Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

ERIC Educational Resources Information Center

Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

2015-01-01

Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…

A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

PubMed

Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

2015-08-01

The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For

The Socioeconomic Benefit to Individuals of Achieving the 2020 Targets for Five Preventive Chemotherapy Neglected Tropical Diseases.

PubMed

Redekop, William K; Lenk, Edeltraud J; Luyendijk, Marianne; Fitzpatrick, Christopher; Niessen, Louis; Stolk, Wilma A; Tediosi, Fabrizio; Rijnsburger, Adriana J; Bakker, Roel; Hontelez, Jan A C; Richardus, Jan H; Jacobson, Julie; de Vlas, Sake J; Severens, Johan L

2017-01-01

Lymphatic filariasis (LF), onchocerciasis, schistosomiasis, soil-transmitted helminths (STH) and trachoma represent the five most prevalent neglected tropical diseases (NTDs). They can be controlled or eliminated by means of safe and cost-effective interventions delivered through programs of Mass Drug Administration (MDA)-also named Preventive Chemotherapy (PCT). The WHO defined targets for NTD control/elimination by 2020, reinforced by the 2012 London Declaration, which, if achieved, would result in dramatic health gains. We estimated the potential economic benefit of achieving these targets, focusing specifically on productivity and out-of-pocket payments. Productivity loss was calculated by combining disease frequency with productivity loss from the disease, from the perspective of affected individuals. Productivity gain was calculated by deducting the total loss expected in the target achievement scenario from the loss in a counterfactual scenario where it was assumed the pre-intervention situation in 1990 regarding NTDs would continue unabated until 2030. Economic benefits from out-of-pocket payments (OPPs) were calculated similarly. Benefits are reported in 2005 US$ (purchasing power parity-adjusted and discounted at 3% per annum from 2010). Sensitivity analyses were used to assess the influence of changes in input parameters. The economic benefit from productivity gain was estimated to be I$251 billion in 2011-2020 and I$313 billion in 2021-2030, considerably greater than the total OPPs averted of I$0.72 billion and I$0.96 billion in the same periods. The net benefit is expected to be US$ 27.4 and US$ 42.8 for every dollar invested during the same periods. Impact varies between NTDs and regions, since it is determined by disease prevalence and extent of disease-related productivity loss. Achieving the PCT-NTD targets for 2020 will yield significant economic benefits to affected individuals. Despite large uncertainty, these benefits far exceed the investment

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.

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

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.

The Socioeconomic Benefit to Individuals of Achieving the 2020 Targets for Five Preventive Chemotherapy Neglected Tropical Diseases

PubMed Central

Luyendijk, Marianne; Fitzpatrick, Christopher; Niessen, Louis; Stolk, Wilma A.; Tediosi, Fabrizio; Rijnsburger, Adriana J.; Bakker, Roel; Hontelez, Jan A. C.; Richardus, Jan H.; Jacobson, Julie; de Vlas, Sake J.; Severens, Johan L.

2017-01-01

Background Lymphatic filariasis (LF), onchocerciasis, schistosomiasis, soil-transmitted helminths (STH) and trachoma represent the five most prevalent neglected tropical diseases (NTDs). They can be controlled or eliminated by means of safe and cost-effective interventions delivered through programs of Mass Drug Administration (MDA)—also named Preventive Chemotherapy (PCT). The WHO defined targets for NTD control/elimination by 2020, reinforced by the 2012 London Declaration, which, if achieved, would result in dramatic health gains. We estimated the potential economic benefit of achieving these targets, focusing specifically on productivity and out-of-pocket payments. Methods Productivity loss was calculated by combining disease frequency with productivity loss from the disease, from the perspective of affected individuals. Productivity gain was calculated by deducting the total loss expected in the target achievement scenario from the loss in a counterfactual scenario where it was assumed the pre-intervention situation in 1990 regarding NTDs would continue unabated until 2030. Economic benefits from out-of-pocket payments (OPPs) were calculated similarly. Benefits are reported in 2005 US$ (purchasing power parity-adjusted and discounted at 3% per annum from 2010). Sensitivity analyses were used to assess the influence of changes in input parameters. Results The economic benefit from productivity gain was estimated to be I$251 billion in 2011–2020 and I$313 billion in 2021–2030, considerably greater than the total OPPs averted of I$0.72 billion and I$0.96 billion in the same periods. The net benefit is expected to be US$ 27.4 and US$ 42.8 for every dollar invested during the same periods. Impact varies between NTDs and regions, since it is determined by disease prevalence and extent of disease-related productivity loss. Conclusion Achieving the PCT-NTD targets for 2020 will yield significant economic benefits to affected individuals. Despite large

Achieving consensus for clinical trials

PubMed Central

Blakeley, Jaishri O.; Dombi, Eva; Fisher, Michael J.; Hanemann, C. Oliver; Walsh, Karin S.; Wolters, Pamela L.; Widemann, Brigitte C.

2013-01-01

The neurofibromatoses (NF)—including neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2), and schwannomatosis—are related tumor-suppressor syndromes characterized by a predisposition to multiple tumor types and other disease manifestations, which often result in functional disability, reduced quality of life, pain, and, in some cases, malignancy. With increasing knowledge of the biology and pathogenesis of NF, clinical trials with targeted agents directed at NF tumors have become available. Most clinical trials for patients with NF have used designs and endpoints similar to oncology trials. However, differences in the disease manifestations and natural history of NF (compared to cancers) require the development of new designs and endpoints to perform meaningful NF clinical trials. The Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration was established in 2011 at the Children's Tumor Foundation meeting to achieve consensus within the NF community about the design of future clinical trials, with a specific emphasis on endpoints. The REiNS Collaboration includes 7 working groups that focus on imaging of tumor response; functional, visual, patient-reported, and neurocognitive outcomes; whole-body MRI; and disease biomarkers. This supplement includes the first series of recommendations by the REiNS Collaboration. The hope is that these recommendations will be used by members of the group and by researchers outside of the REiNS International Collaboration to standardize the measurement of outcomes and thus improve clinical trials for patients with NF. Ultimately, we plan to engage industry partners and national regulatory agencies in this process to facilitate the approval of drugs for patients with NF. PMID:24249801

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

Component Prioritization Schema for Achieving Maximum Time and Cost Benefits from Software Testing

NASA Astrophysics Data System (ADS)

Srivastava, Praveen Ranjan; Pareek, Deepak

Software testing is any activity aimed at evaluating an attribute or capability of a program or system and determining that it meets its required results. Defining the end of software testing represents crucial features of any software development project. A premature release will involve risks like undetected bugs, cost of fixing faults later, and discontented customers. Any software organization would want to achieve maximum possible benefits from software testing with minimum resources. Testing time and cost need to be optimized for achieving a competitive edge in the market. In this paper, we propose a schema, called the Component Prioritization Schema (CPS), to achieve an effective and uniform prioritization of the software components. This schema serves as an extension to the Non Homogenous Poisson Process based Cumulative Priority Model. We also introduce an approach for handling time-intensive versus cost-intensive projects.

Achieving the World Health Organization's vision for clinical pharmacology

PubMed Central

Henry, David; Gray, Jean; Day, Richard; Bochner, Felix; Ferro, Albert; Pirmohamed, Munir; Mörike, Klaus; Schwab, Matthias

2015-01-01

Clinical pharmacology is a medical specialty whose practitioners teach, undertake research, frame policy, give information and advice about the actions and proper uses of medicines in humans and implement that knowledge in clinical practice. It involves a combination of several activities: drug discovery and development, training safe prescribers, providing objective and evidence‐based therapeutic information to ethics, regulatory and pricing bodies, supporting patient care in an increasingly subspecialized arena where co‐morbidities, polypharmacy, altered pharmacokinetics and drug interactions are common and developing and contributing to medicines policies for Governments. Clinical pharmacologists must advocate drug quality and they must also advocate for sustainability of the Discipline. However for this they need appropriate clinical service and training support. This Commentary discusses strategies to ensure the Discipline is supported by teaching, training and policy organizations, to communicate the full benefits of clinical pharmacology services, put a monetary value on clinical pharmacology services and to grow the clinical pharmacology workforce to support a growing clinical, academic and regulatory need. PMID:26466826

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.

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.

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.

Which Benefits and Harms of Using Fenugreek as a Galactogogue Need to Be Discussed during Clinical Consultations? A Delphi Study among Breastfeeding Women, Gynecologists, Pediatricians, Family Physicians, Lactation Consultants, and Pharmacists

PubMed Central

Qiblawi, Sara; Ghanayem, Haifa

2018-01-01

Background Breastfeeding women with hypogalactia are commonly recommended to use fenugreek as a galactogogue. This study aimed to achieve formal consensus among breastfeeding women and healthcare providers on which potential harms and benefits of using fenugreek need to be communicated and discussed during clinical consultations. Methods A two-iterative round Delphi technique was used in two separate panels of breastfeeding women (n = 65) and healthcare providers (n = 56) to achieve formal consensus on a list of 24 and 16 items related to potential harms and benefits of fenugreek. Results About 70% of the healthcare providers recommended quite often herbal remedies for breastfeeding women and about 68% of the women had been recommended to use herbal remedies many times by their healthcare providers. Consensus was achieved on 21 potential harms and 14 potential benefits of using fenugreek to enhance human milk supply that need to be discussed with breastfeeding women during consultations. Conclusion Probably, potential harms and benefits of recommending fenugreek as herbal galactogogue for breastfeeding women seeking recommendations to increase their human milk supply need to be discussed during clinical consultations. Further observational studies are needed to assess what is being discussed in daily consultations when herbal remedies are recommended. PMID:29849697

Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine

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

Annesley, Thomas M.; Cooks, Robert G.; Herold, David A.

Each year the journal Clinical Chemistry publishes a January special issue on a topic that is relevant to the laboratory medicine community. In January 2016 the topic is mass spectrometry, and the issue is entitled “Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine”. One popular feature in our issues is a Q&A on a topic, clearly in this case mass spectrometry. The journal is assembling a panel of 5-6 experts from various areas of mass spectrometry ranging from instrument manufacturing to practicing clinical chemists. Dick Smith is one of the scientist requested to participate in this special issue Q&A onmore » Mass Spectrometry. The Q&A Transcript is attached« less

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.

Translating eHealth Visions from Strategy to Practice - A Benefit Management Approach.

PubMed

Villumsen, Sidsel; Nøhr, Christian; Faxvaag, Arild

2018-01-01

The municipalities and the Regional Health Authorities in Central Norway have been assigned a mandate to implement a shared electronic health record, Helseplattformen, reflecting the visions set out in the national eHealth white paper 'One Citizen - One Record'. This study identifies and describe anticipated benefit streams of clinical decision support in 'One Citizen - One Record' and the user requirement specification documents of Helseplattformen. This study found that the benefit stream of clinical decision support translates from the health policy visions stated in 'One Citizen - One Record' into Helseplattformen. However, business changes, although a critical element of achieving benefits, were not emphasised in either. This calls for the programme of Helseplattformen to pay careful attention to how the information system and information technology requirements must be accompanied by enabling changes as well as business changes in order to achieve the identified benefits of 'One Citizen - One Record' and Helseplattformen.

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.

The World Already Avoided: Quantifying the Ozone Benefits Achieved by the Montreal Protocol

NASA Astrophysics Data System (ADS)

Chipperfield, Martyn; Dhomse, Sandip; Feng, Wuhu; McKenzie, Richard; Velders, Guus; Pyle, John

2015-04-01

Chlorine and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic Ozone Hole expected to disappear by ~2050. However, we show that by 2014 the Montreal Protocol has already achieved significant benefits for the ozone layer. Using an off-line 3-D atmospheric chemistry model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with benefits for surface UV and climate. A deep Arctic Ozone Hole, with column values <120 DU, would have occurred given the meteorological conditions in 2011. The Antarctic Ozone Hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The ozone decline over northern hemisphere middle latitudes would have continued, more than doubling to ~15% by 2013.

Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

PubMed Central

2012-01-01

Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance. PMID:22233221

Interleaving subthalamic nucleus deep brain stimulation to avoid side effects while achieving satisfactory motor benefits in Parkinson disease

PubMed Central

Zhang, Shizhen; Zhou, Peizhi; Jiang, Shu; Wang, Wei; Li, Peng

2016-01-01

Abstract Background: Deep brain stimulation (DBS) of the subthalamic nucleus is an effective treatment for advanced Parkinson disease (PD). However, achieving ideal outcomes by conventional programming can be difficult in some patients, resulting in suboptimal control of PD symptoms and stimulation-induced adverse effects. Interleaving stimulation (ILS) is a newer programming technique that can individually optimize the stimulation area, thereby improving control of PD symptoms while alleviating stimulation-induced side effects after conventional programming fails to achieve the desired results. Methods: We retrospectively reviewed PD patients who received DBS programming during the previous 4 years in our hospital. We collected clinical and demographic data from 12 patients who received ILS because of incomplete alleviation of PD symptoms or stimulation-induced adverse effects after conventional programming had proven ineffective or intolerable. Appropriate lead location was confirmed with postoperative reconstruction images. The rationale and clinical efficacy of ILS was analyzed. Results: We divided our patients into 4 groups based on the following symptoms: stimulation-induced dysarthria and choreoathetoid dyskinesias, gait disturbance, and incomplete control of parkinsonism. After treatment with ILS, patients showed satisfactory improvement in PD symptoms and alleviation of stimulation-induced side effects, with a mean improvement in Unified PD Rating Scale motor scores of 26.9%. Conclusions: ILS is a newer choice and effective programming strategy to maximize symptom control in PD while decreasing stimulation-induced adverse effects when conventional programming fails to achieve satisfactory outcome. However, we should keep in mind that most DBS patients are routinely treated with conventional stimulation and that not all patients benefit from ILS. ILS is not recommended as the first choice of programming, and it is recommended only when patients have

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 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 of the economic benefit of clinical pharmacy services: 1996-2000.

PubMed

Schumock, Glen T; Butler, Melissa G; Meek, Patrick D; Vermeulen, Lee C; Arondekar, Bhakti V; Bauman, Jerry L

2003-01-01

We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly assigned to reviewers who confirmed inclusion and abstracted key information. Results were compared with those of a similar review of literature published from 1988-1995. In the 59 included articles, the studies were conducted across a variety of practice sites that consisted of hospitals (52%), community pharmacies and clinics (41%), health maintenance organizations (3%), and long-term or intermediate care facilities (3%). They focused on a broad range of clinical pharmacy services such as general pharmacotherapeutic monitoring (47%), target drug programs (20%), disease management programs (10%), and patient education or cognitive services (10%). Compared with the studies of the previous review, a greater proportion of evaluations were conducted in community pharmacies or clinics, and the types of services evaluated tended to be more comprehensive rather than specialized. Articles were categorized by type of evaluation: 36% were considered outcome analyses, 24% full economic analyses, 17% outcome descriptions, 15% cost and outcome descriptions, and 8% cost analyses. Compared with the studies of the previous review, a greater proportion of studies in the current review used more rigorous study designs. Most studies reported positive financial benefits of the clinical pharmacy service evaluated. In 16 studies, a benefit:cost ratio was reported by the authors or was able to be calculated by the reviewers (these ranged from 1.7:1-17.0:1, median 4.68:1). The body of literature from this 5-year period provides continued evidence of the economic benefit of clinical pharmacy services. Although the quality of study design has improved, whenever possible

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.

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.

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

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

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.

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.

Achieving Core Indicators for HIV Clinical Care Among New Patients at an Urban HIV Clinic.

PubMed

Greer, Gillian A; Tamhane, Ashutosh; Malhotra, Rakhi; Burkholder, Greer A; Mugavero, Michael J; Raper, James L; Zinski, Anne

2015-09-01

Following the release of the 2010 National HIV/AIDS Strategy for the United States, the Institute of Medicine (IOM) issued core clinical indicators for measuring health outcomes in HIV-positive persons. As early retention in HIV primary care is associated with improved long-term health outcomes, we employed IOM indicators as a guide to examine a cohort of persons initiating HIV outpatient medical care at a university-affiliated HIV clinic in the Southern United States (January 2007-July 2012). Using indicators for visit attendance, CD4 and viral load laboratory testing frequency, and antiretroviral therapy initiation, we evaluated factors associated with achieving IOM core indicators among care- and treatment-naïve patients during the first year of HIV care. Of 448 patients (mean age = 35 years, 35.7% white, 79.0% male, 58.4% education beyond high school, 35.9% monthly income > $1,000 US, 47.3% uninsured), 84.6% achieved at least four of five IOM indicators. In multivariable analyses, persons with monthly income > $1,000 (ORadj. = 3.71; 95% CI: 1.68-8.19; p = 0.001) and depressive symptoms (ORadj. = 2.13; 95% CI: 1.02-4.45; p = 0.04) were significantly more likely to achieve at least four of the five core indicators, while patients with anxiety symptoms were significantly less likely to achieve these indicators (ORadj. = 0.50; 95% CI: 0.26-0.97; p = 0.04). Age, sex, race, education, insurance status, transportation barriers, alcohol use, and HIV status disclosure to family were not associated with achieving core indicators. Evaluating and addressing financial barriers and anxiety symptoms during the first year of HIV outpatient care may improve individual health outcomes and subsequent achievement of the National HIV/AIDS Strategy.

[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.

A counterfactual p-value approach for benefit-risk assessment in clinical trials.

PubMed

Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

2015-01-01

Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs.

PubMed

Tapuria, Archana; Kalra, Dipak; Kobayashi, Shinji

2013-12-01

The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes.

Relationship between toxicities and clinical benefits of newly approved tyrosine kinase inhibitors in thyroid cancer: A meta-analysis of literature.

PubMed

Ye, Xiaobing; Zhu, Yiping; Cai, Juan

2015-10-01

The aim of this meta-analysis was to analyze the relationship of toxicities and clinical benefits of newly approved lenvatinib and sorafenib to thyroid cancer (TC) in patients. Three major medical databases, PubMed, EMBASE, and ISI web of science were systematically searched to identify all studies on lenvatinib and sorafenib in TC. A meta-analysis was performed to clarify the toxicities and clinical benefits of newly Food and Drug Administration (FDA) approved lenvatinib and sorafenib to thyroid cancer. Ten studies (n = 749) were included which evaluated the toxicities and clinical benefits of newly FDA approved lenvatinib and sorafenib to thyroid cancer. 537 (71.7%) of the 749 patients bearing TC (radioiodine-refractory, differentiated thyroid cancer) clinical benefits from lenvatinib or sorafenib, and serious adverse events occurred in 430 (57.4%) of the 749 patients ([risk ratio (RR) = 1.27, 95% confidence interval (CI) = (1.05-1.53), P = 0.01]). While 31 (4.1%) of the 749 patients died due to various reasons, that mainly accounts for severe bleeding events and cardiac arrest. The clinical benefit is obvious compared to deaths ([RR = 17.06, 95% CI = (12.08-24.11), P < 0.001]). Subgroup analyses were then conducted according to cancer type (radioiodine-refractory thyroid cancer [RR-TC] and TC). We found that in treating RR-TC, the clinical benefits are close to toxicities. While in treating TC, the clinical benefits are better than toxicities. And we found that sorafenib and lenvatinib might be proper to deal with TC (benefits rate 79.7%) compared to RR-TC (benefits rate 69.5%), taking consider of toxicities. Lenvatinib and sorafenib are useful in the treatment of TC. Although, their toxicities remain high (57.4%) in the patients, the death rate is controlled (4.1%). Take consider of toxicities, lenvatinib, and sorafenib are more useful for TC compared to RR-TC.

Which potential harms and benefits of using ginger in the management of nausea and vomiting of pregnancy should be addressed? a consensual study among pregnant women and gynecologists.

PubMed

Shawahna, Ramzi; Taha, Assim

2017-04-08

Nausea and vomiting of pregnancy (NVP) affect approximately 80-90% of the pregnant women. Ginger (Zingiber officinale Roscoe) is the most widely used herbal therapy in the management of NVP. Like conventional therapies, herbal therapies have potential harms and benefits that patients need to be informed about in order to develop their therapy preferences. The aim of this study was to achieve consensus among women who suffered NVP and physicians often consulted by pregnant women on a core list of potential harms and benefits of using ginger to manage NVP to be addressed during clinical consultations. In this study, the Delphi technique was used to achieve consensus on a core list of important harms and benefits of using ginger in the management of NVP to be addressed during the clinical consultation. A Delphi process was followed in two panels in parallel sessions. One panel was composed of 50 gynecologists and other physicians who are often consulted by pregnant women suffering NVP and the other panel was composed of 50 women who suffered NVP. Consensus was achieved on 21 (75%) of the 28 potential harms presented to the panelists. Panelists agreed that potential harms of the anticoagulant effects of ginger, risk with other co-morbidities, and risk of potential allergic reactions are important to address during the clinical consultation. Of the 14 potential benefits presented to the panelists in both panels, consensus was achieved on 13 (92.9%). Partial consensus on 7 potential harms and 1 potential benefit was achieved in both panels. Addressing important potential harms and benefits of using ginger for the management of NVP during the clinical consultations is important in promoting congruence and reducing patient dissatisfaction in clinical practice. Consensus was achieved on a core list of important harms and benefits of using ginger for the management of NVP to be addressed during the clinical consultations by a panel of women and a panel of physicians. Further

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs

PubMed Central

Kalra, Dipak; Kobayashi, Shinji

2013-01-01

Objectives The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Methods Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. Results The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Conclusions Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes. PMID:24523993

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

Sustainable Benefits of a Community Hospital-Based Paediatric Asthma Clinic.

PubMed

Kuzik, Brian A; Chen, Chee P; Hansen, Miriam J; Montgomery, Paula L

2017-01-01

In 2011, we reported that our paediatric asthma clinic (PAC) appeared to significantly reduce the burden of paediatric asthma in our community. Supported by these results, the PAC underwent a gradual threefold expansion while maintaining the same model of care. We now report on the outcome of that expansion and demonstrate that our PAC continues to significantly reduce the burden of paediatric asthma in our community. As previously, newly enrolled PAC patients continue to show a 12-month reduction in asthma-related emergency department (ED) visits and admissions exceeding 60% and 80%, respectively. This consistent short-term benefit, coupled with clinic expansion, has contributed to a significant improvement in our rate of paediatric asthma-related ED visits or hospitalizations when compared to other Ontario hospitals.

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

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

Interleaving subthalamic nucleus deep brain stimulation to avoid side effects while achieving satisfactory motor benefits in Parkinson disease: A report of 12 cases.

PubMed

Zhang, Shizhen; Zhou, Peizhi; Jiang, Shu; Wang, Wei; Li, Peng

2016-12-01

Deep brain stimulation (DBS) of the subthalamic nucleus is an effective treatment for advanced Parkinson disease (PD). However, achieving ideal outcomes by conventional programming can be difficult in some patients, resulting in suboptimal control of PD symptoms and stimulation-induced adverse effects. Interleaving stimulation (ILS) is a newer programming technique that can individually optimize the stimulation area, thereby improving control of PD symptoms while alleviating stimulation-induced side effects after conventional programming fails to achieve the desired results. We retrospectively reviewed PD patients who received DBS programming during the previous 4 years in our hospital. We collected clinical and demographic data from 12 patients who received ILS because of incomplete alleviation of PD symptoms or stimulation-induced adverse effects after conventional programming had proven ineffective or intolerable. Appropriate lead location was confirmed with postoperative reconstruction images. The rationale and clinical efficacy of ILS was analyzed. We divided our patients into 4 groups based on the following symptoms: stimulation-induced dysarthria and choreoathetoid dyskinesias, gait disturbance, and incomplete control of parkinsonism. After treatment with ILS, patients showed satisfactory improvement in PD symptoms and alleviation of stimulation-induced side effects, with a mean improvement in Unified PD Rating Scale motor scores of 26.9%. ILS is a newer choice and effective programming strategy to maximize symptom control in PD while decreasing stimulation-induced adverse effects when conventional programming fails to achieve satisfactory outcome. However, we should keep in mind that most DBS patients are routinely treated with conventional stimulation and that not all patients benefit from ILS. ILS is not recommended as the first choice of programming, and it is recommended only when patients have unsatisfactory control of PD symptoms or stimulation

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.

Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol.

PubMed

Chipperfield, M P; Dhomse, S S; Feng, W; McKenzie, R L; Velders, G J M; Pyle, J A

2015-05-26

Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ∼2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ∼15% by 2013.

Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol

PubMed Central

Chipperfield, M. P.; Dhomse, S. S.; Feng, W.; McKenzie, R. L.; Velders, G.J.M.; Pyle, J. A.

2015-01-01

Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ∼2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ∼15% by 2013. PMID:26011106

Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol

NASA Astrophysics Data System (ADS)

Chipperfield, M. P.; Dhomse, S. S.; Feng, W.; McKenzie, R. L.; Velders, G. J. M.; Pyle, J. A.

2015-05-01

Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ~2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ~15% by 2013.

n-3 fatty acid dietary recommendations and food sources to achieve essentiality and cardiovascular benefits.

PubMed

Gebauer, Sarah K; Psota, Tricia L; Harris, William S; Kris-Etherton, Penny M

2006-06-01

Dietary recommendations have been made for n-3 fatty acids, including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) to achieve nutrient adequacy and to prevent and treat cardiovascular disease. These recommendations are based on a large body of evidence from epidemiologic and controlled clinical studies. The n-3 fatty acid recommendation to achieve nutritional adequacy, defined as the amount necessary to prevent deficiency symptoms, is 0.6-1.2% of energy for ALA; up to 10% of this can be provided by EPA or DHA. To achieve recommended ALA intakes, food sources including flaxseed and flaxseed oil, walnuts and walnut oil, and canola oil are recommended. The evidence base supports a dietary recommendation of approximately 500 mg/d of EPA and DHA for cardiovascular disease risk reduction. For treatment of existing cardiovascular disease, 1 g/d is recommended. These recommendations have been embraced by many health agencies worldwide. A dietary strategy for achieving the 500-mg/d recommendation is to consume 2 fish meals per week (preferably fatty fish). Foods enriched with EPA and DHA or fish oil supplements are a suitable alternate to achieve recommended intakes and may be necessary to achieve intakes of 1 g/d.

Benefits of Personality Characteristics and Self-Efficacy in the Perceived Academic Achievement of Medical Students

ERIC Educational Resources Information Center

Guntern, Sabine; Korpershoek, Hanke; van der Werf, Greetje

2017-01-01

This study investigates the joint impact of personality characteristics and self-efficacy on the perceived academic achievement of medical students on top of their prior high school performance. The sample consisted of medical students in their pre-clinical years. The students' grade point average scores at high school were included as control…

Exploring and Understanding the Benefits of Tutoring Software on Urban Students' Science Achievement: What Are Baltimore City Practitioners' Perspectives?

ERIC Educational Resources Information Center

Pinder, Patrice Juliet

2008-01-01

Historically, very little research that meets the scientifically based standards as defined by the No Child Left Behind Act has been conducted on the effectiveness of educational technology on student achievement. The purpose of this study was to explore and seek to understand urban city teachers' perspectives on the benefits or effects of…

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...

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.

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.

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.

Benefits beyond Achievement? A Comparison of Academic Attitudes and School Satisfaction for Adolescent Girls in Single-Gender and Coeducational Classrooms

ERIC Educational Resources Information Center

Hart, Laura C.

2015-01-01

Overall, the research on the effectiveness of single-gender education is inconclusive. However, research also indicates that some benefits beyond academic achievement may be possible. These findings may be significant for middle school girls, who often struggle with social interactions related to adolescence that create barriers in successfully…

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.

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

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.

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.

[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.

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

Undergraduate Nurse Variables that Predict Academic Achievement and Clinical Competence in Nursing

ERIC Educational Resources Information Center

Blackman, Ian; Hall, Margaret; Darmawan, I Gusti Ngurah.

2007-01-01

A hypothetical model was formulated to explore factors that influenced academic and clinical achievement for undergraduate nursing students. Sixteen latent variables were considered including the students' background, gender, type of first language, age, their previous successes with their undergraduate nursing studies and status given for…

A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials.

PubMed

Chen, Stephanie C; Kim, Scott Yh

2016-12-01

Standard of care pragmatic clinical trials that compare treatments already in use could improve care and reduce costs, but there is considerable debate about the research risks of standard of care pragmatic clinical trials 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. We developed a formal risk-benefit analysis framework for standard of care pragmatic clinical trials and then applied it to key provisions of the US federal regulations. Our formal framework for standard of care pragmatic clinical trial 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 standard of care pragmatic clinical trial, the allocation ratios of treatments inside and outside such a trial, and the significance of some participants receiving a different treatment inside a trial than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to standard of care pragmatic clinical trials. Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of standard of care pragmatic clinical trials and can be used to clarify the implications for informed consent. © The Author(s) 2016.

Realising the Real Benefits of Outsourcing: Measurement Excellence and Its Importance in Achieving Long Term Value

NASA Astrophysics Data System (ADS)

Oshri, Ilan; Kotlarsky, Julia

These days firms are, more than ever, pressed to demonstrate returns on their investment in outsourcing. While the initial returns can always be associated with one-off cost cutting, outsourcing arrangements are complex, often involving inter-related high-value activities, which makes the realisation of long-term benefits from outsourcing ever more challenging. Executives in client firms are no longer satisfied with the same level of service delivery through the outsourcing lifecycle. They seek to achieve business transformation and innovation in their present and future services, beyond satisfying service level agreements (SLAs). Clearly the business world is facing a new challenge: an outsourcing delivery system of high-value activities that demonstrates value over time and across business functions. However, despite such expectations, many client firms are in the dark when trying to measure and quantify the return on outsourcing investments: results of this research show that less than half of all CIOs and CFOs (43%) have attempted to calculate the financial impact of outsourcing to their bottom line, indicating that the financial benefits are difficult to quantify (51%).

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

PubMed

Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal

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

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.

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.

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 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.

Academic training and clinical placement problems to achieve nursing competency

PubMed Central

RAHMATI SHARGHI, NARJES; ALAMI, ALI; KHOSRAVAN, SHAHLA; MANSOORIAN, MOHAMMAD REZA; EKRAMI, ALI

2015-01-01

Introduction: High quality of care is one of the requirements of nursing which depends on the nursing competency. In this connection, the aim of this research was to determine the problems related to the academic training (nursing' educational program) and clinical practice to achieve competency from the viewpoint of nurses, faculty members, and nursing students. Methods: the study was an analytical cross-sectional one. The sample consisted of the academic staff, the third and the fourth year nursing students and nurses in practice. The instrument of the study was a two-part researcher-made questionnaire with 22 questions in the theoretical- clinical realm to assess  problems related to the theoretical and clinical teaching in nursing, and 23 questions to assess the clinical functions. The questionnaire was validated in terms of both face and content validity. Its reliability, using Cronbach's Alpha coefficient, was 0.72 in the theoretical-clinical and 0.73 in the clinical realm. Both descriptive and analytical statistics were used to analyze the data, using SPSS software. Results: The results of this study indicated that from the participants’ viewpoints, the most important problems in the academic education for nursea to acquire competency were as follows: lack of academic research the clinical period (88.9%), no application of theoretical aspects of the nursing process in practice (85.6%), insufficient knowledgeable and professional educators (81.1%), the use of traditional routine-oriented methods on the wards (75.6%); also insufficient time for performance based on knowledge in relation to  the nurse's workload (86.5%), weakness and usefulness of scientific function encouragement systems in clinic (85.2%), and learnt theoretical subjects not coming into practice in clinical fields after graduation (75.6%). Conclusion: Efforts to reduce the gap between the theoretical and practical (clinical function) knowledge in educational and work environment are

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

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England

PubMed Central

Freeman, T; Walshe, K

2004-01-01

Background: A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. Participants: A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Methods: Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Results: Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England.

PubMed

Freeman, T; Walshe, K

2004-10-01

A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission

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

[THE IMPACT OF ACCREDITATION - ACHIEVEMENTS, BENEFITS AND BARRIERS: COMPARING THE VIEWPOINTS OF THE PROCESS LEADERS AND THE HOSPITAL STAFF].

