29 CFR Appendix B to Subpart L of... - National Consensus Standards

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 5 2010-07-01 2010-07-01 false National Consensus Standards B Appendix B to Subpart L of... Appendix B to Subpart L of Part 1910—National Consensus Standards The following table contains a cross-reference listing of those current national consensus standards which contains information and guidelines...

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

PubMed

Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

2014-01-01

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.

75 FR 65052 - Consensus Standards, Standard Practice for Maintenance of Airplane Electrical Wiring Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... systems. By this notice, the FAA finds the standards to be acceptable methods and procedures for... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Consensus Standards, Standard... consensus standards and the Federal Aviation Administration (FAA) intention to accept the ASTM International...

75 FR 58016 - Consensus Standards, Standard Practice for Design, Alteration, and Certification of Airplane...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Consensus Standards, Standard... announces the availability of consensus standards and the Federal Aviation Administration (FAA) intention to accept the ASTM International's F2639-07 Standard Practice for Design, Alteration, and Certification of...

Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

PubMed

Binkley, Neil; Carter, Graham D

2017-12-01

Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

75 FR 65051 - Consensus Standards, Standard Practice for Inspection of Airplane Electrical Wiring Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

.... By this notice, the FAA finds the standards to be acceptable methods and procedures for inspection of... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Consensus Standards, Standard... consensus standards and the Federal Aviation Administration (FAA) intention to accept the ASTM International...

A consensus-based gold standard for the evaluation of mass casualty triage systems.

PubMed

Lerner, E Brooke; McKee, Courtney H; Cady, Charles E; Cone, David C; Colella, M Riccardo; Cooper, Arthur; Coule, Phillip L; Lairet, Julio R; Liu, J Marc; Pirrallo, Ronald G; Sasser, Scott M; Schwartz, Richard; Shepherd, Greene; Swienton, Raymond E

2015-01-01

Accuracy and effectiveness analyses of mass casualty triage systems are limited because there are no gold standard definitions for each of the triage categories. Until there is agreement on which patients should be identified by each triage category, it will be impossible to calculate sensitivity and specificity or to compare accuracy between triage systems. To develop a consensus-based, functional gold standard definition for each mass casualty triage category. National experts were recruited through the lead investigators' contacts and their suggested contacts. Key informant interviews were conducted to develop a list of potential criteria for defining each triage category. Panelists were interviewed in order of their availability until redundancy of themes was achieved. Panelists were blinded to each other's responses during the interviews. A modified Delphi survey was developed with the potential criteria identified during the interview and delivered to all recruited experts. In the early rounds, panelists could add, remove, or modify criteria. In the final rounds edits were made to the criteria until at least 80% agreement was achieved. Thirteen national and local experts were recruited to participate in the project. Six interviews were conducted. Three rounds of voting were performed, with 12 panelists participating in the first round, 12 in the second round, and 13 in the third round. After the first two rounds, the criteria were modified according to respondent suggestions. In the final round, over 90% agreement was achieved for all but one criterion. A single e-mail vote was conducted on edits to the final criterion and consensus was achieved. A consensus-based, functional gold standard definition for each mass casualty triage category was developed. These gold standard definitions can be used to evaluate the accuracy of mass casualty triage systems after an actual incident, during training, or for research.

Expert agreed standards for the selection and development of cancer support group leaders: an online reactive Delphi study.

PubMed

Pomery, Amanda; Schofield, Penelope; Xhilaga, Miranda; Gough, Karla

2018-01-01

The aim of this study was to develop pragmatic, consensus-based minimum standards for the role of a cancer support group leader. Secondly, to produce a structured interview designed to assess the knowledge, skills and attributes of the individuals who seek to undertake the role. An expert panel of 73 academics, health professionals, cancer agency workers and cancer support group leaders were invited to participate in a reactive online Delphi study involving three online questionnaire rounds. Participants determined and ranked requisite knowledge, skills and attributes (KSA) for cancer support group leaders, differentiated ideal from required KSA to establish minimum standards, and agreed on a method of rating KSA to determine suitability and readiness. Forty-five experts (62%) participated in round 1, 36 (49%) in round 2 and 23 (31%) in round 3. In round 1, experts confirmed 59 KSA identified via a systemic review and identified a further 55 KSA. In round 2, using agreement ≥75%, 52 KSA emerged as minimum standards for support group leaders. In round 3, consensus was reached on almost every aspect of the content and structure of a structured interview. Panel member comments guided refinement of wording, re-ordering of questions and improvement of probing questions. Alongside a novel structured interview, the first consensus-based minimum standards have been developed for cancer support group leaders, incorporating expert consensus and pragmatic considerations. Pilot and field testing will be used to appraise aspects of clinical utility and establish a rational scoring model for the structured interview.

Reformation of Regulatory Technical Standards for Nuclear Power Generation Equipments in Japan

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

Mikio Kurihara; Masahiro Aoki; Yu Maruyama

2006-07-01

Comprehensive reformation of the regulatory system has been introduced in Japan in order to apply recent technical progress in a timely manner. 'The Technical Standards for Nuclear Power Generation Equipments', known as the Ordinance No.622) of the Ministry of International Trade and Industry, which is used for detailed design, construction and operating stage of Nuclear Power Plants, was being modified to performance specifications with the consensus codes and standards being used as prescriptive specifications, in order to facilitate prompt review of the Ordinance with response to technological innovation. The activities on modification were performed by the Nuclear and Industrial Safetymore » Agency (NISA), the regulatory body in Japan, with support of the Japan Nuclear Energy Safety Organization (JNES), a technical support organization. The revised Ordinance No.62 was issued on July 1, 2005 and is enforced from January 1 2006. During the period from the issuance to the enforcement, JNES carried out to prepare enforceable regulatory guide which complies with each provisions of the Ordinance No.62, and also made technical assessment to endorse the applicability of consensus codes and standards, in response to NISA's request. Some consensus codes and standards were re-assessed since they were already used in regulatory review of the construction plan submitted by licensee. Other consensus codes and standards were newly assessed for endorsement. In case that proper consensus code or standards were not prepared, details of regulatory requirements were described in the regulatory guide as immediate measures. At the same time, appropriate standards developing bodies were requested to prepare those consensus code or standards. Supplementary note which provides background information on the modification, applicable examples etc. was prepared for convenience to the users of the Ordinance No. 62. This paper shows the activities on modification and the results, following the NISA's presentation at ICONE-13 that introduced the framework of the performance specifications and the modification process of the Ordinance NO. 62. (authors)« less

15 CFR 280.300 - Recorded insignia required prior to offer for sale.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Recorded insignia required prior to... consensus standard(s) to bear an insignia identifying its manufacturer, the manufacturer must: (a) Record... the applicable consensus standard(s), or, if the applicable consensus standard(s) do(es) not specify a...

Standards application and development plan for solar thermal technologies

NASA Astrophysics Data System (ADS)

Cobb, H. R. W.

1981-07-01

Functional and standards matrices, developed from input from ST users and from the industry that will be continually reviewed and updated as commercial aspects develop are presented. The matrices highlight codes, standards, test methods, functions and definitions that need to be developed. They will be submitted through ANSI for development by national consensus bodies. A contingency action is proposed for standards development if specific input is lacking at the committee level or if early development of a standard would hasten commercialization or gain needed jurisdictional acceptance.

[German national consensus on wound documentation of leg ulcer : Part 1: Routine care - standard dataset and minimum dataset].

PubMed

Heyer, K; Herberger, K; Protz, K; Mayer, A; Dissemond, J; Debus, S; Augustin, M

2017-09-01

Standards for basic documentation and the course of treatment increase quality assurance and efficiency in health care. To date, no standards for the treatment of patients with leg ulcers are available in Germany. The aim of the study was to develop standards under routine conditions in the documentation of patients with leg ulcers. This article shows the recommended variables of a "standard dataset" and a "minimum dataset". Consensus building among experts from 38 scientific societies, professional associations, insurance and supply networks (n = 68 experts) took place. After conducting a systematic international literature research, available standards were reviewed and supplemented with our own considerations of the expert group. From 2012-2015 standards for documentation were defined in multistage online visits and personal meetings. A consensus was achieved for 18 variables for the minimum dataset and 48 variables for the standard dataset in a total of seven meetings and nine online Delphi visits. The datasets involve patient baseline data, data on the general health status, wound characteristics, diagnostic and therapeutic interventions, patient reported outcomes, nutrition, and education status. Based on a multistage continuous decision-making process, a standard in the measurement of events in routine care in patients with a leg ulcer was developed.

Consensus on Recording Deep Endometriosis Surgery: the CORDES statement.

PubMed

Vanhie, A; Meuleman, C; Tomassetti, C; Timmerman, D; D'Hoore, A; Wolthuis, A; Van Cleynenbreugel, B; Dancet, E; Van den Broeck, U; Tsaltas, J; Renner, S P; Ebert, A D; Carmona, F; Abbott, J; Stepniewska, A; Taylor, H; Saridogan, E; Mueller, M; Keckstein, J; Pluchino, N; Janik, G; Zupi, E; Minelli, L; Cooper, M; Dunselman, G; Koh, C; Abrao, M S; Chapron, C; D'Hooghe, T

2016-06-01

Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. International expert consensus based on a systematic review of literature. Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research is needed to validate and evaluate the recommendations presented here. This international expert consensus for standardized reporting of surgical treatment in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. N/A. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Standard operating procedures for female orgasmic disorder: consensus of the International Society for Sexual Medicine.

PubMed

Laan, Ellen; Rellini, Alessandra H; Barnes, Tricia

2013-01-01

As the field of sexual medicine evolves, it is important to continually improve patient care by developing contemporary "standard operating procedures" (SOPs), reflecting the consensus view of experts in sexual medicine. Few, if any, consensus SOPs have been developed for the diagnosis and treatment of Female Orgasmic Disorder (FOD). The objective is to provide standard operating procedures for FOD. The SOP Committee was composed of a chair, selected by the International Society for the Study of Sexual Medicine, and two additional experts. To inform its key recommendations, the Committee used systematic reviews of available evidence and discussions during a group meeting, conference calls and e-mail communications. The Committee received no corporate funding or remuneration. A total of 12 recommendations for the assessment and treatment of FOD were generated, including suggestions for further research. Evidence-based, practice recommendations for the treatment of FOD are provided that will hopefully inform clinical decision making for those treating this common condition. © 2012 International Society for Sexual Medicine.

Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

PubMed

Kirkham, Jamie J; Davis, Katherine; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Tunis, Sean; Williamson, Paula R

2017-11-01

The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease.

PubMed

Chen, Shengdi; Gao, Guodong; Feng, Tao; Zhang, Jianguo

2018-01-01

Deep Brain Stimulation (DBS) therapy for the treatment of Parkinson's Disease (PD) is now a well-established option for some patients. Postoperative standardized programming processes can improve the level of postoperative management and programming, relieve symptoms and improve quality of life. In order to improve the quality of the programming, the experts on DBS and PD in neurology and neurosurgery in China reviewed the relevant literatures and combined their own experiences and developed this expert consensus on the programming of deep brain stimulation in patients with PD in China. This Chinese expert consensus on postoperative programming can standardize and improve postoperative management and programming of DBS for PD.

Fast and Accurate Construction of Ultra-Dense Consensus Genetic Maps Using Evolution Strategy Optimization

PubMed Central

Mester, David; Ronin, Yefim; Schnable, Patrick; Aluru, Srinivas; Korol, Abraham

2015-01-01

Our aim was to develop a fast and accurate algorithm for constructing consensus genetic maps for chip-based SNP genotyping data with a high proportion of shared markers between mapping populations. Chip-based genotyping of SNP markers allows producing high-density genetic maps with a relatively standardized set of marker loci for different mapping populations. The availability of a standard high-throughput mapping platform simplifies consensus analysis by ignoring unique markers at the stage of consensus mapping thereby reducing mathematical complicity of the problem and in turn analyzing bigger size mapping data using global optimization criteria instead of local ones. Our three-phase analytical scheme includes automatic selection of ~100-300 of the most informative (resolvable by recombination) markers per linkage group, building a stable skeletal marker order for each data set and its verification using jackknife re-sampling, and consensus mapping analysis based on global optimization criterion. A novel Evolution Strategy optimization algorithm with a global optimization criterion presented in this paper is able to generate high quality, ultra-dense consensus maps, with many thousands of markers per genome. This algorithm utilizes "potentially good orders" in the initial solution and in the new mutation procedures that generate trial solutions, enabling to obtain a consensus order in reasonable time. The developed algorithm, tested on a wide range of simulated data and real world data (Arabidopsis), outperformed two tested state-of-the-art algorithms by mapping accuracy and computation time. PMID:25867943

Fourth consensus of the International Society for Premenstrual Disorders (ISPMD): auditable standards for diagnosis and management of premenstrual disorder.

PubMed

Ismaili, Elgerta; Walsh, Sally; O'Brien, Patrick Michael Shaughn; Bäckström, Torbjorn; Brown, Candace; Dennerstein, Lorraine; Eriksson, Elias; Freeman, Ellen W; Ismail, Khaled M K; Panay, Nicholas; Pearlstein, Teri; Rapkin, Andrea; Steiner, Meir; Studd, John; Sundström-Paromma, Inger; Endicott, Jean; Epperson, C Neill; Halbreich, Uriel; Reid, Robert; Rubinow, David; Schmidt, Peter; Yonkers, Kimberley

2016-12-01

Whilst professional bodies such as the Royal College and the American College of Obstetricians and Gynecologists have well-established standards for audit of management for most gynaecology disorders, such standards for premenstrual disorders (PMDs) have yet to be developed. The International Society of Premenstrual Disorders (ISPMD) has already published three consensus papers on PMDs covering areas that include definition, classification/quantification, clinical trial design and management (American College Obstetricians and Gynecologists 2011; Brown et al. in Cochrane Database Syst Rev 2:CD001396, 2009; Dickerson et al. in Am Fam Physician 67(8):1743-1752, 2003). In this fourth consensus of ISPMD, we aim to create a set of auditable standards for the clinical management of PMDs. All members of the original ISPMD consensus group were invited to submit one or more auditable standards to be eligible in the inclusion of the consensus. Ninety-five percent of members (18/19) responded with at least one auditable standard. A total of 66 auditable standards were received, which were returned to all group members who then ranked the standards in order of priority, before the results were collated. Proposed standards related to the diagnosis of PMDs identified the importance of obtaining an accurate history, that a symptom diary should be kept for 2 months prior to diagnosis and that symptom reporting demonstrates symptoms in the premenstrual phase of the menstrual cycle and relieved by menstruation. Regarding treatment, the most important standards were the use of selective serotonin reuptake inhibitors (SSRIs) as a first line treatment, an evidence-based approach to treatment and that SSRI side effects are properly explained to patients. A set of comprehensive standards to be used in the diagnosis and treatment of PMD has been established, for which PMD management can be audited against for standardised and improved care.

Standards Development Activities at White Sands Test Facility

NASA Technical Reports Server (NTRS)

Baker, D. L.; Beeson, H. D.; Saulsberry, R. L.; Julien, H. L.; Woods, S. S.

2003-01-01

The development of standards and standard activities at the JSC White Sands Test Facility (WSTF) has been expanded to include the transfer of technology and standards to voluntary consensus organizations in five technical areas of importance to NASA. This effort is in direct response to the National Technology Transfer Act designed to accelerate transfer of technology to industry and promote government-industry partnerships. Technology transfer is especially important for WSTF, whose longterm mission has been to develop and provide vital propellant safety and hazards information to aerospace designers, operations personnel, and safety personnel. Meeting this mission is being accomplished through the preparation of consensus guidelines and standards, propellant hazards analysis protocols, and safety courses for the propellant use of hydrogen, oxygen, and hypergols, as well as the design and inspection of spacecraft pressure vessels and the use of pyrovalves in spacecraft propulsion systems. The overall WSTF technology transfer program is described and the current status of technology transfer activities are summarized.

The use of Delphi and Nominal Group Technique in nursing education: A review.

PubMed

Foth, Thomas; Efstathiou, Nikolaos; Vanderspank-Wright, Brandi; Ufholz, Lee-Anne; Dütthorn, Nadin; Zimansky, Manuel; Humphrey-Murto, Susan

2016-08-01

Consensus methods are used by healthcare professionals and educators within nursing education because of their presumed capacity to extract the profession's' "collective knowledge" which is often considered tacit knowledge that is difficult to verbalize and to formalize. Since their emergence, consensus methods have been criticized and their rigour has been questioned. Our study focuses on the use of consensus methods in nursing education and seeks to explore how extensively consensus methods are used, the types of consensus methods employed, the purpose of the research and how standardized the application of the methods is. A systematic approach was employed to identify articles reporting the use of consensus methods in nursing education. The search strategy included keyword search in five electronic databases [Medline (Ovid), Embase (Ovid), AMED (Ovid), ERIC (Ovid) and CINAHL (EBSCO)] for the period 2004-2014. We included articles published in English, French, German and Greek discussing the use of consensus methods in nursing education or in the context of identifying competencies. A standardized extraction form was developed using an iterative process with results from the search. General descriptors such as type of journal, nursing speciality, type of educational issue addressed, method used, geographic scope were recorded. Features reflecting methodology such as number, selection and composition of panel participants, number of rounds, response rates, definition of consensus, and feedback were recorded. 1230 articles were screened resulting in 101 included studies. The Delphi was used in 88.2% of studies. Most were reported in nursing journals (63.4%). The most common purpose to use these methods was defining competencies, curriculum development and renewal, and assessment. Remarkably, both standardization and reporting of consensus methods was noted to be generally poor. Areas where the methodology appeared weak included: preparation of the initial questionnaire; the selection and description of participants; number of rounds and number of participants remaining after each round; formal feedback of group ratings; definitions of consensus and a priori definition of numbers of rounds; and modifications to the methodology. The findings of this study are concerning if interpreted within the context of the structural critiques because our findings lend support to these critiques. If consensus methods should continue being used to inform best practices in nursing education, they must be rigorous in design. Copyright © 2016 Elsevier Ltd. All rights reserved.

Understanding diagnostic variability in breast pathology: lessons learned from an expert consensus review panel

PubMed Central

Allison, Kimberly H; Reisch, Lisa M; Carney, Patricia A; Weaver, Donald L; Schnitt, Stuart J; O’Malley, Frances P; Geller, Berta M; Elmore, Joann G

2015-01-01

Aims To gain a better understanding of the reasons for diagnostic variability, with the aim of reducing the phenomenon. Methods and results In preparation for a study on the interpretation of breast specimens (B-PATH), a panel of three experienced breast pathologists reviewed 336 cases to develop consensus reference diagnoses. After independent assessment, cases coded as diagnostically discordant were discussed at consensus meetings. By the use of qualitative data analysis techniques, transcripts of 16 h of consensus meetings for a subset of 201 cases were analysed. Diagnostic variability could be attributed to three overall root causes: (i) pathologist-related; (ii) diagnostic coding/study methodology-related; and (iii) specimen-related. Most pathologist-related root causes were attributable to professional differences in pathologists’ opinions about whether the diagnostic criteria for a specific diagnosis were met, most frequently in cases of atypia. Diagnostic coding/study methodology-related root causes were primarily miscategorizations of descriptive text diagnoses, which led to the development of a standardized electronic diagnostic form (BPATH-Dx). Specimen-related root causes included artefacts, limited diagnostic material, and poor slide quality. After re-review and discussion, a consensus diagnosis could be assigned in all cases. Conclusions Diagnostic variability is related to multiple factors, but consensus conferences, standardized electronic reporting formats and comments on suboptimal specimen quality can be used to reduce diagnostic variability. PMID:24511905

Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus.

PubMed

Kim, Andrew H; Roberts, Charlotte; Feagan, Brian G; Banerjee, Rupa; Bemelman, Willem; Bodger, Keith; Derieppe, Marc; Dignass, Axel; Driscoll, Richard; Fitzpatrick, Ray; Gaarentstroom-Lunt, Janette; Higgins, Peter D; Kotze, Paulo Gustavo; Meissner, Jillian; O'Connor, Marian; Ran, Zhi-Hua; Siegel, Corey A; Terry, Helen; van Deen, Welmoed K; van der Woude, C Janneke; Weaver, Alandra; Yang, Suk-Kyun; Sands, Bruce E; Vermeire, Séverine; Travis, Simon Pl

2018-03-28

Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. A minimum Standard Set of outcomes was developed for patients [aged ≥16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaemia], disutility of care [treatment-related complications], healthcare utilization [IBD-related admissions, emergency room visits] and patient-reported outcomes [including quality of life, nutritional status and impact of fistulae] measured at baseline and at 6 or 12 month intervals. A single PROM [IBD-Control questionnaire] was recommended in the Standard Set and minimum risk adjustment data collected at baseline and annually were included: demographics, basic clinical information and treatment factors. A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.

[Consensus on clinical diagnosis, treatment and pedigree management of hereditary colorectal cancer in China].

PubMed

2018-01-23

Hereditary colorectal cancer can be divded into two categories based on the presence or absence of polyps. The first category is characterized by the development of polyposis, which includes familial adenomatous polyposis (FAP); The second category is nonpolyposis colorectal cancer, which is represented by Lynch syndrome. "Consensus on clinical diagnosis, treatment and pedigree management of hereditary colorectal cancer in China" developed by the Genetics Group of the Committee of Colorectal Cancer, Chinese Anti-cancer Association, is composed of three sections, including hereditary nonpolyposis syndrome, polyposis syndrome as well as genetic evaluation of hereditary colorectal cancer. The consensus aims to provide recommendations on management of the respective hereditary syndromes in terms of definition, clinical and pathological features, diagnostic standards, treatment, and follow-ups. In addition to describing diagnostic and treatment strategies, prophylactic treatment as well as genetic screening and pedigree monitoring is highly recommended. Through the establishment of this expert consensus, we hope to promote better understanding of hereditary colorectal cancer for clinicians and encourage standardized treatment through multidisciplinery approaches, eventually improving clinical treatment and pedigree management of hereditary colorectal cancer in China.

75 FR 70074 - Consensus Standards, Light-Sport Aircraft

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Consensus Standards, Light-Sport... accepted consensus standards relating to the provisions of the Sport Pilot and Light-Sport Aircraft rule issued July 16, 2004, and effective September 1, 2004. ASTM International Committee F37 on Light Sport...

EULAR/PReS standards and recommendations for the transitional care of young people with juvenile-onset rheumatic diseases.

PubMed

Foster, Helen E; Minden, Kirsten; Clemente, Daniel; Leon, Leticia; McDonagh, Janet E; Kamphuis, Sylvia; Berggren, Karin; van Pelt, Philomine; Wouters, Carine; Waite-Jones, Jennifer; Tattersall, Rachel; Wyllie, Ruth; Stones, Simon R; Martini, Alberto; Constantin, Tamas; Schalm, Susanne; Fidanci, Berna; Erer, Burak; Demirkaya, Erkan; Ozen, Seza; Carmona, Loreto

2017-04-01

To develop standards and recommendations for transitional care for young people (YP) with juvenile-onset rheumatic and musculoskeletal diseases (jRMD). The consensus process involved the following: (1) establishing an international expert panel to include patients and representatives from multidisciplinary teams in adult and paediatric rheumatology; (2) a systematic review of published models of transitional care in jRMDs, potential standards and recommendations, strategies for implementation and tools to evaluate services and outcomes; (3) setting the framework, developing the process map and generating a first draft of standards and recommendations; (4) further iteration of recommendations; (5) establishing consensus recommendations with Delphi methodology and (6) establishing standards and quality indicators. The final consensus derived 12 specific recommendations for YP with jRMD focused on transitional care. These included: high-quality, multidisciplinary care starting in early adolescence; the integral role of a transition co-ordinator; transition policies and protocols; efficient communications; transfer documentation; an open electronic-based platform to access resources; appropriate training for paediatric and adult healthcare teams; secure funding to continue treatments and services into adult rheumatology and the need for increased evidence to inform best practice. These consensus-based recommendations inform strategies to reach optimal outcomes in transitional care for YP with jRMD based on available evidence and expert opinion. They need to be implemented in the context of individual countries, healthcare systems and regulatory frameworks. 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/.

Designing a Standardized Laparoscopy Curriculum for Gynecology Residents: A Delphi Approach

PubMed Central

Shore, Eliane M.; Lefebvre, Guylaine G.; Husslein, Heinrich; Bjerrum, Flemming; Sorensen, Jette Led; Grantcharov, Teodor P.

2015-01-01

Background Evidence suggests that simulation leads to improved operative skill, shorter operating room time, and better patient outcomes. Currently, no standardized laparoscopy curriculum exists for gynecology residents. Objective To design a structured laparoscopy curriculum for gynecology residents using Delphi consensus methodology. Methods This study began with Delphi methodology to determine expert consensus on the components of a gynecology laparoscopic skills curriculum. We generated a list of cognitive content, technical skills, and nontechnical skills for training in laparoscopic surgery, and asked 39 experts in gynecologic education to rate the items on a Likert scale (1–5) for inclusion in the curriculum. Consensus was predefined as Cronbach α of ≥ 0.80. We then conducted another Delphi survey with 9 experienced users of laparoscopic virtual reality simulators to delineate relevant curricular tasks. Finally, a cross-sectional design defined benchmark scores for all identified tasks, with 10 experienced gynecologic surgeons performing the identified tasks at basic, intermediate, and advanced levels. Results Consensus (Cronbach α = 0.85) was achieved in the first round of the curriculum Delphi, and after 2 rounds (Cronbach α = 0.80) in the virtual reality curriculum Delphi. Consensus was reached for cognitive, technical, and nontechnical skills as well as for 6 virtual reality tasks. Median time and economy of movement scores defined benchmarks for all tasks. Conclusions This study used Delphi consensus to develop a comprehensive curriculum for teaching gynecologic laparoscopy. The curriculum conforms to current educational standards of proficiency-based training, and is suggested as a standard in residency programs. PMID:26221434

Consensus-based guidelines for Video EEG monitoring in the pre-surgical evaluation of children with epilepsy in the UK.

PubMed

Pressler, Ronit M; Seri, Stefano; Kane, Nick; Martland, Tim; Goyal, Sushma; Iyer, Anand; Warren, Elliott; Notghi, Lesley; Bill, Peter; Thornton, Rachel; Appleton, Richard; Doyle, Sarah; Rushton, Sarah; Worley, Alan; Boyd, Stewart G

2017-08-01

Paediatric Epilepsy surgery in the UK has recently been centralised in order to improve expertise and quality of service available to children. Video EEG monitoring or telemetry is a highly specialised and a crucial component of the pre-surgical evaluation. Although many Epilepsy Monitoring Units work to certain standards, there is no national or international guideline for paediatric video telemetry. Due to lack of evidence we used a modified Delphi process utilizing the clinical and academic expertise of the clinical neurophysiology sub-specialty group of Children's Epilepsy Surgical Service (CESS) centres in England and Wales. This process consisted of the following stages I: Identification of the consensus working group, II: Identification of key areas for guidelines, III: Consensus practice points and IV: Final review. Statements that gained consensus (median score of either 4 or 5 using a five-point Likerttype scale) were included in the guideline. Two rounds of feedback and amendments were undertaken. The consensus guidelines includes the following topics: referral pathways, neurophysiological equipment standards, standards of recording techniques, with specific emphasis on safety of video EEG monitoring both with and without drug withdrawal, a protocol for testing patient's behaviours, data storage and guidelines for writing factual reports and conclusions. All statements developed received a median score of 5 and were adopted by the group. Using a modified Delphi process we were able to develop universally-accepted video EEG guidelines for the UK CESS. Although these recommendations have been specifically developed for the pre-surgical evaluation of children with epilepsy, it is assumed that most components are transferable to any paediatric video EEG monitoring setting. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

75 FR 5888 - Federal Manufactured Home Construction and Safety Standards and Other Orders: HUD Statements That...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 3280 and 3282 [Docket No. FR-5343-IN-01... Housing Programs, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 9164... provided that the consensus committee was to develop the original proposed model installation standards for...

Risk Analysis as Regulatory Science: Toward The Establishment of Standards

PubMed Central

Murakami, Michio

2016-01-01

Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional ‘Standard I’, which has a paternalistic orientation, and ‘Standard II’, established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. PMID:27475751

Risk Analysis as Regulatory Science: Toward The Establishment of Standards.

PubMed

Murakami, Michio

2016-09-01

Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional 'Standard I', which has a paternalistic orientation, and 'Standard II', established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. © The Author 2016. Published by Oxford University Press.

29 CFR 1910.3 - Petitions for the issuance, amendment, or repeal of a standard.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 5 2010-07-01 2010-07-01 false Petitions for the issuance, amendment, or repeal of a... major sources of national consensus standards. National consensus standards adopted on May 29, 1971... itself a producer of national consensus standards, within the meaning of section 3(9) of the Act, is...

Reporting standards for studies of diagnostic test accuracy in dementia

PubMed Central

Noel-Storr, Anna H.; McCleery, Jenny M.; Richard, Edo; Ritchie, Craig W.; Flicker, Leon; Cullum, Sarah J.; Davis, Daniel; Quinn, Terence J.; Hyde, Chris; Rutjes, Anne W.S.; Smailagic, Nadja; Marcus, Sue; Black, Sandra; Blennow, Kaj; Brayne, Carol; Fiorivanti, Mario; Johnson, Julene K.; Köpke, Sascha; Schneider, Lon S.; Simmons, Andrew; Mattsson, Niklas; Zetterberg, Henrik; Bossuyt, Patrick M.M.; Wilcock, Gordon

2014-01-01

Objective: To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. Methods: An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. Results: More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. Conclusion: STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers. PMID:24944261

Consensus Treatment Plans for New-Onset Systemic Juvenile Idiopathic Arthritis

PubMed Central

DeWitt, Esi Morgan; Kimura, Yukiko; Beukelman, Timothy; Nigrovic, Peter A.; Onel, Karen; Prahalad, Sampath; Schneider, Rayfel; Stoll, Matthew L.; Angeles-Han, Sheila; Milojevic, Diana; Schikler, Kenneth N.; Vehe, Richard K.; Weiss, Jennifer E.; Weiss, Pamela; Ilowite, Norman T.; Wallace, Carol A.

2012-01-01

Objective There is wide variation in therapeutic approaches to systemic juvenile idiopathic arthritis (sJIA) among North American rheumatologists. Understanding the comparative effectiveness of the diverse therapeutic options available for treatment of sJIA can result in better health outcomes. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans and standardized assessment schedules for use in clinical practice to facilitate such studies. Methods Case-based surveys were administered to CARRA members to identify prevailing treatments for new-onset sJIA. A 2-day consensus conference in April 2010 employed modified nominal group technique to formulate preliminary treatment plans and determine important data elements for collection. Follow-up surveys were employed to refine the plans and assess clinical acceptability. Results The initial case-based survey identified significant variability among current treatment approaches for new onset sJIA, underscoring the utility of standardized plans to evaluate comparative effectiveness. We developed four consensus treatment plans for the first 9 months of therapy, as well as case definitions and clinical and laboratory monitoring schedules. The four treatment regimens included glucocorticoids only, or therapy with methotrexate, anakinra or tocilizumab, with or without glucocorticoids. This approach was approved by >78% of CARRA membership. Conclusion Four standardized treatment plans were developed for new-onset sJIA. Coupled with data collection at defined intervals, use of these treatment plans will create the opportunity to evaluate comparative effectiveness in an observational setting to optimize initial management of sJIA. PMID:22290637

American National Standards: The Consensus Process

NASA Technical Reports Server (NTRS)

Schafer, Thom

2000-01-01

Since the early 20th Century, technical and professional societies have developed standards within their areas of expertise addressing aspects of their industries which they feel would benefit from a degree of standardization. From the beginning, the use of these standards was strictly voluntary. It did not take jurisdictional authorities long, however, to recognize that application of these voluntary standards enhanced public safety, as well as leveling the playing field in trade. Hence, laws were passed mandating their use. Purchasers of goods and services also recognized the advantages of standardization, and began requiring the use of standards in their procurement contracts. But how do jurisdictions and purchasers know that the standard they are mandating is a broad-based industry standard, or a narrowly focused set of rules which only apply to one company or institution, thereby giving them an unfair advantage? The answer is "consensus", and a unified approach in achieving it.

15 CFR 10.7 - Procedure when a recommended standard is not supported by a consensus.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Procedure when a recommended standard is not supported by a consensus. 10.7 Section 10.7 Commerce and Foreign Trade Office of the Secretary... recommended standard is not supported by a consensus. If the Department determines that a recommended standard...

A historical examination of the nature of science and its consensus as presented in the Benchmarks for Science Literacy and National Science Education Standards

NASA Astrophysics Data System (ADS)

Felske, Daniel D.

Developing a scientific literate citizenry has fueled science education reforms for the past 40 years. A review of the literature reveals that definitions of scientific literacy during this period were greatly influenced by the goals, directions, and political agendas of the day. This approach has resulted in programs emphasizing certain aspects of scientific literacy while neglecting others. Additionally, consensus on what scientific literacy means or how to develop it has not been achieved. One aspect of scientific literacy that is agreed upon is the essential role that the nature of science (NOS) plays in its development. For this reason, an extensive review of the literature was conducted to develop a comprehensive background of this topic. The component structure of the NOS revealed in the literature was then synthesized into a NOS framework. The NOS framework served to guide the construction of a 21 item questionnaire taken from statements embedded in the consensual documents Benchmarks for Science Literacy (AAAS, 1993) and National Science Education Standards (NRC, 1996). A panel of five experts who have written extensively on the nature of science was then assembled and the degree of NOS consensus measured using a modified Delphi technique. The results of the survey indicated a high level of consensus (95%) at the ≥80% level. The panelists concurred positively on 19 of 21 NOS items, concurred negatively on one of 21 NOS items (item 10), and could not reach consensus on one of 21 NOS items (item 16). These findings, as well as, the NOS framework, are important first steps toward developing programs that foster the development of scientific literacy.

International consensus on a complications list after gastrectomy for cancer.

PubMed

Baiocchi, Gian Luca; Giacopuzzi, Simone; Marrelli, Daniele; Reim, Daniel; Piessen, Guillaume; Matos da Costa, Paulo; Reynolds, John V; Meyer, Hans-Joachim; Morgagni, Paolo; Gockel, Ines; Lara Santos, Lucio; Jensen, Lone Susanne; Murphy, Thomas; Preston, Shaun R; Ter-Ovanesov, Mikhail; Fumagalli Romario, Uberto; Degiuli, Maurizio; Kielan, Wojciech; Mönig, Stefan; Kołodziejczyk, Piotr; Polkowski, Wojciech; Hardwick, Richard; Pera, Manuel; Johansson, Jan; Schneider, Paul M; de Steur, Wobbe O; Gisbertz, Suzanne S; Hartgrink, Henk; van Sandick, Joanna W; Portolani, Nazario; Hölscher, Arnulf H; Botticini, Maristella; Roviello, Franco; Mariette, Christophe; Allum, William; De Manzoni, Giovanni

2018-05-30

Perioperative complications can affect outcomes after gastrectomy for cancer, with high mortality and morbidity rates ranging between 10 and 40%. The absence of a standardized system for recording complications generates wide variation in evaluating their impacts on outcomes and hinders proposals of quality-improvement projects. The aim of this study was to provide a list of defined gastrectomy complications approved through international consensus. The Gastrectomy Complications Consensus Group consists of 34 European gastric cancer experts who are members of the International Gastric Cancer Association. A group meeting established the work plan for study implementation through Delphi surveys. A consensus was reached regarding a set of standardized methods to define gastrectomy complications. A standardized list of 27 defined complications (grouped into 3 intraoperative, 14 postoperative general, and 10 postoperative surgical complications) was created to provide a simple but accurate template for recording individual gastrectomy complications. A consensus was reached for both the list of complications that should be considered major adverse events after gastrectomy for cancer and their specific definitions. The study group also agreed that an assessment of each surgical case should be completed at patient discharge and 90 days postoperatively using a Complication Recording Sheet. The list of defined complications (soon to be validated in an international multicenter study) and the ongoing development of an electronic datasheet app to record them provide the basic infrastructure to reach the ultimate goals of standardized international data collection, establishment of benchmark results, and fostering of quality-improvement projects.

Standards of scientific conduct: are there any?

PubMed

Kalichman, Michael; Sweet, Monica; Plemmons, Dena

2014-12-01

The practice of research is full of ethical challenges, many of which might be addressed through the teaching of responsible conduct of research (RCR). Although such training is increasingly required, there is no clear consensus about either the goals or content of an RCR curriculum. The present study was designed to assess community standards in three domains of research practice: authorship, collaboration, and data management. A survey, developed through advice from content matter experts, focus groups, and interviews, was distributed in November 2010 to U.S. faculty from 50 graduate programs for each of four different disciplines: microbiology, neuroscience, nursing, and psychology. The survey addressed practices and perceived standards, as well as perceptions about teaching and learning. Over 1,300 responses (response rate of 21 %) yielded statistically significant differences in responses to nearly all questions. However the magnitude of these differences was typically small, leaving little reason to argue for community consensus on standards. For nearly all questions asked, the clear finding was that there was nothing approaching consensus. These results may be useful not so much to teach what the standards are, but to increase student awareness of the diversity of those standards in reported practice.

Standards of Scientific Conduct: Are there any?

PubMed Central

Kalichman, Michael; Sweet, Monica; Plemmons, Dena

2014-01-01

The practice of research is full of ethical challenges, many of which might be addressed through the teaching of responsible conduct of research (RCR). Although such training is increasingly required, there is no clear consensus about either the goals or content of an RCR curriculum. The present study was designed to assess community standards in three domains of research practice: authorship, collaboration, and data management. A survey, developed through advice from content matter experts, focus groups, and interviews, was distributed in November 2010 to U.S. faculty from 50 graduate programs for each of four different disciplines: microbiology, neuroscience, nursing, and psychology. The survey addressed practices and perceived standards, as well as perceptions about teaching and learning. Over 1,300 responses (response rate of 21%) yielded statistically significant differences in responses to nearly all questions. However the magnitude of these differences was typically small, leaving little reason to argue for community consensus on standards. For nearly all questions asked, the clear finding was that there was nothing approaching consensus. These results may be useful not so much to teach what the standards are, but to increase student awareness of the diversity of those standards in reported practice. PMID:24337932

DEVELOPMENT OF STANDARDS FOR EVALUATING THE IMPORTANCE OF CONTAMINANTS IN THE ENVIRONMENT: FIERY DISCUSSIONS, COMMON PURPOSE, A PROVEN WIN-WIN PARTNERSHIP BETWEEN THE U.S. ENVIRONMENTAL PROTECTION AGENCY AND ASTM COMMITTEE E47 (NON-PEER REV'D. JOURNAL)

EPA Science Inventory

The development of standards through the consensus based process is often a long and arduous process even in the best of circumstances. The impetus to develop standards is a need to obtain high quality data for the evaluation of questions that often pertain to the development of...

Development of a Consensus Standard for School Equipment: NSF/NSSEA 380

ERIC Educational Resources Information Center

Breitner, Ashlee

2011-01-01

For many years, the school supplies and equipment industry has investigated methods to ensure product safety and compliance across all its product categories. In early 2010, NSF International and the National School Supply and Equipment Association (NSSEA) came together to develop quality standards for products and equipment designed for use in…

A Case for Common Core State Standards: Gifted Curriculum 3.0

ERIC Educational Resources Information Center

VanTassel-Baska, Joyce

2012-01-01

The Common Core State Standards (CCSS) is the most successful attempt to gain consensus across states for 21st century standards in language arts and mathematics. So far, 46 states have accepted these standards, with two consortia organized to translate them into resources and sample activities. A consultant firm has been hired to develop the…

Critical appraisal of the Vienna consensus: performance indicators for assisted reproductive technology laboratories.

PubMed

Lopez-Regalado, María Luisa; Martínez-Granados, Luis; González-Utor, Antonio; Ortiz, Nereyda; Iglesias, Miriam; Ardoy, Manuel; Castilla, Jose A

2018-05-24

The Vienna consensus, based on the recommendations of an expert panel, has identified 19 performance indicators for assisted reproductive technology (ART) laboratories. Two levels of reference values are established for these performance indicators: competence and benchmark. For over 10 years, the Spanish embryology association (ASEBIR) has participated in the definition and design of ART performance indicators, seeking to establish specific guidelines for ART laboratories to enhance quality, safety and patient welfare. Four years ago, ASEBIR took part in an initiative by AENOR, the Spanish Association for Standardization and Certification, to develop a national standard in this field (UNE 17900:2013 System of quality management for assisted reproduction laboratories), extending the former requirements, based on ISO 9001, to include performance indicators. Considering the experience acquired, we discuss various aspects of the Vienna consensus and consider certain discrepancies in performance indicators between the consensus and UNE 179007:2013, and analyse the definitions, methodology and reference values used. Copyright © 2018. Published by Elsevier Ltd.

The NOAA IOOS Data Integration Framework: Initial Implementation Report

DTIC Science & Technology

2008-09-01

based services (http://www.opengeospatial.org/); NOAA is a Principal Member. Figure 2: Specialization of XML for in situ data To standardize...1 OGC is a non-profit, international, voluntary consensus organization that develops standards for geospatial and location

Updating OSHA standards based on national consensus standards. Direct final rule.

PubMed

2007-12-14

In this direct final rule, the Agency is removing several references to consensus standards that have requirements that duplicate, or are comparable to, other OSHA rules; this action includes correcting a paragraph citation in one of these OSHA rules. The Agency also is removing a reference to American Welding Society standard A3.0-1969 ("Terms and Definitions") in its general-industry welding standards. This rulemaking is a continuation of OSHA's ongoing effort to update references to consensus and industry standards used throughout its rules.

Development of a standardized, citywide process for managing smart-pump drug libraries.

PubMed

Walroth, Todd A; Smallwood, Shannon; Arthur, Karen; Vance, Betsy; Washington, Alana; Staublin, Therese; Haslar, Tammy; Reddan, Jennifer G; Fuller, James

2018-06-15

Development and implementation of an interprofessional consensus-driven process for review and optimization of smart-pump drug libraries and dosing limits are described. The Indianapolis Coalition for Patient Safety (ICPS), which represents 6 Indianapolis-area health systems, identified an opportunity to reduce clinically insignificant alerts that smart infusion pumps present to end users. Through a consensus-driven process, ICPS aimed to identify best practices to implement at individual hospitals in order to establish specific action items for smart-pump drug library optimization. A work group of pharmacists, nurses, and industrial engineers met to evaluate variability within and lack of scrutiny of smart-pump drug libraries. The work group used Lean Six Sigma methodologies to generate a list of key needs and barriers to be addressed in process standardization. The group reviewed targets for smart-pump drug library optimization, including dosing limits, types of alerts reviewed, policies, and safety best practices. The work group also analyzed existing processes at each site to develop a final consensus statement outlining a model process for reviewing alerts and managing smart-pump data. Analysis of the total number of alerts per device across ICPS-affiliated health systems over a 4-year period indicated a 50% decrease (from 7.2 to 3.6 alerts per device per month) after implementation of the model by ICPS member organizations. Through implementation of a standardized, consensus-driven process for smart-pump drug library optimization, ICPS member health systems reduced clinically insignificant smart-pump alerts. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Seeking worldwide professional consensus on the principles of end-of-life care for the critically ill. The Consensus for Worldwide End-of-Life Practice for Patients in Intensive Care Units (WELPICUS) study.

PubMed

Sprung, Charles L; Truog, Robert D; Curtis, J Randall; Joynt, Gavin M; Baras, Mario; Michalsen, Andrej; Briegel, Josef; Kesecioglu, Jozef; Efferen, Linda; De Robertis, Edoardo; Bulpa, Pierre; Metnitz, Philipp; Patil, Namrata; Hawryluck, Laura; Manthous, Constantine; Moreno, Rui; Leonard, Sara; Hill, Nicholas S; Wennberg, Elisabet; McDermid, Robert C; Mikstacki, Adam; Mularski, Richard A; Hartog, Christiane S; Avidan, Alexander

2014-10-15

Great differences in end-of-life practices in treating the critically ill around the world warrant agreement regarding the major ethical principles. This analysis determines the extent of worldwide consensus for end-of-life practices, delineates where there is and is not consensus, and analyzes reasons for lack of consensus. Critical care societies worldwide were invited to participate. Country coordinators were identified and draft statements were developed for major end-of-life issues and translated into six languages. Multidisciplinary responses using a web-based survey assessed agreement or disagreement with definitions and statements linked to anonymous demographic information. Consensus was prospectively defined as >80% agreement. Definitions and statements not obtaining consensus were revised based on comments of respondents, and then translated and redistributed. Of the initial 1,283 responses from 32 countries, consensus was found for 66 (81%) of the 81 definitions and statements; 26 (32%) had >90% agreement. With 83 additional responses to the original questionnaire (1,366 total) and 604 responses to the revised statements, consensus could be obtained for another 11 of the 15 statements. Consensus was obtained for informed consent, withholding and withdrawing life-sustaining treatment, legal requirements, intensive care unit therapies, cardiopulmonary resuscitation, shared decision making, medical and nursing consensus, brain death, and palliative care. Consensus was obtained for 77 of 81 (95%) statements. Worldwide consensus could be developed for the majority of definitions and statements about end-of-life practices. Statements achieving consensus provide standards of practice for end-of-life care; statements without consensus identify important areas for future research.

Standardizing terms for clinical pharmacogenetic test results: consensus terms from the Clinical Pharmacogenetics Implementation Consortium (CPIC).

PubMed

Caudle, Kelly E; Dunnenberger, Henry M; Freimuth, Robert R; Peterson, Josh F; Burlison, Jonathan D; Whirl-Carrillo, Michelle; Scott, Stuart A; Rehm, Heidi L; Williams, Marc S; Klein, Teri E; Relling, Mary V; Hoffman, James M

2017-02-01

Reporting and sharing pharmacogenetic test results across clinical laboratories and electronic health records is a crucial step toward the implementation of clinical pharmacogenetics, but allele function and phenotype terms are not standardized. Our goal was to develop terms that can be broadly applied to characterize pharmacogenetic allele function and inferred phenotypes. Terms currently used by genetic testing laboratories and in the literature were identified. The Clinical Pharmacogenetics Implementation Consortium (CPIC) used the Delphi method to obtain a consensus and agree on uniform terms among pharmacogenetic experts. Experts with diverse involvement in at least one area of pharmacogenetics (clinicians, researchers, genetic testing laboratorians, pharmacogenetics implementers, and clinical informaticians; n = 58) participated. After completion of five surveys, a consensus (>70%) was reached with 90% of experts agreeing to the final sets of pharmacogenetic terms. The proposed standardized pharmacogenetic terms will improve the understanding and interpretation of pharmacogenetic tests and reduce confusion by maintaining consistent nomenclature. These standard terms can also facilitate pharmacogenetic data sharing across diverse electronic health care record systems with clinical decision support.Genet Med 19 2, 215-223.

Developments in Surge Research Priorities: A Systematic Review of the Literature Following the Academic Emergency Medicine Consensus Conference, 2007-2015.

PubMed

Morton, Melinda J; DeAugustinis, Matthew L; Velasquez, Christina A; Singh, Sonal; Kelen, Gabor D

2015-11-01

In 2006, Academic Emergency Medicine (AEM) published a special issue summarizing the proceedings of the AEM consensus conference on the "Science of Surge." One major goal of the conference was to establish research priorities in the field of "disasters" surge. For this review, we wished to determine the progress toward the conference's identified research priorities: 1) defining criteria and methods for allocation of scarce resources, 2) identifying effective triage protocols, 3) determining decision-makers and means to evaluate response efficacy, 4) developing communication and information sharing strategies, and 5) identifying methods for evaluating workforce needs. Specific criteria were developed in conjunction with library search experts. PubMed, Embase, Web of Science, Scopus, and the Cochrane Library databases were queried for peer-reviewed articles from 2007 to 2015 addressing scientific advances related to the above five research priorities identified by AEM consensus conference. Abstracts and foreign language articles were excluded. Only articles with quantitative data on predefined outcomes were included; consensus panel recommendations on the above priorities were also included for the purposes of this review. Included study designs were randomized controlled trials, prospective, retrospective, qualitative (consensus panel), observational, cohort, case-control, or controlled before-and-after studies. Quality assessment was performed using a standardized tool for quantitative studies. Of the 2,484 unique articles identified by the search strategy, 313 articles appeared to be related to disaster surge. Following detailed text review, 50 articles with quantitative data and 11 concept papers (consensus conference recommendations) addressed at least one AEM consensus conference surge research priority. Outcomes included validation of the benchmark of 500 beds/million of population for disaster surge capacity, effectiveness of simulation- and Internet-based tools for forecasting of hospital and regional demand during disasters, effectiveness of reverse triage approaches, development of new disaster surge metrics, validation of mass critical care approaches (altered standards of care), use of telemedicine, and predictions of optimal hospital staffing levels for disaster surge events. Simulation tools appeared to provide some of the highest quality research. Disaster simulation studies have arguably revolutionized the study of disaster surge in the intervening years since the 2006 AEM Science of Surge conference, helping to validate some previously known disaster surge benchmarks and to generate new surge metrics. Use of reverse triage approaches and altered standards of care, as well as Internet-based tools such as Google Flu Trends, have also proven effective. However, there remains significant work to be done toward standardizing research methodologies and outcomes, as well as validating disaster surge metrics. © 2015 by the Society for Academic Emergency Medicine.

29 CFR (non - mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 8 2010-07-01 2010-07-01 false mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards (Non Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Consensus Standards ANSI/SIA A92.2-1990Vehicle-Mounted Elevating and Rotating Aerial Devices ANSI/SIA A92.3...

DEVELOPMENT OF A NATIONAL CONSENSUS STANDARD FOR QUALITY ASSURANCE FOR ENVIRONMENTAL PROGRAMS

EPA Science Inventory

Decisions on where and how to clean-up Federally-owned facilities contaminated by mixtures of hazardous chemical and radioactive wastes requires that quality environmental data be obtained. he Federal Government currently using several different standards or sets of requirements ...

Consensus statement for standard of care in spinal muscular atrophy.

PubMed

Wang, Ching H; Finkel, Richard S; Bertini, Enrico S; Schroth, Mary; Simonds, Anita; Wong, Brenda; Aloysius, Annie; Morrison, Leslie; Main, Marion; Crawford, Thomas O; Trela, Anthony

2007-08-01

Spinal muscular atrophy is a neurodegenerative disease that requires multidisciplinary medical care. Recent progress in the understanding of molecular pathogenesis of spinal muscular atrophy and advances in medical technology have not been matched by similar developments in the care for spinal muscular atrophy patients. Variations in medical practice coupled with differences in family resources and values have resulted in variable clinical outcomes that are likely to compromise valid measure of treatment effects during clinical trials. The International Standard of Care Committee for Spinal Muscular Atrophy was formed in 2005, with a goal of establishing practice guidelines for clinical care of these patients. The 12 core committee members worked with more than 60 spinal muscular atrophy experts in the field through conference calls, e-mail communications, a Delphi survey, and 2 in-person meetings to achieve consensus on 5 care areas: diagnostic/new interventions, pulmonary, gastrointestinal/nutrition, orthopedics/rehabilitation, and palliative care. Consensus was achieved on several topics related to common medical problems in spinal muscular atrophy, diagnostic strategies, recommendations for assessment and monitoring, and therapeutic interventions in each care area. A consensus statement was drafted to address the 5 care areas according to 3 functional levels of the patients: nonsitter, sitter, and walker. The committee also identified several medical practices lacking consensus and warranting further investigation. It is the authors' intention that this document be used as a guideline, not as a practice standard for their care. A practice standard for spinal muscular atrophy is urgently needed to help with the multidisciplinary care of these patients.

A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society.

PubMed

Doggweiler, Regula; Whitmore, Kristene E; Meijlink, Jane M; Drake, Marcus J; Frawley, Helena; Nordling, Jørgen; Hanno, Philip; Fraser, Matthew O; Homma, Yukio; Garrido, Gustavo; Gomes, Mario J; Elneil, Sohier; van de Merwe, Joop P; Lin, Alex T L; Tomoe, Hikaru

2017-04-01

Terms used in the field of chronic pelvic pain (CPP) are poorly defined and often confusing. An International Continence Society (ICS) Standard for Terminology in chronic pelvic pain syndromes (CPPS) has been developed with the aim of improving diagnosis and treatment of patients affected by chronic pelvic pain syndromes. The standard aims to facilitate research, enhance therapy development and support healthcare delivery, for healthcare providers, and patients. This document looks at the whole person and all the domains (organ systems) in a systematic way. A dedicated working group (WG) was instituted by the ICS Standardisation Steering Committee according to published procedures. The WG extracted information from existing relevant guidelines, consensus documents, and scientific publications. Medline and other databases were searched in relation to each chronic pelvic pain domain from 1980 to 2014. Existing ICS Standards for terminology were utilized where appropriate to ensure transparency, accessibility, flexibility, and evolution. Consensus was based on majority agreement. The multidisciplinary CPPS Standard reports updated consensus terminology in nine domains; lower urinary tract, female genital, male genital, gastrointestinal, musculoskeletal, neurological aspects, psychological aspects, sexual aspects, and comorbidities. Each is described in terms of symptoms, signs and further evaluation. The document presents preferred terms and definitions for symptoms, signs, and evaluation (diagnostic work-up) of female and male patients with chronic pelvic pain syndromes, serving as a platform for ongoing development in this field. Neurourol. Urodynam. 36:984-1008, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

CONSENSUS TREATMENT PLANS FOR INDUCTION THERAPY OF NEWLY-DIAGNOSED PROLIFERATIVE LUPUS NEPHRITIS IN JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS

PubMed Central

Mina, Rina; von Scheven, Emily; Ardoin, Stacy P.; Eberhard, B. Anne; Punaro, Marilynn; Ilowite, Norman; Hsu, Joyce; Klein-Gitelman, Marisa; Moorthy, L. Nandini; Muscal, Eyal; Radhakrishna, Suhas M.; Wagner-Weiner, Linda; Adams, Matthew; Blier, Peter; Buckley, Lenore; Chalom, Elizabeth; Chédeville, Gaëlle; Eichenfield, Andrew; Fish, Natalya; Henrickson, Michael; Hersh, Aimee O.; Hollister, Roger; Jones, Olcay; Jung, Lawrence; Levy, Deborah; Lopez-Benitez, Jorge; McCurdy, Deborah; Miettunen, Paivi M.; Quintero-Del Rio, Ana I.; Rothman, Deborah; Rullo, Ornella; Ruth, Natasha; Schanberg, Laura E.; Silverman, Earl; Singer, Nora G.; Soep, Jennifer; MBBS, Reema Syed; Vogler, Larry B.; Yalcindag, Ali; Yildirim-Toruner, Cagri; Wallace, Carol A.; Brunner, Hermine I.

2012-01-01

Objective To formulate consensus treatment plans (CTPs) for induction therapy of newly-diagnosed proliferative lupus nephritis (LN) in juvenile systemic lupus erythematosus (jSLE). Methods A structured consensus formation process was employed by the members of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) after considering the existing medical evidence and current treatment approaches. Results After an initial Delphi survey (response rate 70%), a 2-day consensus conference, and two follow-up Delphi surveys (response rates 63–79%), consensus was achieved for a limited set of CTPs addressing the induction therapy of proliferative LN. These CTPs were developed for prototypic patients defined by eligibility characteristics, and included immunosuppressive therapy with either mycophenolic acid orally twice per day, or intravenous cyclophosphamide once per month at standardized doses for six months. Additionally, the CTPs describe three options for standardized use of glucocorticoids; including a primarily oral, a mixed oral/intravenous, and a primarily intravenous regimen. There was consensus on measures of effectiveness and safety of the CTPs. The CTPs were well accepted by the pediatric rheumatology providers treating children with LN, and up to 300 children per year in North America are expected to be candidates for the treatment with the CTPs. Conclusion CTPs for induction therapy of proliferative LN in jSLE based on the available scientific evidence and pediatric rheumatology group experience have been developed. Consistent use of the CTPs may improve the prognosis of proliferative LN, and support the conduct of comparative effectiveness studies aimed at optimizing therapeutic strategies for proliferative LN in jSLE. PMID:22162255

Toward an International Classification of Functioning, Disability and Health clinical data collection tool: the Italian experience of developing simple, intuitive descriptions of the Rehabilitation Set categories.

PubMed

Selb, Melissa; Gimigliano, Francesca; Prodinger, Birgit; Stucki, Gerold; Pestelli, Germano; Iocco, Maurizio; Boldrini, Paolo

2017-04-01

As part of international efforts to develop and implement national models including the specification of ICF-based clinical data collection tools, the Italian rehabilitation community initiated a project to develop simple, intuitive descriptions of the ICF Rehabilitation Set, highlighting the core concept of each category in user-friendly language. This paper outlines the Italian experience in developing simple, intuitive descriptions of the ICF Rehabilitation Set as an ICF-based clinical data collection tool for Italy. Consensus process. Expert conference. Multidisciplinary group of rehabilitation professionals. The first of a two-stage consensus process involved developing an initial proposal for simple, intuitive descriptions of each ICF Rehabilitation Set category based on descriptions generated in a similar process in China. Stage two involved a consensus conference. Divided into three working groups, participants discussed and voted (vote A) whether the initially proposed descriptions of each ICF Rehabilitation Set category was simple and intuitive enough for use in daily practice. Afterwards the categories with descriptions considered ambiguous i.e. not simple and intuitive enough, were divided among the working groups, who were asked to propose a new description for the allocated categories. These proposals were then voted (vote B) on in a plenary session. The last step of the consensus conference required each working group to develop a new proposal for each and the same categories with descriptions still considered ambiguous. Participants then voted (final vote) for which of the three proposed descriptions they preferred. Nineteen clinicians from diverse rehabilitation disciplines from various regions of Italy participated in the consensus process. Three ICF categories already achieved consensus in vote A, while 20 ICF categories were accepted in vote B. The remaining 7 categories were decided in the final vote. The findings were discussed in light of current efforts toward developing strategies for ICF implementation, specifically for the application of an ICF-based clinical data collection tool, not only for Italy but also for the rest of Europe. Promising as minimal standards for monitoring the impact of interventions and for standardized reporting of functioning as a relevant outcome in rehabilitation.

Consensus on best practice standards for Fracture Liaison Service in the Asia-Pacific region.

PubMed

Chan, Ding-Cheng Derrick; Chang, Lo-Yu; Akesson, Kristina E; Mitchell, Paul; Chen, Chung-Hwan; Michael Lewiecki, E; Lee, Joon Kiong; Lau, Tang Ching; Songpatanasilp, Thawee; Lee, Kin Bong; Kim, Kwang Joon; Chen, Jung-Fu; Huang, Ko-En; Gau, Yih-Lan; Chang, Yin-Fan; Ebeling, Peter; Xia, Weibo; Yu, Wei; Suzuki, Atsushi; Hew, Fen Lee; Mercado-Asis, Leilani B; Chung, Yoon-Sok; Tsai, Keh-Sung; Lin, Gau-Tyan; Yang, Rong-Sen; Wu, Chih-Hsing

2018-05-12

The Fracture Liaison Service (FLS) Consensus Meeting endorsed by the International Osteoporosis Foundation (IOF), Asian Federation of Osteoporosis Societies (AFOS), and Asia Pacific Osteoporosis Foundation (APOF) was hosted by the Taiwanese Osteoporosis Association on October 14, 2017. International and domestic experts reviewed the 13 Best Practice Framework (BPF) standards and concluded that all standards were generally applicable in the Asia-Pacific region and needed only minor modifications to fit the healthcare settings in the region. To review and generate consensus on best practices of fracture liaison service (FLS) in the Asia-Pacific (AP) region. In October 2017, the Taiwanese Osteoporosis Association (TOA) invited experts from the AP region (n = 23), the Capture the Fracture Steering Committee (n = 2), and the USA (n = 1) to join the AP region FLS Consensus Meeting in Taipei. After two rounds of consensus generation, the recommendations on the 13 Best Practice Framework (BPF) standards were reported and reviewed by the attendees. Experts unable to attend the on-site meeting reviewed the draft, made suggestions, and approved the final version. Because the number of FLSs in the region is rapidly increasing, experts agreed that it was timely to establish consensus on benchmark quality standards for FLSs in the region. They also agreed that the 13 BPF standards and the 3 levels of standards were generally applicable, but that some clarifications were necessary. They suggested, for example, that patient and family education be incorporated into the current standards and that communication with the public to promote FLSs be increased. The consensus on the 13 BPF standards reviewed in this meeting was that they were generally applicable and required only a few advanced clarifications to increase the quality of FLSs in the region.

48 CFR 52.211-7 - Alternatives to Government-unique standards.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Alternatives to Government... Government-unique standards. The offeror may propose voluntary consensus standards that meet the Government's... voluntary consensus standard instead of the Government-unique standard if it meets the Government's...

29 CFR 1910.1 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 5 2010-07-01 2010-07-01 false Purpose and scope. 1910.1 Section 1910.1 Labor Regulations... consensus standard, and any established Federal standard, unless he determines that the promulgation of such... national consensus standards or established Federal standards. ...

48 CFR 11.201 - Identification and availability of specifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Identification and... nongovernment standards, including voluntary consensus standards, from the National Technical Information... obtain from the DoDSSP those nongovernment standards, including voluntary consensus standards, adopted...

[Reflection of the evidence-based medicine's principles in the Russian consensus documents on angiology and vascular surgery].

