40 CFR 78.15 - Motions in evidentiary hearings.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Motions in evidentiary hearings. 78.15 Section 78.15 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPEAL PROCEDURES § 78.15 Motions in evidentiary hearings. (a) Any party may make a motion to the...

10 CFR 820.8 - Evidentiary matters.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Evidentiary matters. 820.8 Section 820.8 Energy DEPARTMENT OF ENERGY PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES General § 820.8 Evidentiary matters. (a... matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may...

10 CFR 820.8 - Evidentiary matters.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Evidentiary matters. 820.8 Section 820.8 Energy DEPARTMENT OF ENERGY PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES General § 820.8 Evidentiary matters. (a... matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may...

10 CFR 820.8 - Evidentiary matters.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Evidentiary matters. 820.8 Section 820.8 Energy DEPARTMENT OF ENERGY PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES General § 820.8 Evidentiary matters. (a... matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may...

10 CFR 820.8 - Evidentiary matters.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Evidentiary matters. 820.8 Section 820.8 Energy DEPARTMENT OF ENERGY PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES General § 820.8 Evidentiary matters. (a... matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may...

10 CFR 820.8 - Evidentiary matters.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Evidentiary matters. 820.8 Section 820.8 Energy DEPARTMENT OF ENERGY PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES General § 820.8 Evidentiary matters. (a... matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may...

On the evidentiary standards for nutrition advice.

PubMed

Jukola, Saana

2018-06-01

This paper evaluates the application of evidentiary standards originating from evidence-based medicine in nutrition advice. It shows that it is problematic to criticize nutrition recommendations for not being based on randomized controlled trials. Due to practical, ethical and methodological and reasons, it is difficult to conduct rigorous randomized controlled trials for acquiring evidence that is relevant for achieving the goals of population-level nutrition recommendations. Given the non-epistemic goals of the dietary recommendations, criteria of acceptable evidence should be adapted to the goals of the practice and the practical, ethical, and methodological constraints of the situation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Data Set for Pathology Reporting of Cutaneous Invasive Melanoma

PubMed Central

Judge, Meagan J.; Evans, Alan; Frishberg, David P.; Prieto, Victor G.; Thompson, John F.; Trotter, Martin J.; Walsh, Maureen Y.; Walsh, Noreen M.G.; Ellis, David W.

2013-01-01

An accurate and complete pathology report is critical for the optimal management of cutaneous melanoma patients. Protocols for the pathologic reporting of melanoma have been independently developed by the Royal College of Pathologists of Australasia (RCPA), Royal College of Pathologists (United Kingdom) (RCPath), and College of American Pathologists (CAP). In this study, data sets, checklists, and structured reporting protocols for pathologic examination and reporting of cutaneous melanoma were analyzed by an international panel of melanoma pathologists and clinicians with the aim of developing a common, internationally agreed upon, evidence-based data set. The International Collaboration on Cancer Reporting cutaneous melanoma expert review panel analyzed the existing RCPA, RCPath, and CAP data sets to develop a protocol containing “required” (mandatory/core) and “recommended” (nonmandatory/noncore) elements. Required elements were defined as those that had agreed evidentiary support at National Health and Medical Research Council level III-2 level of evidence or above and that were unanimously agreed upon by the review panel to be essential for the clinical management, staging, or assessment of the prognosis of melanoma or fundamental for pathologic diagnosis. Recommended elements were those considered to be clinically important and recommended for good practice but with lesser degrees of supportive evidence. Sixteen core/required data elements for cutaneous melanoma pathology reports were defined (with an additional 4 core/required elements for specimens received with lymph nodes). Eighteen additional data elements with a lesser level of evidentiary support were included in the recommended data set. Consensus response values (permitted responses) were formulated for each data item. Development and agreement of this evidence-based protocol at an international level was accomplished in a timely and efficient manner, and the processes described herein may facilitate the development of protocols for other tumor types. Widespread utilization of an internationally agreed upon, structured pathology data set for melanoma will lead not only to improved patient management but is a prerequisite for research and for international benchmarking in health care. PMID:24061524

28 CFR 8.5 - Custody.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., to the extent practicable, seized foreign currency and negotiable instruments) must be deposited... potential evidentiary significance of the currency is being determined by scientific testing or otherwise... necessary while the potential evidentiary significance of the currency is being determined by scientific...

28 CFR 8.5 - Custody.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., to the extent practicable, seized foreign currency and negotiable instruments) must be deposited... potential evidentiary significance of the currency is being determined by scientific testing or otherwise... necessary while the potential evidentiary significance of the currency is being determined by scientific...

The Effectiveness of an Online Curriculum on High School Students' Understanding of Biological Evolution

NASA Astrophysics Data System (ADS)

Marsteller, Robert B.; Bodzin, Alec M.

2015-12-01

An online curriculum about biological evolution was designed to promote increased student content knowledge and evidentiary reasoning. A feasibility study was conducted with 77 rural high school biology students who learned with the online biological evolution unit. Data sources included the Biological Evolution Assessment Measure (BEAM), an analysis of discussion forum posts, and a post-implementation perceptions and attitudes questionnaire. BEAM posttest scores were significantly higher than the pretest scores. However, the findings revealed that the students required additional support to develop evidentiary reasoning. Many students perceived that the Web-based curriculum would have been enhanced by increased immediate interaction and feedback. Students required greater scaffolding to support complex, process-oriented tasks. Implications for designing Web-based science instruction with curriculum materials to support students' acquisition of content knowledge and science process skills in a Web-based setting are discussed.

Evidence-based management of deep wound infection after spinal instrumentation.

PubMed

Lall, Rishi R; Wong, Albert P; Lall, Rohan R; Lawton, Cort D; Smith, Zachary A; Dahdaleh, Nader S

2015-02-01

In this study, evidence-based medicine is used to assess optimal surgical and medical management of patients with post-operative deep wound infection following spinal instrumentation. A computerized literature search of the PubMed database was performed. Twenty pertinent studies were identified. Studies were separated into publications addressing instrumentation retention versus removal and publications addressing antibiotic therapy regimen. The findings were classified based on level of evidence (I-III) and findings were summarized into evidentiary tables. No level I or II evidence was identified. With regards to surgical management, five studies support instrumentation retention in the setting of early deep infection. In contrast, for delayed infection, the evidence favors removal of instrumentation at the time of initial debridement. Surgeons should be aware that for deformity patients, even if solid fusion is observed, removal of instrumentation may be associated with significant loss of correction. A course of intravenous antibiotics followed by long-term oral suppressive therapy should be pursued if instrumentation is retained. A shorter treatment course may be appropriate if hardware is removed. Copyright © 2014 Elsevier Ltd. All rights reserved.

The School-Based Violence Prevention Planning Program: A Pilot Test

ERIC Educational Resources Information Center

Armstrong, Todd A.; Webb, Vincent

2006-01-01

Despite a growing research literature identifying evidence-based prevention strategies, schools often adopt programs lacking evidentiary support (Gottfredson and Gottfredson, 2002; Ringwalt et al., 2002). Further, when evidence-based programs are adopted they often suffer from poor implementation (Gottfredson and Gottfredson, 2002). This gap…

28 CFR 115.272 - Evidentiary standard for administrative investigations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Evidentiary standard for administrative investigations. 115.272 Section 115.272 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Community Confinement Facilities Investigations § 115.272...

28 CFR 115.272 - Evidentiary standard for administrative investigations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Evidentiary standard for administrative investigations. 115.272 Section 115.272 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Community Confinement Facilities Investigations § 115.272...

28 CFR 115.272 - Evidentiary standard for administrative investigations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Evidentiary standard for administrative investigations. 115.272 Section 115.272 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Community Confinement Facilities Investigations § 115.272...

42 CFR 431.153 - Evidentiary hearing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Evidentiary hearing. 431.153 Section 431.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Appeals Process for NFs and ICFs...

42 CFR 431.153 - Evidentiary hearing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Evidentiary hearing. 431.153 Section 431.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Appeals Process for NFs and ICFs...

42 CFR 431.153 - Evidentiary hearing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Evidentiary hearing. 431.153 Section 431.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Appeals Process for NFs and ICFs...

42 CFR 431.153 - Evidentiary hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Evidentiary hearing. 431.153 Section 431.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Appeals Process for NFs and ICFs...

42 CFR 431.153 - Evidentiary hearing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Evidentiary hearing. 431.153 Section 431.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Appeals Process for NFs and ICFs...

14 CFR 302.214 - Oral evidentiary hearing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Oral evidentiary hearing. 302.214 Section 302.214 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION... administrative law judge. The issues will be those set forth in the order establishing further procedures. The...

40 CFR 78.3 - Petition for administrative review and request for evidentiary hearing.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Petition for administrative review and request for evidentiary hearing. 78.3 Section 78.3 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPEAL PROCEDURES § 78.3 Petition for administrative review...

24 CFR 941.610 - Evidentiary materials and other documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... with respect to the implementation of the proposal, including all rights and liabilities (financial and... development and operation of the development. The allocation of expenses and risks shall be based upon a ratio... proposed public housing units. Such payments, exemption and services must be based upon a ratio reflecting...

24 CFR 941.610 - Evidentiary materials and other documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... with respect to the implementation of the proposal, including all rights and liabilities (financial and... development and operation of the development. The allocation of expenses and risks shall be based upon a ratio... proposed public housing units. Such payments, exemption and services must be based upon a ratio reflecting...

24 CFR 941.610 - Evidentiary materials and other documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... with respect to the implementation of the proposal, including all rights and liabilities (financial and... development and operation of the development. The allocation of expenses and risks shall be based upon a ratio... proposed public housing units. Such payments, exemption and services must be based upon a ratio reflecting...

Building the Evidentiary Argument in Game-Based Assessment

ERIC Educational Resources Information Center

DiCerbo, Kristen E.

2017-01-01

While game-based assessment offers new potential for understanding the processes students use to solve problems, it also presents new challenges in uncovering which player actions provide evidence that contributes to understanding about students' knowledge, skill, and attributes that we are interested in assessing. A development process that…

33 CFR 148.228 - What if a formal evidentiary hearing is necessary?

Code of Federal Regulations, 2011 CFR

2011-07-01

... § 148.222 of this part are concluded, the Commandant (G-PSO), in coordination with the MARAD... resolved by a formal evidentiary hearing. (b) If the Commandant (G-PSO), in coordination with the MARAD...) The Commandant (G-PSO) files a request for assignment of an administrative law judge (ALJ) with the...

33 CFR 148.228 - What if a formal evidentiary hearing is necessary?

Code of Federal Regulations, 2010 CFR

2010-07-01

... § 148.222 of this part are concluded, the Commandant (G-PSO), in coordination with the MARAD... resolved by a formal evidentiary hearing. (b) If the Commandant (G-PSO), in coordination with the MARAD...) The Commandant (G-PSO) files a request for assignment of an administrative law judge (ALJ) with the...

Antioxidant and Associated Capacities of Camu Camu (Myrciaria dubia): A Systematic Review

PubMed Central

Langley, Paul C.; Pergolizzi, Joseph V.; Taylor, Robert

2015-01-01

Abstract An aging population in the United States presents important challenges for patients and physicians. The presence of inflammation can contribute to an accelerated aging process, the increasing presence of comorbidities, oxidative stress, and an increased prevalence of chronic pain. As patient-centered care is embracing a multimodal, integrative approach to the management of disease, patients and physicians are increasingly looking to the potential contribution of natural products. Camu camu, a well-researched and innovative natural product, has the potential to contribute, possibly substantially, to this management paradigm. The key issue is to raise camu camu's visibility through increased emphasis on its robust evidentiary base and its various formulations, as well as making consumers, patients, and physicians more aware of its potential. A program to increase the visibility of camu camu can contribute substantially not only to the management of inflammatory conditions and its positive contribution to overall good health but also to its potential role in many disease states. PMID:25275221

Antioxidant and associated capacities of Camu camu (Myrciaria dubia): a systematic review.

PubMed

Langley, Paul C; Pergolizzi, Joseph V; Taylor, Robert; Ridgway, Caroline

2015-01-01

An aging population in the United States presents important challenges for patients and physicians. The presence of inflammation can contribute to an accelerated aging process, the increasing presence of comorbidities, oxidative stress, and an increased prevalence of chronic pain. As patient-centered care is embracing a multimodal, integrative approach to the management of disease, patients and physicians are increasingly looking to the potential contribution of natural products. Camu camu, a well-researched and innovative natural product, has the potential to contribute, possibly substantially, to this management paradigm. The key issue is to raise camu camu's visibility through increased emphasis on its robust evidentiary base and its various formulations, as well as making consumers, patients, and physicians more aware of its potential. A program to increase the visibility of camu camu can contribute substantially not only to the management of inflammatory conditions and its positive contribution to overall good health but also to its potential role in many disease states.

40 CFR 178.27 - Form and manner of submission of request for evidentiary hearing.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Form and manner of submission of... Objections and Requests for Hearing § 178.27 Form and manner of submission of request for evidentiary hearing... hearing. (e) Include a discussion of the relationship between the factual issues and the relief requested...