PubMed

Tal, Orna; Rassin, Michal

2018-05-01

Evaluating the impact of the accreditation process on the basis of achievements, benefits and barriers from the viewpoint of leaders of the hospital accreditation in comparison to the hospital staff members. The implementation of standards for accreditation aim to improve the safety and quality of treatment. Partaking in this process has raised dilemmas regarding the actual benefits of accreditation in relation to the efforts invested in its achievement. Examining the standpoints of leaders of the process can reflect on the influence of this mechanism both on hospital activity and on hospital staff. A survey was conducted among two groups: The first group, the JCI accreditation leaders group, included 35 participants (the steering committee, 15 chapter heads and the hospital management); and 71 participants from the extended headquarters (senior physicians, nurses and administration staff). The second group included 564 hospital personnel from the medical, nursing, alternative medicine, administrators and housekeeping staff. The questionnaire included 46 statements in five fields: the effectiveness and benefit from the process, weaknesses, barriers, leadership and administration of the accreditation. All the respondents to the survey perceived the process as a leverage for implementing significant changes in all levels of the organization. There were high levels of agreement on the benefit of the process regarding the effective and affective contribution - high morale, feelings of accomplishment and team pride, improvement in communication, cooperation and social cohesion. The weaknesses of the process, including financial costs, bureaucracy, paper overflow and work overload, were awarded relatively low scores. The advantages of the process were ranked high in both groups; the accreditation leaders group attributed the process benefits to the organization as a whole, ranking it significantly higher, as well as for the individual. The hospital staff rated as

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.

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.

Using Technology, Clinical Workflow Redesign, and Team Solutions to Achieve the Patient Centered Medical Home

DTIC Science & Technology

2011-01-01

The Quadruple Aim: Working Together, Achieving Success 2011 Military Health System Conference TMA and Services Using Technology, Clinical Workflow...Redesign, and Team Solutions to Achieve the Patient Centered Medical Home LTC Nicole Kerkenbush, MHA, MN Army Medical Department, Office of the...Surgeon General Chief Medical Information Officer 1 Military Health System Conference Report Documentation Page Form ApprovedOMB No. 0704-0188 Public

Self-regulated learning strategies used in surgical clerkship and the relationship with clinical achievement.

PubMed

Turan, Sevgi; Konan, Ali

2012-01-01

Self-regulated learning indicates students' skills in controlling their own learning. Self-regulated learning, which a context-specific process, emphasizes autonomy and control. Students gain more autonomy with respect to learning in the clinical years. Examining the self-regulated learning skills of students in this period will provide important clues about the level at which students are ready to use these skills in real-life conditions. The self-regulated learning strategies used by medical students in surgical clerkship were investigated in this study and their relation with clinical achievement was analyzed. The study was conducted during the surgery clerkship of medical students. The participation rate was 94% (309 students). Motivated Strategies for Learning Questionnaire (MSLQ), a case-based examination, Objective Structured Clinical Examination (OSCE), and tutor evaluations for assessing achievement were used. The relationship between the Motivated Strategies for Learning Questionnaire scores of the students and clinical achievement was analyzed with multilinear regression analysis. The findings showed that students use self-regulated learning skills at medium levels during their surgery clerkship. A relationship between these skills and OSCE scores and tutor evaluations was determined. OSCE scores of the students were observed to increase in conjunction with increased self-efficacy levels. However, as students' beliefs regarding control over learning increased, OSCE scores decreased. No significant relationship was defined between self-regulated learning skills and case-based examination scores. We observed that a greater self-efficacy for learning resulted in higher OSCE scores. Conversely, students who believe that learning is a result of their own effort had lower OSCE scores. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

A holistic approach on the neurological benefits of music.

PubMed

Jimenez-Dabdoub, Lily; Catterall, Jenn

2015-09-01

A holistic perspective on human beings allows health carers to achieve an understanding of all the physiological, psychological and social disturbances of the patient as a whole. Through this article we wish to focus on how music has holistic neurological benefits. Music-therapy interventions can be more accessible and even "self-managed" by the patient's relatives. They can reinforce social cohesion, family ties and patients' self-esteem and thus produce a better quality of life. Overall, it is important to consider the benefits that an evolutionary understanding of musical behaviour and a holistic clinical perspective of the role of music may bring for rehabilitation of a wide range of symptoms and conditions.

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

[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.

Clinical Benefits of Joint Mobilization on Ankle Sprains: A Systematic Review and Meta-Analysis.

PubMed

Weerasekara, Ishanka; Osmotherly, Peter; Snodgrass, Suzanne; Marquez, Jodie; de Zoete, Rutger; Rivett, Darren A

2018-07-01

To assess the clinical benefits of joint mobilization for ankle sprains. MEDLINE, MEDLINE In-Process, Embase, AMED, PsycINFO, CINAHL, Cochrane Library, PEDro, Scopus, SPORTDiscus, and Dissertations and Theses were searched from inception to June 2017. Studies investigating humans with grade I or II lateral or medial sprains of the ankle in any pathologic state from acute to chronic, who had been treated with joint mobilization were considered for inclusion. Any conservative intervention was considered as a comparator. Commonly reported clinical outcomes were considered such as ankle range of movement, pain, and function. After screening of 1530 abstracts, 56 studies were selected for full-text screening, and 23 were eligible for inclusion. Eleven studies on chronic sprains reported sufficient data for meta-analysis. Data were extracted using the participants, interventions, comparison, outcomes, and study design approach. Clinically relevant outcomes (dorsiflexion range, proprioception, balance, function, pain threshold, pain intensity) were assessed at immediate, short-term, and long-term follow-up points. Methodological quality was assessed independently by 2 reviewers, and most studies were found to be of moderate quality, with no studies rated as poor. Meta-analysis revealed significant immediate benefits of joint mobilization compared with comparators on improving posteromedial dynamic balance (P=.0004), but not for improving dorsiflexion range (P=.16), static balance (P=.96), or pain intensity (P=.45). Joint mobilization was beneficial in the short-term for improving weight-bearing dorsiflexion range (P=.003) compared with a control. Joint mobilization appears to be beneficial for improving dynamic balance immediately after application, and dorsiflexion range in the short-term. Long-term benefits have not been adequately investigated. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Academic achievement and primary care specialty selection of volunteers at a student-run free clinic.

PubMed

Vaikunth, Sumeet S; Cesari, Whitney A; Norwood, Kimberlee V; Satterfield, Suzanne; Shreve, Robert G; Ryan, J Patrick; Lewis, James B

2014-01-01

Previous studies have reached conflicting conclusions about the associations between service and academic achievement and service and primary care specialty choice. This study examines the associations between service at a student-run clinic and academic achievement and primary care specialty choice. Retrospective review of medical student service and statistical analysis of grade point average (GPA), Step 1 and Step 2 Clinical Knowledge (CK) scores, and specialty choice were conducted, as approved by our Institutional Review Board. Volunteers, compared to nonvolunteers, had higher GPA (3.59 ± 0.33 vs. 3.40 ± 0.39, p < .001), Step 1 (229 ± 19 vs. 220 ± 21, p < .001), and Step 2 CK (240 ± 18 vs. 230 ± 21, p < .001) scores, but did not pursue primary care specialties at a significantly higher percentage (52% vs. 51%, χ² = .051, p = .82). Further exploration of the associations between service and academic achievement and primary care specialty choice is warranted.

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

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

Achievements in Stratospheric Ozone Protection

EPA Pesticide Factsheets

This report describes achievements in protecting the ozone layer, the benefits of these achievements, and strategies involved (e.g., using alternatives to ozone-depleting substances, phasing out harmful substances, and creating partnerships).

Actualizing system benefits--Part II.

PubMed

Zinn, T K; DiGiulio, L W

1988-05-01

Do benefits impact the psychology of the information system buying decision? Is system success tied to achieving "promoted" benefits? Part II of this series reveals responses from a survey of some 3,000 executives about the importance of qualitative and quantitative benefits in the "buying process."

Clinical use of three-dimensional video measurements of eye movements

NASA Technical Reports Server (NTRS)

Merfeld, D. M.; Black, F. O.; Wade, S.; Paloski, W. H. (Principal Investigator)

1998-01-01

Noninvasive measurements of three-dimensional eye position can be accurately achieved with video methods. A case study showing the potential clinical benefit of these enhanced measurements is presented along with some thoughts about technological advances, essential for clinical application, that are likely to occur in the next several years.

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

Cross-Domain Effects of Achievement Goals: Social Costs and Benefits

ERIC Educational Resources Information Center

Barrera, Andrea Eugenia; Schuster, Beate

2018-01-01

In this research, we examined cross-domain effects of achievement goals. In two experimental studies, we manipulated achievement goals and assessed social reactions towards a hypothetical (study 1) and a real (study 2) target. Measurement of social reactions included prosocial behaviours such as helping, sharing and cooperating with others.…

Student Team Achievement Divisions (STAD) Technique through the Moodle to Enhance Learning Achievement

ERIC Educational Resources Information Center

Tiantong, Monchai; Teemuangsai, Sanit

2013-01-01

One of the benefits of using collaborative learning is enhancing learning achievement and increasing social skills, and the second benefits is as the more students work together in collaborative groups, the more they understand, retain, and feel better about themselves and their peers, moreover working together in a collaborative environment…

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

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.

What Happens to the Fish's Achievement in a Little Pond? A Simultaneous Analysis of Class-Average Achievement Effects on Achievement and Academic Self-Concept

ERIC Educational Resources Information Center

Stäbler, Franziska; Dumont, Hanna; Becker, Michael; Baumert, Jürgen

2017-01-01

Empirical studies have demonstrated that students who are taught in a group of students with higher average achievement benefit in terms of their achievement. However, there is also evidence showing that being surrounded by high-achieving students has a negative effect on students' academic self-concept, also known as the big-fish--little-pond…

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.

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/.

Substantial Air Quality and Climate Co-benefits Achievable Now with Industrial Efficiency Improvements in China

NASA Astrophysics Data System (ADS)

Mauzerall, D. L.; Peng, W.; Wagner, F.; Yang, J.

2016-12-01

China is the world's top carbon emitter and suffers from severe air pollution. It has recently made commitments to improve air quality and peak its carbon emissions by 2030. Here we examine near-term air quality and implications for CO2 emissions of various sector-based policies in China that are widely discussed and technically plausible for immediate implementation. For each sector, we consider the effect of a 20% increase in the installation rate of available air pollution control devices, along with the following sector-specific policies. Power sector (POW): 80% replacement of small coal power plants with larger more efficient ones; Industry sector (IND): 20% improvement in energy efficiency; Transport sector (TRA): replacement of high emitters with average vehicle fleet emissions; and Residential sector (RES): replacement of 20% of coal-based stoves with those using liquefied petroleum gas. We conduct an integrated assessment using the air pollution model WRF-Chem and epidemiological concentration-response relationships to evaluate a 2015 base case and various counterfactual scenarios. We find that the IND scenario would reduce both the total national air-pollution-related deaths and carbon emissions the most of the four sectorial scenarios examined. Benefits of addressing the industrial sector remain large even when efficiency improvements are smaller than 20%. Moreover, we find that simultaneously implementing all the measures in all four sectors (combined, COMB) leads to slightly larger air quality and health benefits than obtained by summing the benefits achieved from the four sectorial scenarios individually. This is because nonlinearity in atmospheric chemistry leads to a larger reduction in fine particulate concentrations when emissions from all sectors are reduced simultaneously. The resulting lower concentrations imply a lower position on the concave human premature mortality relative risk curve with fewer associated deaths. While much effort has

The Economic Benefits of Closing Educational Achievement Gaps: Promoting Growth and Strengthening the Nation by Improving the Educational Outcomes of Children of Color

ERIC Educational Resources Information Center

Lynch, Robert G.; Oakford, Patrick

2014-01-01

Our nation is currently experiencing growing levels of income and wealth inequality, which are contributing to longstanding racial and ethnic gaps in education outcomes and other areas. This report quantifies the economic benefits of closing one of the most harmful racial and ethnic gaps: the educational achievement gap that exists between black…

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

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.

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.

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.

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

The Use of Group Activities in Introductory Biology Supports Learning Gains and Uniquely Benefits High-Achieving Students†

PubMed Central

Marbach-Ad, Gili; Rietschel, Carly H.; Saluja, Neeti; Carleton, Karen L.; Haag, Eric S.

2016-01-01

This study describes the implementation and effectiveness of small-group active engagement (GAE) exercises in an introductory biology course (BSCI207) taught in a large auditorium setting. BSCI207 (Principles of Biology III—Organismal Biology) is the third introductory core course for Biological Sciences majors. In fall 2014, the instructors redesigned one section to include GAE activities to supplement lecture content. One section (n = 198) employed three lectures per week. The other section (n = 136) replaced one lecture per week with a GAE class. We explored the benefits and challenges associated with implementing GAE exercises and their relative effectiveness for unique student groups (e.g., minority students, high- and low-grade point average [GPA] students). Our findings show that undergraduates in the GAE class exhibited greater improvement in learning outcomes than undergraduates in the traditional class. Findings also indicate that high-achieving students experienced the greatest benefit from GAE activities. Some at-risk student groups (e.g., two-year transfer students) showed comparably low learning gains in the course, despite the additional support that may have been afforded by active learning. Collectively, these findings provide valuable feedback that may assist other instructors who wish to revise their courses and recommendations for institutions regarding prerequisite coursework approval policies. PMID:28101262

The Use of Group Activities in Introductory Biology Supports Learning Gains and Uniquely Benefits High-Achieving Students.

PubMed

Marbach-Ad, Gili; Rietschel, Carly H; Saluja, Neeti; Carleton, Karen L; Haag, Eric S

2016-12-01

This study describes the implementation and effectiveness of small-group active engagement (GAE) exercises in an introductory biology course (BSCI207) taught in a large auditorium setting. BSCI207 (Principles of Biology III-Organismal Biology) is the third introductory core course for Biological Sciences majors. In fall 2014, the instructors redesigned one section to include GAE activities to supplement lecture content. One section ( n = 198) employed three lectures per week. The other section ( n = 136) replaced one lecture per week with a GAE class. We explored the benefits and challenges associated with implementing GAE exercises and their relative effectiveness for unique student groups (e.g., minority students, high- and low-grade point average [GPA] students). Our findings show that undergraduates in the GAE class exhibited greater improvement in learning outcomes than undergraduates in the traditional class. Findings also indicate that high-achieving students experienced the greatest benefit from GAE activities. Some at-risk student groups (e.g., two-year transfer students) showed comparably low learning gains in the course, despite the additional support that may have been afforded by active learning. Collectively, these findings provide valuable feedback that may assist other instructors who wish to revise their courses and recommendations for institutions regarding prerequisite coursework approval policies.

"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.

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.

[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.

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

Connecting Medical Records: An Evaluation of Benefits and Challenges for Primary Care Practices.

PubMed

Compeau, Deborah Ruth; Terry, Amanda

2017-06-30

Implementation of systems to support health information sharing has lagged other areas of healthcare IT, yet offers a strong possibility for benefit.  Clinical acceptance is a key limiting factor in health IT adoption. To assess the benefits and challenges experienced by clinicians using a custom-developed health information exchange system, and to show how perceptions of benefits and challenges influence perceptions of productivity and care-related outcomes. We used a mixed methods design with two phases. First, we conducted interviews with stakeholders who were familiar with the health information exchange system to inform the development of a measure of benefits and challenges of the use of this system. Second, using this measure we conducted a survey of current and former users of the health information exchange system using a modified Dillman method. 105 current and former users completed the survey. The results showed information quality, ease of completing tasks and clinical process improvement as key benefits that reduced workload and improved patient care.  Challenges related to system reliability, quality of reports and service quality increased workload and decreased impact on care, though the effect of the challenges was smaller than that of the benefits.  Even very limited health information exchange capabilities can improve outcomes for primary care users.  Improving perceptions of benefits may be even more important the removing challenges to use, though it is likely that a threshold of quality must be achieved for this to be true.

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.

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.

The air quality and health co-benefits of alternative post-2020 pathways for achieving peak carbon targets in Jiangsu, China

NASA Astrophysics Data System (ADS)

Liu, M.; Bi, J.; Huang, Y.; Kinney, P. L.

2016-12-01

Jiangsu, which has three national low-carbon pilot cities, is set to be a model province in China for achieving peak carbon targets before 2030. However, according to local planning of responding to climate change, carbon emissions are projected to keep going up before 2020 even the strictest measures are implemented. In other words, innovative measures must be in action after 2020. This work aimed at assessing the air quality and health co-benefits of alternative post-2020 measures to help remove barriers of policy implementation through tying it to local incentives for air quality improvement. To achieve the aim, we select 2010 as baseline year and develop Bussiness As Usual (BAU) and Traditional Carbon Reduction (TCR) scenarios before 2020. Under BAU, only existing climate and air pollution control policies are considered; under TCR, potential climate policies in local planning and existing air pollution control policies are considered. After 2020, integrated gasification combined cycle (IGCC) plant with carbon capture and storage (CCS) technology and large-scale substitution of renewable energy seem to be two promising pathways for achieving peak carbon targets. Therefore, two additional scenarios (TCR-IGCC and TCR-SRE) are set after 2020. Based on the projections of future energy balances and industrial productions, we estimate the pollutant emissions and simulate PM2.5 and ozone concentrations by 2017, 2020, 2030 and 2050 using CMAQ. Then using health impact assessment approach, the premature deaths are estimated and monetized. Results show that the carbon peak in Jiangsu will be achieved before 2030 only under TCR-IGCC and TCR-SRE scenarios. Under three policy scenarios, Jiangsu's carbon emission control targets would have substantial effects on primary air pollutant emissions far beyond those we estimate would be needed to meet the PM2.5 concentration targets in 2017. Compared with IGCC with CCS, large-scale substitutions of renewable energy bring

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

Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes.

PubMed

Oster, Gerry; Sullivan, Sean D; Dalal, Mehul R; Kazemi, Mahmood R; Rojeski, Maria; Wysham, Carol H; Sung, Jennifer; Johnstone, Bryan; Cali, Anna M G; Wei, L J; Traylor, Louise; Anhalt, Henry; Hull, Michelle; Van Vleet, John; Meneghini, Luigi F

2016-11-01

This study aims to compare the effectiveness of insulin glargine 300 U/mL (Gla-300) with its accompanying patient support program with that of other basal insulin and available patient support programs in patients with type 2 diabetes (T2D) in a real-world setting in terms of achieving HEDIS (Healthcare Effectiveness Data and Information Set) individualized glycemic targets without documented symptomatic hypoglycemia. Achieve Control is a US-based, multicenter, randomized, open-label, active-controlled, parallel group pragmatic Phase IV trial in insulin-naïve patients with T2D uncontrolled on ≥2 oral antidiabetes drugs (OAD) and/or glucagon-like peptide-1 receptor antagonists (GLP-1 RA). Inclusion criteria include a diagnosis of T2D, age ≥18 years, and glycated hemoglobin (HbA1c) between 8.0% and 11.0%. Patients will be assigned to either the Gla-300 or other basal insulin group. The primary end point is the proportion of patients achieving HEDIS HbA1c targets (<8.0% [64 mmol/mol] in patients with comorbidities or aged ≥65 years; <7.0% [58 mmol/mol] in all other patients) without occurrence of symptomatic hypoglycemia (blood glucose ≤70 mg/dL) from baseline to 6 months. Secondary end points include rates of documented symptomatic nocturnal hypoglycemia and severe hypoglycemia; change from baseline in HbA1c, fasting glucose, and body weight; treatment persistence; patient-reported outcomes; and healthcare resource utilization. Planned enrollment is 3270 patients across approximately 400 clinical sites. Pragmatic clinical trials offer the potential to assess comparative effectiveness in broadly based patient populations receiving care (with or without a corresponding educational support program) in real-world clinical settings. The results of Achieve Control should elucidate the benefits of management of T2D with Gla-300 versus other basal insulins in terms of patient outcomes, experiences, and perceptions, and its impact on healthcare resource

The clinical impact of continuing to prescribe antiretroviral therapy in patients with advanced AIDS who manifest no virologic or immunologic benefit.

PubMed

Wohl, David A; Kendall, Michelle A; Feinberg, Judith; Alston-Smith, Beverly; Owens, Susan; Chafey, Suzette; Marco, Michael; Maxwell, Sharon; Benson, Constance; Keiser, Philip; van der Horst, Charles; Jacobson, Mark A

2013-01-01

Despite the efficacy and tolerability of modern antiretroviral therapy (ART), many patients with advanced AIDS prescribed these regimens do not achieve viral suppression or immune reconstitution as a result of poor adherence, drug resistance, or both. The clinical outcomes of continued ART prescription for such patients have not been well characterized. We examined the causes and predictors of all-cause mortality, AIDS-defining conditions, and serious non-AIDS-defining events among a cohort of participants in a clinical trial of pre-emptive therapy for CMV disease. We focused on participants who, despite ART had failed to achieve virologic suppression and substantive immune reconstitution. 233 ART-receiving participants entered with a median baseline CD4+ T cell count of 30/mm(3) and plasma HIV RNA of 5 log10 copies/mL. During a median 96 weeks of follow-up, 24.0% died (a mortality rate of 10.7/100 patient-years); 27.5% reported a new AIDS-defining condition, and 22.3% a new serious non-AIDS event. Of the deaths, 42.8% were due to an AIDS-defining condition, 44.6% were due to a non-AIDS-defining condition, and 12.5% were of unknown etiology. Decreased risk of mortality was associated with baseline CD4+ T cell count ≥25/mm(3) and lower baseline HIV RNA. Among patients with advanced AIDS prescribed modern ART who achieve neither virologic suppression nor immune reconstitution, crude mortality percentages appear to be lower than reported in cohorts of patients studied a decade earlier. Also, in contrast to the era before modern ART became available, nearly half of the deaths in our modern-era study were caused by serious non-AIDS-defining events. Even among the most advanced AIDS patients who were not obtaining apparent immunologic and virologic benefit from ART, continued prescription of these medications appears to alter the natural history of AIDS--improving survival and shifting the causes of death from AIDS- to non-AIDS-defining conditions.

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.

Exploring the benefits of a stroke telemedicine programme: An organisational and societal perspective.

PubMed

Bagot, Kathleen L; Bladin, Christopher F; Vu, Michelle; Kim, Joosup; Hand, Peter J; Campbell, Bruce; Walker, Alison; Donnan, Geoffrey A; Dewey, Helen M; Cadilhac, Dominique A

2016-12-01

We undertook a qualitative analysis to identify the broader benefits of a state-wide acute stroke telemedicine service beyond the patient-clinician consultation. Since 2010, the Victorian Stroke Telemedicine (VST) programme has provided a clinical service for regional hospitals in Victoria, Australia. The benefits of the Victorian Stroke Telemedicine programme were identified through document analysis of governance activities, including communications logs and reports from hospital co-ordinators of the programme. Discussions with the Victorian Stroke Telemedicine management were undertaken and field notes were also reviewed. Several benefits of telemedicine were identified within and across participating hospitals, as well as for the state government and community. For hospitals, standardisation of clinical processes was reported, including improved stroke care co-ordination. Capacity building occurred through professional development and educational workshops. Enhanced networking, and resource sharing across hospitals was achieved between hospitals and organisations. Governments leveraged the Victorian Stroke Telemedicine programme infrastructure to provide immediate access to new treatments for acute stroke care in regional areas. Standardised data collection allowed routine quality of care monitoring. Community awareness of stroke symptoms occurred with media reports on the novel technology and improved patient outcomes. The value of telemedicine services extends beyond those involved in the clinical consultation to healthcare funders and the community. © The Author(s) 2016.

Economic Benefits of Achieving Realistic Smoking Cessation Targets in Australia

PubMed Central

Cadilhac, Dominique; Sheppard, Lauren; Cumming, Toby; Pearce, Dora; Carter, Rob

2011-01-01

Objectives. We estimated the economic impact of reductions in the prevalence of tobacco smoking on health, production, and leisure in the 2008 Australian population. Methods. We selected a prevalence target of 15%. Cohort lifetime health benefits were modeled as fewer incident cases of tobacco-related diseases, deaths, and disability-adjusted life-years. We estimated production gains by comparing surveyed participation and absenteeism rates of adult smokers and ex-smokers valued according to the human capital and friction cost approaches. We estimated household production and leisure gains from time use surveys and valued these gains with the appropriate proxy. Results. In the 2008 Australian population, an absolute reduction in smoking prevalence of 8% would result in 158 000 fewer incident cases of disease, 5000 fewer deaths, 2.2 million fewer lost working days, and 3000 fewer early retirements and would reduce health sector costs by AUD 491 million. The gain in workforce production was AUD 415 million (friction cost) or AUD 863 million (human capital), along with gains of 373 000 days of household production and 23 000 days of leisure time. Conclusions. Lowering smoking prevalence rates can lead to substantial economic savings and health benefits. PMID:21164092

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.

[Clinical ecomomics: a pleading for complementing the medical curriculum and specialty training].

PubMed

Porzsolt, F; Weiss, M; Hege-Scheuing, G; Fangerau, H

2010-11-01

Clinical economics requires an understanding of clinical relationships just like health economy requires an understanding of economic relationships. Hitherto we have ensured that economists can differentiate symptoms from diagnoses and diagnostics from screening at the interface between medicine and economy. However, we overlooked the fact that physicians should be able to understand the principles of marginal benefit and medical ethics, as well as the differences among efficacy, effectiveness, and benefit, to be able to make sound decisions. To make up for this neglected demand, we present our definition of clinical economics, identify the potential conflicts between medical professionalism and commercialized medicine, describe the importance - but also the limits - of scientific evidence, explain the difference between 'prioritization' and strict rationing, and attempt to justify the fact that the necessary changes in the provision of healthcare will probably only be achieved if we instill this new way of thinking in medical students during their medical education. Complementing the medical curriculum with clinical economics would achieve this goal. © Georg Thieme Verlag KG Stuttgart · New York.

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

Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission.

PubMed

Lichtenstein, Gary R; Gordon, Glenn L; Zakko, Salam; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ron; Barrett, Andrew C; Bortey, Enoch; Paterson, Craig; Forbes, William P

2016-01-01

Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults. Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission. Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months. Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25-0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31-0.84; P = 0.009) that was sustained during the OLE. MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. CLINICALTRIALS.GOV: NCT00744016, NCT00767728, and NCT00326209.

A risk-benefit assessment of paracetamol (acetaminophen) combined with caffeine.

PubMed

Palmer, Hazel; Graham, Garry; Williams, Kenneth; Day, Richard

2010-06-01

To determine the risk: benefit of paracetamol combined with caffeine in the short-term management of acute pain conditions. Database searches were conducted to identify double-blind trials comparing paracetamol/caffeine with paracetamol alone (benefit analysis) and any data pertaining to hepatotoxicity of paracetamol when combined with caffeine (risk analysis). Paracetamol/caffeine (1,000 mg/130 mg) vs paracetamol (1,000 mg) alone. Assessment of benefit has been derived by meta-analysis. Information on the pain condition and number of patients studied, dosing regimen, study design and analgesic outcome measures (total pain relief scores) was extracted and dichotomous outcomes were obtained by calculating the number of patients in each treatment group who achieved at least 50% of the maximum total pain relief score. Assessment of risk has been made by appraisal of the literature. Eight studies from four papers provided sufficient quantitative data for satisfactory meta-analysis. The relative benefit (of achieving at least 50% pain relief) of paracetamol/caffeine vs paracetamol alone was 1.12 (95% Confidence Interval 1.05-1.19) across a number of acute pain states (dysmenorrhoea, headache, post-partum pain, and dental pain). Review of the effects of the combination of paracetamol and caffeine on the liver revealed no compelling data to suggest a clinically meaningful increase in hepatotoxicity with use of paracetamol/caffeine combinations. Paracetamol/caffeine (1,000 mg/130 mg) is effective and safe for use in acute management of pain. The hepatotoxicity of overdoses of paracetamol results from its oxidative metabolism, caffeine does not produce any increase in oxidative metabolism of therapeutic concentrations of paracetamol.

Clinical benefits and oncologic equivalence of self-expandable metallic stent insertion for right-sided malignant colonic obstruction.

PubMed

Ji, Woong Bae; Kwak, Jung Myun; Kang, Dong Woo; Kwak, Han Deok; Um, Jun Won; Lee, Sun-Il; Min, Byung-Wook; Sung, Nak Song; Kim, Jin; Kim, Seon Hahn

2017-01-01

The efficacy of stenting for right-sided malignant colonic obstruction is unknown. This study aimed to evaluate the safety, feasibility, and clinical benefits of self-expandable metallic stent insertion for right-sided malignant colonic obstruction. Clinical data from patients who underwent right hemicolectomy for right colon cancer from January 2006 to July 2014 at three Korea University hospitals were retrospectively reviewed. A total of 39 patients who developed malignant obstruction in the right-sided colon were identified, and their data were analyzed. Stent insertion was attempted in 16 patients, and initial technical success was achieved in 14 patients (87.5 %). No stent-related immediate complications were reported. Complete relief from obstruction was achieved in all 14 patients. Twenty-five patients, including two patients who failed stenting, underwent emergency surgery. In the stent group, 93 % (13/14) of patients underwent elective laparoscopic surgery, and only one surgery was converted to an open procedure. All patients in the emergency group underwent emergency surgery within 24 h of admission. In the emergency group, only 12 % (3/25) of patients underwent laparoscopic surgery, with one surgery converted to an open procedure. All patients in both groups underwent either laparoscopy-assisted or open right/extended right hemicolectomy with primary anastomoses as the first operation. The operative times, retrieved lymph nodes, and pathologic stage did not differ between the two groups. Postoperative hospital stay (9.4 ± 3.4 days in the stent group vs. 12.4 ± 5.9 in the emergency group, p = 0.089) and time to resume oral food intake (3.2 ± 2.1 days in the stent group vs. 5.7 ± 3.4 in the emergency group, p = 0.019) were shorter in the stent group. And there were no significant differences in disease-free survival and overall survival between the two groups. Stent insertion appears to be safe and feasible in patients with right

Metronidazole stewardship initiative at Christchurch hospitals-achievable with immediate benefits.

PubMed

Gardiner, Sharon J; Metcalf, Sarah Cl; Chin, Paul Kl; Doogue, Matthew P; Dalton, Simon C; Chambers, Stephen T

2018-04-13

To evaluate an antimicrobial stewardship (AMS) initiative to change hospital prescribing practice for metronidazole. In October 2015, the Canterbury District Health Board (CDHB) AMS committee changed advice for metronidazole to promote two times daily dosing for most indications, prioritisation of the oral route and avoidance of double anaerobic cover. Adoption of the initiative was facilitated via change in prescribing guidelines, education and ongoing pharmacy support. Usage and expenditure on metronidazole for adult inpatients were compared for the five years pre- and two years post-change. Other district health boards (DHBs) were surveyed to determine their dosing recommendation for metronidazole IV. Mean annual metronidazole IV use, as defined daily doses per 1,000 occupied bed days, decreased by 43% post-initiative. Use of non-IV (oral or rectal) formulations increased by 104%. Total savings associated with the initiative were approximately $33,400 in drug costs plus $78,200 per annum in IV giving sets and post-dose flushes. Twelve of 20 (60%) DHBs (including CDHB) endorse twice daily IV dosing. In addition to financial savings, reduction in IV doses has potential benefits, including avoidance of IV catheter-associated complications such as bloodstream infections. Approaches to metronidazole dosing vary across DHBs and could benefit from national coordination.

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.

20 CFR 416.1225 - An approved plan to achieve self-support; general.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will not...

20 CFR 416.1225 - An approved plan to achieve self-support; general.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will not...

“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.

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

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.

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

Expected benefits of federally-funded thermal energy storage research

NASA Astrophysics Data System (ADS)

Spanner, G. E.; Daellenbach, K. K.; Hughes, K. R.; Brown, D. R.; Drost, M. K.

1992-09-01

Pacific Northwest Laboratory (PNL) conducted this study for the Office of Advanced Utility Concepts of the US Department of Energy (DOE). The objective of this study was to develop a series of graphs that depict the long-term benefits of continuing DOE's thermal energy storage (TES) research program in four sectors: building heating, building cooling, utility power production, and transportation. The study was conducted in three steps. The first step was to assess the maximum possible benefits technically achievable in each sector. In some sectors, the maximum benefit was determined by a 'supply side' limitation, and in other sectors, the maximum benefit is determined by a 'demand side' limitation. The second step was to apply economic cost and diffusion models to estimate the benefits that are likely to be achieved by TES under two scenarios: (1) with continuing DOE funding of TES research; and (2) without continued funding. The models all cover the 20-year period from 1990 to 2010. The third step was to prepare graphs that show the maximum technical benefits achievable, the estimated benefits with TES research funding, and the estimated benefits in the absence of TES research funding. The benefits of federally-funded TES research are largely in four areas: displacement of primary energy, displacement of oil and natural gas, reduction in peak electric loads, and emissions reductions.