PubMed

Pokrovskiĭ, A V; Sapelkin, S V

2009-01-01

Analysed herein are the consensus documents concerning angiology and vascular surgery worked out and adopted in Russia. This is followed by a detailed description of the methodology used while their development, underlying their significance for medical practice and pointing out their strict compliance with the principles of evidence-based medicine. Emphasis is laid on the thesis that the consensus guidelines worked out by the leading specialists, like any rules and norms, contribute favourably to making appropriate decisions by the practicing clinical physicians and may serve as a basis for creation of the branch standards. Also shown are advantages and shortcomings of the adopted documents in angiology, including phlebology, and finally announced is a forthcoming meeting of the Russian experts, devoted to the development of the consensus document entitled "Russian Clinical Guidelines on Diagnosis and Treatment of Chronic Venous Diseases".

Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging.

PubMed

Badano, Luigi P; Kolias, Theodore J; Muraru, Denisa; Abraham, Theodore P; Aurigemma, Gerard; Edvardsen, Thor; D'Hooge, Jan; Donal, Erwan; Fraser, Alan G; Marwick, Thomas; Mertens, Luc; Popescu, Bogdan A; Sengupta, Partho P; Lancellotti, Patrizio; Thomas, James D; Voigt, Jens-Uwe

2018-03-27

The EACVI/ASE/Industry Task Force to standardize deformation imaging prepared this consensus document to standardize definitions and techniques for using two-dimensional (2D) speckle tracking echocardiography (STE) to assess left atrial, right ventricular, and right atrial myocardial deformation. This document is intended for both the technical engineering community and the clinical community at large to provide guidance on selecting the functional parameters to measure and how to measure them using 2D STE.This document aims to represent a significant step forward in the collaboration between the scientific societies and the industry since technical specifications of the software packages designed to post-process echocardiographic datasets have been agreed and shared before their actual development. Hopefully, this will lead to more clinically oriented software packages which will be better tailored to clinical needs and will allow industry to save time and resources in their development.

Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development.

PubMed

Smith, Roger; Patel, Vipul; Satava, Richard

2014-09-01

There is a need for a standardized curriculum for training and assessment of robotic surgeons to proficiency, followed by high-stakes testing (HST) for certification. To standardize the curriculum and certification of robotic surgeons, a series of consensus conferences attended by 14 leading international surgical societies have been used to compile the outcomes measures and curriculum that should form the basis for a Fundamentals of Robotic Surgery (FRS) programme. A set of 25 outcomes measures and a curriculum for teaching the skills needed to safely use current generation surgical robotic systems has been developed and accepted by a committee of experienced robotic surgeons across 14 specialties. A standardized process for certifying the skills of a robotic surgeon has begun to emerge. The work described here documents both the processes used for developing educational material and the educational content of a robotic curriculum. Copyright © 2013 John Wiley & Sons, Ltd.

Structure and Functions of Pediatric Aerodigestive Programs: A Consensus Statement.

PubMed

Boesch, R Paul; Balakrishnan, Karthik; Acra, Sari; Benscoter, Dan T; Cofer, Shelagh A; Collaco, Joseph M; Dahl, John P; Daines, Cori L; DeAlarcon, Alessandro; DeBoer, Emily M; Deterding, Robin R; Friedlander, Joel A; Gold, Benjamin D; Grothe, Rayna M; Hart, Catherine K; Kazachkov, Mikhail; Lefton-Greif, Maureen A; Miller, Claire Kane; Moore, Paul E; Pentiuk, Scott; Peterson-Carmichael, Stacey; Piccione, Joseph; Prager, Jeremy D; Putnam, Philip E; Rosen, Rachel; Rutter, Michael J; Ryan, Matthew J; Skinner, Margaret L; Torres-Silva, Cherie; Wootten, Christopher T; Zur, Karen B; Cotton, Robin T; Wood, Robert E

2018-02-07

Aerodigestive programs provide coordinated interdisciplinary care to pediatric patients with complex congenital or acquired conditions affecting breathing, swallowing, and growth. Although there has been a proliferation of programs, as well as national meetings, interest groups and early research activity, there is, as of yet, no consensus definition of an aerodigestive patient, standardized structure, and functions of an aerodigestive program or a blueprint for research prioritization. The Delphi method was used by a multidisciplinary and multi-institutional panel of aerodigestive providers to obtain consensus on 4 broad content areas related to aerodigestive care: (1) definition of an aerodigestive patient, (2) essential construct and functions of an aerodigestive program, (3) identification of aerodigestive research priorities, and (4) evaluation and recognition of aerodigestive programs and future directions. After 3 iterations of survey, consensus was obtained by either a supermajority of 75% or stability in median ranking on 33 of 36 items. This included a standard definition of an aerodigestive patient, level of participation of specific pediatric disciplines in a program, essential components of the care cycle and functions of the program, feeding and swallowing assessment and therapy, procedural scope and volume, research priorities and outcome measures, certification, coding, and funding. We propose the first consensus definition of the aerodigestive care model with specific recommendations regarding associated personnel, infrastructure, research, and outcome measures. We hope that this may provide an initial framework to further standardize care, develop clinical guidelines, and improve outcomes for aerodigestive patients. Copyright © 2018 by the American Academy of Pediatrics.

Sentinel node biopsy for prostate cancer: report from a consensus panel meeting.

PubMed

van der Poel, Henk G; Wit, Esther M; Acar, Cenk; van den Berg, Nynke S; van Leeuwen, Fijs W B; Valdes Olmos, Renato A; Winter, Alexander; Wawroschek, Friedhelm; Liedberg, Fredrik; Maclennan, Steven; Lam, Thomas

2017-08-01

To explore the evidence and knowledge gaps in sentinel node biopsy (SNB) in prostate cancer through a consensus panel of experts. A two-round Delphi survey among experts was followed by a consensus panel meeting of 16 experts in February 2016. Agreement voting was performed using the research and development project/University of California, Los Angeles Appropriateness Methodology on 150 statements in nine domains. The disagreement index based on the interpercentile range, adjusted for symmetry score, was used to assess consensus and non-consensus among panel members. Consensus was obtained on 91 of 150 statements (61%). The main outcomes were: (1) the results from an extended lymph node dissection (eLND) are still considered the 'gold standard', and sentinel node (SN) detection should be combined with eLND, at least in patients with intermediate- and high-risk prostate cancer; (2) the role of SN detection in low-risk prostate cancer is unclear; and (3) future studies should contain oncological endpoints as number of positive nodes outside the eLND template, false-negative and false-positive SN procedures, and recurrence-free survival. A high rate of consensus was obtained regarding outcome measures of future clinical trials on SNB (89%). Consensus on tracer technology was only obtained in 47% of statements, reflecting a need for further research and standardization in this area. The low-level evidence in the available literature and the composition of mainly SNB users in the panel constitute the major limitations of the study. Consensus on a majority of elementary statements on SN detection in prostate cancer was obtained.; therefore, the results from this consensus report will provide a basis for the design of further studies in the field. A group of experts identified evidence and knowledge gaps on SN detection in prostate cancer and its application in daily practice. Information from the consensus statements can be used to direct further studies. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

The development of a decision aid for tinnitus.

PubMed

Pryce, Helen; Durand, Marie-Anne; Hall, Amanda; Shaw, Rachel; Culhane, Beth-Anne; Swift, Sarah; Straus, Jean; Marks, Elizabeth; Ward, Melanie; Chilvers, Katie

2018-05-09

To develop a decision aid for tinnitus care that would meet international consensus for decision aid quality. A mixed methods design that included qualitative in-depth interviews, literature review, focus groups, user testing and readability checking. Patients and clinicians who have clinical experience of tinnitus. A decision aid for tinnitus care was developed. This incorporates key evidence of efficacy for the most frequently used tinnitus care options, together with information derived from patient priorities when deciding which choice to make. The decision aid has potential to enable shared decision making between clinicians and patients in audiology. The decision aid meets consensus standards.

CSE database: extended annotations and new recommendations for ECG software testing.

PubMed

Smíšek, Radovan; Maršánová, Lucie; Němcová, Andrea; Vítek, Martin; Kozumplík, Jiří; Nováková, Marie

2017-08-01

Nowadays, cardiovascular diseases represent the most common cause of death in western countries. Among various examination techniques, electrocardiography (ECG) is still a highly valuable tool used for the diagnosis of many cardiovascular disorders. In order to diagnose a person based on ECG, cardiologists can use automatic diagnostic algorithms. Research in this area is still necessary. In order to compare various algorithms correctly, it is necessary to test them on standard annotated databases, such as the Common Standards for Quantitative Electrocardiography (CSE) database. According to Scopus, the CSE database is the second most cited standard database. There were two main objectives in this work. First, new diagnoses were added to the CSE database, which extended its original annotations. Second, new recommendations for diagnostic software quality estimation were established. The ECG recordings were diagnosed by five new cardiologists independently, and in total, 59 different diagnoses were found. Such a large number of diagnoses is unique, even in terms of standard databases. Based on the cardiologists' diagnoses, a four-round consensus (4R consensus) was established. Such a 4R consensus means a correct final diagnosis, which should ideally be the output of any tested classification software. The accuracy of the cardiologists' diagnoses compared with the 4R consensus was the basis for the establishment of accuracy recommendations. The accuracy was determined in terms of sensitivity = 79.20-86.81%, positive predictive value = 79.10-87.11%, and the Jaccard coefficient = 72.21-81.14%, respectively. Within these ranges, the accuracy of the software is comparable with the accuracy of cardiologists. The accuracy quantification of the correct classification is unique. Diagnostic software developers can objectively evaluate the success of their algorithm and promote its further development. The annotations and recommendations proposed in this work will allow for faster development and testing of classification software. As a result, this might facilitate cardiologists' work and lead to faster diagnoses and earlier treatment.

Childhood Arthritis and Rheumatology Research Alliance consensus clinical treatment plans for juvenile dermatomyositis with skin predominant disease.

PubMed

Kim, Susan; Kahn, Philip; Robinson, Angela B; Lang, Bianca; Shulman, Andrew; Oberle, Edward J; Schikler, Kenneth; Curran, Megan Lea; Barillas-Arias, Lilliana; Spencer, Charles H; Rider, Lisa G; Huber, Adam M

2017-01-11

Juvenile dermatomyositis (JDM) is the most common form of the idiopathic inflammatory myopathies in children. A subset of children have the rash of JDM without significant weakness, and the optimal treatments for these children are unknown. The goal of this study was to describe the development of consensus clinical treatment plans (CTPs) for children with JDM who have active skin rashes, without significant muscle involvement, referred to as skin predominant JDM in this manuscript. The Children's Arthritis and Rheumatology Research Alliance (CARRA) is a North American consortium of pediatric rheumatology health care providers. CARRA members collaborated to determine consensus on typical treatments for JDM patients with skin findings without significant weakness, to develop CTPs for this subgroup of patients. We used a combination of Delphi surveys and nominal group consensus meetings to develop these CTPs. Consensus was reached on patient characteristics and outcome assessment, and CTPs were developed and finalized for patients with skin predominant JDM. Treatment option A included hydroxychloroquine alone, Treatment option B included hydroxychloroquine and methotrexate, and Treatment option C included hydroxychloroquine, methotrexate and corticosteroids. Three CTPs were developed for use in children with skin predominant JDM, which reflect typical treatment approaches. These are not considered to be specific recommendations or standard of care. Using the CARRA network and prospective data collection, we will be able to apply statistical methods in the future to allow comparisons of JDM patients following these consensus treatment plans.

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

Probabilistic consensus scoring improves tandem mass spectrometry peptide identification.

PubMed

Nahnsen, Sven; Bertsch, Andreas; Rahnenführer, Jörg; Nordheim, Alfred; Kohlbacher, Oliver

2011-08-05

Database search is a standard technique for identifying peptides from their tandem mass spectra. To increase the number of correctly identified peptides, we suggest a probabilistic framework that allows the combination of scores from different search engines into a joint consensus score. Central to the approach is a novel method to estimate scores for peptides not found by an individual search engine. This approach allows the estimation of p-values for each candidate peptide and their combination across all search engines. The consensus approach works better than any single search engine across all different instrument types considered in this study. Improvements vary strongly from platform to platform and from search engine to search engine. Compared to the industry standard MASCOT, our approach can identify up to 60% more peptides. The software for consensus predictions is implemented in C++ as part of OpenMS, a software framework for mass spectrometry. The source code is available in the current development version of OpenMS and can easily be used as a command line application or via a graphical pipeline designer TOPPAS.

Ultracapacitors for automotive applications

NASA Astrophysics Data System (ADS)

Ashtiani, Cyrus; Wright, Randy; Hunt, Gary

In response to a growing consensus in the auto industry that ultracapacitors can potentially play a key role in the modern vehicle power distribution network, a task force was created at the United States Advanced Battery Consortium (USABC) to tackle issues facing the fledging industry. The task force embarked on first developing and establishing standards for performance and abuse tolerance of ultracapacitors in collaboration with the U.S. Department of Energy and National Labs. Subsequently, potential applications in the automotive industry were identified and a consensus requirement specification was drawn as a development guide for the industry.

Oncology Gold Standard™ practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma.

PubMed

Batra, U; Parikh, P M; Prabhash, K; Tongaonkar, H B; Chibber, P; Dabkara, D; Deshmukh, C; Ghadyalpatil, N; Hingmire, S; Joshi, A; Raghunath, S K; Rajappa, S; Rajendranath, R; Rawal, S K; Singh, Manisha; Singh, R; Somashekhar, S P; Sood, R

2016-01-01

The Oncology Gold Standard (OGS) Expert Group on renal cell carcinoma (RCC) developed the consensus statement to provide community oncologists practical guidelines on the management of advanced clear cell (cc) RCC using published evidence, practical experience of experts in real life management, and results of a nationwide survey involving 144 health-care professionals. Six broad question categories containing 33 unique questions cover major situations in the routine management of RCC. This document serves as a ready guide for the standard of care to optimize outcome. The table of "Take Home Messages" at the end is a convenient tool for busy practitioners.

The Use of the Delphi and Other Consensus Group Methods in Medical Education Research: A Review.

PubMed

Humphrey-Murto, Susan; Varpio, Lara; Wood, Timothy J; Gonsalves, Carol; Ufholz, Lee-Anne; Mascioli, Kelly; Wang, Carol; Foth, Thomas

2017-10-01

Consensus group methods, such as the Delphi method and nominal group technique (NGT), are used to synthesize expert opinions when evidence is lacking. Despite their extensive use, these methods are inconsistently applied. Their use in medical education research has not been well studied. The authors set out to describe the use of consensus methods in medical education research and to assess the reporting quality of these methods and results. Using scoping review methods, the authors searched the Medline, Embase, PsycInfo, PubMed, Scopus, and ERIC databases for 2009-2016. Full-text articles that focused on medical education and the keywords Delphi, RAND, NGT, or other consensus group methods were included. A standardized extraction form was used to collect article demographic data and features reflecting methodological rigor. Of the articles reviewed, 257 met the inclusion criteria. The Modified Delphi (105/257; 40.8%), Delphi (91/257; 35.4%), and NGT (23/257; 8.9%) methods were most often used. The most common study purpose was curriculum development or reform (68/257; 26.5%), assessment tool development (55/257; 21.4%), and defining competencies (43/257; 16.7%). The reporting quality varied, with 70.0% (180/257) of articles reporting a literature review, 27.2% (70/257) reporting what background information was provided to participants, 66.1% (170/257) describing the number of participants, 40.1% (103/257) reporting if private decisions were collected, 37.7% (97/257) reporting if formal feedback of group ratings was shared, and 43.2% (111/257) defining consensus a priori. Consensus methods are poorly standardized and inconsistently used in medical education research. Improved criteria for reporting are needed.

Standardizing terms for clinical pharmacogenetic test results: consensus terms from the Clinical Pharmacogenetics Implementation Consortium (CPIC)

PubMed Central

Caudle, Kelly E.; Dunnenberger, Henry M.; Freimuth, Robert R.; Peterson, Josh F.; Burlison, Jonathan D.; Whirl-Carrillo, Michelle; Scott, Stuart A.; Rehm, Heidi L.; Williams, Marc S.; Klein, Teri E.; Relling, Mary V.; Hoffman, James M.

2017-01-01

Introduction: Reporting and sharing pharmacogenetic test results across clinical laboratories and electronic health records is a crucial step toward the implementation of clinical pharmacogenetics, but allele function and phenotype terms are not standardized. Our goal was to develop terms that can be broadly applied to characterize pharmacogenetic allele function and inferred phenotypes. Materials and methods: Terms currently used by genetic testing laboratories and in the literature were identified. The Clinical Pharmacogenetics Implementation Consortium (CPIC) used the Delphi method to obtain a consensus and agree on uniform terms among pharmacogenetic experts. Results: Experts with diverse involvement in at least one area of pharmacogenetics (clinicians, researchers, genetic testing laboratorians, pharmacogenetics implementers, and clinical informaticians; n = 58) participated. After completion of five surveys, a consensus (>70%) was reached with 90% of experts agreeing to the final sets of pharmacogenetic terms. Discussion: The proposed standardized pharmacogenetic terms will improve the understanding and interpretation of pharmacogenetic tests and reduce confusion by maintaining consistent nomenclature. These standard terms can also facilitate pharmacogenetic data sharing across diverse electronic health care record systems with clinical decision support. Genet Med 19 2, 215–223. PMID:27441996

Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group.

PubMed

Rodeghiero, Francesco; Stasi, Roberto; Gernsheimer, Terry; Michel, Marc; Provan, Drew; Arnold, Donald M; Bussel, James B; Cines, Douglas B; Chong, Beng H; Cooper, Nichola; Godeau, Bertrand; Lechner, Klaus; Mazzucconi, Maria Gabriella; McMillan, Robert; Sanz, Miguel A; Imbach, Paul; Blanchette, Victor; Kühne, Thomas; Ruggeri, Marco; George, James N

2009-03-12

Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.

Development of a clinical definition for acute respiratory distress syndrome using the Delphi technique.

PubMed

Ferguson, Niall D; Davis, Aileen M; Slutsky, Arthur S; Stewart, Thomas E

2005-06-01

The objective of this study is to describe the implementation of formal consensus techniques in the development of a clinical definition for acute respiratory distress syndrome. A Delphi consensus process was conducted using e-mail. Sixteen panelists who were both researchers and opinion leaders were systematically recruited. The Delphi technique was performed over 4 rounds on the background of an explicit definition framework. Item generation was performed in round 1, item reduction in rounds 2 and 3, and definition evaluation in round 4. Explicit consensus thresholds were used throughout. Of the 16 panelists, 11 actually participated in developing a definition that met a priori consensus rules on the third iteration. New incorporations in the Delphi definition include the use of a standardized oxygenation assessment and the documentation of either a predisposing factor or decreased thoracic compliance. The panelists rated the Delphi definition as acceptable to highly acceptable (median score, 6; range, 5-7 on a 7-point Likert scale). We conclude that it is feasible to consider using formal consensus in the development of future definitions of acute respiratory distress syndrome. Testing of sensibility, reliability, and validity are needed for this preliminary definition; these test results should be incorporated into future iterations of this definition.

Vitamin D measurement standardization: the way out of the chaos

USDA-ARS?s Scientific Manuscript database

Substantial variability is associated with laboratory measurement of serum total 25-hydroxyvitamin D [25(OH)D]. The resulting chaos impedes development of consensus 25(OH)D values to define stages of vitamin D status. As resolving this situation requires standardized measurement of 25(OH)D, the Vita...

From Crisis to Consensus. Setting Standards in Chicago.

ERIC Educational Resources Information Center

Barth, Patte

1994-01-01

In 1993 the Council for Basic Education assisted in the drafting of academic standards for the students of the Chicago (Illinois) Public Schools. The results of this project, the Chicago Learning Outcomes, are now the official basis for designing new curricula, citywide assessments, and professional development throughout the district. The Chicago…

International Society for Heart and Lung Transplantation working formulation of a standardized nomenclature for cardiac allograft vasculopathy-2010.

PubMed

Mehra, Mandeep R; Crespo-Leiro, Maria G; Dipchand, Anne; Ensminger, Stephan M; Hiemann, Nicola E; Kobashigawa, Jon A; Madsen, Joren; Parameshwar, Jayan; Starling, Randall C; Uber, Patricia A

2010-07-01

The development of cardiac allograft vasculopathy remains the Achilles heel of cardiac transplantation. Unfortunately, the definitions of cardiac allograft vasculopathy are diverse, and there are no uniform international standards for the nomenclature of this entity. This consensus document, commissioned by the International Society of Heart and Lung Transplantation Board, is based on best evidence and clinical consensus derived from critical analysis of available information pertaining to angiography, intravascular ultrasound imaging, microvascular function, cardiac allograft histology, circulating immune markers, non-invasive imaging tests, and gene-based and protein-based biomarkers. This document represents a working formulation for an international nomenclature of cardiac allograft vasculopathy, similar to the development of the system for adjudication of cardiac allograft rejection by histology.

77 FR 68717 - Updating OSHA Standards Based on National Consensus Standards; Head Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

..., 1918, and 1926 [Docket No. OSH-2011-0184] RIN 1218-AC65 Updating OSHA Standards Based on National Consensus Standards; Head Protection AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Proposed rule; withdrawal. SUMMARY: With this notice, OSHA is withdrawing the proposed rule that...

77 FR 68684 - Updating OSHA Standards Based on National Consensus Standards; Head Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

..., 1918, and 1926 [Docket No. OSHA-2011-0184] RIN 1218-AC65 Updating OSHA Standards Based on National Consensus Standards; Head Protection AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Final rule; confirmation of effective date. SUMMARY: OSHA is confirming the effective date of its...

Improving Patient Safety in Public Hospitals: Developing Standard Measures to Track Medical Errors and Process Breakdowns.

PubMed

Ackerman, Sara L; Gourley, Gato; Le, Gem; Williams, Pamela; Yazdany, Jinoos; Sarkar, Urmimala

2018-03-14

The aim of the study was to develop standards for tracking patient safety gaps in ambulatory care in safety net health systems. Leaders from five California safety net health systems were invited to participate in a modified Delphi process sponsored by the Safety Promotion Action Research and Knowledge Network (SPARKNet) and the California Safety Net Institute in 2016. During each of the three Delphi rounds, the feasibility and validity of 13 proposed patient safety measures were discussed and prioritized. Surveys and transcripts from the meetings were analyzed to understand the decision-making process. The Delphi process included eight panelists. Consensus was reached to adopt 9 of 13 proposed measures. All 9 measures were unanimously considered valid, but concern was expressed about the feasibility of implementing several of the measures. Although safety net health systems face high barriers to standardized measurement, our study demonstrates that consensus can be reached on acceptable and feasible methods for tracking patient safety gaps in safety net health systems. If accompanied by the active participation key stakeholder groups, including patients, clinicians, staff, data system professionals, and health system leaders, the consensus measures reported here represent one step toward improving ambulatory patient safety in safety net health systems.

A Survey Examining Photopatch Test and Phototest Methodologies of Contact Dermatologists in the United States: Platform for Developing A Consensus.

PubMed

Asemota, Eseosa; Crawford, Glen; Kovarik, Carrie; Brod, Bruce A

There is currently no standardized protocol for photopatch testing and phototesting in the United States. Certain testing paramaters (such as chemicals tested, time between test application and irradiation, and time of final interpretation) vary from provider to provider. These variations may impact comparability and consistency of test results. The goal of our survey-based study was to outline the photopatch test and phototest protocols used by US contact dermatologists. The information obtained will aid in the development of a national consensus on testing methodologies. Based on a literature search conducted on differences in testing methodologies, we constructed a questionnaire. The survey was distributed at the American Contact Dermatitis Society annual meeting and via the American Contact Dermatitis Society Web site. Standard descriptive analysis was performed on data obtained. Of the 800 dermatologists contacted, 117 agreed to participate in the survey. Among these respondents, 64 (54.8%) conduct photopatch testing. Results of the survey are presented, and they confirm that a variety of techniques and testing materials are used. It would be beneficial to enlist a panel of expert contact dermatologists to create by formal consensus, using these research findings, a standard photopatch test protocol for use in this country.

Expert consensus v. evidence-based approaches in the revision of the DSM.

PubMed

Kendler, K S; Solomon, M

2016-08-01

The development of DSM-III through DSM-5 has relied heavily on expert consensus. In this essay, we provide an historical and critical perspective on this process. Over the last 40 years, medicine has struggled to find appropriate methods for summarizing research results and making clinical recommendations. When such recommendations are issued by authorized organizations, they can have widespread influence (i.e. DSM-III and its successors). In the 1970s, expert consensus conferences, led by the NIH, reviewed research about controversial medical issues and successfully disseminated results. However, these consensus conferences struggled with aggregating the complex available evidence. In the 1990s, the rise of evidence-based medicine cast doubt on the reliability of expert consensus. Since then, medicine has increasingly relied on systematic reviews, as developed by the evidence-based medicine movement, and advocated for their early incorporation in expert consensus efforts. With the partial exception of DSM-IV, such systematic evidence-based reviews have not been consistently integrated into the development of the DSMs, leaving their development out of step with the larger medical field. Like the recommendations made for the NIH consensus conferences, we argue that the DSM process should be modified to require systematic evidence-based reviews before Work Groups make their assessments. Our suggestions - which would require leadership and additional resources to set standards for appropriate evidence hierarchies, carry out systematic reviews, and upgrade the group process - should improve the objectivity of the DSM, increase the validity of its results, and improve the reception of any changes in nosology.

78 FR 66642 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... single standard is best. The ANSI Z535 designs, the traditional safety sign and tag designs, as well as... [Docket No. OSHA-2013-0005] RIN 1218-AC77 Updating OSHA Standards Based on National Consensus Standards... rule; confirmation of effective date. SUMMARY: On June 13, 2013, OSHA published in the Federal Register...

Aiming for a holistic integrated service for men diagnosed with prostate cancer - Definitions of standards and skill sets for nurses and allied healthcare professionals.

PubMed

Lamb, Alastair D; Thompson, Sue; Kinsella, Netty; Gerbitz, Ingmar; Chapman, Elaine; Putt, Lisa; Bennett, Sophie; Thankappannair, Vineetha; Geoghegan, Lisa; Wright, Naomi; Stirton-Croft, Alison; Nixon, Penny; Styling, Andrew; Whitney, Diane; Hodgson, Lindsay; Punt, Lisa; Longmore, Jenny; Carter, Mike; Petch, Bill; Rimmer, Yvonne; Russell, Simon; Hughes-Davies, Luke; Mazhar, Danish; Shah, Nimish C; Gnanapragasam, Vincent J; Doble, Andrew; Bratt, Ola; Kastner, Christof

2017-08-01

To establish a comprehensive set of recommendations for the service structure and skill set of nurses and allied healthcare professionals in prostate cancer care. Using components of formal consensus methodology, a 30-member multidisciplinary panel produced 53 items for discussion relating to the provision of care for prostate cancer patients by specialist nurses and allied healthcare professionals. Items were developed by two rounds of email correspondence in which, first, items were generated and, second, items refined to form the basis of a consensus meeting which constituted the third round of review. The fourth and final round was an email review of the consensus output. The panel agreed on 33 items that were appropriate for recommendations to be made. These items were grouped under categories of "Environment" and "Patient Pathway" and included comments on training, leadership, communication and quality assessment as well as specific items related to prostate diagnosis clinics, radical treatment clinics and follow-up survivor groups. Specialist nurses and allied healthcare professionals play a vital role alongside urologists and oncologists to provide care to men with prostate cancer and their families. We present a set of standards and consensus recommendations for the roles and skill-set required for these practitioners to provide gold-standard prostate cancer care. These recommendations could form the basis for development of comprehensive integrated prostate cancer pathways in prostate cancer centres as well as providing guidance for any units treating men with prostate cancer. Copyright © 2017. Published by Elsevier Ltd.

Hydrogen and Storage Initiatives at the NASA JSC White Sands Test Facility

NASA Technical Reports Server (NTRS)

Maes, Miguel; Woods, Stephen S.

2006-01-01

NASA WSTF Hydrogen Activities: a) Aerospace Test; b) System Certification & Verification; c) Component, System, & Facility Hazard Assessment; d) Safety Training Technical Transfer: a) Development of Voluntary Consensus Standards and Practices; b) Support of National Hydrogen Infrastructure Development.

Developing standards for the development of glaucoma virtual clinics using a modified Delphi approach.

PubMed

Kotecha, Aachal; Longstaff, Simon; Azuara-Blanco, Augusto; Kirwan, James F; Morgan, James Edwards; Spencer, Anne Fiona; Foster, Paul J

2018-04-01

To obtain consensus opinion for the development of a standards framework for the development and implementation of virtual clinics for glaucoma monitoring in the UK using a modified Delphi methodology. A modified Delphi technique was used that involved sampling members of the UK Glaucoma and Eire Society (UKEGS). The first round scored the strength of agreement to a series of standards statements using a 9-point Likert scale. The revised standards were subjected to a second round of scoring and free-text comment. The final standards were discussed and agreed by an expert panel consisting of seven glaucoma subspecialists from across the UK. A version of the standards was submitted to external stakeholders for a 3-month consultation. There was a 44% response rate of UKEGS members to rounds 1 and 2, consisting largely of consultant ophthalmologists with a specialist interest in glaucoma. The final version of the standards document was validated by stakeholder consultation and contains four sections pertaining to the patient groups, testing methods, staffing requirements and governance structure of NHS secondary care glaucoma virtual clinic models. Use of a modified Delphi approach has provided consensus agreement for the standards required for the development of virtual clinics to monitor glaucoma in the UK. It is anticipated that this document will be useful as a guide for those implementing this model of service delivery. © 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.

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

PubMed Central

Leon, Martin B.; Piazza, Nicolo; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael; Mehran, Roxana; Miller, Craig; Morel, Marie-angèle; Petersen, John; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; van Es, Gerrit-Anne; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

2011-01-01

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Conclusion Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes. PMID:21216739

Standardised neonatal parenteral nutrition formulations – an Australasian group consensus 2012

PubMed Central

2014-01-01

Standardised parenteral nutrition formulations are routinely used in the neonatal intensive care units in Australia and New Zealand. In 2010, a multidisciplinary group was formed to achieve a consensus on the formulations acceptable to majority of the neonatal intensive care units. Literature review was undertaken for each nutrient and recommendations were developed in a series of meetings held between November 2010 and April 2011. Three standard and 2 optional amino acid/dextrose formulations and one lipid emulsion were agreed by majority participants in the consensus. This has a potential to standardise neonatal parenteral nutrition guidelines, reduce costs and prescription errors. PMID:24548745

Autoimmune Retinopathy: Current Concepts and Practices (An American Ophthalmological Society Thesis).

PubMed

Sen, H Nida; Grange, Landon; Akanda, Marib; Fox, Austin

2017-08-01

To elicit and evaluate opinions in the diagnosis and management of nonparaneoplastic autoimmune retinopathy (npAIR) among members of the American Uveitis Society (AUS) and to further the development of consensus and criteria in the diagnosis and management of npAIR. We hypothesize that despite lack of any clear guidelines, a general consensus in the clinical diagnosis and treatment of npAIR exists among uveitis experts. A literature review was performed and a panel of uveitis experts was consulted to formulate a survey regarding the diagnosis and management of npAIR. An online survey of 10 questions was developed, and a link was distributed through the AUS membership discussion list. We defined "general consensus" as meaning that a majority (>50%) of the respondents provided the same answer to a question. Fifty-four members of the AUS responded to the survey. Thirty-eight members (70.4%) see one to three AIR patients per year. Greater than 50% consensus was reached on most items, particularly items relating to diagnostic features and tests (up to 96% consensus). The diagnosis and management of npAIR is challenging, as standardized clinical and laboratory diagnostic criteria have yet to be established. The results of this study support the presence of consensus regarding certain aspects of npAIR, but also indicate the need for developing clear clinical diagnostic criteria and treatment guidelines.

Childhood Arthritis and Rheumatology Research Alliance Consensus Clinical Treatment Plans for Juvenile Dermatomyositis with Persistent Skin Rash.

PubMed

Huber, Adam M; Kim, Susan; Reed, Ann M; Carrasco, Ruy; Feldman, Brian M; Hong, Sandy D; Kahn, Philip; Rahimi, Homaira; Robinson, Angela Byun; Vehe, Richard K; Weiss, Jennifer E; Spencer, Charles

2017-01-01

Juvenile dermatomyositis (JDM) is the most common form of idiopathic inflammatory myopathy in children. While outcomes are generally thought to be good, persistence of skin rash is a common problem. The goal of this study was to describe the development of clinical treatment plans (CTP) for children with JDM characterized by persistent skin rash despite complete resolution of muscle involvement. The Childhood Arthritis and Rheumatology Research Alliance, a North American consortium of pediatric rheumatologists and other healthcare providers, used a combination of Delphi surveys and nominal group consensus meetings to develop CTP that reflected consensus on typical treatments for patients with JDM with persistent skin rash. Consensus was reached on patient characteristics and outcome assessment. Patients should have previously received corticosteroids and methotrexate (MTX). Three consensus treatment plans were developed. Plan A added intravenous immunoglobulin (IVIG) if it was not already being used. Plan B added mycophenolate mofetil, while Plan C added cyclosporine. Continuation of previous treatments, including corticosteroids, MTX, and IVIG, was permitted in plans B and C. Three consensus CTP were developed for use in children with JDM and persistent skin rash despite complete resolution of muscle disease. These CTP reflect typical treatment approaches and are not to be considered treatment recommendations or standard of care. Using prospective data collection and statistical methods to account for nonrandom treatment assignment, it is expected that these CTP will be used to allow treatment comparisons, and ultimately determine the best treatment for these patients.

Development of a space universal modular architecture (SUMO)

NASA Astrophysics Data System (ADS)

Collins, Bernie F.

This concept paper proposes that the space community should develop and implement a universal standard for spacecraft modularity - to improve interoperability of spacecraft components. Pursuing a global industry consensus standard for open and modular spacecraft architecture will encourage trade, remove standards-related market barriers, and in the long run increase both value provided to customers and profitability of the space industrial sector. This concept paper sets out: (1) the goals for a SUMO standard and how it will benefit the space community; (2) background on spacecraft modularity and existing related standards; (3) the proposed technical scope of the current standardization effort; and (4) an approach for creating a SUMO standard.

European standards for protective apparel against UV radiation.

PubMed

Laperre, Jan; Foubert, Fred

2002-01-01

The first European standard which describes the test procedure to determine the UV-protection factor of clothing is about to be completed. A second part of the same standard, dealing with labelling and marking aspects, is ready to be submitted to public enquiry. In this effort a group of experts from most EU member states have cooperated with a high degree of consensus. In this chapter we explain this European standard together with the standard developed in the UK.

The National Clinical Assessment Tool for Medical Students in the Emergency Department (NCAT-EM)

PubMed Central

Jung, Julianna; Franzen, Douglas; Lawson, Luan; Manthey, David; Tews, Matthew; Dubosh, Nicole; Fisher, Jonathan; Haughey, Marianne; House, Joseph B.; Trainor, Arleigh; Wald, David A.; Hiller, Katherine

2018-01-01

Introduction Clinical assessment of medical students in emergency medicine (EM) clerkships is a highly variable process that presents unique challenges and opportunities. Currently, clerkship directors use institution-specific tools with unproven validity and reliability that may or may not address competencies valued most highly in the EM setting. Standardization of assessment practices and development of a common, valid, specialty-specific tool would benefit EM educators and students. Methods A two-day national consensus conference was held in March 2016 in the Clerkship Directors in Emergency Medicine (CDEM) track at the Council of Residency Directors in Emergency Medicine (CORD) Academic Assembly in Nashville, TN. The goal of this conference was to standardize assessment practices and to create a national clinical assessment tool for use in EM clerkships across the country. Conference leaders synthesized the literature, articulated major themes and questions pertinent to clinical assessment of students in EM, clarified the issues, and outlined the consensus-building process prior to consensus-building activities. Results The first day of the conference was dedicated to developing consensus on these key themes in clinical assessment. The second day of the conference was dedicated to discussing and voting on proposed domains to be included in the national clinical assessment tool. A modified Delphi process was initiated after the conference to reconcile questions and items that did not reach an a priori level of consensus. Conclusion The final tool, the National Clinical Assessment Tool for Medical Students in Emergency Medicine (NCAT-EM) is presented here. PMID:29383058

40 CFR 80.582 - What are the sampling and testing methods for the fuel marker?

Code of Federal Regulations, 2010 CFR

2010-07-01

... developed by a Voluntary Consensus-Based Standards Body, such as the American Society for Testing and... test method documentation, including a description of the technology and/or instrumentation that makes... this standard from the American Society for Testing and Materials, 100 Barr Harbor Dr., West...

40 CFR 80.582 - What are the sampling and testing methods for the fuel marker?

Code of Federal Regulations, 2011 CFR

2011-07-01

... developed by a Voluntary Consensus-Based Standards Body, such as the American Society for Testing and... test method documentation, including a description of the technology and/or instrumentation that makes... this standard from the American Society for Testing and Materials, 100 Barr Harbor Dr., West...

Now What? Imperatives & Options for "Common Core" Implementation & Governance

ERIC Educational Resources Information Center

Finn, Chester E., Jr.; Petrilli, Michael J.

2010-01-01

Over the past year, the nation's governors and state school chiefs have achieved laudable consensus around a set of math and English standards, developed voluntarily and without federal involvement through the Common Core State Standards Initiative (CCSSI). Most states have signed on to them. More recently, the states have again teamed up--this…

In search of consensus: Terminology for entheseal changes (EC).

PubMed

Villotte, Sébastien; Assis, Sandra; Cardoso, Francisca Alves; Henderson, Charlotte Yvette; Mariotti, Valentina; Milella, Marco; Pany-Kucera, Doris; Speith, Nivien; Wilczak, Cynthia A; Jurmain, Robert

2016-06-01

This article presents a consensus terminology for entheseal changes that was developed in English by an international team of scholars and then translated into French, Italian, Portuguese, Spanish and German. Use of a standard, neutral terminology to describe entheseal morphology will reduce misunderstandings between researchers, improve the reliability of comparisons between studies, and eliminate unwarranted etiological assumptions inherent in some of the descriptive terms presently used in the literature. Copyright © 2016 Elsevier Inc. All rights reserved.

International development of methods of analysis for the presence of products of modern biotechnology.

PubMed

Cantrill, Richard C

2008-01-01

Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.

Direct Final Rule for Technical Amendments for Marine Spark-Ignition Engines and Vessels

EPA Pesticide Factsheets

Rule published September 16, 2010 to make technical amendments to the design standard for portable marine fuel tanks. This rule incorporates safe recommended practices, developed through industry consensus.

76 FR 27925 - Requirements for Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... State Compatibility IX. Voluntary Consensus Standards X. Environmental Impact--Categorical Exclusion XI... endorsed guidance developed by the Nuclear Energy Institute (NEI) in NEI 08-01, ``Industry Guideline for...

Building Consensus on Community Standards for Reproducible Science

NASA Astrophysics Data System (ADS)

Lehnert, K. A.; Nielsen, R. L.

2015-12-01

As geochemists, the traditional model by which standard methods for generating, presenting, and using data have been generated relied on input from the community, the results of seminal studies, a variety of authoritative bodies, and has required a great deal of time. The rate of technological and related policy change has accelerated to the point that this historical model does not satisfy the needs of the community, publishers, or funders. The development of a new mechanism for building consensus raises a number of questions: Which aspects of our data are the focus of reproducibility standards? Who sets the standards? How do we subdivide the development of the consensus? We propose an open, transparent, and inclusive approach to the development of data and reproducibility standards that is organized around specific sub-disciplines and driven by the community of practitioners in those sub-disciplines. It should involve editors, program managers, and representatives of domain data facilities as well as professional societies, but avoid any single group to be the final authority. A successful example of this model is the Editors Roundtable, a cross section of editors, funders, and data facility managers that discussed and agreed on leading practices for the reporting of geochemical data in publications, including accessibility and format of the data, data quality information, and metadata and identifiers for samples (Goldstein et al., 2014). We argue that development of data and reproducibility standards needs to heavily rely on representatives from the community of practitioners to set priorities and provide perspective. Groups of editors, practicing scientists, and other stakeholders would be assigned the task of reviewing existing practices and recommending changes as deemed necessary. They would weigh the costs and benefits of changing the standards for that community, propose appropriate tools to facilitate those changes, work through the professional societies, gain community support, collect suggestions/edits, and ultimately approval and implementation through the journals. Domain data facilities such as the Interdisciplinary Earth Data Alliance (IEDA) can facilitate this process and support the groups. Goldstein et al. (2014): EarthChem Library. http://dx.doi.org/10.1594/IEDA/100426

Oncology Gold Standard™ practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

PubMed Central

Batra, U; Parikh, PM; Prabhash, K; Tongaonkar, HB; Chibber, P; Dabkara, D; Deshmukh, C; Ghadyalpatil, N; Hingmire, S; Joshi, A; Raghunath, SK; Rajappa, S; Rajendranath, R; Rawal, SK; Singh, Manisha; Singh, R; Somashekhar, SP; Sood, R

2016-01-01

The Oncology Gold Standard (OGS) Expert Group on renal cell carcinoma (RCC) developed the consensus statement to provide community oncologists practical guidelines on the management of advanced clear cell (cc) RCC using published evidence, practical experience of experts in real life management, and results of a nationwide survey involving 144 health-care professionals. Six broad question categories containing 33 unique questions cover major situations in the routine management of RCC. This document serves as a ready guide for the standard of care to optimize outcome. The table of “Take Home Messages” at the end is a convenient tool for busy practitioners. PMID:28032079

Building Consensus: Development of Best Practice Guidelines on Wrong Level Surgery in Spinal Deformity.

PubMed

Vitale, Michael; Minkara, Anas; Matsumoto, Hiroko; Albert, Todd; Anderson, Richard; Angevine, Peter; Buckland, Aaron; Cho, Samuel; Cunningham, Matthew; Errico, Thomas; Fischer, Charla; Kim, Han Jo; Lehman, Ronald; Lonner, Baron; Passias, Peter; Protopsaltis, Themistocles; Schwab, Frank; Lenke, Lawrence

Consensus-building using the Delphi and nominal group technique. To establish best practice guidelines using formal techniques of consensus building among a group of experienced spinal deformity surgeons to avert wrong-level spinal deformity surgery. Numerous previous studies have demonstrated that wrong-level spinal deformity occurs at a substantial rate, with more than half of all spine surgeons reporting direct or indirect experience operating on the wrong levels. Nevertheless, currently, guidelines to avert wrong-level spinal deformity surgery have not been developed. The Delphi process and nominal group technique were used to formally derive consensus among 16 fellowship-trained spine surgeons. Surgeons were surveyed for current practices, presented with the results of a systematic review, and asked to vote anonymously for or against item inclusion during three iterative rounds. Agreement of 80% or higher was considered consensus. Items near consensus (70% to 80% agreement) were probed in detail using the nominal group technique in a facilitated group meeting. Participants had a mean of 13.4 years of practice (range: 2-32 years) and 103.1 (range: 50-250) annual spinal deformity surgeries, with a combined total of 24,200 procedures. Consensus was reached for the creation of best practice guidelines (BPGs) consisting of 17 interventions to avert wrong-level surgery. A final checklist consisting of preoperative and intraoperative methods, including standardized vertebral-level counting and optimal imaging criteria, was supported by 100% of participants. We developed consensus-based best practice guidelines for the prevention of wrong-vertebral-level surgery. This can serve as a tool to reduce the variability in preoperative and intraoperative practices and guide research regarding the effectiveness of such interventions on the incidence of wrong-level surgery. Level V. Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

Reference materials for cellular therapeutics.

PubMed

Bravery, Christopher A; French, Anna

2014-09-01

The development of cellular therapeutics (CTP) takes place over many years, and, where successful, the developer will anticipate the product to be in clinical use for decades. Successful demonstration of manufacturing and quality consistency is dependent on the use of complex analytical methods; thus, the risk of process and method drift over time is high. The use of reference materials (RM) is an established scientific principle and as such also a regulatory requirement. The various uses of RM in the context of CTP manufacturing and quality are discussed, along with why they are needed for living cell products and the analytical methods applied to them. Relatively few consensus RM exist that are suitable for even common methods used by CTP developers, such as flow cytometry. Others have also identified this need and made proposals; however, great care will be needed to ensure any consensus RM that result are fit for purpose. Such consensus RM probably will need to be applied to specific standardized methods, and the idea that a single RM can have wide applicability is challenged. Written standards, including standardized methods, together with appropriate measurement RM are probably the most appropriate way to define specific starting cell types. The characteristics of a specific CTP will to some degree deviate from those of the starting cells; consequently, a product RM remains the best solution where feasible. Each CTP developer must consider how and what types of RM should be used to ensure the reliability of their own analytical measurements. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

77 FR 43018 - Updating OSHA Construction Standards Based on National Consensus Standards; Head Protection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

.... OSHA-2011-0184] RIN 1218-AC65 Updating OSHA Construction Standards Based on National Consensus... Health Administration (OSHA), Department of Labor. ACTION: Notice of proposed rulemaking; correction. SUMMARY: OSHA is correcting a notice of proposed rulemaking (NPRM) with regard to the construction...

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument.

PubMed

Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; Vet, Henrica C W de; Terwee, Caroline B

2016-01-19

COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

PubMed Central

Mokkink, Lidwine B.; Prinsen, Cecilia A. C.; Bouter, Lex M.; de Vet, Henrica C. W.; Terwee, Caroline B.

2016-01-01

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. PMID:26786084

Improving the Spiritual Dimension of Whole Person Care: Reaching National and International Consensus

PubMed Central

Vitillo, Robert; Hull, Sharon K.; Reller, Nancy

2014-01-01

Abstract Two conferences, Creating More Compassionate Systems of Care (November 2012) and On Improving the Spiritual Dimension of Whole Person Care: The Transformational Role of Compassion, Love and Forgiveness in Health Care (January 2013), were convened with the goals of reaching consensus on approaches to the integration of spirituality into health care structures at all levels and development of strategies to create more compassionate systems of care. The conferences built on the work of a 2009 consensus conference, Improving the Quality of Spiritual Care as a Dimension of Palliative Care. Conference organizers in 2012 and 2013 aimed to identify consensus-derived care standards and recommendations for implementing them by building and expanding on the 2009 conference model of interprofessional spiritual care and its recommendations for palliative care. The 2013 conference built on the 2012 conference to produce a set of standards and recommended strategies for integrating spiritual care across the entire health care continuum, not just palliative care. Deliberations were based on evidence that spiritual care is a fundamental component of high-quality compassionate health care and it is most effective when it is recognized and reflected in the attitudes and actions of both patients and health care providers. PMID:24842136

Core Items for a Standardized Resource Use Measure: Expert Delphi Consensus Survey.

PubMed

Thorn, Joanna C; Brookes, Sara T; Ridyard, Colin; Riley, Ruth; Hughes, Dyfrig A; Wordsworth, Sarah; Noble, Sian M; Thornton, Gail; Hollingworth, William

2018-06-01

Resource use measurement by patient recall is characterized by inconsistent methods and a lack of validation. A validated standardized resource use measure could increase data quality, improve comparability between studies, and reduce research burden. To identify a minimum set of core resource use items that should be included in a standardized adult instrument for UK health economic evaluation from a provider perspective. Health economists with experience of UK-based economic evaluations were recruited to participate in an electronic Delphi survey. Respondents were asked to rate 60 resource use items (e.g., medication names) on a scale of 1 to 9 according to the importance of the item in a generic context. Items considered less important according to predefined consensus criteria were dropped and a second survey was developed. In the second round, respondents received the median score and their own score from round 1 for each item alongside summarized comments and were asked to rerate items. A final project team meeting was held to determine the recommended core set. Forty-five participants completed round 1. Twenty-six items were considered less important and were dropped, 34 items were retained for the second round, and no new items were added. Forty-two respondents (93.3%) completed round 2, and greater consensus was observed. After the final meeting, 10 core items were selected, with further items identified as suitable for "bolt-on" questionnaire modules. The consensus on 10 items considered important in a generic context suggests that a standardized instrument for core resource use items is feasible. Copyright © 2018. Published by Elsevier Inc.

77 FR 35860 - Safety Zone; Bay Swim V, Presque Isle Bay, Erie, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... and the boating public. Discussion of Proposed Rule With the aforementioned hazards in mind, the... management systems practices) that are developed or adopted by voluntary consensus standards bodies. This...

Coordination and standardization of federal sedimentation activities

USGS Publications Warehouse

Glysson, G. Douglas; Gray, John R.

1997-01-01

- precipitation information critical to water resources management. Memorandum M-92-01 covers primarily freshwater bodies and includes activities, such as "development and distribution of consensus standards, field-data collection and laboratory analytical methods, data processing and interpretation, data-base management, quality control and quality assurance, and water- resources appraisals, assessments, and investigations." Research activities are not included.

40 CFR 80.582 - What are the sampling and testing methods for the fuel marker?

Code of Federal Regulations, 2013 CFR

2013-07-01

... marker content of distillate fuels and how will EPA qualify or decline to qualify a test method?—(1... developed by a Voluntary Consensus-Based Standards Body, such as the American Society for Testing and... this standard from the American Society for Testing and Materials, 100 Barr Harbor Dr., West...

40 CFR 80.582 - What are the sampling and testing methods for the fuel marker?

Code of Federal Regulations, 2012 CFR

2012-07-01

... marker content of distillate fuels and how will EPA qualify or decline to qualify a test method?—(1... developed by a Voluntary Consensus-Based Standards Body, such as the American Society for Testing and... this standard from the American Society for Testing and Materials, 100 Barr Harbor Dr., West...

40 CFR 80.582 - What are the sampling and testing methods for the fuel marker?

Code of Federal Regulations, 2014 CFR

2014-07-01

... marker content of distillate fuels and how will EPA qualify or decline to qualify a test method?—(1... developed by a Voluntary Consensus-Based Standards Body, such as the American Society for Testing and... this standard from the American Society for Testing and Materials, 100 Barr Harbor Dr., West...

Laser safety: regulations, standards, and recommendations

NASA Astrophysics Data System (ADS)

Smalley, Penny J.

1993-07-01

All healthcare professionals involved in the delivery of laser technology to patients, must develop and monitor clinical laser safety programs that ensure compliance with national, state, and local regulations, professional standards of practice, and national consensus standards. Laser safe treatment environments for patients and for personnel can be established and maintained through understanding the impact of both regulatory and advisory guidelines, comprehensive program planning, appropriate continuing education, and routine safety audits.

Development of a standardized training course for laparoscopic procedures using Delphi methodology.

PubMed

Bethlehem, Martijn S; Kramp, Kelvin H; van Det, Marc J; ten Cate Hoedemaker, Henk O; Veeger, Nicolaas J G M; Pierie, Jean Pierre E N

2014-01-01

Content, evaluation, and certification of laparoscopic skills and procedure training lack uniformity among different hospitals in The Netherlands. Within the process of developing a new regional laparoscopic training curriculum, a uniform and transferrable curriculum was constructed for a series of laparoscopic procedures. The aim of this study was to determine regional expert consensus regarding the key steps for laparoscopic appendectomy and cholecystectomy using Delphi methodology. Lists of suggested key steps for laparoscopic appendectomy and cholecystectomy were created using surgical textbooks, available guidelines, and local practice. A total of 22 experts, working for teaching hospitals throughout the region, were asked to rate the suggested key steps for both procedures on a Likert scale from 1-5. Consensus was reached with Crohnbach's α ≥ 0.90. Of the 22 experts, 21 completed and returned the survey (95%). Data analysis already showed consensus after the first round of Delphi on the key steps for laparoscopic appendectomy (Crohnbach's α = 0.92) and laparoscopic cholecystectomy (Crohnbach's α = 0.90). After the second round, 15 proposed key steps for laparoscopic appendectomy and 30 proposed key steps for laparoscopic cholecystectomy were rated as important (≥4 by at least 80% of the expert panel). These key steps were used for the further development of the training curriculum. By using the Delphi methodology, regional consensus was reached on the key steps for laparoscopic appendectomy and cholecystectomy. These key steps are going to be used for standardized training and evaluation purposes in a new regional laparoscopic curriculum. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

29 CFR 1917.93 - Head protection.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 7 2010-07-01 2010-07-01 false Head protection. 1917.93 Section 1917.93 Labor Regulations... of the following consensus standards: (i) ANSI Z89.1-2003, “American National Standard for Industrial... constructed in accordance with one of the above consensus standards will be deemed to be in compliance with...

77 FR 42988 - Updating OSHA Construction Standards Based on National Consensus Standards; Head Protection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

.... OSHA-2011-0184] RIN 1218-AC65 Updating OSHA Construction Standards Based on National Consensus... Administration (OSHA), Department of Labor. ACTION: Direct final rule; correction. SUMMARY: OSHA is correcting a... confusion resulting from a drafting error. OSHA published the DFR on June 22, 2012 (77 FR 37587). OSHA also...

American lifelines alliance efforts to improve electric power transmission reliability

USGS Publications Warehouse

Nishenko, S.P.; Savage, W.U.; Honegger, D.G.; McLane, T.R.; ,

2002-01-01

A study was performed on American Lifelines Alliance (ALA) efforts to improve electric power transmission reliability. ALA is a public-private partnership project, with the goal of reducing risks to lifelines from natural hazards and human threat events. The mechanism used by ALA for developing national guidelines for lifeline systems is dependent upon using existing Standards Developing Organizations (SDO) accredited by the American National Standards Institute (ANSI) as means to achieve national consensus.

Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium.

PubMed

Delahunt, Eamonn; Bleakley, Chris M; Bossard, Daniela S; Caulfield, Brian M; Docherty, Carrie L; Doherty, Cailbhe; Fourchet, François; Fong, Daniel T; Hertel, Jay; Hiller, Claire E; Kaminski, Thomas W; McKeon, Patrick O; Refshauge, Kathryn M; Remus, Alexandria; Verhagen, Evert; Vicenzino, Bill T; Wikstrom, Erik A; Gribble, Phillip A

2018-06-09

Lateral ankle sprain injury is the most common musculoskeletal injury incurred by individuals who participate in sports and recreational physical activities. Following initial injury, a high proportion of individuals develop long-term injury-associated symptoms and chronic ankle instability. The development of chronic ankle instability is consequent on the interaction of mechanical and sensorimotor insufficiencies/impairments that manifest following acute lateral ankle sprain injury. To reduce the propensity for developing chronic ankle instability, clinical assessments should evaluate whether patients in the acute phase following lateral ankle sprain injury exhibit any mechanical and/or sensorimotor impairments. This modified Delphi study was undertaken under the auspices of the executive committee of the International Ankle Consortium. The primary aim was to develop recommendations, based on expert (n=14) consensus, for structured clinical assessment of acute lateral ankle sprain injuries. After two modified Delphi rounds, consensus was achieved on the clinical assessment of acute lateral ankle sprain injuries. Consensus was reached on a minimum standard clinical diagnostic assessment. Key components of this clinical diagnostic assessment include: establishing the mechanism of injury, as well as the assessment of ankle joint bones and ligaments. Through consensus, the expert panel also developed the International Ankle Consortium Rehabilitation-Oriented ASsessmenT (ROAST). The International Ankle Consortium ROAST will help clinicians identify mechanical and/or sensorimotor impairments that are associated with chronic ankle instability. This consensus statement from the International Ankle Consortium aims to be a key resource for clinicians who regularly assess individuals with acute lateral ankle sprain injuries. © 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.

What should DOE do to help establish voluntary consensus standards for measuring and rating the performance of PV modules?

NASA Technical Reports Server (NTRS)

Runkle, L. D.

1984-01-01

In response to concern expressed by the photovoltaics community over progress toward the establishment and issuance of concensus standards on photovoltaic performance measurements, a review of the status of and progress in developing these standards was conducted. It examined the roles of manufacturers, and consumers and the national laboratories funded by the U.S. Department of Energy (DOE) in supporting this effort. This was done by means of a series of discussions with knowledgeable members of the photovoltaic community. Results of these interviews are summarized and a new approach to managing support of standards activity is recommended that responds to specific problems found in the performance measurement standards area. The study concludes that there is a positive role to be played by the U.S. Department of Energy in establishing collector performance measurement standards. It recommends that DOE continue to provide direct financial support for selected committees and for research at national laboratories, and that management of the activity be restructured to increase the authority and responsibility of the consensus committees.

Ocean Literacy: Tools for Scientists and Educators to use in the Development of Education and Outreach Programs About the Ocean

NASA Astrophysics Data System (ADS)

Strang, C.; Lemus, J.; Schoedinger, S.

2006-12-01

Ocean sciences were idiosyncratically left out of the National Science Education Standards and most state standards, resulting in a decline in the public's attention to ocean issues. Concepts about the ocean are hardly taught in K-12 schools, and hardly appear in K-12 curriculum materials, textbooks, assessments or standards. NGS, COSEE, NMEA, NOAA, the US Commission on Ocean Policy, the Pew Ocean Commission have all urgently called for inclusion of the ocean in science standards as a means to increase ocean literacy nationwide. There has never been consensus, however, about what ocean literacy is or what concepts should be included in future standards. Scientists interested in education and outreach activities have not had a framework to guide them in prioritizing the content they present or in determining how that content fits into the context of what K-12 students and the public need to know about science in general. In 2004, an on-line workshop on Ocean Literacy Through Science Standards began the process of developing consensus about what that framework should include. Approximately 100 ocean scientists and educators participated in the workshop, followed by a series of meetings and extensive review by leading scientists, resulting in a series of draft documents and statements. The importance of community-wide involvement and consensus was reinforced through circulation of the draft documents for public comment April -May, 2005. The community agreed on an Ocean Literacy definition, tagline, seven ocean principles, 44 concepts and a matrix aligning the concepts to the National Science Education Standards (NSES). The elements are described in more detail in the final Ocean Literacy brochure. Broad ownership of the resulting documents is a tribute to the inclusiveness of the process used to develop them. The emerging consensus on Ocean Literacy has become an instrument for change, and has served as an important tool guiding the ocean sciences education efforts of scientists, educators, and most importantly, has provided a common language for scientists and educators working together. In this past year, a similar community-wide effort has been mounted to develop an "Ocean Literacy Scope and Sequence" to serve as a critical companion to "Ocean Literacy: The Essential Principles of Ocean Sciences Grades K-12." The Scope and Sequence shows how the principles and concepts develop and build in logical and developmentally sound learning progressions across grade spans K-12. This document will provide further guidance to teachers, curriculum developers, textbook writers, and ocean scientists, as to what concepts about the ocean are appropriate to introduce at various grade spans. It will show the relationship between the new discoveries of cutting edge science and the basic science concepts on which they are built and which students are accountable to understand. Those concerned about science education and about the future health of the ocean must be poised to influence the development of science standards by local educational agencies, state departments of education and professional societies and associations. In order to be effective, we must have tools, products, documents, web sites that contain agreed upon science content and processes related to the ocean.

Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment.

PubMed

Schnakers, Caroline; Vanhaudenhuyse, Audrey; Giacino, Joseph; Ventura, Manfredi; Boly, Melanie; Majerus, Steve; Moonen, Gustave; Laureys, Steven

2009-07-21

Previously published studies have reported that up to 43% of patients with disorders of consciousness are erroneously assigned a diagnosis of vegetative state (VS). However, no recent studies have investigated the accuracy of this grave clinical diagnosis. In this study, we compared consensus-based diagnoses of VS and MCS to those based on a well-established standardized neurobehavioral rating scale, the JFK Coma Recovery Scale-Revised (CRS-R). We prospectively followed 103 patients (55 +/- 19 years) with mixed etiologies and compared the clinical consensus diagnosis provided by the physician on the basis of the medical staff's daily observations to diagnoses derived from CRS-R assessments performed by research staff. All patients were assigned a diagnosis of 'VS', 'MCS' or 'uncertain diagnosis.' Of the 44 patients diagnosed with VS based on the clinical consensus of the medical team, 18 (41%) were found to be in MCS following standardized assessment with the CRS-R. In the 41 patients with a consensus diagnosis of MCS, 4 (10%) had emerged from MCS, according to the CRS-R. We also found that the majority of patients assigned an uncertain diagnosis by clinical consensus (89%) were in MCS based on CRS-R findings. Despite the importance of diagnostic accuracy, the rate of misdiagnosis of VS has not substantially changed in the past 15 years. Standardized neurobehavioral assessment is a more sensitive means of establishing differential diagnosis in patients with disorders of consciousness when compared to diagnoses determined by clinical consensus.

Consensus Guidelines on Evaluation and Management of the Febrile Child Presenting to the Emergency Department in India.

PubMed

Mahajan, Prashant; Batra, Prerna; Thakur, Neha; Patel, Reena; Rai, Narendra; Trivedi, Nitin; Fassl, Bernhard; Shah, Binita; Lozon, Marie; Oteng, Rockerfeller A; Saha, Abhijeet; Shah, Dheeraj; Galwankar, Sagar

2017-08-15

India, home to almost 1.5 billion people, is in need of a country-specific, evidence-based, consensus approach for the emergency department (ED) evaluation and management of the febrile child. We held two consensus meetings, performed an exhaustive literature review, and held ongoing web-based discussions to arrive at a formal consensus on the proposed evaluation and management algorithm. The first meeting was held in Delhi in October 2015, under the auspices of Pediatric Emergency Medicine (PEM) Section of Academic College of Emergency Experts in India (ACEE-INDIA); and the second meeting was conducted at Pune during Emergency Medical Pediatrics and Recent Trends (EMPART 2016) in March 2016. The second meeting was followed with futher e-mail-based discussions to arrive at a formal consensus on the proposed algorithm. To develop an algorithmic approach for the evaluation and management of the febrile child that can be easily applied in the context of emergency care and modified based on local epidemiology and practice standards. We created an algorithm that can assist the clinician in the evaluation and management of the febrile child presenting to the ED, contextualized to health care in India. This guideline includes the following key components: triage and the timely assessment; evaluation; and patient disposition from the ED. We urge the development and creation of a robust data repository of minimal standard data elements. This would provide a systematic measurement of the care processes and patient outcomes, and a better understanding of various etiologies of febrile illnesses in India; both of which can be used to further modify the proposed approach and algorithm.