40 CFR 178.27 - Form and manner of submission of request for evidentiary hearing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Form and manner of submission of... Objections and Requests for Hearing § 178.27 Form and manner of submission of request for evidentiary hearing... hearing. (e) Include a discussion of the relationship between the factual issues and the relief requested...

40 CFR 178.27 - Form and manner of submission of request for evidentiary hearing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Form and manner of submission of... Objections and Requests for Hearing § 178.27 Form and manner of submission of request for evidentiary hearing... hearing. (e) Include a discussion of the relationship between the factual issues and the relief requested...

40 CFR 178.27 - Form and manner of submission of request for evidentiary hearing.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Form and manner of submission of... Objections and Requests for Hearing § 178.27 Form and manner of submission of request for evidentiary hearing... hearing. (e) Include a discussion of the relationship between the factual issues and the relief requested...

21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and... action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right...) on regulations for animal antibiotic drugs and certification requirements. (13) Section 721 (b) and...

21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and... action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right...) on regulations for animal antibiotic drugs and certification requirements. (13) Section 721 (b) and...

21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and... action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right...) on regulations for animal antibiotic drugs and certification requirements. (13) Section 721 (b) and...

21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and... action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right...) on regulations for animal antibiotic drugs and certification requirements. (13) Section 721 (b) and...

21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and... action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right...) on regulations for animal antibiotic drugs and certification requirements. (13) Section 721 (b) and...

Evaluating the Diagnostic Validity of the Facet-Based Formative Assessment System

ERIC Educational Resources Information Center

DeBarger, Angela H.; DiBello, Louis; Minstrell, Jim; Stout, William; Pellegrino, James; Haertel, Geneva; Feng, Mingyu

2011-01-01

The research design and team constitute a multidisciplinary attack on problems of educational and assessment design in physics instruction. Components of the research include: (a) an Evidence-Centered Design analysis of Diagnoser instructional materials and assessments that provides a view of the evidentiary coherence of the existing system; (b)…

Development of Standardized Clinical Training Cases for Diagnosis of Sexual Abuse using a Secure Telehealth Application

ERIC Educational Resources Information Center

Frasier, Lori D.; Thraen, Ioana; Kaplan, Rich; Goede, Patricia

2012-01-01

Objectives: The training of physicians, nurse examiners, social workers and other health professional on the evidentiary findings of sexual abuse in children is challenging. Our objective was to develop peer reviewed training cases for medical examiners of child sexual abuse, using a secure web based telehealth application (TeleCAM). Methods:…

Providing Cryptographic Security and Evidentiary Chain-of-Custody with the Advanced Forensic Format, Library, and Tools

DTIC Science & Technology

2008-08-19

1 hash of the page page%d sha256 The segment for the SHA256 hash of the page Bad Sector Management: badsectors The number of sectors in the image...written, AFFLIB can automatically compute the page’s MD5, SHA-1, and/or SHA256 hash and write an associated segment containing the hash value. The...are written into segments themselves, with the segment name being name/ sha256 where name is the original segment name sha256 is the hash algorithm used

Psychology's Lost Boy: Will the Real Little Albert Please Stand Up?

ERIC Educational Resources Information Center

Griggs, Richard A.

2015-01-01

This article is concerned with the recent debate about the identity of psychology's lost boy-Little Albert, the infant subject in Watson and Rayner's classic experiment on fear conditioning. For decades, psychologists and psychology students have been intrigued by the mystery of Albert's fate. Now two evidentiary-based solutions to…

Comparison of cervical os versus vaginal evidentiary findings during sexual assault exam.

PubMed

Morgan, Jean A

2008-04-01

Evidence collection post sexual assault varies across the nation. The Ohio Department of Health has a standardized kit for evidence collection used during the forensic exams of sexual assault survivors. The protocol includes obtaining 4 swabs: 2 from the vaginal pooled fluid and 2 from the cervical area. The purpose is to determine if augmenting the state protocol with cervical os swabs and a comparison slide will improve evidentiary findings in adolescent and adult female rape survivors. A descriptive study of 30 months for sexual assault female survivors over the age of 13 treated at a level II emergency department by a trained sexual assault nurse examiner (SANE). The comparisons of cervical os specimens versus vaginal pool findings were analyzed by the Canton-Stark County Crime Laboratory (C-SCCL). Eighty-six cases were completed. After investigation, local law enforcement officials turned in 36 kits (42%) to be processed at the C-SCCL for the standard vaginal pool swabs and slide. The average estimated time interval between assault and treatment time was 20.46 hours (range, 2.83 to 80.83 hours). The average age of the survivor was 23.7 years, (range, 15 to 48). Eight percent (3/36) had only cervical os semen evidentiary findings. Forty-four percent (16/36) had positive semen evidentiary findings in vaginal pool and cervical os. Successful convictions were aided by the cervical os research study, especially because vaginal pool evidence diminishes when collected after 24 hours, but may be present longer in the cervical os.

Some evidentiary considerations for physician billing.

PubMed

Rooks, Franklin J

2011-01-01

In a criminal prosecution for medical billing fraud alleging up-coding and overbilling, the government's evidence may encompass the practice's entire billings and draw inferences from them. In addition, fraud may be demonstrated through statistical analysis comparing a physician's billings relative to other providers of the same specialty. The Federal Rules of Evidence govern the admissibility of evidence during a trial, to provide fairness for both the prosecution and the defense. Physicians and practice managers should be well versed in the billing requirements and particularly careful when CPT codes are expressed in terms of "required times" as opposed to "typical times."

Chain of custody; recommendations for acceptance and analysis of evidentiary geochemical samples

USGS Publications Warehouse

Murphy, Christine M.; Briggs, Paul H.; Adrian, Betty M.; Wilson, Steve A.; Hageman, Phil L.; Theodorakos, Pete M.

1997-01-01

Personnel from the Analytical Chemistry Services Group (ACSG), Mineral Resource Survey Program, formed a team to determine the policies for acceptance and analysis of geochemical samples. This team contacted law enforcement agencies that handle litigious samples, laboratories that work with samples of special nature, and the Solicitor General, Department of the Interior. Using the knowledge from these agencies as well as the expertise of ACSG personnel, sample control routine procedures, sample control evidentiary procedures, personnel policy governing chain-of-custody samples, and the general polices governing physical security of chain-of custody samples have been enacted.

Little Albert's alleged neurological impairment: Watson, Rayner, and historical revision.

PubMed

Digdon, Nancy; Powell, Russell A; Harris, Ben

2014-11-01

In 2012, Fridlund, Beck, Goldie, and Irons (2012) announced that "Little Albert"-the infant that Watson and Rayner used in their 1920 study of conditioned fear (Watson & Rayner, 1920)-was not the healthy child the researchers described him to be, but was neurologically impaired almost from birth. Fridlund et al. also alleged that Watson had committed serious ethical breaches in regard to this research. Our article reexamines the evidentiary bases for these claims and arrives at an alternative interpretation of Albert as a normal infant. In order to set the stage for our interpretation, we first briefly describe the historical context for the Albert study, as well as how the study has been construed and revised since 1920. We then discuss the evidentiary issues in some detail, focusing on Fridlund et al.'s analysis of the film footage of Albert, and on the context within which Watson and Rayner conducted their study. In closing, we return to historical matters to speculate about why historiographical disputes matter and what the story of neurologically impaired Albert might be telling us about the discipline of psychology today.

Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

PubMed

Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

2018-06-01

To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Abandonment and reconciliation: addressing political and common law objections to fetal homicide laws.

PubMed

Curran, Douglas S

2009-03-01

Fetal homicide laws criminalize killing a fetus largely to the same extent as killing any other human being. Historically, the common law did not generally recognize feticide as a crime, but this was because of the evidentiary "born-alive" rule, not because of the substantive understanding of the term "human being." As medicine and science have advanced, states have become increasingly willing to abandon this evidentiary rule and to criminalize feticide as homicide. Although most states have recognized the crime of fetal homicide, fourteen have not. This is largely the result of two independent obstacles: (judicial) adherence to the born-alive rule and (legislative) concern that fetal homicide laws could erode constitutionally protected reproductive rights. This Note explores a variety of fetal homicide laws that states have adopted, demonstrating that popular opinion has shifted toward recognizing this crime. It then directly confronts the objections that have prevented other states from adopting such laws: it first reviews the literature suggesting that the born-alive rule should be abandoned, as it is an obsolete evidentiary standard; it then argues that constitutionally protected reproductive liberties can be reconciled with, and in fact augmented by, punishing the killing of a fetus as a homicide.

Heterodoxy, iconoclasm and spuriousness: the limits of novel expert evidence.

PubMed

Freckelton, Ian

2007-12-01

A difficult issue arises for courts' decision-making at common law and under statutory evidentiary regimes when expert opinions are significantly unorthodox, iconoclastic or methodologically flawed. This editorial analyses the relevant evidentiary principles and the Australian jurisprudence on the subject, giving particular attention to the decisions of the South Australian Supreme Court in R v Parenzee [2007] SASC 143 and R v Parenzee [2007] SASC 316 in which expert opinions about the existence, identifiability and transmissibility of HIV and its relationship to AIDS adduced on behalf of the defence in a criminal trial were found to be seriously wanting. A variety of factors indicative of low probative value in expert opinions are distilled.

Evaluation and Management of Female Victims of Sexual Assault.

PubMed

Vrees, Roxanne A

2017-01-01

Sexual assault is characterized by any sexual contact or behavior that occurs without explicit consent. Classifications vary based on the status of the perpetrator's relationship to the victim (eg, stranger, acquaintance) and characteristics of the victim herself (eg, child, elder adult, mentally disabled adult). Regardless of the classification, sexual assault is a significant individual as well as public health issue affecting women of all ages. While the majority of sexual assault cases are not initially reported to law enforcement, the best available data suggest the lifetime prevalence of sexual assault in the United States is approximately 20% among adult women. With such a significant proportion of women affected by sexual assault, women's health care providers in both ambulatory and emergency care settings play key roles in the evaluation, management, and advocacy of these victims. Establishing standard protocols based on state laws and on victim-centered practices to avoid revictimization of the patient is critical. The primary goals of care include the assessment and treatment of physical injuries, psychological assessment and support, pregnancy assessment and prevention, and therapy for prevention of sexually transmitted infections. In addition, evidentiary collection is a critical component of the sexual assault evaluation and subsequent legal proceedings. This report focuses specifically on the immediate evaluation and management of adult female victims of sexual assault. Best practices include the utility of the Sexual Assault Nurse Examiner and Sexual Assault Forensic Examiner programs, as well as standardized treatment protocols.

Feeding management practices and feed characteristics associated with Salmonella prevalence in live and slaughtered market-weight finisher swine: a systematic review and summation of evidence from 1950 to 2005.

PubMed

O'Connor, A M; Denagamage, T; Sargeant, J M; Rajić, A; McKean, J

2008-11-17

This review summarizes evidence for associations between Salmonella prevalence in market-weight swine and changes in feeding management practices or feed characteristics. A systematic review of the topic was conducted with the goal of minimizing the impact of bias on the review conclusions. Potential interventions included feed withdrawal from swine prior to slaughter, feed acidification, heat treatment of feed, pelletized feed versus mash, course versus fine grind, and wet versus dry feeds. In the reviewed literature, Salmonella prevalence was measured either by culture or by the presence of antibodies to Salmonella. The evidentiary value of studies was assessed, and studies that failed to meet predetermined standards were excluded. 7694 potentially relevant references were identified by an extensive literature search; however, 2623 references that were not published in English were excluded, because funds for translation were not available. Of the remaining references, only 277 were considered relevant to the review topic by two independent reviewers, and assessed for methodological quality. During quality assessment, 233 references were excluded because they failed to report design features that limit the introduction of bias or were conducted in a non-target population such as gnotobiotic, neonatal, nursery, or recently weaned pigs and sows. Forty-four publications passed the quality assessment conducted by 2 independent reviewers, but only 15 of the 44 publications reported studies that tested hypotheses associated with feeding management practices and feed characteristics and Salmonella prevalence in market-weight swine. The most common study design was cross-sectional (7/15). The included studies failed to provide strong evidence of an association between any of the potential interventions and Salmonella prevalence, due to the potential for confounding, and the failure to document temporal association between the intervention and Salmonella prevalence. The strongest evidence of an association was found for feed form, i.e. the use of non-pelleted may be potential interventions associated with reduced Salmonella prevalence. The uncertainty is primarily based on studies containing moderate to low evidentiary value or insufficient numbers of tested individuals, resulting in a low degree of confidence that results could be extrapolated to the target population. Therefore, the conclusion of the review is that there should be a low level of comfort among qualified scientists that the claimed association between non-pelleted feed and reduced Salmonella prevalence is scientifically valid. There is no strong evidence regarding associations between presence of Salmonella and the other feed characteristics examined.

EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.

PubMed

Levin, Leslie

2015-01-01

With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.