Integration of PKPD relationships into benefit-risk analysis.

PubMed

Bellanti, Francesco; van Wijk, Rob C; Danhof, Meindert; Della Pasqua, Oscar

2015-11-01

Despite the continuous endeavour to achieve high standards in medical care through effectiveness measures, a quantitative framework for the assessment of the benefit-risk balance of new medicines is lacking prior to regulatory approval. The aim of this short review is to summarise the approaches currently available for benefit-risk assessment. In addition, we propose the use of pharmacokinetic-pharmacodynamic (PKPD) modelling as the pharmacological basis for evidence synthesis and evaluation of novel therapeutic agents. A comprehensive literature search has been performed using MESH terms in PubMed, in which articles describing benefit-risk assessment and modelling and simulation were identified. In parallel, a critical review of multi-criteria decision analysis (MCDA) is presented as a tool for characterising a drug's safety and efficacy profile. A definition of benefits and risks has been proposed by the European Medicines Agency (EMA), in which qualitative and quantitative elements are included. However, in spite of the value of MCDA as a quantitative method, decisions about benefit-risk balance continue to rely on subjective expert opinion. By contrast, a model-informed approach offers the opportunity for a more comprehensive evaluation of benefit-risk balance before extensive evidence is generated in clinical practice. Benefit-risk balance should be an integral part of the risk management plan and as such considered before marketing authorisation. Modelling and simulation can be incorporated into MCDA to support the evidence synthesis as well evidence generation taking into account the underlying correlations between favourable and unfavourable effects. In addition, it represents a valuable tool for the optimization of protocol design in effectiveness trials. © 2015 The British Pharmacological Society.

Clinical engagement: improving healthcare together.

PubMed

Riches, E; Robson, B

2014-02-01

Clinical engagement can achieve lasting change in the delivery of healthcare. In October 2011, Healthcare Improvement Scotland formulated a clinical engagement strategy to ensure that a progressive and sustainable approach to engaging healthcare professionals is firmly embedded in its health improvement and public assurance activities. The strategy was developed using a 90-day process, combining an evidence base of best practice and feedback from semi-structured interviews and focus groups. The strategy aims to create a culture where clinicians view working with Healthcare Improvement Scotland as a worthwhile venture, which offers a number of positive benefits such as training, career development and research opportunities. The strategy works towards developing a respectful partnership between Healthcare Improvement Scotland, the clinical community and key stakeholders whereby clinicians' contributions are recognised in a non-financial reward system. To do this, the organisation needs a sustainable infrastructure and an efficient, cost-effective approach to clinical engagement. There are a number of obstacles to achieving successful clinical engagement and these must be addressed as key drivers in its implementation. The implementation of the strategy is supported by an action and resource plan, and its impact will be monitored by a measurement plan to ensure the organisation reviews its approaches towards clinical engagement.

Clinical and economic impact of clinical pharmacy service on hyperlipidemic management in Hong Kong.

PubMed

Chung, Jennifer S T; Lee, Kenneth K C; Tomlinson, Brian; Lee, Vivian W Y

2011-03-01

To assess the clinical and economic outcomes of a clinical pharmacy service (CPS) in dyslipidemic management. This was a 24-month prospective controlled trial conducted at the lipid clinic of a public hospital in Hong Kong. In the intervention group, a clinical pharmacist assessed low-density lipoprotein cholesterol (LDL-C) levels and provided recommendations in accordance to the Adult Treatment Panel III (ATP III) guidelines. Medication compliance and the proper use of drugs were assessed. Education on healthy lifestyles was reinforced. Monthly telephone follow-ups were made to check on the progress of patients. In the control group, patients received usual medical care with no pharmacist intervention. Primary outcome was the percentage of patients achieving the ATP III LDL-C goal at the end of study. The estimated cost of such service was also evaluated. A total of 300 patients were recruited into the study (150 in intervention group and 150 in control group). In the intervention group, 58.7% patients achieved LDL-C goals compared with 45.3% in the control group (P < .05). The intervention group achieved 26.4%, 17.4%, and 30.0% mean reduction in LDL-C, total cholesterol (TC), and triglycerides (TG) levels, respectively, compared with 12.6%, 6.6%, and 11.5% in the control group (P < .05). The estimated cost for this clinical service was US$385/month for a total of 600 dyslipidemic patients seen per year. The results of this study demonstrate the positive impact CPS can have on achieving treatment goals in lipid management. Similar services for other problematic conditions such as hypertension and diabetes mellitus may also be benefited by similar CPSs.

Digital image analysis in pathology: benefits and obligation.

PubMed

Laurinavicius, Arvydas; Laurinaviciene, Aida; Dasevicius, Darius; Elie, Nicolas; Plancoulaine, Benoît; Bor, Catherine; Herlin, Paulette

2012-01-01

Pathology has recently entered the era of personalized medicine. This brings new expectations for the accuracy and precision of tissue-based diagnosis, in particular, when quantification of histologic features and biomarker expression is required. While for many years traditional pathologic diagnosis has been regarded as ground truth, this concept is no longer sufficient in contemporary tissue-based biomarker research and clinical use. Another major change in pathology is brought by the advancement of virtual microscopy technology enabling digitization of microscopy slides and presenting new opportunities for digital image analysis. Computerized vision provides an immediate benefit of increased capacity (automation) and precision (reproducibility), but not necessarily the accuracy of the analysis. To achieve the benefit of accuracy, pathologists will have to assume an obligation of validation and quality assurance of the image analysis algorithms. Reference values are needed to measure and control the accuracy. Although pathologists' consensus values are commonly used to validate these tools, we argue that the ground truth can be best achieved by stereology methods, estimating the same variable as an algorithm is intended to do. Proper adoption of the new technology will require a new quantitative mentality in pathology. In order to see a complete and sharp picture of a disease, pathologists will need to learn to use both their analogue and digital eyes.

Knee OA: which patients are unlikely to benefit from manual PT and exercise?

PubMed

Deyle, Gail D; Gill, Norman W; Allison, Stephen C; Hando, Benjamin R; Rochino, Duneley A

2012-01-01

The combination of manual physical therapy and exercise provides important benefit for more than 80% of patients with knee osteoarthritis (OA). Our objective was to determine predictor variables for patients unlikely to respond to these interventions. We used a retrospective combined cohort study design to develop a preliminary clinical prediction rule (CPR). To determine useful predictors of nonsuccess, we used an extensive set of 167 baseline variables. These variables were extracted from standardized examination forms used with 101 patients(64 women and 37 men with a mean age of 60.5}11.8 and 63.6}9.3 years, respectively) in 2 previously published clinical trials. We classified patients based on whether they achieved a clinically meaningful benefit of at least 12%improvement in Western Ontario MacMaster(WOMAC) scores after 4 weeks of treatment using the smallest and most efficient subset of predictors. The variables of patellofemoral pain, anterior cruciate ligament laxity, and height >1.71 m (5’7’’) comprise the CPR. Patients with at least 2 positive tests yield eda posttest probability of 88% for nonsuccess with this treatment (positive likelihood ratio=36.7). The overall prognostic accuracy of the CPR was 96%. Most patients with knee OA will benefit from a low-risk, cost-effective program of manual physical therapy and supporting exercise.1,2 The few patients who may not benefit from such a program are identifiable by a simple (preliminary) CPR. After validation,this rule could improve primary patient management,allowing more appropriate referrals and choices in intervention.

A Cost-Benefit Analysis for Per-Student Expenditures and Academic Achievement

ERIC Educational Resources Information Center

Womack, Sid T.; Roberts, Kerry; Bell, C. David; Womack, Karen

2015-01-01

Cost-benefit correlations have been subject to "selective sampling" in the media. Usually extremes of data from a very few high-funding and low-funding states are cited in the media to construct the case that there is no relationship between economic inputs and academic outputs. This study, using average per-pupil expenditures and ACT…

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.

Are research papers reporting results from nutrigenetics clinical research a potential source of biohype?

PubMed

Stenne, R; Hurlimann, T; Godard, Béatrice

2012-01-01

Nutrigenetics is a promising field, but the achievability of expected benefits is challenged by the methodological limitations that are associated with clinical research in that field. The mere existence of these limitations suggests that promises about potential outcomes may be premature. Thus, benefits claimed in scientific journal articles in which these limitations are not acknowledged might stimulate biohype. This article aims to examine whether nutrigenetics clinical research articles are a potential source of biohype. Of the 173 articles identified, 16 contained claims in which clinical applications were extrapolated from study results. The methodological limitations being incompletely acknowledged, these articles could potentially be a source of biohype.

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.

The principles of quality-associated costing: derivation from clinical transfusion practice.

PubMed

Trenchard, P M; Dixon, R

1997-01-01

As clinical transfusion practice works towards achieving cost-effectiveness, prescribers of blood and its derivatives must be certain that the prices of such products are based on real manufacturing costs and not market forces. Using clinical cost-benefit analysis as the context for the costing and pricing of blood products, this article identifies the following two principles: (1) the product price must equal the product cost (the "price = cost" rule) and (2) the product cost must equal the real cost of product manufacture. In addition, the article describes a new method of blood product costing, quality-associated costing (QAC), that will enable valid cost-benefit analysis of blood products.

Modelling the implications of reducing smoking prevalence: the public health and economic benefits of achieving a 'tobacco-free' UK.

PubMed

Hunt, Daniel; Knuchel-Takano, André; Jaccard, Abbygail; Bhimjiyani, Arti; Retat, Lise; Selvarajah, Chit; Brown, Katrina; Webber, Laura L; Brown, Martin

2018-03-01

Smoking is still the most preventable cause of cancer, and a leading cause of premature mortality and health inequalities in the UK. This study modelled the health and economic impacts of achieving a 'tobacco-free' ambition (TFA) where, by 2035, less than 5% of the population smoke tobacco across all socioeconomic groups. A non-linear multivariate regression model was fitted to cross-sectional smoking data to create projections to 2035. These projections were used to predict the future incidence and costs of 17 smoking-related diseases using a microsimulation approach. The health and economic impacts of achieving a TFA were evaluated against a predicted baseline scenario, where current smoking trends continue. If trends continue, the prevalence of smoking in the UK was projected to be 10% by 2035-well above a TFA. If this ambition were achieved by 2035, it could mean 97 300 +/- 5 300 new cases of smoking-related diseases are avoided by 2035 (tobacco-related cancers: 35 900+/- 4 100; chronic obstructive pulmonary disease: 29 000 +/- 2 700; stroke: 24 900 +/- 2 700; coronary heart disease: 7600 +/- 2 700), including around 12 350 diseases avoided in 2035 alone. The consequence of this health improvement is predicted to avoid £67 +/- 8 million in direct National Health Service and social care costs, and £548 million in non-health costs, in 2035 alone. These findings strengthen the case to set bold targets on long-term declines in smoking prevalence to achieve a tobacco 'endgame'. Results demonstrate the health and economic benefits that meeting a TFA can achieve over just 20 years. Effective ambitions and policy interventions are needed to reduce the disease and economic burden of smoking. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

"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.

Are Adults Diagnosed with Diabetes achieving the American Diabetes Association Clinical Practice Recommendations?

PubMed Central

Pérez, Cynthia M.; Febo-Vázquez, Isaedmarie; Guzmán, Manuel; Ortiz, Ana Patricia; Suárez, Erick

2012-01-01

Objective This study assessed the proportion of adults with previously diagnosed diabetes mellitus (DM) who met selected preventive practices and treatment goals according to the American Diabetes Association (ADA) standards of medical care. Methods A secondary analysis of data collected for a previous epidemiologic study that used a probability cluster design to select 859 persons aged 21–79 years in the San Juan metropolitan area was undertaken. This study focused on 136 (15.8%) adults who self-reported DM. The Standards of Medical Care in Diabetes published by the ADA in 2011 were used to determine the proportion of adults achieving selected clinical practice recommendations. Results Less than half of adults achieved recommended treatment goals for LDL-cholesterol (47.8%), HDL-cholesterol (44.1%), blood pressure (41.2%) and HbA1c (28.7%). The percentage of adults achieving recommended levels of HbA1c, blood pressure and LDL-cholesterol simultaneously was 6.6%; the percentage achieving HbA1c, blood pressure, LDL-cholesterol, HDL-cholesterol, triglycerides and albumin-to-creatinine ratio target levels was only 2.2%. More than half (60.2%) reported daily self-monitoring of foot ulcers and HbA1c testing at least twice over the past year (52.3%). However, less than half reported annual dilated eye examination (49.2%), annual comprehensive foot examination (43.8%), daily self-monitoring blood glucose (37.5%), moderate or vigorous physical activity (33.8%), and self-management DM education (28.9%). Conclusion This study showed that a substantial proportion of adults with DM did not achieve ADA recommendations on selected preventive practices and treatment goals. Strategies to improve DM medical care and surveillance of preventive-care practices and treatment goals among affected individuals are essential for planning further initiatives that contribute to reduce the burden of DM complications. PMID:22432404

On the Path to SunShot - The Environmental and Public Health Benefits of Achieving High Penetrations of Solar Energy in the United States

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

Wiser, Ryan; Mai, Trieu; Millstein, Dev

Monetizing the environmental health benefits of solar could add ~3.5¢/kWh to the value of solar energy (see Wiser et al. 2016). The monetary impacts due to environmental degradation and public health impacts seem far removed from the apparent “sticker price” of electricity. Yet quantifying these impacts is essential to understanding the true costs and benefits of solar and conventional generating technologies. Compared with fossil fuel generators, PV and CSP produce far lower lifecycle levels of greenhouse gas (GHG) emissions and harmful pollutants including fine particular matter (PM2.5), sulfur dioxide (SO2), and nitrogen oxides (NOx). Achieving the SunShot-level solar deployment targets—14%more » of U.S. electricity demand met by solar in 2030 and 27% in 2050—could reduce cumulative power-sector GHG emissions by 10% between 2015 and 2050, resulting in savings of $238–$252 billion. This is equivalent to 2.0–2.2 cents per kilowatt-hour of solar installed (¢/kWh-solar). Similarly, realizing these levels of solar deployment could reduce cumulative power-sector emissions of PM2.5 by 8%, SO2 by 9%, and NOx by 11% between 2015 and 2050. This could produce $167 billion in savings from lower future health and environmental damages, or 1.4¢/kWh-solar—while also preventing 25,000–59,000 premature deaths. To put this in perspective, the estimated 3.5¢/kWh-solar in benefits due to SunShot-level solar deployment is approximately equal to the additional LCOE reduction needed to make unsubsidized utility-scale solar competitive with conventional generators today. In addition, water savings from achieving the SunShot goals, could result in the 2015–2050 cumulative savings of 4% of total power-sector withdrawals and 9% of total power-sector consumption—a particularly important consideration for arid states where substantial solar will be deployed. Improving public health and the environment is but one aspect of solar’s many costs and benefits. Clearly

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

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

Achieving low anastomotic leak rates utilizing clinical perfusion assessment.

PubMed

Kream, Jacob; Ludwig, Kirk A; Ridolfi, Timothy J; Peterson, Carrie Y

2016-10-01

Anastomotic leak after colorectal resection increases morbidity, mortality, and in the setting of cancer, increases recurrences rates and reduces survival odds. Recent reports suggest that fluorescence evaluation of perfusion after colorectal anastomosis creation is associated with low anastomotic leak rates (1.4%). The purpose of this work was to evaluate whether a similar low anastomotic leak rate after left-sided colorectal resections could be achieved using standard assessment of blood flow to the bowel ends. We performed a retrospective chart review at an academic tertiary referral center, evaluating 317 consecutive patients who underwent a pelvic anastomosis after sigmoid colectomy, left colectomy, or low anterior resection. All operations were performed by a single surgeon from March 2008 to January 2015 with only standard clinical measures used to assess perfusion to the bowel ends. The primary outcome measure was the anastomotic leak rate as diagnosed by clinical symptoms, exam, or routine imaging. The average patient age was 59.7 years with an average body mass index of 28.8 kg/m(2). Rectal cancer (128, 40.4%) was the most common indication for operation while hypertension (134, 42.3%) was the most common comorbidity. In total, 177 operations were laparoscopic (55.8%), 13 were reoperative resections (4.1%), and 108 were protected with a loop ileostomy (34.1%). Preoperative chemotherapy was administered to 25 patients (7.9%) while preoperative chemo/radiation was administered to 64 patients (20.2%). The anastomotic leak rate was 1.6% (5/317). Our data suggests that standard, careful evaluation of adequate blood flow via inspection and confirmation of pulsatile blood flow to the bowel ends and meticulous construction of the colorectal or coloanal anastomoses can result in very low leak rates, similar to the rate reported when intraoperative imaging is used to assess perfusion. Copyright © 2016 Elsevier Inc. All rights reserved.

Home media and children's achievement and behavior.

PubMed

Hofferth, Sandra L

2010-01-01

This study provides a national picture of the time American 6- to 12-year-olds spent playing video games, using the computer, and watching TV at home in 1997 and 2003, and the association of early use with their achievement and behavior as adolescents. Girls benefited from computer use more than boys, and Black children benefited more than White children. Greater computer use in middle childhood was associated with increased achievement for White and Black girls, and for Black but not White boys. Increased video game play was associated with an improved ability to solve applied problems for Black girls but lower verbal achievement for all girls. For boys, increased video game play was linked to increased aggressive behavior problems. © 2010 The Author. Child Development © 2010 Society for Research in Child Development, Inc.

Scope-of-practice laws for nurse practitioners limit cost savings that can be achieved in retail clinics.

PubMed

Spetz, Joanne; Parente, Stephen T; Town, Robert J; Bazarko, Dawn

2013-11-01

Retail clinics have the potential to reduce health spending by offering convenient, low-cost access to basic health care services. Retail clinics are often staffed by nurse practitioners (NPs), whose services are regulated by state scope-of-practice regulations. By limiting NPs' work scope, restrictive regulations could affect possible cost savings. Using multistate insurance claims data from 2004-07, a period in which many retail clinics opened, we analyzed whether the cost per episode associated with the use of retail clinics was lower in states where NPs are allowed to practice independently and to prescribe independently. We also examined whether retail clinic use and scope of practice were associated with emergency department visits and hospitalizations. We found that visits to retail clinics were associated with lower costs per episode, compared to episodes of care that did not begin with a retail clinic visit, and the costs were even lower when NPs practiced independently. Eliminating restrictions on NPs' scope of practice could have a large impact on the cost savings that can be achieved by retail clinics.

Optimization of spatiotemporally fractionated radiotherapy treatments with bounds on the achievable benefit

NASA Astrophysics Data System (ADS)

Gaddy, Melissa R.; Yıldız, Sercan; Unkelbach, Jan; Papp, Dávid

2018-01-01

Spatiotemporal fractionation schemes, that is, treatments delivering different dose distributions in different fractions, can potentially lower treatment side effects without compromising tumor control. This can be achieved by hypofractionating parts of the tumor while delivering approximately uniformly fractionated doses to the surrounding tissue. Plan optimization for such treatments is based on biologically effective dose (BED); however, this leads to computationally challenging nonconvex optimization problems. Optimization methods that are in current use yield only locally optimal solutions, and it has hitherto been unclear whether these plans are close to the global optimum. We present an optimization framework to compute rigorous bounds on the maximum achievable normal tissue BED reduction for spatiotemporal plans. The approach is demonstrated on liver tumors, where the primary goal is to reduce mean liver BED without compromising any other treatment objective. The BED-based treatment plan optimization problems are formulated as quadratically constrained quadratic programming (QCQP) problems. First, a conventional, uniformly fractionated reference plan is computed using convex optimization. Then, a second, nonconvex, QCQP model is solved to local optimality to compute a spatiotemporally fractionated plan that minimizes mean liver BED, subject to the constraints that the plan is no worse than the reference plan with respect to all other planning goals. Finally, we derive a convex relaxation of the second model in the form of a semidefinite programming problem, which provides a rigorous lower bound on the lowest achievable mean liver BED. The method is presented on five cases with distinct geometries. The computed spatiotemporal plans achieve 12-35% mean liver BED reduction over the optimal uniformly fractionated plans. This reduction corresponds to 79-97% of the gap between the mean liver BED of the uniform reference plans and our lower bounds on the lowest

The Impact of Worksite Clinics on Teacher Healthcare Utilization and Cost, Self-reported Health Status, and Student Academic Achievement growth in a Public School District.

PubMed

Engberg, John B; Harris-Shapiro, Jon; Hines, David; McCarver, Patti; Liu, Harry H

2018-05-29

To examine the impact of worksite clinics on healthcare utilization and cost, self-reported health status, and student achievement growth in a public school district. We used insurance claims, health risk assessment, and student achievement growth data for active teachers during 2007-2015. A difference-in-differences approach was applied to measure the impact of worksite clinics. Compared to using a community-based clinic as the usual source of primary care, using a worksite clinic was associated with significantly lower inpatient admissions (53 vs. 31 per 1,000 teacher years), annual healthcare cost ($5,043 vs. $4,298 in 2016 US dollars, a difference of $62 per teacher per month), and annual absent work hours (63 vs. 61). No significant differences were detected in self-reported health status or student achievement growth. Worksite clinics reduce teacher healthcare cost and absenteeism.

TESTOSTERONE LEVELS ACHIEVED BY MEDICALLY TREATED TRANSGENDER WOMEN IN A UNITED STATES ENDOCRINOLOGY CLINIC COHORT.

PubMed

Liang, Jennifer J; Jolly, Divya; Chan, Kelly J; Safer, Joshua D

2018-02-01

Most transgender women depend on medical treatment alone to lower testosterone levels in order to align physical appearance with gender identity. The medical regimen in the United States typically includes spironolactone and estrogens. The purpose of this cross-sectional study was to assess the testosterone suppression achieved among transgender women treated with spironolactone and estrogens. Testosterone and estradiol levels were extracted from the electronic medical records of 98 anonymized transgender women treated with oral spironolactone and oral estrogen therapy at the Endocrinology Clinic at Boston Medical Center. Patients starting therapy required about 9 months to reach a steady-state testosterone, with significant heterogeneity of levels achieved among patients. Patients with normal body mass index (BMI) had higher testosterone levels, whereas patients with obese BMI had lower testosterone levels throughout treatment. Stratification of patients by age or spironolactone dosage revealed no significant difference in testosterone levels achieved. At steady state, patients in the highest suppressing quartile were able to achieve testosterone levels of 27 ng/dL, with a standard deviation of 21 ng/dL. Measured serum estradiol levels did not change over time and did not correlate with dosage of estradiol administered. Among a cohort of transgender women treated with spironolactone and estrogen, the highest suppressing quartile could reliably achieve testosterone levels in the female range at virtually all times. The second highest suppressing quartile could not achieve female levels but remained below the male range virtually all of the time. One quartile was unable to achieve any significant suppression. BMC = Boston Medical Center BMI = body mass index CPY = cyproterone acetate LC-MS/MS = liquid chromatography-tandem mass spectrometry Q = quartile.

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.

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

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.

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.

Treatments for Parkinson disease--past achievements and current clinical needs.

PubMed

Poewe, Werner

2009-02-17

Although idiopathic Parkinson disease (PD) remains the only neurodegenerative disorder for which there are highly effective symptomatic therapies, there are still major unmet needs regarding its long-term management. Although levodopa continues as the gold standard for efficacy, its chronic use is associated with potentially disabling motor complications. Current evidence suggests that these are related to mode of administration, whereby multiple oral doses of levodopa generate pulsatile stimulation of striatal dopamine receptors. Current dopamine agonists, while producing more constant plasma levels, fail to match levodopa's efficacy. Strategies to treat levodopa-related motor complications are only partially effective, rarely abolishing motor fluctuations or dyskinesias. Best results are currently achieved with invasive strategies via subcutaneous (s.c.) or intraduodenal delivery of apomorphine or levodopa, or deep brain stimulation of the subthalamic nucleus. Another area of major unmet medical need is related to nondopaminergic and nonmotor symptoms of PD. Targeting transmitter systems beyond the dopamine system is an interesting approach, both for the motor and nonmotor problems of PD. So far, clinical trial evidence regarding 5-HT agonists, glutamate antagonists, adenosine A(2) antagonists and alpha-adrenergic receptor antagonists, has been inconsistent, but trials with cholinesterase inhibitors and atypical antipsychotics to treat dementia and psychosis, have been successful. However, the ultimate goal of PD medical management is modifying disease progression, thereby delaying the evolution of motor and nonmotor complications of advanced disease. As understanding of preclinical markers for PD develops, there is new hope for neuropreventive strategies to target "at risk" populations before clinical onset of disease.

Scale-up of HIV Treatment Through PEPFAR: A Historic Public Health Achievement

PubMed Central

El-Sadr, Wafaa M.; Holmes, Charles B.; Mugyenyi, Peter; Thirumurthy, Harsha; Ellerbrock, Tedd; Ferris, Robert; Sanne, Ian; Asiimwe, Anita; Hirnschall, Gottfried; Nkambule, Rejoice N.; Stabinski, Lara; Affrunti, Megan; Teasdale, Chloe; Zulu, Isaac; Whiteside, Alan

2012-01-01

Since its inception in 2003, the US President’s Emergency Plan for AIDS Relief (PEPFAR) has been an important driving force behind the global scale-up of HIV care and treatment services, particularly in expansion of access to antiretroviral therapy. Despite initial concerns about cost and feasibility, PEPFAR overcame challenges by leveraging and coordinating with other funders, by working in partnership with the most affected countries, by supporting local ownership, by using a public health approach, by supporting task-shifting strategies, and by paying attention to health systems strengthening. As of September 2011, PEPFAR directly supported initiation of antiretroviral therapy for 3.9 million people and provided care and support for nearly 13 million people. Benefits in terms of prevention of morbidity and mortality have been reaped by those receiving the services, with evidence of societal benefits beyond the anticipated clinical benefits. However, much remains to be accomplished to achieve universal access, to enhance the quality of programs, to ensure retention of patients in care, and to continue to strengthen health systems. PMID:22797746

Scale-up of HIV treatment through PEPFAR: a historic public health achievement.

PubMed

El-Sadr, Wafaa M; Holmes, Charles B; Mugyenyi, Peter; Thirumurthy, Harsha; Ellerbrock, Tedd; Ferris, Robert; Sanne, Ian; Asiimwe, Anita; Hirnschall, Gottfried; Nkambule, Rejoice N; Stabinski, Lara; Affrunti, Megan; Teasdale, Chloe; Zulu, Isaac; Whiteside, Alan

2012-08-15

Since its inception in 2003, the US President's Emergency Plan for AIDS Relief (PEPFAR) has been an important driving force behind the global scale-up of HIV care and treatment services, particularly in expansion of access to antiretroviral therapy. Despite initial concerns about cost and feasibility, PEPFAR overcame challenges by leveraging and coordinating with other funders, by working in partnership with the most affected countries, by supporting local ownership, by using a public health approach, by supporting task-shifting strategies, and by paying attention to health systems strengthening. As of September 2011, PEPFAR directly supported initiation of antiretroviral therapy for 3.9 million people and provided care and support for nearly 13 million people. Benefits in terms of prevention of morbidity and mortality have been reaped by those receiving the services, with evidence of societal benefits beyond the anticipated clinical benefits. However, much remains to be accomplished to achieve universal access, to enhance the quality of programs, to ensure retention of patients in care, and to continue to strengthen health systems.

Home Media and Children's Achievement and Behavior

ERIC Educational Resources Information Center

Hofferth, Sandra L.

2010-01-01

This study provides a national picture of the time American 6- to 12-year-olds spent playing video games, using the computer, and watching TV at home in 1997 and 2003, and the association of early use with their achievement and behavior as adolescents. Girls benefited from computer use more than boys, and Black children benefited more than White…

Teacher Research Programs: An Effective Form of Professional Development to Increase Student Achievement and Benefit the Economy

NASA Astrophysics Data System (ADS)

Dubner, J.

2008-12-01

development. Columbia University's teacher research program is a very effective form of professional development for pre- college science teachers and has a direct correlation to increased student motivation and achievement in science. The Program is premised on the beliefs that hands-on experience in the practice of science improves the quality and authenticity of science teaching, and that improved science teaching is correlated with increased student interest and achievement in science. The author will present the methodology of the program's evaluation citing statistically significant findings. The author will also show the economic benefits of teacher participation in a well-designed research program.

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

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.

Failure of Ivermectin per Rectum to Achieve Clinically Meaningful Serum Levels in Two Cases of Strongyloides Hyperinfection

PubMed Central

Bogoch, Isaac I.; Khan, Kamran; Abrams, Howard; Nott, Caroline; Leung, Elizabeth; Fleckenstein, Lawrence; Keystone, Jay S.

2015-01-01

Two cases of Strongyloides hyperinfection are presented. Ivermectin was initially administered orally and per rectum pending the availability of subcutaneous (SC) preparations. In neither case did rectal suppositories of ivermectin achieve clinically meaningful serum values. Clinicians should use SC preparations of ivermectin as early as possible in Strongyloides hyperinfection and dissemination. PMID:25918215

Substantial air quality and climate co-benefits achievable now with sectoral mitigation strategies in China.

PubMed

Peng, Wei; Yang, Junnan; Wagner, Fabian; Mauzerall, Denise L

2017-11-15

China is the world's top carbon emitter and suffers from severe air pollution. We examine near-term air quality and CO 2 co-benefits of various current sector-based policies in China. Using a 2015 base case, we evaluate the potential benefits of four sectoral mitigation strategies. All scenarios include a 20% increase in conventional air pollution controls as well as the following sector-specific fuel switching or technology upgrade strategies. Power sector (POW): 80% replacement of small coal power plants with larger more efficient ones; Industry sector (IND): 10% improvement in energy efficiency; Transport sector (TRA): replacement of high emitters with average vehicle fleet emissions; and Residential sector (RES): replacement of 20% of coal-based stoves with stoves using liquefied petroleum gas (LPG). Conducting an integrated assessment using the regional air pollution model WRF-Chem, we find that the IND scenario reduces national air-pollution-related deaths the most of the four scenarios examined (27,000, 24,000, 13,000 and 23,000 deaths reduced annually in IND, POW, TRA and RES, respectively). In addition, the IND scenario reduces CO 2 emissions more than 8times as much as any other scenario (440, 53, 0 and 52Mt CO 2 reduced in IND, POW, TRA and RES, respectively). We also examine the benefits of an industrial efficiency improvement of just 5%. We find the resulting air quality and health benefits are still among the largest of the sectoral scenarios, while the carbon mitigation benefits remain more than 3 times larger than any other scenario. Our analysis hence highlights the importance of even modest industrial energy efficiency improvements and air pollution control technology upgrades for air quality, health and climate benefits in China. Copyright © 2017 Elsevier B.V. All rights reserved.

Family Literacy Programs: Who Benefits? Occasional Paper #2.

ERIC Educational Resources Information Center

Padak, Nancy; Rasinski, Tim

Family literacy programs have been demonstrated to have significant and widespread benefits for children, parents, families, and society. Documented benefits of family literacy programs to children appear in the following areas: children's achievement in school, school attendance, oral language development, reading comprehension and vocabulary,…

The relationship between medical students' epistemological beliefs and achievement on a clinical performance examination.

PubMed

Oh, Sun-A; Chung, Eun-Kyung; Han, Eui-Ryoung; Woo, Young-Jong; Kevin, Deiter

2016-03-01

This study was to explore the relationship between clinical performance examination (CPX) achievement and epistemological beliefs to investigate the potentials of epistemological beliefs in ill-structured medical problem solving tasks. We administered the epistemological beliefs questionnaire (EBQ) to fourth-year medical students and correlated the results with their CPX scores. The EBQ comprised 61 items reflecting five belief systems: certainty of knowledge, source of knowledge, rigidity of learning, ability to learn, and speed of knowledge acquisition. The CPX included scores for history taking, physical examination, and patient-physician interaction. The higher epistemological beliefs group obtained significantly higher scores on the CPX with regard to history taking and patient-physician interaction. The epistemological beliefs scores on certainty of knowledge and source of knowledge were significantly positively correlated with patient-physician interaction. The epistemological beliefs scores for ability to learn were significantly positively correlated with those for history taking, physical examination, and patient-physician interaction. Students with more sophisticated and advanced epistemological beliefs stances used more comprehensive and varied approaches in the patient-physician interaction. Therefore, educational efforts that encourage discussions pertaining to epistemological views should be considered to improve clinical reasoning and problem-solving competence in the clinic setting.

