria had reasonable diagnostic values. CPIS was not superior to conventional clinical criteria. Non-invasive and invasive sampling techniques had diagnostic values comparable to clinical criteria. An algorithm guiding antibiotic treatment exclusively by microbiological results does not increase the overall diagnostic accuracy and carries the risk of undertreatment.

 PMID:10491448