Commission decision on the Department of Water Resources' Application for Certification for the Bottle Rock Geothermal Project

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

Not Available

1980-11-01

The Application for Certification for the construction of a 55 MW geothermal power plant and related facilities in Lake County was approved subject to terms identified in the Final Decision. The following are covered: findings on compliance with statutory site-certification requirements; final environmental impact report; procedural steps; evidentiary bases; need, environmental resources; public health and safety; plant and site safety and reliability; socioeconomic, land use, and cultural concerns, and transmission tap line. (MHR)

Evidence-based decision-making within the context of globalization: A “Why–What–How” for leaders and managers of health care organizations

PubMed Central

Lapaige, Véronique

2009-01-01

In the globalized knowledge economy, the challenge of translating knowledge into policy and practice is universal. At the dawn of the 21st century, the clinicians, leaders, and managers of health care organizations are increasingly required to bridge the research-practice gap. A shift from moving evidence to solving problems is due. However, despite a vast literature on the burgeoning field of knowledge translation research, the “evidence-based” issue remains for many health care professionals a day-to-day debate leading to unresolved questions. On one hand, many clinicians still resist to the implementation of evidence-based clinical practice, asking themselves why their current practice should be changed or expanded. On the other hand, many leaders and managers of health care organizations are searching how to keep pace with the demand of actionable knowledge. For example, they are wondering: (a) if managerial and policy innovations are subjected to the same evidentiary standards as clinical innovations, and (b) how they can adapt the scope of evidence-based medicine to the culture, context, and content of health policy and management. This paper focuses on evidence-based health care management within the context of contemporary globalization. In this paper, our heuristic hypothesis is that decision-making process related changes within clinical/managerial/policy environments must be given a socio-historical backdrop. We argue that the relationship between research on the transfer of knowledge and its uptake by clinical, managerial and policy target audiences has undergone a shift, resulting in increasing pressures in health care for intense researcher-practitioner collaboration and the development of “integrative KT platforms” at the crossroads of different fields (the field of knowledge management and the field of knowledge translation). The objectives of this paper are: (a) to provide an answer to the questions that health professionals ask most frequently about “Why” and “How” to bridge the know-do gap, (b) to illustrate by a Canadian example how the PRO-ACTIVE program helps in closing the evidence-based practice gap. PMID:22312206

Text image authenticating algorithm based on MD5-hash function and Henon map

NASA Astrophysics Data System (ADS)

Wei, Jinqiao; Wang, Ying; Ma, Xiaoxue

2017-07-01

In order to cater to the evidentiary requirements of the text image, this paper proposes a fragile watermarking algorithm based on Hash function and Henon map. The algorithm is to divide a text image into parts, get flippable pixels and nonflippable pixels of every lump according to PSD, generate watermark of non-flippable pixels with MD5-Hash, encrypt watermark with Henon map and select embedded blocks. The simulation results show that the algorithm with a good ability in tampering localization can be used to authenticate and forensics the authenticity and integrity of text images

38 CFR 3.303 - Principles relating to service connection.

Code of Federal Regulations, 2010 CFR

2010-07-01

... permit service connection of arthritis, disease of the heart, nephritis, or pulmonary disease, first..., tuberculosis, multiple sclerosis, etc.), there is no requirement of evidentiary showing of continuity...

24 CFR 26.47 - Evidence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... this part, the Federal Rules of Evidence shall provide guidance to the ALJ's evidentiary ruling, but shall not be binding. Parties may object to clearly irrelevant material, but technical and hearsay...

Convergent evolution as natural experiment: the tape of life reconsidered

PubMed Central

Powell, Russell; Mariscal, Carlos

2015-01-01

Stephen Jay Gould argued that replaying the ‘tape of life’ would result in radically different evolutionary outcomes. Recently, biologists and philosophers of science have paid increasing attention to the theoretical importance of convergent evolution—the independent origination of similar biological forms and functions—which many interpret as evidence against Gould's thesis. In this paper, we examine the evidentiary relevance of convergent evolution for the radical contingency debate. We show that under the right conditions, episodes of convergent evolution can constitute valid natural experiments that support inferences regarding the deep counterfactual stability of macroevolutionary outcomes. However, we argue that proponents of convergence have problematically lumped causally heterogeneous phenomena into a single evidentiary basket, in effect treating all convergent events as if they are of equivalent theoretical import. As a result, the ‘critique from convergent evolution’ fails to engage with key claims of the radical contingency thesis. To remedy this, we develop ways to break down the heterogeneous set of convergent events based on the nature of the generalizations they support. Adopting this more nuanced approach to convergent evolution allows us to differentiate iterated evolutionary outcomes that are probably common among alternative evolutionary histories and subject to law-like generalizations, from those that do little to undermine and may even support, the Gouldian view of life. PMID:26640647

Convergent evolution as natural experiment: the tape of life reconsidered.

PubMed

Powell, Russell; Mariscal, Carlos

2015-12-06

Stephen Jay Gould argued that replaying the 'tape of life' would result in radically different evolutionary outcomes. Recently, biologists and philosophers of science have paid increasing attention to the theoretical importance of convergent evolution-the independent origination of similar biological forms and functions-which many interpret as evidence against Gould's thesis. In this paper, we examine the evidentiary relevance of convergent evolution for the radical contingency debate. We show that under the right conditions, episodes of convergent evolution can constitute valid natural experiments that support inferences regarding the deep counterfactual stability of macroevolutionary outcomes. However, we argue that proponents of convergence have problematically lumped causally heterogeneous phenomena into a single evidentiary basket, in effect treating all convergent events as if they are of equivalent theoretical import. As a result, the 'critique from convergent evolution' fails to engage with key claims of the radical contingency thesis. To remedy this, we develop ways to break down the heterogeneous set of convergent events based on the nature of the generalizations they support. Adopting this more nuanced approach to convergent evolution allows us to differentiate iterated evolutionary outcomes that are probably common among alternative evolutionary histories and subject to law-like generalizations, from those that do little to undermine and may even support, the Gouldian view of life.

Evidentiary, extraevidentiary, and deliberation process predictors of real jury verdicts.

PubMed

Devine, Dennis J; Krouse, Paige C; Cavanaugh, Caitlin M; Basora, Jaime Colon

2016-12-01

In contrast to the extensive literature based on mock jurors, large-sample studies of decision making by real juries are relatively rare. In this field study, we examined relationships between jury verdicts and variables representing 3 classes of potential determinants-evidentiary, extraevidentiary, and deliberation process-using a sample of 114 criminal jury trials. Posttrial data were collected from 11 presiding judges, 31 attorneys, and 367 jurors using a Web-based questionnaire. The strength of the prosecution's evidence was strongly related to the occurrence of a conviction, whereas most extraevidentiary and deliberation process variables were only weakly to modestly related in bivariate form and when the prosecution's evidence strength was controlled. Notable exceptions to this pattern were jury demographic diversity as represented by the number of different race-gender subgroups (e.g., Black males) present in the jury, and several deliberation process variables reflecting advocacy for acquittal (e.g., presence of an identifiable proacquittal faction within the jury and proacquittal advocacy by the foreperson). Variables reflecting advocacy for conviction were essentially unrelated to jury verdict. Sets of extraevidentiary and deliberation variables were each able to modestly improve the explanation of jury verdicts over prosecution evidence strength in multivariate models. This study highlights the predictive efficacy of prosecution evidence strength with respect to jury verdicts, as well as the potential importance of jury demographic diversity and advocacy for acquittal during deliberation. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

PAYER PERSPECTIVES ON FUTURE ACCEPTABILITY OF COMPARATIVE EFFECTIVENESS AND RELATIVE EFFECTIVENESS RESEARCH.

PubMed

Moloney, Rachael; Mohr, Penny; Hawe, Emma; Shah, Koonal; Garau, Martina; Towse, Adrian

2015-01-01

Our objective was to gather perspectives from payers on how comparative effectiveness research (CER) in the United States and relative effectiveness (RE) research in Europe will impact evidentiary standards for access decisions of new drugs by 2020. We conducted semi-structured interviews with fourteen senior officials representing public and private payers, health technology assessment groups, and pricing and reimbursement bodies in the United States and Europe. An online survey assessed current use of CER/RE evidence and potential trends that might influence its use for decision making by 2020. A semi-structured interview elicited payers' definitions of CER/RE and was structured around four hypothetical cases resembling drugs expected to be more common or poised to create policy challenges by 2020. Topics included acceptance of study designs and analytic methods associated with CER/RE. A systematic content review was done to extract relevant information. According to key informants, randomization will remain an essential component for assessing comparative or relative effectiveness. They anticipate greater use of policy levers such as conditional reimbursement or prior authorization to manage diffusion of new drugs. Case studies provided important insights into situations when certain types of CER evidence may be acceptable (e.g., observational data when differences between drugs are largely convenience). Industry perceptions that CER/RE will change payers' evidentiary requirements in the future are consistent with our findings. Growing investment in payers' own data and increased reliance on policy tools to control diffusion of new drugs may also influence the type of evidence industry will be required to produce by 2020.

Direct PCR amplification of forensic touch and other challenging DNA samples: A review.

PubMed

Cavanaugh, Sarah E; Bathrick, Abigail S

2018-01-01

DNA evidence sample processing typically involves DNA extraction, quantification, and STR amplification; however, DNA loss can occur at both the DNA extraction and quantification steps, which is not ideal for forensic evidence containing low levels of DNA. Direct PCR amplification of forensic unknown samples has been suggested as a means to circumvent extraction and quantification, thereby retaining the DNA typically lost during those procedures. Direct PCR amplification is a method in which a sample is added directly to an amplification reaction without being subjected to prior DNA extraction, purification, or quantification. It allows for maximum quantities of DNA to be targeted, minimizes opportunities for error and contamination, and reduces the time and monetary resources required to process samples, although data analysis may take longer as the increased DNA detection sensitivity of direct PCR may lead to more instances of complex mixtures. ISO 17025 accredited laboratories have successfully implemented direct PCR for limited purposes (e.g., high-throughput databanking analysis), and recent studies indicate that direct PCR can be an effective method for processing low-yield evidence samples. Despite its benefits, direct PCR has yet to be widely implemented across laboratories for the processing of evidentiary items. While forensic DNA laboratories are always interested in new methods that will maximize the quantity and quality of genetic information obtained from evidentiary items, there is often a lag between the advent of useful methodologies and their integration into laboratories. Delayed implementation of direct PCR of evidentiary items can be attributed to a variety of factors, including regulatory guidelines that prevent laboratories from omitting the quantification step when processing forensic unknown samples, as is the case in the United States, and, more broadly, a reluctance to validate a technique that is not widely used for evidence samples. The advantages of direct PCR of forensic evidentiary samples justify a re-examination of the factors that have delayed widespread implementation of this method and of the evidence supporting its use. In this review, the current and potential future uses of direct PCR in forensic DNA laboratories are summarized. Copyright © 2017 Elsevier B.V. All rights reserved.

7 CFR 3022.10 - Reporting to USDA.

Code of Federal Regulations, 2013 CFR

2013-01-01

... MISCONDUCT § 3022.10 Reporting to USDA. Following completion of an investigation into allegations of research misconduct, the institution conducting extramural research must provide to the ARIO a copy of the evidentiary...

Establishing CASA as an evidence-based practice.

PubMed

Lawson, Jennifer; Berrick, Jill Duerr

2013-01-01

In this article the authors examine the evidentiary status of the Court Appointed Special Advocates (CASA) program through a review of current research findings and a critical analysis of the study methodologies used to produce those findings. Due to the equivocal research findings and widespread methodological weaknesses (most notably selection bias) in the literature base, it is determined that there is not currently enough evidence to establish CASA as an evidence-based practice. In spite of the challenges to the feasibility of such research, a future research agenda is suggested that calls for the execution of large randomized controlled trials in order to produce findings that will inform a deeper understanding of CASA effectiveness in improving child outcomes.

47 CFR 0.151 - Functions of the Office.

Code of Federal Regulations, 2014 CFR

2014-10-01

... all adjudicatory cases designated for any evidentiary adjudicatory hearing other than those designated to be heard by the Commission en banc, those designated to be heard by one or more members of the...

47 CFR 0.151 - Functions of the Office.

Code of Federal Regulations, 2013 CFR

2013-10-01

... all adjudicatory cases designated for any evidentiary adjudicatory hearing other than those designated to be heard by the Commission en banc, those designated to be heard by one or more members of the...

47 CFR 0.151 - Functions of the Office.

Code of Federal Regulations, 2011 CFR

2011-10-01

... all adjudicatory cases designated for any evidentiary adjudicatory hearing other than those designated to be heard by the Commission en banc, those designated to be heard by one or more members of the...

47 CFR 0.151 - Functions of the Office.

Code of Federal Regulations, 2012 CFR

2012-10-01

... all adjudicatory cases designated for any evidentiary adjudicatory hearing other than those designated to be heard by the Commission en banc, those designated to be heard by one or more members of the...

Chemical warfare in Colombia, evidentiary ecologies and senti-actuando practices of justice.