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.

Home Media and Children’s Achievement and Behavior

PubMed Central

Hofferth, Sandra L.

2010-01-01

This study provides a national picture of the time American 6–12 year olds spent playing video games, using the computer, and watching television at home in 1997 and 2003 and the association of early use with their achievement and behavior as adolescents. Girls benefited from computers more than boys and Black children’s achievement benefited more from greater computer use than did that of White children. Greater computer use in middle childhood was associated with increased achievement for White and Black girls and Black boys, but not White boys. Greater computer play was also associated with a lower risk of becoming socially isolated among girls. Computer use does not crowd out positive learning-related activities, whereas video game playing does. Consequently, increased video game play had both positive and negative associations with the achievement of girls but not boys. For boys, increased video game play was linked to increased aggressive behavior problems. PMID:20840243

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.

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.

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

Improving healthcare value through clinical community and supply chain collaboration.

PubMed

Ishii, Lisa; Demski, Renee; Ken Lee, K H; Mustafa, Zishan; Frank, Steve; Wolisnky, Jean Paul; Cohen, David; Khanna, Jay; Ammerman, Joshua; Khanuja, Harpal S; Unger, Anthony S; Gould, Lois; Wachter, Patricia Ann; Stearns, Lauren; Werthman, Ronald; Pronovost, Peter

2017-03-01

We hypothesized that integrating supply chain with clinical communities would allow for clinician-led supply cost reduction and improved value in an academic health system. Three clinical communities (spine, joint, blood management) and one clinical community-like physician led team of surgeon stakeholders partnered with the supply chain team on specific supply cost initiatives. The teams reviewed their specific utilization and cost data, and the physicians led consensus-building conversations over a series of team meetings to agree to standard supply utilization. The spine and joint clinical communities each agreed upon a vendor capping model that led to cost savings of $3 million dollars and $1.5 million dollars respectively. The blood management decreased blood product utilization and achieved $1.2 million dollars savings. $5.6 million dollars in savings was achieved by a clinical community-like group of surgeon stakeholders through standardization of sutures and endomechanicals. Physician led clinical teams empowered to lead change achieved substantial supply chain cost savings in an academic health system. The model of combining clinical communities with supply chain offers hope for an effective, practical, and scalable approach to improving value and engaging physicians in other academic health systems. This clinician led model could benefit both private and academic health systems engaging in value optimization efforts. N/A. Copyright © 2016 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.

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

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.

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.

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.

Pre-operative Thresholds for Achieving Meaningful Clinical Improvement after Arthroscopic Treatment of Femoroacetabular Impingement

PubMed Central

Nwachukwu, Benedict U.; Fields, Kara G.; Nawabi, Danyal H.; Kelly, Bryan T.; Ranawat, Anil S.

2016-01-01

Objectives: Knowledge of the thresholds and determinants for successful femoroacetabular impingement (FAI) treatment is evolving. The primary purpose of this study was to define pre-operative outcome score thresholds that can be used to predict patients most likely to achieve meaningful clinically important difference (MCID) after arthroscopic FAI treatment. Secondarily determinants of achieving MCID were evaluated. Methods: A prospective institutional hip arthroscopy registry was reviewed to identify patients with FAI treated with arthroscopic labral surgery, acetabular rim trimming, and femoral osteochondroplasty. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS) and the international Hip Outcome Tool (iHOT-33) tools were administered at baseline and at one year post-operatively. MCID was calculated using a distribution-based method. A receiver operating characteristic (ROC) analysis was used to calculate cohort-based threshold values predictive of achieving MCID. Area under the curve (AUC) was used to define predictive ability (strength of association) with AUC >0.7 considered acceptably predictive. Univariate and multivariable analyses were used to analyze demographic, radiographic and intra-operative factors associated with achieving MCID. Results: There were 374 patients (mean + SD age, 32.9 + 10.5) and 56.4% were female. The MCID for mHHS, HOS activities of daily living (HOS-ADL), HOS Sports, and iHOT-33 was 8.2, 8.4,14.5, and 12.0 respectively. ROC analysis (threshold, % achieving MCID, strength of association) for these tools in our population was: mHHS (61.6, 78%, 0.68), HOS-ADL (83.8, 68%, 0.84), HOS-Sports (63.9, 64%, 0.74), and iHOT-33 (54.3, 82%, 0.65). Likelihood for achieving MCID declined above and increased below these thresholds. In univariate analysis female sex, femoral version, lower acetabular outerbridge score and increasing CT sagittal center edge angle (CEA) were predictive of achieving MCID. In multivariable analysis

Growing Power?: Social Benefits From Urban Greening Projects

Treesearch

Lynne Westphal

1999-01-01

In this study I investigated practitioners claims for social benefits of urban greening projects (e.g., tree planting, community gardens). Practitioners' claims of increased neighborliness, reduced drug dealing and other social benefits have led to interest in using greening projects specifically to achieve these ends.Four sites that...

20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Income Rules for Helping Blind and Disabled Individuals Achieve...

20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Income Rules for Helping Blind and Disabled Individuals Achieve...

20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Income Rules for Helping Blind and Disabled Individuals Achieve...

20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Income Rules for Helping Blind and Disabled Individuals Achieve...

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

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 a clinical TOF-PET detector design that achieves ⩽100 ps coincidence time resolution

NASA Astrophysics Data System (ADS)

Cates, Joshua W.; Levin, Craig S.

2018-06-01

Commercially available clinical positron emission tomography (PET) detectors employ scintillation crystals that are long (20 mm length) and narrow (4–5 mm width) optically coupled on their narrow end to a photosensor. The aspect ratio of this traditional crystal rod configuration and 511 keV photon attenuation properties yield significant variances in scintillation light collection efficiency and transit time to the photodetector, due to variations in the 511 keV photon interaction depth in the crystal. These variances contribute significant to coincidence time resolution degradation. If instead, crystals are coupled to a photosensor on their long side, near-complete light collection efficiency can be achieved, and scintillation photon transit time jitter is reduced. In this work, we compare the achievable coincidence time resolution (CTR) of LGSO:Ce(0.025 mol%) crystals 3–20 mm in length when optically coupled to silicon photomultipliers (SiPMs) on either their short end or long side face. In this ‘side readout’ configuration, a CTR of 102  ±  2 ps FWHM was measured with mm3 crystals coupled to rows of mm2 SensL-J SiPMs using leading edge time pickoff and a single timing channel. This is in contrast to a CTR of 137  ±  3 ps FWHM when the same crystals were coupled to single mm2 SiPMs on their narrow ends. We further study the statistical limit on CTR using side readout via the Cramér–Rao lower bound (CRLB), with consideration given to ongoing work to further improve photosensor technologies and exploit fast phenomena to ultimately achieve 10 ps FWHM CTR. Potential design aspects of scalable front-end signal processing readout electronics using this side readout configuration are discussed. Altogether, we demonstrate that the side readout configuration offers an immediate solution for 100 ps CTR clinical PET detectors and mitigates factors prohibiting future efforts to achieve 10 ps FWHM CTR.

Evaluation of a clinical TOF-PET detector design that achieves ⩽100 ps coincidence time resolution.

PubMed

Cates, Joshua W; Levin, Craig S

2018-06-07

Commercially available clinical positron emission tomography (PET) detectors employ scintillation crystals that are long ([Formula: see text]20 mm length) and narrow (4-5 mm width) optically coupled on their narrow end to a photosensor. The aspect ratio of this traditional crystal rod configuration and 511 keV photon attenuation properties yield significant variances in scintillation light collection efficiency and transit time to the photodetector, due to variations in the 511 keV photon interaction depth in the crystal. These variances contribute significant to coincidence time resolution degradation. If instead, crystals are coupled to a photosensor on their long side, near-complete light collection efficiency can be achieved, and scintillation photon transit time jitter is reduced. In this work, we compare the achievable coincidence time resolution (CTR) of LGSO:Ce(0.025 mol%) crystals 3-20 mm in length when optically coupled to silicon photomultipliers (SiPMs) on either their short end or long side face. In this 'side readout' configuration, a CTR of 102  ±  2 ps FWHM was measured with [Formula: see text] mm 3 crystals coupled to rows of [Formula: see text] mm 2 SensL-J SiPMs using leading edge time pickoff and a single timing channel. This is in contrast to a CTR of 137  ±  3 ps FWHM when the same crystals were coupled to single [Formula: see text] mm 2 SiPMs on their narrow ends. We further study the statistical limit on CTR using side readout via the Cramér-Rao lower bound (CRLB), with consideration given to ongoing work to further improve photosensor technologies and exploit fast phenomena to ultimately achieve 10 ps FWHM CTR. Potential design aspects of scalable front-end signal processing readout electronics using this side readout configuration are discussed. Altogether, we demonstrate that the side readout configuration offers an immediate solution for 100 ps CTR clinical PET detectors and mitigates factors prohibiting future

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

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 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.

Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits.

PubMed

Koo, Bon-Min; Kim, Jang-Ho Jay; Kim, Tae-Kyun; Kim, Byung-Yun

2015-09-17

In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder). To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability.

Conducting a Multisite Education Research Project: Strategies to Overcome the Barriers to Achieve the Benefits.

PubMed

Beischel, Kelly P; Hart, Julie; Turkelson, Sandra L

2016-01-01

Multisite education research projects have many benefits as well as perceived barriers. In this article, we share our experiences with a multisite education research project and the barriers we overcame to reap the benefits. The outcome of our research resulted in increased rigor, role-modeling professional collaboration, and promotion of future multisite education studies. The strategies presented in this article will help alleviate perceived barriers and ameliorate the process of conducting multisite education research studies.

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.

Is thymectomy in non-thymomatous myasthenia gravis of any benefit?

PubMed

Diaz, Andres; Black, Edward; Dunning, Joel

2014-03-01

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was if thymectomy in non-thymomatous myasthenia gravis was of any benefit? Overall, 137 papers were found using the reported search, of which 16 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The outcome variables were similar in all of the papers, including complete stable remission (CSR), pharmacological remission, age at presentation, gender, duration of symptoms, preoperative classification (Oosterhius, Osserman or myasthenia gravis Foundation of America (MGFA)), thymic pathology, preoperative medications (steroids, immunosuppressants), mortality and morbidity. We conclude that evidence-based reviews have shown that relative rates of thymectomy patients compared with non-thymectomy patients attaining outcome indicate that the former group of patients is more likely to achieve medication-free remission, become asymptomatic and clinically improve (54%, P < 0.01), particularly patients with severe and generalized symptoms (P = 0.007). Patients with generalized myasthenia gravis showed 11% stronger association with favourable outcomes after thymectomy. Some studies show early remission rates (RRs), as early as 6 months post-thymectomy, of 44%. Overall, the reported remission rate for non-thymomatous myasthenia gravis is between 38 and 72% up to 10 years of follow-up. Among these patients, those with thymic hyperplasia show the best complete stable remission rates (42%, P < 0.04) in the majority of studies. Age showed variability across the studies and the cut-off was also different among them. Overall age < 45 years showed a higher probability of achieving complete stable remission during follow-up (81% benefit rate (BR), P < 0.02). Pharmacological improvement is reported between 6 and 42

Working memory and executive functions: effects of training on academic achievement.

PubMed

Titz, Cora; Karbach, Julia

2014-11-01

The aim of this review is to illustrate the role of working memory and executive functions for scholastic achievement as an introduction to the question of whether and how working memory and executive control training may improve academic abilities. The review of current research showed limited but converging evidence for positive effects of process-based complex working-memory training on academic abilities, particularly in the domain of reading. These benefits occurred in children suffering from cognitive and academic deficits as well as in healthy students. Transfer of training to mathematical abilities seemed to be very limited and to depend on the training regime and the characteristics of the study sample. A core issue in training research is whether high- or low-achieving children benefit more from cognitive training. Individual differences in terms of training-related benefits suggested that process-based working memory and executive control training often induced compensation effects with larger benefits in low performing individuals. Finally, we discuss the effects of process-based training in relation to other types of interventions aimed at improving academic achievement.

Motivation and academic achievement in medical students.

PubMed

Yousefy, Alireza; Ghassemi, Gholamreza; Firouznia, Samaneh

2012-01-01

Despite their ascribed intellectual ability and achieved academic pursuits, medical students' academic achievement is influenced by motivation. This study is an endeavor to examine the role of motivation in the academic achievement of medical students. In this cross-sectional correlational study, out of the total 422 medical students, from 4th to final year during the academic year 2007-2008, at School of Medicine, Isfahan University of Medical Sciences, 344 participated in completion of the Inventory of School Motivation (ISM), comprising 43 items and measuring eight aspects of motivation. The gold standard for academic achievement was their average academic marks at pre-clinical and clinical levels. Data were computer analyzed by running a couple of descriptive and analytical tests including Pearson Correlation and Student's t-student. Higher motivation scores in areas of competition, effort, social concern, and task were accompanied by higher average marks at pre-clinical as well as clinical levels. However, the latter ones showed greater motivation for social power as compared to the former group. Task and competition motivation for boys was higher than for girls. In view of our observations, students' academic achievement requires coordination and interaction between different aspects of motivation.

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 (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

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.

Benefits of simulation based training for neonatal resuscitation education: a systematic review.

PubMed

Rakshasbhuvankar, A A; Patole, S K

2014-10-01

Simulation-based training (SBT) is being more frequently recommended for neonatal resuscitation education (NRE). It is important to assess if SBT improves clinical outcomes as neonatal resuscitation aims to improve survival without long-term neurodevelopmental impairment. We aimed to assess the evidence supporting benefits of SBT in NRE. A systematic review was conducted using the Cochrane methodology. PubMed, Embase, PsycInfo and Cochrane databases were searched. Related abstracts were scanned and full texts of the potentially relevant articles were studied. Randomised controlled trials (RCT) and quasi-experimental studies with controls (non-RCT) assessing SBT for NRE were eligible for inclusion in the review. Four small studies [three RCT (n=126) and one non-RCT (n=60)] evaluated SBT for NRE. Participants included medical students (one RCT and one non-RCT), residents (one RCT) and nursing staff (one RCT). Outcomes included performance in a simulation scenario, theoretical knowledge, and confidence in leading a resuscitation scenario. One RCT favoured simulation [improved resuscitation score (p=0.016), 2.31 more number of critical actions (p=0.017) and decreased time to achieve resuscitation steps (p=<0.001)]. The remaining two RCTs and the non-RCT did not find any difference between SBT and alternate methods of instruction. None of the four studies reported clinical outcomes. Evidence regarding benefits of SBT for NRE is limited. There are no data on clinical outcomes following SBT for NRE. Large RCTs assessing clinically important outcomes are required before SBT can be recommended widely for NRE. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Benefits of Multilingualism in Education

ERIC Educational Resources Information Center

Okal, Benard Odoyo

2014-01-01

The article gives a brief analytical survey of multilingualism practices, its consequences, its benefits in education and discussions on the appropriate ways towards its achievement in education. Multilingualism refers to speaking more than one language competently. Generally there are both the official and unofficial multilingualism practices. A…

Maximizing the benefits of antiretroviral therapy for key affected populations.

PubMed

Grubb, Ian R; Beckham, Sarah W; Kazatchkine, Michel; Thomas, Ruth M; Albers, Eliot R; Cabral, Mauro; Lange, Joep; Vella, Stefano; Kurian, Manoj; Beyrer, Chris

2014-01-01

Scientific research has demonstrated the clinical benefits of earlier initiation of antiretroviral treatment (ART), and that ART can markedly reduce HIV transmission to sexual partners. Ensuring universal access to ART for those who need it has long been a core principle of the HIV response, and extending the benefits of ART to key populations is critical to increasing the impact of ART and the overall effectiveness of the HIV response. However, this can only be achieved through coordinated efforts to address political, social, legal and economic barriers that key populations face in accessing HIV services. Recent analyses show that HIV prevalence levels among key populations are far higher than among the general population, and they experience a range of biological and behavioural factors, and social, legal and economic barriers that increase their vulnerability to HIV and have resulted in alarmingly low ART coverage. World Health Organization 2014 consolidated guidance on HIV among key populations offers the potential for increased access to ART by key populations, following the same principles as for the general adult population. However, it should not be assumed that key populations will achieve greater access to ART unless stigma, discrimination and punitive laws, policies and practices that limit access to ART and other HIV interventions in many countries are addressed. Rights-based approaches and investments in critical enablers, such as supportive legal and policy environments, are essential to enable wider access to ART and other HIV interventions for key populations. The primary objective of ART should always be to treat the person living with HIV; prevention is an important, additional benefit. ART should be provided only with informed consent. The preventive benefits of treatment must not be used as a pretext for failure to provide other necessary HIV programming for key populations, including comprehensive harm reduction and other prevention

GRAPHIC REANALYSIS OF THE TWO NINDS-TPA TRIALS CONFIRMS SUBSTANTIAL TREATMENT BENEFIT

PubMed Central

Saver, Jeffrey L.; Gornbein, Jeffrey; Starkman, Sidney

2010-01-01

Background of Comment/Review Multiple statistical analyses of the two NINDS-TPA Trials have confirmed study findings of benefit of fibrinolytic therapy. A recent graphic analysis departed from best practices in the visual display of quantitative information by failing to take into account the skewed functional importance NIH Stroke Scale raw scores and by scaling change axes at up to twenty times the range achievable by individual patients. Methods Using the publicly available datasets of the 2 NINDS-TPA Trials, we generated a variety of figures appropriate to the characteristics of acute stroke trial data. Results A diverse array of figures all visually delineated substantial benefits of fibrinolytic therapy, including: bar charts of normalized gain and loss; stacked bar, bar, and matrix plots of clinically relevant ordinal ranks; a time series stacked line plot of continuous scale disability weights; and line plot, bubble chart, and person icon array graphs of joint outcome table analysis. The achievable change figure showed substantially greater improvement among TPA than placebo patients, median 66.7% (IQR 0–92.0) vs 50.0% (IQR −7.1 – 80.0), p=0.003. Conclusions On average, under 3 hour patients treated with TPA recovered two-thirds while placebo patients improved only half of the way towards fully normal. Graphical analyses of the two NINDS-TPA trials, when performed according to best practices, is a useful means of conveying details about patient response to therapy not fully delineated by summary statistics, and confirms a valuable treatment benefit of under 3 hour fibrinolytic therapy in acute stroke. PMID:20829518

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

Quantifying the costs and benefits of occupational health and safety interventions at a Bangladesh shipbuilding company

PubMed Central

Thiede, Irene; Thiede, Michael

2015-01-01

Background: This study is the first cost–benefit analysis (CBA) of occupational health and safety (OHS) in a low-income country. It focuses on one of the largest shipbuilding companies in Bangladesh, where globally recognised Occupational Health and Safety Advisory Services (OHSAS) 18001 certification was achieved in 2012. Objectives: The study examines the relative costs of implementing OHS measures against qualitative and quantifiable benefits of implementation in order to determine whether OHSAS measures are economically advantageous. Methods: Quantifying past costs and benefits and discounting future ones, this study looks at the returns of OHS measures at Western Marine Shipbuilding Company Ltd. Results: Costs included investments in workplace and environmental safety, a new clinic that also serves the community, and personal protective equipment (PPE) and training. The results are impressive: previously high injury statistics dropped to close to zero. Conclusions: OHS measures decrease injuries, increase efficiency, and bring income security to workers’ families. Certification has proven a competitive edge for the shipyard, resulting in access to greater markets. Intangible benefits such as trust, motivation and security are deemed crucial in the CBA, and this study finds the high investments made are difficult to offset with quantifiable benefits alone. PMID:25589369

Quantifying the costs and benefits of occupational health and safety interventions at a Bangladesh shipbuilding company.

PubMed

Thiede, Irene; Thiede, Michael

2015-01-01

This study is the first cost-benefit analysis (CBA) of occupational health and safety (OHS) in a low-income country. It focuses on one of the largest shipbuilding companies in Bangladesh, where globally recognised Occupational Health and Safety Advisory Services (OHSAS) 18001 certification was achieved in 2012. The study examines the relative costs of implementing OHS measures against qualitative and quantifiable benefits of implementation in order to determine whether OHSAS measures are economically advantageous. Quantifying past costs and benefits and discounting future ones, this study looks at the returns of OHS measures at Western Marine Shipbuilding Company Ltd. Costs included investments in workplace and environmental safety, a new clinic that also serves the community, and personal protective equipment (PPE) and training. The results are impressive: previously high injury statistics dropped to close to zero. OHS measures decrease injuries, increase efficiency, and bring income security to workers' families. Certification has proven a competitive edge for the shipyard, resulting in access to greater markets. Intangible benefits such as trust, motivation and security are deemed crucial in the CBA, and this study finds the high investments made are difficult to offset with quantifiable benefits alone.

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

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

Long-term benefit of PD-L1 blockade in lung cancer associated with JAK3 activation

PubMed Central

Van Allen, Eliezer M.; Golay, Hadrien G.; Liu, Yan; Koyama, Shohei; Wong, Karrie; Taylor-Weiner, Amaro; Giannakis, Marios; Harden, Maegan; Rojas-Rudilla, Vanesa; Chevalier, Aaron; Thai, Tran; Lydon, Christine; Mach, Stacy; Wong, Joshua A.; Rabin, Alexandra R.; Helmkamp, Joshua; Sholl, Lynette; Carter, Scott L.; Oxnard, Geoffrey; Janne, Pasi; Getz, Gad; Lindeman, Neal; Hammerman, Peter S.; Garraway, Levi A.; Hodi, F. Stephen; Rodig, Scott; Dranoff, Glenn; Wong, Kwok-Kin; Barbie, David A.

2015-01-01

PD-1 immune checkpoint blockade occasionally results in durable clinical responses in advanced metastatic cancers. However, mechanism-based predictors of response to this immunotherapy remain incompletely characterized. We performed comprehensive genomic profiling on a tumor and germline sample from a patient with refractory lung adenocarcinoma who achieved marked long-term clinical benefit from anti-PD-L1 therapy. We discovered activating somatic and germline amino acid variants in JAK3 that promoted PD-L1 induction in lung cancer cells and in the tumor immune microenvironment. These findings suggest that genomic alterations that deregulate cytokine receptor signal transduction could contribute to PD-L1 activation and engagement of the PD-1 immune checkpoint in lung cancer. PMID:26014096

[Wholegrain cereals and sanitary benefits].

PubMed

Ortega, Rosa M; Aparicio Vizuete, Aránzazu; Jiménez Ortega, Ana Isabel; Rodríguez Rodríguez, Elena

2015-07-18

Dietary guidelines indicate that to get a proper nutrition is recommended eating 3 or more servings per day of whole grain. However, the recommendation is little known in the Spanish population, and almost the entire population doesn't fulfill it. Therefore, the aim of this review is to analyze the nutritional and health benefits associated with the consumption of whole grain cereals and the potential benefits related to the meeting of this guideline. Literature search regarding the topic. Whole grain cereals are rich in carbohydrates, fiber, vitamins and minerals, and its contribution to the average diet helps to achieve current recommended intakes and nutritional goals, so its consumption in the recommended amount supposes a nutritional benefit. Moreover, several studies indicate that increased consumption of whole grain cereal is associated with protection against various chronic degenerative diseases (cardiovascular, diabetes, cancer and metabolic syndrome), assisting in the maintenance of digestive health and body weight. These results may be due to the contribution of nutrients, fiber and phytochemicals of these foods, as well as the displacement of the diet of other products with a less desirable nutritional profile, taking into account the composition of the average Spanish diet. In fact, the consumption of whole grain cereals has been linked with a possible improvement in the intestinal microbiota and antioxidant protection. In spite of these advantages, cereal consumption is looked with suspicion by many individuals, especially those concerned about weight control and additional benefits associated to consumption of whole grain cereals are not known. Whole grain cereals should be daily consumed in amounts of 3 or more servings/day, to achieve the nutritional and health benefits described in numerous investigations. More outreach is needed to ensure that the guideline is known and it's applied. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

PubMed

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

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.

Pharmacy Benefit Management Companies: Do They Create Value in the US Healthcare System?

PubMed

Lyles, Alan

2017-05-01

Pharmacy benefit management companies (PBMs) perform functions in the US market-based healthcare system that may be performed by public agencies or quasi-public institutions in other nations. By aggregating lives covered under their many individual contracts with payers, PBMs have formidable negotiating power. They influence pharmaceutical insurance coverage, design the terms of coverage in a plan's drug benefit, and create competition among providers for inclusion in a plan's network. PBMs have, through intermediation, the potential to secure lower drug prices and to improve rational prescribing. Whether these potential outcomes are realized within the relevant budget is a function of the healthcare system and the interaction of benefit design and clinical processes-not just individually vetted components. Efficiencies and values achieved in price discounts and cost sharing can be nullified if there is irrational prescribing (over-utilization, under-utilization and mis-utilization), variable patient adherence to medication regimens, ineffective formulary processes, or fraud, waste and abuse. Rising prescription drug costs and the increasing prevalence of 'high deductible health plans', which require much greater patient out-of-pocket costs, is creating a crisis for PBM efforts towards an affordable pharmacy benefit. Since PBM rebate and incentive contracts are opaque to the public, whether they add value by restraining higher drug prices or benefit from them is debatable.

Achievement goal profiles and developments in effort and achievement in upper elementary school.

PubMed

Hornstra, Lisette; Majoor, Marieke; Peetsma, Thea

2017-12-01

The multiple goal perspective posits that certain combinations of achievement goals are more favourable than others in terms of educational outcomes. This study aimed to examine longitudinally whether students' achievement goal profiles and transitions between profiles are associated with developments in self-reported and teacher-rated effort and academic achievement in upper elementary school. Participants were 722 fifth-grade students and their teachers in fifth and sixth grade (N = 68). Students reported on their achievement goals and effort in language and mathematics three times in grade 5 to grade 6. Teachers rated students' general school effort. Achievement scores were obtained from school records. Goal profiles were derived with latent profile and transition analyses. Longitudinal multilevel analyses were conducted. Theoretically favourable goal profiles (high mastery and performance-approach goals, low on performance-avoidance goals), as well as transitions from less to more theoretically favourable goal profiles, were associated with higher levels and more growth in effort for language and mathematics and with stronger language achievement gains. Overall, these results provide support for the multiple goal perspective and show the sustained benefits of favourable goal profiles beyond effects of cognitive ability and background characteristics. © 2017 The Authors. British Journal of Education Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

Cross-Sectional Assessment of Achievement of Therapeutic Goals in a Canadian Multidisciplinary Clinic for Patients With Advanced Chronic Kidney Disease.

PubMed

Rinfret, Félix; Lambert, France; Youmbissi, Joseph Tchetagni; Arcand, Jean-François; Turcot, Richard; Bessette, Maral Alimardani; Bourque, Solange; Moreau, Vincent; Tousignant, Karine; Deschênes, Diane; Cloutier, Lyne

2018-01-01

The implementation of advanced chronic kidney disease (CKD) multidisciplinary clinics has now demonstrated their effectiveness in delaying and even avoiding dialysis for patients with CKD. However, very little has been documented on the management and achievement of targets for a number of parameters in this context. Our goal was to assess our multidisciplinary clinic therapy performance in relation to the targets for hypertension, anemia, and calcium phosphate assessment. A cross-sectional descriptive study was conducted with a cohort including all patients followed up in our multidisciplinary clinic in July 2014. Comorbidity, laboratory, and clinical data were collected and compared with the recommendations of scientific organizations. The cohort included 128 patients, 37.5% of whom were women. Mean follow-up time was 26.6 ± 25.1 months and mean estimated glomerular filtration rate (eGFR) was 14.0 ± 4.7 mL/min/1.73 m 2 . A total of 24.2% of patients with diabetes achieved blood pressure targets of <130/80 mm Hg, while 56.5% of patients without diabetes achieved targets of <140/90 mm Hg. Hemoglobin of patients treated with erythropoiesis-stimulating agents was 100 to 110 g/L in 36.2% of the patients, below 100 for 39.7% of them, and above 110 for 24.1%, whereas 67.2% were within the acceptable limits of 95 to 115 g/L. In addition, 63.4% of patients had a serum phosphate of <1.5 mmol/L, and 90.9% of patients had total serum calcium <2.5 mmol/L. Our study is a single center study with the majority of our patients being Caucasian. This limits the generalizability of our findings. The control rates of various parameters were satisfactory given the difficult clinical context, but could be optimized. We publish these data in the hope that they are helpful to others engaged in quality improvement in their own programs or more generally.

Estimating the clinical and economic benefit associated with incremental improvements in sustained virologic response in chronic hepatitis C.

PubMed

McEwan, Phil; Ward, Thomas; Bennett, Hayley; Kalsekar, Anupama; Webster, Samantha; Brenner, Michael; Yuan, Yong

2015-01-01

Hepatitis C virus (HCV) infection is one of the principle causes of chronic liver disease. Successful treatment significantly decreases the risk of hepatic morbidity and mortality. Current standard of care achieves sustained virologic response (SVR) rates of 40-80%; however, the HCV therapy landscape is rapidly evolving. The objective of this study was to quantify the clinical and economic benefit associated with increasing levels of SVR. A published Markov model (MONARCH) that simulates the natural history of hepatitis C over a lifetime horizon was used. Discounted and non-discounted life-years (LYs), quality-adjusted life-years (QALYs) and cost of complication management were estimated for various plausible SVR rates. To demonstrate the robustness of projections obtained, the model was validated to ten UK-specific HCV studies. QALY estimates ranged from 18.0 years for those treated successfully in fibrosis stage F0 to 7.5 years (discounted) for patients in fibrosis stage F4 who remain untreated. Predicted QALY gains per 10% improvement in SVR ranged from 0.23 (F0) to 0.64 (F4) and 0.58 (F0) to 1.35 (F4) in 40 year old patients (discounted and non-discounted results respectively). In those aged 40, projected discounted HCV-related costs are minimised with successful treatment in F0/F1 (at approximately £ 300), increasing to £ 49,300 in F4 patients who remain untreated. Validation of the model to published UK cost-effectiveness studies produce R2 goodness of fit statistics of 0.988, 0.978 and of 0.973 for total costs, QALYs and incremental cost effectiveness ratios, respectively. Projecting the long-term clinical and economic consequences associated with chronic hepatitis C is a necessary requirement for the evaluation of new treatments. The principle analysis demonstrates the significant impact on expected costs, LYs and QALYs associated with increasing SVR. A validation analysis demonstrated the robustness of the results reported.

Challenges in Achieving Collaboration in Clinical Practice: The Case of Norwegian Health Care

PubMed Central

Johannessen, Anne-Kari; Ådnanes, Marian; Paulsen, Bård; Mannion, Russell

2016-01-01

Introduction: This article summarizes and synthesizes the findings of four separate but inter-linked empirical projects which explored challenges of collaboration in the Norwegian health system from the perspectives of providers and patients. The results of the four projects are summarised in eight articles. Methods: The eight articles constituted our empirical material. Meta-ethnography was used as a method to integrate, translate, and synthesize the themes and concepts contained in the articles in order to understand how challenges related to collaboration impact on clinical work. Results: Providers’ collaboration across all contexts was hampered by organizational and individual factors, including, differences in professional power, knowledge bases, and professional culture. The lack of appropriate collaboration between providers impeded clinical work. Mental health service users experienced fragmented services leading to insecurity and frustration. The lack of collaboration resulted in inadequate rehabilitation services and lengthened the institutional stay for older patients. Conclusion: Focusing on the different perspectives and the inequality in power between patients and healthcare providers and between different providers might contribute to a better environment for achieving appropriate collaboration. Organizational systems need to be redesigned to better nurture collaborative relationships and information sharing and support integrated working between providers, health care professionals and patients. PMID:28435416

The health and economic benefits of the global programme to eliminate lymphatic filariasis (2000-2014).