77 FR 2017 - Safety Zone; Ice Rescue Exercise; Green Bay, Dyckesville, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

.... Discussion of Rule With the aforementioned hazards in mind, the Captain of the Port Sector Lake Michigan has... are developed or adopted by voluntary consensus standards bodies. This rule does not use technical...

Building a biomedical cyberinfrastructure for collaborative research.

PubMed

Schad, Peter A; Mobley, Lee Rivers; Hamilton, Carol M

2011-05-01

For the potential power of genome-wide association studies (GWAS) and translational medicine to be realized, the biomedical research community must adopt standard measures, vocabularies, and systems to establish an extensible biomedical cyberinfrastructure. Incorporating standard measures will greatly facilitate combining and comparing studies via meta-analysis. Incorporating consensus-based and well-established measures into various studies should reduce the variability across studies due to attributes of measurement, making findings across studies more comparable. This article describes two well-established consensus-based approaches to identifying standard measures and systems: PhenX (consensus measures for phenotypes and eXposures), and the Open Geospatial Consortium (OGC). NIH support for these efforts has produced the PhenX Toolkit, an assembled catalog of standard measures for use in GWAS and other large-scale genomic research efforts, and the RTI Spatial Impact Factor Database (SIFD), a comprehensive repository of geo-referenced variables and extensive meta-data that conforms to OGC standards. The need for coordinated development of cyberinfrastructure to support measures and systems that enhance collaboration and data interoperability is clear; this paper includes a discussion of standard protocols for ensuring data compatibility and interoperability. Adopting a cyberinfrastructure that includes standard measures and vocabularies, and open-source systems architecture, such as the two well-established systems discussed here, will enhance the potential of future biomedical and translational research. Establishing and maintaining the cyberinfrastructure will require a fundamental change in the way researchers think about study design, collaboration, and data storage and analysis. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Building a Biomedical Cyberinfrastructure for Collaborative Research

PubMed Central

Schad, Peter A.; Mobley, Lee Rivers; Hamilton, Carol M.

2018-01-01

For the potential power of genome-wide association studies (GWAS) and translational medicine to be realized, the biomedical research community must adopt standard measures, vocabularies, and systems to establish an extensible biomedical cyberinfrastructure. Incorporating standard measures will greatly facilitate combining and comparing studies via meta-analysis, which is a means for deriving larger populations, needed for increased statistical power to detect less apparent and more complex associations (gene-environment interactions and polygenic gene-gene interactions). Incorporating consensus-based and well-established measures into various studies should reduce the variability across studies due to attributes of measurement, making findings across studies more comparable. This article describes two consensus-based approaches to establishing standard measures and systems: PhenX (consensus measures for Phenotypes and eXposures), and the Open Geospatial Consortium (OGC). National Institutes of Health support for these efforts has produced the PhenX Toolkit, an assembled catalog of standard measures for use in GWAS and other large-scale genomic research efforts, and the RTI Spatial Impact Factor Database (SIFD), a comprehensive repository of georeferenced variables and extensive metadata that conforms to OGC standards. The need for coordinated development of cyberinfrastructure to support collaboration and data interoperability is clear, and we discuss standard protocols for ensuring data compatibility and interoperability. Adopting a cyberinfrastructure that includes standard measures, vocabularies, and open-source systems architecture will enhance the potential of future biomedical and translational research. Establishing and maintaining the cyberinfrastructure will require a fundamental change in the way researchers think about study design, collaboration, and data storage and analysis. PMID:21521587

Regulating Professional Services in ICFs/MR: Remembering the Past and Looking to the Future.

ERIC Educational Resources Information Center

Sparr, Margaret P.; Smith, Wayne

1990-01-01

This article reviews regulations governing Intermediate Care Facilities for the Mentally Retarded (ICF/MR), including 1971 ICF/MR Medicaid funding legislation, standards development by professional consensus, development of federal regulations, intergovernmental roles, and possible directions for the future. A need is seen for professionals to…

77 FR 19357 - Federal Participation in the Development and Use of Voluntary Consensus Standards and in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... OFFICE OF MANAGEMENT AND BUDGET Federal Participation in the Development and Use of Voluntary... public workshop. SUMMARY: The Office of Management and Budget (OMB) invites interested parties to provide... with agency and departmental missions, authorities, priorities, and budget resources, participate with...

[Conjunctival melanoma : Standard operating procedures in diagnosis, treatment and follow-up care].

PubMed

Glossmann, Jan-Peter; Skoetz, Nicole; Starbatty, Barbara; Bischoff, Martina; Leyvraz, Serge; Westekemper, Henrike; Heindl, Ludwig M

2018-06-01

In cases of rare cancer entities, such as malignant melanoma of the conjunctiva, there are often no evidence-based national guidelines available. Standard operating procedures (SOP) are an alternative in these cases. The aim of this project was to develop a consensus SOP for diagnosis, treatment, and follow-up care of conjunctival melanomas between the 14 Centers of Excellence in Germany supported by German Cancer Aid. The SOP was prepared according to a defined process including timelines, flow of information, and roles. This is the first consensus SOP of the Centers of Excellence in Germany (certified by the German Cancer Aid) regarding diagnosis, treatment, and follow-up for malignant melanomas of the conjunctiva.

Key Features of Academic Detailing: Development of an Expert Consensus Using the Delphi Method.

PubMed

Yeh, James S; Van Hoof, Thomas J; Fischer, Michael A

2016-02-01

Academic detailing is an outreach education technique that combines the direct social marketing traditionally used by pharmaceutical representatives with unbiased content summarizing the best evidence for a given clinical issue. Academic detailing is conducted with clinicians to encourage evidence-based practice in order to improve the quality of care and patient outcomes. The adoption of academic detailing has increased substantially since the original studies in the 1980s. However, the lack of standard agreement on its implementation makes the evaluation of academic detailing outcomes challenging. To identify consensus on the key elements of academic detailing among a group of experts with varying experiences in academic detailing. This study is based on an online survey of 20 experts with experience in academic detailing. We used the Delphi process, an iterative and systematic method of developing consensus within a group. We conducted 3 rounds of online surveys, which addressed 72 individual items derived from a previous literature review of 5 features of academic detailing, including (1) content, (2) communication process, (3) clinicians targeted, (4) change agents delivering intervention, and (5) context for intervention. Nonrespondents were removed from later rounds of the surveys. For most questions, a 4-point ordinal scale was used for responses. We defined consensus agreement as 70% of respondents for a single rating category or 80% for dichotomized ratings. The overall survey response rate was 95% (54 of 57 surveys) and nearly 92% consensus agreement on the survey items (66 of 72 items) by the end of the Delphi exercise. The experts' responses suggested that (1) focused clinician education offering support for clinical decision-making is a key component of academic detailing, (2) detailing messages need to be tailored and provide feasible strategies and solutions to challenging cases, and (3) academic detailers need to develop specific skill sets required to overcome barriers to changing clinician behavior. Consensus derived from this Delphi exercise can serve as a useful template of general principles in academic detailing initiatives and evaluation. The study findings are limited by the lack of standard definitions of certain terms used in the Delphi process.

Key Features of Academic Detailing: Development of an Expert Consensus Using the Delphi Method

PubMed Central

Yeh, James S.; Van Hoof, Thomas J.; Fischer, Michael A.

2016-01-01

Background Academic detailing is an outreach education technique that combines the direct social marketing traditionally used by pharmaceutical representatives with unbiased content summarizing the best evidence for a given clinical issue. Academic detailing is conducted with clinicians to encourage evidence-based practice in order to improve the quality of care and patient outcomes. The adoption of academic detailing has increased substantially since the original studies in the 1980s. However, the lack of standard agreement on its implementation makes the evaluation of academic detailing outcomes challenging. Objective To identify consensus on the key elements of academic detailing among a group of experts with varying experiences in academic detailing. Methods This study is based on an online survey of 20 experts with experience in academic detailing. We used the Delphi process, an iterative and systematic method of developing consensus within a group. We conducted 3 rounds of online surveys, which addressed 72 individual items derived from a previous literature review of 5 features of academic detailing, including (1) content, (2) communication process, (3) clinicians targeted, (4) change agents delivering intervention, and (5) context for intervention. Nonrespondents were removed from later rounds of the surveys. For most questions, a 4-point ordinal scale was used for responses. We defined consensus agreement as 70% of respondents for a single rating category or 80% for dichotomized ratings. Results The overall survey response rate was 95% (54 of 57 surveys) and nearly 92% consensus agreement on the survey items (66 of 72 items) by the end of the Delphi exercise. The experts' responses suggested that (1) focused clinician education offering support for clinical decision-making is a key component of academic detailing, (2) detailing messages need to be tailored and provide feasible strategies and solutions to challenging cases, and (3) academic detailers need to develop specific skill sets required to overcome barriers to changing clinician behavior. Conclusion Consensus derived from this Delphi exercise can serve as a useful template of general principles in academic detailing initiatives and evaluation. The study findings are limited by the lack of standard definitions of certain terms used in the Delphi process. PMID:27066195

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement

PubMed Central

Hong, Dae Gy; Shin, So-Jin; Ju, Woong; Cho, Hanbyoul; Lee, Chulmin; Kim, Hyun-Jung; Bae, Duk-Soo

2017-01-01

Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement. PMID:27894165

Developing guidelines for return to play: consensus and evidence-based approaches.

PubMed

Echemendia, Ruben J; Giza, Christopher C; Kutcher, Jeffrey S

2015-01-01

Sports-related concussions are commonplace at all levels of play and across all age groups. The dynamic, evolving nature of this injury coupled with a lack of objective biomarkers creates a challenging management issue for the sports medicine team. Athletes who return to play following a concussion are known to be at higher risk for an additional brain injury, which necessitates a careful, informed return to play (RTP) process. The goal of this paper is to outline historical attempts at developing RTP guidelines and trace their evolution over time, culminating in a discussion of the process and outcomes of the most recent consensus statements/guidelines published by the international Concussion In Sport Group (CISG), the American Academy of Neurology (AAN), the National Athletic Trainers' Association, and the 2013 Team Physician Consensus Statement Update. An evaluation of the pros and cons of these guidelines is presented along with suggestions for future directions. In addition, the Institute of Medicine recently conducted a comprehensive report outlining the current state of evidence regarding youth concussions, which provides specific recommendations for future research. The different methodologies utilized in the development of consensus statements have distinct advantages and disadvantages, and both approaches add value to the everyday management of sports concussions. Importantly, the overall approach for management of sports concussion is remarkably similar using either consensus-based or formal evidence-based methods, which adds confidence to the current guidelines and allows practitioners to focus on accepted standards of clinical care. Moving forward, careful study designs need to be utilized to avoid bias in selection of research subjects, collection of data, and interpretation of results. Although useful, clinicians must venture beyond consensus statements to examine reviews of the literature that are published in much greater frequency than consensus statements.

Moral consensus theory: paradigm cases of abortion and orthothanasia in Brazil.

PubMed

Miziara, Ivan Dieb; Miziara, Carmen Silvia Molleis Galego

2013-01-01

Bioethics is a relatively new way of thinking about relationships in medical practice. It enables reflection on ethical conflicts, and opens up management options without dictating rules. Despite this historical context, medical ethics has been sidelined in the course of the development of bioethics. Bioethical reflection does not automatically result in changes to conflict resolution in daily doctor-patient relationships. However, these reflections are important because they promote the search for a "moral consensus" that establishes new ethical rules for day-to-day medical practice. We suggest that there is no conflict between bioethics and medical ethics; rather, these areas interact to establish new standards of behaviour among physicians. The legalisation of orthothanasia in Brazil is one example of how this theory of moral consensus might operate. On the other hand, the legal battle on abortion illustrates how the law cannot change without such a moral consensus.

Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy

PubMed Central

Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dubé, Catherine; Enns, Robert; Hollingworth, Roger; MacIntosh, Donald; Borgaonkar, Mark; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Kuipers, Ernst J; Valori, Roland

2012-01-01

BACKGROUND: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy. OBJECTIVE: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery. METHODS: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants. RESULTS: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified. DISCUSSION: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services. CONCLUSIONS: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy. PMID:22308578

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL.

PubMed

Deans, Zandra C; Costa, Jose Luis; Cree, Ian; Dequeker, Els; Edsjö, Anders; Henderson, Shirley; Hummel, Michael; Ligtenberg, Marjolijn Jl; Loddo, Marco; Machado, Jose Carlos; Marchetti, Antonio; Marquis, Katherine; Mason, Joanne; Normanno, Nicola; Rouleau, Etienne; Schuuring, Ed; Snelson, Keeda-Marie; Thunnissen, Erik; Tops, Bastiaan; Williams, Gareth; van Krieken, Han; Hall, Jacqueline A

2017-01-01

The clinical demand for mutation detection within multiple genes from a single tumour sample requires molecular diagnostic laboratories to develop rapid, high-throughput, highly sensitive, accurate and parallel testing within tight budget constraints. To meet this demand, many laboratories employ next-generation sequencing (NGS) based on small amplicons. Building on existing publications and general guidance for the clinical use of NGS and learnings from germline testing, the following guidelines establish consensus standards for somatic diagnostic testing, specifically for identifying and reporting mutations in solid tumours. These guidelines cover the testing strategy, implementation of testing within clinical service, sample requirements, data analysis and reporting of results. In conjunction with appropriate staff training and international standards for laboratory testing, these consensus standards for the use of NGS in molecular pathology of solid tumours will assist laboratories in implementing NGS in clinical services.

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist.

PubMed

Sepucha, Karen R; Abhyankar, Purva; Hoffman, Aubri S; Bekker, Hilary L; LeBlanc, Annie; Levin, Carrie A; Ropka, Mary; Shaffer, Victoria A; Sheridan, Stacey L; Stacey, Dawn; Stalmeier, Peep; Vo, Ha; Wills, Celia E; Thomson, Richard

2018-05-01

Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist. © 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.

Early psychosocial interventions after disasters, terrorism and other shocking events: is there a gap between norms and practice in Europe?

PubMed Central

Te Brake, Hans

2013-01-01

Background Internationally, several initiatives exist to describe standards for post-disaster psychosocial care. Objective This study explored the level of consensus of experts within Europe on a set of recommendations on early psychosocial intervention after shocking events (Dutch guidelines), and to what degree these standards are implemented into mental health care practice. Methods Two hundred and six (mental) health care professionals filled out a questionnaire to assess the extent to which they consider the guidelines’ scope and recommendations relevant and part of the regular practice in their own country. Forty-five European experts from 24 EU countries discussed the guidelines at an international seminar. Results The data suggest overall agreement on the standards although many of the recommendations appear not (yet) to be embedded in everyday practice. Conclusions Although large consensus exists on standards for early psychosocial care, a chasm between norms and practice appears to exist throughout the EU, stressing the general need for investments in guideline development and implementation. PMID:23393613

Evolution of standardized procedures for adjusting lumber properties for change in moisture content

Treesearch

David W. Green; James W. Evans

2001-01-01

This paper documents the development of procedures in American Society for Testing and Materials standards for adjusting the allowable properties of lumber for changes in moisture content. The paper discusses the historical context of efforts to establish allowable properties on a consensus basis, beginning in the 19th century. Where possible, the reasons for proposed...

48 CFR 11.107 - Solicitation provision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Solicitation provision. 11... transaction-based reporting method to report its use of voluntary consensus standards to the National... Use of Voluntary Consensus Standards and in Conformity Assessment Activities”). Use of the provision...

EUnetHTA information management system: development and lessons learned.

PubMed

Chalon, Patrice X; Kraemer, Peter

2014-11-01

The aim of this study was to describe the techniques used in achieving consensus on common standards to be implemented in the EUnetHTA Information Management System (IMS); and to describe how interoperability between tools was explored. Three face to face meetings were organized to identify and agree on common standards to the development of online tools. Two tools were created to demonstrate the added value of implementing interoperability standards at local levels. Developers of tools outside EUnetHTA were identified and contacted. Four common standards have been agreed on by consensus; and consequently all EUnetHTA tools have been modified or designed accordingly. RDF Site Summary (RSS) has demonstrated a good potential to support rapid dissemination of HTA information. Contacts outside EUnetHTA resulted in direct collaboration (HTA glossary, HTAi Vortal), evaluation of options for interoperability between tools (CRD HTA database) or a formal framework to prepare cooperation on concrete projects (INAHTA projects database). While being entitled a project on IT infrastructure, the work program was also about people. When having to agree on complex topics, fostering a cohesive group dynamic and hosting face to face meetings brings added value and enhances understanding between partners. The adoption of widespread standards enhanced the homogeneity of the EUnetHTA tools and should thus contribute to their wider use, therefore, to the general objective of EUnetHTA. The initiatives on interoperability of systems need to be developed further to support a general interoperable information system that could benefit the whole HTA community.

76 FR 43153 - Approval and Promulgation of Air Quality Implementation Plan; New Jersey and New York; Final...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome... procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies...

77 FR 39411 - Safety Zone; Village of Sackets Harbor, Lake Ontario, Sackets Harbor, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... Rule With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this... are developed or adopted by voluntary consensus standards bodies. This rule does not use technical...

77 FR 33309 - Safety Zone; Race on the Lake, Onondaga Lake, Syracuse, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... participants and the boating public. C. Discussion of the Final Rule With the aforementioned risks in mind, the... are developed or adopted by voluntary consensus standards bodies. This rule does not use technical...

Standardization of terminology in dermoscopy/dermatoscopy: Results of the third consensus conference of the International Society of Dermoscopy.

PubMed

Kittler, Harald; Marghoob, Ashfaq A; Argenziano, Giuseppe; Carrera, Cristina; Curiel-Lewandrowski, Clara; Hofmann-Wellenhof, Rainer; Malvehy, Josep; Menzies, Scott; Puig, Susana; Rabinovitz, Harold; Stolz, Wilhelm; Saida, Toshiaki; Soyer, H Peter; Siegel, Eliot; Stoecker, William V; Scope, Alon; Tanaka, Masaru; Thomas, Luc; Tschandl, Philipp; Zalaudek, Iris; Halpern, Allan

2016-06-01

Evolving dermoscopic terminology motivated us to initiate a new consensus. We sought to establish a dictionary of standardized terms. We reviewed the medical literature, conducted a survey, and convened a discussion among experts. Two competitive terminologies exist, a more metaphoric terminology that includes numerous terms and a descriptive terminology based on 5 basic terms. In a survey among members of the International Society of Dermoscopy (IDS) 23.5% (n = 201) participants preferentially use descriptive terminology, 20.1% (n = 172) use metaphoric terminology, and 484 (56.5%) use both. More participants who had been initially trained by metaphoric terminology prefer using descriptive terminology than vice versa (9.7% vs 2.6%, P < .001). Most new terms that were published since the last consensus conference in 2003 were unknown to the majority of the participants. There was uniform consensus that both terminologies are suitable, that metaphoric terms need definitions, that synonyms should be avoided, and that the creation of new metaphoric terms should be discouraged. The expert panel proposed a dictionary of standardized terms taking account of metaphoric and descriptive terms. A consensus seeks a workable compromise but does not guarantee its implementation. The new consensus provides a revised framework of standardized terms to enhance the consistent use of dermoscopic terminology. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Standardization of terminology in dermoscopy/dermatoscopy: Results of the third consensus conference of the International Society of Dermoscopy

PubMed Central

Kittler, Harald; Marghoob, Ashfaq A.; Argenziano, Giuseppe; Carrera, Cristina; Curiel-Lewandrowski, Clara; Hofmann-Wellenhof, Rainer; Malvehy, Josep; Menzies, Scott; Puig, Susana; Rabinovitz, Harold; Stolz, Wilhelm; Saida, Toshiaki; Soyer, H. Peter; Siegel, Eliot; Stoecker, William V.; Scope, Alon; Tanaka, Masaru; Thomas, Luc; Tschandl, Philipp; Zalaudek, Iris; Halpern, Allan

2017-01-01

Background Evolving dermoscopic terminology motivated us to initiate a new consensus. Objective We sought to establish a dictionary of standardized terms. Methods We reviewed the medical literature, conducted a survey, and convened a discussion among experts. Results Two competitive terminologies exist, a more metaphoric terminology that includes numerous terms and a descriptive terminology based on 5 basic terms. In a survey among members of the International Society of Dermoscopy (IDS) 23.5% (n = 201) participants preferentially use descriptive terminology, 20.1% (n = 172) use metaphoric terminology, and 484 (56.5%) use both. More participants who had been initially trained by metaphoric terminology prefer using descriptive terminology than vice versa (9.7% vs 2.6%, P < .001). Most new terms that were published since the last consensus conference in 2003 were unknown to the majority of the participants. There was uniform consensus that both terminologies are suitable, that metaphoric terms need definitions, that synonyms should be avoided, and that the creation of new metaphoric terms should be discouraged. The expert panel proposed a dictionary of standardized terms taking account of metaphoric and descriptive terms. Limitations A consensus seeks a workable compromise but does not guarantee its implementation. Conclusion The new consensus provides a revised framework of standardized terms to enhance the consistent use of dermoscopic terminology. PMID:26896294

Integrated methodology for standard-setting norms of innovative product in the new competitive environment

NASA Astrophysics Data System (ADS)

Polyakova, Marina; Rubin, Gennadiy

2017-07-01

Modern theory of technological and economical development is based on long-term cycles. So far it has been proved that the technological structure of the economy can be subdivided into groups of technological complexes, which are inter-related with each other by similar technological links, so called technological modes. Technological mode is defined as a complex of interrelated production units of similar technological level, which develop simultaneously. In order to provide competitiveness of products in the new changing conditions, it is necessary to make sure that they meet all the regulatory requirements specified in standards. But the existing and the fast changing situation on the merchandise markets causes disbalance between the growing customer requirements and the technological capabilities of the manufacturer. This makes the issue of standardization development even more urgent both from the point of view of establishing the current positions and from the point of view of possible promising development trends in technology. In the paper scientific and engineering principles of developing standardization as a science are described. It is shown that further development of standardization is based on the principles of advanced standardization the main idea of which is to set up the prospective requirements to the innovative product. Modern approaches of advanced standardization are shown in this paper. The complexity of the negotiation procedure between customer and manufacturer as a whole and achieving of consensus, in particular, make it necessary to find conceptually new approaches to developing mathematical models. The developed methodology picture the process of achieving the consensus between customer and manufacturer while developing the standard norms in the form of decreasing S-curve diagram. It means that in the end of the negotiation process, there is no difference between customer and manufacturer positions. It makes it possible to provide the basics of the assessment using the differential equation of the relationship between the rate of change of quality assessment and the distance of the estimated parameter value from the best value to the worst one. The obtained mathematical model can be used in the practice of standardization decreasing time of setting standard norms.

Diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment

PubMed Central

Schnakers, Caroline; Vanhaudenhuyse, Audrey; Giacino, Joseph; Ventura, Manfredi; Boly, Melanie; Majerus, Steve; Moonen, Gustave; Laureys, Steven

2009-01-01

Background Previously published studies have reported that up to 43% of patients with disorders of consciousness are erroneously assigned a diagnosis of vegetative state (VS). However, no recent studies have investigated the accuracy of this grave clinical diagnosis. In this study, we compared consensus-based diagnoses of VS and MCS to those based on a well-established standardized neurobehavioral rating scale, the JFK Coma Recovery Scale-Revised (CRS-R). Methods We prospectively followed 103 patients (55 ± 19 years) with mixed etiologies and compared the clinical consensus diagnosis provided by the physician on the basis of the medical staff's daily observations to diagnoses derived from CRS-R assessments performed by research staff. All patients were assigned a diagnosis of 'VS', 'MCS' or 'uncertain diagnosis.' Results Of the 44 patients diagnosed with VS based on the clinical consensus of the medical team, 18 (41%) were found to be in MCS following standardized assessment with the CRS-R. In the 41 patients with a consensus diagnosis of MCS, 4 (10%) had emerged from MCS, according to the CRS-R. We also found that the majority of patients assigned an uncertain diagnosis by clinical consensus (89%) were in MCS based on CRS-R findings. Conclusion Despite the importance of diagnostic accuracy, the rate of misdiagnosis of VS has not substantially changed in the past 15 years. Standardized neurobehavioral assessment is a more sensitive means of establishing differential diagnosis in patients with disorders of consciousness when compared to diagnoses determined by clinical consensus. PMID:19622138

Consensus Treatment Plans for Chronic Nonbacterial Osteomyelitis Refractory to Nonsteroidal Anti-Inflammatory Drugs and/or with Active Spinal Lesions.

PubMed

Zhao, Yongdong; Wu, Eveline Y; Oliver, Melissa S; Cooper, Ashley M; Basiaga, Matthew L; Vora, Sheetal S; Lee, Tzielan C; Fox, Emily; Amarilyo, Gil; Stern, Sara M; Dvergsten, Jeffrey A; Haines, Kathleen A; Rouster-Stevens, Kelly A; Onel, Karen B; Cherian, Julie; Hausmann, Jonathan S; Miettunen, Paivi; Cellucci, Tania; Nuruzzaman, Farzana; Taneja, Angela; Barron, Karyl S; Hollander, Matthew C; Lapidus, Sivia K; Li, Suzanne C; Ozen, Seza; Girschick, Hermann; Laxer, Ronald M; Dedeoglu, Fatma; Hedrich, Christian M; Ferguson, Polly J

2017-11-07

To develop standardized treatment regimens for chronic nonbacterial osteomyelitis (CNO), also known as chronic recurrent multifocal osteomyelitis (CRMO) to enable comparative effectiveness treatment studies. Virtual and face-to-face discussions and meetings were held within the CNO subgroup of the Childhood Arthritis and Rheumatology Research Alliance (CARRA). A literature search was conducted, and CARRA membership was surveyed to evaluate available treatment data and identify current treatment practices. Nominal group technique was used to achieve consensus on treatment plans for CNO refractory to non-steroidal anti-inflammatory drug (NSAID) monotherapy and/or with active spinal lesions. Three consensus treatment plans (CTPs) were developed for the first 12 months of therapy for CNO patients refractory to NSAID monotherapy and/or with active spinal lesions. The three CTPs are: (1) methotrexate or sulfasalazine, (2) tumor necrosis factor (TNF)-alpha inhibitors with optional use of methotrexate, and (3) bisphosphonates. Short courses of glucocorticoids and continuation of NSAIDs are permitted for all regimens. Consensus was achieved on these CTPs among CARRA members. Consensus was also reached on subject eligibility criteria, initial evaluations that should be conducted prior to the initiation of CTPs, and data items to collect to assess treatment response. Three consensus treatment plans were developed for pediatric patients with CNO refractory to NSAIDs and/or with active spinal lesions. Use of these CTPs will provide additional information on efficacy and will generate meaningful data for comparative effectiveness research in CNO. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Chiropractic management of low back disorders: report from a consensus process.

PubMed

Globe, Gary A; Morris, Craig E; Whalen, Wayne M; Farabaugh, Ronald J; Hawk, Cheryl

2008-01-01

Although a number of guidelines addressing manipulation, an important component of chiropractic professional care, exist, none to date have incorporated a broad-based consensus of chiropractic research and clinical experts representing mainstream chiropractic practice into a practical document designed to provide standardized parameters of care. The purpose of this project was to develop such a document. Development of the document began with seed materials, from which seed statements were distilled. These were circulated electronically to the Delphi panel until consensus was reached, which was considered to be present when there was agreement by at least 80% of the panelists. The panel consisted of 40 clinically experienced doctors of chiropractic, representing 15 chiropractic colleges and 16 states, as well as both the American Chiropractic Association and the International Chiropractic Association. The panel reached 80% consensus of the 27 seed statements after 2 rounds. Specific recommendations regarding treatment frequency and duration, as well as outcome assessment and contraindications for manipulation were agreed upon by the panel. A broad-based panel of experienced chiropractors was able to reach a high level (80%) of consensus regarding specific aspects of the chiropractic approach to care for patients with low back pain, based on both the scientific evidence and their clinical experience.

2014 Consensus conference on viscoelastic test-based transfusion guidelines for early trauma resuscitation: Report of the panel.

PubMed

Inaba, Kenji; Rizoli, Sandro; Veigas, Precilla V; Callum, Jeannie; Davenport, Ross; Hess, John; Maegele, Marc

2015-06-01

There has been an increased interest in the use of viscoelastic testing to guide blood product replacement during the acute resuscitation of the injured patient. Currently, no uniformly accepted guidelines exist for how this technology should be integrated into clinical care. In September 2014, an international multidisciplinary group of leaders in the field of trauma coagulopathy and resuscitation was assembled for a 2-day consensus conference in Philadelphia, Pennsylvania. This panel included trauma surgeons, hematologists, blood bank specialists, anesthesiologists, and the lay public.Nine questions regarding the impact of viscoelastic testing in the early resuscitation of trauma patients were developed before the conference by panel consensus. Early use was defined as baseline viscoelastic test result thresholds obtained within the first minutes of hospital arrival-when conventional laboratory results are not available. The available data for each question were then reviewed in person using standardized presentations by the expert panel. A consensus summary document was then developed and reviewed by the panel in an open forum. Finally, a two-round Delphi poll was administered to the panel of experts regarding viscoelastic thresholds for triggering the initiation of specific treatments including fibrinogen, platelets, plasma, and prothrombin complex concentrates. This report summarizes the findings and recommendations of this consensus conference.

Assessing and Reporting Dancer Capacities, Risk Factors, and Injuries: Recommendations from the IADMS Standard Measures Consensus Initiative.

PubMed

Liederbach, Marijeanne; Hagins, Marshall; Gamboa, Jennifer M; Welsh, Thomas M

2012-12-01

This technical report of the Standard Measures Consensus Initiative of the International Association for Dance Medicine and Science (IADMS) describes the results of the committee’s multi-year effort to synthesize information regarding the tests and measures used in dance-related research, protocols for reporting injuries, and appropriate use of available technologies to aid in standardizing such matters. Specific recommendations are presented, with accompanying rationales, to facilitate consensus among members of the dance medicine and science community. An Executive Summary of this Technical Report, which contains implementation strategies and appendices, should soon be available on the IADMS website.

77 FR 30195 - Safety Zone; Flagship Niagara Mariners Ball Fireworks, Presque Isle Bay, Erie, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

... aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is... are developed or adopted by voluntary consensus standards bodies. This rule does not use technical...

Development of the Gross Motor Function Classification System (1997)

ERIC Educational Resources Information Center

Morris, Christopher

2008-01-01

To address the need for a standardized system to classify the gross motor function of children with cerebral palsy, the authors developed a five-level classification system analogous to the staging and grading systems used in medicine. Nominal group process and Delphi survey consensus methods were used to examine content validity and revise the…

76 FR 3540 - U.S. Advanced Boiling Water Reactor Aircraft Impact Design Certification Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

.... Plain Language IX. Voluntary Consensus Standards X. Finding of No Significant Environmental Impact... information (or its equivalent) which was originally developed by GE Nuclear Energy (GE) and approved by the... from GE Hitachi Nuclear Energy (GEH) to use the GE- developed U.S. ABWR proprietary information for...

Developing a holistic accreditation system for medical universities of the Islamic Republic of Iran.

PubMed

Yousefy, A; Changiz, T; Yamani, N; Zahrai, R H; Ehsanpour, S

2009-01-01

This report describes the steps in the development of an accreditation system for medical universities in the Islamic Republic of Iran. The national accreditation project, supported by the government, was performed from 2001 to 2005. The project was carried out in 3 main phases, each phase including a number of tasks. After a review of the international literature on accreditation and through national consensus, a set of national institutional accreditation standards was developed, including 95 standards and 504 indicators in 10 areas. By complying with accepted national standards, Iranian medical universities will play an important role in promoting health system performance.

77 FR 71369 - Updates to Voluntary Consensus Standards Incorporated by Reference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-30

... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Chapter I 46 CFR Chapter I [Docket No. USCG-2012-0866] Updates to Voluntary Consensus Standards Incorporated by Reference AGENCY: Coast Guard, DHS. ACTION: Request for comments. SUMMARY: Many of the Coast Guard's regulations incorporate industry...

78 FR 2214 - Enhanced Weapons, Firearms Background Checks, and Security Event Notifications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-10

.... Voluntary Consensus Standards XI. Finding of No Significant Environmental Impact XII. Paperwork Reduction... ML110480470 of Nuclear Energy Institute, on the proposed ``Enhanced Weapons, Firearms Background Checks and... consensus standards. XI. Finding of No Significant Environmental Impact In the proposed rule published on...

Beyond the false negative rate: development of quality indicators for sentinel lymph node biopsy in breast cancer.

PubMed

Quan, May Lynn; Wells, Bryan J; McCready, David; Wright, Frances C; Fraser, Novlette; Gagliardi, Anna R

2010-02-01

Sentinel lymph node biopsy (SNLB) has been adopted as the standard method of axillary staging for women with clinically node-negative early-stage breast cancer. The false negative rate as a quality indicator is impractical given the need for a completion axillary dissection to calculate. The objective of this study was to develop practical quality indicators for SLNB using an expert consensus method and to determine if they were feasible to measure. We used a modified Delphi consensus process to develop quality indicators for SLNB. A multidisciplinary expert panel reviewed potential indicators extracted from the medical literature to select quality indicators that were relevant and measurable. Feasibility was determined by abstracting the quality indicator variables from a retrospective chart review. The expert panel prioritized 11 quality indicators as benchmarks for assessing the quality of surgical care in SNLB. Nine of the indicators were measurable at the chart or institutional level. A systematic evidence- and consensus-based approach was used to develop measurable quality indicators that could be used by practicing surgeons and administrators to evaluate performance of SLNB in breast cancer.

An update on the Society for Immunotherapy of Cancer consensus statement on tumor immunotherapy for the treatment of cutaneous melanoma: version 2.0.

PubMed

Sullivan, Ryan J; Atkins, Michael B; Kirkwood, John M; Agarwala, Sanjiv S; Clark, Joseph I; Ernstoff, Marc S; Fecher, Leslie; Gajewski, Thomas F; Gastman, Brian; Lawson, David H; Lutzky, Jose; McDermott, David F; Margolin, Kim A; Mehnert, Janice M; Pavlick, Anna C; Richards, Jon M; Rubin, Krista M; Sharfman, William; Silverstein, Steven; Slingluff, Craig L; Sondak, Vernon K; Tarhini, Ahmad A; Thompson, John A; Urba, Walter J; White, Richard L; Whitman, Eric D; Hodi, F Stephen; Kaufman, Howard L

2018-05-30

Cancer immunotherapy has been firmly established as a standard of care for patients with advanced and metastatic melanoma. Therapeutic outcomes in clinical trials have resulted in the approval of 11 new drugs and/or combination regimens for patients with melanoma. However, prospective data to support evidence-based clinical decisions with respect to the optimal schedule and sequencing of immunotherapy and targeted agents, how best to manage emerging toxicities and when to stop treatment are not yet available. To address this knowledge gap, the Society for Immunotherapy of Cancer (SITC) Melanoma Task Force developed a process for consensus recommendations for physicians treating patients with melanoma integrating evidence-based data, where available, with best expert consensus opinion. The initial consensus statement was published in 2013, and version 2.0 of this report is an update based on a recent meeting of the Task Force and extensive subsequent discussions on new agents, contemporary peer-reviewed literature and emerging clinical data. The Academy of Medicine (formerly Institute of Medicine) clinical practice guidelines were used as a basis for consensus development with an updated literature search for important studies published between 1992 and 2017 and supplemented, as appropriate, by recommendations from Task Force participants. The Task Force considered patients with stage II-IV melanoma and here provide consensus recommendations for how they would incorporate the many immunotherapy options into clinical pathways for patients with cutaneous melanoma. These clinical guidleines provide physicians and healthcare providers with consensus recommendations for managing melanoma patients electing treatment with tumor immunotherapy.

Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

PubMed

Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

2005-09-01

To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

National Standards for United States History: Exploring the American Experience. Grades 5-12. Expanded Edition. Including Examples of Student Achievement.

ERIC Educational Resources Information Center

Crabtree, Charlotte; Nash, Gary B.

Developed through a broad-based national consensus building process, the National History Standards project has involved working toward agreement both on the larger purposes of history in the school curriculum and on the more specific history understandings and thinking processes that all students should have equal opportunity to acquire over 12…

National Standards for World History: Exploring Paths to the Present. Grades 5-12, Expanded Edition. Including Examples of Student Achievement.

ERIC Educational Resources Information Center

Crabtree, Charlotte; Nash, Gary B.

Developed through a broad based national consensus building process, the National History Standards project has involved working toward agreement both on the larger purposes of history in the school curriculum and on the more specific history understandings and thinking processes that all students should have equal opportunity to acquire over 12…

Cystic Fibrosis Diagnostic Challenges over 4 Decades: Historical Perspectives and Lessons Learned.

PubMed

Farrell, Philip M; White, Terry B; Derichs, Nico; Castellani, Carlo; Rosenstein, Beryl J

2017-02-01

Because cystic fibrosis (CF) can be difficult to diagnose, and because information about the genetic complexities and pathologic basis of the disease has grown so rapidly over the decades, several consensus conferences have been held by the US CF Foundation, and a variety of other efforts to improve diagnostic practices have been organized by the European CF Society. Despite these efforts, the application of diagnostic criteria has been variable and caused confusion. To improve diagnosis and achieve standardization in terms and definitions worldwide, the CF Foundation in 2015 convened a committee of 32 experts in the diagnosis of CF from 9 countries. As part of the process, all previous consensus-seeking exercises sponsored by the CF Foundation, along with the important efforts of the European CF Society, were comprehensively and critically reviewed. The goal was to better understand why consensus conferences and their publications have not led to the desired results. Lessons learned from previous diagnosis consensus processes and products were identified. It was decided that participation in developing a consensus was generally not inclusive enough for global impact. It was also found that many efforts to address sweat test issues were valuable but did not always improve clinical practices as CF diagnostic testing evolved. It also became clear from this review that premature applications of potential diagnostic tests such as nasal potential difference and intestinal current measurement should be avoided until validation and standardization occur. Finally, we have learned that due to the significant and growing number of cases that are challenging to diagnose, an associated continuing medical education program is both desirable and necessary. It is necessary but not sufficient to organize and publish CF diagnosis consensus processes. Follow-up implementation efforts and monitoring practices seem essential. Copyright © 2016. Published by Elsevier Inc.

1 CFR 21.21 - General requirements: References.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1 General Provisions 1 2010-01-01 2010-01-01 false General requirements: References. 21.21 Section... to test methods or consensus standards produced by a Federal agency that have replaced or preempted private or voluntary test methods or consensus standards in a subject matter area. (5) The reference is to...

Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

PubMed

Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

2009-01-01

Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group.

PubMed

Rao, Sunil V; Eikelboom, John; Steg, Ph Gabriel; Lincoff, A Michael; Weintraub, William S; Bassand, Jean-Pierre; Rao, A Koneti; Gibson, C Michael; Petersen, John L; Mehran, Roxana; Manoukian, Steven V; Charnigo, Richard; Lee, Kerry L; Moscucci, Mauro; Harrington, Robert A

2009-12-01

Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

Framework for continuous palliative sedation therapy in Canada.

PubMed

Dean, Mervyn M; Cellarius, Victor; Henry, Blair; Oneschuk, Doreen; Librach Canadian Society Of Palliative Care Physicians Taskforce, S Lawrence

2012-08-01

Canada does not have a standardized ethical and practice framework for continuous palliative sedation therapy (CPST). Although a number of institutional and regional guidelines exist, Canadian practice varies. Given the lack of international and national consensus on CPST, the Canadian Society for Palliative Care Physicians (CSPCP) formed a special task force to develop a consensus-based framework for CPST. Through a preliminary review of sedation practices nationally and internationally, it was determined that although considerable consensus was emerging on this topic, there remained both areas of contention and a lack of credible scientific evidence to support a definitive clinical practice guideline. This led to the creation of a framework to help guide policy, practice, and research. This framework was developed through the following steps: 1) literature review; 2) identification of issues; 3) preparation of a draft framework; 4) expert consultation and revision; 5) presentation at conferences and further revision; and 6) further revision and national consensus building. A thorough literature review, including gray literature, of sedation therapy at the end of life was conducted from which an initial framework was drafted. This document was reviewed by 30 multidisciplinary experts in Canada and internationally, revised several times, and then submitted to CSPCP members for review. Consensus was high on most parts of the framework. The framework for CPST will provide a basis for the development of safe, effective, and ethical use of CPST for patients in palliative care and at the end of life.

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date.

PubMed

2008-03-14

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.

Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi.

PubMed

Pinnock, Hilary; Epiphaniou, Eleni; Sheikh, Aziz; Griffiths, Chris; Eldridge, Sandra; Craig, Peter; Taylor, Stephanie J C

2015-03-30

Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI). Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9. We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators. Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts. We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned. The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17 .

16 CFR 260.6 - Certifications and seals of approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... benefit being asserted. To avoid deception, marketers should use clear and prominent qualifying language... marketer accompanied the seal with clear and prominent language: (1) indicating that the marketer awarded... that have been developed and maintained by a voluntary consensus standard body.45 An independent...

16 CFR 260.6 - Certifications and seals of approval.

Code of Federal Regulations, 2013 CFR

2013-01-01

... benefit being asserted. To avoid deception, marketers should use clear and prominent qualifying language... marketer accompanied the seal with clear and prominent language: (1) indicating that the marketer awarded... that have been developed and maintained by a voluntary consensus standard body.45 An independent...

The CARE guidelines: consensus-based clinical case reporting guideline development

PubMed Central

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2013-01-01

A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

Workshop on Treatment of and Postexposure Prophylaxis for Burkholderia pseudomallei and B. mallei Infection, 2010

PubMed Central

Garges, Susan; Aurigemma, Rosemarie; Baccam, Prasith; Blaney, David D.; Cheng, Allen C.; Currie, Bart J.; Dance, David; Gee, Jay E.; Larsen, Joseph; Limmathurotsakul, Direk; Morrow, Meredith G.; Norton, Robert; O’Mara, Elizabeth; Peacock, Sharon J.; Pesik, Nicki; Rogers, L. Paige; Schweizer, Herbert P.; Steinmetz, Ivo; Tan, Gladys; Tan, Patrick; Wiersinga, W. Joost; Wuthiekanun, Vanaporn; Smith, Theresa L.

2012-01-01

The US Public Health Emergency Medical Countermeasures Enterprise convened subject matter experts at the 2010 HHS Burkholderia Workshop to develop consensus recommendations for postexposure prophylaxis against and treatment for Burkholderia pseudomallei and B. mallei infections, which cause melioidosis and glanders, respectively. Drugs recommended by consensus of the participants are ceftazidime or meropenem for initial intensive therapy, and trimethoprim/sulfamethoxazole or amoxicillin/clavulanic acid for eradication therapy. For postexposure prophylaxis, recommended drugs are trimethoprim/sulfamethoxazole or co-amoxiclav. To improve the timely diagnosis of melioidosis and glanders, further development and wide distribution of rapid diagnostic assays were also recommended. Standardized animal models and B. pseudomallei strains are needed for further development of therapeutic options. Training for laboratory technicians and physicians would facilitate better diagnosis and treatment options. PMID:23171644

Workshop on treatment of and postexposure prophylaxis for Burkholderia pseudomallei and B. mallei Infection, 2010.

PubMed

Lipsitz, Rebecca; Garges, Susan; Aurigemma, Rosemarie; Baccam, Prasith; Blaney, David D; Cheng, Allen C; Currie, Bart J; Dance, David; Gee, Jay E; Larsen, Joseph; Limmathurotsakul, Direk; Morrow, Meredith G; Norton, Robert; O'Mara, Elizabeth; Peacock, Sharon J; Pesik, Nicki; Rogers, L Paige; Schweizer, Herbert P; Steinmetz, Ivo; Tan, Gladys; Tan, Patrick; Wiersinga, W Joost; Wuthiekanun, Vanaporn; Smith, Theresa L

2012-12-01

The US Public Health Emergency Medical Countermeasures Enterprise convened subject matter experts at the 2010 HHS Burkholderia Workshop to develop consensus recommendations for postexposure prophylaxis against and treatment for Burkholderia pseudomallei and B. mallei infections, which cause melioidosis and glanders, respectively. Drugs recommended by consensus of the participants are ceftazidime or meropenem for initial intensive therapy, and trimethoprim/sulfamethoxazole or amoxicillin/clavulanic acid for eradication therapy. For postexposure prophylaxis, recommended drugs are trimethoprim/sulfamethoxazole or co-amoxiclav. To improve the timely diagnosis of melioidosis and glanders, further development and wide distribution of rapid diagnostic assays were also recommended. Standardized animal models and B. pseudomallei strains are needed for further development of therapeutic options. Training for laboratory technicians and physicians would facilitate better diagnosis and treatment options.

NASA Technical Standards Program

NASA Technical Reports Server (NTRS)

Gill, Paul S.; Vaughan, William W.; Parker, Nelson C. (Technical Monitor)

2002-01-01

The NASA Technical Standards Program was officially established in 1997 as result of a directive issued by the Administrator. It is responsible for Agency wide technical standards development, adoption (endorsement), and conversion of Center-unique standards for Agency wide use. One major element of the Program is the review of NSA technical standards products and replacement with non-Government Voluntary Consensus Standards in accordance with directions issued by the Office of Management and Budget. As part of the Program's function, it developed a NASA Integrated Technical Standards Initiative that consists of and Agency wide full-text system, standards update notification system, and lessons learned-standards integration system. The Program maintains a 'one stop-shop' Website for technical standards ad related information on aerospace materials, etc. This paper provides information on the development, current status, and plans for the NAS Technical Standards Program along with metrics on the utility of the products provided to both users within the nasa.gov Domain and the Public Domain.

NASA Technical Standards Program

NASA Technical Reports Server (NTRS)

Gill, Paul S.; Vaughan, WIlliam W.

2003-01-01

The NASA Technical Standards Program was officially established in 1997 as result of a directive issued by the Administrator. It is responsible for Agency wide technical standards development, adoption (endorsement), and conversion of Center-unique standards for Agency wide use. One major element of the Program is the review of NSA technical standards products and replacement with non-Government Voluntary Consensus Standards in accordance with directions issued by the Office of Management and Budget. As part of the Program s function, it developed a NASA Integrated Technical Standards Initiative that consists of and Agency wide full-text system, standards update notification system, and lessons learned - standards integration system. The Program maintains a "one stop-shop" Website for technical standards ad related information on aerospace materials, etc. This paper provides information on the development, current status, and plans for the NAS Technical Standards Program along with metrics on the utility of the products provided to both users within the nasa.gov Domain and the Public Domain.

Consensus Based Definition of Growth Restriction in the Newborn.

PubMed

Beune, Irene M; Bloomfield, Frank H; Ganzevoort, Wessel; Embleton, Nicholas D; Rozance, Paul J; van Wassenaer-Leemhuis, Aleid G; Wynia, Klaske; Gordijn, Sanne J

2018-05-01

To develop a consensus definition of growth restriction in the newborn that can be used clinically to identify newborn infants at risk and in research to harmonize reporting and definition in the current absence of a gold standard. An international panel of pediatric leaders in the field of neonatal growth were invited to participate in an electronic Delphi procedure using standardized methods and predefined consensus rules. Responses were fed back at group-level and the list of participants was provided. Nonresponders were excluded from subsequent rounds. In the first round, variables were scored on a 5-point Likert scale; in subsequent rounds, inclusion of variables and cut-offs were determined with a 70% level of agreement. In the final round participants selected the ultimate algorithm. In total, 57 experts participated in the first round; 79% completed the procedure. Consensus was reached on the following definition: birth weight less than the third percentile, or 3 out of the following: birth weight <10th percentile; head circumference <10th percentile; length <10th percentile; prenatal diagnosis of fetal growth restriction; and maternal pregnancy information. Consensus was reached on a definition for growth restriction in the newborn. This definition recognizes that infants with birth weights <10th percentile may not be growth restricted and that infants with birth weights >10th percentile can be growth restricted. This definition can be adopted in clinical practice and in clinical trials to better focus on newborns at risk, and is complementary to the previously determined definition of fetal growth restriction. Copyright © 2017 Elsevier Inc. All rights reserved.

Assessment, Diagnosis, and Treatment of HIV-Associated Neurocognitive Disorder: A Consensus Report of the Mind Exchange Program

PubMed Central

Antinori, Andrea; Arendt, Gabriele; Grant, Igor; Letendre, Scott; Chair; Muñoz-Moreno, Jose A.; Eggers, Christian; Brew, Bruce; Brouillette, Marie-Josée; Bernal-Cano, Francisco; Carvalhal, Adriana; Christo, Paulo Pereira; Cinque, Paola; Cysique, Lucette; Ellis, Ronald; Everall, Ian; Gasnault, Jacques; Husstedt, Ingo; Korten, Volkan; Machala, Ladislav; Obermann, Mark; Ouakinin, Silvia; Podzamczer, Daniel; Portegies, Peter; Rackstraw, Simon; Rourke, Sean; Sherr, Lorraine; Streinu-Cercel, Adrian; Winston, Alan; Wojna, Valerie; Yazdanpannah, Yazdan; Arbess, Gordon; Baril, Jean-Guy; Begovac, Josip; Bergin, Colm; Bonfanti, Paolo; Bonora, Stefano; Brinkman, Kees; Canestri, Ana; Cholewińska-Szymańska, Graźyna; Chowers, Michal; Cooney, John; Corti, Marcelo; Doherty, Colin; Elbirt, Daniel; Esser, Stefan; Florence, Eric; Force, Gilles; Gill, John; Goffard, Jean-Christophe; Harrer, Thomas; Li, Patrick; de Kerckhove, Linos Van; Knecht, Gaby; Matsushita, Shuzo; Matulionyte, Raimonda; McConkey, Sam; Mouglignier, Antoine; Oka, Shinichi; Penalva, Augusto; Riesenberg, Klaris; Sambatakou, Helen; Tozzi, Valerio; Vassallo, Matteo; Wetterberg, Peter; Drapato, Alicia Wiercińska

2013-01-01

Many practical clinical questions regarding the management of human immunodeficiency virus (HIV)–associated neurocognitive disorder (HAND) remain unanswered. We sought to identify and develop practical answers to key clinical questions in HAND management. Sixty-six specialists from 30 countries provided input into the program, which was overseen by a steering committee. Fourteen questions were rated as being of greatest clinical importance. Answers were drafted by an expert group based on a comprehensive literature review. Sixty-three experts convened to determine consensus and level of evidence for the answers. Consensus was reached on all answers. For instance, good practice suggests that all HIV patients should be screened for HAND early in disease using standardized tools. Follow-up frequency depends on whether HAND is already present or whether clinical data suggest risk for developing HAND. Worsening neurocognitive impairment may trigger consideration of antiretroviral modification when other causes have been excluded. The Mind Exchange program provides practical guidance in the diagnosis, monitoring, and treatment of HAND. PMID:23175555

Procedural considerations for CPV outdoor power ratings per IEC 62670

NASA Astrophysics Data System (ADS)

Muller, Matthew; Kurtz, Sarah; Rodriguez, Jose

2013-09-01

The IEC Working Group 7 (WG7) is in the process of developing a draft procedure for an outdoor concentrating photovoltaic (CPV) module power rating at Concentrator Standard Operating Conditions (CSOC). WG7 recently achieved some consensus that using component reference cells to monitor/limit spectral variation is the preferred path for the outdoor power rating. To build on this consensus, the community must quantify these spectral limits and select a procedure for calculating and reporting a power rating. This work focuses on statistically comparing several procedures the community is considering in context with monitoring/limiting spectral variation.

Society of Vascular and Interventional Neurology (SVIN) Stroke Interventional Laboratory Consensus (SILC) Criteria: A 7M Management Approach to Developing a Stroke Interventional Laboratory in the Era of Stroke Thrombectomy for Large Vessel Occlusions

PubMed Central

Shams, Tanzila; Zaidat, Osama; Yavagal, Dileep; Xavier, Andrew; Jovin, Tudor; Janardhan, Vallabh

2016-01-01

Brain attack care is rapidly evolving with cutting-edge stroke interventions similar to the growth of heart attack care with cardiac interventions in the last two decades. As the field of stroke intervention is growing exponentially globally, there is clearly an unmet need to standardize stroke interventional laboratories for safe, effective, and timely stroke care. Towards this goal, the Society of Vascular and Interventional Neurology (SVIN) Writing Committee has developed the Stroke Interventional Laboratory Consensus (SILC) criteria using a 7M management approach for the development and standardization of each stroke interventional laboratory within stroke centers. The SILC criteria include: (1) manpower: personnel including roles of medical and administrative directors, attending physicians, fellows, physician extenders, and all the key stakeholders in the stroke chain of survival; (2) machines: resources needed in terms of physical facilities, and angiography equipment; (3) materials: medical device inventory, medications, and angiography supplies; (4) methods: standardized protocols for stroke workflow optimization; (5) metrics (volume): existing credentialing criteria for facilities and stroke interventionalists; (6) metrics (quality): benchmarks for quality assurance; (7) metrics (safety): radiation and procedural safety practices. PMID:27610118

Using the modified Delphi method to establish clinical consensus for the diagnosis and treatment of patients with rotator cuff pathology.

PubMed

Eubank, Breda H; Mohtadi, Nicholas G; Lafave, Mark R; Wiley, J Preston; Bois, Aaron J; Boorman, Richard S; Sheps, David M

2016-05-20

Patients presenting to the healthcare system with rotator cuff pathology do not always receive high quality care. High quality care occurs when a patient receives care that is accessible, appropriate, acceptable, effective, efficient, and safe. The aim of this study was twofold: 1) to develop a clinical pathway algorithm that sets forth a stepwise process for making decisions about the diagnosis and treatment of rotator cuff pathology presenting to primary, secondary, and tertiary healthcare settings; and 2) to establish clinical practice guidelines for the diagnosis and treatment of rotator cuff pathology to inform decision-making processes within the algorithm. A three-step modified Delphi method was used to establish consensus. Fourteen experts representing athletic therapy, physiotherapy, sport medicine, and orthopaedic surgery were invited to participate as the expert panel. In round 1, 123 best practice statements were distributed to the panel. Panel members were asked to mark "agree" or "disagree" beside each statement, and provide comments. The same voting method was again used for round 2. Round 3 consisted of a final face-to-face meeting. In round 1, statements were grouped and reduced to 44 statements that met consensus. In round 2, five statements reached consensus. In round 3, ten statements reached consensus. Consensus was reached for 59 statements representing five domains: screening, diagnosis, physical examination, investigations, and treatment. The final face-to-face meeting was also used to develop clinical pathway algorithms (i.e., clinical care pathways) for three types of rotator cuff pathology: acute, chronic, and acute-on-chronic. This consensus guideline will help to standardize care, provide guidance on the diagnosis and treatment of rotator cuff pathology, and assist in clinical decision-making for all healthcare professionals.

Design of a consensus-derived synoptic operative report for lung cancer surgery.

PubMed

Schneider, Laura; Shargall, Yaron; Schieman, Colin; Seely, Andrew J; Srinathan, Sadeesh; Malthaner, Richard A; Pierre, Andrew F; Safieddine, Najib; Vaillancourt, Rosaire; Plourde, Madelaine; Bond, James; Johnson, Scott; Smith, Shona E; Finley, Christian J

2014-04-01

For lung cancer surgery, a narrative operative report is the standard reporting procedure, whereas a synoptic-style report is increasingly utilized by healthcare professionals in various specialties with great success. A synoptic operative report more succinctly and accurately captures vital information and is rapidly generated with good intraobserver reliability. The objective of this study was to systematically develop a synoptic operative report for lung cancer surgery following a modified Delphi consensus model with the support of the Canadian thoracic surgery community. Using online survey software, thoracic surgeons and related physicians were asked to suggest and rate data elements for a synoptic report following the modified Delphi consensus model. The consensus exercise-derived template was forwarded to a small working group, who further refined the definition and priority designation of elements until the working group had reached a satisfactory consensus. In all, 139 physicians were invited to participate in the consensus exercise, with 36.7%, 44.6%, and 19.5% response rates, respectively, in the three rounds. Eighty-nine elements were agreed upon at the conclusion of the exercise, but 141 elements were forwarded to the working group. The working group agreed upon a final data set of 180 independently defined data elements, with 72 mandatory and 108 optional elements for implementation in the final report. This study demonstrates the process involved in developing a multidisciplinary, consensus-based synoptic lung cancer operative report. This novel report style is a quality improvement initiative to improve the capture, dissemination, readability, and potential utility of critical surgical information. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

PubMed

Chappell, Phillip B; Stewart, Michelle; Alphs, Larry; DiCesare, Franco; DuBrava, Sarah; Harkavy-Friedman, Jill; Lim, Pilar; Ratcliffe, Sian; Silverman, Morton M; Targum, Steven D; Marder, Stephen R

2017-06-01

To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials. Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting. Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting. Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded. All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions. © Copyright 2017 Physicians Postgraduate Press, Inc.

Is solvent/detergent plasma better than standard fresh-frozen plasma? A systematic review and an expert consensus document

PubMed Central

Marietta, Marco; Franchini, Massimo; Bindi, M. Lucia; Picardi, Francesco; Ruggeri, Matteo; De Silvestro, Giustina

2016-01-01

Background Only a few studies have compared solvent/detergent plasma (SD-plasma) to standard fresh-frozen plasma (FFP) in terms of efficacy and safety. Materials and methods A systematic review was performed in order to develop a consensus document on the use of SD-plasma. Moreover, a pharmacoeconomic study was performed in order to assess whether the use of SD-plasma can be cost-effective with respect to the use of FFP. A multidisciplinary panel used the systematic review and the GRADE methodology to develop evidence-based recommendations on this topic. Results Based on moderate to very low quality evidence, the panel developed the following consensus statements: (i) the panel suggested that SD-plasma is safer than FFP; (ii) the panel could not express for or against a greater efficacy of SD-plasma as compared to FFP; (iii) the panel suggested that in patients undergoing liver transplantation SD-plasma can be preferred over FFP; (iv) the panel suggested that SD-plasma can be preferred over FFP in patients with thrombotic thrombocytopenic purpura undergoing plasma-exchange procedures; (v) the panel could not recommend for or against preferring SD-plasma over FFP in critical care patients; and (vi) the panel suggested that the use of SD-plasma can be cost-effective with respect to the use of FFP. Discussion Data from additional randomised studies are needed to establish more definitive guidelines on the use of SD-plasma. PMID:27136429

Detecting inflammation in inflammatory bowel disease - how does ultrasound compare to magnetic resonance enterography using standardised scoring systems?

PubMed

Barber, Joy L; Zambrano-Perez, Alexsandra; Olsen, Øystein E; Kiparissi, Fevronia; Baycheva, Mila; Knaflez, Daniela; Shah, Neil; Watson, Tom A

2018-06-01

Magnetic resonance enterography (MRE) is the current gold standard for imaging in inflammatory bowel disease, but ultrasound (US) is a potential alternative. To determine whether US is as good as MRE for the detecting inflamed bowel, using a combined consensus score as the reference standard. We conducted a retrospective cohort study in children and adolescents <18 years with inflammatory bowel disease (IBD) at a tertiary and quaternary centre. We included children who underwent MRE and US within 4 weeks. We scored MRE using the London score and US using a score adapted from the METRIC (MR Enterography or Ultrasound in Crohn's Disease) trial. Four gastroenterologists assessed an independent clinical consensus score. A combined consensus score using the imaging and clinical scores was agreed upon and used as the reference standard to compare MRE with US. We included 53 children. At a whole-patient level, MRE scores were 2% higher than US scores. We used Lin coefficient to assess inter-observer variability. The repeatability of MRE scores was poor (Lin 0.6). Agreement for US scoring was substantial (Lin 0.95). There was a significant positive correlation between MRE and clinical consensus scores (Spearman's rho = 0.598, P=0.0053) and US and clinical consensus scores (Spearman's rho = 0.657, P=0.0016). US detects as much clinically significant bowel disease as MRE. It is possible that MRE overestimates the presence of disease when using a scoring system. This study demonstrates the feasibility of using a clinical consensus reference standard in paediatric IBD imaging studies.

Asian-Pacific Association for the Study of the Liver (APASL) consensus guidelines on invasive and non-invasive assessment of hepatic fibrosis: a 2016 update.