PubMed

Lyons, Kristina

2018-03-01

Between 1994 and 2015, militarized aerial fumigation was a central component of US-Colombia antidrug policy. Crop duster planes sprayed a concentrated formula of Monsanto's herbicide, glyphosate, over illicit crops, and also forests, soils, pastures, livestock, watersheds, subsistence food and human bodies. Given that a national peace agreement was signed in 2016 between FARC-EP guerrillas and the state to end Colombia's over five decades of war, certain government officials are quick to proclaim aerial fumigation of glyphosate an issue of the past. Rural communities, however, file quejas (complaints or grievances) seeking compensation from the state for the ongoing effects of the destruction of their licit agro-forestry. At the interfaces of feminist science and technology studies and anthropology, this article examines how evidentiary claims are mobilized when war deeply politicizes and moralizes technoscientific knowledge production. By ethnographically tracking the grievances filed by small farmers, I reveal the extent to which evidence circulating in zones of war - tree seedlings, subsistence crops, GPS coordinates and bureaucratic documents - retains (or not) the imprints of violence and toxicity. Given the systematic rejection of compensation claims, farmers engage in everyday material practices that attempt to transform chemically degraded ecologies. These everyday actualizations of justice exist both alongside and outside contestation over the geopolitically backed violence of state law. Rather than simply contrasting everyday acts of justice with denunciatory claims made against the state, farmers' reparative practices produce an evidentiary ecology that holds the state accountable while also ' senti-actuando' (feel-acting) alternative forms of justice.

Parent use of cannabis for intractable pediatric epilepsy: Everyday empiricism and the boundaries of scientific medicine.

PubMed

Sobo, Elisa J

2017-10-01

Cannabis is an increasingly sought-after remedy for US children with intractable (biomedically uncontrollable) epilepsy. However, like other complementary-alternative medicine (CAM) modalities, and particularly as a federally illegal, stigmatized substance, it is unsanctioned by mainstream medicine. Parents are largely on their own when it comes to learning about, procuring, dispensing, and monitoring treatments. Exploring how they manage is crucial to better assist them. Moreover, it can illuminate how 'research' done on the ground by laypeople variously disrupts and reinforces lay-expert and science-non-science divides. To those ends, in 2016, 25 Southern California parents who used, had used, or sought to use cannabis pediatrically for epilepsy/seizures were interviewed regarding their evidentiary standards, research methods, and aims when trying the drug. Parents generally described their work as experimentation; they saw their efforts as adhering to authorized scientific practices and standards, and as contributing to the authorized medical cannabis knowledge base. Findings subverted assumptions, based on an outdated stereotype of CAM, that cannabis-using parents do not believe in biomedicine. Indeed, parents' desire for their children's biomedical demarginalization, combined with biomedical dependency and a high caregiver burden, fueled a collaborative stance. Implications for understanding the boundaries of science are explored, as are norms for parent agency as ill children's care managers, radicalization among people affected by contested illnesses, and the future of 'medical marijuana.' Copyright © 2017 Elsevier Ltd. All rights reserved.

40 CFR 179.95 - Admission or exclusion of evidence; objections; offers of proof.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 179.95 Admission or... briefly the grounds for such objection. The transcript shall include any argument or debate thereon...

40 CFR 179.95 - Admission or exclusion of evidence; objections; offers of proof.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 179.95 Admission or... briefly the grounds for such objection. The transcript shall include any argument or debate thereon...

Preoperative identification of a suspicious adnexal mass: a systematic review and meta-analysis.

PubMed

Dodge, Jason E; Covens, Allan L; Lacchetti, Christina; Elit, Laurie M; Le, Tien; Devries-Aboud, Michaela; Fung-Kee-Fung, Michael

2012-07-01

To systematically review the existing literature in order to determine the optimal strategy for preoperative identification of the adnexal mass suspicious for ovarian cancer. A review of all systematic reviews and guidelines published between 1999 and 2009 was conducted as a first step. After the identification of a 2004 AHRQ systematic review on the topic, searches of MEDLINE for studies published since 2004 was also conducted to update and supplement the evidentiary base. A bivariate, random-effects meta-regression model was used to produce summary estimates of sensitivity and specificity and to plot summary ROC curves with 95% confidence regions. Four meta-analyses and 53 primary studies were included in this review. The diagnostic performance of each technology was compared and contrasted based on the summary data on sensitivity and specificity obtained from the meta-analysis. Results suggest that 3D ultrasonography has both a higher sensitivity and specificity when compared to 2D ultrasound. Established morphological scoring systems also performed with respectable sensitivity and specificity, each with equivalent diagnostic competence. Explicit scoring systems did not perform as well as other diagnostic testing methods. Assessment of an adnexal mass by colour Doppler technology was neither as sensitive nor as specific as simple ultrasonography. Of the three imaging modalities considered, MRI appeared to perform the best, although results were not statistically different from CT. PET did not perform as well as either MRI or CT. The measurement of the CA-125 tumour marker appears to be less reliable than do other available assessment methods. The best available evidence was collected and included in this rigorous systematic review and meta-analysis. The abundant evidentiary base provided the context and direction for the diagnosis of early-staged ovarian cancer. Copyright © 2012 Elsevier Inc. All rights reserved.

Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 3: Endoscopic computer-assisted electromagnetic navigation and ultrasonography as technical adjuvants for shunt placement.

PubMed

Flannery, Ann Marie; Duhaime, Ann-Christine; Tamber, Mandeep S; Kemp, Joanna

2014-11-01

This systematic review was undertaken to answer the following question: Do technical adjuvants such as ventricular endoscopic placement, computer-assisted electromagnetic guidance, or ultrasound guidance improve ventricular shunt function and survival? The US National Library of Medicine PubMed/MEDLINE database and the Cochrane Database of Systematic Reviews were queried using MeSH headings and key words specifically chosen to identify published articles detailing the use of cerebrospinal fluid shunts for the treatment of pediatric hydrocephalus. Articles meeting specific criteria that had been delineated a priori were then examined, and data were abstracted and compiled in evidentiary tables. These data were then analyzed by the Pediatric Hydrocephalus Systematic Review and Evidence-Based Guidelines Task Force to consider evidence-based treatment recommendations. The search yielded 163 abstracts, which were screened for potential relevance to the application of technical adjuvants in shunt placement. Fourteen articles were selected for full-text review. One additional article was selected during a review of literature citations. Eight of these articles were included in the final recommendations concerning the use of endoscopy, ultrasonography, and electromagnetic image guidance during shunt placement, whereas the remaining articles were excluded due to poor evidence or lack of relevance. The evidence included 1 Class I, 1 Class II, and 6 Class III papers. An evidentiary table of relevant articles was created. CONCLUSIONS/RECOMMENDATION: There is insufficient evidence to recommend the use of endoscopic guidance for routine ventricular catheter placement. Level I, high degree of clinical certainty. The routine use of ultrasound-assisted catheter placement is an option. Level III, unclear clinical certainty. The routine use of computer-assisted electromagnetic (EM) navigation is an option. Level III, unclear clinical certainty.

No More Tulias: Drug Law Enforcement Evidentiary Standards Improvement Act of 2013

THOMAS, 113th Congress

Rep. Jackson Lee, Sheila [D-TX-18

2013-01-03

House - 01/25/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, And Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

42 CFR 137.428 - How is a hearing arranged?

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES TRIBAL SELF-GOVERNANCE Appeals Pre-Award Disputes § 137.428 How is a... person, to decide whether an evidentiary hearing is necessary, or whether it is possible to decide the...

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

PubMed

Amur, S; LaVange, L; Zineh, I; Buckman-Garner, S; Woodcock, J

2015-07-01

The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration. © 2015 American Society for Clinical Pharmacology and Therapeutics.

The economic evaluation of personalised oncology medicines: ethical challenges.

PubMed

Lewis, Jan R R; Lipworth, Wendy L; Kerridge, Ian H; Day, Richard O

2013-10-07

Insights into the molecular drivers of cancer are providing opportunities for the development of new targeted treatments and more personalised approaches to cancer management. Drugs targeting mutant epidermal growth factor receptors, such as erlotinib and gefitinib, may provide more effective, safer and better tolerated treatment options compared with chemotherapy among appropriately selected patients with advanced non-small cell lung cancer (NSCLC). First-line access to these newer treatments remains unfunded after several considerations by the Pharmaceutical Benefits Advisory Committee and their assessment that these are not cost-effective treatments. We suggest that there may be evidentiary and ethical challenges associated with the assessment of the cost-effectiveness of personalised oncology medicines in Australia, and that a new approach is needed to determine the value and cost-effectiveness of personalised medicine.

76 FR 61401 - Atomic Safety and Licensing Board; In the Matter of Nuclear Innovation North America LLC (South...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... Fukushima Dai-ichi accident. \\1\\ Intervenors are the Sustainable Energy and Economic Development Coalition... proffered Fukushima-related contention immediately after the conclusion of the evidentiary hearing. As with...

Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease (COPD) Using an Ontario Policy Model

PubMed Central

Chandra, K; Blackhouse, G; McCurdy, BR; Bornstein, M; Campbell, K; Costa, V; Franek, J; Kaulback, K; Levin, L; Sehatzadeh, S; Sikich, N; Thabane, M; Goeree, R

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-Term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Background Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation throughout the airways, parenchyma, and pulmonary vasculature. The inflammation causes repeated cycles of injury and repair in the airway wall— inflammatory cells release a variety of chemicals and lead to cellular damage. The inflammation process also contributes to the loss of elastic recoil pressure in the lung, thereby reducing the driving pressure for expiratory flow through narr

42 CFR 430.88 - Evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS Hearings on Conformity of State Medicaid Plans and Practice to Federal Requirements § 430.88 Evidence. (a) Evidentiary purpose. The hearing is...

29 CFR 2204.307 - Further proceedings.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN PROCEEDINGS BEFORE THE OCCUPATIONAL SAFETY AND HEALTH REVIEW... discovery and an evidentiary hearing, as to issues other than substantial justification (such as the...

Clinical Decision Support Tools for Selecting Interventions for Patients with Disabling Musculoskeletal Disorders: A Scoping Review.

PubMed

Gross, Douglas P; Armijo-Olivo, Susan; Shaw, William S; Williams-Whitt, Kelly; Shaw, Nicola T; Hartvigsen, Jan; Qin, Ziling; Ha, Christine; Woodhouse, Linda J; Steenstra, Ivan A

2016-09-01

Purpose We aimed to identify and inventory clinical decision support (CDS) tools for helping front-line staff select interventions for patients with musculoskeletal (MSK) disorders. Methods We used Arksey and O'Malley's scoping review framework which progresses through five stages: (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies for analysis; (4) charting the data; and (5) collating, summarizing and reporting results. We considered computer-based, and other available tools, such as algorithms, care pathways, rules and models. Since this research crosses multiple disciplines, we searched health care, computing science and business databases. Results Our search resulted in 4605 manuscripts. Titles and abstracts were screened for relevance. The reliability of the screening process was high with an average percentage of agreement of 92.3 %. Of the located articles, 123 were considered relevant. Within this literature, there were 43 CDS tools located. These were classified into 3 main areas: computer-based tools/questionnaires (n = 8, 19 %), treatment algorithms/models (n = 14, 33 %), and clinical prediction rules/classification systems (n = 21, 49 %). Each of these areas and the associated evidence are described. The state of evidentiary support for CDS tools is still preliminary and lacks external validation, head-to-head comparisons, or evidence of generalizability across different populations and settings. Conclusions CDS tools, especially those employing rapidly advancing computer technologies, are under development and of potential interest to health care providers, case management organizations and funders of care. Based on the results of this scoping review, we conclude that these tools, models and systems should be subjected to further validation before they can be recommended for large-scale implementation for managing patients with MSK disorders.

Guidelines and Value-Based Decision Making: An Evolving Role for Payers.

PubMed

McCauley, Janet L

2015-01-01

Payers use evidence-based guidelines to promote effective health diagnoses and treatments for their members and to ensure that members are not subject to harmful or wasteful care. Payer guidelines inform coverage, but the content of these guidelines relies on the same evidentiary base as clinical treatment guidelines. Recent strategies to foster value through benefit design and alternative reimbursement methodologies illustrate emerging applications for evidence-based guidelines. The current focus on cost effectiveness within health technology assessment, comparative effectiveness research in collaboration with payers, and transparency around payer evidence assessment could better align payers' interests in evidence-based care with those of other stakeholders. The move to value in health care will depend upon credible clinical evidence to enable informed decision making. ©2015 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

How International Monetary Fund and World Bank policies undermine labor power and rights.