PubMed

Turner, Hugo C; Bettis, Alison A; Chu, Brian K; McFarland, Deborah A; Hooper, Pamela J; Ottesen, Eric A; Bradley, Mark H

2016-05-24

Lymphatic filariasis (LF), also known as elephantiasis, is a neglected tropical disease (NTD) targeted for elimination through a Global Programme to Eliminate LF (GPELF). Between 2000 and 2014, the GPELF has delivered 5.6 billion treatments to over 763 million people. Updating the estimated health and economic benefits of this significant achievement is important in justifying the resources and investment needed for eliminating LF. We combined previously established models to estimate the number of clinical manifestations and disability-adjusted life years (DALYs) averted from three benefit cohorts (those protected from acquiring infection, those with subclinical morbidity prevented from progressing and those with clinical disease alleviated). The economic savings associated with this disease prevention was then analysed in the context of prevented medical expenses incurred by LF clinical patients, potential income loss through lost-labour, and prevented costs to the health system to care for affected individuals. The indirect cost estimates were calculated using the human capital approach. A combination of four wage sources was used to estimate the fair market value of time for an agricultural worker with LF infection (to ensure a conservative estimate, the lowest wage value was used). We projected that due to the first 15 years of the GPELF 36 million clinical cases and 175 (116-250) million DALYs will potentially be averted. It was estimated that due to this notable health impact, US$100.5 billion will potentially be saved over the lifetimes of the benefit cohorts. This total amount results from summing the medical expenses incurred by LF patients (US$3 billion), potential income loss (US$94 billion), and costs to the health system (US$3.5 billion) that were projected to be prevented. The results were subjected to sensitivity analysis and were most sensitive to the assumed percentage of work hours lost for those suffering from chronic disease (changing the

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.

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

Achieving benefit for patients in primary care informatics: the report of a international consensus workshop at Medinfo 2007.

PubMed

de Lusignan, Simon; Teasdale, Sheila

2007-01-01

Landmark reports suggest that sharing health data between clinical computer systems should improve patient safety and the quality of care. Enhancing the use of informatics in primary care is usually a key part of these strategies. To synthesise the learning from the international use of informatics in primary care. The workshop was attended by 21 delegates drawn from all continents. There were presentations from USA, UK and the Netherlands, and informal updates from Australia, Argentina, and Sweden and the Nordic countries. These presentations were discussed in a workshop setting to identify common issues. Key principles were synthesised through a post-workshop analysis and then sorted into themes. Themes emerged about the deployment of informatics which can be applied at health service, practice and individual clinical consultation level: 1 At the health service or provider level, success appeared proportional to the extent of collaboration between a broad range of stakeholders and identification of leaders. 2 Within the practice much is currently being achieved with legacy computer systems and apparently outdated coding systems. This includes prescribing safety alerts, clinical audit and promoting computer data recording and quality. 3 In the consultation the computer is a 'big player' and may make traditional models of the consultation redundant. We should make more efforts to share learning; develop clear internationally acceptable definitions; highlight gaps between pockets of excellence and real-world practice, and most importantly suggest how they might be bridged. Knowledge synthesis from different health systems may provide a greater understanding of how the third actor (the computer) is best used in primary care.

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

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

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.

Impact of Clinical Factors on the Achievement of Target Blood Pressure in Hypertensive Patients from Ivanovo Region of Russia: Data of 2015.

PubMed

Kiselev, A R; Posnenkova, O M; Belova, O A; Romanchuk, S V; Popova, Y V; Prokhorov, M D; Gridnev, V I

2017-12-01

In Russia, blood pressure (BP) control is below the optimal. The little is known about regional features and barriers to adequate BP control in Russian primary care. To evaluate the impact of clinical factors on achieving the target BP in hypertensive patients in one region of Russia. Retrospective medical data of 2015 on 11,129 patients (31.4% male) with hypertension (Htn) from Ivanovo region of Russia were examined. Achievement of target BP was assessed in all patients. We study association between BP control and clinical factors. 45.9% of studied patients with Htn had controlled BP. The frequency of achieving the target BP in subsets of hypertensive patients was 37.8% in patients with diabetes, 39.5% in patients with coronary artery disease, and 29.9% in patients with chronic heart failure. The main clinical factors associated with achieving the target BP in studied hypertensive patients were the advice on alcohol consumption, advice on smoking cessation, and advice on weight reduction. Therapy with main antihypertensive drugs (in particular, beta-blockers and thiazide diuretics) were also factors of optimal BP control in these patients. Comorbidities (chronic heart failure and cardiovascular diseases requiring the prescription of aspirin and statins) and family history of coronary artery disease were associated with inadequate BP control. A negative effect of some antihypertensive drugs (potassium sparing diuretics, ARBs, ACE-Is, and dihydropyridine CCBs) on BP control that was found out in our study requires further investigation. Other studied factors had no influence on BP control in patients with Htn from Ivanovo region. We identified regional factors of BP control in hypertensive patients from Ivanovo region of Russia. It is shown that individual medical education (in particular, medical advices) is the most important factor of optimal BP control. The intervention with antihypertensive therapy (beta-blockers and thiazide diuretics) facilitates the

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.

Exercise and well-being: a review of mental and physical health benefits associated with physical activity.

PubMed

Penedo, Frank J; Dahn, Jason R

2005-03-01

This review highlights recent work evaluating the relationship between exercise, physical activity and physical and mental health. Both cross-sectional and longitudinal studies, as well as randomized clinical trials, are included. Special attention is given to physical conditions, including obesity, cancer, cardiovascular disease and sexual dysfunction. Furthermore, studies relating physical activity to depression and other mood states are reviewed. The studies include diverse ethnic populations, including men and women, as well as several age groups (e.g. adolescents, middle-aged and older adults). Results of the studies continue to support a growing literature suggesting that exercise, physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes. Generally, participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions. Similarly, participants in randomized clinical trials of physical-activity interventions show better health outcomes, including better general and health-related quality of life, better functional capacity and better mood states. The studies have several implications for clinical practice and research. Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes. Therefore, assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several populations. Several limitations were noted, particularly in research involving randomized clinical trials. These trials tend to involve limited sample sizes with short follow-up periods, thus limiting the clinical implications of the benefits associated with physical activity.

Clinical and financial considerations for implementing an ICU telemedicine program.

PubMed

Kruklitis, Robert J; Tracy, Joseph A; McCambridge, Matthew M

2014-06-01

As the population in the United States increases and ages, the need to provide high-quality, safe, and cost-effective care to the most critically ill patients will be of great importance. With the projected shortage of intensivists, innovative changes to improve efficiency and increase productivity will be necessary. Telemedicine programs in the ICUs (tele-ICUs) are a successful strategy to improve intensivist access to critically ill patients. Although significant capital and maintenance costs are associated with tele-ICUs, these costs can be offset by indirect financial benefits, such as decreased length of stay. To achieve the positive clinical outcomes desired, tele-ICUs must be carefully designed and implemented. In this article, we discuss the clinical benefits of tele-ICUs. We review the financial considerations, including direct and indirect reimbursement and development and maintenance costs. Finally, we review design and implementation considerations for tele-ICUs.

Decision curve analysis revisited: overall net benefit, relationships to ROC curve analysis, and application to case-control studies.

PubMed

Rousson, Valentin; Zumbrunn, Thomas

2011-06-22

Decision curve analysis has been introduced as a method to evaluate prediction models in terms of their clinical consequences if used for a binary classification of subjects into a group who should and into a group who should not be treated. The key concept for this type of evaluation is the "net benefit", a concept borrowed from utility theory. We recall the foundations of decision curve analysis and discuss some new aspects. First, we stress the formal distinction between the net benefit for the treated and for the untreated and define the concept of the "overall net benefit". Next, we revisit the important distinction between the concept of accuracy, as typically assessed using the Youden index and a receiver operating characteristic (ROC) analysis, and the concept of utility of a prediction model, as assessed using decision curve analysis. Finally, we provide an explicit implementation of decision curve analysis to be applied in the context of case-control studies. We show that the overall net benefit, which combines the net benefit for the treated and the untreated, is a natural alternative to the benefit achieved by a model, being invariant with respect to the coding of the outcome, and conveying a more comprehensive picture of the situation. Further, within the framework of decision curve analysis, we illustrate the important difference between the accuracy and the utility of a model, demonstrating how poor an accurate model may be in terms of its net benefit. Eventually, we expose that the application of decision curve analysis to case-control studies, where an accurate estimate of the true prevalence of a disease cannot be obtained from the data, is achieved with a few modifications to the original calculation procedure. We present several interrelated extensions to decision curve analysis that will both facilitate its interpretation and broaden its potential area of application.

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.

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

Clinical outcome and prognostic markers for patients with gynecologic malignancies in phase 1 clinical trials: a single institution experience from 1999 to 2010.

PubMed

Hou, June Y; Aparo, Santiago; Ghalib, Mohammad; Chaudhary, Imran; Shah, Umang; Swami, Umang; Einstein, Mark; Goldberg, Gary L; Mani, Sridhar; Goel, Sanjay

2013-10-01

There is a scarcity of outcome data regarding phase 1 trials for patients with gynecologic malignancy. The objective of this study was to assess toxicity, clinical benefit and prognosticators in gynecologic oncology patients participating in phase 1 trials. All phase 1 oncology trials conducted at Albert Einstein Cancer Center from 1999 to 2010 were reviewed and extracted for relevant demographic and clinical data concerning patients with gynecologic malignancy. Cox-proportional and logistic regression modeling were used for multivariate analysis. 120 distinct patients with gynecologic malignancy participated in 41 trials, constituting 30.6% of all phase 1 patients enrolled in the same time period. The median age is 59 years. Out of the 184 patients enrolled, 160 individual responses were evaluable. Seventeen DLT events (9.2%) occurred, including 1 (0.5%) treatment-related mortality. There were 27.2%≥ grade 3 hematologic and 24.4% non-hematologic toxicity. Eighty patients had stable disease (SD, 50%), including 21.9% with SD ≥ 4 months, 11 (6.3%) with partial response (PR), and 3 (1.9%) achieving complete response (CR). The clinical benefit rate (CBR=SD+CR+PR) was 58.1%. Albumin (Alb)≤ 3.5 g/dL and abnormal ANC were independent negative prognosticators of survival. We also found a continuous correlation between changes in Albumin (p=0.02) and LDH (p=0.02) and odds of achieving CBR≥4month. Our clinical outcome and safety data suggested that phase 1 trials may be a reasonable option for patients with advanced and recurrent gynecologic cancer. The potential prognosticators identified should be further validated in larger trials. © 2013.

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/.

Selected options supporting use of the group embedded figures test in modeling achievement in clinical laboratory science programs.

PubMed

Powell, M E

1995-01-01

To identify, in light of predicted future shortages of allied-health personnel, student and curricular characteristics of clinical laboratory science (CLS) programs relevant to recruitment and retention at the baccalaureate level. Not applicable. Not applicable. Options for modeling achievement in CLS programs are developed, and designs and procedures for clarifying procedural questions are considered in a context of delivery of instruction for specialized curricula and skill development. Considerable attention is given to the potential for using the Group Embedded Figures Test (GEFT) in modeling, advising, designing curricula, and monitoring quality improvement of programs and graduates. Not applicable. Supporting evidence is supplied from the literature for options in developing an appropriate model for examining those salient variables known to have linkages to achievement. An argument is presented for better understanding of antecedent variables affecting achievement and retention of CLS students. In addition, a case is made for development of an appropriate model examining variables identified in the literature as being linked to achievement. Dynamic models based on these considerations should be developed chronologically from entry through graduation with emphasis on growth at year-end milestones.

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.

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.

Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits

PubMed Central

Koo, Bon-Min; Kim, Jang-Ho Jay; Kim, Tae-Kyun; Kim, Byung-Yun

2015-01-01

In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder). To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability. PMID:28793563

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

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.

Interprofessional collaboration in research, education, and clinical practice: working together for a better future.

PubMed

Green, Bart N; Johnson, Claire D

2015-03-01

Interprofessional collaboration occurs when 2 or more professions work together to achieve common goals and is often used as a means for solving a variety of problems and complex issues. The benefits of collaboration allow participants to achieve together more than they can individually, serve larger groups of people, and grow on individual and organizational levels. This editorial provides an overview of interprofessional collaboration in the areas of clinical practice, education, and research; discusses barriers to collaboration; and suggests potential means to overcome them.

Interprofessional collaboration in research, education, and clinical practice: working together for a better future

PubMed Central

Green, Bart N.; Johnson, Claire D.

2015-01-01

Interprofessional collaboration occurs when 2 or more professions work together to achieve common goals and is often used as a means for solving a variety of problems and complex issues. The benefits of collaboration allow participants to achieve together more than they can individually, serve larger groups of people, and grow on individual and organizational levels. This editorial provides an overview of interprofessional collaboration in the areas of clinical practice, education, and research; discusses barriers to collaboration; and suggests potential means to overcome them. PMID:25594446

Social media and physicians: Exploring the benefits and challenges.

PubMed

Panahi, Sirous; Watson, Jason; Partridge, Helen

2016-06-01

Healthcare professionals' use of social media platforms, such as blogs, wikis, and social networking web sites has grown considerably in recent years. However, few studies have explored the perspectives and experiences of physicians in adopting social media in healthcare. This article aims to identify the potential benefits and challenges of adopting social media by physicians and demonstrates this by presenting findings from a survey conducted with physicians. A qualitative survey design was employed to achieve the research goal. Semi-structured interviews were conducted with 24 physicians from around the world who were active users of social media. The data were analyzed using the thematic analysis approach. The study revealed six main reasons and six major challenges for physicians adopting social media. The main reasons to join social media were as follows: staying connected with colleagues, reaching out and networking with the wider community, sharing knowledge, engaging in continued medical education, benchmarking, and branding. The main challenges of adopting social media by physicians were also as follows: maintaining confidentiality, lack of active participation, finding time, lack of trust, workplace acceptance and support, and information anarchy. By revealing the main benefits as well as the challenges of adopting social media by physicians, the study provides an opportunity for healthcare professionals to better understand the scope and impact of social media in healthcare, and assists them to adopt and harness social media effectively, and maximize the benefits for the specific needs of the clinical community. © The Author(s) 2014.

Psychology of the scientist: LXXXI. Professional school and traditional program graduates: comparison on measures of achievement in clinical psychology.

PubMed

Templer, D I; Tomeo, M E; Pointkowski, S R; Mitroff, D; Niederhauser, R N; Siscoe, K

2000-06-01

Clinical psychologists who graduated from traditional programs and those who graduated from professional schools were compared on both scientifically and professionally oriented criteria of achievement and recognition. Upon controlling for year of graduation from a doctoral program, the professional school graduates were less likely to be APA fellows, less likely to be on the editorial board of specified research oriented journals in clinical psychology, less likely to have diplomate status in the American Board of Professional Psychology (ABPP), less likely to have been president of state psychological associations, and less likely to have been APPIC internship directors.

Addition of meloxicam to the treatment of bovine clinical mastitis results in a net economic benefit to the dairy farmer.

PubMed

van Soest, Felix J S; Abbeloos, Elke; McDougall, Scott; Hogeveen, Henk

2018-04-01

Recently, it has been shown that the addition of meloxicam to standard antimicrobial therapy for clinical mastitis (CM) improves the conception rate of dairy cows contracting CM in the first 120 d in milk. The objective of our study was to assess whether this improved reproduction through additional treatment with meloxicam would result in a positive net economic benefit for the farmer. We developed a stochastic bio-economic simulation model, in which a dairy cow with CM in the first 120 d in milk was simulated. Two scenarios were simulated in which CM cases were treated with meloxicam in conjunction with antimicrobial therapy or with antimicrobial therapy alone. The scenarios differed for conception rates (31% with meloxicam or 21% without meloxicam) and for the cost of CM treatment. Sensitivity analyses were undertaken for the biological and economic components of the model to assess the effects of a wide range of inputs on inferences about the cost effectiveness of meloxicam treatment. Model results showed an average net economic benefit of €42 per CM case per year in favor of the meloxicam scenario. Cows in the no-meloxicam treatment scenario had higher returns on milk production, lower costs upon calving, and reduced costs of treatment. However, these did not outweigh the savings associated with lower feed intake, reduced number of inseminations, and the reduced culling rate. The net economic benefit favoring meloxicam therapy was a consequence of the better reproductive performance in the meloxicam scenario in which cows had a shorter calving to conception interval (132 vs. 143 d), a shorter intercalving interval (405 vs. 416 d), and fewer inseminations per conception (2.9 vs. 3.7) compared with cows in the no-meloxicam treatment scenario. This resulted in a shorter lactation, hence a lower lactational milk production (8,441 vs. 8,517 kg per lactation) with lower feeding costs in the meloxicam group. A lower culling rate (12 vs. 25%) resulted in lower

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.

On the Path to SunShot. The Environmental and Public Health Benefits of Achieving High Solar Penetrations in the United States

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

Wiser, Ryan; Mai, Trieu; Millstein, Dev

Compared with fossil fuel generators, photovoltaics (PV) and concentrating solar power (CSP) produce far lower lifecycle levels of greenhouse gas (GHG) emissions and harmful pollutants including fine particular matter (PM2.5), sulfur dioxide (SO 2), and nitrogen oxides (NO x). In this report, we monetize the emission reductions from achieving the U.S. Department of Energy's SunShot deployment goals: 14% of U.S. electricity demand met by solar in 2030 and 27% in 2050. We estimate that achieving these goals could reduce cumulative power-sector GHG emissions by 10% between 2015 and 2050, resulting in savings of $238-$252 billion. This is equivalent to 2.0-2.2more » cents per kilowatt-hour of solar installed (cents/kWh-solar). Similarly, realizing these levels of solar deployment could reduce cumulative power-sector emissions of PM2.5 by 8%, SO 2 by 9%, and NOx by 11% between 2015 and 2050. This could produce $167 billion in savings from lower future health and environmental damages, or 1.4 cents/kWh-solar--while also preventing 25,000-59,000 premature deaths. To put this in perspective, this estimated combined benefit of 3.5 cents/kWh-solar due to SunShot-level solar deployment is approximately equal to the additional levelized cost of electricity reduction needed to make unsubsidized utility-scale solar competitive with conventional generators today. In addition, the analysis shows that achieving the SunShot goals could save 4% of total power-sector water withdrawals and 9% of total power-sector water consumption over the 2015-2050 period--a particularly important consideration for arid states where substantial solar will be deployed. These results have potential implications for policy innovation and the economic competitiveness of solar and other generation technologies.« less

Mutual benefits in academic-service partnership: An integrative review.

PubMed

Sadeghnezhad, Maliheh; Heshmati Nabavi, Fatemeh; Najafi, Fereshteh; Kareshki, Hossein; Esmaily, Habibollah

2018-05-30

Academic and service institutions involve with many challenges. Partnership programs are a golden opportunity to achieve mutual benefits to overcome these challenges. Identifying mutual benefits is the cornerstone of forming a successful partnership and guarantee to its continuity. There are definitions and instances of mutual benefits in the literature related to partnership programs, but there is no coherent evidence and clear picture of these benefits. This study is conducted to identify mutual benefits in academic-service partnership by analyzing the definitions and instances of it in the literature. An integrative review of key papers regarding mutual benefits in academic-service partnership was undertaken. This review was guided by the framework described by Whittemore and Knafl. Search of the following databases was conducted: MEDLINE, ERIC, Google Scholar, Emerald Insight and Science Direct. The search terms were mutual benefits, mutual gains, mutual interest, mutual expectations, mutual goals, mutual demand, partnership, collaboration, academic-service partnership and academic service collaboration. Cooper's five-stage integrative review method was used. Quality evaluation of articles was conducted. Data were abstracted from included articles. The analysis was conducted based on the qualitative content analysis of the literature suggested by Zhang and Wildemuth. 28 articles were included in this review. Mutual benefits are described in four categories include: synergy in training and empowerment of human resources, education improvement, access to shared resources, facilitate production and application of beneficial knowledge into practice. Mutual benefits in the academic-service partnership include a range of goals, interests, expectations, and needs of partner organizations that is achievable and measurable through joint planning and collaboration. We suggest academic and service policymakers to consider these benefits in the planning and evaluating

A Benefit Cost Analysis of the Abecedarian Early Childhood Intervention.

ERIC Educational Resources Information Center

Masse, Leonard N.; Barnett, W. Steven

Although the benefits to academic achievement and cognitive development experienced by children participating in the Carolina Abecedarian Project have been well documented, there is little information available on the cost effectiveness of programs based on the Abecedarian preschool model. This study involved a benefit-cost analysis of the…

The environmental and public health benefits of achieving high penetrations of solar energy in the United States

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

Wiser, Ryan; Millstein, Dev; Mai, Trieu

We estimate the environmental and public health benefits that may be realized if solar energy cost reductions continue until solar power is competitive across the U.S. without subsidies. Specifically, we model, from 2015 to 2050, solar power-induced reductions to greenhouse gas (GHG) emissions, air pollutant emissions, and water usage. To find the incremental benefits of new solar deployment, we compare the difference between two scenarios, one where solar costs have fallen such that solar supplies 14% of the nation's electricity by 2030 and 27% by 2050, and a baseline scenario in which no solar is added after 2014. We monetizemore » benefits, where credible methods exist to do so. We find that under these scenarios, solar power reduces GHG and air pollutants by ~10%, from 2015 to 2050, providing a discounted present value of $56-$789 billion (central value of ~$250 billion, equivalent to ~2 cents/kWh-solar) in climate benefits and $77-$298 billion (central value of $167 billion, or ~1.4 cents/kWh-solar) in air quality and public health benefits. The ranges reflect uncertainty within the literature about the marginal impact of emissions of GHG and air pollutants. Solar power is also found to reduce water withdrawals and consumption by 4% and 9%, respectively, including in many drought-prone states.« less

Current status of achieving blood pressure target and its clinical correlates in Japanese type 2 diabetes.

PubMed

Yokoyama, Hiroki; Araki, Shin-Ichi; Kawai, Koichi; Hirao, Koichi; Kurihara, Yoshio; Seino, Hiroaki; Takamura, Hiroshi; Sugimoto, Hidekatsu; Okada, Akira; Maegawa, Hiroshi

2017-07-21

To investigate the current status of achieved blood pressure levels in association with the number of antihypertensive drug classes as of 2013, and to explore the clinical correlates with achievement of target blood pressure in a large-scale cohort of Japanese subjects with type 2 diabetes. A nationwide survey was conducted including 12,811 subjects with type 2 diabetes. Subjects were divided by achieved blood pressure, <130/80 or 140/90 mmHg, and the number of drug classes taken. The percentages achieving a blood pressure of <130/80 or 140/90 mmHg were 52.0% and 86.1%, respectively. The prevalence of hypertension, if defined as ≥130/80 mmHg or treated, became 67.9%. Among subjects taking antihypertensive drugs, a blood pressure of <130/80 or <140/90 mmHg was 46.7% and 83.2%, respectively. The percentages of <130/80 mmHg were 55.9% without drugs, 47.1% on 1, 42.5% on 2, 47.2% on 3, and 56.8% on ≥4 drugs, respectively. The most prescribed drugs were renin-angiotensin system inhibitors, followed by calcium channel blockers, diuretics, and β-blockers. The multiple logistic regression analysis indicated that a blood pressure <130/80 mmHg was associated with lower values in age, body mass index, albuminuria, and glomerular filtration rate, higher proportions on targets for HbA 1C and lipids, and less retinopathy. In type 2 diabetes, hypertension is common and only 52% achieved <130/80 mmHg, indicating a difficulty in blood pressure lowering. This was correlated with difficulties in glycemic and lipid management, obesity, and vascular complications, implying these clustering to be a serious problem. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Undergraduate Students' Achievement Goals for Conducting Research: Examining the Motivational Benefits of Laboratory Classroom Affiliation

ERIC Educational Resources Information Center

Deemer, Eric D.; Dotterer, Aryn M.; Morel, Samantha A.; Bastnagel, Abigail E.

2017-01-01

Rooted in achievement goal theory, the buffering hypothesis posits that contextual factors serve to moderate the deleterious effects of personal achievement goals on relevant outcomes. The present study sought to test this hypothesis by examining the interactive effects of classroom affiliation perceptions and personal achievement goals for…

Clinical significance of achieving a flexion limitation with a tension band system in grade 1 degenerative spondylolisthesis: a minimum 5-year follow-up.

PubMed

Lee, Sang-Ho; Lee, Ho-Yeon; Baek, Oon Ki; Bae, Jun Seok; Yoo, Seung-Hwa; Lee, June-Ho

2015-03-15

Retrospective clinical study. To evaluate the effect of the limitation of flexion rotation clinically and radiologically after interspinous soft stabilization using a tension band system in grade 1 degenerative spondylolisthesis. Although several studies have been published on the clinical effects of limiting rotatory motion using tension band systems, which mainly targets the limitation of flexion rather than that of extension, they were confined to the category of pedicle screw-based systems, revealing inconsistent long-term outcomes. Sixty-one patients with a mean age of 60.6 years (range, 28-76 yr) who underwent interspinous soft stabilization after decompression for grade 1 degenerative spondylolisthesis with stenosis between 2002 and 2004 were analyzed. At follow-up, the patients were divided into 2 groups on the basis of their achievement or failure to achieve flexion limitation. The clinical and radiological findings were analyzed. A multiple linear regression analysis was performed to determine the prognostic factors for surgical outcomes. At a mean follow-up duration of 72.5 months (range, 61-82 mo), 51 patients were classified into the flexion-limited group and 10 into the flexion-unlimited group. Statistically significant improvements were noted only in the flexion-limited group in all clinical scores. In the flexion-unlimited group, there were significant deteriorations in flexion angle (P = 0.009), axial thickness of the ligamentum flavum (P = 0.013), and the foraminal cross-sectional area (P = 0.011), resulting in significant intergroup differences. The preoperative extension angle was identified as the most influential variable for the flexion limitation and the clinical outcomes. The effects of the limitation of flexion rotation achieved through interspinous soft stabilization using a tension band system after decompression were related to the prevention of late recurrent stenosis and resultant radicular pain caused by flexion instability. The

Valuing the commons: An international study on the recreational benefits of the Baltic Sea.

PubMed

Czajkowski, Mikołaj; Ahtiainen, Heini; Artell, Janne; Budziński, Wiktor; Hasler, Berit; Hasselström, Linus; Meyerhoff, Jürgen; Nõmmann, Tea; Semeniene, Daiva; Söderqvist, Tore; Tuhkanen, Heidi; Lankia, Tuija; Vanags, Alf; Zandersen, Marianne; Żylicz, Tomasz; Hanley, Nick

2015-06-01

The Baltic Sea provides benefits to all of the nine nations along its coastline, with some 85 million people living within the catchment area. Achieving improvements in water quality requires international cooperation. The likelihood of effective cooperation is known to depend on the distribution across countries of the benefits and costs of actions needed to improve water quality. In this paper, we estimate the benefits associated with recreational use of the Baltic Sea in current environmental conditions using a travel cost approach, based on data from a large, standardized survey of households in each of the 9 Baltic Sea states. Both the probability of engaging in recreation (participation) and the number of visits people make are modeled. A large variation in the number of trips and the extent of participation is found, along with large differences in current annual economic benefits from Baltic Sea recreation. The total annual recreation benefits are close to 15 billion EUR. Under a water quality improvement scenario, the proportional increases in benefits range from 7 to 18% of the current annual benefits across countries. Depending on how the costs of actions are distributed, this could imply difficulties in achieving more international cooperation to achieve such improvements. Copyright © 2015 Elsevier Ltd. All rights reserved.

Deliberations about the functional benefits and complications of partial foot amputation: do we pay heed to the purported benefits at the expense of minimizing complications?

PubMed

Dillon, Michael P; Fatone, Stefania

2013-08-01

While discussion about the benefits and complications of partial foot amputation (PFA) is not new, much of it has hinged on anecdotal evidence and led to the popular view that the risk of complications and secondary amputation is reasonable when weighed against the perceived benefits associated with maintaining the ankle joint and residual foot length, including more normal walking, reduced energy expenditure, and improved quality of life. The research evidence makes it difficult not to question whether these benefits are valid and worth striving to achieve. When you consider that persons who undergo PFA are typically in the later years of their life and have limited mobility, it raises the question of whether we place too much emphasis on achieving the purported functional benefits of PFA and too little emphasis on achieving primary wound healing and mitigating the high rates of complications and subsequent amputation. If further research supports what we see emerging in the evidence, there will be a case to be made for selecting the level of PFA based primarily on the potential for wound healing, rather than trying to strike a balance with the perceived functional benefits. This may mean that transtibial amputation is preferable in many cases, given the lower rates of complications and secondary amputation, very similar function in terms of walking and energy expenditure, and similar lived experience of limb loss when compared with persons with PFA. Further research is needed to better understand the complications and benefits of PFA to make this a more viable, first-and-final amputation procedure. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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.

Novel drugs in clinical development for hepatocellular carcinoma.

PubMed

Waidmann, Oliver; Trojan, Jörg

2015-01-01

Sorafenib is the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). Within recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development either due to toxicity or lack of benefit. This review covers recent clinical data on systemic agents and ongoing trials in patients with advanced HCC. In unselected patients with advanced HCC, disappointing results have been reported from several large trials. However, in two subgroups encouraging results have been achieved. Treatment with the MET inhibitor tivantinib resulted in a substantial survival benefit in the subgroup of MET overexpressing tumors in a randomized Phase II trial. Furthermore, the vascular endothelial growth factor receptor 2 antibody ramucirumab resulted in improved overall survival in patients with baseline α-fetoprotein (AFP) ≥ 400 ng/ml in a Phase III trial. These two agents, and several others, will be further developed in HCC. Moreover, immunotherapeutics such as checkpoint inhibitors, programmed death receptor-1 blocking antibodies and oncolytic viruses are under investigation in advanced HCC.

Some economic benefits of a synchronous earth observatory satellite

NASA Technical Reports Server (NTRS)

Battacharyya, R. K.; Greenberg, J. S.; Lowe, D. S.; Sattinger, I. J.

1974-01-01

An analysis was made of the economic benefits which might be derived from reduced forecasting errors made possible by data obtained from a synchronous satellite system which can collect earth observation and meteorological data continuously and on demand. User costs directly associated with achieving benefits are included. In the analysis, benefits were evaluated which might be obtained as a result of improved thunderstorm forecasting, frost warning, and grain harvest forecasting capabilities. The anticipated system capabilities were used to arrive at realistic estimates of system performance on which to base the benefit analysis. Emphasis was placed on the benefits which result from system forecasting accuracies. Benefits from improved thunderstorm forecasts are indicated for the construction, air transportation, and agricultural industries. The effects of improved frost warning capability on the citrus crop are determined. The benefits from improved grain forecasting capability are evaluated in terms of both U.S. benefits resulting from domestic grain distribution and U.S. benefits from international grain distribution.

Maximizing the benefits of antiretroviral therapy for key affected populations

PubMed Central

Grubb, Ian R; Beckham, Sarah W; Kazatchkine, Michel; Thomas, Ruth M; Albers, Eliot R; Cabral, Mauro; Lange, Joep; Vella, Stefano; Kurian, Manoj; Beyrer, Chris

2014-01-01

Introduction Scientific research has demonstrated the clinical benefits of earlier initiation of antiretroviral treatment (ART), and that ART can markedly reduce HIV transmission to sexual partners. Ensuring universal access to ART for those who need it has long been a core principle of the HIV response, and extending the benefits of ART to key populations is critical to increasing the impact of ART and the overall effectiveness of the HIV response. However, this can only be achieved through coordinated efforts to address political, social, legal and economic barriers that key populations face in accessing HIV services. Discussion Recent analyses show that HIV prevalence levels among key populations are far higher than among the general population, and they experience a range of biological and behavioural factors, and social, legal and economic barriers that increase their vulnerability to HIV and have resulted in alarmingly low ART coverage. World Health Organization 2014 consolidated guidance on HIV among key populations offers the potential for increased access to ART by key populations, following the same principles as for the general adult population. However, it should not be assumed that key populations will achieve greater access to ART unless stigma, discrimination and punitive laws, policies and practices that limit access to ART and other HIV interventions in many countries are addressed. Conclusions Rights-based approaches and investments in critical enablers, such as supportive legal and policy environments, are essential to enable wider access to ART and other HIV interventions for key populations. The primary objective of ART should always be to treat the person living with HIV; prevention is an important, additional benefit. ART should be provided only with informed consent. The preventive benefits of treatment must not be used as a pretext for failure to provide other necessary HIV programming for key populations, including comprehensive harm

South Korean Male Adolescents' Internal and External Influences in Academic Achievement

ERIC Educational Resources Information Center

Geesa, Rachel Louise

2014-01-01

South Korean adolescents' motivation for high academic achievement is strongly influenced by extraordinary parental support, pressures to achieve, and the practice of utilizing both public and private learning environments in South Korea. To remain competitive, educational leaders may benefit from observations of other countries' academic…

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.