PubMed

Shiha, Gamal; Ibrahim, Alaa; Helmy, Ahmed; Sarin, Shiv Kumar; Omata, Masao; Kumar, Ashish; Bernstien, David; Maruyama, Hitushi; Saraswat, Vivek; Chawla, Yogesh; Hamid, Saeed; Abbas, Zaigham; Bedossa, Pierre; Sakhuja, Puja; Elmahatab, Mamun; Lim, Seng Gee; Lesmana, Laurentius; Sollano, Jose; Jia, Ji-Dong; Abbas, Bahaa; Omar, Ashraf; Sharma, Barjesh; Payawal, Diana; Abdallah, Ahmed; Serwah, Abdelhamid; Hamed, Abdelkhalek; Elsayed, Aly; AbdelMaqsod, Amany; Hassanein, Tarek; Ihab, Ahmed; GHaziuan, Hamsik; Zein, Nizar; Kumar, Manoj

2017-01-01

Hepatic fibrosis is a common pathway leading to liver cirrhosis, which is the end result of any injury to the liver. Accurate assessment of the degree of fibrosis is important clinically, especially when treatments aimed at reversing fibrosis are being evolved. Despite the fact that liver biopsy (LB) has been considered the "gold standard" of assessment of hepatic fibrosis, LB is not favored by patients or physicians owing to its invasiveness, limitations, sampling errors, etc. Therefore, many alternative approaches to assess liver fibrosis are gaining more popularity and have assumed great importance, and many data on such approaches are being generated. The Asian Pacific Association for the Study of the Liver (APASL) set up a working party on liver fibrosis in 2007, with a mandate to develop consensus guidelines on various aspects of liver fibrosis relevant to disease patterns and clinical practice in the Asia-Pacific region. The first consensus guidelines of the APASL recommendations on hepatic fibrosis were published in 2009. Due to advances in the field, we present herein the APASL 2016 updated version on invasive and non-invasive assessment of hepatic fibrosis. The process for the development of these consensus guidelines involved review of all available published literature by a core group of experts who subsequently proposed consensus statements followed by discussion of the contentious issues and unanimous approval of the consensus statements. The Oxford System of the evidence-based approach was adopted for developing the consensus statements using the level of evidence from one (highest) to five (lowest) and grade of recommendation from A (strongest) to D (weakest). The topics covered in the guidelines include invasive methods (LB and hepatic venous pressure gradient measurements), blood tests, conventional radiological methods, elastography techniques and cost-effectiveness of hepatic fibrosis assessment methods, in addition to fibrosis assessment in special and rare situations.

How to Choose? Using the Delphi Method to Develop Consensus Triggers and Indicators for Disaster Response.

PubMed

Lis, Rebecca; Sakata, Vicki; Lien, Onora

2017-08-01

To identify key decisions along the continuum of care (conventional, contingency, and crisis) and the critical triggers and data elements used to inform those decisions concerning public health and health care response during an emergency. A classic Delphi method, a consensus-building survey technique, was used with clinicians around Washington State to identify regional triggers and indicators. Additionally, using a modified Delphi method, we combined a workshop and single-round survey with panelists from public health (state and local) and health care coalitions to identify consensus state-level triggers and indicators. In the clinical survey, 122 of 223 proposed triggers or indicators (43.7%) reached consensus and were deemed important in regional decision-making during a disaster. In the state-level survey, 110 of 140 proposed triggers or indicators (78.6%) reached consensus and were deemed important in state-level decision-making during a disaster. The identification of consensus triggers and indicators for health care emergency response is crucial in supporting a comprehensive health care situational awareness process. This can inform the creation of standardized questions to ask health care, public health, and other partners to support decision-making during a response. (Disaster Med Public Health Preparedness. 2017;11:467-472).

The role of stakeholders in developing an international regulatory framework for carbon capture and storage

NASA Astrophysics Data System (ADS)

Augustin, C. M.; Broad, K.; Swart, P. K.

2011-12-01

It is estimated that carbon capture and storage (CCS) could be used to achieve between 15% and 55% of the carbon emission reductions necessary to avoid dangerous levels of climate change. It is also believed that achieving emission reduction goals will be less costly with CCS than without it. The expansion of active CCS sites over the past decade, from three to 53 demonstrates the value that industry sees in CCS as a transition technology for governments seeking to reduce their CO2 emissions. However, to continue developing CCS for industry scale implementation, it is essential to provide the regulatory certainty needed to foster energy industry wide adoption of CCS. Existing CCS regulatory regimes are inadequate, fragmented and contradictory. There is a need for comprehensive, unifying regulations for CCS that are flexible enough to adapt as the technology develops. Governments are limited by the fact that carbon capture and storage is a multidisciplinary issue that touches on the fields of oil drilling, groundwater quality, greenhouse gas management, air quality, and risk management. Though it is in part a technological, environmental and management issue there is also a complex political element to tackling the CCS problem. Due to its cross-cutting nature, CCS regulations should be based off the best practices and standards developed by industry stakeholders. Industry standards are stakeholder developed and consensus based, created through a democratic and collaborative process by bodies such as the International Standards Organization, the National Institutes of Standards and Testing (USA), ASTM International, and the Canadian Standards Organization. Standards can typically be broken down into six general categories: test methods, specifications, classifications, practices, guides, and terminology. These standards are created by stakeholders across the industry and across geographic boundaries to create an trade-wide, rather than nationwide, consensus and ensuring that the standards are international in scope. This paper examines regulatory issues post-capture, particularly the transport and geological storage of carbon dioxide and seeks to identify areas where relevant stakeholders should collaborate to develop a comprehensive list of industry standards and provides several case study examples.

Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology.

PubMed

Howes, Oliver D; McCutcheon, Rob; Agid, Ofer; de Bartolomeis, Andrea; van Beveren, Nico J M; Birnbaum, Michael L; Bloomfield, Michael A P; Bressan, Rodrigo A; Buchanan, Robert W; Carpenter, William T; Castle, David J; Citrome, Leslie; Daskalakis, Zafiris J; Davidson, Michael; Drake, Richard J; Dursun, Serdar; Ebdrup, Bjørn H; Elkis, Helio; Falkai, Peter; Fleischacker, W Wolfgang; Gadelha, Ary; Gaughran, Fiona; Glenthøj, Birte Y; Graff-Guerrero, Ariel; Hallak, Jaime E C; Honer, William G; Kennedy, James; Kinon, Bruce J; Lawrie, Stephen M; Lee, Jimmy; Leweke, F Markus; MacCabe, James H; McNabb, Carolyn B; Meltzer, Herbert; Möller, Hans-Jürgen; Nakajima, Shinchiro; Pantelis, Christos; Reis Marques, Tiago; Remington, Gary; Rossell, Susan L; Russell, Bruce R; Siu, Cynthia O; Suzuki, Takefumi; Sommer, Iris E; Taylor, David; Thomas, Neil; Üçok, Alp; Umbricht, Daniel; Walters, James T R; Kane, John; Correll, Christoph U

2017-03-01

Research and clinical translation in schizophrenia is limited by inconsistent definitions of treatment resistance and response. To address this issue, the authors evaluated current approaches and then developed consensus criteria and guidelines. A systematic review of randomized antipsychotic clinical trials in treatment-resistant schizophrenia was performed, and definitions of treatment resistance were extracted. Subsequently, consensus operationalized criteria were developed through 1) a multiphase, mixed methods approach, 2) identification of key criteria via an online survey, and 3) meetings to achieve consensus. Of 2,808 studies identified, 42 met inclusion criteria. Of these, 21 studies (50%) did not provide operationalized criteria. In the remaining studies, criteria varied considerably, particularly regarding symptom severity, prior treatment duration, and antipsychotic dosage thresholds; only two studies (5%) utilized the same criteria. The consensus group identified minimum and optimal criteria, employing the following principles: 1) current symptoms of a minimum duration and severity determined by a standardized rating scale; 2) moderate or worse functional impairment; 3) prior treatment consisting of at least two different antipsychotic trials, each for a minimum duration and dosage; 4) systematic monitoring of adherence and meeting of minimum adherence criteria; 5) ideally at least one prospective treatment trial; and 6) criteria that clearly separate responsive from treatment-resistant patients. There is considerable variation in current approaches to defining treatment resistance in schizophrenia. The authors present consensus guidelines that operationalize criteria for determining and reporting treatment resistance, adequate treatment, and treatment response, providing a benchmark for research and clinical translation.

Equipped for the Future Content Standards. What Adults Need To Know and Be Able To Do in the 21st Century.

ERIC Educational Resources Information Center

Stein, Sondra

This document presents the Equipped for the Future Framework (EFF) content standards that were developed over a 6-year period by hundreds of adult education practitioners, experts, and others nationwide to create a working consensus on what adults need to know and be able to do in the 21st century. Chapter 1 defines adult literacy for the 21st…

National Standards for History for Grades K-4: Expanding Children's World in Time and Space. Expanded Edition. Including Examples of Student Achievement for Grades K-2 and 3-4.

ERIC Educational Resources Information Center

Crabtree, Charlotte; Nash, Gary B.

Developed through a broad-based national consensus building process, the national history standards project has involved working toward agreement both on the larger purposes of history in the school curriculum and on the more specific history understandings and thinking processes all students should have equal opportunity to acquire over 12 years…

EDRN Standard Operating Procedures (SOP) — EDRN Public Portal

Cancer.gov

The NCI’s Early Detection Research Network is developing a number of standard operating procedures for assays, methods, and protocols for collection and processing of biological samples, and other reference materials to assist investigators to conduct experiments in a consistent, reliable manner. These SOPs are established by the investigators of the Early Detection Research Network to maintain constancy throughout the Network. These SOPs represent neither a consensus, nor are the recommendations of NCI.

Data Management Rubric for Video Data in Organismal Biology.

PubMed

Brainerd, Elizabeth L; Blob, Richard W; Hedrick, Tyson L; Creamer, Andrew T; Müller, Ulrike K

2017-07-01

Standards-based data management facilitates data preservation, discoverability, and access for effective data reuse within research groups and across communities of researchers. Data sharing requires community consensus on standards for data management, such as storage and formats for digital data preservation, metadata (i.e., contextual data about the data) that should be recorded and stored, and data access. Video imaging is a valuable tool for measuring time-varying phenotypes in organismal biology, with particular application for research in functional morphology, comparative biomechanics, and animal behavior. The raw data are the videos, but videos alone are not sufficient for scientific analysis. Nearly endless videos of animals can be found on YouTube and elsewhere on the web, but these videos have little value for scientific analysis because essential metadata such as true frame rate, spatial calibration, genus and species, weight, age, etc. of organisms, are generally unknown. We have embarked on a project to build community consensus on video data management and metadata standards for organismal biology research. We collected input from colleagues at early stages, organized an open workshop, "Establishing Standards for Video Data Management," at the Society for Integrative and Comparative Biology meeting in January 2017, and then collected two more rounds of input on revised versions of the standards. The result we present here is a rubric consisting of nine standards for video data management, with three levels within each standard: good, better, and best practices. The nine standards are: (1) data storage; (2) video file formats; (3) metadata linkage; (4) video data and metadata access; (5) contact information and acceptable use; (6) camera settings; (7) organism(s); (8) recording conditions; and (9) subject matter/topic. The first four standards address data preservation and interoperability for sharing, whereas standards 5-9 establish minimum metadata standards for organismal biology video, and suggest additional metadata that may be useful for some studies. This rubric was developed with substantial input from researchers and students, but still should be viewed as a living document that should be further refined and updated as technology and research practices change. The audience for these standards includes researchers, journals, and granting agencies, and also the developers and curators of databases that may contribute to video data sharing efforts. We offer this project as an example of building community consensus for data management, preservation, and sharing standards, which may be useful for future efforts by the organismal biology research community. © The Author 2017. Published by Oxford University Press on behalf of the Society for Integrative and Comparative Biology.

Data Management Rubric for Video Data in Organismal Biology

PubMed Central

Brainerd, Elizabeth L.; Blob, Richard W.; Hedrick, Tyson L.; Creamer, Andrew T.; Müller, Ulrike K.

2017-01-01

Synopsis Standards-based data management facilitates data preservation, discoverability, and access for effective data reuse within research groups and across communities of researchers. Data sharing requires community consensus on standards for data management, such as storage and formats for digital data preservation, metadata (i.e., contextual data about the data) that should be recorded and stored, and data access. Video imaging is a valuable tool for measuring time-varying phenotypes in organismal biology, with particular application for research in functional morphology, comparative biomechanics, and animal behavior. The raw data are the videos, but videos alone are not sufficient for scientific analysis. Nearly endless videos of animals can be found on YouTube and elsewhere on the web, but these videos have little value for scientific analysis because essential metadata such as true frame rate, spatial calibration, genus and species, weight, age, etc. of organisms, are generally unknown. We have embarked on a project to build community consensus on video data management and metadata standards for organismal biology research. We collected input from colleagues at early stages, organized an open workshop, “Establishing Standards for Video Data Management,” at the Society for Integrative and Comparative Biology meeting in January 2017, and then collected two more rounds of input on revised versions of the standards. The result we present here is a rubric consisting of nine standards for video data management, with three levels within each standard: good, better, and best practices. The nine standards are: (1) data storage; (2) video file formats; (3) metadata linkage; (4) video data and metadata access; (5) contact information and acceptable use; (6) camera settings; (7) organism(s); (8) recording conditions; and (9) subject matter/topic. The first four standards address data preservation and interoperability for sharing, whereas standards 5–9 establish minimum metadata standards for organismal biology video, and suggest additional metadata that may be useful for some studies. This rubric was developed with substantial input from researchers and students, but still should be viewed as a living document that should be further refined and updated as technology and research practices change. The audience for these standards includes researchers, journals, and granting agencies, and also the developers and curators of databases that may contribute to video data sharing efforts. We offer this project as an example of building community consensus for data management, preservation, and sharing standards, which may be useful for future efforts by the organismal biology research community. PMID:28881939

14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Technical criteria for reviewing a safety approval application. 414.19 Section 414.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... regulations. (2) Government-developed or adopted standards. (3) Industry consensus performance-based criteria...

Dance Education in American Public Schools.

ERIC Educational Resources Information Center

Knowles, Patricia

1993-01-01

Reviews issues related to preservice teacher education in dance. Asserts that the development of national standards in arts education has led to a consensus on teacher education. Maintains that, for the first time in U.S. educational history, dance is included in the fine arts curriculum, rather than in physical education. (CFR)

Examining Evidence Construction as the Transformation of the Material World into Community Knowledge

ERIC Educational Resources Information Center

Manz, Eve

2016-01-01

Recent consensus documents in science education (e.g., the Next Generation Science Standards) emphasize helping students develop facility with constructing and critiquing both claims and the evidence that supports them. While students typically view evidence as necessary for supporting scientific claims, they tend to "objectify"…

Reports of the Hope College Conference on Designing the Undergraduate Curriculum in Communication.

ERIC Educational Resources Information Center

Rosenthal, Ann

2002-01-01

Presents in full a consensus document produced from the 2000 Hope College National Communication Association Faculty Development Institute conference. Agrees that all graduates of an undergraduate degree program in communication should meet conceptual and competency standards in eight different areas: theoretical approaches, sensitivity to diverse…

The International Confederation of Midwives: Global Standards for Midwifery Education (2010) with companion guidelines.

PubMed

Thompson, Joyce B; Fullerton, Judith T; Sawyer, Angela J

2011-08-01

a 2-year study was conducted to develop Global Standards for Midwifery Education in keeping with core documents of the International Confederation of Midwives. Elements of the standards were based on evidence available in the published and unpublished literature. Companion Guidelines to assist in implementing the standards were also developed. a modified Delphi survey process was conducted in two rounds following item validation by a panel of midwifery education experts. a global survey conducted in 88 countries. midwifery educators and clinicians associated with midwifery education located in any of the ICM member association countries. Additional participants included an Expert Midwifery Resource Group, other Key Stakeholders, midwifery regulators and policy makers. A total of 241 individuals from 46 ICM member association countries and ten non-member countries responded to one or both of the survey rounds. survey respondents expressed an opinion on whether to retain or to delete any of the proposed components of the standards. Version one had 109 proposed components and version two had 111 items for consideration. a majority consensus of .80 was required to accept an item without further deliberation. The Education Standards Task Force (expert panel) made final decisions in the four instances where this level of consensus was not reached, retaining all four items. The panel also amended the wording of selected items or added new items based on feedback received from survey respondents. The final document contains 10 Preface items, 35 glossary terms, and 37 discrete standards with 27 sub-sections. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Physiotherapeutic assessment of chronic pelvic pain syndrome : Development of a standardized physiotherapeutic assessment instrument for interprofessional cooperation in patients with chronic pelvic pain syndrome].

PubMed

Klotz, S G R; Ketels, G; Richardsen, B; Löwe, B; Brünahl, C A

2018-04-24

The chronic pelvic pain syndrome (CPPS) can be associated with physiotherapeutic findings. An interprofessional approach is recommended for patients with CPPS; however, no standardized physiotherapeutic assessment and documentation instrument for specific physiotherapeutic assessments exist, which is not only the foundation for physiotherapy but also for interprofessional communication. The aim was the development of a physiotherapeutic assessment instrument for patients with CPPS and therefore, to create a tool for clinical use, research and interprofessional communication. Based on an explorative literature search and an expert consensus, the first version of the instrument was developed as part of a specialized outpatient clinic. This version was applied clinically for 13 months, edited and finalized after another expert consensus. The developed instrument Physical Therapy Assessment for Chronic Pelvic Pain Syndrome (PTA-CPPS) lists external and internal groups of muscles for a systematic assessment of myofascial findings. Functional capacity, breathing movements as well as scars and regions of pain are recorded. A manual for the assessment protocol was developed as accompanying material. The developed instrument provides for the first time a physiotherapeutic assessment tool for patients with CPPS for interprofessional clinical and scientific use.

Democracy-based consensus in medicine.

PubMed

Greco, Massimiliano; Zangrillo, Alberto; Mucchetti, Marta; Nobile, Leda; Landoni, Paolo; Bellomo, Rinaldo; Landoni, Giovanni

2015-04-01

High-quality evidence and derived guidelines, as typically published in major academic journals, are a major process that shapes physician decision-making worldwide. However, for many aspects of medical practice, there is a lack of High-quality evidence or an overload of somewhat contradictory low-quality information, which makes decision-making a difficult, uncertain, and unpredictable process. When the issues in question are important and evidence limited or controversial, the medical community seeks to establish common ground for "best practice" through consensus conferences and consensus statements or guidelines. Such consensus statements are seen as a useful tool to establish expert agreement, define the boundaries of acceptable practice, provide priorities for the research agenda, and obtain opinions from different countries and healthcare systems. This standard approach, however, can be criticized for being elitist, noninclusive, and poorly representative of the community of clinicians who will have to make decisions about the implementation of such recommendations. Accordingly, the authors propose a new model based on a combination of a local core meeting (detailed review and expert input) followed by a worldwide web-based network assessment (democracy-based consensus). The authors already have applied this approach to develop consensus on all nonsurgical interventions that increase or reduce perioperative mortality in critically ill patients and in those with acute kidney injury. The methodology was based on 5 sequential local and web-based steps. Both a panel of experts and a large number of professionals from all over the world were involved, giving birth to a new type of "democracy-based consensus." This new type of "democracy-based consensus" has the potential to increase grass-root clinician involvement, expand the reach to less-developed countries, provide a more global perspective on proposed interventions, and perhaps more importantly, increase awareness, ownership, and the statistical likelihood of subsequent implementation. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel.

PubMed

Graham, Stephen M; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E; Gale, Marianne; Gie, Robert P; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J; McNeeley, David F; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R; Swaminathan, Soumya; Wingfield, Claire

2012-05-15

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Priorities for Standards and Measurements to Accelerate Innovations in Nano-Electrotechnologies: Analysis of the NIST-Energetics-IEC TC 113 Survey+,*

PubMed Central

Bennett, Herbert S.; Andres, Howard; Pellegrino, Joan; Kwok, Winnie; Fabricius, Norbert; Chapin, J. Thomas

2009-01-01

In 2008, the National Institute of Standards and Technology and Energetics Incorporated collaborated with the International Electrotechnical Commission Technical Committee 113 (IEC TC 113) on nano-electrotechnologies to survey members of the international nanotechnologies community about priorities for standards and measurements to accelerate innovations in nano-electrotechnologies. In this paper, we analyze the 459 survey responses from 45 countries as one means to begin building a consensus on a framework leading to nano-electrotechnologies standards development by standards organizations and national measurement institutes. The distributions of priority rankings from all 459 respondents are such that there are perceived distinctions with statistical confidence between the relative international priorities for the several items ranked in each of the following five Survey category types: 1) Nano-electrotechnology Properties, 2) Nano-electrotechnology Taxonomy: Products, 3) Nano-electrotechnology Taxonomy: Cross-Cutting Technologies, 4) IEC General Discipline Areas, and 5) Stages of the Linear Economic Model. The global consensus prioritizations for ranked items in the above five category types suggest that the IEC TC 113 should focus initially on standards and measurements for electronic and electrical properties of sensors and fabrication tools that support performance assessments of nano-technology enabled sub-assemblies used in energy, medical, and computer products. PMID:27504216

29 CFR (non - mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 8 2011-07-01 2011-07-01 false mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards (Non Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Scaffolds Pt. 1926, Subpt. L, App. C ...

29 CFR (non - mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 8 2012-07-01 2012-07-01 false mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards (Non Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Scaffolds Pt. 1926, Subpt. L, App. C ...

29 CFR (non - mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 8 2013-07-01 2013-07-01 false mandatory) Appendix C to Subpart L of Part 1926-List of National Consensus Standards (Non Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Scaffolds Pt. 1926, Subpt. L, App. C ...

How Do You Measure That Ceramic Property?

NASA Technical Reports Server (NTRS)

Salem, Jonathan; Helfinstine, John; Quinn, George; Gonczy, Stephen

2011-01-01

By using the dozens of consensus test standards and practices developed by the Advanced Ceramics Committee of ASTM, C-28, the measurement of mechanical, physical, thermal, and performance properties can be properly performed. The what, how, how not, and why are clearly illustrated for beginning as well as experienced testers. Using these standards will provide accurate, reliable, and complete data for rigorous comparisons with other test results. The C-28 Committee has involved academics, and producers, and users of ceramics to write and continually update more than 45 standards since the committee's inception in 1986.

Publication Guidelines for Quality Improvement Studies in Health Care: Evolution of the SQUIRE Project

PubMed Central

Batalden, Paul; Stevens, David; Ogrinc, Greg; Mooney, Susan

2008-01-01

In 2005 we published draft guidelines for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. The current article contains the revised version, which we refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). We describe the consensus process, which included informal feedback, formal written commentaries, input from publication guideline developers, review of the literature on the epistemology of improvement and on methods for evaluating complex social programs, and a meeting of stakeholders for critical review of the guidelines’ content and wording, followed by commentary on sequential versions from an expert consultant group. Finally, we examine major differences between SQUIRE and the initial draft, and consider limitations of and unresolved questions about SQUIRE; we also describe ancillary supporting documents and alternative versions under development, and plans for dissemination, testing, and further development of SQUIRE. PMID:18830766

It's not what you do it's the way that it's measured: quality assessment of minor ailment management in community pharmacies.

PubMed

Inch, Jackie; Porteous, Terry; Maskrey, Vivienne; Blyth, Annie; Burr, Jackie; Cleland, Jennifer; Wright, David J; Holland, Richard; Bond, Christine M; Watson, Margaret C

2017-08-01

Effective management of minor ailments in community pharmacies could reduce the burden on alternative high-cost services (general practices, Emergency Departments). Evidence is needed regarding the appropriateness of management of these conditions in community pharmacies. To explore the appropriateness of minor ailment management in community pharmacies. Prospective, observational study of simulated patient (SP) visits to community pharmacies in Grampian (Scotland) and East Anglia (England). Eighteen pharmacies (nine per centre) were recruited within a 25-mile radius of Aberdeen or Norwich. Consultations for four minor ailments were evaluated: back pain; vomiting/diarrhoea; sore throat; and eye discomfort. Each pharmacy received one SP visit per ailment (four visits/pharmacy; 72 visits total). Visits were audio-recorded and SPs completed a data collection form immediately after each visit. Each SP consultation was assessed for appropriateness against product licence, practice guidelines and study-specific consensus standards developed by a multi-disciplinary consensus panel. Evaluable data were available for 68/72 (94.4%) visits. Most (96%) visits resulted in the sale of a product; advice alone was the outcome of three visits. All product sales complied with the product licence, 52 (76%) visits complied with practice guidelines and seven visits achieved a 'basic' standard according to the consensus standard. Appropriateness of care varied according to the standard used. Pharmacy-specific quality standards are needed which are realistic and relevant to the pharmacy context and which reflect legal and clinical guidelines to promote the safe and effective management of minor ailments in this setting. © 2016 The Authors. International Journal of Pharmacy Practice published by John Wiley & Sons Ltd on behalf of Royal Pharmaceutical Society.

Curriculum guidelines and standards for dental laser education

NASA Astrophysics Data System (ADS)

White, Joel M.; et al.

1993-07-01

The curriculum guidelines for dental laser education were developed through a consensus process with members from dental academia, industry and private practice. This document was developed at a workshop on the development of standards for dental laser education and laser instructor certification held at the University of California, San Francisco on July 25 and 26, 1992. A working draft is currently being circulated among dental laser educators, researchers, practitioners, organized dentistry and members of industry. After further discussion, modification and review, the final document will be widely distributed and updated annually. Any questions concerning the guidelines may be addressed to the authors of this document in care of the organizer. Suggestions for the improvement of this standard and endorsement of this document are invited.

Developing a clinical pathway for the identification and management of anxiety and depression in adult cancer patients: an online Delphi consensus process.

PubMed

Shaw, Joanne M; Price, Melanie A; Clayton, Josephine M; Grimison, Peter; Shaw, Tim; Rankin, Nicole; Butow, Phyllis N

2016-01-01

People with cancer and their families experience high levels of psychological morbidity. However, many cancer services do not routinely screen patients for anxiety and depression, and there are no standardized clinical referral pathways. This study aimed to establish consensus on elements of a draft clinical pathway tailored to the Australian context. A two-round Delphi study was conducted to gain consensus among Australian oncology and psycho-oncology clinicians about the validity of 39 items that form the basis of a clinical pathway that includes screening, assessment, referral and stepped care management of anxiety and depression in the context of cancer. The expert panel comprised 87 multidisciplinary clinician members of the Australian Psycho-oncology Co-operative Research Group (PoCoG). Respondents rated their level of agreement with each statement on a 5-point Likert scale. Consensus was defined as >80% of respondents scoring within 2 points on the Likert scale. Consensus was reached for 21 of 39 items, and a further 15 items approached consensus except for specific contextual factors, after two Delphi rounds. Formal screening for anxiety and depression, a stepped care model of management and recommendations for inclusion of length of treatment and time to review were endorsed. Consensus was not reached on items related to roles and responsibilities, particularly those not applicable across cancer settings. This study identified a core set of evidence- and consensus-based principles considered essential to a stepped care model of care incorporating identification, referral and management of anxiety and depression in adult cancer patients.

Adolescence transitional care in neurogenic detrusor overactivity and the use of OnabotulinumtoxinA: A clinical algorithm from an Italian consensus statement.

PubMed

Palleschi, Giovanni; Mosiello, Giovanni; Iacovelli, Valerio; Musco, Stefania; Del Popolo, Giulio; Giannantoni, Antonella; Carbone, Antonio; Carone, Roberto; Tubaro, Andrea; De Gennaro, Mario; Marte, Antonio; Finazzi Agrò, Enrico

2018-03-01

OnabotulinumtoxinA (onaBNTa) for treating neurogenic detrusor overactivity (NDO) is widely used after its regulatory approval in adults. Although the administration of onaBNTa is still considered off-label in children, data have already been reported on its efficacy and safety. Nowadays, there is a lack of standardized protocols for treatment of NDO with onaBNTa in adolescent patients in their transition from the childhood to the adult age. With the aim to address this issue a consensus panel was obtained. A panel of leading urologists and urogynaecologists skilled in functional urology, neuro-urology, urogynaecology, and pediatric urology participated in a consensus-forming project using a Delphi method to reach national consensus on NDO-onaBNTa treatment in adolescence transitional care. In total, 11 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥70% of the experts agreed on recommendations. To facilitate a common understanding among all experts, a face-to-face consensus meeting was held in Rome in march 2015 and then with a follow-up teleconference in march 2017. By the end of the Delphi process, formal consensus was achieved for 100% of the items and an algorithm was then developed. This manuscript represents the first report on the onaBNTa in adolescents. Young adults should be treated as a distinct sub-population in policy, planning, programming, and research, as strongly sustained by national public health care. This consensus and the algorithm could support multidisciplinary communication, reduce the extent of variations in clinical practice and optimize clinical decision making. © 2017 Wiley Periodicals, Inc.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

PubMed Central

Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O’Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

2017-01-01

Objectives We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. Design and methods This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. Outcome We developed principles and practical recommendations on how to share data from clinical trials. Results The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. Conclusions The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains. PMID:29247106

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus

PubMed Central

Rezaie, Ali; Buresi, Michelle; Lembo, Anthony; Lin, Henry; McCallum, Richard; Rao, Satish; Schmulson, Max; Valdovinos, Miguel; Zakko, Salam; Pimentel, Mark

2017-01-01

Objectives: Breath tests (BTs) are important for the diagnosis of carbohydrate maldigestion syndromes and small intestinal bacterial overgrowth (SIBO). However, standardization is lacking regarding indications for testing, test methodology and interpretation of results. A consensus meeting of experts was convened to develop guidelines for clinicians and research. Methods: Pre-meeting survey questions encompassing five domains; indications, preparation, performance, interpretation of results, and knowledge gaps, were sent to 17 clinician-scientists, and 10 attended a live meeting. Using an evidence-based approach, 28 statements were finalized and voted on anonymously by a working group of specialists. Results: Consensus was reached on 26 statements encompassing all five domains. Consensus doses for lactulose, glucose, fructose and lactose BT were 10, 75, 25 and 25 g, respectively. Glucose and lactulose BTs remain the least invasive alternatives to diagnose SIBO. BT is useful in the diagnosis of carbohydrate maldigestion, methane-associated constipation, and evaluation of bloating/gas but not in the assessment of oro-cecal transit. A rise in hydrogen of ≥20 p.p.m. by 90 min during glucose or lactulose BT for SIBO was considered positive. Methane levels ≥10 p.p.m. was considered methane-positive. SIBO should be excluded prior to BT for carbohydrate malabsorption to avoid false positives. A rise in hydrogen of ≥20 p.p.m. from baseline during BT was considered positive for maldigestion. Conclusions: BT is a useful, inexpensive, simple and safe diagnostic test in the evaluation of common gastroenterology problems. These consensus statements should help to standardize the indications, preparation, performance and interpretation of BT in clinical practice and research. PMID:28323273

Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus.

PubMed

Rezaie, Ali; Buresi, Michelle; Lembo, Anthony; Lin, Henry; McCallum, Richard; Rao, Satish; Schmulson, Max; Valdovinos, Miguel; Zakko, Salam; Pimentel, Mark

2017-05-01

Breath tests (BTs) are important for the diagnosis of carbohydrate maldigestion syndromes and small intestinal bacterial overgrowth (SIBO). However, standardization is lacking regarding indications for testing, test methodology and interpretation of results. A consensus meeting of experts was convened to develop guidelines for clinicians and research. Pre-meeting survey questions encompassing five domains; indications, preparation, performance, interpretation of results, and knowledge gaps, were sent to 17 clinician-scientists, and 10 attended a live meeting. Using an evidence-based approach, 28 statements were finalized and voted on anonymously by a working group of specialists. Consensus was reached on 26 statements encompassing all five domains. Consensus doses for lactulose, glucose, fructose and lactose BT were 10, 75, 25 and 25 g, respectively. Glucose and lactulose BTs remain the least invasive alternatives to diagnose SIBO. BT is useful in the diagnosis of carbohydrate maldigestion, methane-associated constipation, and evaluation of bloating/gas but not in the assessment of oro-cecal transit. A rise in hydrogen of ≥20 p.p.m. by 90 min during glucose or lactulose BT for SIBO was considered positive. Methane levels ≥10 p.p.m. was considered methane-positive. SIBO should be excluded prior to BT for carbohydrate malabsorption to avoid false positives. A rise in hydrogen of ≥20 p.p.m. from baseline during BT was considered positive for maldigestion. BT is a useful, inexpensive, simple and safe diagnostic test in the evaluation of common gastroenterology problems. These consensus statements should help to standardize the indications, preparation, performance and interpretation of BT in clinical practice and research.

Polyphasic taxonomy, a consensus approach to bacterial systematics.

PubMed Central

Vandamme, P; Pot, B; Gillis, M; de Vos, P; Kersters, K; Swings, J

1996-01-01

Over the last 25 years, a much broader range of taxonomic studies of bacteria has gradually replaced the former reliance upon morphological, physiological, and biochemical characterization. This polyphasic taxonomy takes into account all available phenotypic and genotypic data and integrates them in a consensus type of classification, framed in a general phylogeny derived from 16S rRNA sequence analysis. In some cases, the consensus classification is a compromise containing a minimum of contradictions. It is thought that the more parameters that will become available in the future, the more polyphasic classification will gain stability. In this review, the practice of polyphasic taxonomy is discussed for four groups of bacteria chosen for their relevance, complexity, or both: the genera Xanthomonas and Campylobacter, the lactic acid bacteria, and the family Comamonadaceae. An evaluation of our present insights, the conclusions derived from it, and the perspectives of polyphasic taxonomy are discussed, emphasizing the keystone role of the species. Taxonomists did not succeed in standardizing species delimitation by using percent DNA hybridization values. Together with the absence of another "gold standard" for species definition, this has an enormous repercussion on bacterial taxonomy. This problem is faced in polyphasic taxonomy, which does not depend on a theory, a hypothesis, or a set of rules, presenting a pragmatic approach to a consensus type of taxonomy, integrating all available data maximally. In the future, polyphasic taxonomy will have to cope with (i) enormous amounts of data, (ii) large numbers of strains, and (iii) data fusion (data aggregation), which will demand efficient and centralized data storage. In the future, taxonomic studies will require collaborative efforts by specialized laboratories even more than now is the case. Whether these future developments will guarantee a more stable consensus classification remains an open question. PMID:8801440

Caries: Review of Human Genetics Research

PubMed Central

Vieira, Alexandre R.; Modesto, Adriana; Marazita, Mary L.

2014-01-01

The NIH Consensus Development Program released a statement in 2001 (NIH Consensus Statement, 2001) and listed six major clinical caries research directions. One of these directions was the need for genetic studies to identify genes and genetic markers of diagnostic, prognostic, and therapeutic value. This last decade has seen a steep increase in studies investigating the presence of genetic factors influencing individual susceptibility to caries. This review revisits recent caries human genetic studies and provides a perspective for future studies in order to fulfill their promise of revolutionizing our understanding of and the standard of care for the most prevalent bacteria-mediated non-contagious disease in the world. PMID:24853115

International consensus on preliminary definitions of improvement in adult and juvenile myositis.

PubMed

Rider, Lisa G; Giannini, Edward H; Brunner, Hermine I; Ruperto, Nicola; James-Newton, Laura; Reed, Ann M; Lachenbruch, Peter A; Miller, Frederick W

2004-07-01

To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials. Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >/=75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation. The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >/=20%, with no more than 2 worse by >/=25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials. Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now proposed for use as end points in all myositis trials.

Procedures for developing allowable properties for a single species under ASTM D1990 and computer programs useful for the calculations

Treesearch

James W. Evans; David E. Kretschmann; Victoria L. Herian; David W. Green

2001-01-01

ASTM D1990, “Establishing Allowable Properties for Visually Graded Dimension Lumber from In-Grade Tests of Full-Size Specimens,” is the consensus standard used to make submissions of allowable properties for many U.S., Canadian, and foreign species to the Board of Review of the American Lumber Standards Committee. Recently, it has become apparent how difficult it is to...

International consensus for neuroblastoma molecular diagnostics: report from the International Neuroblastoma Risk Group (INRG) Biology Committee

PubMed Central

Ambros, P F; Ambros, I M; Brodeur, G M; Haber, M; Khan, J; Nakagawara, A; Schleiermacher, G; Speleman, F; Spitz, R; London, W B; Cohn, S L; Pearson, A D J; Maris, J M

2009-01-01

Neuroblastoma serves as a paradigm for utilising tumour genomic data for determining patient prognosis and treatment allocation. However, before the establishment of the International Neuroblastoma Risk Group (INRG) Task Force in 2004, international consensus on markers, methodology, and data interpretation did not exist, compromising the reliability of decisive genetic markers and inhibiting translational research efforts. The objectives of the INRG Biology Committee were to identify highly prognostic genetic aberrations to be included in the new INRG risk classification schema and to develop precise definitions, decisive biomarkers, and technique standardisation. The review of the INRG database (n=8800 patients) by the INRG Task Force finally enabled the identification of the most significant neuroblastoma biomarkers. In addition, the Biology Committee compared the standard operating procedures of different cooperative groups to arrive at international consensus for methodology, nomenclature, and future directions. Consensus was reached to include MYCN status, 11q23 allelic status, and ploidy in the INRG classification system on the basis of an evidence-based review of the INRG database. Standardised operating procedures for analysing these genetic factors were adopted, and criteria for proper nomenclature were developed. Neuroblastoma treatment planning is highly dependant on tumour cell genomic features, and it is likely that a comprehensive panel of DNA-based biomarkers will be used in future risk assignment algorithms applying genome-wide techniques. Consensus on methodology and interpretation is essential for uniform INRG classification and will greatly facilitate international and cooperative clinical and translational research studies. PMID:19401703

Health promotion competencies: providing a road map for health promotion to assume a prominent role in global health.

PubMed

Shilton, Trevor

2009-06-01

Understanding of health and its determinants is rapidly expanding and changing. The emergence of chronic diseases as the leading cause of global disease burden and improved understanding of social determinants of health has brought greater focus to the role of prevention in health. The IUHPE has shown outstanding leadership through the Galway Consensus Statement. Its three recommendations appropriately focus on stimulating dialogue, developing global consensus and communicating the results to key stakeholders. The IUHPE can further enhance progress of the statement by developing participative processes to ensure engagement and ownership by its members. The Galway Consensus Statement can be used to advance professional standards in global health promotion by: (1) providing a common language by which health promotion and its meaning can be communicated to others; (2) providing a framework for building capacity in the health promotion workforce and in the health workforce in general; (3) providing international consensus for consistency in university health promotion courses; (4) providing a framework for credentialing in health promotion; (5) better informing health promotion engagement with other significant workforce sectors and advancing partnership as a key way of working. A vital further application of the Galway Consensus Statement is to inform advocacy. Advocacy is vital to ensure health promotion is better resourced and prioritized by policy makers. Advocacy and communication are vital tools to highlight the evidence, establish the policy fit and infrastructure requirements of health promotion, and present health promotion solutions based on evidence of effectiveness.

International Expert Panel Consensus Guidelines for Structure and Delivery of Qigong Exercise for Cancer Care Programming

PubMed Central

Klein, Penelope; Picard, George; Schneider, Roger; Oh, Byeongsang

2017-01-01

Integrative oncology, including Qigong, is a relatively new concept in modern healthcare. Evidence of benefits of Qigong in cancer survivors is emerging. As such, several cancer centers, world-wide, have introduced Qigong as part of integrative medicine within supportive cancer care programming. Qigong exercise programming content and quality varies among institutions due to lack of standard guidelines and, at present, relies solely on the instructor’s skills, knowledge, personal preferences and clinical experience. Development of consensus guidelines recommending the basic structure and delivery of Qigong programming in cancer care can potentiate quality assurance and reduce risk of harm. This applied qualitative research utilized a modified Delphi approach to formulate consensus guidelines. Guidelines were developed through discussions among an international expert panel (N = 13) with representation from Australia, Canada, Ireland, and the United States. Panel communication was predominantly conducted by email and occurred from November 2016 through February 2017. Expert panel work resulted in the generation of a work product: Qigong in Cancer Care Guidelines: A Working Paper including: (a) Consensus Guidelines for structure and delivery of Qigong exercise for Cancer care programming; (b) Consensus guidelines for instructor competence for teaching Qigong exercise for cancer care classes; (c) Screening tool for safe participation in Qigong exercise; (d) Class participant instructions for maintaining safety during Qigong exercise; and (e) Advice from the field. Generation of these resources is the first step in establishing recommendations for ‘best practice’ in the area of Qigong for cancer care programming.

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

PubMed

Tricarico, Pierfrancesco; Tardivo, Stefano; Sotgiu, Giovanni; Moretti, Francesca; Poletti, Piera; Fiore, Alberto; Monturano, Massimo; Mura, Ida; Privitera, Gaetano; Brusaferro, Silvio

2016-08-08

Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

Better infrastructure for critical care trials: nomenclature, etymology, and informatics.

PubMed

Singh, Jeffrey M; Ferguson, Niall D

2009-01-01

The goals of this review article are to review the importance and value of standardized definitions in clinical research, as well as to propose the necessary tools and infrastructure needed to advance nosology and medial taxonomy to improve the quality of clinical trials in the field of critical care. We searched MEDLINE for relevant articles, reviewed those selected and their reference lists, and consulted personal files for relevant information. When the pathobiology of diseases is well understood, standard disease definitions can be extremely specific and precise; however, when the pathobiology of the disease is less well understood or more complex, biological markers may not be diagnostically useful or even available. In these cases, syndromic definitions effectively classify and group illnesses with similar symptoms and clinical signs. There is no clear gold standard for the diagnosis of many clinical entities in the intensive care unit, including notably both acute respiratory distress syndrome and sepsis. There are several types of consensus methods that can be used to explicate the judgmental approach that is often needed in these cases, including interactive or consensus groups, the nominal group technique, and the Delphi technique. Ideally, the definition development process will create clear and unambiguous language in which each definition accurately reflects the current understanding of the disease state. The development, implementation, evaluation, revision, and reevaluation of standardized definitions are keys for advancing the quality of clinical trials in the critical care arena.

Thermographic imaging in sports and exercise medicine: A Delphi study and consensus statement on the measurement of human skin temperature.

PubMed

Moreira, Danilo Gomes; Costello, Joseph T; Brito, Ciro J; Adamczyk, Jakub G; Ammer, Kurt; Bach, Aaron J E; Costa, Carlos M A; Eglin, Clare; Fernandes, Alex A; Fernández-Cuevas, Ismael; Ferreira, José J A; Formenti, Damiano; Fournet, Damien; Havenith, George; Howell, Kevin; Jung, Anna; Kenny, Glen P; Kolosovas-Machuca, Eleazar S; Maley, Matthew J; Merla, Arcangelo; Pascoe, David D; Priego Quesada, Jose I; Schwartz, Robert G; Seixas, Adérito R D; Selfe, James; Vainer, Boris G; Sillero-Quintana, Manuel

2017-10-01

The importance of using infrared thermography (IRT) to assess skin temperature (t sk ) is increasing in clinical settings. Recently, its use has been increasing in sports and exercise medicine; however, no consensus guideline exists to address the methods for collecting data in such situations. The aim of this study was to develop a checklist for the collection of t sk using IRT in sports and exercise medicine. We carried out a Delphi study to set a checklist based on consensus agreement from leading experts in the field. Panelists (n = 24) representing the areas of sport science (n = 8; 33%), physiology (n = 7; 29%), physiotherapy (n = 3; 13%) and medicine (n = 6; 25%), from 13 different countries completed the Delphi process. An initial list of 16 points was proposed which was rated and commented on by panelists in three rounds of anonymous surveys following a standard Delphi procedure. The panel reached consensus on 15 items which encompassed the participants' demographic information, camera/room or environment setup and recording/analysis of t sk using IRT. The results of the Delphi produced the checklist entitled "Thermographic Imaging in Sports and Exercise Medicine (TISEM)" which is a proposal to standardize the collection and analysis of t sk data using IRT. It is intended that the TISEM can also be applied to evaluate bias in thermographic studies and to guide practitioners in the use of this technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

Consensus-based recommendations for the management of juvenile dermatomyositis

PubMed Central

Enders, Felicitas Bellutti; Bader-Meunier, Brigitte; Baildam, Eileen; Constantin, Tamas; Dolezalova, Pavla; Feldman, Brian M; Lahdenne, Pekka; Magnusson, Bo; Nistala, Kiran; Ozen, Seza; Pilkington, Clarissa; Ravelli, Angelo; Russo, Ricardo; Uziel, Yosef; van Brussel, Marco; van der Net, Janjaap; Vastert, Sebastiaan; Wedderburn, Lucy R; Wulffraat, Nicolaas; McCann, Liza J; van Royen-Kerkhof, Annet

2017-01-01

Background In 2012, a European initiative called Single Hub and Access point for pediatric Rheumatology in Europe (SHARE) was launched to optimise and disseminate diagnostic and management regimens in Europe for children and young adults with rheumatic diseases. Juvenile dermatomyositis (JDM) is a rare disease within the group of paediatric rheumatic diseases (PRDs) and can lead to significant morbidity. Evidence-based guidelines are sparse and management is mostly based on physicians' experience. Consequently, treatment regimens differ throughout Europe. Objectives To provide recommendations for diagnosis and treatment of JDM. Methods Recommendations were developed by an evidence-informed consensus process using the European League Against Rheumatism standard operating procedures. A committee was constituted, consisting of 19 experienced paediatric rheumatologists and 2 experts in paediatric exercise physiology and physical therapy, mainly from Europe. Recommendations derived from a validated systematic literature review were evaluated by an online survey and subsequently discussed at two consensus meetings using nominal group technique. Recommendations were accepted if >80% agreement was reached. Results In total, 7 overarching principles, 33 recommendations on diagnosis and 19 recommendations on therapy were accepted with >80% agreement among experts. Topics covered include assessment of skin, muscle and major organ involvement and suggested treatment pathways. Conclusions The SHARE initiative aims to identify best practices for treatment of patients suffering from PRD. Within this remit, recommendations for the diagnosis and treatment of JDM have been formulated by an evidence-informed consensus process to produce a standard of care for patients with JDM throughout Europe. PMID:27515057

2 nd Brazilian Consensus on Chagas Disease, 2015.

PubMed

Dias, João Carlos Pinto; Ramos, Alberto Novaes; Gontijo, Eliane Dias; Luquetti, Alejandro; Shikanai-Yasuda, Maria Aparecida; Coura, José Rodrigues; Torres, Rosália Morais; Melo, José Renan da Cunha; Almeida, Eros Antonio de; Oliveira, Wilson de; Silveira, Antônio Carlos; Rezende, Joffre Marcondes de; Pinto, Fabiane Scalabrini; Ferreira, Antonio Walter; Rassi, Anis; Fragata, Abílio Augusto; Sousa, Andréa Silvestre de; Correia, Dalmo; Jansen, Ana Maria; Andrade, Glaucia Manzan Queiroz; Britto, Constança Felícia De Paoli de Carvalho; Pinto, Ana Yecê das Neves; Rassi, Anis; Campos, Dayse Elisabeth; Abad-Franch, Fernando; Santos, Silvana Eloi; Chiari, Egler; Hasslocher-Moreno, Alejandro Marcel; Moreira, Eliane Furtado; Marques, Divina Seila de Oliveira; Silva, Eliane Lages; Marin-Neto, José Antonio; Galvão, Lúcia Maria da Cunha; Xavier, Sergio Salles; Valente, Sebastião Aldo da Silva; Carvalho, Noêmia Barbosa; Cardoso, Alessandra Viana; Silva, Rafaella Albuquerque E; Costa, Veruska Maia da; Vivaldini, Simone Monzani; Oliveira, Suelene Mamede; Valente, Vera da Costa; Lima, Mayara Maia; Alves, Renato Vieira

2016-12-01

Chagas disease is a neglected chronic condition with a high burden of morbidity and mortality. It has considerable psychological, social, and economic impacts. The disease represents a significant public health issue in Brazil, with different regional patterns. This document presents the evidence that resulted in the Brazilian Consensus on Chagas Disease. The objective was to review and standardize strategies for diagnosis, treatment, prevention, and control of Chagas disease in the country, based on the available scientific evidence. The consensus is based on the articulation and strategic contribution of renowned Brazilian experts with knowledge and experience on various aspects of the disease. It is the result of a close collaboration between the Brazilian Society of Tropical Medicine and the Ministry of Health. It is hoped that this document will strengthen the development of integrated actions against Chagas disease in the country, focusing on epidemiology, management, comprehensive care (including families and communities), communication, information, education, and research .

Developing 21st century accreditation standards for teaching hospitals: the Taiwan experience.

PubMed

Huang, Chung-I; Wung, Cathy; Yang, Che-Ming

2009-12-15

The purpose of this study is to establish teaching hospital accreditation standards anew with the hope that Taiwan's teaching hospitals can live up to the expectations of our society and ensure quality teaching. The development process lasted two years, 2005-2006, and was separated into three stages. The first stage centered on leadership meetings and consensus building, the second on drafting the new standards with expert focus groups, and the third on a pilot study and subsequent revision. Our new teaching hospital accreditation standards have six categories and 95 standards as follows: educational resources (20 items), teaching and training plans and outcomes (42 items), research and results (9 items), development of clinical faculty and continuing education (8 items), academic exchanges and community education (8 items), and administration (8 items). The new standards have proven feasible and posed reasonable challenges in the pilot study. We hope the new standards will strengthen teaching and research, and improve the quality of hospital services at the same time.

Consensus-Driven Development of a Terminology for Biobanking, the Duke Experience.

PubMed

Ellis, Helena; Joshi, Mary-Beth; Lynn, Aenoch J; Walden, Anita

2017-04-01

Biobanking at Duke University has existed for decades and has grown over time in silos and based on specialized needs, as is true with most biomedical research centers. These silos developed informatics systems to support their own individual requirements, with no regard for semantic or syntactic interoperability. Duke undertook an initiative to implement an enterprise-wide biobanking information system to serve its many diverse biobanking entities. A significant part of this initiative was the development of a common terminology for use in the commercial software platform. Common terminology provides the foundation for interoperability across biobanks for data and information sharing. We engaged experts in research, informatics, and biobanking through a consensus-driven process to agree on 361 terms and their definitions that encompass the lifecycle of a biospecimen. Existing standards, common terms, and data elements from published articles provided a foundation on which to build the biobanking terminology; a broader set of stakeholders then provided additional input and feedback in a secondary vetting process. The resulting standardized biobanking terminology is now available for sharing with the biobanking community to serve as a foundation for other institutions who are considering a similar initiative.

Consensus-Driven Development of a Terminology for Biobanking, the Duke Experience

PubMed Central

Joshi, Mary-Beth; Lynn, Aenoch J.; Walden, Anita

2017-01-01

Biobanking at Duke University has existed for decades and has grown over time in silos and based on specialized needs, as is true with most biomedical research centers. These silos developed informatics systems to support their own individual requirements, with no regard for semantic or syntactic interoperability. Duke undertook an initiative to implement an enterprise-wide biobanking information system to serve its many diverse biobanking entities. A significant part of this initiative was the development of a common terminology for use in the commercial software platform. Common terminology provides the foundation for interoperability across biobanks for data and information sharing. We engaged experts in research, informatics, and biobanking through a consensus-driven process to agree on 361 terms and their definitions that encompass the lifecycle of a biospecimen. Existing standards, common terms, and data elements from published articles provided a foundation on which to build the biobanking terminology; a broader set of stakeholders then provided additional input and feedback in a secondary vetting process. The resulting standardized biobanking terminology is now available for sharing with the biobanking community to serve as a foundation for other institutions who are considering a similar initiative. PMID:28338350

Outdoor Test Facility and Related Facilities | Photovoltaic Research | NREL

Science.gov Websites

advanced or emerging photovoltaic (PV) technologies under simulated, accelerated indoor and outdoor, and evaluate prototype, pre-commercial, and commercial PV modules. One of the major roles of researchers at the OTF is to work with industry to develop uniform and consensus standards and codes for testing PV

77 FR 18739 - Safety Zone; Bay Swim V, Presque Isle Bay, Erie, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... body of your document so that we can contact you if we have questions regarding your submission. To... and the boating public. Discussion of Proposed Rule With the aforementioned risks in mind, the Captain... management systems practices) that are developed or adopted by voluntary consensus standards bodies. This...

76 FR 72120 - Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Rule-Compliance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-22

... commenter stated that a vast majority of farming clients have indicated that they are out of harvest and... responsibilities would be of far greater benefit to the farming community. The commenter cited three primary... business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs...

Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans for new-onset polyarticular juvenile idiopathic arthritis.

PubMed

Ringold, Sarah; Weiss, Pamela F; Colbert, Robert A; DeWitt, Esi Morgan; Lee, Tzielan; Onel, Karen; Prahalad, Sampath; Schneider, Rayfel; Shenoi, Susan; Vehe, Richard K; Kimura, Yukiko

2014-07-01

There is no standardized approach to the initial treatment of polyarticular juvenile idiopathic arthritis (JIA) among pediatric rheumatologists. Understanding the comparative effectiveness of the diverse therapeutic options available will result in better health outcomes for polyarticular JIA. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) for use in clinical practice to facilitate such studies. A case-based survey was administered to CARRA members to identify the common treatment approaches for new-onset polyarticular JIA. Two face-to-face consensus conferences employed modified nominal group technique to identify treatment strategies, operational case definition, end points, and data elements to be collected. A core workgroup reviewed the relevant literature, refined plans, and developed medication dosing and monitoring recommendations. The initial case-based survey identified significant variability among treatment approaches for new-onset polyarticular JIA. We developed 3 CTPs based on treatment strategies for the first 12 months of therapy, as well as case definitions and clinical and laboratory monitoring schedules. The CTPs include a step-up plan (nonbiologic disease-modifying antirheumatic drug [DMARD] followed by a biologic DMARD), an early combination plan (nonbiologic and biologic DMARD combined within a month of treatment initiation), and a biologic only plan. This approach was approved by 96% of the CARRA JIA Research Committee members attending the 2013 CARRA face-to-face meeting. Three standardized CTPs were developed for new-onset polyarticular JIA. Coupled with data collection at defined intervals, use of these CTPs will enable the study of their comparative effectiveness in an observational setting to optimize initial management of polyarticular JIA. Copyright © 2014 by the American College of Rheumatology.

Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.

PubMed

Eremenco, Sonya; Pease, Sheryl; Mann, Sarah; Berry, Pamela

2017-01-01

This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium's instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium's Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process

PubMed Central

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2015-01-01

Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). PMID:26517437

The APOSTEL recommendations for reporting quantitative optical coherence tomography studies.

PubMed

Cruz-Herranz, Andrés; Balk, Lisanne J; Oberwahrenbrock, Timm; Saidha, Shiv; Martinez-Lapiscina, Elena H; Lagreze, Wolf A; Schuman, Joel S; Villoslada, Pablo; Calabresi, Peter; Balcer, Laura; Petzold, Axel; Green, Ari J; Paul, Friedemann; Brandt, Alexander U; Albrecht, Philipp

2016-06-14

To develop consensus recommendations for reporting of quantitative optical coherence tomography (OCT) study results. A panel of experienced OCT researchers (including 11 neurologists, 2 ophthalmologists, and 2 neuroscientists) discussed requirements for performing and reporting quantitative analyses of retinal morphology and developed a list of initial recommendations based on experience and previous studies. The list of recommendations was subsequently revised during several meetings of the coordinating group. We provide a 9-point checklist encompassing aspects deemed relevant when reporting quantitative OCT studies. The areas covered are study protocol, acquisition device, acquisition settings, scanning protocol, funduscopic imaging, postacquisition data selection, postacquisition data analysis, recommended nomenclature, and statistical analysis. The Advised Protocol for OCT Study Terminology and Elements recommendations include core items to standardize and improve quality of reporting in quantitative OCT studies. The recommendations will make reporting of quantitative OCT studies more consistent and in line with existing standards for reporting research in other biomedical areas. The recommendations originated from expert consensus and thus represent Class IV evidence. They will need to be regularly adjusted according to new insights and practices. © 2016 American Academy of Neurology.

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2015-01-01

Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org).

Cryogenic Insulation Standard Data and Methodologies Project

NASA Technical Reports Server (NTRS)

Summerfield, Burton; Thompson, Karen; Zeitlin, Nancy; Mullenix, Pamela; Fesmire, James; Swanger, Adam

2015-01-01

Extending some recent developments in the area of technical consensus standards for cryogenic thermal insulation systems, a preliminary Inter-Laboratory Study of foam insulation materials was performed by NASA Kennedy Space Center and LeTourneau University. The initial focus was ambient pressure cryogenic boil off testing using the Cryostat-400 flat-plate instrument. Completion of a test facility at LETU has enabled direct, comparative testing, using identical cryostat instruments and methods, and the production of standard thermal data sets for a number of materials under sub-ambient conditions. The two sets of measurements were analyzed and indicate there is reasonable agreement between the two laboratories. Based on cryogenic boiloff calorimetry, new equipment and methods for testing thermal insulation systems have been successfully developed. These boiloff instruments (or cryostats) include both flat plate and cylindrical models and are applicable to a wide range of different materials under a wide range of test conditions. Test measurements are generally made at large temperature difference (boundary temperatures of 293 K and 78 K are typical) and include the full vacuum pressure range. Results are generally reported in effective thermal conductivity (ke) and mean heat flux (q) through the insulation system. The new cryostat instruments provide an effective and reliable way to characterize the thermal performance of materials under subambient conditions. Proven in through thousands of tests of hundreds of material systems, they have supported a wide range of aerospace, industry, and research projects. Boiloff testing technology is not just for cryogenic testing but is a cost effective, field-representative methodology to test any material or system for applications at sub-ambient temperatures. This technology, when adequately coupled with a technical standards basis, can provide a cost-effective, field-representative methodology to test any material or system for applications at sub-ambient to cryogenic temperatures. A growing need for energy efficiency and cryogenic applications is creating a worldwide demand for improved thermal insulation systems for low temperatures. The need for thermal characterization of these systems and materials raises a corresponding need for insulation test standards and thermal data targeted for cryogenic-vacuum applications. Such standards have a strong correlation to energy, transportation, and environment and the advancement of new materials technologies in these areas. In conjunction with this project, two new standards on cryogenic insulation were recently published by ASTM International: C1774 and C740. Following the requirements of NPR 7120.10, Technical Standards for NASA Programs and Projects, the appropriate information in this report can be provided to the NASA Chief Engineer as input for NASA's annual report to NIST, as required by OMB Circular No. A-119, describing NASA's use of voluntary consensus standards and participation in the development of voluntary consensus standards and bodies.

Updating OSHA Standards Based on National Consensus Standards; Eye and Face Protection. Final rule.

PubMed

2016-03-25

On March 13, 2015, OSHA published in the Federal Register a notice of proposed rulemaking (NPRM) to revise its eye and face protection standards for general industry, shipyard employment, marine terminals, longshoring, and construction by updating the references to national consensus standards approved by the American National Standards Institute (ANSI). OSHA received no significant objections from commenters and therefore is adopting the amendments as proposed. This final rule updates the references in OSHA's eye and face standards to reflect the most recent edition of the ANSI/International Safety Equipment Association (ISEA) eye and face protection standard. It removes the oldest-referenced edition of the same ANSI standard. It also amends other provisions of the construction eye and face protection standard to bring them into alignment with OSHA's general industry and maritime standards.

Pitfalls in the measurement of muscle mass: a need for a reference standard

PubMed Central

Landi, Francesco; Cesari, Matteo; Fielding, Roger A.; Visser, Marjolein; Engelke, Klaus; Maggi, Stefania; Dennison, Elaine; Al‐Daghri, Nasser M.; Allepaerts, Sophie; Bauer, Jurgen; Bautmans, Ivan; Brandi, Maria Luisa; Bruyère, Olivier; Cederholm, Tommy; Cerreta, Francesca; Cherubini, Antonio; Cooper, Cyrus; Cruz‐Jentoft, Alphonso; McCloskey, Eugene; Dawson‐Hughes, Bess; Kaufman, Jean‐Marc; Laslop, Andrea; Petermans, Jean; Reginster, Jean‐Yves; Rizzoli, René; Robinson, Sian; Rolland, Yves; Rueda, Ricardo; Vellas, Bruno; Kanis, John A.

2018-01-01

Abstract Background All proposed definitions of sarcopenia include the measurement of muscle mass, but the techniques and threshold values used vary. Indeed, the literature does not establish consensus on the best technique for measuring lean body mass. Thus, the objective measurement of sarcopenia is hampered by limitations intrinsic to assessment tools. The aim of this study was to review the methods to assess muscle mass and to reach consensus on the development of a reference standard. Methods Literature reviews were performed by members of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis working group on frailty and sarcopenia. Face‐to‐face meetings were organized for the whole group to make amendments and discuss further recommendations. Results A wide range of techniques can be used to assess muscle mass. Cost, availability, and ease of use can determine whether the techniques are better suited to clinical practice or are more useful for research. No one technique subserves all requirements but dual energy X‐ray absorptiometry could be considered as a reference standard (but not a gold standard) for measuring muscle lean body mass. Conclusions Based on the feasibility, accuracy, safety, and low cost, dual energy X‐ray absorptiometry can be considered as the reference standard for measuring muscle mass. PMID:29349935

Reaching consensus on communication of critical laboratory results using a collective intelligence method.