PubMed

Lloyd, Vincent; Weissman, Robert

2002-01-01

Based on reviews of hundreds of loan and project documents from the International Monetary Fund (IMF) and World Bank, this article provides detailed evidentiary support for critics who have long claimed that the international financial institutions require Third World countries to adopt policies that harm the interests of working people. After reviewing loan documents between the IMF and World Bank and 26 countries, the authors show that the institutions' loan conditionalities include a variety of provisions that undermine labor rights, labor power, and tens of millions of workers' standard of living. These include downsizing of the civil service and privatization of government-owned enterprises; promotion of labor flexibility: the notion that firms should be able to hire and fire workers, or change terms and conditions of work, with minimal regulatory restrictions; mandated wage rate reductions, minimum-wage reductions or containment, and spreading the wage gap between government employees and managers; and pension reforms, including privatization, that cut social security benefits. These labor-related policies take place in the context of broader IMF and World Bank structural adjustment packages that emphasize trade liberalization, with macroeconomic policies that further advance corporate interests at the expense of labor.

31 CFR 501.732 - Evidence.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Enemy Act (TWEA) Penalties § 501.732 Evidence. The applicable evidentiary standard for proceedings... Administrative Law Judge shall admit any relevant and material oral, documentary, or demonstrative evidence. The... by oral or documentary evidence, to submit rebuttal evidence, and to conduct such cross-examination...

75 FR 39843 - Stressor Determinations for Posttraumatic Stress Disorder

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

... Posttraumatic Stress Disorder AGENCY: Department of Veterans Affairs. ACTION: Final rule. SUMMARY: The... posttraumatic stress disorder (PTSD) by liberalizing in some cases the evidentiary standard for establishing the... Psychosocial Effects of Deployment- Related Stress, 319 (2008) (IOM Report), which states: The epidemiologic...

12 CFR 747.613 - Further proceedings.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and Procedures Applicable to Recovery of Attorneys Fees and Other Expenses Under the Equal Access to... argument, additional written submissions or an evidentiary hearing. Such further proceedings shall be held... the disputed issues and shall explain why the additional proceedings are necessary to resolve the...

12 CFR 747.613 - Further proceedings.

Code of Federal Regulations, 2012 CFR

2012-01-01

... and Procedures Applicable to Recovery of Attorneys Fees and Other Expenses Under the Equal Access to... argument, additional written submissions or an evidentiary hearing. Such further proceedings shall be held... the disputed issues and shall explain why the additional proceedings are necessary to resolve the...

12 CFR 747.613 - Further proceedings.

Code of Federal Regulations, 2013 CFR

2013-01-01

... and Procedures Applicable to Recovery of Attorneys Fees and Other Expenses Under the Equal Access to... argument, additional written submissions or an evidentiary hearing. Such further proceedings shall be held... the disputed issues and shall explain why the additional proceedings are necessary to resolve the...

Assessment as Evidential Reasoning

ERIC Educational Resources Information Center

Gorin, Joanna S.

2014-01-01

Background/Context: Principles of evidential reasoning have often been discussed in the context of educational and psychological measurement with respect to construct validity and validity arguments. More recently, Mislevy proposed the metaphor of assessment as an evidentiary argument about students' learning and abilities given their…

14 CFR 302.25 - Subpoenas.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGULATIONS RULES OF PRACTICE IN PROCEEDINGS Rules of General Applicability Oral Evidentiary Hearing... hearing or the production of documentary evidence may be made without notice by any party to the... such applications, whether written or oral, shall contain a statement or showing of general relevance...

AN AUDITING FRAMEWORK TO SUBSTANTIATE ELECTRONIC RECORDKEEPING PRACTICES

EPA Science Inventory

Quality assurance audits of computer systems help to ensure that the end data meet the needs of the user. Increasingly complex systems require the stepwise procedures outlined below.

The areas reviewed in this paper include both technical and evidentiary criteria. I...

Dealing with Uncertainty and Accounting for Social Value Judgments in Assessments of Orphan Drugs: Evidence from Four European Countries.

PubMed

Nicod, Elena; Berg Brigham, Karen; Durand-Zaleski, Isabelle; Kanavos, Panos

To better understand the reasons for differences in reimbursement decisions for orphan drugs in four European countries that were not readily apparent from health technology assessment (HTA) reports and operating procedures. Semistructured interviews with representatives of HTA bodies in England, Scotland, Sweden, and France were conducted. An interview topic guide was developed on the basis of findings from a systematic comparison of HTA decisions for 10 orphan drugs. Qualitative thematic data analysis was applied to the interview transcripts using the framework approach. Eight representatives from the four HTA bodies were interviewed between March and June 2015. Evidentiary requirements and approaches to dealing with imperfect or incomplete evidence were explored, including trial design and duration, study population and subgroups, comparators, and end points. Interviewees agreed that decisions regarding orphan drugs are made in a context of lower quality evidence, and the threshold of acceptable uncertainty varied by country. Some countries imposed higher evidentiary standards for greater clinical claims, which may be more challenging for orphan diseases. The acceptability of surrogate end points was not consistent across countries nor were the validation requirements. The most common social value judgments identified related to innovation, disease severity, and unmet need. Differences were seen in the way these concepts were defined and accounted for across countries. Although agreement was seen in evidentiary requirements or preferences, there were subtle differences in the circumstances in which uncertain evidence may be considered acceptable, possibly explaining differences in HTA recommendations across countries. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

What's in a Name? The Incorrect Use of Case Series as a Study Design Label in Studies Involving Dogs and Cats.

PubMed

Sargeant, J M; O'Connor, A M; Cullen, J N; Makielski, K M; Jones-Bitton, A

2017-07-01

Study design labels are used to identify relevant literature to address specific clinical and research questions and to aid in evaluating the evidentiary value of research. Evidence from the human healthcare literature indicates that the label "case series" may be used inconsistently and inappropriately. Our primary objective was to determine the proportion of studies in the canine and feline veterinary literature labeled as case series that actually corresponded to descriptive cohort studies, population-based cohort studies, or other study designs. Our secondary objective was to identify the proportion of case series in which potentially inappropriate inferential statements were made. Descriptive evaluation of published literature. One-hundred published studies (from 19 journals) labeled as case series. Studies were identified by a structured literature search, with random selection of 100 studies from the relevant citations. Two reviewers independently characterized each study, with disagreements resolved by consensus. Of the 100 studies, 16 were case series. The remaining studies were descriptive cohort studies (35), population-based cohort studies (36), or other observational or experimental study designs (13). Almost half (48.8%) of the case series or descriptive cohort studies, with no control group and no formal statistical analysis, included inferential statements about the efficacy of treatment or statistical significance of potential risk factors. Authors, peer-reviewers, and editors should carefully consider the design elements of a study to accurately identify and label the study design. Doing so will facilitate an understanding of the evidentiary value of the results. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

PubMed

Brooks, Steven S

2017-06-01

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

40 CFR 179.93 - Testimony.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Testimony. 179.93 Section 179.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY... the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form...

12 CFR 1081.212 - Dispositive motions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... as to which official notice may be taken, and any other evidentiary materials properly submitted in... stated therein, and must be signed under oath and penalty of perjury. (e) Page limitations for... motion (exclusive of any declarations, affidavits, or attachments) shall not exceed 35 pages in length...

12 CFR 1081.212 - Dispositive motions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... as to which official notice may be taken, and any other evidentiary materials properly submitted in... stated therein, and must be signed under oath and penalty of perjury. (e) Page limitations for... motion (exclusive of any declarations, affidavits, or attachments) shall not exceed 35 pages in length...

12 CFR 1081.212 - Dispositive motions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... as to which official notice may be taken, and any other evidentiary materials properly submitted in... stated therein, and must be signed under oath and penalty of perjury. (e) Page limitations for... motion (exclusive of any declarations, affidavits, or attachments) shall not exceed 35 pages in length...

28 CFR 77.1 - Purpose and authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) ETHICAL STANDARDS FOR ATTORNEYS FOR THE GOVERNMENT § 77.1 Purpose and authority. (a) The Department of Justice is committed to ensuring that its... any way to alter federal substantive, procedural, or evidentiary law or to interfere with the Attorney...

28 CFR 77.1 - Purpose and authority.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) ETHICAL STANDARDS FOR ATTORNEYS FOR THE GOVERNMENT § 77.1 Purpose and authority. (a) The Department of Justice is committed to ensuring that its... any way to alter federal substantive, procedural, or evidentiary law or to interfere with the Attorney...

28 CFR 77.1 - Purpose and authority.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) ETHICAL STANDARDS FOR ATTORNEYS FOR THE GOVERNMENT § 77.1 Purpose and authority. (a) The Department of Justice is committed to ensuring that its... any way to alter federal substantive, procedural, or evidentiary law or to interfere with the Attorney...

28 CFR 77.1 - Purpose and authority.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) ETHICAL STANDARDS FOR ATTORNEYS FOR THE GOVERNMENT § 77.1 Purpose and authority. (a) The Department of Justice is committed to ensuring that its... any way to alter federal substantive, procedural, or evidentiary law or to interfere with the Attorney...

28 CFR 77.1 - Purpose and authority.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) ETHICAL STANDARDS FOR ATTORNEYS FOR THE GOVERNMENT § 77.1 Purpose and authority. (a) The Department of Justice is committed to ensuring that its... any way to alter federal substantive, procedural, or evidentiary law or to interfere with the Attorney...

42 CFR 93.106 - Evidentiary standards.

Code of Federal Regulations, 2011 CFR

2011-10-01

... EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC HEALTH SERVICE POLICIES ON RESEARCH... under this part. (a) Standard of proof. An institutional or HHS finding of research misconduct must be... of proof for making a finding of research misconduct. The destruction, absence of, or respondent's...

42 CFR 93.106 - Evidentiary standards.

Code of Federal Regulations, 2010 CFR

2010-10-01

... EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC HEALTH SERVICE POLICIES ON RESEARCH... under this part. (a) Standard of proof. An institutional or HHS finding of research misconduct must be... of proof for making a finding of research misconduct. The destruction, absence of, or respondent's...

20 CFR 402.95 - Exemption five for withholding records: Internal memoranda.

Code of Federal Regulations, 2010 CFR

2010-04-01

... memoranda. This exemption covers internal government communications and notes that fall within a generally recognized evidentiary privilege. Internal government communications include an agency's communications with... communications are for a purpose similar to the purpose of privileged intra-agency communications. Some of the...

40 CFR 179.93 - Testimony.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Testimony. 179.93 Section 179.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY... the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form...

40 CFR 179.93 - Testimony.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Testimony. 179.93 Section 179.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY... the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form...

40 CFR 179.93 - Testimony.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Testimony. 179.93 Section 179.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY... the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form...

40 CFR 179.93 - Testimony.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Testimony. 179.93 Section 179.93 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS FORMAL EVIDENTIARY... the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form...

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.

PubMed

Schneeweiss, S; Eichler, H-G; Garcia-Altes, A; Chinn, C; Eggimann, A-V; Garner, S; Goettsch, W; Lim, R; Löbker, W; Martin, D; Müller, T; Park, B J; Platt, R; Priddy, S; Ruhl, M; Spooner, A; Vannieuwenhuyse, B; Willke, R J

2016-12-01

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare. © 2016 American Society for Clinical Pharmacology and Therapeutics.

[Forensic evidence-based medicine in computer communication networks].

PubMed

Qiu, Yun-Liang; Peng, Ming-Qi

2013-12-01

As an important component of judicial expertise, forensic science is broad and highly specialized. With development of network technology, increasement of information resources, and improvement of people's legal consciousness, forensic scientists encounter many new problems, and have been required to meet higher evidentiary standards in litigation. In view of this, evidence-based concept should be established in forensic medicine. We should find the most suitable method in forensic science field and other related area to solve specific problems in the evidence-based mode. Evidence-based practice can solve the problems in legal medical field, and it will play a great role in promoting the progress and development of forensic science. This article reviews the basic theory of evidence-based medicine and its effect, way, method, and evaluation in the forensic medicine in order to discuss the application value of forensic evidence-based medicine in computer communication networks.

Selecting, Adapting, and Implementing Evidence-based Interventions in Rural Settings: An Analysis of 70 Community Examples.

PubMed

Smith, Tina Anderson; Adimu, Tanisa Foxworth; Martinez, Amanda Phillips; Minyard, Karen

2016-01-01

This paper explores how communities translate evidence-based and promising health practices to rural contexts. A descriptive, qualitative analysis was conducted using data from 70 grantees funded by the Federal Office of Rural Health Policy to implement evidence-based health practices in rural settings. Findings were organized using The Interactive Systems Framework for Dissemination and Implementation. Grantees broadly interpreted evidence-based and promising practices, resulting in the implementation of a patchwork of health-related interventions that fell along a spectrum of evidentiary rigor. The cohort faced common challenges translating recognized practices into rural community settings and reported making deliberate modifications to original models as a result. Opportunities for building a more robust rural health evidence base include investments to incentivize evidence-based programming in rural settings; rural-specific research and theory-building; translation of existing evidence using a rural lens; technical assistance to support rural innovation; and prioritization of evaluation locally.

18 CFR 1308.33 - Hearings.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 2 2011-04-01 2011-04-01 false Hearings. 1308.33... Prehearing and Hearing Procedures § 1308.33 Hearings. (a) TVA shall arrange for the verbatim reporting of evidentiary hearings before the Hearing Officer, and shall provide the Hearing Officer with the original...