Similar clinical benefits from below-target and target dose enalapril in patients with heart failure in the SOLVD Treatment trial.

PubMed

Lam, Phillip H; Dooley, Daniel J; Fonarow, Gregg C; Butler, Javed; Bhatt, Deepak L; Filippatos, Gerasimos S; Deedwania, Prakash; Forman, Daniel E; White, Michel; Fletcher, Ross D; Arundel, Cherinne; Blackman, Marc R; Adamopoulos, Chris; Kanonidis, Ioannis E; Aban, Inmaculada B; Patel, Kanan; Aronow, Wilbert S; Allman, Richard M; Anker, Stefan D; Pitt, Bertram; Ahmed, Ali

2018-02-01

To examine associations of below-target and target dose of enalapril, an angiotensin-converting enzyme (ACE) inhibitor, with outcomes in patients with heart failure and reduced ejection fraction (HFrEF) in the Studies of Left Ventricular Dysfunction (SOLVD) Treatment trial. Two thousand five hundred and sixty-nine patients with HFrEF (ejection fraction ≤35%) were randomized to below-target (5-10 mg/day) dose placebo (n = 1284) or enalapril (n = 1285). One month post-randomization, blind up-titration to target (20 mg/day) dose was attempted for both study drugs in 2458 patients. Among the 1444 patients who achieved dose up-titration (placebo, n = 748; enalapril, n = 696; mean dose for both groups, 20.0 mg/day), target dose enalapril (vs. target dose placebo) was associated with a 9% absolute lower risk of the combined endpoint of heart failure hospitalization or all-cause mortality [adjusted hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.60-0.81; P < 0.001] during 4 years of follow-up. Among the 1014 patients who could not achieve target dose (placebo, n = 486; enalapril, n = 528; mean dose for both groups, 8.8 mg/day), below-target dose enalapril (vs. below-target dose placebo) was associated with a 12% absolute lower risk of the combined endpoint of heart failure hospitalization or all-cause mortality (adjusted HR 0.68; 95% CI 0.57-0.81; P < 0.001). Among the 1224 patients receiving enalapril, target (vs. below-target) dose had no association with the combined endpoint of heart failure hospitalization or all-cause mortality (adjusted HR 1.04; 95% CI 0.87-1.23; P = 0.695). In patients with HFrEF, the clinical benefits of ACE inhibitors appear to be similar at both below-target and target doses. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Policy-Relevant Nonconvexities in the Production of Multiple Forest Benefits?

Treesearch

Stephen K. Swallow; Peter J. Parks; David N. Wear

1990-01-01

This paper challenges common assumptions about convexity in forest rotation models which optimize timber plus nontimber benefits. If a local optimum occurs earlier than the globally optimal age, policy based on marginal incentives may achieve suboptimal results. Policy-relevant nonconvexities are more likely if (i) nontimber benefits dominate for young stands while...

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.

Cost-benefit analysis of interferon alfa-2b in treatment of hairy cell leukemia.

PubMed

Ozer, H; Golomb, H M; Zimmerman, H; Spiegel, R J

1989-04-19

The clinical benefits as well as the cost benefits of use of recombinant interferon (IFN) alfa-2b instead of conventional chemotherapy (primarily chlorambucil) for progressive hairy cell leukemia were assessed retrospectively on the basis of 12 months of clinical data from 128 patients treated with IFN alfa-2b. Data from 71 matched historical control patients who had received conventional treatment were used for survival analysis. Hematologic response (reversal of cytopenias) was achieved by 18% of the control patients versus 73% of the IFN-treated patients. This response was associated with virtual elimination of the need for transfusions and splenectomy as well as dramatic decreases in the frequency of fatal infections (22.5% vs. 1.6%) and the 12-month mortality rate (28% vs. 3.1%). Direct costs per patient per year for medical care (transfusions, antibiotic treatment, splenectomy, and chemotherapy) of those receiving IFN alfa-2b were 2.8-fold lower than costs for medical care of control patients ($5,027 vs. $14,046). Indirect costs, which reflect the present value of future earnings lost due to premature death, were 13.3-fold lower for IFN-treated patients than for control patients ($4,771 vs. $63,507). Our analysis demonstrates that IFN alfa-2b offers substantial clinical and cost advantages to patients with hairy cell leukemia and that the introduction of this therapy using novel biotechnology furthers the health care community's commitment to cost containment.

Distinguishing community benefits: tax exemption versus organizational legitimacy.

PubMed

Byrd, James D; Landry, Amy

2012-01-01

US policymakers continue to call into question the tax-exempt status of hospitals. As nonprofit tax-exempt entities, hospitals are required by the Internal Revenue Service (IRS) to report the type and cost of community benefits they provide. Institutional theory indicates that organizations derive organizational legitimacy from conforming to the expectations of their environment. Expectations from the state and federal regulators (the IRS, state and local taxing authorities in particular) and the community require hospitals to provide community benefits to achieve legitimacy. This article examines community benefit through an institutional theory framework, which includes regulative (laws and regulation), normative (certification and accreditation), and cultural-cognitive (relationship with the community including the provision of community benefits) pillars. Considering a review of the results of a 2006 IRS study of tax-exempt hospitals, the authors propose a model of hospital community benefit behaviors that distinguishes community benefits between cost-quantifiable activities appropriate for justifying tax exemption and unquantifiable activities that only contribute to hospitals' legitimacy.

ACCP: economic evaluations of clinical pharmacy services: 2001-2005.

PubMed

Perez, Alexandra; Doloresco, Fred; Hoffman, James M; Meek, Patrick D; Touchette, Daniel R; Vermeulen, Lee C; Schumock, Glen T

2009-01-01

The objectives of this review were to summarize and evaluate studies that measured the economic impact of clinical pharmacy services published between 2001 and 2005 (inclusive) and to provide guidance on methodologic considerations to individuals performing such research in the future. A systematic literature search using the MEDLINE and International Pharmaceutical Abstracts databases was conducted to identify published economic evaluations of clinical pharmacy services. Studies were screened and then randomly assigned to reviewers, who reassessed inclusion and exclusion criteria and abstracted prespecified data from each study. Among the many characteristics examined in each study were study design and type of economic evaluation, setting and type of clinical pharmacy service, study quality, and results. Ninety-three articles were included in the final analysis. These studies were published in 43 different journals, most of which (68 [73.1%]) were pharmacy-based. Most studies were performed in hospitals (40 [43.0%]), ambulatory care clinics or physician's offices (20 [21.5%]), or community pharmacies (16 [17.2%]). The most common types of clinical pharmacy services evaluated were general pharmacotherapeutic monitoring services (32 [34.4%]), target drug programs (27 [29%]), and disease state-management services (21 [22.6%]). Full economic evaluations were performed in just less than half (45 [48.4%]) of the studies, and a positive economic benefit associated with clinical pharmacy services was noted in 31 (69%) of the 45 studies. Among 15 studies reporting data necessary to determine a benefit:cost ratio, the pooled median value was 4.81:1-meaning that for every $1 invested in clinical pharmacy services, $4.81 was achieved in reduced costs or other economic benefits. The quality of studies varied widely, with less than one half considered to be good to fair (40 [43.0%]); however, the proportion of studies using appropriate study designs increased compared with

Energy Efficient Engine Program: Technology Benefit/Cost Study, Volume II

NASA Technical Reports Server (NTRS)

Gray, D. E.; Gardner, W. B.

1983-01-01

The Benefit/Cost Study portion of the NASA-sponsored Energy Efficient Engine Component Development and Integration program was successful in achieving its objectives: identification of air transport propulsion system technology requirements for the years 2000 and 2010, and formulation of programs for developing these technologies. It is projected that the advanced technologies identified, when developed to a state of readiness, will provide future commercial and military turbofan engines with significant savings in fuel consumption and related operating costs. These benefits are significant and far from exhausted. The potential savings translate into billions of dollars in annual savings for the airlines. Analyses indicate that a significant portion of the overall savings is attributed to aerodynamic and structure advancements. Another important consideration in acquiring these benefits is developing a viable reference technology base that will permit engines to operate at substantially higher overall pressure ratios and bypass ratios. Results have pointed the direction for future research and a comprehensive program plan for achieving this was formulated. The next major step is initiating the program effort that will convert the advanced technologies into the expected benefits.

Learning nanotechnology with texts and comics: the impacts on students of different achievement levels

NASA Astrophysics Data System (ADS)

Lin, Shu-Fen; Lin, Huann-shyang

2016-05-01

Comics are popular with adolescents because of their features of humor, narrative, and visual imagery. The purposes of this study were to examine the learning outcomes and emotional perceptions of reading a science comic book and a science text booklet for students of different levels of achievement, and to explore the main factors of the two media which attract high-school students to learn science. A mixed-method quasi-experimental design was adopted. The participants were 697 grade ten students from eight schools with different levels of academic achievement. Two similar classes in each of the eight schools were assigned as the comic group or the text group. The results indicated that the science comic book benefited medium achievers more than the science text booklet did, but the contrary result was found for the high achievers. In comparison, the two media benefited the low achievers equally, but both had only a limited effect due to the students' lack of prior knowledge. We conclude four kinds of evidence, including perceived difficulty of comprehension, reasons for interest/disinterest, emotional perceptions of learning science, and learning time, to support the phenomenon of the learning benefit of media specific to certain achievers' science learning.

Comparing Pharmacy Benefit Managers: Moving Well Beyond the Simple Spreadsheet Analysis

PubMed Central

Calabrese, David

2008-01-01

Unabated increases in prescription drug demands, advancing technology, and rising drug inflation rates combined with a sagging economy, continue to intensify budget pressures for payors responsible for delivering pharmacy benefits to plan members. At the same time, high levels of complexity and resource requirements in drug benefit administration have led to a state in which plan sponsors remain heavily dependent on pharmacy benefit managers to assist in these efforts. With pharmacy representing such a critical component of healthcare delivery from clinical and economic perspectives, it is essential that sponsors exercise high levels of due diligence in pharmacy benefit manager review and appraisal to ensure proper balance of quality clinical care, sufficient access, and optimal cost-efficiency in the delivery of such benefits. This review is designed to provide a comprehensive understanding of current pharmacy benefit management business practices and help equip plan sponsors with the knowledge, strategies, and safeguards to drive a well-informed pharmacy benefit selection process and, inevitably, a better-aligned pharmacy benefit management–payor relationship. PMID:25126235

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.

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

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.

Recent advances in liquid-phase separations for clinical metabolomics.

PubMed

Kohler, Isabelle; Giera, Martin

2017-01-01

Over the last decades, several technological improvements have been achieved in liquid-based separation techniques, notably, with the advent of fully porous sub-2 μm particles and superficially porous sub-3 μm particles, the comeback of supercritical fluid chromatography, and the development of alternative chromatographic modes such as hydrophilic interaction chromatography. Combined with mass spectrometry, these techniques have demonstrated their added value, substantially increasing separation efficiency, selectivity, and speed of analysis. These benefits are essential in modern clinical metabolomics typically involving the study of large-scale sample cohorts and the analysis of thousands of metabolites showing extensive differences in physicochemical properties. This review presents a brief overview of the recent developments in liquid-phase separation sciences in the context of clinical metabolomics, focusing on increased throughput as well as metabolite coverage. Relevant metabolomics applications highlighting the benefits of ultra-high performance liquid chromatography, core-shell technology, high-temperature liquid chromatography, capillary electrophoresis, supercritical fluid chromatography, and hydrophilic interaction chromatography are discussed. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Reflective Assessment in Knowledge Building by Students with Low Academic Achievement

ERIC Educational Resources Information Center

Yang, Yuqin; van Aalst, Jan; Chan, Carol K. K.; Tian, Wen

2016-01-01

This study investigated whether and how students with low prior achievement can carry out and benefit from reflective assessment supported by the Knowledge Connections Analyzer (KCA) to collaboratively improve their knowledge-building discourse. Participants were a class of 20 Grade 11 students with low achievement taking visual art from an…

Designer policy for carbon and biodiversity co-benefits under global change

NASA Astrophysics Data System (ADS)

Bryan, Brett A.; Runting, Rebecca K.; Capon, Tim; Perring, Michael P.; Cunningham, Shaun C.; Kragt, Marit E.; Nolan, Martin; Law, Elizabeth A.; Renwick, Anna R.; Eber, Sue; Christian, Rochelle; Wilson, Kerrie A.

2016-03-01

Carbon payments can help mitigate both climate change and biodiversity decline through the reforestation of agricultural land. However, to achieve biodiversity co-benefits, carbon payments often require support from other policy mechanisms such as regulation, targeting, and complementary incentives. We evaluated 14 policy mechanisms for supplying carbon and biodiversity co-benefits through reforestation of carbon plantings (CP) and environmental plantings (EP) in Australia’s 85.3 Mha agricultural land under global change. The reference policy--uniform payments (bidders are paid the same price) with land-use competition (both CP and EP eligible for payments), targeting carbon--achieved significant carbon sequestration but negligible biodiversity co-benefits. Land-use regulation (only EP eligible) and two additional incentives complementing the reference policy (biodiversity premium, carbon levy) increased biodiversity co-benefits, but mostly inefficiently. Discriminatory payments (bidders are paid their bid price) with land-use competition were efficient, and with multifunctional targeting of both carbon and biodiversity co-benefits increased the biodiversity co-benefits almost 100-fold. Our findings were robust to uncertainty in global outlook, and to key agricultural productivity and land-use adoption assumptions. The results suggest clear policy directions, but careful mechanism design will be key to realising these efficiencies in practice. Choices remain for society about the amount of carbon and biodiversity co-benefits desired, and the price it is prepared to pay for them.

Clinical applications of somatostatin analogs for growth hormone-secreting pituitary adenomas

PubMed Central

Wang, Ji-wen; Li, Ying; Mao, Zhi-gang; Hu, Bin; Jiang, Xiao-bing; Song, Bing-bing; Wang, Xin; Zhu, Yong-hong; Wang, Hai-jun

2014-01-01

Excessive growth hormone (GH) is usually secreted by GH-secreting pituitary adenomas and causes gigantism in juveniles or acromegaly in adults. The clinical complications involving cardiovascular, respiratory, and metabolic systems lead to elevated morbidity in acromegaly. Control of serum GH and insulin-like growth factor (IGF) 1 hypersecretion by surgery or pharmacotherapy can decrease morbidity. Current pharmacotherapy includes somatostatin analogs (SAs) and GH receptor antagonist; the former consists of lanreotide Autogel (ATG) and octreotide long-acting release (LAR), and the latter refers to pegvisomant. As primary medical therapy, lanreotide ATG and octreotide LAR can be supplied in a long-lasting formulation to achieve biochemical control of GH and IGF-1 by subcutaneous injection every 4–6 weeks. Lanreotide ATG and octreotide LAR provide an effective medical treatment, whether as a primary or secondary therapy, for the treatment of GH-secreting pituitary adenoma; however, to maximize benefits with the least cost, several points should be emphasized before the application of SAs. A comprehensive assessment, especially of the observation of clinical predictors and preselection of SA treatment, should be completed in advance. A treatment process lasting at least 3 months should be implemented to achieve a long-term stable blood concentration. More satisfactory surgical outcomes for noninvasive macroadenomas treated with presurgical SA may be achieved, although controversy of such adjuvant therapy exists. Combination of SA and pegvisomant or cabergoline shows advantages in some specific cases. Thus, an individual treatment program should be established for each patient under a full evaluation of the risks and benefits. PMID:24421637

Decision curve analysis revisited: overall net benefit, relationships to ROC curve analysis, and application to case-control studies

PubMed Central

2011-01-01

Background Decision curve analysis has been introduced as a method to evaluate prediction models in terms of their clinical consequences if used for a binary classification of subjects into a group who should and into a group who should not be treated. The key concept for this type of evaluation is the "net benefit", a concept borrowed from utility theory. Methods We recall the foundations of decision curve analysis and discuss some new aspects. First, we stress the formal distinction between the net benefit for the treated and for the untreated and define the concept of the "overall net benefit". Next, we revisit the important distinction between the concept of accuracy, as typically assessed using the Youden index and a receiver operating characteristic (ROC) analysis, and the concept of utility of a prediction model, as assessed using decision curve analysis. Finally, we provide an explicit implementation of decision curve analysis to be applied in the context of case-control studies. Results We show that the overall net benefit, which combines the net benefit for the treated and the untreated, is a natural alternative to the benefit achieved by a model, being invariant with respect to the coding of the outcome, and conveying a more comprehensive picture of the situation. Further, within the framework of decision curve analysis, we illustrate the important difference between the accuracy and the utility of a model, demonstrating how poor an accurate model may be in terms of its net benefit. Eventually, we expose that the application of decision curve analysis to case-control studies, where an accurate estimate of the true prevalence of a disease cannot be obtained from the data, is achieved with a few modifications to the original calculation procedure. Conclusions We present several interrelated extensions to decision curve analysis that will both facilitate its interpretation and broaden its potential area of application. PMID:21696604

[Analysis of Late AMNOG Benefit Assessments].

PubMed

Rieder, Veronika; Hammerschmidt, Thomas

2018-04-26

Since 2011, new drugs are assessed at the time of launch in Germany (AMNOG). Based on this early benefit assessment (EBA), drug prices are negotiated. At this time, the evidence base might be weak. A later benefit assessment (LBA) is not done on a regular basis except for selected drugs. Our objective was to analyze the impact of LBAs of drugs for the same indication. Analysis of all completed LBAs between 2011 and 2016. 228 benefit assessments have been performed since 2011. 26 drugs were assessed twice for the same indication. Oncology and diabetes were the most common therapeutic areas in LBA and more pronounced than in EBA. 15 LBAs were due to the EBAs having a time limitation because of insufficient evidence base partially based on conditional approval. Time between EBA and LBA was 2.6 years. All 15 drugs had added benefit in the EBA, 4 got a better, 5 a worse assessment in the LBA. Seven drugs without added benefit in the EBA were assessed at the request of the manufacturer because of new data after 1.7 years. Three drugs could show added benefit in the LBA. Finally, 4 orphan drugs were reassessed according to the AMNOG regulation after achieving annual sales of 50 million euros. One got a better, 2 got a worse benefit assessment. Average improvement of benefit was +1.5 on a scale between - 3 (worst negative benefit) and +9 (highest positive benefit). Average deterioration of added benefit was - 1.4. Negotiated prices were significantly correlated with the change in the benefit assessment. LBA on a broader evidence base did not result in a significantly changed outcome. A general LBA for all drugs does not appear to be necessary because of the limited effect on the benefit assessment and the price when considering cost and administrative burden of the AMNOG benefit assessment. The selective approach of LBA for specific drugs is sufficient in cases in which the evidence base was limited at launch. © Georg Thieme Verlag KG Stuttgart · New York.

Postgraduate general dentistry residency: a clinical model.

PubMed

Gowan, J

1995-01-01

Dental graduates today are expected to be knowledgeable in many more areas than their predecessors. Changing technology and increased competition require entering the dental profession with more experience and skills. One approach to achieving this skill level is a postgraduate general dentistry residency in a clinical setting during the year following dental school graduation (PGY1). The clinical residency provides new dentists with additional hands-on training and reinforces classroom learning. HealthPartners was selected as a clinical rotation for residents in the advanced general dentistry program at the University of Minnesota Dental School. The program provides dental graduates in PGY1 training in all areas of practice. The HealthPartners rotation is highly unique. It is a staff model HMO with a clinical, multi-specialty setting. Today, HealthPartners--a Minnesota-based healthcare organization--has 116,000 members with prepaid dental benefits. Residents trained in the program develop increased skills in all areas of dental practice. In addition, they develop a good working knowledge in the basic sciences. Methods of instruction include didactic training in the form of seminars, lectures, and clinical training in HealthPartners' dental clinics.

Developing Federal Clinical Care Recommendations for Women.

PubMed

Godfrey, Emily M; Tepper, Naomi K; Curtis, Kathryn M; Moskosky, Susan B; Gavin, Loretta E

2015-08-01

The provision of family planning services has important health benefits for the U.S. Approximately 25 million women in the U.S. receive contraceptive services annually and 44 million make at least one family planning-related clinical visit each year. These services are provided by private clinicians, as well as publicly funded clinics, including specialty family planning clinics, health departments, Planned Parenthoods, community health centers, and primary care clinics. Recommendations for providing quality family planning services have been published by CDC and the Office of Population Affairs of the DHHS. This paper describes the process used to develop the women's clinical services portion of the new recommendations and the rationale underpinning them. The recommendations define family planning services as contraceptive care, pregnancy testing and counseling, achieving pregnancy, basic infertility care, sexually transmitted disease services, and preconception health. Because many women who seek family planning services have no other source of care, the recommendations also include additional screening services related to women's health, such as cervical cancer screening. These clinical guidelines are aimed at providing the highest-quality care and are designed to establish a national standard for family planning in the U.S. Published by Elsevier Inc.

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.

Evaluation of cardiovascular risk-lowering health benefits accruing from laboratory-based, community-based and exercise-referral exercise programmes.

PubMed

Webb, R; Thompson, J E S; Ruffino, J-S; Davies, N A; Watkeys, L; Hooper, S; Jones, P M; Walters, G; Clayton, D; Thomas, A W; Morris, K; Llewellyn, D H; Ward, M; Wyatt-Williams, J; McDonnell, B J

2016-01-01

To evaluate the ability of community-based exercise programmes to facilitate public participation in exercise and hence improved cardiovascular health, we assessed the respective impacts of: a continuously monitored exercise programme based within our university (study 1); a Valleys Regional Park-facilitated community-based outdoor exercise programme (study 2); a Wales National Exercise Referral Scheme-delivered exercise-referral programme (study 3). Biomolecular (monocytic PPARγ target gene expression), vascular haemodynamic (central/peripheral blood pressure, arterial stiffness), clinical (insulin sensitivity, blood lipids) and anthropometric (body mass index, waist circumference, heart rate) parameters were investigated using RT-PCR, applanation tonometry, chemical analysis and standard anthropometric techniques. In studies 1-3, 22/28, 32/65 and 11/14 participants adhered to their respective exercise programmes, and underwent significant increases in physical activity levels. Importantly, beneficial effects similar to those seen in our previous studies (eg, modulations in expression of monocytic PPARγ target genes, decreases in blood pressure/arterial stiffness, improvements in blood lipids/insulin sensitivity) were observed (albeit to slightly differing extents) only in participants who adhered to their respective exercise programmes. While study 1 achieved more intense exercise and more pronounced beneficial effects, significant cardiovascular risk-lowering health benefits related to biomolecular markers, blood pressure, arterial stiffness and blood lipids were achieved via community/referral-based delivery modes in studies 2 and 3. Because cardiovascular health benefits were observed in all 3 studies, we conclude that the majority of benefits previously reported in laboratory-based studies can also be achieved in community-based/exercise-referral settings. These findings may be of use in guiding policymakers with regard to introduction and/or continued

Low-dose CT in clinical diagnostics.

PubMed

Fuentes-Orrego, Jorge M; Sahani, Dushyant V

2013-09-01

Computed tomography (CT) has become key for patient management due to its outstanding capabilities for detecting disease processes and assessing treatment response, which has led to expansion in CT imaging for diagnostic and image-guided therapeutic interventions. Despite these benefits, the growing use of CT has raised concerns as radiation risks associated with radiation exposure. The purpose of this article is to familiarize the reader with fundamental concepts of dose metrics for assessing radiation exposure and weighting radiation-associated risks. The article also discusses general approaches for reducing radiation dose while preserving diagnostic quality. The authors provide additional insight for undertaking protocol optimization, customizing scanning techniques based on the patients' clinical scenario and demographics. Supplemental strategies are postulated using more advanced post-processing techniques for achieving further dose improvements. The technologic offerings of CT are integral to modern medicine and its role will continue to evolve. Although, the estimated risks from low levels of radiation of a single CT exam are uncertain, it is prudent to minimize the dose from CT by applying common sense solutions and using other simple strategies as well as exploiting technologic innovations. These efforts will enable us to take advantage of all the clinical benefits of CT while minimizing the likelihood of harm to patients.

Exemplary Care and Learning Sites: A Model for Achieving Continual Improvement in Care and Learning in the Clinical Setting

PubMed Central

Ogrinc, Greg; Hoffman, Kimberly G.; Stevenson, Katherine M.; Shalaby, Marc; Beard, Albertine S.; Thörne, Karin E.; Coleman, Mary T.; Baum, Karyn D.

2016-01-01

Problem Current models of health care quality improvement do not explicitly describe the role of health professions education. The authors propose the Exemplary Care and Learning Site (ECLS) model as an approach to achieving continual improvement in care and learning in the clinical setting. Approach From 2008–2012, an iterative, interactive process was used to develop the ECLS model and its core elements—patients and families informing process changes; trainees engaging both in care and the improvement of care; leaders knowing, valuing, and practicing improvement; data transforming into useful information; and health professionals competently engaging both in care improvement and teaching about care improvement. In 2012–2013, a three-part feasibility test of the model, including a site self-assessment, an independent review of each site’s ratings, and implementation case stories, was conducted at six clinical teaching sites (in the United States and Sweden). Outcomes Site leaders reported the ECLS model provided a systematic approach toward improving patient (and population) outcomes, system performance, and professional development. Most sites found it challenging to incorporate the patients and families element. The trainee element was strong at four sites. The leadership and data elements were self-assessed as the most fully developed. The health professionals element exhibited the greatest variability across sites. Next Steps The next test of the model should be prospective, linked to clinical and educa tional outcomes, to evaluate whether it helps care delivery teams, educators, and patients and families take action to achieve better patient (and population) outcomes, system performance, and professional development. PMID:26760058

Gender differences among treatment-seeking adults with cannabis use disorder: Clinical profiles of women and men enrolled in the Achieving Cannabis Cessation – Evaluating N-acetylcysteine Treatment (ACCENT) study

PubMed Central

Sherman, Brian J.; McRae-Clark, Aimee L.; Baker, Nathaniel L.; Sonne, Susan C.; Killeen, Therese K.; Cloud, Kasie; Gray, Kevin M.

2017-01-01

Background and Objectives Recent evidence suggests that women may fare worse than men in cannabis trials with pharmacologic interventions. Identifying baseline clinical profiles of treatment-seeking cannabis-dependent adults could inform gender-specific treatment planning and development. Methods The current study compared baseline demographic, cannabis use, and psychiatric factors between women (n = 86) and men (n = 216) entering the Achieving Cannabis Cessation – Evaluating N-acetylcysteine Treatment (ACCENT) study, a multi-site, randomized controlled trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Results Women reported greater withdrawal intensity (p = 0.001) and negative impact of withdrawal (p = 0.001), predominantly due to physiological and mood symptoms. Women were more likely to have lifetime panic disorder (p = 0.038) and current agoraphobia (p = 0.022), and reported more days of poor physical health (p = 0.006) and cannabis-related medical problems (p = 0.023). Women reporting chronic pain had greater mean pain scores than men with chronic pain (p = 0.006). Men and women did not differ on any measures of baseline cannabis use. Discussion and Conclusion Cannabis-dependent women may present for treatment with more severe and impairing withdrawal symptoms and psychiatric conditions compared to cannabis-dependent men. This might help explain recent evidence suggesting that women fare worse than men in cannabis treatment trials of pharmacologic interventions. Baseline clinical profiles of treatment-seeking adults can inform gender-specific treatment planning and development. Scientific Significance Cannabis-dependent women may benefit from integrated treatment focusing on co-occurring psychiatric disorders and targeted treatment of cannabis withdrawal syndrome. PMID:28152236

COST–RISK–BENEFIT ANALYSIS IN DIAGNOSTIC RADIOLOGY: A THEORETICAL AND ECONOMIC BASIS FOR RADIATION PROTECTION OF THE PATIENT

PubMed Central

Moores, B. Michael

2016-01-01

In 1973, International Commission on Radiological Protection Publication 22 recommended that the acceptability of radiation exposure levels for a given activity should be determined by a process of cost–benefit analysis. It was felt that this approach could be used to underpin both the principle of ALARA as well for justification purposes. The net benefit, B, of an operation involving irradiation was regarded as equal to the difference between its gross benefit, V, and the sum of three components; the basic production cost associated with the operation, P; the cost of achieving the selected level of protection, X; and the cost Y of the detriment involved in the operation: B=V−(P+X+Y). This article presents a theoretical cost–risk–benefit analysis that is applicable to the diagnostic accuracy (Levels 1 and 2) of the hierarchical efficacy model presented by National Council on Radiation Protection and Measurements in 1992. This enables the costs of an examination to be related to the sensitivity and specificity of an X-ray examination within a defined clinical problem setting and introduces both false-positive/false-negative diagnostic outcomes into the patient radiation protection framework. PMID:26705358

COST-RISK-BENEFIT ANALYSIS IN DIAGNOSTIC RADIOLOGY: A THEORETICAL AND ECONOMIC BASIS FOR RADIATION PROTECTION OF THE PATIENT.

PubMed

Moores, B Michael

2016-06-01

In 1973, International Commission on Radiological Protection Publication 22 recommended that the acceptability of radiation exposure levels for a given activity should be determined by a process of cost-benefit analysis. It was felt that this approach could be used to underpin both the principle of ALARA as well for justification purposes. The net benefit, B, of an operation involving irradiation was regarded as equal to the difference between its gross benefit, V, and the sum of three components; the basic production cost associated with the operation, P; the cost of achieving the selected level of protection, X; and the cost Y of the detriment involved in the operation: [Formula: see text] This article presents a theoretical cost-risk-benefit analysis that is applicable to the diagnostic accuracy (Levels 1 and 2) of the hierarchical efficacy model presented by National Council on Radiation Protection and Measurements in 1992. This enables the costs of an examination to be related to the sensitivity and specificity of an X-ray examination within a defined clinical problem setting and introduces both false-positive/false-negative diagnostic outcomes into the patient radiation protection framework. © The Author 2015. Published by Oxford University Press.

Benefits and costs of integrating technology into undergraduate nursing programs.

PubMed

Glasgow, Mary Ellen Smith; Cornelius, Frances H

2005-01-01

Advances in technology over the last decade have resulted in increased opportunities for educators to become more innovative in classroom and clinical teaching. These innovations have allowed students and faculty to access essential clinical information at the point of care/need. By capitalizing on technologies such as personal digital assistants and course delivery shells, faculty and students have both portable and remote access to information that can guide practice and learning activities in clinical, classroom, and distance settings. For instance, a student can use a personal digital assistant to research a patient's new medication at the bedside, study course information, access references during class in response to a question, or download clinical materials from home. Although the benefits of having ready access to information seem obvious, there are costs and strategic planning activities associated with implementing these projects. Clearly, the objective of any academic nursing program is to develop skills among students so they can efficiently access information and use that information to guide their nursing practice. To do so, academic nursing administrators must have the forethought to envision how new technologies can support achieving this goal as well as the ability to put in place the infrastructure supports needed for success. This article presents a case study of how one institution developed the necessary infrastructure and garnished the appropriate resources to implement an ambitious technology initiative integrated throughout a large undergraduate nursing program. In addition, how the integration of technology, online and mobile, can enhance clinical learning will be discussed.

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

Challenges and opportunities in SLE clinical trials.

PubMed

van Vollenhoven, Ronald F

2013-09-01

To provide an update on the field of clinical trials in systemic lupus erythematosus (SLE). This review will examine failed and successful clinical trials in SLE in order to draw lessons and determine the optimal ways forward. Over the past decade, many clinical trials in SLE met with limited success, but in the past 2 years several SLE clinical trials have been successful. The two large phase III randomized controlled trials (RCTs) of belimumab achieved their primary endpoints and resulted in food and drug administration and European medicines agency approval of the drug. Characteristics of these trials were, among other things, a very large number of patients (>800 each), compound clinical endpoints, and a flexible design with regards to concomitant medication use. Likewise, large randomized controlled trials with mycophenolate mofetil, although nominally unsuccessful, clearly demonstrated the clinical benefit of this drug in lupus nephritis. Posthoc analyses of several failed trials involving abatacept and rituximab revealed design elements and/or outcomes that might have changed the outcomes of these studies. Many smaller trials have also been reported, in some instances with surprisingly positive results. An improved understanding of specific design features in SLE clinical trials combined with robust outcomes will make it possible more effectively to design and conduct clinical trials in SLE.