PubMed

Llovet, Maria Isabel; Biosca, Carmen; Martínez-Iribarren, Alicia; Blanco, Aurora; Busquets, Glòria; Castro, María José; Llopis, Maria Antonia; Montesinos, Mercè; Minchinela, Joana; Perich, Carme; Prieto, Judith; Ruiz, Rosa; Serrat, Núria; Simón, Margarita; Trejo, Alex; Monguet, Josep Maria; López-Pablo, Carlos; Ibarz, Mercè

2018-02-23

There is no consensus in the literature about what analytes or values should be informed as critical results and how they should be communicated. The main aim of this project is to establish consensual standards of critical results for the laboratories participating in the study. Among the project's secondary objectives, establishing consensual procedures for communication can be highlighted. Consensus was reached among all participating laboratories establishing the basis for the construction of the initial model put forward for consensus in conjunction with the clinicians. A real-time Delphi, methodology "health consensus" (HC), with motivating and participative questions was applied. The physician was expected to choose a numeric value within a scale designed for each analyte. The medians of critical results obtained represent the consensus on critical results for outpatient and inpatient care. Both in primary care and in hospital care a high degree of consensus was observed for critical values proposed in the analysis of creatinine, digoxin, phosphorus, glucose, international normalized ratio (INR), leukocytes, magnesium, neutrophils, chloride, sodium, calcium and lithium. For the rest of critical results the degree of consensus obtained was "medium high". The results obtained showed that in 72% of cases the consensual critical value coincided with the medians initially proposed by the laboratories. The real-time Delphi has allowed obtaining consensual standards for communication of critical results among the laboratories participating in the study, which can serve as a basis for other organizations.

International recommendation for a comprehensive neuropathologic workup of epilepsy surgery brain tissue: A consensus Task Force report from the ILAE Commission on Diagnostic Methods.

PubMed

Blümcke, Ingmar; Aronica, Eleonora; Miyata, Hajime; Sarnat, Harvey B; Thom, Maria; Roessler, Karl; Rydenhag, Bertil; Jehi, Lara; Krsek, Pavel; Wiebe, Samuel; Spreafico, Roberto

2016-03-01

Epilepsy surgery is an effective treatment in many patients with drug-resistant focal epilepsies. An early decision for surgical therapy is facilitated by a magnetic resonance imaging (MRI)-visible brain lesion congruent with the electrophysiologically abnormal brain region. Recent advances in the pathologic diagnosis and classification of epileptogenic brain lesions are helpful for clinical correlation, outcome stratification, and patient management. However, application of international consensus classification systems to common epileptic pathologies (e.g., focal cortical dysplasia [FCD] and hippocampal sclerosis [HS]) necessitates standardized protocols for neuropathologic workup of epilepsy surgery specimens. To this end, the Task Force of Neuropathology from the International League Against Epilepsy (ILAE) Commission on Diagnostic Methods developed a consensus standard operational procedure for tissue inspection, distribution, and processing. The aims are to provide a systematic framework for histopathologic workup, meeting minimal standards and maximizing current and future opportunities for morphofunctional correlations and molecular studies for both clinical care and research. Whenever feasible, anatomically intact surgical specimens are desirable to enable systematic analysis in selective hippocampectomies, temporal lobe resections, and lesional or nonlesional neocortical samples. Correct orientation of sample and the sample's relation to neurophysiologically aberrant sites requires good communication between pathology and neurosurgical teams. Systematic tissue sampling of 5-mm slabs along a defined anatomic axis and application of a limited immunohistochemical panel will ensure a reliable differential diagnosis of main pathologies encountered in epilepsy surgery. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study.

PubMed

Mokkink, Lidwine B; Terwee, Caroline B; Patrick, Donald L; Alonso, Jordi; Stratford, Paul W; Knol, Dirk L; Bouter, Lex M; de Vet, Henrica C W

2010-05-01

Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'. Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.

Nutrition management guideline for maple syrup urine disease: an evidence- and consensus-based approach.

PubMed

Frazier, Dianne M; Allgeier, Courtney; Homer, Caroline; Marriage, Barbara J; Ogata, Beth; Rohr, Frances; Splett, Patricia L; Stembridge, Adrya; Singh, Rani H

2014-07-01

In an effort to increase harmonization of care and enable outcome studies, the Genetic Metabolic Dietitians International (GMDI) and the Southeast Regional Newborn Screening and Genetics Collaborative (SERC) are partnering to develop nutrition management guidelines for inherited metabolic disorders (IMD) using a model combining both evidence- and consensus-based methodology. The first guideline to be completed is for maple syrup urine disease (MSUD). This report describes the methodology used in its development: formulation of five research questions; review, critical appraisal and abstraction of peer-reviewed studies and unpublished practice literature; and expert input through Delphi surveys and a nominal group process. This report includes the summary statements for each research question and the nutrition management recommendations they generated. Each recommendation is followed by a standardized rating based on the strength of the evidence and consensus used. The application of technology to build the infrastructure for this project allowed transparency during development of this guideline and will be a foundation for future guidelines. Online open access of the full, published guideline allows utilization by health care providers, researchers, and collaborators who advise, advocate and care for individuals with MSUD and their families. There will be future updates as warranted by developments in research and clinical practice. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Dysglycemias in pregnancy: from diagnosis to treatment. Brazilian consensus statement

PubMed Central

2010-01-01

There is an urgent need to find consensus on screening, diagnosing and treating all degrees of DYSGLYCEMIA that may occur during pregnancies in Brazil, considering that many cases of DYSGLYCEMIA in pregnant women are currently not diagnosed, leading to maternal and fetal complications. For this reason the Brazilian Diabetes Society (SBD) and the Brazilian Federation of Gynecology and Obstetrics Societies (FEBRASGO), got together to introduce this proposal. We present here a joint consensus regarding the standardization of clinical management for pregnant women with any degree of Dysglycemia, on the basis of current information, to improve medical assistance and to avoid related complications of Dysglycemia in pregnancy to the mother and the fetus. This consensus aims to standardize the diagnosis among general practitioners, endocrinologists and obstetricians allowing the dissemination of information in basic health units, public and private services, that are responsible for screening, diagnosing and treating disglycemic pregnant patients. PMID:20416099

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

PubMed

Zhang, Yan; Phy, Jennifer; Scott-Johnson, Chris; Garos, Sheila; Orlando, Jennie; Prien, Samuel; Huang, Jaou-Chen

2017-04-04

The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. ClinicalTrials NCT02591186 registered on October 7, 2015.

Fitness voter model: Damped oscillations and anomalous consensus.

PubMed

Woolcock, Anthony; Connaughton, Colm; Merali, Yasmin; Vazquez, Federico

2017-09-01

We study the dynamics of opinion formation in a heterogeneous voter model on a complete graph, in which each agent is endowed with an integer fitness parameter k≥0, in addition to its + or - opinion state. The evolution of the distribution of k-values and the opinion dynamics are coupled together, so as to allow the system to dynamically develop heterogeneity and memory in a simple way. When two agents with different opinions interact, their k-values are compared, and with probability p the agent with the lower value adopts the opinion of the one with the higher value, while with probability 1-p the opposite happens. The agent that keeps its opinion (winning agent) increments its k-value by one. We study the dynamics of the system in the entire 0≤p≤1 range and compare with the case p=1/2, in which opinions are decoupled from the k-values and the dynamics is equivalent to that of the standard voter model. When 0≤p<1/2, agents with higher k-values are less persuasive, and the system approaches exponentially fast to the consensus state of the initial majority opinion. The mean consensus time τ appears to grow logarithmically with the number of agents N, and it is greatly decreased relative to the linear behavior τ∼N found in the standard voter model. When 1/2

Discordant identification of pediatric severe sepsis by research and clinical definitions in the SPROUT international point prevalence study.

PubMed

Weiss, Scott L; Fitzgerald, Julie C; Maffei, Frank A; Kane, Jason M; Rodriguez-Nunez, Antonio; Hsing, Deyin D; Franzon, Deborah; Kee, Sze Ying; Bush, Jenny L; Roy, Jason A; Thomas, Neal J; Nadkarni, Vinay M

2015-09-16

Consensus criteria for pediatric severe sepsis have standardized enrollment for research studies. However, the extent to which critically ill children identified by consensus criteria reflect physician diagnosis of severe sepsis, which underlies external validity for pediatric sepsis research, is not known. We sought to determine the agreement between physician diagnosis and consensus criteria to identify pediatric patients with severe sepsis across a network of international pediatric intensive care units (PICUs). We conducted a point prevalence study involving 128 PICUs in 26 countries across 6 continents. Over the course of 5 study days, 6925 PICU patients <18 years of age were screened, and 706 with severe sepsis defined either by physician diagnosis or on the basis of 2005 International Pediatric Sepsis Consensus Conference consensus criteria were enrolled. The primary endpoint was agreement of pediatric severe sepsis between physician diagnosis and consensus criteria as measured using Cohen's κ. Secondary endpoints included characteristics and clinical outcomes for patients identified using physician diagnosis versus consensus criteria. Of the 706 patients, 301 (42.6%) met both definitions. The inter-rater agreement (κ ± SE) between physician diagnosis and consensus criteria was 0.57 ± 0.02. Of the 438 patients with a physician's diagnosis of severe sepsis, only 69% (301 of 438) would have been eligible to participate in a clinical trial of pediatric severe sepsis that enrolled patients based on consensus criteria. Patients with physician-diagnosed severe sepsis who did not meet consensus criteria were younger and had lower severity of illness and lower PICU mortality than those meeting consensus criteria or both definitions. After controlling for age, severity of illness, number of comorbid conditions, and treatment in developed versus resource-limited regions, patients identified with severe sepsis by physician diagnosis alone or by consensus criteria alone did not have PICU mortality significantly different from that of patients identified by both physician diagnosis and consensus criteria. Physician diagnosis of pediatric severe sepsis achieved only moderate agreement with consensus criteria, with physicians diagnosing severe sepsis more broadly. Consequently, the results of a research study based on consensus criteria may have limited generalizability to nearly one-third of PICU patients diagnosed with severe sepsis.

The Norwegian General Practice--Nursing Home criteria (NORGEP-NH) for potentially inappropriate medication use: A web-based Delphi study.

PubMed

Nyborg, Gunhild; Straand, Jørund; Klovning, Atle; Brekke, Mette

2015-06-01

To develop a set of explicit criteria for pharmacologically inappropriate medication use in nursing homes. In an expert panel, a three-round Delphi consensus process was conducted via survey software. Norway. Altogether 80 participants - specialists in geriatrics or clinical pharmacology, physicians in nursing homes and experienced pharmacists - agreed to participate in the survey. Of these, 62 completed the first round, and 49 panellists completed all three rounds (75.4% of those ultimately entering the survey). The authors developed a list of 27 criteria based on the Norwegian General Practice (NORGEP) criteria, literature, and clinical experience. The main outcome measure was the panellists' evaluation of the clinical relevance of each suggested criterion on a digital Likert scale from 1 (no clinical relevance) to 10. In the first round panellists could also suggest new criteria to be included in the process. For each criterion, degree of consensus was based on the average Likert score and corresponding standard deviation (SD). A list of 34 explicit criteria for potentially inappropriate medication use in nursing homes was developed through a three-round web-based Delphi consensus process. Degree of consensus increased with each round. No criterion was voted out. Suggestions from the panel led to the inclusion of seven additional criteria in round two. The NORGEP-NH list may serve as a tool in the prescribing process and in medication list reviews and may also be used in quality assessment and for research purposes.

Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus.

PubMed

Jiang, Jun-jie; Zhang, Wen; Xie, Yan-ming; Wang, Jian-nong; He, Fu-yuan; Xiong, Xin

2016-02-01

Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2009-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.

PubMed

Boers, Maarten; Kirwan, John R; Wells, George; Beaton, Dorcas; Gossec, Laure; d'Agostino, Maria-Antonietta; Conaghan, Philip G; Bingham, Clifton O; Brooks, Peter; Landewé, Robert; March, Lyn; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-07-01

Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n=125) at the OMERACT 11 consensus conference endorsed this model and process. The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

[Materiality Analysis of Health Plans Based on Stakeholder Engagement and the Issues Included at ISO 26000:2010].

PubMed

Moyano Santiago, Miguel Angel; Rivera Lirio, Juana María

2017-01-18

Health plans of the Spanish autonomous communities can incorporate sustainable development criteria in its development. There have been no analysis or proposals about development and indicators. The goal is to add a contribution to help build better health plans aimed at sustainable development and help to manage economic, social and environmental impacts of health systems criteria. We used a variation of the RAND/UCLA or modified Delphi technique method. The process consisted of a bibliographical and context matters and issues related to health and social responsibility analysis based on ISO 26000: 2010. A survey by deliberately to a selection of 70 expert members of the identified stakeholders was carried out and a discussion group was held to determine the consensus on the issues addressed in the survey sample. The research was conducted in 2015. From the literature review 33 health issues included in ISO 26000:2010 were obtained. 7 survey proved relevant high consensus, 8 relevance and average consensus and 18 with less relevance and high level of dissent. The expert group excluded 4 of the 18 subjects with less consensus. 29 issues included 33 at work, divided into 7 subjects contained in the guide ISO 26000 of social responsibility, were relevant stakeholders regarding possible inclusion in health plans. Considering the direct relationship published by ISO (International Organization for Standardization) among the issues ISO 26000 and the economic, social and environmental indicators in GRI (Global Reporting Initiative) in its G4 version, a panel with monitoring indicators related to relevant issues were elaborated.

The impact of preclinical irreproducibility on drug development.

PubMed

Freedman, L P; Gibson, M C

2015-01-01

The development of novel therapeutics depends and builds upon the validity and reproducibility of previously published data and findings. Yet irreproducibility is pervasive in preclinical life science research and can be traced to cumulative errors or flaws in several areas, including reference materials, study design, laboratory protocols, and data collection and analysis. The expanded development and use of consensus-based standards and well-documented best practices is needed to both enhance reproducibility and drive therapeutic innovations. © 2014 ASCPT.

[Principles for the evaluation of telemedicine applications: Results of a systematic review and consensus process].

PubMed

Arnold, Katrin; Scheibe, Madlen; Müller, Olaf; Schmitt, Jochen

2016-11-01

The limited number of telemedicine applications being transferred to standard medical care in Germany may to some extent be explained by deficits in the current evaluation practice. Effectiveness and cost effectiveness can only be demonstrated to decision makers and potential users with methodologically sound and fully published evaluations. There is a lack of well-founded and mandatory standards for adequate, comparable evaluations of telemedicine applications. As part of the project CCS Telehealth Eastern Saxony (CCS THOS), a systematic review on evaluation concepts for telemedicine applications (search period until September 2014, databases Medline, Embase, HTA-Database, DARE, NHS EED) as well as an additional selective literature search were conducted. Suggestions for evaluation fundamentals were derived from the results. These suggestions were subjected to a formal consensus process (nominal group process) with relevant stakeholder groups (healthcare payers, healthcare providers, health policy representatives, researchers). 19 papers were included in the systematic review. In accordance with the predefined inclusion criteria, each presented an evaluation concept for telemedicine applications that was based upon a systematic review and/or a consensus process. Via a formal consensus process, the suggestions for evaluation principles derived from the review and the selective literature search (23 papers) resulted in ten agreed evaluation principles. Eight of them were unanimously agreed upon, two were arrived at with one abstention each. The principles enclose criteria for the planning, conduct and reporting of telemedicine evaluations. Adherence to them is obligatory for users of the telemedical infrastructure provided by CCS THOS. Furthermore, right from the beginning the intention was very much for these principles to be seized upon by other projects and initiatives. The agreed evaluation principles for telemedicine applications are the first in Germany to be based both upon evidence and consensus. Due to the methodology of development, they have a strong scientific and health policy legitimation. Therefore, and because of their general applicability, adherence to these principles beyond the context of the telemedicine platform developed within CCS THOS is recommended, namely throughout the German telemedicine scene. Copyright © 2016. Published by Elsevier GmbH.

A consensus definition of running-related injury in recreational runners: a modified Delphi approach.

PubMed

Yamato, Tiê Parma; Saragiotto, Bruno Tirotti; Lopes, Alexandre Dias

2015-05-01

Delphi study. To reach a consensus definition of running-related injury in recreational runners through a modified Delphi approach. Many studies have suggested the need for a standardized definition of running-related injury to provide uniformity to injury surveillance in running. We invited 112 researchers from running-related injury studies identified in a previous systematic review to classify words and terms frequently used in definitions of running-related injury in an online form during 3 rounds of study. In the last round, participants were asked to approve or disapprove the consensus definition. We considered an agreement level of at least 75% to be a consensus. Thirty-eight participants agreed to participate in the study. The response rates were 94.7% (n = 36) for the first round, 83.3% (n = 30) for the second round, and 86.7% (n = 26) for the third round. A consensus definition of running-related injury was reached, with 80% of participants approving the following: "Running-related (training or competition) musculoskeletal pain in the lower limbs that causes a restriction on or stoppage of running (distance, speed, duration, or training) for at least 7 days or 3 consecutive scheduled training sessions, or that requires the runner to consult a physician or other health professional." The proposed standardized definition of running-related injury could assist in standardizing the definitions used in sport science research and facilitate between-study comparisons. Future studies testing the validity of the proposed consensus definition, as well as its accurate translation to other languages, are also needed.

Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel

PubMed Central

Graham, Stephen M.; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E.; Gale, Marianne; Gie, Robert P.; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C.; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J.; McNeeley, David F.; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R.; Swaminathan, Soumya; Wingfield, Claire

2012-01-01

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis. PMID:22448023

Parent-Practitioner Partnerships in Early Childhood Provision in England, Hungary and Kazakhstan: Similarities and Differences in Discourses

ERIC Educational Resources Information Center

Murray, Jane; Teszenyi, Eleonora; Varga, Anikó Nagy; Pálfi, Sándor; Tajiyeva, Marzhan; Iskakova, Aigul

2018-01-01

Whilst international policymakers have reached consensus on the importance of investing in early childhood development and increasingly monitor that investment using standardized measurement, the nature and rationale of early childhood education and care (ECEC) provision remain diverse. In the context of that disparity, this article explores an…

E-Standards For Mass Properties Engineering

NASA Technical Reports Server (NTRS)

Cerro, Jeffrey A.

2008-01-01

A proposal is put forth to promote the concept of a Society of Allied Weight Engineers developed voluntary consensus standard for mass properties engineering. This standard would be an e-standard, and would encompass data, data manipulation, and reporting functionality. The standard would be implemented via an open-source SAWE distribution site with full SAWE member body access. Engineering societies and global standards initiatives are progressing toward modern engineering standards, which become functioning deliverable data sets. These data sets, if properly standardized, will integrate easily between supplier and customer enabling technically precise mass properties data exchange. The concepts of object-oriented programming support all of these requirements, and the use of a JavaTx based open-source development initiative is proposed. Results are reported for activity sponsored by the NASA Langley Research Center Innovation Institute to scope out requirements for developing a mass properties engineering e-standard. An initial software distribution is proposed. Upon completion, an open-source application programming interface will be available to SAWE members for the development of more specific programming requirements that are tailored to company and project requirements. A fully functioning application programming interface will permit code extension via company proprietary techniques, as well as through continued open-source initiatives.

Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process.

PubMed

Lisi, Anthony J; Salsbury, Stacie A; Hawk, Cheryl; Vining, Robert D; Wallace, Robert B; Branson, Richard; Long, Cynthia R; Burgo-Black, A Lucille; Goertz, Christine M

2018-02-01

The purpose of this study was to develop an integrated care pathway for doctors of chiropractic, primary care providers, and mental health professionals who manage veterans with low back pain, with or without mental health comorbidity, within Department of Veterans Affairs health care facilities. The research method used was a consensus process. A multidisciplinary investigative team reviewed clinical guidelines and Veterans Affairs pain and mental health initiatives to develop seed statements and care algorithms to guide chiropractic management and collaborative care of veterans with low back pain. A 5-member advisory committee approved initial recommendations. Veterans Affairs-based panelists (n = 58) evaluated the pathway via e-mail using a modified RAND/UCLA methodology. Consensus was defined as agreement by 80% of panelists. The modified Delphi process was conducted in July to December 2016. Most (93%) seed statements achieved consensus during the first round, with all statements reaching consensus after 2 rounds. The final care pathway addressed the topics of informed consent, clinical evaluation including history and examination, screening for red flags, documentation, diagnostic imaging, patient-reported outcomes, adverse event reporting, chiropractic treatment frequency and duration standards, tailored approaches to chiropractic care in veteran populations, and clinical presentation of common mental health conditions. Care algorithms outlined chiropractic case management and interprofessional collaboration and referrals between doctors of chiropractic and primary care and mental health providers. This study offers an integrative care pathway that includes chiropractic care for veterans with low back pain. Copyright © 2018. Published by Elsevier Inc.

Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop.

PubMed

Scheyer, E Todd; Sanz, Mariano; Dibart, Serge; Greenwell, Henry; John, Vanchit; Kim, David M; Langer, Laureen; Neiva, Rodrigo; Rasperini, Giulio

2015-02-01

Soft tissue grafting for the purposes of increasing the width of keratinized tissue (KT) is an important aspect of periodontal treatment. A systematic review was analyzed, focusing on non-root coverage tissue grafts. The references were updated to reflect the current literature. To formulate the consensus report, group members submitted any new literature related to the topic that met criteria fitting the systematic review, and this information was reviewed for inclusion in this report. A consensus report was developed to summarize the findings from the systematic review and to guide clinicians in their treatment decision-making process. Forty-six articles met the criteria for inclusion in the final analysis, and two articles were added that were used to formulate this consensus report. A list of eight clinically relevant questions was posed, and consensus statements were developed. The evidence suggests that a minimum amount of KT is not needed to prevent attachment loss (AL) when optimal plaque control is present. However, if plaque control is suboptimal, a minimum of 2 mm of KT is needed. The standard procedure to predictably gain KT is the autogenous gingival graft. There is limited evidence for alternative treatment options. However, additional research may offer promising results in certain clinical scenarios. Before patient treatment, the clinician should evaluate etiology, including the role of inflammation and various types of trauma that contribute to AL. The best outcome procedure (autograft) and alternative options should be reviewed with the patient during appropriate informed consent. Proper assessment of the outcome should be included during supportive periodontal care.

Life Support Goals Including High Closure and Low Mass Should Be Reconsidered Using Systems Analysis

NASA Technical Reports Server (NTRS)

Jones, Harry W.

2017-01-01

Recycling space life support systems have been built and tested since the 1960s and have operated on the International Space Station (ISS) since the mid 2000s. The development of space life support has been guided by a general consensus focused on two important related goals, increasing system closure and reducing launch mass. High closure is achieved by recycling crew waste products such as carbon dioxide and condensed humidity. Recycling directly reduces the mass of oxygen and water for the crew that must be launched from Earth. The launch mass of life support can be further reduced by developing recycling systems with lower hardware mass and reduced power. The life support consensus has also favored using biological systems. The goal of increasing closure using biological systems suggests that food should be grown in space and that biological processors be used for air, water, and waste recycling. The goal of reducing launch mass led to use of Equivalent System Mass (ESM) in life support advocacy and technology selection. The recent consensus assumes that the recycling systems architecture developed in the 1960s and implemented on ISS will be used on all future long missions. NASA and other project organizations use the standard systems engineering process to guide hardware development. The systems process was used to develop ISS life support, but it has been less emphasized in planning future systems for the moon and Mars. Since such missions are far in the future, there has been less immediate need for systems engineering analysis to consider trade-offs, reliability, and Life Cycle Cost (LCC). Preliminary systems analysis suggests that the life support consensus concepts should be revised to reflect systems engineering requirements.

Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans for juvenile idiopathic arthritis-associated and idiopathic chronic anterior uveitis.

PubMed

Angeles-Han, Sheila T; Lo, Mindy S; Henderson, Lauren A; Lerman, Melissa A; Abramson, Leslie; Cooper, Ashley M; Parsa, Miriam F; Zemel, Lawrence S; Ronis, Tova; Beukelman, Timothy; Cox, Erika; Sen, H Nida; Holland, Gary N; Brunner, Hermine I; Lasky, Andrew; Rabinovich, C Egla

2018-05-28

Systemic immunosuppressive treatment of pediatric chronic anterior uveitis (CAU), both juvenile idiopathic arthritis (JIA)-associated and idiopathic varies, making it difficult to identify best treatments. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) for CAU for the purpose of reducing practice variability and allowing future comparison of treatments by comparative effectiveness analysis techniques. A core group of pediatric rheumatologists, ophthalmologists with uveitis expertise, and a lay advisor comprised the CARRA uveitis workgroup who performed literature review on pharmacologic treatments, held teleconferences, and developed a case-based survey administered to the CARRA membership to delineate treatment practices. We utilized 3 face-to-face consensus meetings using nominal group technique to develop CTPs. The survey identified areas of treatment practice variability. We developed 2 CTPs for the treatment of CAU, case definitions, and monitoring parameters. The first CTP is directed at children naïve to steroid-sparing medication, and the second at children initiating biologic therapy with options for methotrexate, adalimumab and infliximab. We defined a core dataset and outcome measures with data collection at 3 and 6 months after therapy initiation. The CARRA membership voted acceptance of the CTPs with a >95% (N = 233) approval. Using consensus methodology, two standardized CTPs were developed for systemic immunosuppressive treatment of CAU. These CTPs are not meant as treatment guidelines, but are designed for further pragmatic research within the CARRA research network. Use of these CTPs in a prospective comparison effectiveness study should improve outcomes by identifying best practice options. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The CARE guidelines: consensus-based clinical case report guideline development.

PubMed

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

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

Gaffney, David K., E-mail: david.gaffney@hci.utah.edu; King, Bronwyn; Viswanathan, Akila N.

Purpose: The purpose of this study was to develop a radiation therapy (RT) contouring atlas and recommendations for women with postoperative and locally advanced vulvar carcinoma. Methods and Materials: An international committee of 35 expert gynecologic radiation oncologists completed a survey of the treatment of vulvar carcinoma. An initial set of recommendations for contouring was discussed and generated by consensus. Two cases, 1 locally advanced and 1 postoperative, were contoured by 14 physicians. Contours were compared and analyzed using an expectation-maximization algorithm for simultaneous truth and performance level estimation (STAPLE), and a 95% confidence interval contour was developed. The levelmore » of agreement among contours was assessed using a kappa statistic. STAPLE contours underwent full committee editing to generate the final atlas consensus contours. Results: Analysis of the 14 contours showed substantial agreement, with kappa statistics of 0.69 and 0.64 for cases 1 and 2, respectively. There was high specificity for both cases (≥99%) and only moderate sensitivity of 71.3% and 64.9% for cases 1 and 2, respectively. Expert review and discussion generated consensus recommendations for contouring target volumes and treatment for postoperative and locally advanced vulvar cancer. Conclusions: These consensus recommendations for contouring and treatment of vulvar cancer identified areas of complexity and controversy. Given the lack of clinical research evidence in vulvar cancer radiation therapy, the committee advocates a conservative and consistent approach using standardized recommendations.« less

An independent jury-based consensus conference model for the development of recommendations in medico-surgical practice.

PubMed

Lesurtel, Mickaël; Perrier, Arnaud; Bossuyt, Patrick M M; Langer, Bernard; Clavien, Pierre-Alain

2014-03-01

There is an increasing demand for standardization in the choice of treatments for specific conditions, so-called personalized medicine. The task is far from trivial, because the perspectives from many stakeholders must be respected, including patients and health care providers, as well as payers or governments to better control costs while optimizing quality of care. One approach to provide widely accepted therapies is the consensus conference. We describe a novel methodology to achieve consensus in controversial areas with the main goal to minimize biases. The principle of this approach relies on a clear distinction between those who provide the evidence (experts) and those who draw the final recommendations (the jury). The jury consists of individuals with sufficient background knowledge to cover the perspectives of all stakeholders' without being involved directly in the topic under evaluation. The organizing committee, the experts, and the jury interact within 3 phases: Preparation, the actual consensus conference, and deliberations. Each question is addressed by a panel of experts, leading to the proposition of recommendations at the conference meeting, which are challenged by the jury and the audience. Based on all available information, the jury finalizes the consensus recommendations, which are eventually published and made available to all. This novel model of consensus conference allows the construction of consensual, evidence-based, explicit recommendations for therapies in a process that may also identify issues for further research, eventually fostering progress in the field. Copyright © 2014 Mosby, Inc. All rights reserved.

Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma.

PubMed

Kamat, Ashish M; Bellmunt, Joaquim; Galsky, Matthew D; Konety, Badrinath R; Lamm, Donald L; Langham, David; Lee, Cheryl T; Milowsky, Matthew I; O'Donnell, Michael A; O'Donnell, Peter H; Petrylak, Daniel P; Sharma, Padmanee; Skinner, Eila C; Sonpavde, Guru; Taylor, John A; Abraham, Prasanth; Rosenberg, Jonathan E

2017-08-15

The standard of care for most patients with non-muscle-invasive bladder cancer (NMIBC) is immunotherapy with intravesical Bacillus Calmette-Guérin (BCG), which activates the immune system to recognize and destroy malignant cells and has demonstrated durable clinical benefit. Urologic best-practice guidelines and consensus reports have been developed and strengthened based on data on the timing, dose, and duration of therapy from randomized clinical trials, as well as by critical evaluation of criteria for progression. However, these reports have not penetrated the community, and many patients do not receive appropriate therapy. Additionally, several immune checkpoint inhibitors have recently been approved for treatment of metastatic disease. The approval of immune checkpoint blockade for patients with platinum-resistant or -ineligible metastatic bladder cancer has led to considerations of expanded use for both advanced and, potentially, localized disease. To address these issues and others surrounding the appropriate use of immunotherapy for the treatment of bladder cancer, the Society for Immunotherapy of Cancer (SITC) convened a Task Force of experts, including physicians, patient advocates, and nurses, to address issues related to patient selection, toxicity management, clinical endpoints, as well as the combination and sequencing of therapies. Following the standard approach established by the Society for other cancers, a systematic literature review and analysis of data, combined with consensus voting was used to generate guidelines. Here, we provide a consensus statement for the use of immunotherapy in patients with bladder cancer, with plans to update these recommendations as the field progresses.

Delphi-RAND consensus of the Spanish Society of Internal Medicine on the controversies in anticoagulant therapy and prophylaxis in medical diseases. INTROMBIN Project (Uncertainty in thromboprophylaxis in internal medicine).

PubMed

Ruiz-Ruiz, F; Medrano, F J; Navarro-Puerto, M A; Rodríguez-Torres, P; Romero-Alonso, A; Santos-Lozano, J M; Alonso-Ortiz Del Rio, C; Varela-Aguilar, J M; Calderón, E J; Marín-León, I

2018-05-21

The aim of this study was to determine the opinion of internists on the management of anticoagulation and thromboembolism prophylaxis in complex clinical scenarios in which the risk-benefit ratio of surgery is narrow and to develop a consensus document on the use of drugs anticoagulant therapy in this patient group. To this end, we identified by consensus the clinical areas of greatest uncertainty, a survey was created with 20 scenarios laid out in 40 clinical questions, and we reviewed the specific literature. The survey was distributed among the internists of the Spanish Society of Internal Medicine (SEMI) and was completed by 290 of its members. The consensus process was implemented by changing the Delphi-RAND appropriateness method in an anonymous, double-round process that enabled an expert panel to identify the areas of agreement and uncertainty. In our case, we also added the survey results to the panel, a methodological innovation that helps provide additional information on the standard clinical practice. The result of the process is a set of 19 recommendations formulated by SEMI experts, which helps establish guidelines for action on anticoagulant therapy in complex scenarios (high risk or active haemorrhage, short life expectancy, coexistence of antiplatelet therapy or comorbidities such as kidney disease and liver disease), which are not uncommon in standard clinical practice. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Report of the Association of Coloproctology of Great Britain and Ireland/British Society of Gastroenterology Colorectal Polyp Working Group: the development of a complex colorectal polyp minimum dataset.

PubMed

Chattree, A; Barbour, J A; Thomas-Gibson, S; Bhandari, P; Saunders, B P; Veitch, A M; Anderson, J; Rembacken, B J; Loughrey, M B; Pullan, R; Garrett, W V; Lewis, G; Dolwani, S; Rutter, M D

2017-01-01

The management of large non-pedunculated colorectal polyps (LNPCPs) is complex, with widespread variation in management and outcome, even amongst experienced clinicians. Variations in the assessment and decision-making processes are likely to be a major factor in this variability. The creation of a standardized minimum dataset to aid decision-making may therefore result in improved clinical management. An official working group of 13 multidisciplinary specialists was appointed by the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG) to develop a minimum dataset on LNPCPs. The literature review used to structure the ACPGBI/BSG guidelines for the management of LNPCPs was used by a steering subcommittee to identify various parameters pertaining to the decision-making processes in the assessment and management of LNPCPs. A modified Delphi consensus process was then used for voting on proposed parameters over multiple voting rounds with at least 80% agreement defined as consensus. The minimum dataset was used in a pilot process to ensure rigidity and usability. A 23-parameter minimum dataset with parameters relating to patient and lesion factors, including six parameters relating to image retrieval, was formulated over four rounds of voting with two pilot processes to test rigidity and usability. This paper describes the development of the first reported evidence-based and expert consensus minimum dataset for the management of LNPCPs. It is anticipated that this dataset will allow comprehensive and standardized lesion assessment to improve decision-making in the assessment and management of LNPCPs. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Towards a Consensus Annotation System (GSC8 Meeting)

ScienceCinema

White, Owen

2018-02-01

The Genomic Standards Consortium was formed in September 2005. It is an international, open-membership working body which promotes standardization in the description of genomes and the exchange and integration of genomic data. The 2009 meeting was an activity of a five-year funding from the National Science Foundation and was organized held at the DOE Joint Genome Institute with organizational support provided by the JGI and by the University of California - San Diego. Towards Consensus Annotation at the Genomic Standards Consortium's 8th meeting at the DOE JGI in Walnut Creek, CA on Sept. 10, 2009.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

Making Sense of Clinical Practice: Order Set Design Strategies in CPOE

PubMed Central

Novak, Laurie L.

2007-01-01

A case study was conducted during the customization phase of a commercial CPOE system at a multi-hospital, academic health system. The study focused on the development of order sets. Three distinct approaches to order set development were observed: Empirical, Local Consensus and Departmental. The three approaches are first described and then examined using the framework of sensemaking. Different approaches to sensemaking in the context of order set development reflect variations in sources of knowledge related to the standardization of care. PMID:18693900

Standards for dielectric elastomer transducers

NASA Astrophysics Data System (ADS)

Carpi, Federico; Anderson, Iain; Bauer, Siegfried; Frediani, Gabriele; Gallone, Giuseppe; Gei, Massimiliano; Graaf, Christian; Jean-Mistral, Claire; Kaal, William; Kofod, Guggi; Kollosche, Matthias; Kornbluh, Roy; Lassen, Benny; Matysek, Marc; Michel, Silvain; Nowak, Stephan; O'Brien, Benjamin; Pei, Qibing; Pelrine, Ron; Rechenbach, Björn; Rosset, Samuel; Shea, Herbert

2015-10-01

Dielectric elastomer transducers consist of thin electrically insulating elastomeric membranes coated on both sides with compliant electrodes. They are a promising electromechanically active polymer technology that may be used for actuators, strain sensors, and electrical generators that harvest mechanical energy. The rapid development of this field calls for the first standards, collecting guidelines on how to assess and compare the performance of materials and devices. This paper addresses this need, presenting standardized methods for material characterisation, device testing and performance measurement. These proposed standards are intended to have a general scope and a broad applicability to different material types and device configurations. Nevertheless, they also intentionally exclude some aspects where knowledge and/or consensus in the literature were deemed to be insufficient. This is a sign of a young and vital field, whose research development is expected to benefit from this effort towards standardisation.

Huntington's Disease Outpatient Clinic for Functional Diagnosis and Treatment: Coming to Consensus: How Long Term Care Facility Procedures Complement Specialist Diagnosis and Treatment.

PubMed

Veenhuizen, Ruth; Nijsten, Hanneke; van Roosmalen, Paul; Lammertsen, Karen; Stor, Tom; de Jager, Lia; de Man, Jesseke; van der Doelen, Rina; Landa, Karin; Grond, Vera; Heffels, Joyce; Groenewoud, Rinske; Rovers, Luce; Bakker, Christian; Leiwakabessy, Saskia; van der Wedden, Dirk; van Blitterswijk, Jacqueline; van den Bosch, Dieuwke

2018-01-01

Huntington's disease (HD) patients and families deserve expert treatment and care throughout their lives, but uniformity in functional diagnosis and treatment was lacking. In the aim of reaching this uniformity on day-to-day treatment and care offered by multidisciplinary outreach teams from Dutch long term care facilities for ambulatory HD patients, a consensus trajectory was started to harmonise our care programme with international standards and within the country. The consensus statements, given as supplementary material, should lead to expert treatment and care for HD families throughout the Netherlands and this manuscript should contribute and revitalise a global discussion on standards of treatment and care.

Domains of core competency, standards, and quality assurance for building global capacity in health promotion: the galway consensus conference statement.

PubMed

Allegrante, John P; Barry, Margaret M; Airhihenbuwa, Collins O; Auld, M Elaine; Collins, Janet L; Lamarre, Marie-Claude; Magnusson, Gudjon; McQueen, David V; Mittelmark, Maurice B

2009-06-01

This paper reports the outcome of the Galway Consensus Conference, an effort undertaken as a first step toward international collaboration on credentialing in health promotion and health education. Twenty-nine leading authorities in health promotion, health education, and public health convened a 2-day meeting in Galway, Ireland, during which the available evidence on credentialing in health promotion was reviewed and discussed. Conference participants reached agreement on core values and principles, a common definition, and eight domains of core competency required to engage in effective health promotion practice. The domains of competency are catalyzing change, leadership, assessment, planning, implementation, evaluation, advocacy, and partnerships. The long-term aim of this work is to stimulate a global dialogue that will lead to the development and widespread adoption of standards and quality assurance systems in all countries to strengthen capacity in health promotion, a critical element in achieving goals for the improvement of global population health.

Consensus Statement on Research Definitions for Drug-Resistant Tuberculosis in Children.

PubMed

Seddon, James A; Perez-Velez, Carlos M; Schaaf, H Simon; Furin, Jennifer J; Marais, Ben J; Tebruegge, Marc; Detjen, Anne; Hesseling, Anneke C; Shah, Sarita; Adams, Lisa V; Starke, Jeffrey R; Swaminathan, Soumya; Becerra, Mercedes C

2013-06-01

Few children with drug-resistant (DR) tuberculosis (TB) are identified, diagnosed, and given an appropriate treatment. The few studies that have described this vulnerable population have used inconsistent definitions. The World Health Organization (WHO) definitions used for adults with DR-TB and for children with drug-susceptible TB are not always appropriate for children with DR-TB. The Sentinel Project on Pediatric Drug-Resistant Tuberculosis was formed in 2011 as a network of experts and stakeholders in childhood DR-TB. An early priority was to establish standardized definitions for key parameters in order to facilitate study comparisons and the development of an evidence base to guide future clinical management. This consensus statement proposes standardized definitions to be used in research. In particular, it suggests consistent terminology, as well as definitions for measures of exposure, drug resistance testing, previous episodes and treatment, certainty of diagnosis, site and severity of disease, adverse events, and treatment outcome. © The Author 2013. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society.

Standards for the user interface - Developing a user consensus. [for Space Station Information System

NASA Technical Reports Server (NTRS)

Moe, Karen L.; Perkins, Dorothy C.; Szczur, Martha R.

1987-01-01

The user support environment (USE) which is a set of software tools for a flexible standard interactive user interface to the Space Station systems, platforms, and payloads is described in detail. Included in the USE concept are a user interface language, a run time environment and user interface management system, support tools, and standards for human interaction methods. The goals and challenges of the USE are discussed as well as a methodology based on prototype demonstrations for involving users in the process of validating the USE concepts. By prototyping the key concepts and salient features of the proposed user interface standards, the user's ability to respond is greatly enhanced.

Intelligent Transportation Systems : critical standards

DOT National Transportation Integrated Search

1999-06-01

Intelligent Transportation Systems (ITS) standards are industry-consensus standards that provide the details about how different systems interconnect and communicate information to deliver the ITS user services described in the National ITS Architect...

A process for developing standards to promote quality in general practice.

PubMed

Khoury, Julie; Krejany, Catherine J; Versteeg, Roald W; Lodewyckx, Michaela A; Pike, Simone R; Civil, Michael S; Jiwa, Moyez

2018-06-02

Since 1991, the Royal Australian College of General Practitioners' (RACGP) Standards for General Practices (the Standards) have provided a framework for quality care, risk management and best practice in the operation of Australian general practices. The Standards are also linked to incentives for general practice remuneration. These Standards were revised in 2017. The objective of this study is to describe the process undertaken to develop the fifth edition Standards published in 2017 to inform future standards development both nationally and internationally. A modified Delphi process was deployed to develop the fifth edition Standards. Development was directed by the RACGP and led by an expert panel of GPs and representatives of stakeholder groups who were assisted and facilitated by a team from RACGP. Each draft was released for stakeholder feedback and tested twice before the final version was submitted for approval by the RACGP board. Four rounds of consultation and two rounds of piloting were carried out over 32 months. The Standards were redrafted after each round. One hundred and fifty-two individuals and 225 stakeholder groups participated in the development of the Standards. Twenty-three new indicators were recommended and grouped into three sections in a new modular structure that was different from the previous edition. The Standards represent the consensus view of national stakeholders on the indicators of quality and safety in Australian general practice and primary care.

A Delphi Consensus of the Crucial Steps in Gastric Bypass and Sleeve Gastrectomy Procedures in the Netherlands.

PubMed

Kaijser, Mirjam A; van Ramshorst, Gabrielle H; Emous, Marloes; Veeger, Nic J G M; van Wagensveld, Bart A; Pierie, Jean-Pierre E N

2018-04-09

Bariatric procedures are technically complex and skill demanding. In order to standardize the procedures for research and training, a Delphi analysis was performed to reach consensus on the practice of the laparoscopic gastric bypass and sleeve gastrectomy in the Netherlands. After a pre-round identifying all possible steps from literature and expert opinion within our study group, questionnaires were send to 68 registered Dutch bariatric surgeons, with 73 steps for bypass surgery and 51 steps for sleeve gastrectomy. Statistical analysis was performed to identify steps with and without consensus. This process was repeated to reach consensus of all necessary steps. Thirty-eight participants (56%) responded in the first round and 32 participants (47%) in the second round. After the first Delphi round, 19 steps for gastric bypass (26%) and 14 for sleeve gastrectomy (27%) gained full consensus. After the second round, an additional amount of 10 and 12 sub-steps was confirmed as key steps, respectively. Thirteen steps in the gastric bypass and seven in the gastric sleeve were deemed advisable. Our expert panel showed a high level of consensus expressed in a Cronbach's alpha of 0.82 for the gastric bypass and 0.87 for the sleeve gastrectomy. The Delphi consensus defined 29 steps for gastric bypass and 26 for sleeve gastrectomy as being crucial for correct performance of these procedures to the standards of our expert panel. These results offer a clear framework for the technical execution of these procedures.

Pitfalls in the measurement of muscle mass: a need for a reference standard.

PubMed

Buckinx, Fanny; Landi, Francesco; Cesari, Matteo; Fielding, Roger A; Visser, Marjolein; Engelke, Klaus; Maggi, Stefania; Dennison, Elaine; Al-Daghri, Nasser M; Allepaerts, Sophie; Bauer, Jurgen; Bautmans, Ivan; Brandi, Maria Luisa; Bruyère, Olivier; Cederholm, Tommy; Cerreta, Francesca; Cherubini, Antonio; Cooper, Cyrus; Cruz-Jentoft, Alphonso; McCloskey, Eugene; Dawson-Hughes, Bess; Kaufman, Jean-Marc; Laslop, Andrea; Petermans, Jean; Reginster, Jean-Yves; Rizzoli, René; Robinson, Sian; Rolland, Yves; Rueda, Ricardo; Vellas, Bruno; Kanis, John A

2018-04-01

All proposed definitions of sarcopenia include the measurement of muscle mass, but the techniques and threshold values used vary. Indeed, the literature does not establish consensus on the best technique for measuring lean body mass. Thus, the objective measurement of sarcopenia is hampered by limitations intrinsic to assessment tools. The aim of this study was to review the methods to assess muscle mass and to reach consensus on the development of a reference standard. Literature reviews were performed by members of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis working group on frailty and sarcopenia. Face-to-face meetings were organized for the whole group to make amendments and discuss further recommendations. A wide range of techniques can be used to assess muscle mass. Cost, availability, and ease of use can determine whether the techniques are better suited to clinical practice or are more useful for research. No one technique subserves all requirements but dual energy X-ray absorptiometry could be considered as a reference standard (but not a gold standard) for measuring muscle lean body mass. Based on the feasibility, accuracy, safety, and low cost, dual energy X-ray absorptiometry can be considered as the reference standard for measuring muscle mass. © 2018 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.

Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations.

PubMed

Keng, T B; De La Salle, B; Bourner, G; Merino, A; Han, J-Y; Kawai, Y; Peng, M T; McCafferty, R

2016-10-01

These recommendations are intended to develop a consensus in the previously published papers as to which parameters and what values should be considered critical. A practical guide on the standardization of critical results management in haematology laboratories would be beneficial as part of good laboratory and clinical practice and for use by laboratory-accrediting agencies. A working group with members from Europe, America, Australasia and Asia was formed by International Council for Standardization in Haematology. A pattern of practice survey of 21 questions was distributed in 2014, and the data were collected electronically by Survey Monkey. The mode, or most commonly occurring value, was selected as the threshold for the upper and lower alert limits for critical results reporting. A total of 666 laboratories submitted data to this study and, of these, 499 submitted complete responses. Full blood count critical results alert thresholds, morphology findings that trigger critical result notification, critical results alert list, notification process and maintenance of critical results management protocol are described. This international survey provided a snapshot of the current practice worldwide and has identified the existence of considerable heterogeneity of critical results management. The recommendations in this study represent a consensus of good laboratory practice. They are intended to encourage the implementation of a standardized critical results management protocol in the laboratory. © 2016 John Wiley & Sons Ltd.

Malnutrition assessment in patients with cancers of the head and neck: a call to action and consensus.

PubMed

Dechaphunkul, Tanadech; Martin, Lisa; Alberda, Cathy; Olson, Karin; Baracos, Vickie; Gramlich, Leah

2013-11-01

A state of the science review to assess how nutritional status and malnutrition are defined by the community of researchers studying head & neck cancer (HNC) patients. In 117 publications, nutritional status was described diversely, ranging from merely one to all six of the following features: weight loss, body composition, quantity/type of food intake, symptoms impacting oral intake, inflammation and altered metabolism. Methods of assessment of each feature were inconsistent. Cancer- and treatment-related symptoms impacting oral intake were a prominent theme. Metabolic changes potentially related to weight loss and efficacy of nutritional therapy were rarely described (<15% of articles). There were 24 different explicit definitions for malnutrition. Consensus is needed regarding the criteria to adequately describe HNC-associated malnutrition. Standardization of assessments will permit aggregation of data, and integration into clinical practice-specifically, development of consensus criteria for implementation and termination of nutrition therapies. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Consensus guidelines for lumbar puncture in patients with neurological diseases.

PubMed

Engelborghs, Sebastiaan; Niemantsverdriet, Ellis; Struyfs, Hanne; Blennow, Kaj; Brouns, Raf; Comabella, Manuel; Dujmovic, Irena; van der Flier, Wiesje; Frölich, Lutz; Galimberti, Daniela; Gnanapavan, Sharmilee; Hemmer, Bernhard; Hoff, Erik; Hort, Jakub; Iacobaeus, Ellen; Ingelsson, Martin; Jan de Jong, Frank; Jonsson, Michael; Khalil, Michael; Kuhle, Jens; Lleó, Alberto; de Mendonça, Alexandre; Molinuevo, José Luis; Nagels, Guy; Paquet, Claire; Parnetti, Lucilla; Roks, Gerwin; Rosa-Neto, Pedro; Scheltens, Philip; Skårsgard, Constance; Stomrud, Erik; Tumani, Hayrettin; Visser, Pieter Jelle; Wallin, Anders; Winblad, Bengt; Zetterberg, Henrik; Duits, Flora; Teunissen, Charlotte E

2017-01-01

Cerebrospinal fluid collection by lumbar puncture (LP) is performed in the diagnostic workup of several neurological brain diseases. Reluctance to perform the procedure is among others due to a lack of standards and guidelines to minimize the risk of complications, such as post-LP headache or back pain. We provide consensus guidelines for the LP procedure to minimize the risk of complications. The recommendations are based on (1) data from a large multicenter LP feasibility study (evidence level II-2), (2) systematic literature review on LP needle characteristics and post-LP complications (evidence level II-2), (3) discussion of best practice within the Joint Programme Neurodegenerative Disease Research Biomarkers for Alzheimer's disease and Parkinson's Disease and Biomarkers for Multiple Sclerosis consortia (evidence level III). Our consensus guidelines address contraindications, as well as patient-related and procedure-related risk factors that can influence the development of post-LP complications. When an LP is performed correctly, the procedure is well tolerated and accepted with a low complication rate.

[The German Disease Management Guideline Asthma: methods and development process].

PubMed

Kopp, Ina; Lelgemann, Monika; Ollenschläger, Günter

2006-01-01

The German National Program for Disease Management Guidelines, which is being operated under the auspices of the German Medical Association (GMA), the Association of the Scientific Medical Societies (AWMF) and the National Association of Statutory Health Insurance Physicians (NASHIP), provides a conceptual basis for the disease management of prioritized healthcare aspects. The main objective of the program is to establish consensus of the medical professions on key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the scope of this program, the Scientific Medical Societies concerned with the prevention, diagnosis, treatment and rehabilitation of asthma in children, adolescents and adults have reached consensus on the core contents for a National Disease Management Guideline for Asthma. This consensus was reached by applying formal techniques and on the basis of the adaptation of recommendations from existing guidelines with high quality standards in methodology and reporting, and information from evidence reports.

Current status and recommendations for biomarkers and biobanking in neurofibromatosis.

PubMed

Hanemann, C Oliver; Blakeley, Jaishri O; Nunes, Fabio P; Robertson, Kent; Stemmer-Rachamimov, Anat; Mautner, Victor; Kurtz, Andreas; Ferguson, Michael; Widemann, Brigitte C; Evans, D Gareth; Ferner, Rosalie; Carroll, Steven L; Korf, Bruce; Wolkenstein, Pierre; Knight, Pamela; Plotkin, Scott R

2016-08-16

Clinically validated biomarkers for neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2), and schwannomatosis (SWN) have not been identified to date. The biomarker working group's goals are to (1) define biomarker needs in NF1, NF2, and SWN; (2) summarize existing data on biomarkers in NF1, NF2, and SWN; (3) outline recommendations for sample collection and biomarker development; and (4) standardize sample collection and methodology protocols where possible to promote comparison between studies by publishing standard operating procedures (SOPs). The biomarker group reviewed published data on biomarkers in NF1, NF2, and SWN and on biobanking efforts outside these diseases via literature search, defined the need for biomarkers in NF, and developed recommendations in a series of consensus meetings. We describe existing biomarkers in NF and report consensus recommendations for SOP and a minimal clinical dataset to accompany samples derived from patients with NF1, NF2, and SWN in decentralized biobanks. These recommendations are intended to provide clinicians and researchers with a common set of guidelines to collect and store biospecimens and for establishment of biobanks for NF1, NF2, and SWN. © 2016 American Academy of Neurology.

Current status and recommendations for biomarkers and biobanking in neurofibromatosis

PubMed Central

Blakeley, Jaishri O.; Nunes, Fabio P.; Robertson, Kent; Stemmer-Rachamimov, Anat; Mautner, Victor; Kurtz, Andreas; Ferguson, Michael; Widemann, Brigitte C.; Evans, D. Gareth; Ferner, Rosalie; Carroll, Steven L.; Korf, Bruce; Wolkenstein, Pierre; Knight, Pamela; Plotkin, Scott R.

2016-01-01

Objective: Clinically validated biomarkers for neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2), and schwannomatosis (SWN) have not been identified to date. The biomarker working group's goals are to (1) define biomarker needs in NF1, NF2, and SWN; (2) summarize existing data on biomarkers in NF1, NF2, and SWN; (3) outline recommendations for sample collection and biomarker development; and (4) standardize sample collection and methodology protocols where possible to promote comparison between studies by publishing standard operating procedures (SOPs). Methods: The biomarker group reviewed published data on biomarkers in NF1, NF2, and SWN and on biobanking efforts outside these diseases via literature search, defined the need for biomarkers in NF, and developed recommendations in a series of consensus meetings. Results: We describe existing biomarkers in NF and report consensus recommendations for SOP and a minimal clinical dataset to accompany samples derived from patients with NF1, NF2, and SWN in decentralized biobanks. Conclusions: These recommendations are intended to provide clinicians and researchers with a common set of guidelines to collect and store biospecimens and for establishment of biobanks for NF1, NF2, and SWN. PMID:27527649

Standards for QUality Improvement Reporting Excellence 2.0: revised publication guidelines from a detailed consensus process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2016-02-01

Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

PubMed

Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Groves, Trish; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Knowles, Rachel L; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O'Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

2017-12-14

We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. We developed principles and practical recommendations on how to share data from clinical trials. The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Developing an ANSI standard for image quality tools for the testing of active millimeter wave imaging systems

NASA Astrophysics Data System (ADS)

Barber, Jeffrey; Greca, Joseph; Yam, Kevin; Weatherall, James C.; Smith, Peter R.; Smith, Barry T.

2017-05-01

In 2016, the millimeter wave (MMW) imaging community initiated the formation of a standard for millimeter wave image quality metrics. This new standard, American National Standards Institute (ANSI) N42.59, will apply to active MMW systems for security screening of humans. The Electromagnetic Signatures of Explosives Laboratory at the Transportation Security Laboratory is supporting the ANSI standards process via the creation of initial prototypes for round-robin testing with MMW imaging system manufacturers and experts. Results obtained for these prototypes will be used to inform the community and lead to consensus objective standards amongst stakeholders. Images collected with laboratory systems are presented along with results of preliminary image analysis. Future directions for object design, data collection and image processing are discussed.

A Consensus Statement on Practical Skills in Medical School – a position paper by the GMA Committee on Practical Skills

PubMed Central

Schnabel, Kai P.; Boldt, Patrick D.; Breuer, Georg; Fichtner, Andreas; Karsten, Gudrun; Kujumdshiev, Sandy; Schmidts, Michael; Stosch, Christoph

2011-01-01

Introduction: Encouraged by the change in licensing regulations the practical professional skills in Germany received a higher priority and are taught in medical schools therefore increasingly. This created the need to standardize the process more and more. On the initiative of the German skills labs the German Medical Association Committee for practical skills was established and developed a competency-based catalogue of learning objectives, whose origin and structure is described here. Goal of the catalogue is to define the practical skills in undergraduate medical education and to give the medical schools a rational planning basis for the necessary resources to teach them. Methods: Building on already existing German catalogues of learning objectives a multi-iterative process of condensation was performed, which corresponds to the development of S1 guidelines, in order to get a broad professional and political support. Results: 289 different practical learning goals were identified and assigned to twelve different organ systems with three overlapping areas to other fields of expertise and one area of across organ system skills. They were three depths and three different chronological dimensions assigned and the objectives were matched with the Swiss and the Austrian equivalent. Discussion: This consensus statement may provide the German faculties with a basis for planning the teaching of practical skills and is an important step towards a national standard of medical learning objectives. Looking ahead: The consensus statement may have a formative effect on the medical schools to teach practical skills and plan the resources accordingly. PMID:22205916

Standardised assessment of functioning in ADHD: consensus on the ICF Core Sets for ADHD.

PubMed

Bölte, Sven; Mahdi, Soheil; Coghill, David; Gau, Susan Shur-Fen; Granlund, Mats; Holtmann, Martin; Karande, Sunil; Levy, Florence; Rohde, Luis A; Segerer, Wolfgang; de Vries, Petrus J; Selb, Melissa

2018-02-12

Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairments in social, educational, and occupational functioning, as well as specific strengths. Currently, there is no internationally accepted standard to assess the functioning of individuals with ADHD. WHO's International Classification of Functioning, Disability and Health-child and youth version (ICF) can serve as a conceptual basis for such a standard. The objective of this study is to develop a comprehensive, a common brief, and three age-appropriate brief ICF Core Sets for ADHD. Using a standardised methodology, four international preparatory studies generated 132 second-level ICF candidate categories that served as the basis for developing ADHD Core Sets. Using these categories and following an iterative consensus process, 20 ADHD experts from nine professional disciplines and representing all six WHO regions selected the most relevant categories to constitute the ADHD Core Sets. The consensus process resulted in 72 second-level ICF categories forming the comprehensive ICF Core Set-these represented 8 body functions, 35 activities and participation, and 29 environmental categories. A Common Brief Core Set that included 38 categories was also defined. Age-specific brief Core Sets included a 47 category preschool version for 0-5 years old, a 55 category school-age version for 6-16 years old, and a 52 category version for older adolescents and adults 17 years old and above. The ICF Core Sets for ADHD mark a milestone toward an internationally standardised functional assessment of ADHD across the lifespan, and across educational, administrative, clinical, and research settings.

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group.

PubMed

Obbarius, Alexander; van Maasakkers, Lisa; Baer, Lee; Clark, David M; Crocker, Anne G; de Beurs, Edwin; Emmelkamp, Paul M G; Furukawa, Toshi A; Hedman-Lagerlöf, Erik; Kangas, Maria; Langford, Lucie; Lesage, Alain; Mwesigire, Doris M; Nolte, Sandra; Patel, Vikram; Pilkonis, Paul A; Pincus, Harold A; Reis, Roberta A; Rojas, Graciela; Sherbourne, Cathy; Smithson, Dave; Stowell, Caleb; Woolaway-Bickel, Kelly; Rose, Matthias

2017-12-01

National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online ( www.ichom.org ). An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge.

Utilization and Harmonization of Adult Accelerometry Data: Review and Expert Consensus.

PubMed

Wijndaele, Katrien; Westgate, Kate; Stephens, Samantha K; Blair, Steven N; Bull, Fiona C; Chastin, Sebastien F M; Dunstan, David W; Ekelund, Ulf; Esliger, Dale W; Freedson, Patty S; Granat, Malcolm H; Matthews, Charles E; Owen, Neville; Rowlands, Alex V; Sherar, Lauren B; Tremblay, Mark S; Troiano, Richard P; Brage, Søren; Healy, Genevieve N

2015-10-01

This study aimed to describe the scope of accelerometry data collected internationally in adults and to obtain a consensus from measurement experts regarding the optimal strategies to harmonize international accelerometry data. In March 2014, a comprehensive review was undertaken to identify studies that collected accelerometry data in adults (sample size, n ≥ 400). In addition, 20 physical activity experts were invited to participate in a two-phase Delphi process to obtain consensus on the following: unique research opportunities available with such data, additional data required to address these opportunities, strategies for enabling comparisons between studies/countries, requirements for implementing/progressing such strategies, and value of a global repository of accelerometry data. The review identified accelerometry data from more than 275,000 adults from 76 studies across 36 countries. Consensus was achieved after two rounds of the Delphi process; 18 experts participated in one or both rounds. The key opportunities highlighted were the ability for cross-country/cross-population comparisons and the analytic options available with the larger heterogeneity and greater statistical power. Basic sociodemographic and anthropometric data were considered a prerequisite for this. Disclosure of monitor specifications and protocols for data collection and processing were deemed essential to enable comparison and data harmonization. There was strong consensus that standardization of data collection, processing, and analytical procedures was needed. To implement these strategies, communication and consensus among researchers, development of an online infrastructure, and methodological comparison work were required. There was consensus that a global accelerometry data repository would be beneficial and worthwhile. This foundational resource can lead to implementation of key priority areas and identification of future directions in physical activity epidemiology, population monitoring, and burden of disease estimates.

The Determination of Relevant Goals and Criteria Used to Select an Automated Patient Care Information System

PubMed Central

Chocholik, Joan K.; Bouchard, Susan E.; Tan, Joseph K. H.; Ostrow, David N.

1999-01-01

Objectives: To determine the relevant weighted goals and criteria for use in the selection of an automated patient care information system (PCIS) using a modified Delphi technique to achieve consensus. Design: A three-phase, six-round modified Delphi process was implemented by a ten-member PCIS selection task force. The first phase consisted of an exploratory round. It was followed by the second phase, of two rounds, to determine the selection goals and finally the third phase, of three rounds, to finalize the selection criteria. Results: Consensus on the goals and criteria for selecting a PCIS was measured during the Delphi process by reviewing the mean and standard deviation of the previous round's responses. After the study was completed, the results were analyzed using a limits-of-agreement indicator that showed strong agreement of each individual's responses between each of the goal determination rounds. Further analysis for variability in the group's response showed a significant movement to consensus after the first goal-determination iteration, with consensus reached on all goals by the end of the second iteration. Conclusion: The results indicated that the relevant weighted goals and criteria used to make the final decision for an automated PCIS were developed as a result of strong agreement among members of the PCIS selection task force. It is therefore recognized that the use of the Delphi process was beneficial in achieving consensus among clinical and nonclinical members in a relatively short time while avoiding a decision based on political biases and the “groupthink” of traditional committee meetings. The results suggest that improvements could be made in lessening the number of rounds by having information available through side conversations, by having other statistical indicators besides the mean and standard deviation available between rounds, and by having a content expert address questions between rounds. PMID:10332655

Simulations of motor unit number estimation techniques

NASA Astrophysics Data System (ADS)

Major, Lora A.; Jones, Kelvin E.