18 CFR 1308.33 - Hearings.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 2 2014-04-01 2014-04-01 false Hearings. 1308.33... Prehearing and Hearing Procedures § 1308.33 Hearings. (a) TVA shall arrange for the verbatim reporting of evidentiary hearings before the Hearing Officer, and shall provide the Hearing Officer with the original...

18 CFR 1308.33 - Hearings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 2 2012-04-01 2012-04-01 false Hearings. 1308.33... Prehearing and Hearing Procedures § 1308.33 Hearings. (a) TVA shall arrange for the verbatim reporting of evidentiary hearings before the Hearing Officer, and shall provide the Hearing Officer with the original...

18 CFR 1308.33 - Hearings.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 2 2013-04-01 2012-04-01 true Hearings. 1308.33... Prehearing and Hearing Procedures § 1308.33 Hearings. (a) TVA shall arrange for the verbatim reporting of evidentiary hearings before the Hearing Officer, and shall provide the Hearing Officer with the original...

42 CFR 93.310 - Institutional investigation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records— (1...

42 CFR 93.310 - Institutional investigation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records— (1...

42 CFR 93.310 - Institutional investigation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records— (1...

42 CFR 93.310 - Institutional investigation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Whenever possible, the institution must take custody of the records— (1...

Implications of Evidence-Centered Design for Educational Testing

ERIC Educational Resources Information Center

Mislevy, Robert J.; Haertel, Geneva D.

2006-01-01

Evidence-centered assessment design (ECD) provides language, concepts, and knowledge representations for designing and delivering educational assessments, all organized around the evidentiary argument an assessment is meant to embody. This article describes ECD in terms of layers for analyzing domains, laying out arguments, creating schemas for…

18 CFR 1308.33 - Hearings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Hearings. 1308.33... Prehearing and Hearing Procedures § 1308.33 Hearings. (a) TVA shall arrange for the verbatim reporting of evidentiary hearings before the Hearing Officer, and shall provide the Hearing Officer with the original...

15 CFR 768.3 - Foreign availability assessment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... availability assessment. A foreign availability assessment is an evidentiary analysis that BIS conducts to... if there is no foreign policy reason to deny the license, unless the President exercises a National... foreign policy controls may be considered independent of this part. (b) Types of assessments. There are...

47 CFR 27.1172 - Dispute Resolution Under the Cost-Sharing Plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 2 2010-10-01 2010-10-01 false Dispute Resolution Under the Cost-Sharing Plan. 27.1172 Section 27.1172 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... provide evidentiary support to demonstrate that their calculation is reasonable and made in good faith...

47 CFR 27.1172 - Dispute Resolution Under the Cost-Sharing Plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 2 2011-10-01 2011-10-01 false Dispute Resolution Under the Cost-Sharing Plan. 27.1172 Section 27.1172 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... provide evidentiary support to demonstrate that their calculation is reasonable and made in good faith...

Timing of the Medical Examination

ERIC Educational Resources Information Center

Christian, Cindy W.

2011-01-01

The medical examination of the sexually abused child may have evidentiary, medical, and therapeutic purposes, and the timing of the examination requires consideration of each of these objectives. In cases of acute sexual assault, emergent examinations may be needed to identify injury, collect forensic evidence, and provide infection and pregnancy…

16 CFR 1502.31 - Summary decisions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Summary decisions. 1502.31 Section 1502.31... PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 1502.31 Summary decisions. (a) After the hearing commences, a participant may move, with or without supporting affidavits, for a summary...

Sexual Misconduct by School Employees Involving Students.

ERIC Educational Resources Information Center

Mawdsley, Ralph D.; Hampton, Frederick M.

1992-01-01

Analyzes judicial response to employees who had been dismissed for sexual misconduct and objected to their school districts' dismissal processes. Issues tend to fall into three categories: elements of proof; relationship to the judicial evidentiary process; and standard for judicial review. Advises administrators to prepare, publish, and enforce…

Diabetes Care Management Teams Did Not Reduce Utilization When Compared With Traditional Care: A Randomized Cluster Trial.

PubMed

Kearns, Patrick

2017-10-01

PURPOSE: Health services research evaluates redesign models for primary care. Care management is one alternative. Evaluation includes resource utilization as a criterion. Compare the impact of care-manager teams on resource utilization. The comparison includes entire panes of patients and the subset of patients with diabetes. DESIGN: Randomized, prospective, cohort study comparing change in utilization rates between groups, pre- and post-intervention. METHODOLOGY: Ten primary care physician panels in a safety-net setting. Ten physicians were randomized to either a care-management approach (Group 1) or a traditional approach (Group 2). Care managers focused on diabetes and the cardiovascular cluster of diseases. Analysis compared rates of hospitalization, 30-day readmission, emergency room visits, and urgent care visits. Analysis compared baseline rates to annual rates after a yearlong run-in for entire panels and the subset of patients with diabetes. RESULTS: Resource utilization showed no statistically significant change between baseline and Year 3 (P=.79). Emergency room visits and hospital readmission increased for both groups (P=.90), while hospital admissions and urgent care visits decreased (P=.73). Similarly, utilization was not significantly different for patients with diabetes (P=.69). CONCLUSIONS: A care-management team approach failed to improve resource utilization rates by entire panels and the subset of diabetic patients compared to traditional care. This reinforces the need for further evidentiary support for the care-management model's hypothesis in the safety net.

Avoidable Ignorance and the Role of Cochrane and Campbell Reviews

ERIC Educational Resources Information Center

Gambrill, Eileen

2015-01-01

The Campbell and Cochrane Collaborations were created to reveal the evidentiary status of claims focusing especially on the effectiveness of specific interventions. Such reviews are constrained by the population of studies available and biases that may influence this availability such as preferred framing of problems. This highlights the…

40 CFR 179.125 - Judicial review.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Judicial review. 179.125 Section 179... EVIDENTIARY PUBLIC HEARING Judicial Review § 179.125 Judicial review. (a) The Administrator's final decision... judicial review within the period ending on the 60th day after the date of the publication of the order...

40 CFR 179.91 - Burden of going forward; burden of persuasion.

Code of Federal Regulations, 2014 CFR

2014-07-01

... persuasion. 179.91 Section 179.91 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED...; burden of persuasion. (a) The party whose request for an evidentiary hearing was granted has the burden... FFDCA has the burden of persuasion in the hearing on that issue, whether the proceeding concerns the...

40 CFR 179.91 - Burden of going forward; burden of persuasion.

Code of Federal Regulations, 2013 CFR

2013-07-01

... persuasion. 179.91 Section 179.91 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED...; burden of persuasion. (a) The party whose request for an evidentiary hearing was granted has the burden... FFDCA has the burden of persuasion in the hearing on that issue, whether the proceeding concerns the...

40 CFR 179.91 - Burden of going forward; burden of persuasion.

Code of Federal Regulations, 2012 CFR

2012-07-01

... persuasion. 179.91 Section 179.91 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED...; burden of persuasion. (a) The party whose request for an evidentiary hearing was granted has the burden... FFDCA has the burden of persuasion in the hearing on that issue, whether the proceeding concerns the...

42 CFR 93.307 - Institutional inquiry.

Code of Federal Regulations, 2012 CFR

2012-10-01

... research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. (c) Review of evidence. The purpose of an inquiry is...

42 CFR 93.307 - Institutional inquiry.

Code of Federal Regulations, 2013 CFR

2013-10-01

... research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. (c) Review of evidence. The purpose of an inquiry is...

42 CFR 93.307 - Institutional inquiry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. (c) Review of evidence. The purpose of an inquiry is...

42 CFR 93.307 - Institutional inquiry.

Code of Federal Regulations, 2010 CFR

2010-10-01

... research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. (c) Review of evidence. The purpose of an inquiry is...

42 CFR 93.307 - Institutional inquiry.

Code of Federal Regulations, 2014 CFR

2014-10-01

... research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. (c) Review of evidence. The purpose of an inquiry is...

77 FR 32623 - City of Denton; Notice of Application Accepted for Filing, Soliciting Comments, Motions To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... Project facilities to provide an improved low-flow release system for the City's water treatment plant. l... ``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the name of... protests must set forth their evidentiary [[Page 32624

16 CFR 1502.39 - Examination of record.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Examination of record. 1502.39 Section 1502... REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Administrative Record § 1502.39 Examination of... available for examination or copying will be placed on public display in the Office of the Secretary...

14 CFR 302.17 - Administrative law judges.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Administrative law judges. 302.17 Section... Evidentiary Hearing Proceedings § 302.17 Administrative law judges. (a) Powers and delegation of authority. (1) An administrative law judge shall have the following powers, in addition to any others specified in...

33 CFR 20.1313 - Medical examination of respondents.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Medical examination of... COAST GUARD Supplementary Evidentiary Rules for Suspension and Revocation Hearings § 20.1313 Medical... relevant, the ALJ may order him or her to undergo a medical examination. Any examination ordered by the ALJ...

33 CFR 20.1313 - Medical examination of respondents.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Medical examination of... COAST GUARD Supplementary Evidentiary Rules for Suspension and Revocation Hearings § 20.1313 Medical... relevant, the ALJ may order him or her to undergo a medical examination. Any examination ordered by the ALJ...

33 CFR 20.1313 - Medical examination of respondents.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Medical examination of... COAST GUARD Supplementary Evidentiary Rules for Suspension and Revocation Hearings § 20.1313 Medical... relevant, the ALJ may order him or her to undergo a medical examination. Any examination ordered by the ALJ...

33 CFR 20.1313 - Medical examination of respondents.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Medical examination of... COAST GUARD Supplementary Evidentiary Rules for Suspension and Revocation Hearings § 20.1313 Medical... relevant, the ALJ may order him or her to undergo a medical examination. Any examination ordered by the ALJ...

Paul Ricoeur, Memory, and the Historical Gaze: Implications for Education Histories

ERIC Educational Resources Information Center

Colby, Sherri Rae

2012-01-01

In this article, the author shares the potential applications of Paul Ricoeur's philosophies of history, memory, and narrative to the interpretation of educational histories, and those histories' life spans: moving cyclically from early conception, to evidentiary construction, to published dissemination; and ultimately to death or immortality. Her…

Evidentiary Reasoning in Diagnostic Classification Models

ERIC Educational Resources Information Center

Levy, Roy

2009-01-01

In "Unique Characteristics of Diagnostic Classification Models: A Comprehensive Review of the Current State-of-the-Art," Rupp and Templin (2008) undertake the ambitious task of providing a thorough portrait of the current state of diagnostic classification models (DCM). In this commentary, the author applauds Rupp and Templin for their…

16 CFR 1502.4 - Office of the Secretary.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Office of the Secretary. 1502.4 Section 1502... REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING General Provisions § 1502.4 Office of the Secretary. (a) The mailing address of the Commission's Office of the Secretary is: Office of the Secretary...

40 CFR 179.90 - Summary decisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Summary decisions. 179.90 Section 179... EVIDENTIARY PUBLIC HEARING Hearing Procedures § 179.90 Summary decisions. (a) After the hearing commences, a party may file a written motion, with or without supporting affidavits or brief, for a summary decision...

Navigating the evidentiary turn in public health: Sensemaking strategies to integrate genomics into state-level chronic disease prevention programs.

PubMed

Senier, Laura; Smollin, Leandra; Lee, Rachael; Nicoll, Lauren; Shields, Michael; Tan, Catherine

2018-06-23

In the past decade, healthcare delivery has faced two major disruptions: the mapping of the human genome and the rise of evidence-based practice. Sociologists have documented the paradigmatic shift towards evidence-based practice in medicine, but have yet to examine its effect on other health professions or the broader healthcare arena. This article shows how evidence-based practice is transforming public health in the United States. We present an in-depth qualitative analysis of interview, ethnographic, and archival data to show how Michigan's state public health agency has navigated the turn to evidence-based practice, as they have integrated scientific advances in genomics into their chronic disease prevention programming. Drawing on organizational theory, we demonstrate how they managed ambiguity through a combination of sensegiving and sensemaking activities. Specifically, they linked novel developments in genomics to a long-accepted public health planning model, the Core Public Health Functions. This made cutting edge advances in genomics more familiar to their peers in the state health agency. They also marshaled state-specific surveillance data to illustrate the public health burden of hereditary cancers in Michigan, and to make expert panel recommendations for genetic screening more locally relevant. Finally, they mobilized expertise to help their internal colleagues and external partners modernize conventional public health activities in chronic disease prevention. Our findings show that tools and concepts from organizational sociology can help medical sociologists understand how evidence-based practice is shaping institutions and interprofessional relations in the healthcare arena. Copyright © 2018 Elsevier Ltd. All rights reserved.

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study.

PubMed

Vitry, Agnes; Nguyen, Tuan; Entwistle, Vikky; Roughead, Elizabeth

2015-01-01

Withdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. We present a case study of the US Food and Drug Administration (FDA)'s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding. We drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders. In 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes. Improving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, 'black-triangle' equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.