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

Applications of PET CT in clinical practice: Present and future

NASA Astrophysics Data System (ADS)

Costa, Durval Campos

2007-02-01

Radionuclide imaging and specially positron emission tomography (PET) has already demonstrated its benefits in three major medical subjects, i.e. neurology, cardiology and particularly clinical oncology. More recently the combination of PET and X-ray computed tomography (CT) as PET-CT led to a significant increment of the already large number of clinical applications of this imaging modality. This "anatomy-metabolic fusion" also known as Metabolic Imaging has its future assured if we can: (1) improve resolution reducing partial volume effect, (2) achieve very fast whole body imaging, (3) obtain accurate quantification of specific functions with higher contrast resolution and, if possible, (4) reduce exposure rates due to the unavoidable use of ionizing radiation.

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

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.

[Evidence-based Risk and Benefit Communication for Shared Decision Making].

PubMed

Nakayama, Takeo

2018-01-01

　Evidence-based medicine (EBM) can be defined as "the integration of the best research evidence with clinical expertise and a patient's unique values and circumstances". However, even with the best research evidence, many uncertainties can make clinical decisions difficult. As the social requirement of respecting patient values and preferences has been increasingly recognized, shared decision making (SDM) and consensus development between patients and clinicians have attracted attention. SDM is a process by which patients and clinicians make decisions and arrive at a consensus through interactive conversations and communications. During the process of SDM, patients and clinicians share information with each other on the goals they hope to achieve and responsibilities in meeting those goals. From the clinician's standpoint, information regarding the benefits and risks of potential treatment options based on current evidence and professional experience is provided to patients. From the patient's standpoint, information on personal values, preferences, and social roles is provided to clinicians. SDM is a sort of "wisdom" in the context of making autonomous decisions in uncertain, difficult situations through interactions and cooperation between patients and clinicians. Joint development of EBM and SDM will help facilitate patient-clinician relationships and improve the quality of healthcare.

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

High-Ability Grouping: Benefits for Gifted Students' Achievement Development Without Costs in Academic Self-Concept.

PubMed

Preckel, Franzis; Schmidt, Isabelle; Stumpf, Eva; Motschenbacher, Monika; Vogl, Katharina; Scherrer, Vsevolod; Schneider, Wolfgang

2017-11-23

Effects of full-time ability grouping on students' academic self-concept (ASC) and mathematics achievement were investigated in the first 3 years of secondary school (four waves of measurement; students' average age at first wave: 10.5 years). Students were primarily from middle and upper class families living in southern Germany. The study sample comprised 148 (60% male) students from 14 gifted classes and 148 (57% male) students from 25 regular classes (matched by propensity score matching). Data analyses involved multilevel and latent growth curve analyses. Findings revealed no evidence for contrast effects of class-average achievement or assimilation effects of class type on students' ASC. ASC remained stable over time. Students in gifted classes showed higher achievement gains than students in regular classes. © 2017 The Authors. Child Development © 2017 Society for Research in Child Development, Inc.

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

Intelligence and Academic Achievement in a Clinical Adolescent Population

ERIC Educational Resources Information Center

Stewart, David W.; Morris, Linda

1977-01-01

The present study was undertaken with two related goals: (a) to examine the relationships between the WRAT and CAT, and (b) to examine the relationships which may exist between these academic achievement tests -nd a standard intelligence battery such as the Wechsler Scale. (Author)

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.

Pre-admission criteria and pre-clinical achievement: Can they predict medical students performance in the clinical phase?

PubMed

Salem, Raneem O; Al-Mously, Najwa; AlFadil, Sara; Baalash, Amal

2016-01-01

Various factors affect medical students' performance during clinical phase. Identifying these factors would help in mentoring weak students and help in selection process for residency programmes. Our study objective is to evaluate the impact of pre-admission criteria, and pre-clinical grade point average (GPA) on undergraduate medical students' performance during clinical phase. This study has a cross-sectional design that includes fifth- and sixth-year female medical students (71). Data of clinical and pre-clinical GPA in medical school and pre-admission to medical school tests scores were collected. A significant correlation between clinical GPA with the pre-clinical GPA was observed (p < 0.05). Such significant correlation was not seen with other variables under study. A regression analysis was performed, and the only significant predictor of students clinical performance was the pre-clinical GPA (p < 0.001). However, no significant difference between students' clinical and pre-clinical GPA for both cohorts was observed (p > 0.05). Pre-clinical GPA is strongly correlated with and can predict medical students' performance during clinical years. Our study highlighted the importance of evaluating the academic performances of students in pre-clinical years before they move into clinical years in order to identify weak students to mentor them and monitor their progress.

[Cost-benefit analysis of a school-based smoking prevention program].

PubMed

Hormigo Amaro, Jordi; García-Altés, Anna; López, M José; Bartoll, Xavier; Nebot, Manel; Ariza, Carles

2009-01-01

To analyze the efficiency of a school-based smoking prevention program in Barcelona (PASE.bcn program). A cost-benefit analysis was performed. As costs we included those corresponding to the design and implementation of the program. As benefits we considered healthcare costs and the productivity losses avoided. This study was conducted from a societal perspective, and the estimations of costs and benefits related to 2005. Assuming an effectiveness of 1%, the PASE.bcn program would achieve a total benefit of 1,558,311.46euro. The healthcare benefits per prevented smoker were 1997.57euro, and the indirect benefits per prevented smoker were 21,260.80euro. Given the total cost of the school-based program (68,526.03euro), the cost-benefit ratio was 22.74. From a societal perspective, the benefits of school-based tobacco prevention programs, in terms of healthcare costs and productivity losses avoided, are far greater than the costs. These results support universal application of this type of intervention.

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.

Strategies For Clinical Implementation: Precision Oncology At Three Distinct Institutions.

PubMed

Nadauld, Lincoln D; Ford, James M; Pritchard, Daryl; Brown, Thomas

2018-05-01

Despite rapid advances in molecular diagnostics and targeted therapeutics, the adoption of precision medicine into clinical oncology workflows has been slow. Questions about clinical utility, inconsistent reimbursement for molecular diagnostics, and limited access to targeted therapies are some of the major hurdles that have hampered clinical adoption. Despite these challenges, providers have invested in precision medicine programs in an ongoing search for innovative care models to deliver improved patient outcomes and achieve economic gains. We describe the precision oncology medicine programs implemented by an integrated delivery system, a community care center, and an academic medical center, to demonstrate the approaches and challenges associated with clinical implementation efforts designed to advance this treatment paradigm. Payer policies that include coverage for broad genomic testing panels would support the broader application of precision medicine, deepen research benefits, and bring targeted therapies to more patients with advanced cancer.

Gender differences among treatment-seeking adults with cannabis use disorder: Clinical profiles of women and men enrolled in the achieving cannabis cessation-evaluating N-acetylcysteine treatment (ACCENT) study.

PubMed

Sherman, Brian J; McRae-Clark, Aimee L; Baker, Nathaniel L; Sonne, Susan C; Killeen, Therese K; Cloud, Kasie; Gray, Kevin M

2017-03-01

Recent evidence suggests that women may fare worse than men in cannabis trials with pharmacologic interventions. Identifying baseline clinical profiles of treatment-seeking cannabis-dependent adults could inform gender-specific treatment planning and development. The current study compared baseline demographic, cannabis use, and psychiatric factors between women (n = 86) and men (n = 216) entering the Achieving Cannabis Cessation-Evaluating N-acetylcysteine Treatment (ACCENT) study, a multi-site, randomized controlled trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Women reported greater withdrawal intensity (p = .001) and negative impact of withdrawal (p = .001), predominantly due to physiological and mood symptoms. Women were more likely to have lifetime panic disorder (p = .038) and current agoraphobia (p = .022), and reported more days of poor physical health (p = .006) and cannabis-related medical problems (p = .023). Women reporting chronic pain had greater mean pain scores than men with chronic pain (p = .006). Men and women did not differ on any measures of baseline cannabis use. Cannabis-dependent women may present for treatment with more severe and impairing withdrawal symptoms and psychiatric conditions compared to cannabis-dependent men. This might help explain recent evidence suggesting that women fare worse than men in cannabis treatment trials of pharmacologic interventions. Baseline clinical profiles of treatment-seeking adults can inform gender-specific treatment planning and development. Cannabis-dependent women may benefit from integrated treatment focusing on co-occurring psychiatric disorders and targeted treatment of cannabis withdrawal syndrome.(Am J Addict 2017;26:136-144). © 2017 American Academy of Addiction Psychiatry.

20 CFR 416.1227 - When the resources excluded under a plan to achieve self-support begin to count.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false When the resources excluded under a plan to achieve self-support begin to count. 416.1227 Section 416.1227 Employees' Benefits SOCIAL SECURITY... When the resources excluded under a plan to achieve self-support begin to count. The resources that...

20 CFR 416.1227 - When the resources excluded under a plan to achieve self-support begin to count.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false When the resources excluded under a plan to achieve self-support begin to count. 416.1227 Section 416.1227 Employees' Benefits SOCIAL SECURITY... When the resources excluded under a plan to achieve self-support begin to count. The resources that...

Benefits of Repeated Reading Intervention for Low-Achieving Fourth- and Fifth-Grade Students

ERIC Educational Resources Information Center

Vadasy, Patricia F.; Sanders, Elizabeth A.

2008-01-01

Many students have difficulty achieving reading fluency, and nearly half of fourth graders are not fluent readers in grade-level texts. Intensive and focused reading practice is recommended to help close the gap between students with poor fluency and their average reading peers. In this study, the "Quick Reads" fluency program was used…

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.

Improving a Dental School's Clinic Operations Using Lean Process Improvement.

PubMed

Robinson, Fonda G; Cunningham, Larry L; Turner, Sharon P; Lindroth, John; Ray, Deborah; Khan, Talib; Yates, Audrey

2016-10-01

The term "lean production," also known as "Lean," describes a process of operations management pioneered at the Toyota Motor Company that contributed significantly to the success of the company. Although developed by Toyota, the Lean process has been implemented at many other organizations, including those in health care, and should be considered by dental schools in evaluating their clinical operations. Lean combines engineering principles with operations management and improvement tools to optimize business and operating processes. One of the core concepts is relentless elimination of waste (non-value-added components of a process). Another key concept is utilization of individuals closest to the actual work to analyze and improve the process. When the medical center of the University of Kentucky adopted the Lean process for improving clinical operations, members of the College of Dentistry trained in the process applied the techniques to improve inefficient operations at the Walk-In Dental Clinic. The purpose of this project was to reduce patients' average in-the-door-to-out-the-door time from over four hours to three hours within 90 days. Achievement of this goal was realized by streamlining patient flow and strategically relocating key phases of the process. This initiative resulted in patient benefits such as shortening average in-the-door-to-out-the-door time by over an hour, improving satisfaction by 21%, and reducing negative comments by 24%, as well as providing opportunity to implement the electronic health record, improving teamwork, and enhancing educational experiences for students. These benefits were achieved while maintaining high-quality patient care with zero adverse outcomes during and two years following the process improvement project.

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.

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

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

[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

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.

Prospective registration of clinical trials in India: strategies, achievements & challenges.

PubMed

Tharyan, Prathap

2009-02-01

This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of

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.

Future technology in cochlear implants: assessing the benefit.

PubMed

Briggs, Robert J S

2011-05-01

It has been over 50 years since Djourno and Eyries first attempted electric stimulation in a patient with deafness. Over this time, the Cochlear Implant (CI) has become not only remarkably successful, but increasingly complex. Although the basic components of the system still comprise an implanted receiver stimulator and electrode, externally worn speech processor, microphone, control system, and power source, there are now several alternative designs of these components with different attributes that can be variably combined to meet the needs of specific patient groups. Development by the manufacturers has been driven both by these various patient needs, and also by the desire to achieve technological superiority, or at least differentiation, ultimately in pursuit of market share. Assessment of benefit is the responsibility of clinicians. It is incumbent on both industry and clinicians to ensure appropriate, safe, and affordable introduction of new technology. For example, experience with the totally implanted cochlear implant (TIKI) has demonstrated that quality of hearing is the over-riding consideration for CI users. To date, improved hearing outcomes have been achieved by improvements in: speech processing strategies; microphone technology; pre-processing strategies; electrode placement; bilateral implantation; use of a hearing aid in the opposite ear (bimodal stimulation); and the combination of electric and acoustic stimulation in the same ear. The resulting expansion of CI candidacy, with more residual hearing, further improves the outcomes achieved. Largely facilitated by advances in electronic capability and computerization, it can be expected that these improvements will continue. However, marked variability of results still occurs and we cannot assure any individual patient of their outcome. Realistic goals for implementation of new technology include: improved hearing in noise and music perception; effective invisible hearing (no external apparatus

Grand Challenges in Clinical Decision Support v10

PubMed Central

Sittig, Dean F.; Wright, Adam; Osheroff, Jerome A.; Middleton, Blackford; Teich, Jonathan M.; Ash, Joan S.; Campbell, Emily; Bates, David W.

2008-01-01

There is a pressing need for high-quality, effective means of designing, developing, presenting, implementing, evaluating, and maintaining all types of clinical decision support capabilities for clinicians, patients and consumers. Using an iterative, consensus-building process we identified a rank-ordered list of the top 10 grand challenges in clinical decision support. This list was created to educate and inspire researchers, developers, funders, and policy-makers. The list of challenges in order of importance that they be solved if patients and organizations are to begin realizing the fullest benefits possible of these systems consists of: Improve the human-computer interface; Disseminate best practices in CDS design, development, and implementation; Summarize patient-level information; Prioritize and filter recommendations to the user; Create an architecture for sharing executable CDS modules and services; Combine recommendations for patients with co-morbidities; Prioritize CDS content development and implementation; Create internet-accessible clinical decision support repositories; Use freetext information to drive clinical decision support; Mine large clinical databases to create new CDS. Identification of solutions to these challenges is critical if clinical decision support is to achieve its potential and improve the quality, safety and efficiency of healthcare. PMID:18029232

Effects of individualized assignments on biology achievement

NASA Astrophysics Data System (ADS)

Kremer, Philip L.

A pretest-posttest, randomized, two groups, experimental, factorial design compared effects of detailed and nondetailed assignments on biology achievement over seven and a half months. Detailed assignments (favoring field independence and induction) employed block diagrams and stepwise directions. Nondetailed assignments (favoring field dependence and deduction) virtually lacked these. The accessible population was 101 tenth grade preparatory school male students. The 95 students enrolled in first year biology constituted the sample. Two by three ANOVA was done on residualized posttest score means of the students. Totally, the detailed students achieved significantly higher than the nondetailed students. This significantly higher achievement was only true of detailed students in the middle thirds of the deviation intelligence quotient (DIQ) range and of the grade point average (G.P.A.) range after the breakdown into upper, middle, and lower thirds of intellectual capability (ability and achievement). The upper third detailed DIQ grouping indirectly achieved higher than its peers, whereas the lower detailed DIQ third achieved lower than its peers. Thus, high capability students apparently benefit from flow and block diagrams, inductions, field independence, and high structure, whereas low capability students may be hindered by these.

The Impact of Structured Note Taking Strategies on Math Achievement of Middle School Students

ERIC Educational Resources Information Center

Wilkinson, Gregory Ashley

2012-01-01

Student math achievement continues to be a national, state, and local concern. Research suggests that note taking can improve academic achievement, but current research has failed to report how low achievers might benefit from using note taking during math classes. The purpose of this study was to determine if teaching students structured note…

SGLT2 inhibitors with cardiovascular benefits: Transforming clinical care in Type 2 diabetes mellitus.

PubMed

d'Emden, Michael; Amerena, John; Deed, Gary; Pollock, Carol; Cooper, Mark E

2018-02-01

Cardiovascular risk reduction in individuals with Type 2 diabetes mellitus (T2DM) is a key part of clinical management. Sodium-glucose co-transporter (SGLT2) inhibitors improve glycaemic control, reduce body weight and decrease blood pressure. In addition, the SGLT2 inhibitors empagliflozin and canagliflozin reduced the risk of composite cardiovascular events in high-risk individuals with T2DM in the EMPA-REG OUTCOME trial and the CANVAS Program, respectively. Empagliflozin also reduced cardiovascular deaths and improved renal outcomes. This class of agents should be considered in people with established cardiovascular disease, usually in combination with other glucose lowering medications, when satisfactory glycaemic control has not been achieved. The dose of insulin or sulfonylureas may need to be lowered when used with SGLT2 inhibitors, to reduce the risk of hypoglycaemia. Genitourinary infections can occur with SGLT2 inhibitors in a small proportion of people. In people with osteoporosis or prior amputation, it may be prudent to use empagliflozin rather than canagliflozin, based on the increased risk for bone fractures and amputations observed with canagliflozin in the CANVAS Program. SGLT2 inhibitors have the potential to transform the clinical care of persons with T2DM by not only improving glycaemic control but also reducing blood pressure, body weight and diabetes-related end-organ complications. Copyright © 2017 Elsevier B.V. All rights reserved.

Cost-Benefit Analysis of SCILS for Early Childhood Training in Academic Achievement. Report 1977-78.

ERIC Educational Resources Information Center

Steg, D. R.; And Others

This report documents the long term cost benefits to society of the Self Controlled Interactive Learning Systems (SCILS), a program based on cybernetics and designed to teach early reading skills to children ages 3 to 6. SCILS required children to spend not more than 20 minutes daily using a "talking typewriter," a "talking…

Obtaining the Greatest Scientific Benefit from Observational Platforms by Consideration of the Relative Benefit of Observations

NASA Technical Reports Server (NTRS)

Chelberg, David; Drews, Frank; Fleeman, David; Welch, Lonnie; Marquart, Jane; Pfarr, Barbara

2003-01-01

One of the current trends in spacecraft software design is to increase the autonomy of onboard flight and science software. This is especially true when real-time observations may affect the observation schedule of a mission. For many science missions, such as those conducted by the Swift Burst Alert Telescope, the ability of the spacecraft to autonomously respond in real-time to unpredicted science events is crucial for mission success. We apply utility theory within resource management middleware to optimize the real-time performance of application software and achieve maximum system level benefit. We then explore how this methodology can be extended to manage both software and observational resources onboard a spacecraft to achieve the best possible observations.

Can the multiple mini-interview predict academic achievement in medical school?

PubMed

Kim, Ja Kyoung; Kang, Seok Hoon; Lee, Hee Jae; Yang, JeongHee

2014-09-01

The purpose of this study was to determine whether the multiple mini-interview (MMI) predicts academic achievement for subjects in a medical school curriculum. Of 49 students who were admitted in 2008, 46 students finished the entire medical education curriculum within 4 years. We calculated the Pearson correlation coefficients between the total MMI score of the 46 graduates and their academic achievements in all subjects of the curriculum. The correlation coefficients between total MMI score and academic achievement in Medical Interview and History Taking, Problem-Based Learning, Doctoring I, and Clinical Practice of Surgery ranged from 0.4 to 0.7, indicating that they were moderately related. The values between total MMI score and achievement in Research Overview, Technical and Procedural Skills, Clinical Performance Examinations 1 and 3, Clinical Practice of Laboratory Medicine and Psychiatry, Neurology, and Orthopedics ranged from 0.2 to 0.4, which meant that they were weakly related. MMI score can predict medical student' academic achievement in subjects in the medical humanities and clinical practice.

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.

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.

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.

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.

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

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.

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.

Class Size: Can School Districts Capitalize on the Benefits of Smaller Classes?

ERIC Educational Resources Information Center

Hertling, Elizabeth; Leonard, Courtney; Lumsden, Linda; Smith, Stuart C.

2000-01-01

This report is intended to help policymakers understand the benefits of class-size reduction (CSR). It assesses the costs of CSR, considers some research-based alternatives, and explores strategies that will help educators realize the benefits of CSR when it is implemented. It examines how CSR enhances student achievement, such as when the…

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.

Real change in the real world: an achievable goal.

PubMed

Friedman, Robert M

2010-03-01

This commentary builds on the papers presented at the Vanderbilt Conference by emphasizing the importance of better understanding the process of change-making if real change in the real world is to be achieved. The commentary reviews several frameworks and research findings related to achieving large-scale sustainable change that benefits children and families. It calls for the application of systems thinking as a complement to the more micro-level research that was presented at the Vanderbilt conference. Such an approach would have implications for framing of the issue, for the strategies that are taken to try to achieve change, and for research/evaluation methods for studying complex, dynamic, nonlinear systems.

Metabolomics for Biomarker Discovery: Moving to the Clinic

PubMed Central

Zhang, Aihua; Sun, Hui; Yan, Guangli; Wang, Ping; Wang, Xijun

2015-01-01

To improve the clinical course of diseases, more accurate diagnostic and assessment methods are required as early as possible. In order to achieve this, metabolomics offers new opportunities for biomarker discovery in complex diseases and may provide pathological understanding of diseases beyond traditional technologies. It is the systematic analysis of low-molecular-weight metabolites in biological samples and has become an important tool in clinical research and the diagnosis of human disease and has been applied to discovery and identification of the perturbed pathways. It provides a powerful approach to discover biomarkers in biological systems and offers a holistic approach with the promise to clinically enhance diagnostics. When carried out properly, it could provide insight into the understanding of the underlying mechanisms of diseases, help to identify patients at risk of disease, and predict the response to specific treatments. Currently, metabolomics has become an important tool in clinical research and the diagnosis of human disease and becomes a hot topic. This review will highlight the importance and benefit of metabolomics for identifying biomarkers that accurately screen potential biomarkers of diseases. PMID:26090402

The value of item response theory in clinical assessment: a review.

PubMed

Thomas, Michael L

2011-09-01

Item response theory (IRT) and related latent variable models represent modern psychometric theory, the successor to classical test theory in psychological assessment. Although IRT has become prevalent in the measurement of ability and achievement, its contributions to clinical domains have been less extensive. Applications of IRT to clinical assessment are reviewed to appraise its current and potential value. Benefits of IRT include comprehensive analyses and reduction of measurement error, creation of computer adaptive tests, meaningful scaling of latent variables, objective calibration and equating, evaluation of test and item bias, greater accuracy in the assessment of change due to therapeutic intervention, and evaluation of model and person fit. The theory may soon reinvent the manner in which tests are selected, developed, and scored. Although challenges remain to the widespread implementation of IRT, its application to clinical assessment holds great promise. Recommendations for research, test development, and clinical practice are provided.

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.

Impacts and benefits of implementing BIM on bridge infrastructure projects.

DOT National Transportation Integrated Search

2014-10-01

To date, BIM (Building Information Modeling) is not widely utilized in infrastructure asset management. : Benefits achieved through implementation in vertical construction, however, suggest that BIM represents : significant opportunity for gains in p...

Learning styles and academic achievement among undergraduate medical students in Thailand.

PubMed

Jiraporncharoen, Wichuda; Angkurawaranon, Chaisiri; Chockjamsai, Manoch; Deesomchok, Athavudh; Euathrongchit, Juntima

2015-01-01

This study aimed to explore the associations between learning styles and high academic achievement and to ascertain whether the factors associated with high academic achievement differed between preclinical and clinical students. A survey was conducted among undergraduate medical students in Chiang Mai University, Thailand. The Index of Learning Styles questionnaire was used to assess each student's learning style across four domains. High academic achievement was defined as a grade point average of at least 3.0. Of the 1,248 eligible medical students, 1,014 (81.3%) participated. Learning styles differed between the preclinical and clinical students in the active/reflective domain. A sequential learning style was associated with high academic achievement in both preclinical and clinical students. A reflective learning style was only associated with high academic achievement among preclinical students. The association between learning styles and academic achievement may have differed between preclinical and clinical students due to different learning content and teaching methods. Students should be encouraged to be flexible in their own learning styles in order to engage successfully with various and changing teaching methods across the curriculum. Instructors should be also encouraged to provide a variety of teaching materials and resources to suit different learning styles.

Learning styles and academic achievement among undergraduate medical students in Thailand

PubMed Central

Jiraporncharoen, Wichuda; Angkurawaranon, Chaisiri; Chockjamsai, Manoch; Deesomchok, Athavudh; Euathrongchit, Juntima

2015-01-01

Purpose: This study aimed to explore the associations between learning styles and high academic achievement and to ascertain whether the factors associated with high academic achievement differed between preclinical and clinical students. Methods: A survey was conducted among undergraduate medical students in Chiang Mai University, Thailand. The Index of Learning Styles questionnaire was used to assess each student’s learning style across four domains. High academic achievement was defined as a grade point average of at least 3.0. Results: Of the 1,248 eligible medical students, 1,014 (81.3%) participated. Learning styles differed between the preclinical and clinical students in the active/reflective domain. A sequential learning style was associated with high academic achievement in both preclinical and clinical students. A reflective learning style was only associated with high academic achievement among preclinical students. Conclusion: The association between learning styles and academic achievement may have differed between preclinical and clinical students due to different learning content and teaching methods. Students should be encouraged to be flexible in their own learning styles in order to engage successfully with various and changing teaching methods across the curriculum. Instructors should be also encouraged to provide a variety of teaching materials and resources to suit different learning styles. PMID:26165948

The population-level impacts of a national health insurance program and franchise midwife clinics on achievement of prenatal and delivery care standards in the Philippines

PubMed Central

Kozhimannil, Katy Backes; Valera, Madeleine R.; Adams, Alyce S.; Ross-Degnan, Dennis

2009-01-01

Objectives Adequate prenatal and delivery care are vital components of successful maternal health care provision. Starting in 1998, two programs were widely expanded in the Philippines: a national health insurance program (PhilHealth); and a donor-funded franchise of midwife clinics (Well-Family Midwife Clinics). This paper examines population-level impacts of these interventions on achievement of minimum standards for prenatal and delivery care. Methods Data from two waves of the Demographic and Health Surveys, conducted before (1998) and after (2003) scale up of the interventions, are employed in a pre/post study design, using longitudinal multivariate logistic and linear regression models. Results After controlling for demographic and socioeconomic characteristics, the PhilHealth insurance program scale up was associated with increased odds of receiving at least four prenatal visits (OR 1.04 [95% CI 1.01–1.06]) and receiving a visit during the first trimester of pregnancy (OR 1.03 [95% CI 1.01–1.06]). Exposure to midwife clinics was not associated with significant changes in achievement of prenatal care standards. While both programs were associated with slight increases in the odds of delivery in a health facility, these increases were not statistically significant. Conclusions These results suggest that expansion of an insurance program with accreditation standards was associated with increases in achievement of minimal standards for prenatal care among women in the Philippines. PMID:19327862

The population-level impacts of a national health insurance program and franchise midwife clinics on achievement of prenatal and delivery care standards in the Philippines.

PubMed

Kozhimannil, Katy Backes; Valera, Madeleine R; Adams, Alyce S; Ross-Degnan, Dennis

2009-09-01

Adequate prenatal and delivery care are vital components of successful maternal health care provision. Starting in 1998, two programs were widely expanded in the Philippines: a national health insurance program (PhilHealth); and a donor-funded franchise of midwife clinics (Well Family Midwife Clinics). This paper examines population-level impacts of these interventions on achievement of minimum standards for prenatal and delivery care. Data from two waves of the Demographic and Health Surveys, conducted before (1998) and after (2003) scale-up of the interventions, are employed in a pre/post-study design, using longitudinal multivariate logistic and linear regression models. After controlling for demographic and socioeconomic characteristics, the PhilHealth insurance program scale-up was associated with increased odds of receiving at least four prenatal visits (OR 1.04 [95% CI 1.01-1.06]) and receiving a visit during the first trimester of pregnancy (OR 1.03 [95% CI 1.01-1.06]). Exposure to midwife clinics was not associated with significant changes in achievement of prenatal care standards. While both programs were associated with slight increases in the odds of delivery in a health facility, these increases were not statistically significant. These results suggest that expansion of an insurance program with accreditation standards was associated with increases in achievement of minimal standards for prenatal care among women in the Philippines.

Quantitative Guidance for Stove Usage and Performance to Achieve Health and Environmental Targets.

PubMed

Johnson, Michael A; Chiang, Ranyee A

2015-08-01

Displacing the use of polluting and inefficient cookstoves in developing countries is necessary to achieve the potential health and environmental benefits sought through clean cooking solutions. Yet little quantitative context has been provided on how much displacement of traditional technologies is needed to achieve targets for household air pollutant concentrations or fuel savings. This paper provides instructive guidance on the usage of cooking technologies required to achieve health and environmental improvements. We evaluated different scenarios of displacement of traditional stoves with use of higher performing technologies. The air quality and fuel consumption impacts were estimated for these scenarios using a single-zone box model of indoor air quality and ratios of thermal efficiency. Stove performance and usage should be considered together, as lower performing stoves can result in similar or greater benefits than a higher performing stove if the lower performing stove has considerably higher displacement of the baseline stove. Based on the indoor air quality model, there are multiple performance-usage scenarios for achieving modest indoor air quality improvements. To meet World Health Organization guidance levels, however, three-stone fire and basic charcoal stove usage must be nearly eliminated to achieve the particulate matter target (< 1-3 hr/week), and substantially limited to meet the carbon monoxide guideline (< 7-9 hr/week). Moderate health gains may be achieved with various performance-usage scenarios. The greatest benefits are estimated to be achieved by near-complete displacement of traditional stoves with clean technologies, emphasizing the need to shift in the long term to near exclusive use of clean fuels and stoves. The performance-usage scenarios are also provided as a tool to guide technology selection and prioritize behavior change opportunities to maximize impact.

Iatrogenic disease management: moderating medication errors and risks in a pharmacy benefit management environment.

PubMed

Nair, Vinit; Salmon, J Warren; Kaul, Alan F

2007-12-01

Disease Management (DM) programs have advanced to address costly chronic disease patterns in populations. This is in part due to the programs' significant clinical and economical value, coupled with interest by pharmaceutical manufacturers, managed care organizations, and pharmacy benefit management firms. While cost containment realizations for many such interventions have been less than anticipated, this article explores potentials in marrying Medication Error Risk Reduction into DM programs within managed care environments. Medication errors are an emergent serious problem now gaining attention in US health policy. They represent a failure within population-based health programs because they remain significant cost drivers. Therefore, medication errors should be addressed in an organized fashion, with DM being a worthy candidate for piggybacking such programs to achieve the best synergistic effects.

Fertility and neonatal outcomes of embryos achieving blastulation on Day 7: are they of clinical value?

PubMed

Du, Tong; Wang, Yun; Fan, Yong; Zhang, Shiyi; Yan, Zhiguang; Yu, Weina; Xi, Qianwen; Chen, Qiuju; Mol, Ben W; Lyu, Qifeng; Kuang, Yanping

2018-06-01

Is transferring embryos that achieve blastulation on Day 7 effective and safe? Embryos that achieve blastulation on Day 7 resulted in clinically relevant rates of clinical pregnancy (32.5%) and live birth (25.2%), and newborns have a similar risk of low birth weight, congenital malformations or early neonatal death compared with those derived from Days 5 and 6 blastocysts. Potential advantages of blastocyst transfer over cleavage embryo transfer have led to a shift toward the former in IVF practice. However, published data about the fertility outcomes of transferring embryos with a delayed blastulation on Day 7 are scarce and controversial. Moreover, there are few data available on the neonatal outcomes of Day 7 blastocysts. As a result, the clinical value of Day 7 blastocysts is uncertain. This was a retrospective cohort study that included 2908 women undergoing frozen-thawed embryo transfer cycles of IVF/ICSI from January 2006 to May 2015, and reported on the 1518 live born infants from those cycles. We used propensity score matching to compare the fertility outcomes of women undergoing Day-5, Day-6 and Day-7 vitrified embryo transfers in three matched comparisons (Day 5 vs Day 6, Day 5 vs Day 7 and Day 6 vs Day 7). We also compared neonatal outcomes among babies derived from Day-5, Day-6 and Day-7 vitrified embryo transfers. We studied 922 Day-5, 1752 Day-6 and 234 Day-7 vitrified embryo transfers. Day-7 vitrified embryo transfers had significantly lower implantation, clinical pregnancy and live birth rates than both Day-5 (23.9 vs 49.9%, 31.7 vs 58.1% and 25.1 vs 46.5%, all P < 0.001, respectively) and Day-6 (24.7 vs 42.3%, 33.0 vs 53.2% and 25.6 vs 41.4%, all P < 0.001, respectively) vitrified embryo transfers. Assessment of babies showed no statistically significant difference in the rates of low birth weight, congenital malformations and early neonatal death among the 585, 869 and 64 babies born from Day-5, Day-6 and Day-7 vitrified embryo transfer groups

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

Calibrating the impact of dual RAAS blockade on the heart and the kidney - balancing risks and benefits.