2005-06-01

Motor unit number estimation (MUNE) is an electrodiagnostic procedure used to evaluate the number of motor axons connected to a muscle. All MUNE techniques rely on assumptions that must be fulfilled to produce a valid estimate. As there is no gold standard to compare the MUNE techniques against, we have developed a model of the relevant neuromuscular physiology and have used this model to simulate various MUNE techniques. The model allows for a quantitative analysis of candidate MUNE techniques that will hopefully contribute to consensus regarding a standard procedure for performing MUNE.

Delivery of optimized inpatient anticoagulation therapy: consensus statement from the anticoagulation forum.

PubMed

Nutescu, Edith A; Wittkowsky, Ann K; Burnett, Allison; Merli, Geno J; Ansell, Jack E; Garcia, David A

2013-05-01

To provide recommendations for optimized anticoagulant therapy in the inpatient setting and outline broad elements that need to be in place for effective management of anticoagulant therapy in hospitalized patients; the guidelines are designed to promote optimization of patient clinical outcomes while minimizing the risks for potential anticoagulation-related errors and adverse events. The medical literature was reviewed using MEDLINE (1946-January 2013), EMBASE (1980-January 2013), and PubMed (1947-January 2013) for topics and key words including, but not limited to, standards of practice, national guidelines, patient safety initiatives, and regulatory requirements pertaining to anticoagulant use in the inpatient setting. Non-English-language publications were excluded. Specific MeSH terms used include algorithms, anticoagulants/administration and dosage/adverse effects/therapeutic use, clinical protocols/standards, decision support systems, drug monitoring/methods, humans, inpatients, efficiency/ organizational, outcome and process assessment (health care), patient care team/organization and administration, program development/standards, quality improvement/organization and administration, thrombosis/ drug therapy, thrombosis/prevention and control, risk assessment/standards, patient safety/standards, and risk management/methods. Because of this document's scope, the medical literature was searched using a variety of strategies. When possible, recommendations are supported by available evidence; however, because this paper deals with processes and systems of care, high-quality evidence (eg, controlled trials) is unavailable. In these cases, recommendations represent the consensus opinion of all authors and are endorsed by the Board of Directors of the Anticoagulation Forum, an organization dedicated to optimizing anticoagulation care. The board is composed of physicians, pharmacists, and nurses with demonstrated expertise and experience in the management of patients receiving anticoagulation therapy. Recommendations for delivering optimized inpatient anticoagulation therapy were developed collaboratively by the authors and are summarized in 8 key areas: (1) process, (2) accountability, (3) integration, (4) standards of practice, (5) provider education and competency, (6) patient education, (7) care transitions, and (8) outcomes. Recommendations are intended to inform the development of coordinated care systems containing elements with demonstrated benefit in improvement of anticoagulation therapy outcomes. Recommendations for delivering optimized inpatient anticoagulation therapy are intended to apply to all clinicians involved in the care of hospitalized patients receiving anticoagulation therapy. Anticoagulants are high-risk medications associated with a significant rate of medication errors among hospitalized patients. Several national organizations have introduced initiatives to reduce the likelihood of patient harm associated with the use of anticoagulants. Health care organizations are under increasing pressure to develop systems to ensure the safe and effective use of anticoagulants in the inpatient setting. This document provides consensus guidelines for anticoagulant therapy in the inpatient setting and serves as a companion document to prior guidelines relevant for outpatients.

Quality standards in a rheumatology Day-Care Hospital Unit. The proposal of the Spanish Society of Rheumatology Day Hospitals' Working Group.

PubMed

García-Vicuña, Rosario; Montoro, María; Egües Dubuc, César Antonio; Bustabad Reyes, Sagrario; Gómez-Centeno, Antonio; Muñoz-Fernández, Santiago; Pérez Pampín, Eva; Román Ivorra, Jose Andrés; Balsa, Alejandro; Loza, Estíbaliz

2014-01-01

In recent years, the Rheumatology Day-Care Hospital Units (DHU have undergone extensive development. However, the quality standards are poorly documented and mainly limited to structure items rather than including broad and specific areas of this specialty. To develop specific quality standards for Rheumatology DHU. After a systematic review of the literature and related documents, a working group (WG) involving 8 DHU-experienced rheumatologists developed an initial proposal of the quality standards, under the supervision of an expert methodologist. A second round was held by the WG group to review the initial proposal and to consider further suggestions. Once the content was agreed upon by consensus, a final report was prepared. 17 structure standards, 25 process standards and 10 results standards were defined, with special emphasis on specific aspects of the Rheumatology DHU. The proposal includes: 1) essential standards to 2) excellent standards, 3) a Rheumatology DHU services portfolio and 4) performance criteria. The proposed quality standards are the basis for developing the indicators and other management tools for Rheumatology DHU, thereby ensuring a patient-oriented practice based on both the evidence and the experience. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Canadian consensus conference on the development of training and practice standards in advanced minimally invasive surgery

PubMed Central

Birch, Daniel W.; Bonjer, H. Jaap; Crossley, Claire; Burnett, Gayle; de Gara, Chris; Gomes, Anthony; Hagen, John; Maciver, Angus G.; Mercer, C. Dale; Panton, O. Neely; Schlachta, Chris M.; Smith, Andy J.; Warnock, Garth L.

2009-01-01

Despite the complexities of minimally invasive surgery (MIS), a Canadian approach to training surgeons in this field does not exist. Whereas a limited number of surgeons are fellowship-trained in the specialty, guidelines are still clearly needed to implement advanced MIS. Leaders in the field of gastrointestinal surgery and MIS attended a consensus conference where they proposed a comprehensive mentoring program that may evolve into a framework for a national mentoring and training system. Leadership and commitment from national experts to define the most appropriate template for introducing new surgical techniques into practice is required. This national framework should also provide flexibility for truly novel procedures such as natural orifice translumenal endoscopic surgery. PMID:19680520

Whole-body Magnetic Resonance Imaging in Inflammatory Arthritis: Systematic Literature Review and First Steps Toward Standardization and an OMERACT Scoring System.

PubMed

Østergaard, Mikkel; Eshed, Iris; Althoff, Christian E; Poggenborg, Rene P; Diekhoff, Torsten; Krabbe, Simon; Weckbach, Sabine; Lambert, Robert G W; Pedersen, Susanne J; Maksymowych, Walter P; Peterfy, Charles G; Freeston, Jane; Bird, Paul; Conaghan, Philip G; Hermann, Kay-Geert A

2017-11-01

Whole-body magnetic resonance imaging (WB-MRI) is a relatively new technique that can enable assessment of the overall inflammatory status of people with arthritis, but standards for image acquisition, definitions of key pathologies, and a quantification system are required. Our aim was to perform a systematic literature review (SLR) and to develop consensus definitions of key pathologies, anatomical locations for assessment, a set of MRI sequences and imaging planes for the different body regions, and a preliminary scoring system for WB-MRI in inflammatory arthritis. An SLR was initially performed, searching for WB-MRI studies in arthritis, osteoarthritis, spondyloarthritis, or enthesitis. These results were presented to a meeting of the MRI in Arthritis Working Group together with an MR image review. Following this, preliminary standards for WB-MRI in inflammatory arthritides were developed with further iteration at the Working Group meetings at the Outcome Measures in Rheumatology (OMERACT) 2016. The SLR identified 10 relevant original articles (7 cross-sectional and 3 longitudinal, mostly focusing on synovitis and/or enthesitis in spondyloarthritis, 4 with reproducibility data). The Working Group decided on inflammation in peripheral joints and entheses as primary focus areas, and then developed consensus MRI definitions for these pathologies, selected anatomical locations for assessment, agreed on a core set of MRI sequences and imaging planes for the different regions, and proposed a preliminary scoring system. It was decided to test and further develop the system by iterative multireader exercises. These first steps in developing an OMERACT WB-MRI scoring system for use in inflammatory arthritides offer a framework for further testing and refinement.

An expert panel-based study on recognition of gastro-esophageal reflux in difficult esophageal pH-impedance tracings.

PubMed

Smits, M J; Loots, C M; van Wijk, M P; Bredenoord, A J; Benninga, M A; Smout, A J P M

2015-05-01

Despite existing criteria for scoring gastro-esophageal reflux (GER) in esophageal multichannel pH-impedance measurement (pH-I) tracings, inter- and intra-rater variability is large and agreement with automated analysis is poor. To identify parameters of difficult to analyze pH-I patterns and combine these into a statistical model that can identify GER episodes with an international consensus as gold standard. Twenty-one experts from 10 countries were asked to mark GER presence for adult and pediatric pH-I patterns in an online pre-assessment. During a consensus meeting, experts voted on patterns not reaching majority consensus (>70% agreement). Agreement was calculated between raters, between consensus and individual raters, and between consensus and software generated automated analysis. With eight selected parameters, multiple logistic regression analysis was performed to describe an algorithm sensitive and specific for detection of GER. Majority consensus was reached for 35/79 episodes in the online pre-assessment (interrater κ = 0.332). Mean agreement between pre-assessment scores and final consensus was moderate (κ = 0.466). Combining eight pH-I parameters did not result in a statistically significant model able to identify presence of GER. Recognizing a pattern as retrograde is the best indicator of GER, with 100% sensitivity and 81% specificity with expert consensus as gold standard. Agreement between experts scoring difficult impedance patterns for presence or absence of GER is poor. Combining several characteristics into a statistical model did not improve diagnostic accuracy. Only the parameter 'retrograde propagation pattern' is an indicator of GER in difficult pH-I patterns. © 2015 John Wiley & Sons Ltd.

49 CFR 214.115 - Foot protection.

Code of Federal Regulations, 2014 CFR

2014-10-01

... shock or burns, or other hazardous condition. (b) Safety-toe footwear for railroad bridge workers shall conform to the national consensus standards for safety-toe footwear (American National Standards Institute, American National Standard Z41-1991, Standard for Personal Protection-Protective Footwear). This...

49 CFR 214.115 - Foot protection.

Code of Federal Regulations, 2012 CFR

2012-10-01

... shock or burns, or other hazardous condition. (b) Safety-toe footwear for railroad bridge workers shall conform to the national consensus standards for safety-toe footwear (American National Standards Institute, American National Standard Z41-1991, Standard for Personal Protection-Protective Footwear). This...

49 CFR 214.115 - Foot protection.

Code of Federal Regulations, 2013 CFR

2013-10-01

... shock or burns, or other hazardous condition. (b) Safety-toe footwear for railroad bridge workers shall conform to the national consensus standards for safety-toe footwear (American National Standards Institute, American National Standard Z41-1991, Standard for Personal Protection-Protective Footwear). This...

49 CFR 214.115 - Foot protection.

Code of Federal Regulations, 2011 CFR

2011-10-01

... shock or burns, or other hazardous condition. (b) Safety-toe footwear for railroad bridge workers shall conform to the national consensus standards for safety-toe footwear (American National Standards Institute, American National Standard Z41-1991, Standard for Personal Protection-Protective Footwear). This...

Use of a Pediatric Cardiovascular Nursing Consortium for Development and Evaluation of Quality Measures: The C4-MNP Experience.

PubMed

Connor, Jean A; Larson, Carol; Baird, Jennifer; Hickey, Patricia A

2016-01-01

The evidence linking nursing care and patient outcomes has been globally demonstrated. Thus, it is time for translation and application of this evidence to robust measurement that uniquely demonstrates the value of nursing care and the characteristics of the nursing workforce that contribute to optimal patient outcomes. The aim of this study was to identify and develop standardized measures representative of pediatric nursing care of the cardiovascular patient for benchmarking within freestanding children's hospitals. Using a consensus-based approach, the Consortium of Congenital Cardiac Care- Measurement of Nursing Practice (C4-MNP) members developed quality measures within working groups and then individually critiqued all drafted measures. Final draft measures were then independently reviewed and critiqued by an external nursing quality measurement committee. The final quality measures were also made available to a national parent support group for feedback. The development process used by C4-MNP resulted in 10 measures eligible for testing across freestanding children's hospitals. Employing a collaborative consensus-based method plus implementing the criteria of the National Quality Forum and external vetting period provided a strong framework for the development and evaluation of standardized measures. The Consortium will continue with implementation and testing of each measure in 9 of our 28 collaborating centers. This activity will support initial development of benchmarks and evaluation of the association of the measures with patient outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Consensus on the standardization of terminology in thrombotic thrombocytopenic purpura and related thrombotic microangiopathies.

PubMed

Scully, M; Cataland, S; Coppo, P; de la Rubia, J; Friedman, K D; Kremer Hovinga, J; Lämmle, B; Matsumoto, M; Pavenski, K; Sadler, E; Sarode, R; Wu, H

2017-02-01

Essentials An international collaboration provides a consensus for clinical definitions. This concerns thrombotic microangiopathies and thrombotic thrombocytopenic purpura (TTP). The consensus defines diagnosis, disease monitoring and response to treatment. Requirements for ADAMTS-13 are given. Background Thrombotic thrombocytopenic purpura (TTP) and hemolytic-uremic syndrome (HUS) are two important acute conditions to diagnose. Thrombotic microangiopathy (TMA) is a broad pathophysiologic process that leads to microangiopathic hemolytic anemia and thrombocytopenia, and involves capillary and small-vessel platelet aggregates. The most common cause is disseminated intravascular coagulation, which may be differentiated by abnormal coagulation. Clinically, a number of conditions present with microangiopathic hemolytic anemia and thrombocytopenia, including cancer, infection, transplantation, drug use, autoimmune disease, and pre-eclampsia and hemolysis, elevated liver enzymes and low platelet count syndrome in pregnancy. Despite overlapping clinical presentations, TTP and HUS have distinct pathophysiologies and treatment pathways. Objectives To present a consensus document from an International Working Group on TTP and associated thrombotic microangiopathies (TMAs). Methods The International Working Group has proposed definitions and terminology based on published information and consensus-based recommendations. Conclusion The consensus aims to aid clinical decisions, but also future studies and trials, utilizing standardized definitions. It presents a classification of the causes of TMA, and criteria for clinical response, remission and relapse of congenital and immune-mediated TTP. © 2016 International Society on Thrombosis and Haemostasis.

Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines

PubMed Central

Brett, Jo; Staniszewska, Sophie; Simera, Iveta; Seers, Kate; Mockford, Carole; Goodlad, Susan; Altman, Doug; Moher, David; Barber, Rosemary; Denegri, Simon; Entwistle, Andrew Robert; Littlejohns, Peter; Suleman, Rashida; Thomas, Victoria; Tysall, Colin

2017-01-01

Introduction Patient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)). Methods There were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported. Discussion The process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development. PMID:29061613

Development of Geriatric Competencies for Emergency Medicine Residents Using an Expert Consensus Process

PubMed Central

Hogan, Teresita M.; Losman, Eve D.; Carpenter, Christopher R.; Sauvigne, Karen; Irmiter, Cheryl; Emanuel, Linda; Leipzig, Rosanne M.

2011-01-01

Background The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes. Objectives The objective was to develop a consensus document, “Geriatric Competencies for Emergency Medicine Residents,” by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. Methods This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. Results In Phase I, participants (n = 363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n = 24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. Conclusions The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. PMID:20370765

Development of geriatric competencies for emergency medicine residents using an expert consensus process.

PubMed

Hogan, Teresita M; Losman, Eve D; Carpenter, Christopher R; Sauvigne, Karen; Irmiter, Cheryl; Emanuel, Linda; Leipzig, Rosanne M

2010-03-01

The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes. The objective was to develop a consensus document, "Geriatric Competencies for Emergency Medicine Residents," by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. In Phase I, participants (n=363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n=24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. Copyright (c) 2010 by the Society for Academic Emergency Medicine.

The recognition, assessment and management of dementing disorders: conclusions from the Canadian Consensus Conference on Dementia.

PubMed

Patterson, C J; Gauthier, S; Bergman, H; Cohen, C A; Feightner, J W; Feldman, H; Hogan, D B

1999-06-15

To develop evidence based consensus statements on which to build clinical practice guidelines for primary care physicians toward the recognition, assessment and management of dementing disorders and to disseminate and evaluate the impact of these statements and guidelines built on these statements. Structured approach to assessment, including recommended laboratory tests, choices for neuroimaging and referral, management of complications (especially behavioural problems and depression) and use of cognitive enhancing agents. POTENTIAL OUTCOMES: Consistent and improved clinical care of persons with dementia; cost containment by more selective use of laboratory investigations; neuroimaging and referrals; and appropriate use of cognitive enhancing agents. Authors of each background paper were entrusted to perform a literature search, discover additional relevant material, including references cited in retrieved articles, consult with other experts in the field and then synthesize information. Standard rules of evidence were applied. Based on this evidence, consensus statements were developed by a group of experts, guided by a steering committee of 8 individuals, from the areas of Neurology, Geriatric Medicine, Psychiatry, Family Medicine, Preventive Health Care and Health Care Systems. Recommendations have been developed with particular attention to the context of primary care, and are intended to support family physicians in their ongoing assessment and care of patients with dementia. BENEFITS HARM AND COSTS: Potential for improved clinical care of people with dementia. A dissemination and evaluation strategy will attempt to measure the impact of the recommendations. Forty-eight recommendations are offered that address the following aspects of dementia care: early recognition; importance of careful history and examination in making a positive diagnosis; essential laboratory tests; rules for neuroimaging and referral; disclosure of diagnosis; importance of monitoring and providing support to caregivers; cultural aspects; detection and treatment of depression; observation and management of behavioural disturbances; detection and reporting of unsafe motor vehicle driving; genetic factors and opportunities for preventing dementia; pharmacological treatment with particular emphasis on cognitive enhancing agents. Four other sets of consensus statement or guidelines have been published recently. These recommendations are generally congruent with our own consensus statements. The consensus statements have been endorsed by relevant bodies in Canada.

Standards for Radiation Effects Testing: Ensuring Scientific Rigor in the Face of Budget Realities and Modern Device Challenges

NASA Technical Reports Server (NTRS)

Lauenstein, J M.

2015-01-01

An overview is presented of the space radiation environment and its effects on electrical, electronic, and electromechanical parts. Relevant test standards and guidelines are listed. Test standards and guidelines are necessary to ensure best practices, minimize and bound systematic and random errors, and to ensure comparable results from different testers and vendors. Test standards are by their nature static but exist in a dynamic environment of advancing technology and radiation effects research. New technologies, failure mechanisms, and advancement in our understanding of known failure mechanisms drive the revision or development of test standards. Changes to standards must be weighed against their impact on cost and existing part qualifications. There must be consensus on new best practices. The complexity of some new technologies exceeds the scope of existing test standards and may require development of a guideline specific to the technology. Examples are given to illuminate the value and limitations of key radiation test standards as well as the challenges in keeping these standards up to date.

Standards for Standardized Logistic Regression Coefficients

ERIC Educational Resources Information Center

Menard, Scott

2011-01-01

Standardized coefficients in logistic regression analysis have the same utility as standardized coefficients in linear regression analysis. Although there has been no consensus on the best way to construct standardized logistic regression coefficients, there is now sufficient evidence to suggest a single best approach to the construction of a…

SWOT analysis of Banff: strengths, weaknesses, opportunities and threats of the international Banff consensus process and classification system for renal allograft pathology.

PubMed

Mengel, M; Sis, B; Halloran, P F

2007-10-01

The Banff process defined the diagnostic histologic lesions for renal allograft rejection and created a standardized classification system where none had existed. By correcting this deficit the process had universal impact on clinical practice and clinical and basic research. All trials of new drugs since the early 1990s benefited, because the Banff classification of lesions permitted the end point of biopsy-proven rejection. The Banff process has strengths, weaknesses, opportunities and threats (SWOT). The strength is its self-organizing group structure to create consensus. Consensus does not mean correctness: defining consensus is essential if a widely held view is to be proved wrong. The weaknesses of the Banff process are the absence of an independent external standard to test the classification; and its almost exclusive reliance on histopathology, which has inherent limitations in intra- and interobserver reproducibility, particularly at the interface between borderline and rejection, is exactly where clinicians demand precision. The opportunity lies in the new technology such as transcriptomics, which can form an external standard and can be incorporated into a new classification combining the elegance of histopathology and the objectivity of transcriptomics. The threat is the degree to which the renal transplant community will participate in and support this process.

National turnaround time survey: professional consensus standards for optimal performance and thresholds considered to compromise efficient and effective clinical management.

PubMed

McKillop, Derek J; Auld, Peter

2017-01-01

Background Turnaround time can be defined as the time from receipt of a sample by the laboratory to the validation of the result. The Royal College of Pathologists recommends that a number of performance indicators for turnaround time should be agreed with stakeholders. The difficulty is in arriving at a goal which has some evidence base to support it other than what may simply be currently achievable technically. This survey sought to establish a professional consensus on the goals and meaning of targets for laboratory turnaround time. Methods A questionnaire was circulated by the National Audit Committee to 173 lead consultants for biochemistry in the UK. The survey asked each participant to state their current target turnaround time for core investigations in a broad group of clinical settings. Each participant was also asked to provide a professional opinion on what turnaround time would pose an unacceptable risk to patient safety for each departmental category. A super majority (2/3) was selected as the threshold for consensus. Results The overall response rate was 58% ( n = 100) with a range of 49-72% across the individual Association for Clinical Biochemistry and Laboratory Medicine regions. The consensus optimal turnaround time for the emergency department was <1 h with >2 h considered unacceptable. The times for general practice and outpatient department were <24 h and >48 h and for Wards <4 h and >12 h, respectively. Conclusions We consider that the figures provide a useful benchmark of current opinion, but clearly more empirical standards will have to develop alongside other aspects of healthcare delivery.

Consensus-based recommendations for the management of juvenile dermatomyositis.

PubMed

Enders, Felicitas Bellutti; Bader-Meunier, Brigitte; Baildam, Eileen; Constantin, Tamas; Dolezalova, Pavla; Feldman, Brian M; Lahdenne, Pekka; Magnusson, Bo; Nistala, Kiran; Ozen, Seza; Pilkington, Clarissa; Ravelli, Angelo; Russo, Ricardo; Uziel, Yosef; van Brussel, Marco; van der Net, Janjaap; Vastert, Sebastiaan; Wedderburn, Lucy R; Wulffraat, Nicolaas; McCann, Liza J; van Royen-Kerkhof, Annet

2017-02-01

In 2012, a European initiative called Single Hub and Access point for pediatric Rheumatology in Europe (SHARE) was launched to optimise and disseminate diagnostic and management regimens in Europe for children and young adults with rheumatic diseases. Juvenile dermatomyositis (JDM) is a rare disease within the group of paediatric rheumatic diseases (PRDs) and can lead to significant morbidity. Evidence-based guidelines are sparse and management is mostly based on physicians' experience. Consequently, treatment regimens differ throughout Europe. To provide recommendations for diagnosis and treatment of JDM. Recommendations were developed by an evidence-informed consensus process using the European League Against Rheumatism standard operating procedures. A committee was constituted, consisting of 19 experienced paediatric rheumatologists and 2 experts in paediatric exercise physiology and physical therapy, mainly from Europe. Recommendations derived from a validated systematic literature review were evaluated by an online survey and subsequently discussed at two consensus meetings using nominal group technique. Recommendations were accepted if >80% agreement was reached. In total, 7 overarching principles, 33 recommendations on diagnosis and 19 recommendations on therapy were accepted with >80% agreement among experts. Topics covered include assessment of skin, muscle and major organ involvement and suggested treatment pathways. The SHARE initiative aims to identify best practices for treatment of patients suffering from PRD. Within this remit, recommendations for the diagnosis and treatment of JDM have been formulated by an evidence-informed consensus process to produce a standard of care for patients with JDM throughout Europe. 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/.

Consensus-based recommendations for the management of uveitis associated with juvenile idiopathic arthritis: the SHARE initiative.

PubMed

Constantin, Tamas; Foeldvari, Ivan; Anton, Jordi; de Boer, Joke; Czitrom-Guillaume, Severine; Edelsten, Clive; Gepstein, Raz; Heiligenhaus, Arnd; Pilkington, Clarissa A; Simonini, Gabriele; Uziel, Yosef; Vastert, Sebastian J; Wulffraat, Nico M; Haasnoot, Anne-Mieke; Walscheid, Karoline; Pálinkás, Annamária; Pattani, Reshma; Györgyi, Zoltán; Kozma, Richárd; Boom, Victor; Ponyi, Andrea; Ravelli, Angelo; Ramanan, Athimalaipet V

2018-03-28

In 2012, a European initiative called S ingle Hub and Access point for pediatric Rheumatology in Europe (SHARE) was launched to optimise and disseminate diagnostic and management regimens in Europe for children and young adults with rheumatic diseases. Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children and uveitis is possibly its most devastating extra-articular manifestation. Evidence-based guidelines are sparse and management is mostly based on physicians' experience. Consequently, treatment practices differ widely, within and between nations. To provide recommendations for the diagnosis and treatment of JIA-associated uveitis. Recommendations were developed by an evidence-informed consensus process using the European League Against Rheumatism standard operating procedures. A committee was constituted, consisting of nine experienced paediatric rheumatologists and three experts in ophthalmology from Europe. Recommendations derived from a validated systematic literature review were evaluated by an Expert Committee and subsequently discussed at two consensus meetings using nominal group techniques. Recommendations were accepted if >80% agreement was reached (including all three ophthalmologists). In total, 22 recommendations were accepted (with >80% agreement among experts): 3 on diagnosis, 5 on disease activity measurements, 12 on treatment and 2 on future recommendations. The SHARE initiative aims to identify best practices for treatment of patients suffering from JIA-associated uveitis. Within this remit, recommendations for the diagnosis and treatment of JIA-associated uveitis have been formulated by an evidence-informed consensus process to suggest a standard of care for JIA-associated uveitis patients throughout Europe. © 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.

Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC).

PubMed

Kneyber, Martin C J; de Luca, Daniele; Calderini, Edoardo; Jarreau, Pierre-Henri; Javouhey, Etienne; Lopez-Herce, Jesus; Hammer, Jürg; Macrae, Duncan; Markhorst, Dick G; Medina, Alberto; Pons-Odena, Marti; Racca, Fabrizio; Wolf, Gerhard; Biban, Paolo; Brierley, Joe; Rimensberger, Peter C

2017-12-01

Much of the common practice in paediatric mechanical ventilation is based on personal experiences and what paediatric critical care practitioners have adopted from adult and neonatal experience. This presents a barrier to planning and interpretation of clinical trials on the use of specific and targeted interventions. We aim to establish a European consensus guideline on mechanical ventilation of critically children. The European Society for Paediatric and Neonatal Intensive Care initiated a consensus conference of international European experts in paediatric mechanical ventilation to provide recommendations using the Research and Development/University of California, Los Angeles, appropriateness method. An electronic literature search in PubMed and EMBASE was performed using a combination of medical subject heading terms and text words related to mechanical ventilation and disease-specific terms. The Paediatric Mechanical Ventilation Consensus Conference (PEMVECC) consisted of a panel of 15 experts who developed and voted on 152 recommendations related to the following topics: (1) general recommendations, (2) monitoring, (3) targets of oxygenation and ventilation, (4) supportive measures, (5) weaning and extubation readiness, (6) normal lungs, (7) obstructive diseases, (8) restrictive diseases, (9) mixed diseases, (10) chronically ventilated patients, (11) cardiac patients and (12) lung hypoplasia syndromes. There were 142 (93.4%) recommendations with "strong agreement". The final iteration of the recommendations had none with equipoise or disagreement. These recommendations should help to harmonise the approach to paediatric mechanical ventilation and can be proposed as a standard-of-care applicable in daily clinical practice and clinical research.

Saving the Children--A Rant

ERIC Educational Resources Information Center

Marglin, Stephen A.

2012-01-01

The conception of economics education implicit in the "Voluntary National Content Standards in Economics" is fundamentally at odds with what ought to be a primary goal of a liberal education: to teach students of all ages to treat all truth as provisional. Articulate the consensus, but also articulate questions about this consensus, questions…

The Overreliance of Accreditors on Consensus Standards.

ERIC Educational Resources Information Center

Murray, Frank B.

2001-01-01

Argues that the legitimacy of accreditation in teacher education is rooted in political consensus, power, and scholarship. Because these roots are fragile, there is no accepted concept of educational malpractice. The legitimacy of accreditation should be rooted in scholarly evidence that the program has fulfilled the claim that its graduates are…

[Rehabilitation of prostate cancer patients : A multidisciplinary consensus].

PubMed

Rick, Oliver; Böckmann, J; Dauelsberg, T; Hoffmann, W; Kämpfer, W; Otto, U; Rogge, A; Zermann, D

2016-07-01

Even though several specialist groups, including the German Pension Insurance (Deutsche Rentenversicherung) and health insurance funds, participate in the rehabilitation of patients with prostate carcinoma, there is no standardized rehabilitation program available for these patients. Consequently, there is no transparency regarding the services provided within the scope of rehabilitation for the referring physicians to uro-oncological rehabilitation, in particular, neither for physicians at urological acute-care clinics, nor for the patients concerned. Rehabilitation clinics are rather left to their own devices as to which services they provide in the treatment of the respective disease and in social situations, but also with regard to the consulting services offered. Development of a standard for the rehabilitation of patients with prostate carcinoma, taking into account both specialist circles and self-help groups relevant to this matter. Specialist groups, including self-help groups participating in the rehabilitation of patients with prostate cancer, have formed an expert group and developed the present standard. To this end, a thematic unsystematic literature review was carried out in advance to provide an evidence-based foundation. Views were given with regard to rehabilitation diagnostics, the therapy of urinary incontinence and erectile dysfunction, sport and physical exercise therapy, psycho-oncology, and social- and disease-related consulting. In this context, the focus was set on classification as well as on the consensus strength of the respective recommendations. All parties involved in the rehabilitation of prostate cancer patients, as well as the patients and the responsible cost bearers, can now use the standard as an orientation guide.

Can Less Be More? Comparison of an 8-Item Placement Quality Measure with the 50-Item Dundee Ready Educational Environment Measure (DREEM)

ERIC Educational Resources Information Center

Kelly, Martina; Bennett, Deirdre; Muijtjens, Arno; O'Flynn, Siun; Dornan, Tim

2015-01-01

Clinical clerks learn more than they are taught and not all they learn can be measured. As a result, curriculum leaders evaluate clinical educational environments. The quantitative Dundee Ready Environment Measure (DREEM) is a "de facto" standard for that purpose. Its 50 items and 5 subscales were developed by consensus. Reasoning that…

77 FR 39453 - Safety Zone; Head of the Cuyahoga and U.S. Rowing Masters Head Race National Championship...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

..., an email address, or a telephone number in the body of your document so that we can contact you if we... participants. D. Discussion of Proposed Rule With the aforementioned hazards in mind, the Captain of the Port...) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use...

Environmental Stress Testing of the Single Sample Cylinder: A Proven Consensus Standard for Internal Gas Analysis (IGA) or Residual Gas Analysis (RGA)

NASA Technical Reports Server (NTRS)

Schuessler, Philipp WH

2010-01-01

In August 2008, Schuessler Consulting was contracted by NASA GSFC in support of the NASA Electronic Parts and Packaging (NEPP) program to perform two separate studies on moisture laden air in a stainless steel cylinder that had been designed to become a consensus standard for Test Method 1018. This Test Method was originally released for hybrids under Mil. Std. 883 but was quickly utilized on other microelectronic devices under the auspice of Mil. Std. 750. The cylinder had subsequently been fabricated for the 750 community. It was back-filled with moist air and subsequently analyzed over a period of time under a previous NASA contract. It had been shown that moisture in the 4000 - 5000 ppm range could be analyzed rather precisely with a mass spectrometer, commonly referred to as a Residual Gas Analyzer (RGA). The scope of this study was to ascertain if the composition and precision varied as a function of thermal shock at sub-zero temperatures and whether there was consensus when the standard was submitted to other RGA units. It was demonstrated and published that the consensus standard would yield precise RGA data for moisture within +/- 1% when optimized for a given RGA unit. It has been subsequently shown in this study at Oneida Research Services, that sub-zero storage did not affect that precision when a well-defined protocol for the analysis was followed. The consensus standard was taken to a second facility for analysis where it was found that moisture adsorption on the transfer lines caused precision to drop to +/- 12%. The Single Sample Cylinder (SSC) is a one liter stainless steel cylinder with associated sampling valves and has considerable weight and volume. But this considerable size allows for approximately 300 gas samples of the same composition to be delivered to any RGA unit. Lastly, a smaller cylinder, approximately 75 cc, of a second consensus standard was fabricated and tested with a different mix of fixed gases where moisture was kept in the 100 ppm range. This second standard has the potential of providing 30 gaseous samples and can be readily shipped to any analytical facility that desires to generate comparison RGA data. A series of comparison residual gas analyses was performed at the Honeywell Federal Manufacturing & Technologies facility in the National Nuclear Facility Administration s plant in Kansas City to complete this project. It was shown that improvements in the precision of a given RGA unit can be done by controlling the cycle time for each analysis and increasing analysis temperatures to minimize moisture adsorption. It was also found that a "one time event" in the subzero storage of the large SSC did not effect the units ability to continuously supply precise samples of the same chemistry, however the "event" caused a permanent +8% shift in the reported value of the moisture content. Lastly, a set of SSC RGA results was plotted on a common graph with DSCC "correlation study" RGA data. The result demonstrates the ability of the SSC to remove many of the individual variances that single, individual samples introduce. The consensus standards are now in storage at Oneida Research Services, one of the DSCC certified houses that does RGA to Military Standards, where they await future studies. The analytical data and the operational parameters of the instruments used are provided in the following discussion. Limitations and suggested means for improvement of both precision and accuracy are provided.

OpenMI: the essential concepts and their implications for legacy software

NASA Astrophysics Data System (ADS)

Gregersen, J. B.; Gijsbers, P. J. A.; Westen, S. J. P.; Blind, M.

2005-08-01

Information & Communication Technology (ICT) tools such as computational models are very helpful in designing river basin management plans (rbmp-s). However, in the scientific world there is consensus that a single integrated modelling system to support e.g. the implementation of the Water Framework Directive cannot be developed and that integrated systems need to be very much tailored to the local situation. As a consequence there is an urgent need to increase the flexibility of modelling systems, such that dedicated model systems can be developed from available building blocks. The HarmonIT project aims at precisely that. Its objective is to develop and implement a standard interface for modelling components and other relevant tools: The Open Modelling Interface (OpenMI) standard. The OpenMI standard has been completed and documented. It relies entirely on the "pull" principle, where data are pulled by one model from the previous model in the chain. This paper gives an overview of the OpenMI standard, explains the foremost concepts and the rational behind it.

78 FR 35559 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-13

...; Signage AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION: Direct... signage standards by adding references to the latest versions of the American National Standards Institute... earlier ANSI standards, ANSI Z53.1-1967, Z35.1-1968 and Z35.2-1968, in its signage standards, thereby...

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

PubMed

Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

2018-05-01

Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

First Results from the Test Of Astronomy STandards (TOAST) Assessment Instrument

NASA Astrophysics Data System (ADS)

Slater, Stephanie

2009-01-01

Considerable effort in the astronomy education research over the past several years has focused on developing assessment tools in the form of multiple-choice conceptual diagnostics and content knowledge surveys. This has been critically important in advancing astronomy as a sub-discipline of physics education research, allowing researchers to establish the initial knowledge state of students as well as to attempt to measure some of the impacts of innovative instructional interventions. Before now, few of the existing instruments were constructed upon a solid list of clearly articulated and widely agreed upon learning objectives. Moving beyond the 10-year old Astronomy Diagnostics Test, we have developed and validated a new assessment instrument that is tightly aligned to the consensus learning goals stated by the American Astronomical Society - Chair's Conference on ASTRO 101, the American Association of the Advancement of Science's Project 2061 Benchmarks, and the National Research Council's National Science Education Standards. Researchers from the Cognition in Astronomy, Physics and Earth sciences Research (CAPER) Team at the University of Wyoming's Science and Math Teaching Center (UWYO SMTC) designed a criterion-referenced assessment tool, called the Test Of Astronomy STandards (TOAST). Through iterative development, this multiple-choice instrument has a high degree of reliability and validity for instructors and researchers needing information on students’ initial knowledge state at the beginning of a course and can be used, in aggregate, to help measure the impact of course-length duration instructional strategies for undergraduate science survey courses with learning goals tightly aligned to the consensus goals of the astronomy education community.

Development of the Learning Health System Researcher Core Competencies.

PubMed

Forrest, Christopher B; Chesley, Francis D; Tregear, Michelle L; Mistry, Kamila B

2017-08-04

To develop core competencies for learning health system (LHS) researchers to guide the development of training programs. Data were obtained from literature review, expert interviews, a modified Delphi process, and consensus development meetings. The competencies were developed from August to December 2016 using qualitative methods. The literature review formed the basis for the initial draft of a competency domain framework. Key informant semi-structured interviews, a modified Delphi survey, and three expert panel (n = 19 members) consensus development meetings produced the final set of competencies. The iterative development process yielded seven competency domains: (1) systems science; (2) research questions and standards of scientific evidence; (3) research methods; (4) informatics; (5) ethics of research and implementation in health systems; (6) improvement and implementation science; and (7) engagement, leadership, and research management. A total of 33 core competencies were prioritized across these seven domains. The real-world milieu of LHS research, the embeddedness of the researcher within the health system, and engagement of stakeholders are distinguishing characteristics of this emerging field. The LHS researcher core competencies can be used to guide the development of learning objectives, evaluation methods, and curricula for training programs. © Health Research and Educational Trust.

48 CFR 45.103 - General.

Code of Federal Regulations, 2011 CFR

2011-10-01

... voluntary consensus standards (see FAR 11.101(b)) and industry-leading practices and standards to manage... contractor's established procedures, practices, and systems used to account for and manage contractor-owned...

48 CFR 45.103 - General.

Code of Federal Regulations, 2013 CFR

2013-10-01

... voluntary consensus standards (see FAR 11.101(b)) and industry-leading practices and standards to manage... contractor's established procedures, practices, and systems used to account for and manage contractor-owned...

48 CFR 45.103 - General.

Code of Federal Regulations, 2012 CFR

2012-10-01

... voluntary consensus standards (see FAR 11.101(b)) and industry-leading practices and standards to manage... contractor's established procedures, practices, and systems used to account for and manage contractor-owned...

48 CFR 45.103 - General.

Code of Federal Regulations, 2014 CFR

2014-10-01

... voluntary consensus standards (see FAR 11.101(b)) and industry-leading practices and standards to manage... contractor's established procedures, practices, and systems used to account for and manage contractor-owned...

Development of the Test Of Astronomy STandards (TOAST) Assessment Instrument

NASA Astrophysics Data System (ADS)

Slater, Timothy F.; Slater, S. J.

2008-05-01

Considerable effort in the astronomy education research (AER) community over the past several years has focused on developing assessment tools in the form of multiple-choice conceptual diagnostics and content knowledge surveys. This has been critically important in advancing the AER discipline so that researchers could establish the initial knowledge state of students as well as to attempt measure some of the impacts of innovative instructional interventions. Unfortunately, few of the existing instruments were constructed upon a solid list of clearly articulated and widely agreed upon learning objectives. This was not done in oversight, but rather as a result of the relative youth of AER as a discipline. Now that several important science education reform documents exist and are generally accepted by the AER community, we are in a position to develop, validate, and disseminate a new assessment instrument which is tightly aligned to the consensus learning goals stated by the American Astronomical Society - Chair's Conference on ASTRO 101, the American Association of the Advancement of Science's Project 2061 Benchmarks, and the National Research Council's National Science Education Standards. In response, researchers from the Cognition in Astronomy, Physics and Earth sciences Research (CAPER) Team at the University of Wyoming's Science & Math Teaching Center (UWYO SMTC) have designed a criterion-referenced assessment tool, called the Test Of Astronomy STandards (TOAST). Through iterative development, this instrument has a high degree of reliability and validity for instructors and researchers needing information on students’ initial knowledge state at the beginning of a course and can be used, in aggregate, to help measure the impact of course-length duration instructional strategies for courses with learning goals tightly aligned to the consensus goals of our community.

A consensus definition and core competencies for being an advocate for pharmacy.

PubMed

Bzowyckyj, Andrew S; Janke, Kristin K

2013-03-12

To develop a consensus definition for "advocacy for the profession of pharmacy" and core competencies for doctor of pharmacy (PharmD) graduates to be effective advocates for the profession. A 3-round modified Delphi process was conducted using a panel of 9 experts. Participants revised a definition for "advocacy for the profession" and ultimately rated their agreement using a 5-point Likert scale. Competency statements were developed and subsequently rated for importance for being an advocate and importance to address in PharmD curricula. A consensus-derived definition was developed. Two competency statements achieved consensus for both measures of importance. Four competency statements achieved consensus for only 1 measure and another 4 did not reach consensus for either measure. A consensus-derived definition was developed describing advocacy for the profession of pharmacy and began laying the groundwork for the knowledge and skills necessary to be an effective advocate for the profession of pharmacy.

Lack of international consensus in low-risk drinking guidelines.

PubMed

Furtwaengler, Nina A F F; de Visser, Richard O

2013-01-01

To encourage moderate alcohol consumption, many governments have developed guidelines for alcohol intake, guidelines for alcohol consumption during pregnancy and legislation relating to blood alcohol limits when driving. The aim of this study was to determine the degree of international consensus within such guidelines. Official definitions of standard drinks and consumption guidelines were searched for on government websites, including all 27 European Union Member States and countries from all global geographic regions. There was a remarkable lack of agreement about what constitutes harmful or excessive alcohol consumption on a daily basis, a weekly basis and when driving, with no consensus about the ratios of consumption guidelines for men and women. International consensus in low-risk drinking guidelines is an important--and achievable--goal. Such agreement would facilitate consistent labelling of packaged products and could help to promote moderate alcohol consumption. However, there are some paradoxes related to alcohol content labelling and people's use of such information: although clearer information could increase people's capacity to monitor and regulate their alcohol consumption, not all drinkers are motivated to drink moderately or sensibly, and drinkers who intend to get drunk may use alcohol content labelling to select more alcoholic products. © 2012 Australasian Professional Society on Alcohol and other Drugs.

Indicators to assess the functionality of clubfoot clinics in low-resource settings: a Delphi consensus approach and pilot study.

PubMed

Smythe, Tracey; Mudariki, Debra; Foster, Allen; Lavy, Christopher

2018-05-19

This study aims to determine the indicators for assessing the functionality of clubfoot clinics in a low-resource setting. The Delphi method was employed with experienced clubfoot practitioners in Africa to rate the importance of indicators of a good clubfoot clinic. The consistency among the participants was determined with the intraclass correlation coefficient. Indicators that achieved strong agreement (mean≥9 [SD <1.5]) were included in the final consensus definition. Based on the final consensus definition, a set of questions was developed to form the Functionality Assessment Clubfoot Clinic Tool (FACT). The FACT was used between February and July 2017 to assess the functionality of clinics in the Zimbabwe clubfoot programme. A set of 10 indicators that includes components of five of the six building blocks of a health system-leadership, human resources, essential medical equipment, health information systems and service delivery-was produced. The most common needs identified in Zimbabwe clubfoot clinics were a standard treatment protocol, a process for surgical referrals and a process to monitor dropout of patients. Practitioners had good consistency in rating indicators. The consensus definition includes components of the World Health Organization building blocks of health systems. Useful information was obtained on how to improve the services in the Zimbabwe clubfoot programme.

International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics.

PubMed

Jutel, Marek; Agache, Ioana; Bonini, Sergio; Burks, A Wesley; Calderon, Moises; Canonica, Walter; Cox, Linda; Demoly, Pascal; Frew, Antony J; O'Hehir, Robyn; Kleine-Tebbe, Jörg; Muraro, Antonella; Lack, Gideon; Larenas, Désirée; Levin, Michael; Martin, Bryan L; Nelson, Harald; Pawankar, Ruby; Pfaar, Oliver; van Ree, Ronald; Sampson, Hugh; Sublett, James L; Sugita, Kazunari; Du Toit, George; Werfel, Thomas; Gerth van Wijk, Roy; Zhang, Luo; Akdis, Mübeccel; Akdis, Cezmi A

2016-02-01

This article continues the comprehensive international consensus (ICON) statement on allergen immunotherapy (AIT). The initial article also recently appeared in the Journal. The conclusions below focus on key mechanisms of AIT-triggered tolerance, requirements in allergen standardization, AIT cost-effectiveness, and regulatory guidance. Potential barriers to and facilitators of the use of AIT are described in addition to future directions. International allergy specialists representing the European Academy of Allergy and Clinical Immunology; the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the World Allergy Organization critically reviewed the existing literature and prepared this summary of recommendations for best AIT practice. The authors contributed equally and reached consensus on the statements presented herein. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Developing a Canadian Curriculum for Simulation-Based Education in Obstetrics and Gynaecology: A Delphi Study.

PubMed

Craig, Catherine; Posner, Glenn D

2017-09-01

As obstetrics and gynaecology (Ob/Gyn) residency training programs move towards a competence-based approach to training and assessment, the development of a national standardized simulation curriculum is essential. The primary goal of this study was to define the fundamental content for the Canadian Obstetrics and Gynecology Simulation curriculum. A modified Delphi technique was used to achieve consensus in three rounds by surveying residency program directors or their local simulation educator delegates in 16 accredited Canadian Ob/Gyn residency programs. A consensus rate of 80% was agreed upon. Survey results were collected over 11 months in 2016. Response rates for the Delphi were 50% for the first round, 81% for the second round, and 94% for the third round. The first survey resulted in 84 suggested topics. These were organized into four categories: obstetrics high acuity low frequency events, obstetrics common events, gynaecology high acuity low frequency events, and gynaecology common events. Using the modified Delphi method, consensus was reached on 6 scenarios. This study identified the content for a national simulation-based curriculum for Ob/Gyn residency training programs and is the first step in the development of this curriculum. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Toward improved guideline quality: using the COGS statement with GEM.

PubMed

Shiffman, Richard N; Michel, Georges

2004-01-01

The Conference on Guideline Standardization (COGS) was convened to create a standardized documentation checklist for clinical practice guidelines in an effort to promote guideline quality and facilitate implementation. The statement was created by a multidisciplinary panel using a rigorous consensus development methodology. The Guideline Elements Model (GEM) provides a standardized approach to representing guideline documents using XML. In this work, we demonstrate the sufficiency of GEM for describing COGS components. Using the mapping between COGS and GEM elements we built an XSLT application to examine a guideline's adherence (or non-adherence) to the COGS checklist. Once a guideline has been marked up according to the GEM hierarchy, its knowledge content can be reused in multiple ways.

Expert opinions and scientific evidence for colonoscopy key performance indicators.

PubMed

Rees, Colin J; Bevan, Roisin; Zimmermann-Fraedrich, Katharina; Rutter, Matthew D; Rex, Douglas; Dekker, Evelien; Ponchon, Thierry; Bretthauer, Michael; Regula, Jaroslaw; Saunders, Brian; Hassan, Cesare; Bourke, Michael J; Rösch, Thomas

2016-12-01

Colonoscopy is a widely performed procedure with procedural volumes increasing annually throughout the world. Many procedures are now performed as part of colorectal cancer screening programmes. Colonoscopy should be of high quality and measures of this quality should be evidence based. New UK key performance indicators and quality assurance standards have been developed by a working group with consensus agreement on each standard reached. This paper reviews the scientific basis for each of the quality measures published in the UK standards. 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/.

Chapter 2: Student Performance Data, School Attributes, and Relationships

ERIC Educational Resources Information Center

Mitchell, Murray; Castelli, Darla; Strainer, Skip

2003-01-01

Physical education as a school subject can be characterized as largely void of both consensus and accountability. Until the publication of the national content standards (NASPE, 1995) there was no explicit, shared vision regarding what is important to teach in school programs. There has been a sense that this lack of consensus somehow preserves…

Healthy food procurement and nutrition standards in public facilities: evidence synthesis and consensus policy recommendations

PubMed Central

Kim D., Raine; Kayla, Atkey; Dana Lee, Dana Lee; Alexa R., Ferdinands; Dominique, Beaulieu; Susan, Buhler; Norm, Campbell; Brian, Cook; Mary, L’Abbé; Ashley, Lederer; David, Mowat; Joshna, Maharaj; Candace, Nykiforuk; Jacob, Shelley; Jacqueline, Street

2018-01-01

Abstract Introduction: Unhealthy foods are widely available in public settings across Canada, contributing to diet-related chronic diseases, such as obesity. This is a concern given that public facilities often provide a significant amount of food for consumption by vulnerable groups, including children and seniors. Healthy food procurement policies, which support procuring, distributing, selling, and/or serving healthier foods, have recently emerged as a promising strategy to counter this public health issue by increasing access to healthier foods. Although numerous Canadian health and scientific organizations have recommended such policies, they have not yet been broadly implemented in Canada. Methods: To inform further policy action on healthy food procurement in a Canadian context, we: (1) conducted an evidence synthesis to assess the impact of healthy food procurement policies on health outcomes and sales, intake, and availability of healthier food, and (2) hosted a consensus conference in September 2014. The consensus conference invited experts with public health/nutrition policy research expertise, as well as health services and food services practitioner experience, to review evidence, share experiences, and develop a consensus statement/recommendations on healthy food procurement in Canada. Results: Findings from the evidence synthesis and consensus recommendations for healthy food procurement in Canada are described. Specifically, we outline recommendations for governments, publicly funded institutions, decision-makers and professionals, citizens, and researchers. Conclusion: Implementation of healthy food procurement policies can increase Canadians’ access to healthier foods as part of a broader vision for food policy in Canada. PMID:29323862

Best practices recommendations for chiropractic care for infants, children, and adolescents: results of a consensus process.

PubMed

Hawk, Cheryl; Schneider, Michael; Ferrance, Randy J; Hewitt, Elise; Van Loon, Meghan; Tanis, Lora

2009-10-01

There has been much discussion about the role of chiropractic care in the evaluation, management, and treatment of pediatric patients. To date, no specific guidelines have been adopted that address this issue from an evidence based perspective. Previous systematic reviews of the chiropractic literature concluded that there is not yet a substantial body of high quality evidence from which to develop standard clinical guidelines. The purpose of this project was to develop recommendations on "best practices" related primarily to the evaluation and spinal manipulation aspects of pediatric chiropractic care; nonmanipulative therapies were not addressed in detail. Based on both clinical experience and the results of an extensive literature search, a set of seed documents was compiled to inform development of the seed statements. These were circulated electronically to the Delphi panel until consensus was reached, which was considered to be present when there was agreement by at least 80% of the panelists. A multidisciplinary panel of 37 was made up primarily of doctors of chiropractic with a mean of 18 years in practice, many with post-graduate training in pediatrics. The panel represented 5 countries and 17 states; there were members of the American Chiropractic Association, the International Chiropractors Association, and the International Chiropractic Pediatric Association. The panel reached a minimum of 80% consensus on the 51 seed statements after 4 rounds. A broad-based panel of experienced chiropractors was able to reach a high level (80%) of consensus regarding specific aspects of the chiropractic approach to clinical evaluation, management, and manual treatment for pediatric patients, based on both scientific evidence and clinical experience.

The Research Diagnostic Criteria for Temporomandibular Disorders. I: overview and methodology for assessment of validity.

PubMed

Schiffman, Eric L; Truelove, Edmond L; Ohrbach, Richard; Anderson, Gary C; John, Mike T; List, Thomas; Look, John O

2010-01-01

The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. The aim of this article is to provide an overview of the project's methodology, descriptive statistics, and data for the study participant sample. This article also details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. The Axis I reference standards were based on the consensus of two criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion examination reliability was also assessed within study sites. Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas > or = 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion examiner agreement with reference standards was excellent (k > or = 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods.

Priority target conditions for algorithms for monitoring children's growth: Interdisciplinary consensus.

PubMed

Scherdel, Pauline; Reynaud, Rachel; Pietrement, Christine; Salaün, Jean-François; Bellaïche, Marc; Arnould, Michel; Chevallier, Bertrand; Piloquet, Hugues; Jobez, Emmanuel; Cheymol, Jacques; Bichara, Emmanuelle; Heude, Barbara; Chalumeau, Martin

2017-01-01

Growth monitoring of apparently healthy children aims at early detection of serious conditions through the use of both clinical expertise and algorithms that define abnormal growth. Optimization of growth monitoring requires standardization of the definition of abnormal growth, and the selection of the priority target conditions is a prerequisite of such standardization. To obtain a consensus about the priority target conditions for algorithms monitoring children's growth. We applied a formal consensus method with a modified version of the RAND/UCLA method, based on three phases (preparatory, literature review, and rating), with the participation of expert advisory groups from the relevant professional medical societies (ranging from primary care providers to hospital subspecialists) as well as parent associations. We asked experts in the pilot (n = 11), reading (n = 8) and rating (n = 60) groups to complete the list of diagnostic classification of the European Society for Paediatric Endocrinology and then to select the conditions meeting the four predefined criteria of an ideal type of priority target condition. Strong agreement was obtained for the 8 conditions selected by the experts among the 133 possible: celiac disease, Crohn disease, craniopharyngioma, juvenile nephronophthisis, Turner syndrome, growth hormone deficiency with pituitary stalk interruption syndrome, infantile cystinosis, and hypothalamic-optochiasmatic astrocytoma (in decreasing order of agreement). This national consensus can be used to evaluate the algorithms currently suggested for growth monitoring. The method used for this national consensus could be re-used to obtain an international consensus.

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Publication guidelines for quality improvement in health care: evolution of the SQUIRE project

PubMed Central

Davidoff, F; Batalden, P; Stevens, D; Ogrinc, G; Mooney, S

2008-01-01

In 2005, draft guidelines were published for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. This article contains the full revised version of the guidelines, which the authors refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). This paper also describes the consensus process, which included informal feedback from authors, editors and peer reviewers who used the guidelines; formal written commentaries; input from a group of publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programmes; a two-day meeting of stakeholders for critical discussion and debate of the guidelines’ content and wording; and commentary on sequential versions of the guidelines from an expert consultant group. Finally, the authors consider the major differences between SQUIRE and the initial draft guidelines; limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions that are under development; and plans for dissemination, testing and further development of SQUIRE. PMID:18836063

Consensus statements on occupational therapy ethics related to driving.

PubMed

Slater, Deborah Yarett

2014-04-01

As part of an expert panel convened to examine evidence and practice related to diverse aspects of driving evaluation and rehabilitation, consensus statements were developed on ethics. This paper provides context for the ethical obligation of practitioners to assess and make recommendations about the ability of clients to safely perform the activity of driving. It highlights key articles from the literature as well as principles from the Occupational Therapy Code of Ethics and Ethics Standards (2010). The statements support the importance of identifying impairments affecting driving, which could result in harm to the client as well as to the public. The ethical and professional obligation of practitioners to evaluate, make recommendations, and possibly report and/or refer to a driver rehabilitation specialist for further services is reinforced.

[Treatment of testicular cancer].

PubMed

Droz, Jean-Pierre; Boyle, Helen; Culine, Stéphane; Fizazi, Karim; Fléchon, Aude; Massard, Christophe

2013-12-01

Germ-cell tumours (GCTs) are the most common type of cancer in young men. Since the late 1970s, disseminated GCT have been a paradigm for curable metastatic cancer and metastatic GCTs are highly curable with cisplatin-based chemotherapy followed by surgical resection of residual masses. Patients' prognosis is currently assessed using the International Germ-Cell Consensus Classification (IGCCC) and used to adapt the burden of chemotherapy. Approximately 20% of patients still do not achieve cure after first-line cisplatin-based chemotherapy, and need salvage chemotherapy (high dose or standard dose chemotherapy). Clinical stage I testicular cancer is the most common presentation and different strategies are proposed: adjuvant therapies, surgery or surveillance. During the last three decades, clinical trials and strong international collaborations lead to the development of a consensus in the management of GCTs.

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2010 CFR

2010-07-01

... object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or, American National Standards Institute (ANSI) standard, rough terrain fork lift trucks, B56.6—1987. ...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2010 CFR

2010-07-01

... object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or American National Standards Institute (ANSI) standard, rough terrain fork lift trucks, B 56.6—1987. ...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2011 CFR

2011-07-01

... object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or American National Standards Institute (ANSI) standard, rough terrain fork lift trucks, B 56.6—1987. ...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2011 CFR

2011-07-01

... object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or, American National Standards Institute (ANSI) standard, rough terrain fork lift trucks, B56.6—1987. ...

WHO Expert Committee on specifications for pharmaceutical preparations.

PubMed

2010-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

Constellation's Command, Control, Communications and Information (C3I) Architecture

NASA Technical Reports Server (NTRS)

Breidenthal, Julian C.

2007-01-01

Operations concepts are highly effective for: 1) Developing consensus; 2) Discovering stakeholder needs, goals, objectives; 3) Defining behavior of system components (especially emergent behaviors). An interoperability standard can provide an excellent lever to define the capabilities needed for system evolution. Two categories of architectures are needed in a program of this size are: 1) Generic - Needed for planning, design and construction standards; 2) Specific - Needed for detailed requirement allocations, interface specs. A wide variety of architectural views are needed to address stakeholder concerns, including: 1) Physical; 2) Information (structure, flow, evolution); 3) Processes (design, manufacturing, operations); 4) Performance; 5) Risk.

Pragmatic, consensus-based minimum standards and structured interview to guide the selection and development of cancer support group leaders: a protocol paper.

PubMed

Pomery, Amanda; Schofield, Penelope; Xhilaga, Miranda; Gough, Karla

2017-06-30

Across the globe, peer support groups have emerged as a community-led approach to accessing support and connecting with others with cancer experiences. Little is known about qualities required to lead a peer support group or how to determine suitability for the role. Organisations providing assistance to cancer support groups and their leaders are currently operating independently, without a standard national framework or published guidelines. This protocol describes the methods that will be used to generate pragmatic consensus-based minimum standards and an accessible structured interview with user manual to guide the selection and development of cancer support group leaders. We will: (A) identify and collate peer-reviewed literature that describes qualities of support group leaders through a systematic review; (B) content analyse eligible documents for information relevant to requisite knowledge, skills and attributes of group leaders generally and specifically to cancer support groups; (C) use an online reactive Delphi method with an interdisciplinary panel of experts to produce a clear, suitable, relevant and appropriate structured interview comprising a set of agreed questions with behaviourally anchored rating scales; (D) produce a user manual to facilitate standard delivery of the structured interview; (E) pilot the structured interview to improve clinical utility; and (F) field test the structured interview to develop a rational scoring model and provide a summary of existing group leader qualities. The study is approved by the Department Human Ethics Advisory Group of The University of Melbourne. The study is based on voluntary participation and informed written consent, with participants able to withdraw at any time. The results will be disseminated at research conferences and peer review journals. Presentations and free access to the developed structured interview and user manual will be available to cancer agencies. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pragmatic, consensus-based minimum standards and structured interview to guide the selection and development of cancer support group leaders: a protocol paper

PubMed Central

Schofield, Penelope; Xhilaga, Miranda; Gough, Karla

2017-01-01

Introduction Across the globe, peer support groups have emerged as a community-led approach to accessing support and connecting with others with cancer experiences. Little is known about qualities required to lead a peer support group or how to determine suitability for the role. Organisations providing assistance to cancer support groups and their leaders are currently operating independently, without a standard national framework or published guidelines. This protocol describes the methods that will be used to generate pragmatic consensus-based minimum standards and an accessible structured interview with user manual to guide the selection and development of cancer support group leaders. Methods and analysis We will: (A) identify and collate peer-reviewed literature that describes qualities of support group leaders through a systematic review; (B) content analyse eligible documents for information relevant to requisite knowledge, skills and attributes of group leaders generally and specifically to cancer support groups; (C) use an online reactive Delphi method with an interdisciplinary panel of experts to produce a clear, suitable, relevant and appropriate structured interview comprising a set of agreed questions with behaviourally anchored rating scales; (D) produce a user manual to facilitate standard delivery of the structured interview; (E) pilot the structured interview to improve clinical utility; and (F) field test the structured interview to develop a rational scoring model and provide a summary of existing group leader qualities. Ethics and dissemination The study is approved by the Department Human Ethics Advisory Group of The University of Melbourne. The study is based on voluntary participation and informed written consent, with participants able to withdraw at any time. The results will be disseminated at research conferences and peer review journals. Presentations and free access to the developed structured interview and user manual will be available to cancer agencies. PMID:28667202

49 CFR 214.113 - Head protection.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Bridge Worker Safety Standards § 214.113 Head... conform to the national consensus standards for industrial head protection (American National Standards Institute, Z89.1-1986, Protective Headwear for Industrial Workers). This incorporation by reference was...

49 CFR 214.113 - Head protection.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Bridge Worker Safety Standards § 214.113 Head... conform to the national consensus standards for industrial head protection (American National Standards Institute, Z89.1-1986, Protective Headwear for Industrial Workers). This incorporation by reference was...

49 CFR 214.113 - Head protection.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Bridge Worker Safety Standards § 214.113 Head... conform to the national consensus standards for industrial head protection (American National Standards Institute, Z89.1-1986, Protective Headwear for Industrial Workers). This incorporation by reference was...

49 CFR 214.113 - Head protection.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Bridge Worker Safety Standards § 214.113 Head... conform to the national consensus standards for industrial head protection (American National Standards Institute, Z89.1-1986, Protective Headwear for Industrial Workers). This incorporation by reference was...