Push hard, push fast, if you’re downtown: a citation review of urban-centrism in American and European basic life support guidelines

PubMed Central

2013-01-01

Bystander cardiopulmonary resuscitation (CPR) improves out-of-hospital cardiac arrest (OHCA) survival. In settings with prolonged ambulance response times, skilled bystanders may be even more crucial. In 2010, American Heart Association (AHA) and European Resuscitation Council (ERC) introduced compression-only CPR as an alternative to conventional bystander CPR under some circumstances. The purpose of this citation review and document analysis is to determine whether the evidentiary basis for 2010 AHA and ERC guidelines attends to settings with prolonged ambulance response times or no formal ambulance dispatch services. Primary and secondary citations referring to epidemiological research comparing adult OHCA survival based on the type of bystander CPR were included in the analysis. Details extracted from the citations included a study description and primary outcome measure, the geographic location in which the study occurred, EMS response times, the role of dispatchers, and main findings and summary statistics regarding rates of survival among patients receiving no CPR, conventional CPR or compression-only CPR. The inclusion criteria were met by 10 studies. 9 studies took place exclusively in urban settings. Ambulance dispatchers played an integral role in 7 studies. The cited studies suggest either no survival benefit or harm arising from compression-only CPR in settings with extended ambulance response times. The evidentiary basis for 2010 AHA and ERC bystander CPR guidelines does not attend to settings without rapid ambulance response times or dispatch services. Standardized bystander CPR guidelines may require adaptation or reconsideration in these settings. PMID:23601200

24 CFR 941.610 - Evidentiary materials and other documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... record, that will assure to HUD's satisfaction that the public housing units will be available for use by...) for use in carrying out the proposal, and that such commitment is in the amount required under the... HUD (together with all financing documents) to ensure that they do not provide equity investors...

The Effectiveness of an Online Curriculum on High School Students' Understanding of Biological Evolution

ERIC Educational Resources Information Center

Marsteller, Robert B.; Bodzin, Alec M.

2015-01-01

An online curriculum about biological evolution was designed to promote increased student content knowledge and evidentiary reasoning. A feasibility study was conducted with 77 rural high school biology students who learned with the online biological evolution unit. Data sources included the Biological Evolution Assessment Measure (BEAM), an…

A Brief Introduction to Evidence-Centered Design. CSE Report 632

ERIC Educational Resources Information Center

Mislevy, Robert J.; Almond, Russell G.; Lukas, Janice F.

2004-01-01

Evidence-centered assessment design (ECD) is an approach to constructing educational assessments in terms of evidentiary arguments. This paper provides an introduction to the basic ideas of ECD, including some of the terminology and models that have been developed to implement the approach. In particular, it presents the high-level models of …

76 FR 11684 - Presumption of Insurable Interest for Same-Sex Domestic Partners

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-03

... 842 RIN 3206-AM20 Presumption of Insurable Interest for Same-Sex Domestic Partners AGENCY: Office of... amend its regulations to include same-sex domestic partners to the class of persons for which an... employees with same-sex domestic partners from the evidentiary requirements in existing regulations for...

21 CFR 12.85 - Disclosure of data and information by the participants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Disclosure of data and information by the... SERVICES GENERAL FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 12.85 Disclosure of data and... other documentary data and information relied upon. (4) A narrative position statement on the factual...

21 CFR 12.85 - Disclosure of data and information by the participants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Disclosure of data and information by the... SERVICES GENERAL FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 12.85 Disclosure of data and... other documentary data and information relied upon. (4) A narrative position statement on the factual...

21 CFR 12.85 - Disclosure of data and information by the participants.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Disclosure of data and information by the... SERVICES GENERAL FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 12.85 Disclosure of data and... other documentary data and information relied upon. (4) A narrative position statement on the factual...

21 CFR 12.85 - Disclosure of data and information by the participants.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Disclosure of data and information by the... SERVICES GENERAL FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 12.85 Disclosure of data and... other documentary data and information relied upon. (4) A narrative position statement on the factual...

46 CFR 203.5 - Types of hearings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Types of hearings. 203.5 Section 203.5 Shipping MARITIME... CERTAIN HEARINGS UNDER THE MERCHANT MARINE ACT, 1936, AS AMENDED § 203.5 Types of hearings. (a) Oral... seeking the oral evidentiary hearing. (b) Hearing on Submission of Written Evidence and Argument: If, upon...

Data Do Not Speak for Themselves: The Role of Data in Scientific Controversies

ERIC Educational Resources Information Center

Sadler, Troy D.

2007-01-01

This article presents a learning cycle with the aim of helping students understand the evidentiary basis of scientific claims. Students consider data and interpretations as used to support contradictory views in the debate surrounding the causal relationship between human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS).…

Archival Theory and the Shaping of Educational History: Utilizing New Sources and Reinterpreting Traditional Ones

ERIC Educational Resources Information Center

Glotzer, Richard

2013-01-01

Information technology has spawned new evidentiary sources, better retrieval systems for existing ones, and new tools for interpreting traditional source materials. These advances have contributed to a broadening of public participation in civil society (Blouin and Rosenberg 2006). In these culturally unsettled and economically fragile times…

40 CFR 78.3 - Petition for administrative review and request for evidentiary hearing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Ozone Season NOX Allowance Tracking System account, covered by the decision; or (ii) Any interested... for any CAIR Ozone Season NOX Allowance Tracking System account, covered by the decision; or (ii) Any... concise brief in support of the petition, explaining why the factual or legal issues are material and, if...

Compulsory Disclosure by Newsmen: The Implications of the Legal Heritage for the Contemporary Situation.

ERIC Educational Resources Information Center

Eshelman, David

In the almost 100 years of reported litigation pertaining to compulsory disclosure of news sources, the basic pleadings asserted in common law cases have included employer's regulations, professional ethics, self-incrimination, lack of jurisdictional authority, and relevancy. American courts have consistently denied an evidentiary privilege for…

Elaborations on the Socioegocentric and Dual-Level Connectionist Models of Group Interaction Processes

ERIC Educational Resources Information Center

Hewes, Dean E.

2009-01-01

The purpose of the author's contribution to this colloquy was to spark conversation on the theoretical nature of communication processes and the evidentiary requirements for testing their relationship to group outcomes. Co-discussants have raised important issues concerning the philosophical basis of the socioegocentric model (SM) and dual-level…

21 CFR 12.99 - Motions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Motions. 12.99 Section 12.99 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 12.99 Motions. (a) A motion on any matter relating to the proceeding is to be...

Examining the Parent Trigger as a Strategy for School Reform and Parental Engagement

ERIC Educational Resources Information Center

Rogers, John; Lubienski, Chris; Scott, Janelle; Welner, Kevin G.

2015-01-01

Background: Purpose: This analysis considers the emergence, evidentiary basis, and potential of parent trigger policies. In particular, we focus on the policy, political and social circumstances in which parent trigger legislation emerged in California, the efficacy of the school improvement levers on which it draws, and the underlying assumptions…

40 CFR 179.91 - Burden of going forward; burden of persuasion.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Burden of going forward; burden of...) PESTICIDE PROGRAMS FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 179.91 Burden of going forward... of going forward in the hearing with evidence as to the issues relevant to that request for a hearing...

40 CFR 179.91 - Burden of going forward; burden of persuasion.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Burden of going forward; burden of...) PESTICIDE PROGRAMS FORMAL EVIDENTIARY PUBLIC HEARING Hearing Procedures § 179.91 Burden of going forward... of going forward in the hearing with evidence as to the issues relevant to that request for a hearing...

43 CFR 4.1125 - Summary decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Summary decision. 4.1125 Section 4.1125... Special Rules Applicable to Surface Coal Mining Hearings and Appeals Evidentiary Hearings § 4.1125 Summary decision. (a) At any time after a proceeding has begun, a party may move for summary decision of the whole...

43 CFR 4.1128 - Effect of initial order or decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Effect of initial order or decision. 4... AND APPEALS PROCEDURES Special Rules Applicable to Surface Coal Mining Hearings and Appeals Evidentiary Hearings § 4.1128 Effect of initial order or decision. An initial order or decision shall become...

Mitigating Evidentiary Bias in Planning and Policy-Making Comment on "Reflective Practice: How the World Bank Explored Its Own Biases?"

PubMed

Parkhurst, Justin

2016-07-20

The field of cognitive psychology has increasingly provided scientific insights to explore how humans are subject to unconscious sources of evidentiary bias, leading to errors that can affect judgement and decision-making. Increasingly these insights are being applied outside the realm of individual decision-making to the collective arena of policy-making as well. A recent editorial in this journal has particularly lauded the work of the World Bank for undertaking an open and critical reflection on sources of unconscious bias in its own expert staff that could undermine achievement of its key goals. The World Bank case indeed serves as a remarkable case of a global policy-making agency making its own critical reflections transparent for all to see. Yet the recognition that humans are prone to cognitive errors has been known for centuries, and the scientific exploration of such biases provided by cognitive psychology is now well-established. What still remains to be developed, however, is a widespread body of work that can inform efforts to institutionalise strategies to mitigate the multiple sources and forms of evidentiary bias arising within administrative and policy-making environments. Addressing this gap will require a programme of conceptual and empirical work that supports robust development and evaluation of institutional bias mitigation strategies. The cognitive sciences provides a scientific basis on which to proceed, but a critical priority will now be the application of that science to improve policy-making within those agencies taking responsibility for social welfare and development programmes. © 2017 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

15 CFR 904.507 - Recovery of certain storage costs.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., wildlife, or evidentiary property is seized and forfeited under the Endangered Species Act, 16 U.S.C. 1531 through 1543, any person whose act or omission was the basis for the seizure may be charged a reasonable... property. If any fish or wildlife is seized in connection with a violation of the Lacey Act Amendments of...

15 CFR 904.507 - Recovery of certain storage costs.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., wildlife, or evidentiary property is seized and forfeited under the Endangered Species Act, 16 U.S.C. 1531 through 1543, any person whose act or omission was the basis for the seizure may be charged a reasonable... property. If any fish or wildlife is seized in connection with a violation of the Lacey Act Amendments of...

15 CFR 904.507 - Recovery of certain storage costs.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., wildlife, or evidentiary property is seized and forfeited under the Endangered Species Act, 16 U.S.C. 1531 through 1543, any person whose act or omission was the basis for the seizure may be charged a reasonable... property. If any fish or wildlife is seized in connection with a violation of the Lacey Act Amendments of...

15 CFR 904.507 - Recovery of certain storage costs.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., wildlife, or evidentiary property is seized and forfeited under the Endangered Species Act, 16 U.S.C. 1531 through 1543, any person whose act or omission was the basis for the seizure may be charged a reasonable... property. If any fish or wildlife is seized in connection with a violation of the Lacey Act Amendments of...

15 CFR 904.507 - Recovery of certain storage costs.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., wildlife, or evidentiary property is seized and forfeited under the Endangered Species Act, 16 U.S.C. 1531 through 1543, any person whose act or omission was the basis for the seizure may be charged a reasonable... property. If any fish or wildlife is seized in connection with a violation of the Lacey Act Amendments of...

Creating a Crisis: Selling Neoliberal Policy through the Rebranding of Education

ERIC Educational Resources Information Center

Parker, Lana

2017-01-01

How is it that neoliberal education policies, often lacking evidentiary basis, come to be endorsed--often by the very people they alienate and marginalize? This work seeks to expose how this kind of exclusive policy is sold to a public through intricate hortatory tools. Using critical policy analysis with an emphasis on historical development and…

Risk Comprehension and Judgments of Statistical Evidentiary Appeals: When a Picture Is Not Worth a Thousand Words

ERIC Educational Resources Information Center

Parrott, Roxanne; Silk, Kami; Dorgan, Kelly; Condit, Celeste; Harris, Tina

2005-01-01

Too little theory and research has considered the effects of communicating statistics in various forms on comprehension, perceptions of evidence quality, or evaluations of message persuasiveness. In a considered extension of Subjective Message Construct Theory (Morley, 1987), we advance a rationale relating evidence form to the formation of…

14 CFR 302.37 - Waiver of procedural steps after hearing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Waiver of procedural steps after hearing... Applicability Oral Evidentiary Hearing Proceedings § 302.37 Waiver of procedural steps after hearing. The parties to any proceeding may agree to waive any one or more of the procedural steps provided in § 302.29...

Using Graffiti to Teach Students How to Think Like Historians

ERIC Educational Resources Information Center

Franco, Eric V.

2010-01-01

"Thinking Like a Historian" (TLH) is a tool for framing the past to teach students the elements of historical thinking while, at the same time, grounding students' knowledge of the past through inquiry and evidentiary support. The framework's design allows for a separation of the ways historians study the past from the ways historians organize…

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Management of Patients With Positional Plagiocephaly: The Role of Repositioning.