PubMed

Ziff, O J; Covic, A; Goldsmith, D

2016-07-01

Overactivity of the renin-angiotensin-aldosterone system (RAAS) plays a key role in the pathophysiology of heart failure (HF) and chronic kidney disease (CKD). RAAS antagonists can significantly improve clinical outcomes, but monotherapy blocks but one step of the RAAS and can be bypassed through compensatory mechanisms. Providing more complete RAAS blockade by deploying drugs with complementary actions seemed logical - hence the practice of using dual (or triple) RAAS inhibitors. However, RAAS antagonists also exhibit dose-limiting side effects, including acute kidney injury, hyperkalaemia and hypotension, which blunt their overall effectiveness. Despite achieving better RAAS blockade, several trials failed to show clinical outcome improvements. Patients with concomitant CKD and HF (cardiorenal syndrome) are at the greatest risk of these adverse events and therefore the least able to benefit, yet they also have the worst prognosis. This paradox, where those most in need have fewest therapeutic options, poses three questions which are the focus of this review: whether (i) novel therapies that prevent adverse effects can restore therapeutic benefits to patients who would otherwise be RAAS-therapy intolerant, (ii) there are any validated alternatives to their use and (iii) newer approaches to the detection of fluid congestion are ready for implementation. © 2016 John Wiley & Sons Ltd.

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.

Surgeon Perception of Risk and Benefit in the Decision to Operate.

PubMed

Sacks, Greg D; Dawes, Aaron J; Ettner, Susan L; Brook, Robert H; Fox, Craig R; Maggard-Gibbons, Melinda; Ko, Clifford Y; Russell, Marcia M

2016-12-01

To determine how surgeons' perceptions of treatment risks and benefits influence their decisions to operate. Little is known about what makes one surgeon choose to operate on a patient and another chooses not to operate. Using an online study, we presented a national sample of surgeons (N = 767) with four detailed clinical vignettes (mesenteric ischemia, gastrointestinal bleed, bowel obstruction, appendicitis) where the best treatment option was uncertain and asked them to: (1) judge the risks (probability of serious complications) and benefits (probability of recovery) for operative and nonoperative management and (2) decide whether or not they would recommend an operation. Across all clinical vignettes, surgeons varied markedly in both their assessments of the risks and benefits of operative and nonoperative management (narrowest range 4%-100% for all four predictions across vignettes) and in their decisions to operate (49%-85%). Surgeons were less likely to operate as their perceptions of operative risk increased [absolute difference (AD) = -29.6% from 1.0 standard deviation below to 1.0 standard deviation above mean (95% confidence interval, CI: -31.6, -23.8)] and their perceptions of nonoperative benefit increased [AD = -32.6% (95% CI: -32.8,--28.9)]. Surgeons were more likely to operate as their perceptions of operative benefit increased [AD = 18.7% (95% CI: 12.6, 21.5)] and their perceptions of nonoperative risk increased [AD = 32.7% (95% CI: 28.7, 34.0)]. Differences in risk/benefit perceptions explained 39% of the observed variation in decisions to operate across the four vignettes. Given the same clinical scenarios, surgeons' perceptions of treatment risks and benefits vary and are highly predictive of their decisions to operate.

Formation flying benefits based on vortex lattice calculations

NASA Technical Reports Server (NTRS)

Maskew, B.

1977-01-01

A quadrilateral vortex-lattice method was applied to a formation of three wings to calculate force and moment data for use in estimating potential benefits of flying aircraft in formation on extended range missions, and of anticipating the control problems which may exist. The investigation led to two types of formation having virtually the same overall benefits for the formation as a whole, i.e., a V or echelon formation and a double row formation (with two staggered rows of aircraft). These formations have unequal savings on aircraft within the formation, but this allows large longitudinal spacings between aircraft which is preferable to the small spacing required in formations having equal benefits for all aircraft. A reasonable trade-off between a practical formation size and range benefit seems to lie at about three to five aircraft with corresponding maximum potential range increases of about 46 percent to 67 percent. At this time it is not known what fraction of this potential range increase is achievable in practice.

Building workplace social capital: A longitudinal study of student nurses' clinical placement experiences.

PubMed

Materne, Michelle; Henderson, Amanda; Eaton, Emma

2017-09-01

Quality clinical placement experiences have been associated with nurses' workplace social capital. Social capital is broadly understood as the social organisation of trust, norms and networks that benefit society. Building social capital in the workplace may benefit experiences of staff and students. The aim of this study was to assess the impact of building workplace social capital on student nurse perceptions of clinical learning experiences. A quality improvement process was measured through repeated student surveys. First, second, third year students (n = 1176) from three universities completed a validated Student Clinical Learning Culture Survey (SCLCS) following their placement, at the commencement of quality improvement initiatives and five years later. The SCLCS measured students' perceptions of social affiliation, their motivation, satisfaction and dissatisfaction with clinical contexts. The first year of systematic changes focused on increasing student numbers along with improving communication, trust and knowledge sharing, antecedents to workplace social capital. No change was evident after the first year. Six years after commencement of building workplace social capital differences across all subscales, except dissatisfaction, were significant (p < 0.001). Leadership that promotes open communication and connections across staff and students to achieve common goals can build workplace social capital that enhances student placement experiences. Copyright © 2017 Elsevier Ltd. All rights reserved.

Achieving neuroprotection with LRRK2 kinase inhibitors in Parkinson disease.

PubMed

West, Andrew B

2017-12-01

In the translation of discoveries from the laboratory to the clinic, the track record in developing disease-modifying therapies in neurodegenerative disease is poor. A carefully designed development pipeline built from discoveries in both pre-clinical models and patient populations is necessary to optimize the chances for success. Genetic variation in the leucine-rich repeat kinase two gene (LRRK2) is linked to Parkinson disease (PD) susceptibility. Pathogenic mutations, particularly those in the LRRK2 GTPase (Roc) and COR domains, increase LRRK2 kinase activities in cells and tissues. In some PD models, small molecule LRRK2 kinase inhibitors that block these activities also provide neuroprotection. Herein, the genetic and biochemical evidence that supports the involvement of LRRK2 kinase activity in PD susceptibility is reviewed. Issues related to the definition of a therapeutic window for LRRK2 inhibition and the safety of chronic dosing are discussed. Finally, recommendations are given for a biomarker-guided initial entry of LRRK2 kinase inhibitors in PD patients. Four key areas must be considered for achieving neuroprotection with LRRK2 kinase inhibitors in PD: 1) identification of patient populations most likely to benefit from LRRK2 kinase inhibitors, 2) prioritization of superior LRRK2 small molecule inhibitors based on open disclosures of drug performance, 3) incorporation of biomarkers and empirical measures of LRRK2 kinase inhibition in clinical trials, and 4) utilization of appropriate efficacy measures guided in part by rigorous pre-clinical modeling. Meticulous and rational development decisions can potentially prevent incredibly costly errors and provide the best chances for LRRK2 inhibitors to slow the progression of PD. Copyright © 2017 The Author. Published by Elsevier Inc. All rights reserved.

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines

PubMed Central

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-01-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;Improving patient care provided by members by providing focus on quality and evidence;Creating legislative environments that favour effective clinical practice;Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; andIdentifying areas that require further information or research to improve clinical care.The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement. PMID:25314352

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines.

PubMed

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-10-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.

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.

Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data.

PubMed

Alemao, Evo; Joo, Seongjung; Kawabata, Hugh; Al, Maiwenn J; Allison, Paul D; Rutten-van Mölken, Maureen P M H; Frits, Michelle L; Iannaccone, Christine K; Shadick, Nancy A; Weinblatt, Michael E

2016-03-01

To evaluate associations between achieving guideline-recommended targets of disease activity, defined by the Disease Activity Score in 28 joints using C-reactive protein level (DAS28-CRP) <2.6, the Simplified Disease Activity Index (SDAI) ≤3.3, or the Clinical Disease Activity Index (CDAI) ≤2.8, and other health outcomes in a longitudinal observational study. Other defined thresholds included low disease activity (LDA), moderate (MDA), or severe disease activity (SDA). To control for intraclass correlation and estimate effects of independent variables on outcomes of the modified Health Assessment Questionnaire (M-HAQ), the EuroQol 5-domain (EQ-5D; a quality-of-life measure), hospitalization, and durable medical equipment (DME) use, we employed mixed models for continuous outcomes and generalized estimating equations for binary outcomes. Among 1,297 subjects, achievement (versus nonachievement) of recommended disease targets was associated with enhanced physical functioning and lower health resource utilization. After controlling for baseline covariates, achievement of disease targets (versus LDA) was associated with significantly enhanced physical functioning based on SDAI ≤3.3 (ΔM-HAQ -0.047; P = 0.0100) and CDAI ≤2.8 (-0.073; P = 0.0003) but not DAS28-CRP <2.6 (-0.022; P = 0.1735). Target attainment was associated with significantly improved EQ-5D (0.022-0.096; P < 0.0030 versus LDA, MDA, or SDA). Patients achieving guideline-recommended disease targets were 36-45% less likely to be hospitalized (P < 0.0500) and 23-45% less likely to utilize DME (P < 0.0100). Attaining recommended target disease-activity measures was associated with enhanced physical functioning and health-related quality of life. Some health outcomes were similar in subjects attaining guideline targets versus LDA. Achieving LDA is a worthy clinical objective in some patients. © 2016 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the

Quantitative Guidance for Stove Usage and Performance to Achieve Health and Environmental Targets

PubMed Central

Chiang, Ranyee A.

2015-01-01

Background Displacing the use of polluting and inefficient cookstoves in developing countries is necessary to achieve the potential health and environmental benefits sought through clean cooking solutions. Yet little quantitative context has been provided on how much displacement of traditional technologies is needed to achieve targets for household air pollutant concentrations or fuel savings. Objectives This paper provides instructive guidance on the usage of cooking technologies required to achieve health and environmental improvements. Methods We evaluated different scenarios of displacement of traditional stoves with use of higher performing technologies. The air quality and fuel consumption impacts were estimated for these scenarios using a single-zone box model of indoor air quality and ratios of thermal efficiency. Results Stove performance and usage should be considered together, as lower performing stoves can result in similar or greater benefits than a higher performing stove if the lower performing stove has considerably higher displacement of the baseline stove. Based on the indoor air quality model, there are multiple performance–usage scenarios for achieving modest indoor air quality improvements. To meet World Health Organization guidance levels, however, three-stone fire and basic charcoal stove usage must be nearly eliminated to achieve the particulate matter target (< 1–3 hr/week), and substantially limited to meet the carbon monoxide guideline (< 7–9 hr/week). Conclusions Moderate health gains may be achieved with various performance–usage scenarios. The greatest benefits are estimated to be achieved by near-complete displacement of traditional stoves with clean technologies, emphasizing the need to shift in the long term to near exclusive use of clean fuels and stoves. The performance–usage scenarios are also provided as a tool to guide technology selection and prioritize behavior change opportunities to maximize impact. Citation

Clinical benefit using sperm hyaluronic acid binding technique in ICSI cycles: a systematic review and meta-analysis.

PubMed

Beck-Fruchter, Ronit; Shalev, Eliezer; Weiss, Amir

2016-03-01

The human oocyte is surrounded by hyaluronic acid, which acts as a natural selector of spermatozoa. Human sperm that express hyaluronic acid receptors and bind to hyaluronic acid have normal shape, minimal DNA fragmentation and low frequency of chromosomal aneuploidies. Use of hyaluronic acid binding assays in intracytoplasmic sperm injection (ICSI) cycles to improve clinical outcomes has been studied, although none of these studies had sufficient statistical power. In this systematic review and meta-analysis, electronic databases were searched up to June 2015 to identify studies of ICSI cycles in which spermatozoa able to bind hyaluronic acid was selected. The main outcomes were fertilization rate and clinical pregnancy rate. Secondary outcomes included cleavage rate, embryo quality, implantation rate, spontaneous abortion and live birth rate. Seven studies and 1437 cycles were included. Use of hyaluronic acid binding sperm selection technique yielded no improvement in fertilization and pregnancy rates. A meta-analysis of all available studies showed an improvement in embryo quality and implantation rate; an analysis of prospective studies only showed an improvement in embryo quality. Evidence does not support routine use of hyaluronic acid binding assays in all ICSI cycles. Identification of patients that might benefit from this technique needs further study. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Physical education and academic achievement in elementary school: data from the early childhood longitudinal study.

PubMed

Carlson, Susan A; Fulton, Janet E; Lee, Sarah M; Maynard, L Michele; Brown, David R; Kohl, Harold W; Dietz, William H

2008-04-01

We examined the association between time spent in physical education and academic achievement in a longitudinal study of students in kindergarten through fifth grade. We used data from the Early Childhood Longitudinal Study, Kindergarten Class of 1998 to 1999, which employed a multistage probability design to select a nationally representative sample of students in kindergarten (analytic sample = 5316). Time spent in physical education (minutes per week) was collected from classroom teachers, and academic achievement (mathematics and reading) was scored on an item response theory scale. A small but significant benefit for academic achievement in mathematics and reading was observed for girls enrolled in higher amounts (70-300 minutes per week) of physical education (referent: 0-35 minutes per week). Higher amounts of physical education were not positively or negatively associated with academic achievement among boys. Among girls, higher amounts of physical education may be associated with an academic benefit. Physical education did not appear to negatively affect academic achievement in elementary school students. Concerns about adverse effects on achievement may not be legitimate reasons to limit physical education programs.

STAR Follow-Up Studies, 1996-1997: The Student/Teacher Achievement Ratio (STAR) Project.

ERIC Educational Resources Information Center

Pate-Bain, Helen; Boyd-Zaharias, Jayne; Cain, Van A.; Word, Elizabeth; Binkley, M. Edward

The Student/Teacher Achievement Ratio (STAR) Project first investigated the effect of small class size on student achievement with over 6,000 Tennessee primary students in 1985 through 1989. The study found a consistent and significant benefit of small classes for all students, with the greatest advantages for minority, inner-city students from…

A cost-benefit evaluation of the LANDSAT flow-on operational system

NASA Technical Reports Server (NTRS)

1977-01-01

Disciplines to benefit from the LANDSAT Follow-on System include agriculture, petroleum and mineral exploration, hydrologic land use, water resources management, forestry, land use planning and monitoring, and soil management. The annual quantified benefits are in the range of 420 to 970 million (FY 1976 dollars). The operational system sized to achieve the quantified benefits involves a single orbiting satellite with a backup satellite in launch readiness. The ground system includes a basic processing system which feeds information to three user systems - one for agriculture, one for hydrologic land use, and a third for all other users. The resulting present worth benefit cost ratio is at least equal to four with a reasonable likelihood of exceeding nine. This benefit cost ratio is evaluated for an infinite time horizon at the discount rate of 10 percent.

The impact of two pharmaceutical risk-sharing agreements on pricing, promotion, and net health benefits.

PubMed

Zaric, Gregory S; Xie, Bin

2009-01-01

Health insurers are increasingly making use of risk-sharing agreements with drug manufacturers to manage uncertainties regarding the costs and effectiveness of new drugs. Several risk-sharing models exist including those based on sales volume, achievement of clinical thresholds, and achievement of cost-effectiveness thresholds. The objective of this article is to compare two risk-sharing arrangements and to investigate conditions under which each is preferable from the perspective of the payer and the manufacturer. We develop two two-period models to compare two risk-sharing arrangements between a payer and a drug manufacturer in which there is uncertainty about the effectiveness of the new drug. In the first risk-sharing agreement, the drug is listed on a formulary in the first period but delisted in the second period if the net monetary benefit in the first period is negative. In the second risk-sharing agreement, the manufacturer pays a rebate in each period if the net monetary benefit in that period is negative. We show that the relative performance of the two arrangements depends on several factors and that neither arrangement is always preferred. Additionally, we are able to identify situations in which a payer and a manufacturer would prefer the same plan and other situations in which the two parties would disagree on which plan was most desirable. Because neither risk-sharing arrangement is always preferred, payers and manufacturers must carefully consider the characteristics of their individual situation when entering into such contracts.

An Evaluation of the Health Benefits Achieved at the Time of an Air Quality Intervention in Three Israeli Cities

PubMed Central

Yinon, Lital; Thurston, George

2018-01-01

Background The statistical association between increased exposure to air pollution and increased risk of morbidity and mortality is well established. However, documentation of the health benefits of lowering air pollution levels, which would support the biological plausibility of those past statistical associations, are not as well developed. A better understanding of the aftereffects of interventions to reduce air pollution is needed in order to: 1) better document the benefits of lowered air pollution; and, 2) identify the types of reductions that most effectively provide health benefits. Methods This study analyzes daily health and pollution data from three major cities in Israel that have undergone pollution control interventions to reduce sulfur emissions from combustion sources. In this work, the hypothesis tested is that transitions to cleaner fuels are accompanied by a decreased risk of daily cardiovascular and respiratory mortalities. Interrupted time series regression models are applied in order to test whether the cleaner air interventions are associated with a statistically significant reduction in mortality. Results In the multi-city meta-analysis we found statistically significant reductions of 13.3% [CI −21.9%, −3.8%] in cardiovascular mortality, and a borderline significant (p=0.06) reduction of 19.0% [CI −35.1%, 1.1%] in total mortality. Conclusions Overall, new experiential evidence is provided consistent with human health benefits being associated with interventions to reduce air pollution. The methods employed also provide an approach that may be applied elsewhere in the future to better document and optimize the health benefits of clean air interventions. PMID:28237065

An evaluation of the health benefits achieved at the time of an air quality intervention in three Israeli cities.

PubMed

Yinon, Lital; Thurston, George

2017-05-01

The statistical association between increased exposure to air pollution and increased risk of morbidity and mortality is well established. However, documentation of the health benefits of lowering air pollution levels, which would support the biological plausibility of those past statistical associations, are not as well developed. A better understanding of the aftereffects of interventions to reduce air pollution is needed in order to: 1) better document the benefits of lowered air pollution; and, 2) identify the types of reductions that most effectively provide health benefits. This study analyzes daily health and pollution data from three major cities in Israel that have undergone pollution control interventions to reduce sulfur emissions from combustion sources. In this work, the hypothesis tested is that transitions to cleaner fuels are accompanied by a decreased risk of daily cardiovascular and respiratory mortalities. Interrupted time series regression models are applied in order to test whether the cleaner air interventions are associated with a statistically significant reduction in mortality. In the multi-city meta-analysis we found statistically significant reductions of 13.3% [CI -21.9%, -3.8%] in cardiovascular mortality, and a borderline significant (p=0.06) reduction of 19.0% [CI -35.1%, 1.1%] in total mortality. Overall, new experiential evidence is provided consistent with human health benefits being associated with interventions to reduce air pollution. The methods employed also provide an approach that may be applied elsewhere in the future to better document and optimize the health benefits of clean air interventions. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

Benefits of Required Counseling for Counseling Students

ERIC Educational Resources Information Center

Prosek, Elizabeth A.; Holm, Jessica M.; Daly, Cynthia M.

2013-01-01

Graduate students experience mental health distress. The authors investigated the benefits of required counseling services at a training clinic for students enrolled in counseling courses. Results indicated that after receiving services, students ("N" = 55) reported decreases in overall problems, depressive symptoms, and anxiety…

The antiviral effects of RSV fusion inhibitor, MDT-637, on clinical isolates, vs its achievable concentrations in the human respiratory tract and comparison to ribavirin.

PubMed

Kim, Young-In; Pareek, Rajat; Murphy, Ryan; Harrison, Lisa; Farrell, Eric; Cook, Robert; DeVincenzo, John

2017-11-01

Respiratory syncytial virus (RSV) viral load and disease severity associate, and the timing of viral load and disease run in parallel. An antiviral must be broadly effective against the natural spectrum of RSV genotypes and must attain concentrations capable of inhibiting viral replication within the human respiratory tract. We evaluated a novel RSV fusion inhibitor, MDT-637, and compared it with ribavirin for therapeutic effect in vitro to identify relative therapeutic doses achievable in humans. MDT-637 and ribavirin were co-incubated with RSV in HEp-2 cells. Quantitative PCR assessed viral concentrations; 50% inhibitory concentrations (IC 50 ) were compared to achievable human MDT-637 and ribavirin peak and trough concentrations. The IC 50 for MDT-637 and ribavirin (against RSV-A Long) was 1.42 and 16 973 ng/mL, respectively. The ratio of achievable peak respiratory secretion concentration to IC 50 was 6041-fold for MDT-637 and 25-fold for aerosolized ribavirin. The ratio of trough concentration to IC 50 was 1481-fold for MDT-637 and 3.29-fold for aerosolized ribavirin. Maximal peak and trough levels of oral or intravenous ribavirin were significantly lower than their IC 50 s. We also measured MDT-637 IC 50 s in 3 lab strains and 4 clinical strains. The IC 50 s ranged from 0.36 to 3.4 ng/mL. Achievable human MDT-637 concentrations in respiratory secretions exceed the IC 50 s by factors from hundreds to thousands of times greater than does ribavirin. Furthermore, MDT-637 has broad in vitro antiviral activity on clinical strains of different RSV genotypes and clades. Together, these data imply that MDT-637 may produce a superior clinical effect compared to ribavirin on natural RSV infections. © 2017 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Gender Issues in Gifted Achievement: Are Girls Making Inroads While Boys Fall Behind?

ERIC Educational Resources Information Center

Rimm, Sylvia B.

2015-01-01

School and life achievement patterns for girls and women differ from those of boys and men. While girls have made dramatic progress in school, they need to be inspired to connect to lifelong achievement. Both research and clinical work at the Ohio-based Family Achievement Clinic find that more boys than girls underachieve in school. There is much…

Does Children’s Academic Achievement Improve when Single Mothers Marry?

PubMed Central

Wagmiller, Robert L.; Gershoff, Elizabeth; Veliz, Philip; Clements, Margaret

2011-01-01

Promoting marriage, especially among low-income single mothers with children, is increasingly viewed as a promising public policy strategy for improving developmental outcomes for disadvantaged children. Previous research suggests, however, that children’s academic achievement either does not improve or declines when single mothers marry. In this paper, we argue that previous research may understate the benefits of mothers’ marriages to children from single-parent families because (1) the short-term and long-term developmental consequences of marriage are not adequately distinguished and (2) child and family contexts in which marriage is likely to confer developmental advantages are not differentiated from those that do not. Using multiple waves of data from the ECLS-K, we find that single mothers’ marriages are associated with modest but statistically significant improvements in their children’s academic achievement trajectories. However, only children from more advantaged single-parent families benefit from their mothers’ marriage. PMID:21611134

Does Homogeneous Ability Grouping for High School Honors English Instruction Benefit the High Achiever?

ERIC Educational Resources Information Center

Hostetter, Douglas Paul

2013-01-01

Public schools are examining their policies and instructional practices to address the achievement gap exposed by the reporting requirements of NCLB (Wenglinski, 2004). As accountability measures and stakes rise, there is a call for an improved use of scientific evidence to inform educational policymaking (Wiseman, 2010). In terms of the…

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.

The Effect of Journal Writing on Mathematics Achievement among High-Ability Students in Singapore

ERIC Educational Resources Information Center

Tan, Tracy; Garces-Bacsal, Rhoda Myra

2013-01-01

This study examined the effect of journal writing on mathematics achievement in high-ability students in Singapore. It assessed both the cognitive benefits of journal writing (as evidenced through gains in math test scores) and the socio-affective benefits of journal writing (as demonstrated in their personal reflections) as the students learned…

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

PubMed

DeTora, Lisa M

2017-07-01

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work. © 2017 John Wiley

Predicting Pre-Service Teachers' Intention of Implementing Peer Assessment for Low-Achieving Students

ERIC Educational Resources Information Center

Yim, Su Yon; Cho, Young Hoan

2016-01-01

Despite the benefits of peer assessment, many teachers are not willing to implement it, particularly for low-achieving students. This study used the theory of planned behaviour to predict pre-service teachers' intention to use peer assessment for low-achieving students. A total of 229 pre-service teachers in Singapore participated in the survey…

The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

PubMed

Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

2016-05-01

Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports.

PubMed

Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C

2017-02-06

The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation [stimulating effects such as insomnia, anxiety and agitation]). Duloxetine was significantly better than placebo in terms of percentage change in weekly incontinence episodes (mean difference -13.56%, 95% confidence interval [CI] -21.59% to -5.53%) and change in Incontinence Quality of Life total score (mean difference 3.24, 95% CI 2.00 to 4.48). However, the effect sizes were small, and a sensitivity analysis (with removal of one trial) showed that the number needed to treat for a Patient Global Impression of Improvement rating of "much better or very much better" was 8 (95% CI 6 to 13). The numbers needed to harm were 7 (95% CI 6 to 8) for discontinuing because of an adverse event and 7 (95% CI 6 to 9) for experiencing an activation event. No suicidality, violence or akathisia events were noted

Comparing diagnostic tests on benefit-risk.

PubMed

Pennello, Gene; Pantoja-Galicia, Norberto; Evans, Scott

2016-01-01

Comparing diagnostic tests on accuracy alone can be inconclusive. For example, a test may have better sensitivity than another test yet worse specificity. Comparing tests on benefit risk may be more conclusive because clinical consequences of diagnostic error are considered. For benefit-risk evaluation, we propose diagnostic yield, the expected distribution of subjects with true positive, false positive, true negative, and false negative test results in a hypothetical population. We construct a table of diagnostic yield that includes the number of false positive subjects experiencing adverse consequences from unnecessary work-up. We then develop a decision theory for evaluating tests. The theory provides additional interpretation to quantities in the diagnostic yield table. It also indicates that the expected utility of a test relative to a perfect test is a weighted accuracy measure, the average of sensitivity and specificity weighted for prevalence and relative importance of false positive and false negative testing errors, also interpretable as the cost-benefit ratio of treating non-diseased and diseased subjects. We propose plots of diagnostic yield, weighted accuracy, and relative net benefit of tests as functions of prevalence or cost-benefit ratio. Concepts are illustrated with hypothetical screening tests for colorectal cancer with test positive subjects being referred to colonoscopy.

Does perioperative high-dose prednisolone have clinical benefits for generalized myasthenia gravis?

PubMed

Sekine, Yasuo; Kawaguchi, Naoki; Hamada, Chikuma; Sekiguchi, Hiromi; Yasufuku, Kazuhiro; Iyoda, Akira; Shibuya, Kiyoshi; Fujisawa, Takehiko

2006-06-01

The purpose of this study was to clarify the clinical benefits of perioperative administration of high-dose prednisolone (PSL) combined with extended thymectomy on the long-term outcomes of 116 consecutive patients with generalized myasthenia gravis (MG). A retrospective review was conducted on 116 patients diagnosed with generalized MG who received alternate-day oral administration of high-dose PSL (100 mg/alternate days) and had undergone transsternal extended thymectomy. Incidences of postoperative myasthenic crisis, adverse effects of steroid, long-term outcomes, such as complete stable remission (CSR), pharmacologic remission (PR) or improvement (Imp), and disease recurrence after CSR were evaluated. Six patients (5.2%) experienced post-thymectomy myasthenic crisis. Crude cumulative CSR and PR + CSR rates were 44.8 and 62.7%, respectively. Life table analysis showed that 41.8, 52.8 and 63.4% of the patients were in CSR at 3, 5 and 10 years, respectively. Multivariate analysis revealed that age and pretreatment classification according to the Myasthenia Gravis Foundation of America (MGFA) criteria tended to be independent predictors of CSR. There were 6.9% with compressive vertebral fracture, 13.8% with cataract, and 5.2% with steroid-induced diabetes. Life table analysis revealed that recurrence rates after CSR were 36.8 and 46.0% at 3 and 5 years, respectively. Patients with thymoma had a significantly higher rate of recurrence than those without thymoma (p = 0.001). Alternate-day administration of high-dose prednisolone reduced the risk of post-thymectomy myasthenic crisis. Presence of thymoma was a risk factor for MG recurrence after CSR.

ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers.

PubMed

Montes de Oca, María; López Varela, María Victorina; Acuña, Agustín; Schiavi, Eduardo; Rey, María Alejandra; Jardim, José; Casas, Alejandro; Tokumoto, Antonio; Torres Duque, Carlos A; Ramírez-Venegas, Alejandra; García, Gabriel; Stirbulov, Roberto; Camelier, Aquiles; Bergna, Miguel; Cohen, Mark; Guzmán, Santiago; Sánchez, Efraín

2015-08-01

ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients <65years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics are justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

Use of online clinical videos for clinical skills training for medical students: benefits and challenges.

PubMed

Jang, Hye Won; Kim, Kyong-Jee

2014-03-21

Multimedia learning has been shown effective in clinical skills training. Yet, use of technology presents both opportunities and challenges to learners. The present study investigated student use and perceptions of online clinical videos for learning clinical skills and in preparing for OSCE (Objective Structured Clinical Examination). This study aims to inform us how to make more effective us of these resources. A mixed-methods study was conducted for this study. A 30-items questionnaire was administered to investigate student use and perceptions of OSCE videos. Year 3 and 4 students from 34 Korean medical schools who had access to OSCE videos participated in the online survey. Additionally, a semi-structured interview of a group of Year 3 medical students was conducted for an in-depth understanding of student experience with OSCE videos. 411 students from 31 medical schools returned the questionnaires; a majority of them found OSCE videos effective for their learning of clinical skills and in preparing for OSCE. The number of OSCE videos that the students viewed was moderately associated with their self-efficacy and preparedness for OSCE (p < 0.05). One-thirds of those surveyed accessed the video clips using mobile devices; they agreed more with the statement that it was convenient to access the video clips than their peers who accessed the videos using computers (p < 0.05). Still, students reported lack of integration into the curriculum and lack of interaction as barriers to more effective use of OSCE videos. The present study confirms the overall positive impact of OSCE videos on student learning of clinical skills. Having faculty integrate these learning resources into their teaching, integrating interactive tools into this e-learning environment to foster interactions, and using mobile devices for convenient access are recommended to help students make more effective use of these resources.

Cost-benefit value of microscopic examination of intervertebral discs.

PubMed

Grzybicki, D M; Callaghan, E J; Raab, S S

1998-09-01

Given the virtual absence of histologically detected, clinically unsuspected disease in intervertebral disc specimens, some authors have advocated that histological examination be discontinued. However, the examination of intervertebral disc specimens remains common practice in most pathology laboratories. No cost-benefit analysis of this practice has been made; therefore, the authors' goal in this study was perform such an analysis. Using the University of Iowa surgical pathology database, 1109 patients who had undergone a laminectomy were identified retrospectively. These cases were classified into four categories based on the patients' preoperative clinical diagnosis and final histopathological diagnosis: insignificant clinical diagnosis/insignificant pathological diagnosis (ICIP), significant clinical diagnosis/insignificant pathological diagnosis (SCIP), significant clinical diagnosis/significant pathological diagnosis (SCSP), and insignificant clinical diagnosis/significant pathological diagnosis (ICSP). A significant clinical diagnosis was defined as one other than a benign, noninfectious indication for laminectomy. A significant pathological diagnosis was a diagnosis other than degenerative changes. The cost-benefit value of performing a histological examination in cases with significant or insignificant clinical diagnoses was examined. The cases were classified as: 1068 ICIP, 17 SCIP, 21 SCSP, and three ICSP. On chart review, in all three cases of ICSP an epidural abscess was identified perioperatively and the subsequent histological diagnosis did not affect patient care. The costs per case of identifying a significant pathological diagnosis with a significant and an insignificant clinical diagnosis were $44.79 and $8811, respectively. Histological examination of intervertebral disc specimens is cost beneficial only if there is a significant preoperative clinical diagnosis.

The Impact of Tutoring on Early Reading Achievement for Children With and Without Attention Problems

PubMed Central

Rabiner, David L.; Malone, Patrick S.

2009-01-01