Recommendations for Selecting Drug-Drug Interactions for Clinical Decision Support

PubMed Central

Tilson, Hugh; Hines, Lisa E.; McEvoy, Gerald; Weinstein, David M.; Hansten, Philip D.; Matuszewski, Karl; le Comte, Marianne; Higby-Baker, Stefanie; Hanlon, Joseph T.; Pezzullo, Lynn; Vieson, Kathleen; Helwig, Amy L.; Huang, Shiew-Mei; Perre, Anthony; Bates, David W.; Poikonen, John; Wittie, Michael A.; Grizzle, Amy J.; Brown, Mary; Malone, Daniel C.

2016-01-01

Purpose To recommend principles for including drug-drug interactions (DDIs) in clinical decision support. Methods A conference series was conducted to improve clinical decision support (CDS) for DDIs. The Content Workgroup met monthly by webinar from January 2013 to February 2014, with two in-person meetings to reach consensus. The workgroup consisted of 20 experts in pharmacology, drug information, and CDS from academia, government agencies, health information (IT) vendors, and healthcare organizations. Workgroup members addressed four key questions: (1) What process should be used to develop and maintain a standard set of DDIs?; (2) What information should be included in a knowledgebase of standard DDIs?; (3) Can/should a list of contraindicated drug pairs be established?; and (4) How can DDI alerts be more intelligently filtered? Results To develop and maintain a standard set of DDIs for CDS in the United States, we recommend a transparent, systematic, and evidence-driven process with graded recommendations by a consensus panel of experts and oversight by a national organization. We outline key DDI information needed to help guide clinician decision-making. We recommend judicious classification of DDIs as contraindicated, as only a small set of drug combinations are truly contraindicated. Finally, we recommend more research to identify methods to safely reduce repetitive and less relevant alerts. Conclusion A systematic ongoing process is necessary to select DDIs for alerting clinicians. We anticipate that our recommendations can lead to consistent and clinically relevant content for interruptive DDIs, and thus reduce alert fatigue and improve patient safety. PMID:27045070

When is hub gene selection better than standard meta-analysis?

PubMed

Langfelder, Peter; Mischel, Paul S; Horvath, Steve

2013-01-01

Since hub nodes have been found to play important roles in many networks, highly connected hub genes are expected to play an important role in biology as well. However, the empirical evidence remains ambiguous. An open question is whether (or when) hub gene selection leads to more meaningful gene lists than a standard statistical analysis based on significance testing when analyzing genomic data sets (e.g., gene expression or DNA methylation data). Here we address this question for the special case when multiple genomic data sets are available. This is of great practical importance since for many research questions multiple data sets are publicly available. In this case, the data analyst can decide between a standard statistical approach (e.g., based on meta-analysis) and a co-expression network analysis approach that selects intramodular hubs in consensus modules. We assess the performance of these two types of approaches according to two criteria. The first criterion evaluates the biological insights gained and is relevant in basic research. The second criterion evaluates the validation success (reproducibility) in independent data sets and often applies in clinical diagnostic or prognostic applications. We compare meta-analysis with consensus network analysis based on weighted correlation network analysis (WGCNA) in three comprehensive and unbiased empirical studies: (1) Finding genes predictive of lung cancer survival, (2) finding methylation markers related to age, and (3) finding mouse genes related to total cholesterol. The results demonstrate that intramodular hub gene status with respect to consensus modules is more useful than a meta-analysis p-value when identifying biologically meaningful gene lists (reflecting criterion 1). However, standard meta-analysis methods perform as good as (if not better than) a consensus network approach in terms of validation success (criterion 2). The article also reports a comparison of meta-analysis techniques applied to gene expression data and presents novel R functions for carrying out consensus network analysis, network based screening, and meta analysis.

Information technology principles for management, reporting, and research.

PubMed

Gillam, Michael; Rothenhaus, Todd; Smith, Vernon; Kanhouwa, Meera

2004-11-01

Information technology holds the promise to enhance the ability of individuals and organizations to manage emergency departments, improve data sharing and reporting, and facilitate research. The Society for Academic Emergency Medicine (SAEM) Consensus Committee has identified nine principles to outline a path of optimal features and designs for current and future information technology systems. The principles roughly summarized include the following: utilize open database standards with clear data dictionaries, provide administrative access to necessary data, appoint and recognize individuals with emergency department informatics expertise, allow automated alert and proper identification for enrollment of cases into research, provide visual and statistical tools and training to analyze data, embed automated configurable alarm functionality for clinical and nonclinical systems, allow multiexport standard and format configurable reporting, strategically acquire mission-critical equipment that is networked and capable of automated feedback regarding functional status and location, and dedicate resources toward informatics research and development. The SAEM Consensus Committee concludes that the diligent application of these principles will enhance emergency department management, reporting, and research and ultimately improve the quality of delivered health care.

Assessment of the Validity of the Research Diagnostic Criteria for Temporomandibular Disorders: Overview and Methodology

PubMed Central

Schiffman, Eric L.; Truelove, Edmond L.; Ohrbach, Richard; Anderson, Gary C.; John, Mike T.; List, Thomas; Look, John O.

2011-01-01

AIMS The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. An overview is presented, including Axis I and II methodology and descriptive statistics for the study participant sample. This paper details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. Validity testing for the Axis II biobehavioral instruments was based on previously validated reference standards. METHODS The Axis I reference standards were based on the consensus of 2 criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion exam reliability was also assessed within study sites. RESULTS Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas ≥ 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion exam agreement with reference standards was excellent (k ≥ 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). CONCLUSION The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods. PMID:20213028

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Standard Reporting and Evaluation Guidelines: Results of a National Institutes of Health Working Group.

PubMed

Maverakis, Emanual; Wang, Elizabeth A; Shinkai, Kanade; Mahasirimongkol, Surakameth; Margolis, David J; Avigan, Mark; Chung, Wen-Hung; Goldman, Jennifer; La Grenade, Lois; Pirmohamed, Munir; Shear, Neil H; Tassaeeyakul, Wichittra; Hoetzenecker, Wolfram; Klaewsongkram, Jettanong; Rerkpattanapipat, Ticha; Manuyakorn, Wiparat; Yasuda, Sally Usdin; Sharon, Victoria R; Sukhov, Andrea; Micheletti, Robert; Struewing, Jeff; French, Lars E; Cheng, Michelle Y

2017-06-01

Toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) are rare, acute, life-threatening dermatologic disorders involving the skin and mucous membranes. Research into these conditions is hampered by a lack of standardization of case reporting and data collection. To establish a standardized case report form to facilitate comparisons and maintain data quality based on an international panel of SJS/TEN experts who performed a Delphi consensus-building exercise. The elements presented for committee scrutiny were adapted from previous case report forms and from PubMed literature searches of highly cited manuscripts pertaining to SJS/TEN. The expert opinions and experience of the members of the consensus group were included in the discussion. Overall, 21 out of 29 experts who were invited to participate in the online Delphi exercise agreed to participate. Surveys at each stage were administered via an online survery software tool. For the first 2 Delphi rounds, results were analyzed using the Interpercentile Range Adjusted for Symmetry method and statements that passed consensus formulated a new case report form. For the third Delphi round, the case report form was presented to the committee, who agreed that it was "appropriate and useful" for documenting cases of SJS/TEN, making it more reliable and valuable for future research endeavors. With the consensus of international experts, a case report form for SJS/TEN has been created to help standardize the collection of patient information in future studies and the documentation of individual cases.

Establishing Key Performance Indicators [KPIs] and Their Importance for the Surgical Management of Inflammatory Bowel Disease-Results From a Pan-European, Delphi Consensus Study.

PubMed

Morar, Pritesh S; Hollingshead, James; Bemelman, Willem; Sevdalis, Nick; Pinkney, Thomas; Wilson, Graeme; Dunlop, Malcolm; Davies, R Justin; Guy, Richard; Fearnhead, Nicola; Brown, Steven; Warusavitarne, Janindra; Edwards, Cathryn; Faiz, Omar

2017-10-27

Key performance indicators [KPIs] exist across a range of areas in medicine. They help to monitor outcomes, reduce variation, and drive up standards across services. KPIs exist for inflammatory bowel disease [IBD] care, but none specifically cover inflammatory bowel disease [IBD] surgical service provision. This was a consensus-based study using a panel of expert IBD clinicians from across Europe. Items were developed and fed through a Delphi process to achieve consensus. Items were ranked on a Likert scale from 1 [not important] to 5 [very important]. Consensus was defined when the inter quartile range was ≤ 1, and items with a median score > 3 were considered for inclusion. A panel of 21 experts [14 surgeons and 7 gastroenterologists] was recruited. Consensus was achieved on procedure-specific KPIs for ileocaecal and perianal surgery for Crohn's disease, [N = 10] with themes relating to morbidity [N = 7], multidisciplinary input [N = 2], and quality of life [N = 1]; and for subtotal colectomy, proctocolectomy and ileoanal pouch surgery for ulcerative colitis [N = 11], with themes relating to mortality [N = 2], morbidity [N = 8], and service provision [N = 1]. Consensus was also achieved for measures of the quality of IBD surgical service provision and quality assurance in IBD surgery. This study has provided measurable KPIs for the provision of surgical services in IBD. These indicators cover IBD surgery in general, the governance and structures of the surgical services, and separate indicators for specific subareas of surgery. Monitoring of IBD services with these KPIs may reduce variation across services and improve quality. Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2016-12-01

Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasises the reporting of three key components of systematic efforts to improve the quality, value and safety of healthcare: the use of formal and informal theory in planning, implementing and evaluating improvement work; the context in which the work is done and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve healthcare, recognising that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (http://www.squire-statement.org). 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/.

Chinese expert consensus on cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal malignancies

PubMed Central

Li, Yan; Zhou, Yun-Feng; Liang, Han; Wang, Hua-Qing; Hao, Ji-Hui; Zhu, Zheng-Gang; Wan, De-Seng; Qin, Lun-Xiu; Cui, Shu-Zhong; Ji, Jia-Fu; Xu, Hui-Mian; Wei, Shao-Zhong; Xu, Hong-Bin; Suo, Tao; Yang, Shu-Jun; Xie, Cong-Hua; Yang, Xiao-Jun; Yang, Guo-Liang

2016-01-01

Locoregional spread of abdominopelvic malignant tumors frequently results in peritoneal carcinomatosis (PC). The prognosis of PC patients treated by conventional systemic chemotherapy is poor, with a median survival of < 6 mo. However, over the past three decades, an integrated treatment strategy of cytoreductive surgery (CRS) + hyperthermic intraperitoneal chemotherapy (HIPEC) has been developed by the pioneering oncologists, with proved efficacy and safety in selected patients. Supported by several lines of clinical evidence from phases I, II and III clinical trials, CRS + HIPEC has been regarded as the standard treatment for selected patients with PC in many established cancer centers worldwide. In China, an expert consensus on CRS + HIPEC has been reached by the leading surgical and medical oncologists, under the framework of the China Anti-Cancer Association. This expert consensus has summarized the progress in PC clinical studies and systematically evaluated the CRS + HIPEC procedures in China as well as across the world, so as to lay the foundation for formulating PC treatment guidelines specific to the national conditions of China. PMID:27570426

An update on the management of chronic hepatitis C: 2015 Consensus guidelines from the Canadian Association for the Study of the Liver

PubMed Central

Myers, Robert P; Shah, Hemant; Burak, Kelly W; Cooper, Curtis; Feld, Jordan J

2015-01-01

Chronic hepatitis C remains a significant medical and economic burden in Canada, affecting nearly 1% of the population. Since the last Canadian consensus conference on the management of chronic hepatitis C, major advances have occurred that warrant a review of recommended management approaches for these patients. Specifically, direct-acting antiviral agents with dramatically improved rates of virological clearance compared with standard therapy have been developed and interferon-free, all-oral antiviral regimens have been approved. In light of this new evidence, an update to the 2012 Canadian Association for the Study of the Liver consensus guidelines on the management of hepatitis C was produced. The present document reviews the epidemiology of hepatitis C in Canada, preferred diagnostic testing approaches and recommendations for the treatment of chronically infected patients with the newly approved antiviral agents, including those who have previously failed peginterferon and ribavirin-based therapy. In addition, recommendations are made regarding approaches to reducing the burden of hepatitis C in Canada. PMID:25585348

An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD).

PubMed

Gajewski, Jerzy B; Schurch, Brigitte; Hamid, Rizwan; Averbeck, Márcio; Sakakibara, Ryuji; Agrò, Enrico F; Dickinson, Tamara; Payne, Christopher K; Drake, Marcus J; Haylen, Bernie T

2018-03-01

The terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD) should be defined and organized in a clinically based consensus Report. This Report has been created by a Working Group under the auspices and guidelines of the International Continence Society (ICS) Standardization Steering Committee (SSC) assisted at intervals by external referees. All relevant definitions for ANLUTD were updated on the basis of research over the last 14 years. An extensive process of 18 rounds of internal and external review was involved to exhaustively examine each definition, with decision-making by collective opinion (consensus). A Terminology Report for ANLUTD, encompassing 97 definitions (42 NEW and 8 CHANGED, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different groups involved not only in lower urinary tract dysfunction but additionally in many other medical specialties. A consensus-based Terminology Report for ANLUTD has been produced to aid clinical practice and research. © 2017 Wiley Periodicals, Inc.

National audit of continence care: laying the foundation.

PubMed

Mian, Sarah; Wagg, Adrian; Irwin, Penny; Lowe, Derek; Potter, Jonathan; Pearson, Michael

2005-12-01

National audit provides a basis for establishing performance against national standards, benchmarking against other service providers and improving standards of care. For effective audit, clinical indicators are required that are valid, feasible to apply and reliable. This study describes the methods used to develop clinical indicators of continence care in preparation for a national audit. To describe the methods used to develop and test clinical indicators of continence care with regard to validity, feasibility and reliability. A multidisciplinary working group developed clinical indicators that measured the structure, process and outcome of care as well as case-mix variables. Literature searching, consensus workshops and a Delphi process were used to develop the indicators. The indicators were tested in 15 secondary care sites, 15 primary care sites and 15 long-term care settings. The process of development produced indicators that received a high degree of consensus within the Delphi process. Testing of the indicators demonstrated an internal reliability of 0.7 and an external reliability of 0.6. Data collection required significant investment in terms of staff time and training. The method used produced indicators that achieved a high degree of acceptance from health care professionals. The reliability of data collection was high for this audit and was similar to the level seen in other successful national audits. Data collection for the indicators was feasible to collect, however, issues of time and staffing were identified as limitations to such data collection. The study has described a systematic method for developing clinical indicators for national audit. The indicators proved robust and reliable in primary and secondary care as well as long-term care settings.

16 CFR 1203.3 - Referenced documents.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Referenced documents. 1203.3 Section 1203.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY... international standard, it has become a consensus national standard because all recent major voluntary standards...

Standardization of laboratory lipid profile assessment: A call for action with a special focus on the 2016 ESC/EAS dyslipidemia guidelines - Executive summary: A consensus endorsed by the Cardiovascular Risk and Prevention Group of the Portuguese Internal Medicine Society, the Portuguese Atherosclerosis Society, the Portuguese Society of Cardiology, the Portuguese Society of Laboratory Medicine, and the Portuguese Association of Clinical Chemistry.

PubMed

da Silva, Pedro Marques; Sequeira Duarte, João; von Hafe, Pedro; Gil, Victor; Nunes de Oliveira, Jorge; de Sousa, Germano

2018-04-01

Even with improvements in lifestyle interventions, better control of cardiovascular (CV) risk factors, and improvements in CV outcomes, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in Portugal and Europe. Atherogenic dyslipidemias, particularly hypercholesterolemia, have a crucial causal role in the development of atherosclerotic CVD. The clinical approach to a patient with dyslipidemia requires an accurate diagnosis, based on harmonized and standardized lipid and lipoprotein laboratory assessments. Results and reports of these tests, together with assessment of total CV risk and the respective therapeutic targets, will help ensure that clinical guidelines and good clinical practices are followed, increasing the reliability of screening for lipid disorders, producing more accurate diagnoses and CV risk stratification, and improving CV prevention. To this end, this consensus aims to provide clinicians with practical guidance for the harmonization and standardization of laboratory lipid tests, focusing on the most recent dyslipidemia management guidelines. Copyright © 2018 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research

PubMed Central

Hume, Samuel; Chow, Anthony; Evans, Julie; Malfait, Frederik; Chason, Julie; Wold, J. Darcy; Kubick, Wayne; Becnel, Lauren B.

2018-01-01

The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standards development organization that creates consensus-based standards for clinical and translational research. Several of these standards are now required by regulators for electronic submissions of regulated clinical trials’ data and by government funding agencies. These standards are free and open, available for download on the CDISC Website as PDFs. While these documents are human readable, they are not amenable to ready use by electronic systems. CDISC launched the CDISC Shared Health And Research Electronic library (SHARE) to provide the standards metadata in machine-readable formats to facilitate the automated management and implementation of the standards. This paper describes how CDISC SHARE’S standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis; and its role as a central resource providing information systems with metadata that drives process automation including study setup and data pipelining. PMID:29888049

Improving care standards for patients with spinal trauma combining a modified e-Delphi process and stakeholder interviews: a study protocol.

PubMed

Sharwood, Lisa N; Stanford, Ralph; Middleton, James W; Burns, Brian; Joseph, Anthony; Flower, Oliver; Rigby, Oran; Ball, Jonathon; Dhaliwal, Shelly

2017-01-19

Around 300 people sustain a new traumatic spinal cord injury (TSCI) in Australia each year; a relatively low incidence injury with extremely high long-term associated costs. Care standards are inconsistent nationally, lacking in consensus across important components of care such as prehospital spinal immobilisation, timing of surgery and timeliness of transfer to specialist services. This study aims to develop 'expertly defined' and agreed standards of care across the majority of disciplines involved for these patients. A modified e-Delphi process will be used to gain consensus for best practice across specific clinical early care areas for the patient with TSCI; invited participants will include clinicians across Australia with relevant and significant expertise. A rapid literature review will identify available evidence, including any current guidelines from 2005 to 2015. Level and strength of evidence identified, including areas of contention, will be used to formulate the first round survey questions and statements. Participants will undertake 2-3 online survey rounds, responding anonymously to questionnaires regarding care practices and indicating their agreement or otherwise with practice standard statements. Relevant key stakeholders, including patients, will also be interviewed face to face. Ethics approval for this study was obtained by the NSW Population & Health Services Research Ethics Committee on 14 January 2016 (HREC/12/CIPHS/74). Seeking comprehensive understanding of how the variation in early care pathways and treatment can be addressed to achieve optimal patient outcomes and economic costs; the overall aim is the agreement to a consistent approach to the triage, treatment, transport and definitive care of acute TSCI victims. The agreed practice standards of care will inform the development of a Clinical Pathway with practice change strategies for implementation. These standards will offer a benchmark for state-wide and potentially national policy. 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/.

Equipped for the Future. A Reform Agenda for Adult Literacy and Lifelong Learning.

ERIC Educational Resources Information Center

Stein, Sondra Gayle

The National Institute for Literacy's Equipped for the Future initiative was undertaken to achieve customer-driven, standards-based reform of adult literacy and lifelong learning through a broad, national consensus-building process. The initiative's six stages are as follows: (1) build consensus on the knowledge and skills adults need to fulfill…

Standard operating procedures for vascular surgery in erectile dysfunction: revascularization and venous procedures.

PubMed

Sohn, Michael; Hatzinger, Martin; Goldstein, Irwin; Krishnamurti, Sudhakar

2013-01-01

The impact of penile blood supply on erectile function was recognized some 500 years ago. At the turn of the 20th century first results of penile venous ligation were published and in 1973 the first surgical attempts to restore penile arterial inflow were undertaken. Numerous techniques were published in the meantime, but inclusion criteria, patient selection, and success evaluation differed extremely between study groups. To develop evidence-based standard operating procedures (SOPs) for vascular surgery in erectile dysfunction, based on recent state of the art consensus reports and recently published articles in peer-reviewed journals. Based on the recent publication of the consensus process during the 2009 International Consultation on Sexual Medicine in Paris, recommendations are derived for diagnosis and surgical treatment of vascular erectile dysfunction. In addition several recent publications in this field not mentioned in the consensus statements are included in the discussion. The Oxford system of evidence-based review was systematically applied. Due to the generally low level of evidence in this field expert opinions were accepted, if published after a well-defined consensus process in peer-reviewed journals. Referring to penile revascularization it may be concluded, that in the face of missing randomized trials, only recommendations grade D may be given: this kind of surgery may be offered to men less than 55 years, who are nonsmokers, nondiabetic, and demonstrate isolated arterial stenoses in the absence of generalized vascular disease. The evidence level for recommendations concerning penile venous ligations may be even lower. Too many unsolved controversies exist and universal diagnostic criteria for patient selection as well as operative technique selection have not been unequivocally established. This kind of surgery is still considered investigational but may be offered in special situations on an individualized basis in an investigational or research setting after obtaining written consent, using both pre- and postoperatively validated measuring instruments of success evaluation. SOPs for penile revascularization procedures can be developed, concerning a highly selected patient group with isolated arterial stenoses. Based on the available data it is not yet possible to define SOPs for surgical treatment of corporal veno-occlusive dysfunction. © 2012 International Society for Sexual Medicine.

Advanced Ceramics Property Measurements

NASA Technical Reports Server (NTRS)

Salem, Jonathan; Helfinstine, John; Quinn, George; Gonczy, Stephen

2013-01-01

Mechanical and physical properties of ceramic bodies can be difficult to measure correctly unless the proper techniques are used. The Advanced Ceramics Committee of ASTM, C-28, has developed dozens of consensus test standards and practices to measure various properties of a ceramic monolith, composite, or coating. The standards give the "what, how, how not, and why" for measurement of many mechanical, physical, thermal, and performance properties. Using these standards will provide accurate, reliable, and complete data for rigorous comparisons with other test results from your test lab, or another. The C-28 Committee has involved academics, producers, and users of ceramics to write and continually update more than 45 standards since the committee's inception in 1986. Included in this poster is a pictogram of the C-28 standards and information on how to obtain individual copies with full details or the complete collection of standards in one volume.

Advanced Ceramics Property and Performance Measurements

NASA Technical Reports Server (NTRS)

Jenkins, Michael; Salem, Jonathan; Helfinstine, John; Quinn, George; Gonczy, Stephen

2015-01-01

Mechanical and physical properties of ceramic bodies can be difficult to measure correctly unless the proper techniques are used. The Advanced Ceramics Committee of ASTM, C-28, has developed dozens of consensus test standards and practices to measure various properties of a ceramic monolith, composite, or coating. The standards give the what, how, how not, and why for measurement of many mechanical, physical, thermal, and performance properties. Using these standards will provide accurate, reliable, and complete data for rigorous comparisons with other test results from your test lab, or another. The C-28 Committee has involved academics, producers, and users of ceramics to write and continually update more than 45 standards since the committees inception in 1986. Included in this poster is a pictogram of the C-28 standards and information on how to obtain individual copies with full details or the complete collection of all of the standards in one volume.

Extracorporeal blood treatment (EBT) methods in SIRS/Sepsis.

PubMed

Bellomo, R; Honoré, P M; Matson, J; Ronco, C; Winchester, J

2005-05-01

Extracorporeal blood purification treatment (EBT) methods have been used in the treatment of experimental and human SIRS/Sepsis in a variety of settings and with variable reports of efficacy and safety. Their role in the management of SIRS/Sepsis remains controversial. To develop consensus statements regarding important aspects of research, practice and technical management concerning EBT. Systematic review of published study. Evidence-based grading of information available. Consensus development regarding fundamental questions about EBT. Consensus was achieved on all questions posed during the conference. It was agreed that there is currently a clear biological rational for EBT in SIRS and Sepsis. It was agreed that conventional CVVH has sufficiently been shown not to be effective in SIRS/Sepsis in the absence of concomitant ARF and that other therapies such as plasmapheresis or high-volume hemofiltration or coupled plasma filtration adsorption appear more promising and should be tested in multicentre randomized controlled trials. Patients with ARF and SIRS/Sepsis should be treated differently from those with ARF alone even though current practice in this field is not well known. Patients with refractory septic shock should be considered for EBT. Appropriate end points for clinical trials can be defined and chosen according to the goals of the trial. Different technologies exist for EBT and better understanding of the merits and safety of each is needed as well as better standardization of methodology and dose. Broad consensus can be achieved on several aspects of EBT and can be used to inform clinical practice and to help guide the establishment of a future research agenda.

Clinical implications of molecular drug resistance testing for Mycobacterium tuberculosis: a TBNET/RESIST-TB consensus statement.

PubMed

Domínguez, J; Boettger, E C; Cirillo, D; Cobelens, F; Eisenach, K D; Gagneux, S; Hillemann, D; Horsburgh, R; Molina-Moya, B; Niemann, S; Tortoli, E; Whitelaw, A; Lange, C

2016-01-01

The emergence of drug-resistant strains of Mycobacterium tuberculosis is a challenge to global tuberculosis (TB) control. Although culture-based methods have been regarded as the gold standard for drug susceptibility testing (DST), molecular methods provide rapid information on mutations in the M. tuberculosis genome associated with resistance to anti-tuberculosis drugs. We ascertained consensus on the use of the results of molecular DST for clinical treatment decisions in TB patients. This document has been developed by TBNET and RESIST-TB groups to reach a consensus about reporting standards in the clinical use of molecular DST results. Review of the available literature and the search for evidence included hand-searching journals and searching electronic databases. The panel identified single nucleotide mutations in genomic regions of M. tuberculosis coding for katG, inhA, rpoB, embB, rrs, rpsL and gyrA that are likely related to drug resistance in vivo. Identification of any of these mutations in clinical isolates of M. tuberculosis has implications for the management of TB patients, pending the results of in vitro DST. However, false-positive and false-negative results in detecting resistance-associated mutations in drugs for which there is poor or unproven correlation between phenotypic and clinical drug resistance complicate the interpretation. Reports of molecular DST results should therefore include specific information on the mutations identified and provide guidance for clinicians on interpretation and on the choice of the appropriate initial drug regimen.

[Consensus report for the clinical care of smoking cessation in Spain. Comité Nacional para la Prevención del Tabaquismo].

PubMed

Camarelles Guillem, Francisco; Dalmau González-Gallarza, Regina; Clemente Jiménez, Lourdes; Díaz-Maroto Muñoz, José Luis; Lozano Polo, Adelaida; Pinet Ogué, María Cristina

2013-03-16

Tobacco use presents an odd confluence of circumstances: it is a significant and high threat to health, and there is a lack of motivation among health workers to act accordingly. Yet we have effective interventions. It is really hard to identify any other determinant of health presenting this mixture of lethality, prevalence, and lack of care, despite having effective treatments readily available. On the other hand, smoking cessation interventions are considered as the gold standard of preventive interventions, far above other preventive measures commonly used. This has prompted the National Committee for Smoking Prevention to develop a consensus document for the Clinical Care of Smoking Cessation in Spain. The purpose of this technical and scientific document is to agree on a basic proposal of quality of care to tackle smokers to quit. This document would serve as a guideline in the clinical practice in our country. The aims of this agreement are to review the effectiveness of the existing therapies for smoking cessation, to synthesize their available evidence, and to set the basic minimum standards of care in the clinical practice of patients who smoke. The consensus sets the strategies, and the evidences that support them, in order to assist both the smokers who want to quit, and the smokers who do not, setting out the steps to intervene in the most adequate. Copyright © 2012 Elsevier España, S.L. All rights reserved.

The Lebanese Society for Infectious Diseases and Clinical Microbiology (LSIDCM) guidelines for adult community-acquired pneumonia (Cap) in Lebanon.

PubMed

Moghnieh, Rima; Yared Sakr, Nadine; Kanj, Souha S; Musharrafieh, Umayya; Husni, Rula; Jradeh, Mona; Al-Awar, Ghassan; Matar, Madona; Jureij, Wafa; Antoine, Saad; Azar, Eid; Abi Hanna, Pierre; Minari, Afaf; Hammoud, Jamale; Kfoury, Joumana; Mahfouz, Tahsin; Abou Chakra, Diaa; Zaatari, Mohamad; Tabbarah, Zuhayr A

2014-01-01

Adult community-acquired pneumonia (CAP) is a common cause of morbidity and mortality which is managed by different disciplines in a heterogeneous fashion. Development of consensus guidelines to standardize these wide variations in care has become a prime objective. The Lebanese Society of Infectious Diseases and Clinical Microbiology (LSIDCM) convened to set Lebanese national guidelines for the management of CAP since it is a major and a prevalent disease affecting the Lebanese population. These guidelines, besides being helpful in direct clinical practice, play a major role in establishing stewardship programs in hospitals in an effort to contain antimicrobial resistance on the national level. These guidelines are intended for primary care practitioners and emergency medicine physicians. They constitute an appropriate starting point for specialists' consultation being based on the available local epidemiological and resistance data. This document includes the following: 1/ Rationale and scope of the guidelines; 2/ Microbiology of CAP based on Lebanese data; 3/ Clinical presentation and diagnostic workup of CAP; 4/ Management and prevention strategies based on the IDSA/ATS Consensus Guidelines, 2007, and the ESCMID Guidelines, 2011, and tailored to the microbiological data in Lebanon; 5/ Comparison to regional guidelines. The recommendations made in this document were graded based on the strength of the evidence as in the 2007 IDSA/ATS Consensus Guidelines. Hopefully, these guidelines will be an important step towards standardization of CAP care in Lebanon and set the agenda for further research in this area.

Making the Learning of Mathematics More Meaningful

NASA Technical Reports Server (NTRS)

Ward, Robin A.

1998-01-01

In the early 1980's, the National Commission on Excellence in Education responded to the call for reform in the teaching and learning of mathematics. In particular, the Commission developed a document addressing the consensus that all students need to learn more, and often different, mathematics and that instruction in mathematics must be significantly revised. In a response to these calls for mathematics education reform, the National Council of Teachers of Mathematics (NCTM) developed its Curriculum and Evaluation Standards (1989) with a two-fold purpose: 1) to create a coherent vision of what it means to be mathematically literate in a world that relies on calculators and computers, and 2) to create a set of standards to guide the revisions of school mathematics curriculum.

Breast cancer screening in the era of density notification legislation: summary of 2014 Massachusetts experience and suggestion of an evidence-based management algorithm by multi-disciplinary expert panel.

PubMed

Freer, Phoebe E; Slanetz, Priscilla J; Haas, Jennifer S; Tung, Nadine M; Hughes, Kevin S; Armstrong, Katrina; Semine, A Alan; Troyan, Susan L; Birdwell, Robyn L

2015-09-01

Stemming from breast density notification legislation in Massachusetts effective 2015, we sought to develop a collaborative evidence-based approach to density notification that could be used by practitioners across the state. Our goal was to develop an evidence-based consensus management algorithm to help patients and health care providers follow best practices to implement a coordinated, evidence-based, cost-effective, sustainable practice and to standardize care in recommendations for supplemental screening. We formed the Massachusetts Breast Risk Education and Assessment Task Force (MA-BREAST) a multi-institutional, multi-disciplinary panel of expert radiologists, surgeons, primary care physicians, and oncologists to develop a collaborative approach to density notification legislation. Using evidence-based data from the Institute for Clinical and Economic Review, the Cochrane review, National Comprehensive Cancer Network guidelines, American Cancer Society recommendations, and American College of Radiology appropriateness criteria, the group collaboratively developed an evidence-based best-practices algorithm. The expert consensus algorithm uses breast density as one element in the risk stratification to determine the need for supplemental screening. Women with dense breasts and otherwise low risk (<15% lifetime risk), do not routinely require supplemental screening per the expert consensus. Women of high risk (>20% lifetime) should consider supplemental screening MRI in addition to routine mammography regardless of breast density. We report the development of the multi-disciplinary collaborative approach to density notification. We propose a risk stratification algorithm to assess personal level of risk to determine the need for supplemental screening for an individual woman.

International classification of reliability for implanted cochlear implant receiver stimulators.

PubMed

Battmer, Rolf-Dieter; Backous, Douglas D; Balkany, Thomas J; Briggs, Robert J S; Gantz, Bruce J; van Hasselt, Andrew; Kim, Chong Sun; Kubo, Takeshi; Lenarz, Thomas; Pillsbury, Harold C; O'Donoghue, Gerard M

2010-10-01

To design an international standard to be used when reporting reliability of the implanted components of cochlear implant systems to appropriate governmental authorities, cochlear implant (CI) centers, and for journal editors in evaluating manuscripts involving cochlear implant reliability. The International Consensus Group for Cochlear Implant Reliability Reporting was assembled to unify ongoing efforts in the United States, Europe, Asia, and Australia to create a consistent and comprehensive classification system for the implanted components of CI systems across manufacturers. All members of the consensus group are from tertiary referral cochlear implant centers. None. A clinically relevant classification scheme adapted from principles of ISO standard 5841-2:2000 originally designed for reporting reliability of cardiac pacemakers, pulse generators, or leads. Standard definitions for device failure, survival time, clinical benefit, reduced clinical benefit, and specification were generated. Time intervals for reporting back to implant centers for devices tested to be "out of specification," categorization of explanted devices, the method of cumulative survival reporting, and content of reliability reports to be issued by manufacturers was agreed upon by all members. The methodology for calculating Cumulative survival was adapted from ISO standard 5841-2:2000. The International Consensus Group on Cochlear Implant Device Reliability Reporting recommends compliance to this new standard in reporting reliability of implanted CI components by all manufacturers of CIs and the adoption of this standard as a minimal reporting guideline for editors of journals publishing cochlear implant research results.

Guidelines on "Standards of management of idiopathic scoliosis with corrective braces in everyday clinics and in clinical research": SOSORT Consensus 2008

PubMed Central

Negrini, Stefano; Grivas, Theodoros B; Kotwicki, Tomasz; Rigo, Manuel; Zaina, Fabio

2009-01-01

Background Reported failure rates,(defined based on percentage of cases progressing to surgery) of corrective bracing for idiopathic scoliosis are highly variable. This may be due to the quality of the brace itself, but also of the patient care during treatment. The latter is sometimes neglected, even though it is considered a main determinant of good results among conservative experts of SOSORT. The aim of this paper was to develop and verify the Consensus on management of scoliosis patients treated with braces Methods We followed a Delphi process in four steps, distributing and gradually changing according to the results a set of recommendations: we involved the SOSORT Board twice, then all SOSORT members twice, with a Pre-Meeting Questionnaire (PMQ), and during a Consensus Session at the SOSORT Athens Meeting with a Meeting Questionnaire (MQ). We set a 90% agreement as the minimum to be reached. Results We had a 71% response rate to PMQ, and 66.7% to MQ. Since the PMQ we had a good agreement (no answers below 72% – 70.2% over 90%). With the MQ the agreement consistently increased for all the answers previously below 90% (no answers below 83%, 75% over 90%). With increasing experience in bracing all numerical criteria tended to become more strict. We finally produced a set of 14 recommendations, grouped in 6 Domains (Experience/competence, Behaviours, Prescription, Construction, Brace Check, Follow-up). Conclusion The Consensus permits establishment of recommendations concerning the standards of management of idiopathic scoliosis with bracing, with the aim to increase efficacy and compliance to treatment. The SOSORT recommends to professionals engaged in patient care to follow the guidelines of this Consensus in their clinical practice. The SOSORT criteria should also be followed in clinical research studies to achieve a minimum quality of care. If the aim is to verify the efficacy of bracing these criteria should be companions of the methodological research criteria for bracing proposed by other societies. PMID:19149877

78 FR 35585 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-13

...; Signage AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION: Notice... Administration (``OSHA'' or ``the Agency'') proposes to update its general industry and construction signage... standards, ANSI Z53.1-1967, Z35.1-1968, and Z35.2-1968, in its signage standards, thereby providing...

MedBlock: Efficient and Secure Medical Data Sharing Via Blockchain.

PubMed

Fan, Kai; Wang, Shangyang; Ren, Yanhui; Li, Hui; Yang, Yintang

2018-06-21

With the development of electronic information technology, electronic medical records (EMRs) have been a common way to store the patients' data in hospitals. They are stored in different hospitals' databases, even for the same patient. Therefore, it is difficult to construct a summarized EMR for one patient from multiple hospital databases due to the security and privacy concerns. Meanwhile, current EMRs systems lack a standard data management and sharing policy, making it difficult for pharmaceutical scientists to develop precise medicines based on data obtained under different policies. To solve the above problems, we proposed a blockchain-based information management system, MedBlock, to handle patients' information. In this scheme, the distributed ledger of MedBlock allows the efficient EMRs access and EMRs retrieval. The improved consensus mechanism achieves consensus of EMRs without large energy consumption and network congestion. In addition, MedBlock also exhibits high information security combining the customized access control protocols and symmetric cryptography. MedBlock can play an important role in the sensitive medical information sharing.

Enabling international communication among Brazilian occupational therapists: seeking consensus on occupational terminology.

PubMed

Magalhaes, Lilian; Galheigo, Sandra Maria

2010-09-01

The purpose of this study was to examine how key occupational therapy terminologies are used by Brazilian occupational therapists. A nominal group approach combined with a Delphi technique involving 31 Brazilian occupational therapists was applied. A sociolinguistic approach was adopted since it broadens our understanding of the social and cultural determinants of terminology consolidation. Brazilian occupational therapists were found to adopt the term activity more often than human action or doing. Even less often were praxis and occupation applied. No consensus was reached regarding which of the terms is most preferred. While Brazilian occupational therapists have been developing their profession from international standards, it is still embedded in local demands and policies. Additionally, the political context must be considered when building an international dialogue between members of a professional body. Such a dialogue could engage professionals from different countries in meaningful exchanges about their practices. These exchanges may lead to the development of solid professional communities that can contribute meaningfully to social change. Copyright 2010 John Wiley & Sons, Ltd.

International Society of Urological Pathology (ISUP) Consensus Conference on Handling and Staging of Radical Prostatectomy Specimens. Working group 4: seminal vesicles and lymph nodes.

PubMed

Berney, Daniel M; Wheeler, Thomas M; Grignon, David J; Epstein, Jonathan I; Griffiths, David F; Humphrey, Peter A; van der Kwast, Theo; Montironi, Rodolfo; Delahunt, Brett; Egevad, Lars; Srigley, John R

2011-01-01

The 2009 International Society of Urological Pathology Consensus Conference in Boston made recommendations regarding the standardization of pathology reporting of radical prostatectomy specimens. Issues relating to the infiltration of tumor into the seminal vesicles and regional lymph nodes were coordinated by working group 4. There was a consensus that complete blocking of the seminal vesicles was not necessary, although sampling of the junction of the seminal vesicles and prostate was mandatory. There was consensus that sampling of the vas deferens margins was not obligatory. There was also consensus that muscular wall invasion of the extraprostatic seminal vesicle only should be regarded as seminal vesicle invasion. Categorization into types of seminal vesicle spread was agreed by consensus to be not necessary. For examination of lymph nodes, there was consensus that special techniques such as frozen sectioning were of use only in high-risk cases. There was no consensus on the optimal sampling method for pelvic lymph node dissection specimens, although there was consensus that all lymph nodes should be completely blocked as a minimum. There was also a consensus that a count of the number of lymph nodes harvested should be attempted. In view of recent evidence, there was consensus that the diameter of the largest lymph node metastasis should be measured. These consensus decisions will hopefully clarify the difficult areas of pathological assessment in radical prostatectomy evaluation and improve the concordance of research series to allow more accurate assessment of patient prognosis.

A Delphi survey to determine how educational interventions for evidence-based practice should be reported: Stage 2 of the development of a reporting guideline

PubMed Central

2014-01-01

Background Undertaking a Delphi exercise is recommended during the second stage in the development process for a reporting guideline. To continue the development for the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) a Delphi survey was undertaken to determine the consensus opinion of researchers, journal editors and educators in evidence-based practice (EBP) regarding the information items that should be reported when describing an educational intervention for EBP. Methods A four round online Delphi survey was conducted from October 2012 to March 2013. The Delphi panel comprised international researchers, educators and journal editors in EBP. Commencing with an open-ended question, participants were invited to volunteer information considered important when reporting educational interventions for EBP. Over three subsequent rounds participants were invited to rate the importance of each of the Delphi items using an 11 point Likert rating scale (low 0 to 4, moderate 5 to 6, high 7 to 8 and very high >8). Consensus agreement was set a priori as at least 80 per cent participant agreement. Consensus agreement was initially calculated within the four categories of importance (low to very high), prior to these four categories being merged into two (<7 and ≥7). Descriptive statistics for each item were computed including the mean Likert scores, standard deviation (SD), range and median participant scores. Mean absolute deviation from the median (MAD-M) was also calculated as a measure of participant disagreement. Results Thirty-six experts agreed to participate and 27 (79%) participants completed all four rounds. A total of 76 information items were generated across the four survey rounds. Thirty-nine items (51%) were specific to describing the intervention (as opposed to other elements of study design) and consensus agreement was achieved for two of these items (5%). When the four rating categories were merged into two (<7 and ≥7), 18 intervention items achieved consensus agreement. Conclusion This Delphi survey has identified 39 items for describing an educational intervention for EBP. These Delphi intervention items will provide the groundwork for the subsequent consensus discussion to determine the final inclusion of items in the GREET, the first reporting guideline for educational interventions in EBP. PMID:25081371

76 FR 34197 - Anchorage; Change to Cottonwood Island Anchorage, Columbia River, Oregon and Washington

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-13

.... * * * * * Dated: May 11, 2011. G.T. Blore, Rear Admiral, U.S. Coast Guard Commander, Thirteenth Coast Guard.... Voluntary consensus standards are technical standards (e.g., specifications of materials, performance...

75 FR 72739 - Compliance Testing Procedures: Correction Factor for Room Air Conditioners

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... industry practices or consensus body testing standards which have been superseded by standards which are... accurate. With these facts in mind, DOE compliance enforcement forbearance, or an industry-wide waiver or...

[The current state and prospect of Chinese medicine gastroenterology].

PubMed

Zhang, Sheng-Sheng; Zhou, Tao

2012-03-01

The progress and existent problems of Chinese medicine (CM) gastroenterology since the National Eleventh Five-Year Plan were discussed in this article in terms of theory innovation, formulation of clinical pathway and diagnosis-treatment consensus, efficacy assessment, formulation of efficacy assessment scale, advantage diseases, and exploration of the syndrome standardization, progress in science research, academic exchange, and the construction of study platform, and so on. Meanwhile, the development of CM gastroenterology was prospected in the following five aspects: to enhance the theory inheritance and innovation, the construction of discipline standardization; to establish scientific clinical efficacy assessment methods and the standard system; to expend treatment technologies and feature therapies; and to clarify the modern scientific connotation of CM theory and treatment.

Standards of care for obsessive–compulsive disorder centres

PubMed Central

Menchón, José M.; van Ameringen, Michael; Dell’Osso, Bernardo; Denys, Damiaan; Figee, Martijn; Grant, Jon E.; Hollander, Eric; Marazziti, Donatella; Nicolini, Humberto; Pallanti, Stefano; Ruck, Christian; Shavitt, Roseli; Stein, Dan J.; Andersson, Erik; Bipeta, Rajshekhar; Cath, Danielle C.; Drummond, Lynne; Feusner, Jamie; Geller, Daniel A.; Hranov, Georgi; Lochner, Christine; Matsunaga, Hisato; McCabe, Randy E.; Mpavaenda, Davis; Nakamae, Takashi; O'Kearney, Richard; Pasquini, Massimo; Pérez Rivera, Ricardo; Poyurovsky, Michael; Real, Eva; do Rosário, Maria Conceição; Soreni, Noam; Swinson, Richard P.; Vulink, Nienke; Zohar, Joseph; Fineberg, Naomi

2016-01-01

Abstract In recent years, many assessment and care units for obsessive–compulsive disorder (OCD) have been set up in order to detect, diagnose and to properly manage this complex disorder, but there is no consensus regarding the key functions that these units should perform. The International College of Obsessive-Compulsive Spectrum Disorders (ICOCS) together with the Obsessive Compulsive and Related Disorders Network (OCRN) of the European College of Neuropsychopharmacology (ECNP) and the Anxiety and Obsessive Compulsive Disorders Section of the World Psychiaric Association (WPA) has developed a standards of care programme for OCD centres. The goals of this collaborative initiative are promoting basic standards, improving the quality of clinical care and enhance the validity and reliability of research results provided by different facilities and countries. PMID:27359333

29 CFR 1917.93 - Head protection.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED... of the following consensus standards: (i) ANSI Z89.1-2003, “American National Standard for Industrial... National Standard for Industrial Head Protection,” which is incorporated by reference in § 1917.3; or (iii...

29 CFR 1917.93 - Head protection.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED... of the following consensus standards: (i) ANSI Z89.1-2003, “American National Standard for Industrial... National Standard for Industrial Head Protection,” which is incorporated by reference in § 1917.3; or (iii...

Domains of Core Competency, Standards, and Quality Assurance for Building Global Capacity in Health Promotion: The Galway Consensus Conference Statement

ERIC Educational Resources Information Center

Allegrante, John P.; Barry, Margaret M.; Airhihenbuwa, Collins O.; Auld, M. Elaine; Collins, Janet L.; Lamarre, Marie-Claude; Magnusson, Gudjon; McQueen, David V.; Mittelmark, Maurice B.

2009-01-01

This paper reports the outcome of the Galway Consensus Conference, an effort undertaken as a first step toward international collaboration on credentialing in health promotion and health education. Twenty-nine leading authorities in health promotion, health education, and public health convened a 2-day meeting in Galway, Ireland, during which the…

Designing a proficiency-based, content validated virtual reality curriculum for laparoscopic colorectal surgery: a Delphi approach.

PubMed

Palter, Vanessa N; Graafland, Maurits; Schijven, Marlies P; Grantcharov, Teodor P

2012-03-01

Although task training on virtual reality (VR) simulators has been shown to transfer to the operating room, to date no VR curricula have been described for advanced laparoscopic procedures. The purpose of this study was to develop a proficiency-based VR technical skills curriculum for laparoscopic colorectal surgery. The Delphi method was used to determine expert consensus on which VR tasks (on the LapSim simulator) are relevant to teaching laparoscopic colorectal surgery. To accomplish this task, 19 international experts rated all the LapSim tasks on a Likert scale (1-5) with respect to the degree to which they thought that a particular task should be included in a final technical skills curriculum. Results of the survey were sent back to participants until consensus (Cronbach's α >0.8) was reached. A cross-sectional design was utilized to define the benchmark scores for the identified tasks. Nine expert surgeons completed all identified tasks on the "easy," "medium," and "hard" settings of the simulator. In the first round of the survey, Cronbach's α was 0.715; after the second round, consensus was reached at 0.865. Consensus was reached for 7 basic tasks and 1 advanced suturing task. Median expert time and economy of movement scores were defined as benchmarks for all curricular tasks. This study used Delphi consensus methodology to create a curriculum for an advanced laparoscopic procedure that is reflective of current clinical practice on an international level and conforms to current educational standards of proficiency-based training. Copyright © 2012 Mosby, Inc. All rights reserved.

Report from a consensus conference on antibody-mediated rejection in heart transplantation

PubMed Central

Kobashigawa, Jon; Crespo-Leiro, Maria G.; Ensminger, Stephan M.; Reichenspurner, Hermann; Angelini, Annalisa; Berry, Gerald; Burke, Margaret; Czer, Lawrence; Hiemann, Nicola; Kfoury, Abdallah G.; Mancini, Donna; Mohacsi, Paul; Patel, Jignesh; Pereira, Naveen; Platt, Jeffrey L.; Reed, Elaine F.; Reinsmoen, Nancy; Rodriguez, E. Rene; Rose, Marlene L.; Russell, Stuart D.; Starling, Randy; Suciu-Foca, Nicole; Tallaj, Jose; Taylor, David O.; Van Bakel, Adrian; West, Lori; Zeevi, Adriana; Zuckermann, Andreas

2012-01-01

BACKGROUND The problem of AMR remains unsolved because standardized schemes for diagnosis and treatment remains contentious. Therefore, a consensus conference was organized to discuss the current status of antibody-mediated rejection (AMR) in heart transplantation. METHODS The conference included 83 participants (transplant cardiologists, surgeons, immunologists and pathologists) representing 67 heart transplant centers from North America, Europe, and Asia who all participated in smaller break-out sessions to discuss the various topics of AMR and attempt to achieve consensus. RESULTS A tentative pathology diagnosis of AMR was established, however, the pathologist felt that further discussion was needed prior to a formal recommendation for AMR diagnosis. One of the most important outcomes of this conference was that a clinical definition for AMR (cardiac dysfunction and/or circulating donor-specific antibody) was no longer believed to be required due to recent publications demonstrating that asymptomatic (no cardiac dysfunction) biopsy-proven AMR is associated with subsequent greater mortality and greater development of cardiac allograft vasculopathy. It was also noted that donor-specific antibody is not always detected during AMR episodes as the antibody may be adhered to the donor heart. Finally, recommendations were made for the timing for specific staining of endomyocardial biopsy specimens and the frequency by which circulating antibodies should be assessed. Recommendations for management and future clinical trials were also provided. CONCLUSIONS The AMR Consensus Conference brought together clinicians, pathologists and immunologists to further the understanding of AMR. Progress was made toward a pathology AMR grading scale and consensus was accomplished regarding several clinical issues. PMID:21300295

How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.

PubMed

Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; Boers, Maarten; Tugwell, Peter; Clarke, Mike; Williamson, Paula R; Terwee, Caroline B

2016-09-13

In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a "Core Outcome Set" (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

Crisis checklists for in-hospital emergencies: expert consensus, simulation testing and recommendations for a template determined by a multi-institutional and multi-disciplinary learning collaborative.

PubMed

Subbe, Christian P; Kellett, John; Barach, Paul; Chaloner, Catriona; Cleaver, Hayley; Cooksley, Tim; Korsten, Erik; Croke, Eilish; Davis, Elinor; De Bie, Ashley Jr; Durham, Lesley; Hancock, Chris; Hartin, Jilian; Savijn, Tracy; Welch, John

2017-05-08

'Failure to rescue' of hospitalized patients with deteriorating physiology on general wards is caused by a complex array of organisational, technical and cultural failures including a lack of standardized team and individual expected responses and actions. The aim of this study using a learning collaborative method was to develop consensus recomendations on the utility and effectiveness of checklists as training and operational tools to assist in improving the skills of general ward staff on the effective rescue of patients with abnormal physiology. A scoping study of the literature was followed by a multi-institutional and multi-disciplinary international learning collaborative. We sought to achieve a consensus on procedures and clinical simulation technology to determine the requirements, develop and test a safe using a checklist template that is rapidly accessible to assist in emergency management of common events for general ward use. Safety considerations about deteriorating patients were agreed upon and summarized. A consensus was achieved among an international group of experts on currently available checklist formats performing poorly in simulation testing as first responders in general ward clinical crises. The Crisis Checklist Collaborative ratified a consensus template for a general ward checklist that provides a list of issues for first responders to address (i.e. 'Check In'), a list of prompts regarding common omissions (i.e. 'Stop & Think'), and, a list of items required for the safe "handover" of patients that remain on the general ward (i.e. 'Check Out'). Simulation usability assessment of the template demonstrated feasibility for clinical management of deteriorating patients. Emergency checklists custom-designed for general ward patients have the potential to guide the treatment speed and reliability of responses for emergency management of patients with abnormal physiology while minimizing the risk of adverse events. Interventional trials are needed.

Consensus-based cross-European recommendations for the identification, measurement and valuation of costs in health economic evaluations: a European Delphi study.

PubMed

van Lier, Lisanne I; Bosmans, Judith E; van Hout, Hein P J; Mokkink, Lidwine B; van den Hout, Wilbert B; de Wit, G Ardine; Dirksen, Carmen D; Nies, Henk L G R; Hertogh, Cees M P M; van der Roest, Henriëtte G

2017-12-19

Differences between country-specific guidelines for economic evaluations complicate the execution of international economic evaluations. The aim of this study was to develop cross-European recommendations for the identification, measurement and valuation of resource use and lost productivity in economic evaluations using a Delphi procedure. A comprehensive literature search was conducted to identify European guidelines on the execution of economic evaluations or costing studies as part of economic evaluations. Guideline recommendations were extracted by two independent reviewers and formed the basis for the first round of the Delphi study, which was conducted among European health economic experts. During three written rounds, consensus (agreement of 67% or higher) was sought on items concerning the identification, measurement and valuation of costs. Recommendations from 18 guidelines were extracted. Consensus among 26 panellists from 17 European countries was reached on 61 of 68 items. The recommendations from the Delphi study are to adopt a societal perspective, to use patient report for measuring resource use and lost productivity, to value both constructs with use of country-specific standardized/unit costs and to use country-specific discounting rates. This study provides consensus-based cross-European recommendations on how to measure and value resource use and lost productivity in economic evaluations. These recommendations are expected to support researchers, healthcare professionals, and policymakers in executing and appraising economic evaluations performed in international contexts.

A modified Delphi method toward multidisciplinary consensus on functional convalescence recommendations after abdominal surgery.

PubMed

van Vliet, Daphne C R; van der Meij, Eva; Bouwsma, Esther V A; Vonk Noordegraaf, Antonie; van den Heuvel, Baukje; Meijerink, Wilhelmus J H J; van Baal, W Marchien; Huirne, Judith A F; Anema, Johannes R

2016-12-01

Evidence-based information on the resumption of daily activities following uncomplicated abdominal surgery is scarce and not yet standardized in medical guidelines. As a consequence, convalescence recommendations are generally not provided after surgery, leading to patients' insecurity, needlessly delayed recovery and prolonged sick leave. The aim of this study was to generate consensus-based multidisciplinary convalescence recommendations, including advice on return to work, applicable for both patients and physicians. Using a modified Delphi method among a multidisciplinary panel of 13 experts consisting of surgeons, occupational physicians and general practitioners, detailed recommendations were developed for graded resumption of 34 activities after uncomplicated laparoscopic cholecystectomy, laparoscopic and open appendectomy, laparoscopic and open colectomy and laparoscopic and open inguinal hernia repair. A sample of occupational physicians, general practitioners and surgeons assessed the recommendations on feasibility in daily practice. The response of this group of care providers was discussed with the experts in the final Delphi questionnaire round. Out of initially 56 activities, the expert panel selected 34 relevant activities for which convalescence recommendations were developed. After four Delphi rounds, consensus was reached for all of the 34 activities for all the surgical procedures. A sample of occupational physicians, general practitioners and surgeons regarded the recommendations as feasible in daily practice. Multidisciplinary convalescence recommendations regarding uncomplicated laparoscopic cholecystectomy, appendectomy (laparoscopic, open), colectomy (laparoscopic, open) and inguinal hernia repair (laparoscopic, open) were developed by a modified Delphi procedure. Further research is required to evaluate whether these recommendations are realistic and effective in daily practice.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female anorectal dysfunction.

PubMed

Sultan, Abdul H; Monga, Ash; Lee, Joseph; Emmanuel, Anton; Norton, Christine; Santoro, Giulio; Hull, Tracy; Berghmans, Bary; Brody, Stuart; Haylen, Bernard T

2017-01-01

The terminology for anorectal dysfunction in women has long been in need of a specific clinically-based Consensus Report. This Report combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted on Committee by experts in their fields to form a Joint IUGA/ICS Working Group on Female Anorectal Terminology. Appropriate core clinical categories and sub classifications were developed to give an alphanumeric coding to each definition. An extensive process of twenty rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). A Terminology Report for anorectal dysfunction, encompassing over 130 separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific anorectal investigations and imaging (ultrasound, radiology and MRI) has been included whilst appropriate figures have been included to supplement and help clarify the text. Interval review (5-10 years) is anticipated to keep the document updated and as widely acceptable as possible. A consensus-based Terminology Report for female anorectal dysfunction terminology has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

Malaria vaccine research and development: the role of the WHO MALVAC committee

PubMed Central

2013-01-01

The WHO Malaria Vaccine Advisory Committee (MALVAC) provides advice to WHO on strategic priorities, activities and technical issues related to global efforts to develop vaccines against malaria. MALVAC convened a series of meetings to obtain expert, impartial consensus views on the priorities and best practice for vaccine-related research and development strategies. The technical areas covered during these consultations included: guidance on clinical trial design for candidate sporozoite and asexual blood stage vaccines; measures of efficacy of malaria vaccines in Phase IIb and Phase III trials; standardization of immunoassays; the challenges of developing assays and designing trials for interventions against malaria transmission; modelling impact of anti-malarial interventions; whole organism malaria vaccines, and Plasmodium vivax vaccine-related research and evaluation. These informed discussions and opinions are summarized here to provide guidance on harmonization of strategies to help ensure high standards of practice and comparability between centres and the outcome of vaccine trials. PMID:24112689

A National Agenda for Public Health Informatics

PubMed Central

Yasnoff, William A.; Overhage, J. Marc; Humphreys, Betsy L.; LaVenture, Martin

2001-01-01

The AMIA 2001 Spring Congress brought together members of the the public health and informatics communities to develop a national agenda for public health informatics. Discussions of funding and governance; architecture and infrastructure; standards and vocabulary; research, evaluation, and best practices; privacy, confidentiality, and security; and training and workforce resulted in 74 recommendations with two key themes—that all stakeholders need to be engaged in coordinated activities related to public health information architecture, standards, confidentiality, best practices, and research; and that informatics training is needed throughout the public health workforce. Implementation of this consensus agenda will help promote progress in the application of information technology to improve public health. PMID:11687561

New glossary of terms used in regenerative medicine: standardization continues to emerge as regenerative medicine matures.

PubMed

Sheridan, Ben; Harris, Neil

2009-07-01

Regenerative medicine is an evolving, cross-disciplinary, international field that, as a result, uses terms that are either not widely understood, or may have a number of different meanings. Many stakeholders have identified this lack of clarity as a potential barrier to effective communication within the field. To address this, BSI British Standards, supported by the UK Department for Innovation, Universities and Skills (DIUS), was commissioned to develop guidance on the definitions of terms used within regenerative medicine. The resulting document aims to provide clear consensus terminology to improve communication and facilitate a common understanding for a broad range of potential users.

Development of a consensus operational definition of child assent for research.

PubMed

Tait, Alan R; Geisser, Michael E

2017-06-09

There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research. Based on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel. Consensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children. It is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children's developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Diagnostic standards for dopaminergic augmentation of restless legs syndrome: report from a World Association of Sleep Medicine-International Restless Legs Syndrome Study Group consensus conference at the Max Planck Institute.

PubMed

García-Borreguero, Diego; Allen, Richard P; Kohnen, Ralf; Högl, Birgit; Trenkwalder, Claudia; Oertel, Wolfgang; Hening, Wayne A; Paulus, Walter; Rye, David; Walters, Arthur; Winkelmann, Juliane; Earley, Christopher J

2007-08-01

Augmentation of symptom severity is the main complication of dopaminergic treatment of restless legs syndrome (RLS). The current article reports on the considerations of augmentation that were made during a European Restless Legs Syndrome Study Group (EURLSSG)-sponsored Consensus Conference in April 2006 at the Max Planck Institute (MPI) in Munich, Germany, the conclusions of which were endorsed by the International RLS Study Group (IRLSSG) and the World Association of Sleep Medicine (WASM). The Consensus Conference sought to develop a better understanding of augmentation and generate a better operational definition for its clinical identification. Current concepts of the pathophysiology, clinical features, and therapy of RLS augmentation were evaluated by subgroups who presented a summary of their findings for general consideration and discussion. Recent data indicating sensitivity and specificity of augmentation features for identification of augmentation were also evaluated. The diagnostic criteria of augmentation developed at the National Institutes of Health (NIH) conference in 2002 were reviewed in light of current data and theoretical understanding of augmentation. The diagnostic value and criteria for each of the accepted features of augmentation were considered by the group. A consensus was then developed for a revised statement of the diagnostic criteria for augmentation. Five major diagnostic features of augmentation were identified: usual time of RLS symptom onset each day, number of body parts with RLS symptoms, latency to symptoms at rest, severity of the symptoms when they occur, and effects of dopaminergic medication on symptoms. The quantitative data available relating the time of RLS onset and the presence of other features indicated optimal augmentation criteria of either a 4-h advance in usual starting time for RLS symptoms or a combination of the occurrence of other features. A paradoxical response to changes in medication dose also indicates augmentation. Clinical significance of augmentation is defined. The Consensus Conference agreed upon new operational criteria for the clinical diagnosis of RLS augmentation: the MPI diagnostic criteria for augmentation. Areas needing further consideration for validating these criteria and for understanding the underlying biology of RLS augmentation are indicated.

77 FR 33312 - Safety Zone; Marine Week Cleveland, Lake Erie, Cleveland, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... boating public. Discussion of Rule With the aforementioned risks in mind, the Captain of the Port Buffalo... consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the...

30 CFR Appendix I to Subpart C of... - National Consensus Standards

Code of Federal Regulations, 2010 CFR

2010-07-01

... Subpart C of Part 56 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire... Standards Mine operators seeking further information in the area of fire prevention and control may consult...

Standardization in Andean Languages.

ERIC Educational Resources Information Center

Cerron-Palomino, Rodolfo

1992-01-01

This paper discusses current efforts to standardize the two major Andean languages: Quechua and Aymara. The difficulties in gaining consensus on standardizing phonology, grammar, and lexicon are highlighted. Specific recommendations are offered on how to deal with neologisms, and a proposal is made for the creation of a pan-Andean entity to…

78 FR 65932 - Updating OSHA Standards Based on National Consensus Standards; Signage

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

...; Signage AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor. ACTION... accompanied its direct final rule revising its signage standards for general industry and construction. DATES... proposed rule (NPRM) along with the direct final rule (DFR) (see 78 FR 35585) updating its signage...

Identifying important and feasible policies and actions for health at community sports clubs: a consensus-generating approach.

PubMed

Kelly, Bridget; King, Lesley; Bauman, Adrian E; Baur, Louise A; Macniven, Rona; Chapman, Kathy; Smith, Ben J

2014-01-01

Children's high participation in organised sport in Australia makes sport an ideal setting for health promotion. This study aimed to generate consensus on priority health promotion objectives for community sports clubs, based on informed expert judgements. Delphi survey using three structured questionnaires. Forty-six health promotion, nutrition, physical activity and sport management/delivery professionals were approached to participate in the survey. Questionnaires used an iterative process to determine aspects of sports clubs deemed necessary for developing healthy sporting environments for children. Initially, participants were provided with a list of potential standards for a range of health promotion areas and asked to rate standards based on their importance and feasibility, and any barriers to implementation. Subsequently, participants were provided with information that summarised ratings for each standard to indicate convergence of the group, and asked to review and potentially revise their responses where they diverged. In a third round, participants ranked confirmed standards by priority. 26 professionals completed round 1, 21 completed round 2, and 18 completed round 3. The highest ranked standards related to responsible alcohol practices, availability of healthy food and drinks at sports canteens, smoke-free club facilities, restricting the sale and consumption of alcohol during junior sporting activities, and restricting unhealthy food and beverage company sponsorship. Identifying and prioritising health promotion areas that are relevant to children's sports clubs assists in focusing public health efforts and may guide future engagement of sports clubs. Approaches for providing informational and financial support to clubs to operationalise these standards are proposed. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

PubMed Central

Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

2010-01-01

Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

Climate Consensus and `Misinformation': A Rejoinder to Agnotology, Scientific Consensus, and the Teaching and Learning of Climate Change

NASA Astrophysics Data System (ADS)

Legates, David R.; Soon, Willie; Briggs, William M.; Monckton of Brenchley, Christopher

2015-04-01

Agnotology is the study of how ignorance arises via circulation of misinformation calculated to mislead. Legates et al. (Sci Educ 22:2007-2017, 2013) had questioned the applicability of agnotology to politically-charged debates. In their reply, Bedford and Cook (Sci Educ 22:2019-2030, 2013), seeking to apply agnotology to climate science, asserted that fossil-fuel interests had promoted doubt about a climate consensus. Their definition of climate `misinformation' was contingent upon the post-modernist assumptions that scientific truth is discernible by measuring a consensus among experts, and that a near unanimous consensus exists. However, inspection of a claim by Cook et al. (Environ Res Lett 8:024024, 2013) of 97.1 % consensus, heavily relied upon by Bedford and Cook, shows just 0.3 % endorsement of the standard definition of consensus: that most warming since 1950 is anthropogenic. Agnotology, then, is a two-edged sword since either side in a debate may claim that general ignorance arises from misinformation allegedly circulated by the other. Significant questions about anthropogenic influences on climate remain. Therefore, Legates et al. appropriately asserted that partisan presentations of controversies stifle debate and have no place in education.

Report of the NIH Task Force on Research Standards for Chronic Low Back Pain

PubMed Central

Dworkin, Samuel F.; Amtmann, Dagmar; Andersson, Gunnar; Borenstein, David; Carragee, Eugene; Carrino, John; Chou, Roger; Cook, Karon; Delitto, Anthony; Goertz, Christine; Khalsa, Partap; Loeser, John; Mackey, Sean; Panagis, James; Rainville, James; Tosteson, Tor; Turk, Dennis; Von Korff, Michael; Weiner, Debra K.

2015-01-01

Note from PTJ's Editor in Chief: Both investigators and readers get frustrated reading research on low back pain because of different definitions of “chronic” and different outcome measures. Lack of consensus on study methods makes it difficult to determine if contradictory findings are based on different methods or different interventions; lack of consensus also prevents synthesis across studies. Dr. Partap Khalsa, Deputy Director, National Center for Complementary and Integrative Health, announced the release of Research Standards for Chronic Low Pain, and the hope is that future investigations will adopt them and reduce variability in research reporting. The task force on research standards was an international, multidisciplinary team including Anthony Delitto, PT, PhD, FAPTA. Its findings have been published in leading pain journals. PTJ is among the first professional journals to share the report with its readers. Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement. Perspective: A task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. PMID:25639530

Cutibacterium acnes molecular typing: time to standardize the method.

PubMed

Dagnelie, M-A; Khammari, A; Dréno, B; Corvec, S

2018-03-12

The Gram-positive, anaerobic/aerotolerant bacterium Cutibacterium acnes is a commensal of healthy human skin; it is subdivided into six main phylogenetic groups or phylotypes: IA1, IA2, IB, IC, II and III. To decipher how far specific subgroups of C. acnes are involved in disease physiopathology, different molecular typing methods have been developed to identify these subgroups: i.e. phylotypes, clonal complexes, and types defined by single-locus sequence typing (SLST). However, as several molecular typing methods have been developed over the last decade, it has become a difficult task to compare the results from one article to another. Based on the scientific literature, the aim of this narrative review is to propose a standardized method to perform molecular typing of C. acnes, according to the degree of resolution needed (phylotypes, clonal complexes, or SLST types). We discuss the existing different typing methods from a critical point of view, emphasizing their advantages and drawbacks, and we identify the most frequently used methods. We propose a consensus algorithm according to the needed phylogeny resolution level. We first propose to use multiplex PCR for phylotype identification, MLST9 for clonal complex determination, and SLST for phylogeny investigation including numerous isolates. There is an obvious need to create a consensus about molecular typing methods for C. acnes. This standardization will facilitate the comparison of results between one article and another, and also the interpretation of clinical data. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Consensus statement on the multidisciplinary management of patients with recurrent and primary rectal cancer beyond total mesorectal excision planes.

PubMed

2013-07-01

The management of primary rectal cancer beyond total mesorectal excision planes (PRC-bTME) and recurrent rectal cancer (RRC) is challenging. There is global variation in standards and no guidelines exist. To achieve cure most patients require extended, multivisceral, exenterative surgery, beyond conventional total mesorectal excision planes. The aim of the Beyond TME Group was to achieve consensus on the definitions and principles of management, and to identify areas of research priority. Delphi methodology was used to achieve consensus. The Group consisted of invited experts from surgery, radiology, oncology and pathology. The process included two international dedicated discussion conferences, formal feedback, three rounds of editing and two rounds of anonymized web-based voting. Consensus was achieved with more than 80 per cent agreement; less than 80 per cent agreement indicated low consensus. During conferences held in September 2011 and March 2012, open discussion took place on areas in which there is a low level of consensus. The final consensus document included 51 voted statements, making recommendations on ten key areas of PRC-bTME and RRC. Consensus agreement was achieved on the recommendations of 49 statements, with 34 achieving consensus in over 95 per cent. The lowest level of consensus obtained was 76 per cent. There was clear identification of the need for referral to a specialist multidisciplinary team for diagnosis, assessment and further management. The consensus process has provided guidance for the management of patients with PRC-bTME or RRC, taking into account global variations in surgical techniques and technology. It has further identified areas of research priority.

Consensus Recommendations of the Multiple Sclerosis Study Group and Portuguese Neuroradiological Society for the Use of the Magnetic Resonance Imaging in Multiple Sclerosis in Clinical Practice: Part 1.

PubMed

Abreu, Pedro; Pedrosa, Rui; Sá, Maria José; Cerqueira, João; Sousa, Lívia; Da Silva, Ana Martins; Pinheiro, Joaquim; De Sá, João; Batista, Sónia; Simões, Rita Moiron; Pereira, Daniela Jardim; Vilela, Pedro; Vale, José

2018-05-30

Magnetic resonance imaging is established as a recognizable tool in the diagnosis and monitoring of multiple sclerosis patients. In the present, among multiple sclerosis centers, there are different magnetic resonance imaging sequences and protocols used to study multiple sclerosis that may hamper the optimal use of magnetic resonance imaging in multiple sclerosis. In this context, the Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after a joint discussion, appointed a committee of experts to create recommendations adapted to the national reality on the use of magnetic resonance imaging in multiple sclerosis. The purpose of this document is to publish the first Portuguese consensus recommendations on the use of magnetic resonance imaging in multiple sclerosis in clinical practice. The Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after discussion of the topic in national meetings and after a working group meeting held in Figueira da Foz on May 2017, have appointed a committee of experts that have developed by consensus several standard protocols on the use of magnetic resonance imaging in the diagnosis and follow-up of multiple sclerosis. The document obtained was based on the best scientific evidence and expert opinion. Subsequently, the majority of Portuguese multiple sclerosis consultants and departments of neuroradiology scrutinized and reviewed the consensus paper; comments and suggestions were considered. Technical magnetic resonance imaging protocols regarding diagnostic, monitoring and the recommended information to be included in the magnetic resonance imaging report will be published in a separate paper. We provide some practical guidelines to promote standardized strategies to be applied in the clinical practice setting of Portuguese healthcare professionals regarding the use of magnetic resonance imaging in multiple sclerosis. We hope that these first Portuguese magnetic resonance imaging guidelines, based in the best available clinical evidence and practices, will serve to optimize multiple sclerosis management and improve multiple sclerosis patient care across Portugal.

A modified Delphi translation strategy and challenges of International Classification for Nursing Practice (ICNP®).

PubMed

Hou, I-Ching; Chang, Polun; Chan, Hui-Ya; Dykes, Patricia C

2013-05-01

Standardized terminology is an important infrastructure component of the electronic health record. ICNP(®) is a systemic coding system that can support the development of nursing information systems. Translation of the standardized terminology preferred terms into local terms is an important first step in the translation process. The purpose of this case report is to describe the translation strategy used and challenges faced in translating ICNP(®) Version 2 preferred terms from English to traditional Chinese. A modified Delphi strategy using forward translation and expert consensus was conducted to facilitate semantic and cultural translation and validation of the ICNP(®) and to make the process generalizable. A nursing informatics expert completed the initial forward translation. Five nursing experts with rich clinical and academic experiences joined this process and validated the initial translation. The nursing experts' consensus was then used to finalize the traditional Chinese terms. A total of 1863 preferred terms from the ICNP(®) Version 2 were translated from English into traditional Chinese. Majority agreement from two or more nursing experts was achieved for 98.3% (n=1832) of the preferred term translations. Less than 2% (n=31) of terms had no majority agreement. Translation challenges include the following: (1) changes in code structure of preferred terms from the ICNP(®) β2 version to Verson 2, (2) inability to identify resources to complete the translation that fully met ICNP recommendations for terminology translators, (3) ambiguous preferred term descriptions, and (4) ambiguous preferred term names. Most of the ICNP(®) Version 2 preferred terms were translated from English into traditional Chinese with majority consensus. For the terms without consensus, we recommend that all synonyms be included in the ICNP(®) translation. In countries like Taiwan where nursing education occurs in English, it is recommended that English terms are displayed along with the translated official language to help nurses to interpret and use the terminology correctly. Crown Copyright © 2012. Published by Elsevier Ireland Ltd. All rights reserved.

Consensus Statement of Standards for Interventional Cardiovascular Nursing Practice.

PubMed

White, Kevin; Macfarlane, Heather; Hoffmann, Bernadette; Sirvas-Brown, Helene; Hines, Kathryn; Rolley, John Xavier; Graham, Sandi

2018-05-01

Interventional cardiovascular nursing is a critical care nursing specialty providing complex nursing interventions to patients prone to clinical deterioration, through the combined risks of the pathophysiology of their illness and undergoing technically complex interventional cardiovascular procedures. No guidelines were identified worldwide to assist health care providers and educational institutions in workforce development and education guidelines to minimise patients' risk of adverse events. The Interventional Nurses Council (INC) developed a definition and scope of practice for interventional cardiac nursing (ICN's) in 2013. The INC executive committee established a working party of seven representatives from Australia and New Zealand. Selection was based on expertise in interventional cardiovascular nursing and experience providing education and mentoring in the clinical and postgraduate environment. A literature search of the electronic databases Science Direct, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline and Health Source was performed, using the search terms: clinical deterioration, ST elevation myocardial infarction, vital signs, primary percutaneous coronary intervention, PCI, AMI, STEMI, acute coronary syndrome, peri-procedural care, unstable angina, PCI complications, structural heart disease, TAVI, TAVR, cardiac rhythm management, pacing, electrophysiology studies, vascular access, procedural sedation. Articles were limited to the cardiac catheterisation laboratory and relevance to nursing based outcomes. Reference lists were examined to identify relevant articles missed in the initial search. The literature was compared with national competency standards, quality and safety documents and the INC definition and scope of practice. Consensus of common themes, a taxonomy of education and seven competency domains were achieved via frequent teleconferences and two face-to-face meetings. The working party finalised the standards on 14 July 2017, following endorsement from the CSANZ, INC, Heart Rhythm Council, CSANZ Quality Standards Committee and the Australian College of Critical Care Nurses (ACCCN). The resulting document provides clinical practice and education standards for interventional cardiac nursing practice. Copyright © 2017. Published by Elsevier B.V.

Multicenter prospective evaluation of the express view reading mode for small-bowel capsule endoscopy studies.

PubMed

Saurin, Jean-Christophe; Jacob, Philippe; Heyries, Laurent; Pesanti, Christian; Cholet, Franck; Fassler, Isaac; Boulant, James; Bramli, Slim; De Leusse, Antoin; Rahmi, Gabriel

2018-05-01

 Reducing the reading time of capsule endoscopy films is of high priority for gastroenterologists. We report a prospective multicenter evaluation of an "express view" reading mode (Intromedic capsule system).  Eighty-three patients with obscure gastrointestinal bleeding were prospectively included in 10 centers. All patients underwent small-bowel capsule endoscopy (Intromedic, Seoul, Republic of Korea). Films were read in standard mode, then a second reading was performed in express view mode at a second center. For each lesion, the precise location, nature, and relevance were collected. A consensus reading and review were done by three experts, and considered to be the gold standard.  The mean reading time of capsule films was 39.7 minutes (11 - 180 minutes) and 19.7 minutes (4 - 40 minutes) by standard and express view mode, respectively ( P  < 1 × 10  - 4 ). The consensus review identified a significant lesion in 44/83 patients (53.0 %). Standard reading and express view reading had a 93.3 % and 82.2 % sensitivity, respectively (NS). Consensus review identified 70 significant images from which standard reading and express view reading detected 58 (82.9 %) and 55 (78.6 %), respectively. The informatics algorithm detected 66/70 images (94.3 %) thus missing four small-bowel angiodysplasia.  The express view algorithm allows an important shortening of Intromedic capsule film reading time with a high sensitivity.

ASTM Committee C28: International Standards for Properties and Performance of Advanced Ceramics, Three Decades of High-quality, Technically-rigorous Normalization

NASA Technical Reports Server (NTRS)

Jenkins, Michael G.; Salem, Jonathan A.

2016-01-01

Physical and mechanical properties and performance of advanced ceramics and glasses are difficult to measure correctly without the proper techniques. For over three decades, ASTM Committee C28 on Advanced Ceramics, has developed high quality, rigorous, full-consensus standards (e.g., test methods, practices, guides, terminology) to measure properties and performance of monolithic and composite ceramics that may be applied to glasses in some cases. These standards testing particulars for many mechanical, physical, thermal, properties and performance of these materials. As a result these standards provide accurate, reliable, repeatable and complete data. Within Committee C28 users, producers, researchers, designers, academicians, etc. have written, continually updated, and validated through round-robin test programs, nearly 50 standards since the Committees founding in 1986. This paper provides a retrospective review of the 30 years of ASTM Committee C28 including a graphical pictogram listing of C28 standards along with examples of the tangible benefits of advanced ceramics standards to demonstrate their practical applications.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery.

PubMed

Hedrick, Traci L; McEvoy, Matthew D; Mythen, Michael Monty G; Bergamaschi, Roberto; Gupta, Ruchir; Holubar, Stefan D; Senagore, Anthony J; Gan, Tong Joo; Shaw, Andrew D; Thacker, Julie K M; Miller, Timothy E; Wischmeyer, Paul E; Carli, Franco; Evans, David C; Guilbert, Sarah; Kozar, Rosemary; Pryor, Aurora; Thiele, Robert H; Everett, Sotiria; Grocott, Mike; Abola, Ramon E; Bennett-Guerrero, Elliott; Kent, Michael L; Feldman, Liane S; Fiore, Julio F

2018-06-01

The primary driver of length of stay after bowel surgery, particularly colorectal surgery, is the time to return of gastrointestinal (GI) function. Traditionally, delayed GI recovery was thought to be a routine and unavoidable consequence of surgery, but this has been shown to be false in the modern era owing to the proliferation of enhanced recovery protocols. However, impaired GI function is still common after colorectal surgery, and the current literature is ambiguous with regard to the definition of postoperative GI dysfunction (POGD), or what is typically referred to as ileus. This persistent ambiguity has impeded the ability to ascertain the true incidence of the condition and study it properly within a research setting. Furthermore, a rational and standardized approach to prevention and treatment of POGD is needed. The second Perioperative Quality Initiative brought together a group of international experts to review the published literature and provide consensus recommendations on this important topic with the goal to (1) develop a rational definition for POGD that can serve as a framework for clinical and research efforts; (2) critically review the evidence behind current prevention strategies and provide consensus recommendations; and (3) develop rational treatment strategies that take into account the wide spectrum of impaired GI function in the postoperative period.

49 CFR 214.115 - Foot protection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Foot protection. 214.115 Section 214.115 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... conform to the national consensus standards for safety-toe footwear (American National Standards Institute...

49 CFR 214.113 - Head protection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Head protection. 214.113 Section 214.113 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... conform to the national consensus standards for industrial head protection (American National Standards...

76 FR 3057 - Special Local Regulation; Hydroplane Races Within the Captain of the Port Puget Sound Area of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-19

...: November 24, 2010. G.T. Blore, Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard District.... Voluntary consensus standards are technical standards (e.g., specifications of materials, performance...

Quality Indicators in Radiation Oncology

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

Albert, Jeffrey M.; Das, Prajnan, E-mail: prajdas@mdanderson.org

Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts tomore » define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.« less

In search of the autologous clip: a case for experimental standardization.

PubMed

Krugman, Kimberly A; Martin, Kimberly E; Cosgriff, Ned; Slakey, Douglas P

2011-10-01

In an effort to enable faster and, at times, more challenging surgeries without compromising patient or physician safety, medical device manufacturers have created myriad solutions to vascular ligation through the development of novel tools. The speed of development, FDA approval, and dissemination of these devices into the hands of surgeons often outpaces the ability of investigators to critically evaluate comparative effectiveness of these devices. The Medline database was searched for energy-based vessel ligation devices. To remove any perception bias against non-Covidien instruments, critical review was applied only to the devices manufactured by our company. We report on the variability present in published results and offer vital metrics for future studies. Standardized testing and reporting for measures of safety and efficacy of these surgical instruments awaits definition from a consensus group.

Emergency department performance measures updates: proceedings of the 2014 emergency department benchmarking alliance consensus summit.

PubMed

Wiler, Jennifer L; Welch, Shari; Pines, Jesse; Schuur, Jeremiah; Jouriles, Nick; Stone-Griffith, Suzanne

2015-05-01

The objective was to review and update key definitions and metrics for emergency department (ED) performance and operations. Forty-five emergency medicine leaders convened for the Third Performance Measures and Benchmarking Summit held in Las Vegas, February 21-22, 2014. Prior to arrival, attendees were assigned to workgroups to review, revise, and update the definitions and vocabulary being used to communicate about ED performance and operations. They were provided with the prior definitions of those consensus summits that were published in 2006 and 2010. Other published definitions from key stakeholders in emergency medicine and health care were also reviewed and circulated. At the summit, key terminology and metrics were discussed and debated. Workgroups communicated online, via teleconference, and finally in a face-to-face meeting to reach consensus regarding their recommendations. Recommendations were then posted and open to a 30-day comment period. Participants then reanalyzed the recommendations, and modifications were made based on consensus. A comprehensive dictionary of ED terminology related to ED performance and operation was developed. This article includes definitions of operating characteristics and internal and external factors relevant to the stratification and categorization of EDs. Time stamps, time intervals, and measures of utilization were defined. Definitions of processes and staffing measures are also presented. Definitions were harmonized with performance measures put forth by the Centers for Medicare and Medicaid Services (CMS) for consistency. Standardized definitions are necessary to improve the comparability of EDs nationally for operations research and practice. More importantly, clear precise definitions describing ED operations are needed for incentive-based pay-for-performance models like those developed by CMS. This document provides a common language for front-line practitioners, managers, health policymakers, and researchers. © 2015 by the Society for Academic Emergency Medicine.

Getting It Right the First Time: Defining Regionally Relevant Training Curricula and Provider Core Competencies for Point-of-Care Ultrasound Education on the African Continent.

PubMed

Salmon, Margaret; Landes, Megan; Hunchak, Cheryl; Paluku, Justin; Malemo Kalisya, Luc; Salmon, Christian; Muller, Mundenga Mutendi; Wachira, Benjamin; Mangan, James; Chhaganlal, Kajal; Kalanzi, Joseph; Azazh, Aklilu; Berman, Sara; Zied, El-Sayed; Lamprecht, Hein

2017-02-01

Significant evidence identifies point-of-care ultrasound (PoCUS) as an important diagnostic and therapeutic tool in resource-limited settings. Despite this evidence, local health care providers on the African continent continue to have limited access to and use of ultrasound, even in potentially high-impact fields such as obstetrics and trauma. Dedicated postgraduate emergency medicine residency training programs now exist in 8 countries, yet no current consensus exists in regard to core PoCUS competencies. The current practice of transferring resource-rich PoCUS curricula and delivery methods to resource-limited health systems fails to acknowledge the unique challenges, needs, and disease burdens of recipient systems. As emergency medicine leaders from 8 African countries, we introduce a practical algorithmic approach, based on the local epidemiology and resource constraints, to curriculum development and implementation. We describe an organizational structure composed of nexus learning centers for PoCUS learners and champions on the continent to keep credentialing rigorous and standardized. Finally, we put forth 5 key strategic considerations: to link training programs to hospital systems, to prioritize longitudinal learning models, to share resources to promote health equity, to maximize access, and to develop a regional consensus on training standards and credentialing. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Standardisation of neonatal clinical practice.

PubMed

Bhutta, Z A; Giuliani, F; Haroon, A; Knight, H E; Albernaz, E; Batra, M; Bhat, B; Bertino, E; McCormick, K; Ochieng, R; Rajan, V; Ruyan, P; Cheikh Ismail, L; Paul, V

2013-09-01

The International Fetal and Newborn Growth Consortium for the 21(st) Century (INTERGROWTH-21(st) ) is a large-scale, population-based, multicentre project involving health institutions from eight geographically diverse countries, which aims to assess fetal, newborn and preterm growth under optimal conditions. Given the multicentre nature of the project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21(st) Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. The operational definitions and summary management protocols were developed by consensus through a Delphi process based on systematic reviews of relevant guidelines and management protocols by authoritative bodies. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21(st) participating centres. Finally, thoughts about implementation strategies are presented. © 2013 Royal College of Obstetricians and Gynaecologists.

Consensus Development from the 5th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE 2014)

PubMed Central

Hsu, Chiun; Chen, Bang-Bin; Chen, Chien-Hung; Ho, Ming-Chih; Cheng, Jason Chia-Hsien; Kokudo, Norihiro; Murakami, Takamichi; Yeo, Winnie; Seong, Jinsil; Jia, Ji-Dong; Han, Kwan-Hyub; Cheng, Ann-Lii

2015-01-01

A key mission of the Asia-Pacific Primary Liver Cancer Expert (APPLE) Association is to ensure a coherent view for management of hepatocellular carcinoma (HCC) and to advance new treatment for this difficult disease. At the 5th APPLE meeting, held in July 2014 in Taipei, Taiwan, an APPLE consensus development program was established to facilitate discussion among experts in the Asia-Pacific region on pertinent issues for HCC management, including (1) surgery for intermediate/advanced-stage disease, (2) prevention of HCC recurrence after curative treatment, (3) optimizing imaging diagnosis, (4) radiotherapy: current practice and future clinical trials, and (5) the role of cytotoxic chemotherapy. A pre-congress questionnaire was undertaken with the consensus development committee members to help understand the current practice patterns for HCC in the Asia-Pacific region and to identify issues relating to optimal patient care and further clinical trials for which consensus needs to be developed. In this report, the results of the questionnaire are presented, and the pertinent issues identified by each consensus group for further discussion and consensus development are summarized. PMID:26020032

Tuberous sclerosis complex surveillance and management: recommendations of the 2012 International Tuberous Sclerosis Complex Consensus Conference.

PubMed

Krueger, Darcy A; Northrup, Hope

2013-10-01

Tuberous sclerosis complex is a genetic disorder affecting every organ system, but disease manifestations vary significantly among affected individuals. The diverse and varied presentations and progression can be life-threatening with significant impact on cost and quality of life. Current surveillance and management practices are highly variable among region and country, reflective of the fact that last consensus recommendations occurred in 1998 and an updated, comprehensive standard is lacking that incorporates the latest scientific evidence and current best clinical practices. The 2012 International Tuberous Sclerosis Complex Consensus Group, comprising 79 specialists from 14 countries, was organized into 12 separate subcommittees, each led by a clinician with advanced expertise in tuberous sclerosis complex and the relevant medical subspecialty. Each subcommittee focused on a specific disease area with important clinical management implications and was charged with formulating key clinical questions to address within its focus area, reviewing relevant literature, evaluating the strength of data, and providing a recommendation accordingly. The updated consensus recommendations for clinical surveillance and management in tuberous sclerosis complex are summarized here. The recommendations are relevant to the entire lifespan of the patient, from infancy to adulthood, including both individuals where the diagnosis is newly made as well as individuals where the diagnosis already is established. The 2012 International Tuberous Sclerosis Complex Consensus Recommendations provide an evidence-based, standardized approach for optimal clinical care provided for individuals with tuberous sclerosis complex. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

Breast Cancer Screening in the Era of Density Notification Legislation: Summary of 2014 Massachusetts Experience and Suggestion of An Evidence-Based Management Algorithm by Multi-disciplinary Expert Panel

PubMed Central

Freer, Phoebe E.; Slanetz, Priscilla J.; Haas, Jennifer S.; Tung, Nadine M.; Hughes, Kevin S.; Armstrong, Katrina; Semine, A. Alan; Troyan, Susan L.; Birdwell, Robyn L.

2015-01-01

Purpose Stemming from breast density notification legislation in Massachusetts effective 2015, we sought to develop a collaborative evidence-based approach to density notification that could be used by practitioners across the state. Our goal was to develop an evidence-based consensus management algorithm to help patients and health care providers follow best practices to implement a coordinated, evidence-based, cost-effective, sustainable practice and to standardize care in recommendations for supplemental screening. Methods We formed the Massachusetts Breast Risk Education and Assessment Task Force (MA-BREAST) a multi-institutional, multi-disciplinary panel of expert radiologists, surgeons, primary care physicians, and oncologists to develop a collaborative approach to density notification legislation. Using evidence-based data from the Institute for Clinical and Economic Review (ICER), the Cochrane review, National Comprehensive Cancer Network (NCCN) guidelines, American Cancer Society (ACS) recommendations, and American College of Radiology (ACR) appropriateness criteria, the group collaboratively developed an evidence-based best-practices algorithm. Results The expert consensus algorithm uses breast density as one element in the risk stratification to determine the need for supplemental screening. Women with dense breasts and otherwise low risk (<15% lifetime risk), do not routinely require supplemental screening per the expert consensus. Women of high risk (>20% lifetime) should consider supplemental screening MRI in addition to routine mammography regardless of breast density. Conclusion We report the development of the multi-disciplinary collaborative approach to density notification. We propose a risk stratification algorithm to assess personal level of risk to determine the need for supplemental screening for an individual woman. PMID:26290416

Improving Consensus Scoring of Crowdsourced Data Using the Rasch Model: Development and Refinement of a Diagnostic Instrument.

PubMed

Brady, Christopher John; Mudie, Lucy Iluka; Wang, Xueyang; Guallar, Eliseo; Friedman, David Steven

2017-06-20

Diabetic retinopathy (DR) is a leading cause of vision loss in working age individuals worldwide. While screening is effective and cost effective, it remains underutilized, and novel methods are needed to increase detection of DR. This clinical validation study compared diagnostic gradings of retinal fundus photographs provided by volunteers on the Amazon Mechanical Turk (AMT) crowdsourcing marketplace with expert-provided gold-standard grading and explored whether determination of the consensus of crowdsourced classifications could be improved beyond a simple majority vote (MV) using regression methods. The aim of our study was to determine whether regression methods could be used to improve the consensus grading of data collected by crowdsourcing. A total of 1200 retinal images of individuals with diabetes mellitus from the Messidor public dataset were posted to AMT. Eligible crowdsourcing workers had at least 500 previously approved tasks with an approval rating of 99% across their prior submitted work. A total of 10 workers were recruited to classify each image as normal or abnormal. If half or more workers judged the image to be abnormal, the MV consensus grade was recorded as abnormal. Rasch analysis was then used to calculate worker ability scores in a random 50% training set, which were then used as weights in a regression model in the remaining 50% test set to determine if a more accurate consensus could be devised. Outcomes of interest were the percent correctly classified images, sensitivity, specificity, and area under the receiver operating characteristic (AUROC) for the consensus grade as compared with the expert grading provided with the dataset. Using MV grading, the consensus was correct in 75.5% of images (906/1200), with 75.5% sensitivity, 75.5% specificity, and an AUROC of 0.75 (95% CI 0.73-0.78). A logistic regression model using Rasch-weighted individual scores generated an AUROC of 0.91 (95% CI 0.88-0.93) compared with 0.89 (95% CI 0.86-92) for a model using unweighted scores (chi-square P value<.001). Setting a diagnostic cut-point to optimize sensitivity at 90%, 77.5% (465/600) were graded correctly, with 90.3% sensitivity, 68.5% specificity, and an AUROC of 0.79 (95% CI 0.76-0.83). Crowdsourced interpretations of retinal images provide rapid and accurate results as compared with a gold-standard grading. Creating a logistic regression model using Rasch analysis to weight crowdsourced classifications by worker ability improves accuracy of aggregated grades as compared with simple majority vote. ©Christopher John Brady, Lucy Iluka Mudie, Xueyang Wang, Eliseo Guallar, David Steven Friedman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.06.2017.

Bullying in the clinical training of pharmacy students.

PubMed

Knapp, Katherine; Shane, Patricia; Sasaki-Hill, Debra; Yoshizuka, Keith; Chan, Paul; Vo, Thuy

2014-08-15

To determine whether bullying is a significant factor in the clinical training of pharmacy students. The literature as well as the Accreditation Council for Pharmacy Education (ACPE) Standards and American Association of Colleges of Pharmacy (AACP) surveys were reviewed for mention and/or measurement of bullying behaviors in the clinical training of pharmacy students. The authors used a Delphi process to define bullying behavior. The consensus definition was used to analyze 2,087 in-house student evaluations of preceptors for evidence of bullying behaviors. The authors mapped strings of text from in-house student comments to different, established categories of bullying behaviors. The ACPE Standards and AACP surveys contained no mention or measures of bullying. The 2013 AACP survey data reported overwhelmingly positive preceptor ratings. Of the 2,087 student evaluations of preceptors, 119 (5.7%) had at least 1 low rating. Within those 119 survey instruments, 34 comments were found describing bullying behaviors. Students' responses to the AACP survey were similar to data from the national cohort. Given the evidence that bullying behaviors occur in pharmacy education and that bullying has long-term and short-term damaging effects, more attention should be focused on this problem. Efforts should include addressing bullying in ACPE Standards and AACP survey tools developing a consensus definition for bullying and conducting more research into bullying in the clinical training of pharmacy students.

Pathology Imagebase-a reference image database for standardization of pathology.

PubMed

Egevad, Lars; Cheville, John; Evans, Andrew J; Hörnblad, Jonas; Kench, James G; Kristiansen, Glen; Leite, Katia R M; Magi-Galluzzi, Cristina; Pan, Chin-Chen; Samaratunga, Hemamali; Srigley, John R; True, Lawrence; Zhou, Ming; Clements, Mark; Delahunt, Brett

2017-11-01

Despite efforts to standardize histopathology practice through the development of guidelines, the interpretation of morphology is still hampered by subjectivity. We here describe Pathology Imagebase, a novel mechanism for establishing an international standard for the interpretation of pathology specimens. The International Society of Urological Pathology (ISUP) established a reference image database through the input of experts in the field. Three panels were formed, one each for prostate, urinary bladder and renal pathology, consisting of 24 international experts. Each of the panel members uploaded microphotographs of cases into a non-public database. The remaining 23 experts were asked to vote from a multiple-choice menu. Prior to and while voting, panel members were unable to access the results of voting by the other experts. When a consensus level of at least two-thirds or 16 votes was reached, cases were automatically transferred to the main database. Consensus was reached in a total of 287 cases across five projects on the grading of prostate, bladder and renal cancer and the classification of renal tumours and flat lesions of the bladder. The full database is available to all ISUP members at www.isupweb.org. Non-members may access a selected number of cases. It is anticipated that the database will assist pathologists in calibrating their grading, and will also promote consistency in the diagnosis of difficult cases. © 2017 John Wiley & Sons Ltd.

Bullying in the Clinical Training of Pharmacy Students

PubMed Central

Shane, Patricia; Sasaki-Hill, Debra; Yoshizuka, Keith; Chan, Paul; Vo, Thuy

2014-01-01

Objective. To determine whether bullying is a significant factor in the clinical training of pharmacy students. Methods. The literature as well as the Accreditation Council for Pharmacy Education (ACPE) Standards and American Association of Colleges of Pharmacy (AACP) surveys were reviewed for mention and/or measurement of bullying behaviors in the clinical training of pharmacy students. The authors used a Delphi process to define bullying behavior. The consensus definition was used to analyze 2,087 in-house student evaluations of preceptors for evidence of bullying behaviors. The authors mapped strings of text from in-house student comments to different, established categories of bullying behaviors. Results. The ACPE Standards and AACP surveys contained no mention or measures of bullying. The 2013 AACP survey data reported overwhelmingly positive preceptor ratings. Of the 2,087 student evaluations of preceptors, 119 (5.7%) had at least 1 low rating. Within those 119 survey instruments, 34 comments were found describing bullying behaviors. Students’ responses to the AACP survey were similar to data from the national cohort. Conclusions. Given the evidence that bullying behaviors occur in pharmacy education and that bullying has long-term and short-term damaging effects, more attention should be focused on this problem. Efforts should include addressing bullying in ACPE Standards and AACP survey tools developing a consensus definition for bullying and conducting more research into bullying in the clinical training of pharmacy students. PMID:25147389

Australian recommendations for the integration of emergency care for older people: Consensus Statement.

PubMed

Lowthian, Judy A; Arendts, Glenn; Strivens, Edward

2018-05-07

Management of older patients during acute illness or injury does not occur in isolation in emergency departments. We aimed to develop a collaborative Consensus Statement to enunciate principles of integrated emergency care. Briefing notes, informed by research and evidence reviews, were developed and evaluated by a Consensus Working Party comprising cross-specialty representation from clinical experts, service providers, consumers and policymakers. The Consensus Working Party then convened to discuss and develop the statement's content. A subcommittee produced a draft, which was reviewed and edited by the Consensus Working Party. Consensus was reached after three rounds of discussion, with 12 principles and six recommendations for how to follow these principles, including an integrated care framework for action. Dissemination will encourage stakeholders and associated policy bodies to embrace the principles and priorities for action, potentially leading to collaborative work practices and improvement of care during and after acute illness or injury. © 2018 AJA Inc.

[Consensus document: a model of integrated management of patients with psycomotor agitation].

PubMed

2016-01-01

Psychomotor agitation (PMA) is a heterogeneous clinical syndrome associated with a widenumber of pathological conditions. The currently available recommendations and guidelines on PMA correct assessment and management are significantly dishomogeneous and suffer from a lack of standardization, especially regarding pharmacological interventions. Based on this deficiency, and on multidisciplinary nature of PMA, that includes factors shared by different health professionals other than pharmacoeconomic and risk management aspects, we started a project aimed to elaborate a shared model of integrated management for PMA patients. The model, developed by a scientific board and a multidisciplinary panel using the consensus Delphi-RAND method, aims to give indications of good clinical practice for the management of these patients. The present document reports the results of this consensus process, whose main principles are the centrality of the patient, as an active and collaborating subject, the importance of prompt and not coercive interventions able to block the escalation to violence and to allow a correct diagnostic and therapeutic workup, the appropriate use of pharmacological interventions based on the severity of symptoms and the importance of an integrated and harmonized approach by the different professionals involved in PMA management.

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

PubMed

Waldman, Abigail; Bolotin, Diana; Arndt, Kenneth A; Dover, Jeffrey S; Geronemus, Roy G; Chapas, Anne; Iyengar, Sanjana; Kilmer, Suzanne L; Krakowski, Andrew C; Lawrence, Naomi; Prather, Heidi B; Rohrer, Thomas E; Schlosser, Bethanee J; Kim, John Y S; Shumaker, Peter R; Spring, Leah K; Alam, Murad

2017-10-01

Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

Update of the Grupo Español de Leucemia Linfocítica Crónica clinical guidelines of the management of chronic lymphocytic leukemia.

PubMed

García-Marco, José A; Delgado, Julio; Hernández-Rivas, José A; Ramírez Payer, Ángel; Loscertales Pueyo, Javier; Jarque, Isidro; Abrisqueta, Pau; Giraldo, Pilar; Martínez, Rafael; Yáñez, Lucrecia; Terol, Mª José; González, Marcos; Bosch, Francesc

2017-04-21

The broad therapeutic arsenal and the biological heterogeneity of patients with chronic lymphocytic leukemia (CLL) makes it difficult to standardize treatment for CLL patients with specific clinical settings in routine clinical practice. These considerations prompted us to elaborate the present consensus document, which constitutes an update of the previous version published in 2013, mainly focusing on novel treatment strategies that have been developed over last 5 years, namely B-cell receptor inhibitors (ibrutinib and idelalisib), anti-CD20 monoclonal antibodies (ofatumumab and obinutuzumab), and Bcl-2 inhibitors (venetoclax). A group of experts from the Spanish Chronic Lymphocytic Leukemia Group reviewed all published literature from January 2010 to January 2016, in order to provide recommendations based on clinical evidence. For those areas without strong scientific evidence, the panel of experts established consensus criteria based on their clinical experience. The project has resulted in several practical recommendations that will facilitate the diagnosis, treatment, and follow-up of patients with CLL. There are many controversial issues in the management of CLL with no appropriate studies for making consensus recommendations. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

The Growth Hormone Research Society consensus guidelines for the diagnosis and treatment of adult GH deficiency.

PubMed

Hartman, M L

1998-02-01

The Growth Hormone Research Society (GRS) convened a workshop in Port Stephens, Australia in April 1997 to establish consensus guidelines for the diagnosis and treatment of adults with GH deficiency (GHD). Scientists with expertise in the field, representatives from industry involved in the manufacture of GH and representatives from health authorities from a number of countries participated in the workshop. The workshop considered the following questions: (1) How should adult GHD be defined? (2) Who should be tested for adult GHD? (3) How should the diagnosis of adult GHD be established? (4) How should GH and insulin-like growth factor-I (IGF-I) assays be standardized? (5) Who should be treated for adult GHD? (6) What dose of GH should be used for treatment of adult GHD? (7) How should treatment of adult GHD be monitored? (8) What are the contraindications to treatment of adult GHD? (9) What safety issues need to be considered? (10) How long should treatment of adult GHD be continued? The consensus guidelines developed at this workshop and the rationale for some of these recommendations will be reviewed in this paper.

Palm-Based Standard Reference Materials for Iodine Value and Slip Melting Point

PubMed Central

Tarmizi, Azmil Haizam Ahmad; Lin, Siew Wai; Kuntom, Ainie

2008-01-01

This work described study protocols on the production of Palm-Based Standard Reference Materials for iodine value and slip melting point. Thirty-three laboratories collaborated in the inter-laboratory proficiency tests for characterization of iodine value, while thirty-two laboratories for characterization of slip melting point. The iodine value and slip melting point of palm oil, palm olein and palm stearin were determined in accordance to MPOB Test Methods p3.2:2004 and p4.2:2004, respectively. The consensus values and their uncertainties were based on the acceptability of statistical agreement of results obtained from collaborating laboratories. The consensus values and uncertainties for iodine values were 52.63 ± 0.14 Wijs in palm oil, 56.77 ± 0.12 Wijs in palm olein and 33.76 ± 0.18 Wijs in palm stearin. For the slip melting points, the consensus values and uncertainties were 35.6 ± 0.3 °C in palm oil, 22.7 ± 0.4 °C in palm olein and 53.4 ± 0.2 °C in palm stearin. Repeatability and reproducibility relative standard deviations were found to be good and acceptable, with values much lower than that of 10%. Stability of Palm-Based Standard Reference Materials remained stable at temperatures of −20 °C, 0 °C, 6 °C and 24 °C upon storage for one year. PMID:19609396

Proposed minimum reporting standards for chemical analysis Chemical Analysis Working Group (CAWG) Metabolomics Standards Initiative (MSI)

PubMed Central

Amberg, Alexander; Barrett, Dave; Beale, Michael H.; Beger, Richard; Daykin, Clare A.; Fan, Teresa W.-M.; Fiehn, Oliver; Goodacre, Royston; Griffin, Julian L.; Hankemeier, Thomas; Hardy, Nigel; Harnly, James; Higashi, Richard; Kopka, Joachim; Lane, Andrew N.; Lindon, John C.; Marriott, Philip; Nicholls, Andrew W.; Reily, Michael D.; Thaden, John J.; Viant, Mark R.

2013-01-01

There is a general consensus that supports the need for standardized reporting of metadata or information describing large-scale metabolomics and other functional genomics data sets. Reporting of standard metadata provides a biological and empirical context for the data, facilitates experimental replication, and enables the re-interrogation and comparison of data by others. Accordingly, the Metabolomics Standards Initiative is building a general consensus concerning the minimum reporting standards for metabolomics experiments of which the Chemical Analysis Working Group (CAWG) is a member of this community effort. This article proposes the minimum reporting standards related to the chemical analysis aspects of metabolomics experiments including: sample preparation, experimental analysis, quality control, metabolite identification, and data pre-processing. These minimum standards currently focus mostly upon mass spectrometry and nuclear magnetic resonance spectroscopy due to the popularity of these techniques in metabolomics. However, additional input concerning other techniques is welcomed and can be provided via the CAWG on-line discussion forum at http://msi-workgroups.sourceforge.net/ or http://Msi-workgroups-feedback@lists.sourceforge.net. Further, community input related to this document can also be provided via this electronic forum. PMID:24039616

Consensus Treatments for Moderate Juvenile Dermatomyositis: Beyond the First Two Months

PubMed Central

Huber, Adam M.; Robinson, Angela B.; Reed, Ann M.; Abramson, Leslie; Bout-Tabaku, Sharon; Carrasco, Ruy; Curran, Megan; Feldman, Brian M.; Gewanter, Harry; Griffin, Thomas; Haines, Kathleen; Sanzari, Joseph M.; Hoeltzel, Mark F.; Isgro, Josephine; Kahn, Philip; Lang, Bianca; Lawler, Patti; Shaham, Bracha; Schmeling, Heinrike; Scuccimarri, Rosie; Shishov, Michael; Stringer, Elizabeth; Wohrley, Julie; Ilowite, Norman T.; Wallace, Carol

2011-01-01

Objectives To use consensus methods and the considerable expertise contained within the Children’s Arthritis and Rheumatology Research Alliance (CARRA) organization, to extend the 3 previously developed treatment plans for moderate juvenile dermatomyositis (JDM) to span the full course of treatment. Methods A consensus meeting was held in Chicago on April 23–24, 2010 involving 30 pediatric rheumatologists and 4 lay participants. Nominal group technique was used to achieve consensus on treatment plans which represented typical management of moderate JDM. A pre-conference survey of CARRA, completed by 151/272 (56%) members, was used to provide additional guidance to discussion. Results Consensus was reached on timing and rate of steroid tapering, duration of steroid therapy, and actions to be taken if patients were unchanged, worsening, experiencing medication side effects or disease complications. Of particular importance, a single, consensus steroid taper was developed. Conclusions We were able to develop consensus treatment plans which describe therapy for moderate JDM throughout the treatment course. These treatment plans can now be used clinically, and data collected prospectively regarding treatment effectiveness and toxicity. This will allow comparison of these treatment plans and facilitate the development of evidence-based treatment recommendations for moderate JDM. PMID:22076847

Response evaluation criteria for solid tumours in dogs (v1.0): a Veterinary Cooperative Oncology Group (VCOG) consensus document.

PubMed

Nguyen, S M; Thamm, D H; Vail, D M; London, C A

2015-09-01

In veterinary medical oncology, there is currently no standardized protocol for assessing response to therapy in solid tumours. The lack of such a formalized guideline makes it challenging to critically compare outcome measures across various treatment protocols. The Veterinary Cooperative Oncology Group (VCOG) membership consensus document presented here is based on the recommendations of a subcommittee of American College of Veterinary Internal Medicine (ACVIM) board-certified veterinary oncologists. This consensus paper has used the human response evaluation criteria in solid tumours (RECIST v1.1) as a framework to establish standard procedures for response assessment in canine solid tumours that is meant to be easy to use, repeatable and applicable across a variety of clinical trial structures in veterinary oncology. It is hoped that this new canine RECIST (cRECIST v1.0) will be adopted within the veterinary oncology community and thereby facilitate the comparison of current and future treatment protocols used for companion animals with cancer. © 2013 Blackwell Publishing Ltd.

Case Definitions, Diagnostic Algorithms, and Priorities in Encephalitis: Consensus Statement of the International Encephalitis Consortium

PubMed Central

Venkatesan, A.; Tunkel, A. R.; Bloch, K. C.; Lauring, A. S.; Sejvar, J.; Bitnun, A.; Stahl, J-P.; Mailles, A.; Drebot, M.; Rupprecht, C. E.; Yoder, J.; Cope, J. R.; Wilson, M. R.; Whitley, R. J.; Sullivan, J.; Granerod, J.; Jones, C.; Eastwood, K.; Ward, K. N.; Durrheim, D. N.; Solbrig, M. V.; Guo-Dong, L.; Glaser, C. A.; Sheriff, Heather; Brown, David; Farnon, Eileen; Messenger, Sharon; Paterson, Beverley; Soldatos, Ariane; Roy, Sharon; Visvesvara, Govinda; Beach, Michael; Nasci, Roger; Pertowski, Carol; Schmid, Scott; Rascoe, Lisa; Montgomery, Joel; Tong, Suxiang; Breiman, Robert; Franka, Richard; Keuhnert, Matt; Angulo, Fred; Cherry, James

2013-01-01

Background.Encephalitis continues to result in substantial morbidity and mortality worldwide. Advances in diagnosis and management have been limited, in part, by a lack of consensus on case definitions, standardized diagnostic approaches, and priorities for research. Methods.In March 2012, the International Encephalitis Consortium, a committee begun in 2010 with members worldwide, held a meeting in Atlanta to discuss recent advances in encephalitis and to set priorities for future study. Results.We present a consensus document that proposes a standardized case definition and diagnostic guidelines for evaluation of adults and children with suspected encephalitis. In addition, areas of research priority, including host genetics and selected emerging infections, are discussed. Conclusions.We anticipate that this document, representing a synthesis of our discussions and supported by literature, will serve as a practical aid to clinicians evaluating patients with suspected encephalitis and will identify key areas and approaches to advance our knowledge of encephalitis. PMID:23861361

Consensus Statement on Standard of Care for Congenital Myopathies

PubMed Central

Wang, Ching H.; Dowling, James J.; North, Kathryn; Schroth, Mary K.; Sejersen, Thomas; Shapiro, Frederic; Bellini, Jonathan; Weiss, Hali; Guillet, Marc; Amburgey, Kimberly; Apkon, Susan; Bertini, Enrico; Bonnemann, Carsten; Clarke, Nigel; Connolly, Anne M.; Estournet-Mathiaud, Brigitte; Fitzgerald, Dominic; Florence, Julaine M.; Gee, Richard; Gurgel-Giannetti, Juliana; Glanzman, Allan M.; Hofmeister, Brittany; Jungbluth, Heinz; Koumbourlis, Anastassios C.; Laing, Nigel G.; Main, Marion; Morrison, Leslie A.; Munns, Craig; Rose, Kristy; Schuler, Pamela M.; Sewry, Caroline; Storhaug, Kari; Vainzof, Mariz; Yuan, Nanci

2016-01-01

Recent progress in scientific research has facilitated accurate genetic and neuropathological diagnosis of congenital myopathies. However, given their relatively low incidence, congenital myopathies remain unfamiliar to the majority of care providers, and the levels of patient care are extremely variable. This consensus statement aims to provide care guidelines for congenital myopathies. The International Standard of Care Committee for Congenital Myopathies worked through frequent e-mail correspondences, periodic conference calls, 2 rounds of online surveys, and a 3-day workshop to achieve a consensus for diagnostic and clinical care recommendations. The committee includes 59 members from 10 medical disciplines. They are organized into 5 working groups: genetics/diagnosis, neurology, pulmonology, gastroenterology/nutrition/speech/oral care, and orthopedics/rehabilitation. In each care area the authors summarize the committee’s recommendations for symptom assessments and therapeutic interventions. It is the committee’s goal that through these recommendations, patients with congenital myopathies will receive optimal care and improve their disease outcome. PMID:22431881

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2013 CFR

2013-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or, American...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2014 CFR

2014-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or, American...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2012 CFR

2012-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or, American...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2013 CFR

2013-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or American...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2012 CFR

2012-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or American...

30 CFR Appendix I to Subpart M of... - National Consensus Standards

Code of Federal Regulations, 2014 CFR

2014-07-01

... loaders and bulldozers Society of Automotive Engineers (SAE) minimum performance criteria for falling object protective structures (FOPS) SAE J231—January, 1981. Fork-lift trucks American National Standards Institute (ANSI) safety standard for low lift and high lift trucks, B 56.1, section 7.27—1983; or American...

The Evidence Base for How We Learn: Supporting Students' Social, Emotional, and Academic Development. Consensus Statements of Evidence from the Council of Distinguished Scientists

ERIC Educational Resources Information Center

Jones, Stephanie M.; Kahn, Jennifer

2017-01-01

"The Evidence Base for How We Learn: Supporting Students' Social, Emotional, and Academic Development" articulates the scientific consensus regarding how people learn. The research brief presents a set of consensus statements--developed and unanimously signed onto by the Commission's Council of Distinguished Scientists--that affirm the…

76 FR 55564 - Safety Zone; Revolution 3 Triathlon, Sandusky Bay, Lake Erie, Cedar Point, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-08

... injuries or fatalities. Discussion of Rule With the above safety hazards in mind, the Captain of the Port... consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the...

Hearing aid-compatible mobile handsets, petition of American National Standards Committee C63 (EMC) ANSO ASC C63 (TM). Final rule.

PubMed

2008-05-07

The Federal Communications Commission (Commission) adopts various proposals to amend its hearing aid compatibility policies and requirements pertaining to wireless services, including modifications and other requirements along the framework proposed in a consensus plan (Joint Consensus Plan) developed jointly by industry and representatives for the deaf and hard of hearing community. The Commission anticipates that these rule changes, taken together and largely supported by manufacturers, service providers, and consumers with hearing loss, will meet statutory obligations to ensure reasonable access to telephone service by persons with impaired hearing. These requirements are intended to benefit wireless users in the deaf and hard of hearing community, including the most disadvantaged who are more likely to rely on telecoil-equipped hearing aids, as well as to ensure that these consumers have a variety of handsets available to them, including handsets with innovative features.

Methodology for the systematic reviews on an adjacent segment pathology.

PubMed

Norvell, Daniel C; Dettori, Joseph R; Skelly, Andrea C; Riew, K Daniel; Chapman, Jens R; Anderson, Paul A

2012-10-15

A systematic review. To provide a detailed description of the methods undertaken in the systematic search and analytical summary of adjacent segment pathology (ASP) issues and to describe the process used to develop consensus statements and clinical recommendations regarding factors associated with the prevention and treatment of ASP. We present methods used in conducting the systematic, evidence-based reviews and development of expert panel consensus statements and clinical recommendations on the classification, natural history, risk factors, and treatment of radiographical and clinical ASP. Our intent is that clinicians will combine the information from these reviews with an understanding of their own capacities and experience to better manage patients at risk of ASP and consider future research for the prevention and treatment of ASP. A systematic search and critical review of the English-language literature was undertaken for articles published on the classification, risk, risk factors, and treatment of radiographical and clinical ASP. Articles were screened for relevance using a priori criteria, and relevant articles were critically reviewed. Whether an article was included for review depended on whether the study question was descriptive, one of therapy, or one of prognosis. The strength of evidence for the overall body of literature in each topic area was determined by 2 independent reviewers considering risk of bias, consistency, directness, and precision of results using a modification of the Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria. Disagreements were resolved by consensus. Findings from articles meeting inclusion criteria were summarized. From these summaries, consensus statements or clinical recommendations were formulated among subject experts through a modified Delphi process using the GRADE approach. A total of 3382 articles were identified and screened on 14 topics relating to the classification, risks, risk factors, and treatment of radiographical and clinical ASP. Of these, 127 met our predetermined inclusion criteria and were used to answer specific clinical questions within each topic. Lack of precision in the terminology related to adjacent segment disease and critical evaluation of definitions used across included articles led to a consensus to use ASP and suggest it as a standard. No validated comprehensive classification system for ASP currently exists. The expert panel developed a consensus definition of radiographical and clinical ASP (RASP and CASP). Some of the highlights from the analyses included the annual, 5- and 10-year risks of developing cervical and lumbar ASP after surgery, several important risk factors associated with the development of cervical and lumbar ASP, and the possibility that some motion sparing procedures may be associated with a lower risk of ASP compared with fusion despite kinematic studies demonstrating similar adjacent segment mobility following these procedures. Other highlights included a high risk of proximal junctional kyphosis (PJK) following long fusions for deformity correction, postsurgical malalignment as a potential risk factor for RASP and the paucity of studies on treatment of cervical and lumbar ASP. Systematic reviews were undertaken to understand the classification, risks, risk factors, and treatment of RASP and CASP and to provide consensus statements and clinical recommendations. This article reports the methods used in the reviews.

Exploring International Views on Key Concepts for Mass-gathering Health through a Delphi Process.

PubMed

Steenkamp, Malinda; Hutton, Alison E; Ranse, Jamie C; Lund, Adam; Turris, Sheila A; Bowles, Ron; Arbuthnott, Katherine; Arbon, Paul A

2016-08-01

Introduction The science underpinning mass-gathering health (MGH) is developing rapidly. However, MGH terminology and concepts are not yet well defined or used consistently. These variations can complicate comparisons across settings. There is, therefore, a need to develop consensus and standardize concepts and data points to support the development of a robust MGH evidence-base for governments, event planners, responders, and researchers. This project explored the views and sought consensus of international MGH experts on previously published concepts around MGH to inform the development of a transnational minimum data set (MDS) with an accompanying data dictionary (DD). Report A two-round Delphi process was undertaken involving volunteers from the World Health Organization (WHO) Virtual Interdisciplinary Advisory Group (VIAG) on Mass Gatherings (MGs) and the MG section of the World Association for Disaster and Emergency Medicine (WADEM). The first online survey tested agreement on six key concepts: (1) using the term "MG HEALTH;" (2) purposes of the proposed MDS and DD; (3) event phases; (4) two MG population models; (5) a MGH conceptual diagram; and (6) a data matrix for organizing MGH data elements. Consensus was defined as ≥80% agreement. Round 2 presented five refined MGH principles based on Round 1 input that was analyzed using descriptive statistics and content analysis. Thirty-eight participants started Round 1 with 36 completing the survey and 24 (65% of 36) completing Round 2. Agreement was reached on: the term "MGH" (n=35/38; 92%); the stated purposes for the MDS (n=38/38; 100%); the two MG population models (n=31/36; 86% and n=30/36; 83%, respectively); and the event phases (n=34/36; 94%). Consensus was not achieved on the overall conceptual MGH diagram (n=25/37; 67%) and the proposed matrix to organize data elements (n=28/37; 77%). In Round 2, agreement was reached on all the proposed principles and revisions, except on the MGH diagram (n=18/24; 75%). Discussion/Conclusions Event health stakeholders require sound data upon which to build a robust MGH evidence-base. The move towards standardization of data points and/or reporting items of interest will strengthen the development of such an evidence-base from which governments, researchers, clinicians, and event planners could benefit. There is substantial agreement on some broad concepts underlying MGH amongst an international group of MG experts. Refinement is needed regarding an overall conceptual diagram and proposed matrix for organizing data elements. Steenkamp M , Hutton AE , Ranse JC , Lund A , Turris SA , Bowles R , Arbuthnott K , Arbon PA . Exploring international views on key concepts for mass-gathering health through a Delphi process. Prehosp Disaster Med. 2016;31(4):443-453.

24 CFR 3286.15 - Consultation with the Manufactured Housing Consensus Committee (MHCC).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Consultation with the Manufactured Housing Consensus Committee (MHCC). 3286.15 Section 3286.15 Housing and Urban Development Regulations... Consensus Committee (MHCC). The Secretary will seek input from the MHCC when revising the installation...

24 CFR 3288.305 - Consultation with the Manufactured Housing Consensus Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Consultation with the Manufactured Housing Consensus Committee. 3288.305 Section 3288.305 Housing and Urban Development Regulations Relating... Housing Consensus Committee. HUD will seek input from the MHCC when revising the HUD Manufactured Home...

A Response to Proposed Equal Employment Opportunity Commission Regulations on Employer-Sponsored Health, Safety, and Well-Being Initiatives.

PubMed

2016-03-01

The aim of this study was to identify areas of consensus in response to proposed Equal Employment Opportunity Commission Americans with Disabilities Act of 1990 and Genetic Information Nondiscrimination Act of 2008 regulations on employer-sponsored health, safety, and well-being initiatives. The consensus process included review of existing and proposed regulations, identification of key areas where consensus is needed, and a methodical consensus-building process. Stakeholders representing employees, employers, consulting organizations, and wellness providers reached consensus around five areas, including adequate privacy notice on how medical data are collected, used, and protected; effective, equitable use of inducements that influence participation in programs; observance of reasonable alternative standards; what constitutes reasonably designed programs; and the need for greater congruence between federal agency regulations. Employee health and well-being initiatives that are in accord with federal regulations are comprehensive, evidence-based, and are construed as voluntary by employees and regulators alike.

Outpatient management of febrile neutropenia in children with cancer

PubMed Central

Ziino, Ottavio; Tucci, Fabio; Rossi, Mario Renato

2011-01-01

Optimizing the therapeutic strategies based on the results of randomized studies comparing different regimens led to a better prognosis of nearly all pediatric malignancies during the past four decades. Fever and neutropenia (FN) is a common complication in patients undergoing chemotherapy to treat cancer. There is no consensus on when standard therapy can be safely reduced; this lack of consensus leads to important variations in management of FN between different institutions, usually conducted according to local attitudes. To address this issue, the Infection working group of the Italian association for pediatric hematology oncology (AIEOP) organized a consensus meeting. This paper reports the agreement derived from this meeting. PMID:21647281

Development of national standardized all-hazard disaster core competencies for acute care physicians, nurses, and EMS professionals.

PubMed

Schultz, Carl H; Koenig, Kristi L; Whiteside, Mary; Murray, Rick

2012-03-01

The training of medical personnel to provide care for disaster victims is a priority for the physician community, the federal government, and society as a whole. Course development for such training guided by well-accepted standardized core competencies is lacking, however. This project identified a set of core competencies and performance objectives based on the knowledge, skills, and attitudes required by the specific target audience (emergency department nurses, emergency physicians, and out-of-hospital emergency medical services personnel) to ensure they can treat the injuries and illnesses experienced by victims of disasters regardless of cause. The core competencies provide a blueprint for the development or refinement of disaster training courses. This expert consensus project, supported by a grant from the Robert Wood Johnson Foundation, incorporated an all-hazard, comprehensive emergency management approach addressing every type of disaster to minimize the effect on the public's health. An instructional systems design process was used to guide the development of audience-appropriate competencies and performance objectives. Participants, representing multiple academic and provider organizations, used a modified Delphi approach to achieve consensus on recommendations. A framework of 19 content categories (domains), 19 core competencies, and more than 90 performance objectives was developed for acute medical care personnel to address the requirements of effective all-hazards disaster response. Creating disaster curricula and training based on the core competencies and performance objectives identified in this article will ensure that acute medical care personnel are prepared to treat patients and address associated ramifications/consequences during any catastrophic event. Copyright © 2012 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Call for Standardized Definitions of Osteoarthritis and Risk Stratification for Clinical Trials and Clinical Use

PubMed Central

Kraus, Virginia Byers; Blanco, Francisco J.; Englund, Martin; Karsdal, Morten A.; Lohmander, L. Stefan

2015-01-01

Osteoarthritis is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for osteoarthritis (OA) that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2) To stimulate establishment of ROAD (Risk of Osteoarthritis Development) and ROAP (Risk of Osteoarthritis Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages -- REDI (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more sophisticated definitions, terminology and tools. PMID:25865392