PubMed

Klimo, Paul; Lingo, Patrick Ryan; Baird, Lissa C; Bauer, David F; Beier, Alexandra; Durham, Susan; Lin, Alexander Y; McClung-Smith, Catherine; Mitchell, Laura; Nikas, Dimitrios; Tamber, Mandeep S; Tyagi, Rachana; Mazzola, Catherine; Flannery, Ann Marie

2016-11-01

Plagiocephaly, involving positional deformity of the calvarium in infants, is one of the most common reasons for pediatric neurosurgical consultation. To answer the question: "what is the evidence for the effectiveness of repositioning for positional plagiocephaly?" Treatment recommendations are provided based on the available evidence. The National Library of Medicine MEDLINE database and the Cochrane Library were queried using MeSH headings and key words relevant to repositioning as a means to treat plagiocephaly and brachycephaly. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). Based on the quality of the literature, a recommendation was rendered (Level I, II, or III). There were 3 randomized trials (Class I), 1 prospective cohort study (Class II), and 6 retrospective cohort studies (Class III). Repositioning education was found to be equal to a repositioning device and inferior to a physical therapy program. Five of the 7 cohort studies comparing repositioning with a helmet reported helmets to be better and take less time. Within the limits of this systematic review, repositioning education is effective in affording some degree of correction in virtually all infants with positional plagiocephaly or brachycephaly. Most studies suggest that a molding helmet corrects asymmetry more rapidly and to a greater degree than repositioning education. In a Class I study, repositioning education was as effective as repositioning education in conjunction with a repositioning wrap/device. Another Class I study demonstrated that a bedding pillow was superior to physical therapy for some infants. However, in keeping with the American Academy of Pediatrics' warning against the use of soft positioning pillows in the sleeping environment, the Task Force recommends physical therapy over any positioning device. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_3.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Management of Patients With Positional Plagiocephaly: The Role of Repositioning.

PubMed

Klimo, Paul; Lingo, Patrick Ryan; Baird, Lissa C; Bauer, David F; Beier, Alexandra; Durham, Susan; Lin, Alexander Y; McClung-Smith, Catherine; Mitchell, Laura; Nikas, Dimitrios; Tamber, Mandeep S; Tyagi, Rachana; Mazzola, Catherine; Flannery, Ann Marie

2016-11-01

Plagiocephaly, involving positional deformity of the calvarium in infants, is one of the most common reasons for pediatric neurosurgical consultation. To answer the question: "what is the evidence for the effectiveness of repositioning for positional plagiocephaly?" Treatment recommendations are provided based on the available evidence. The National Library of Medicine MEDLINE database and the Cochrane Library were queried using MeSH headings and key words relevant to repositioning as a means to treat plagiocephaly and brachycephaly. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). Based on the quality of the literature, a recommendation was rendered (Level I, II, or III). There were 3 randomized trials (Class I), 1 prospective cohort study (Class II), and 6 retrospective cohort studies (Class III). Repositioning education was found to be equal to a repositioning device and inferior to a physical therapy program. Five of the 7 cohort studies comparing repositioning with a helmet reported helmets to be better and take less time. Within the limits of this systematic review, repositioning education is effective in affording some degree of correction in virtually all infants with positional plagiocephaly or brachycephaly. Most studies suggest that a molding helmet corrects asymmetry more rapidly and to a greater degree than repositioning education. In a Class I study, repositioning education was as effective as repositioning education in conjunction with a repositioning wrap/device. Another Class I study demonstrated that a bedding pillow was superior to physical therapy for some infants. However, in keeping with the American Academy of Pediatrics' warning against the use of soft positioning pillows in the sleeping environment, the Task Force recommends physical therapy over any positioning device. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_3.

The relationship between cross-sectional shapes and FTIR profiles in synthetic wig fibers and their discriminating abilities - An evidential value perspective.

PubMed

Joslin Yogi, Theresa A; Penrod, Michael; Holt, Melinda; Buzzini, Patrick

2018-02-01

Wig fragments or fibers may occasionally be recognized as potential physical evidence during criminal investigations. While analytical methods traditionally adopted for the examination of textile fibers are utilized for the characterizations and comparisons of wig specimens, it is essential to understand in deeper detail the valuable contribution of features of these non-routine evidentiary materials as well as the relationship of the gathered analytical data. This study explores the dependence between the microscopic features of cross-sectional shapes and the polymer type gathered by Fourier transform infrared (FTIR) spectroscopy. The discriminating power of the two methods of cross-sectioning and FTIR spectroscopy was also investigated. Forty-one synthetic wigs varying in both quality and price were collected: twenty-three brown, twelve blondes and six black samples. The collected samples were observed using light microscopy methods (bright field illumination and polarized light), before obtaining cross-sections using the Joliff method and analyze them using FTIR spectroscopy. The forty-one samples were divided into ten groups based on one or more of the ten types of cross-sectional shapes that were observed. The majority of encountered cross-sectional shapes were defined as horseshoe, dog bone and lobular. Infrared spectroscopy confirmed modacrylic to be the most prevalent fiber type. Blends of modacrylic and polyvinyl chloride fibers were also observed as well as polypropylene wig samples. The Goodman and Kruskal lambda statistical test was used and showed that the cross-sectional shape and infrared profile were related. From an evidentiary value perspective, this finding has implications when addressing questions about a common source between questioned wig specimens and a wig reference sample. Copyright © 2017 Elsevier B.V. All rights reserved.

Study design elements for rigorous quasi-experimental comparative effectiveness research.

PubMed

Maciejewski, Matthew L; Curtis, Lesley H; Dowd, Bryan

2013-03-01

Quasi-experiments are likely to be the workhorse study design used to generate evidence about the comparative effectiveness of alternative treatments, because of their feasibility, timeliness, affordability and external validity compared with randomized trials. In this review, we outline potential sources of discordance in results between quasi-experiments and experiments, review study design choices that can improve the internal validity of quasi-experiments, and outline innovative data linkage strategies that may be particularly useful in quasi-experimental comparative effectiveness research. There is an urgent need to resolve the debate about the evidentiary value of quasi-experiments since equal consideration of rigorous quasi-experiments will broaden the base of evidence that can be brought to bear in clinical decision-making and governmental policy-making.

Developing Academic English Language Proficiency Prototypes for 5th Grade Reading: Psychometric and Linguistic Profiles of Tasks. CSE Technical Report 727

ERIC Educational Resources Information Center

Bailey, Alison L.; Huang, Becky H.; Shin, Hye Won; Farnsworth, Tim; Butler, Frances A.

2007-01-01

Within an evidentiary framework for operationally defining academic English language proficiency (AELP), linguistic analyses of standards, classroom discourse, and textbooks have led to specifications for assessment of AELP. The test development process described here is novel due to the emphasis on using linguistic profiles to inform the …

16 CFR 1502.5 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. 1502.5 Section 1502.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Initiation of Proceedings § 150...

16 CFR 1502.5 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. 1502.5 Section 1502.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Initiation of Proceedings § 150...

16 CFR 1502.5 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. 1502.5 Section 1502.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Initiation of Proceedings § 150...

16 CFR § 1502.5 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. § 1502.5 Section § 1502.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Initiation of Proceedings...

16 CFR 1502.5 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. 1502.5 Section 1502.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING Initiation of Proceedings § 150...

Using the ECD Framework to Support Evidentiary Reasoning in the Context of a Simulation Study for Detecting Learner Differences in Epistemic Games

ERIC Educational Resources Information Center

Sweet, Shauna J.; Rupp, Andre A.

2012-01-01

The "evidence-centered design" (ECD) framework is a powerful tool that supports careful and critical thinking about the identification and accumulation of evidence in assessment contexts. In this paper, we demonstrate how the ECD framework provides critical support for designing simulation studies to investigate statistical methods…

Naval Law Review. Volume 49

DTIC Science & Technology

2002-01-01

the authority of its competent service, they shall continue to carry out, in accordance with their professional ethics , their medical and spiritual...retained chaplains can only be used to serve “in accordance with their professional ethics .”192 Similarly, the Third Convention dictates that they...that question depends upon what is the appropriate controlling authority, whether legal, regulatory, or ethical . 1. Analysis Under Evidentiary

77 FR 1748 - Atomic Safety and Licensing Board; Calvert Cliffs 3 Nuclear Project, LLC, and UniStar Nuclear...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... observe this evidentiary hearing. However, all signs, banners, posters, demonstrations, and displays are... required by NRC policy, signs, banners, posters, and displays not larger than 18 x 18 will be permitted at..., banner, poster or display affixed to a stick, or similar device, will not be permitted at the oral...

The Evidentiary Footprints of Appreciative Inquiry in a Community College: An Interpretive Case Study of Three Micro-Cases

ERIC Educational Resources Information Center

Royer, Dan W.

2017-01-01

I examined the embedding of Appreciative Inquiry (AI) in three micro-cases at Northeastern Regional Community College (NERC). This community college is a rarity for the way AI was adopted as an operational philosophy throughout the institution. The purpose of this research was to understand institutional agents' and students' perceptions of the…

The Oncology of Discrimination and the Disparate Impact Therapy: Title VII and Upper Level Professional and Managerial Jobs.

ERIC Educational Resources Information Center

Sanders, Wayne

An examination was made of the evidentiary problems that exist in using a disparate impact theory to challenge the subjective criteria many organizations use to hire, promote, or dismiss upper-level professional and managerial employees. Although subjective criteria occur at all levels of employment, they are especially prevalent when dealing with…

40 CFR 78.3 - Petition for administrative review and request for evidentiary hearing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... for administrative review of a decision of the Administrator that is made under subparts AAA through... Administrator that is made under subparts AAA through III of part 97 and that is appealable under § 78.1(a): (i... of this chapter, subparts AAA through III of part 96 of this chapter, subparts AAAA through IIII of...

Interrupting Commemoration: Thinking with Art, Thinking through the Strictures of Argentina's "Espacio para la memoria"

ERIC Educational Resources Information Center

Paolantonio, Mario Di

2011-01-01

Recently, a few buildings within the "Espacio para la memoria" in Buenos Aires have been designated as a UNESCO Centre where, amongst other educational activities, evidentiary materials of the past repression are to be stored and displayed. Another building in the complex houses a Community Centre operated by the Mothers of the Plaza de…

The psychiatrist's guide to right and wrong: Part IV: The insanity defense and the Ultimate Issue Rule.

PubMed

Goldstein, R L

1989-01-01

In the wake of Hinckley, widespread public dissatisfaction with the role of psychiatrists in insanity defense litigation prompted Congress in 1984 to amend the Federal Rules of Evidence to prohibit psychiatric testimony on the ultimate legal issue of whether or not a defendant is insane. APA's Statement on the Insanity Defense served as the ably articulated premise for this evidentiary amendment. APA argued that in going beyond their psychiatric expertise by answering ultimate issue questions as to whether defendants are legally insane, experts are likely to confuse the jury and undermine public confidence in psychiatry. APA also asserted that there was an impermissible logical leap between scientific psychiatric inquiry and moral-legal conclusions on the ultimate issue of insanity. This article reviews the origins, history, and vicissitudes of the Ultimate Issue Rule and analyzes the Statement on the Insanity Defense from both a legal and psychiatric perspective on the issue of whether psychiatrists should answer the ultimate question in insanity cases. The analysis suggests that APA's conclusions are not supported on scientific or evidentiary grounds, but may be warranted as a policy consideration to safeguard the public image of psychiatry.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

PubMed

Kreiner, D Scott; Hwang, Steven W; Easa, John E; Resnick, Daniel K; Baisden, Jamie L; Bess, Shay; Cho, Charles H; DePalma, Michael J; Dougherty, Paul; Fernand, Robert; Ghiselli, Gary; Hanna, Amgad S; Lamer, Tim; Lisi, Anthony J; Mazanec, Daniel J; Meagher, Richard J; Nucci, Robert C; Patel, Rakesh D; Sembrano, Jonathan N; Sharma, Anil K; Summers, Jeffrey T; Taleghani, Christopher K; Tontz, William L; Toton, John F

2014-01-01

The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. Systematic review and evidence-based clinical guideline. This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule. Copyright © 2014 Elsevier Inc. All rights reserved.

Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences.

PubMed

Tsoi, Bernice; Masucci, Lisa; Campbell, Kaitryn; Drummond, Michael; O'Reilly, Daria; Goeree, Ron

2013-08-01

A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.

Developing Academic English Language Proficiency Prototypes for 5th Grade Reading: Psychometric and Linguistic Profiles of Tasks. An Extended Executive Summary. CSE Report 720

ERIC Educational Resources Information Center

Bailey, Alison L.; Huang, Becky H.; Shin, Hye Won; Farnsworth, Tim; Butler, Frances A.

2007-01-01

Within an evidentiary framework for operationally defining academic English language proficiency (AELP), linguistic analyses of standards, classroom discourse, and textbooks have led to specifications for assessment of AELP. The test development process described here is novel due to the emphasis on using linguistic profiles to inform the …

The International Nexus Between Drugs and Terror: Lessons in Conflict and Diplomacy

DTIC Science & Technology

2010-12-01

claimed the intelligence recovered provided evidentiary documentation that there were verifiable links between the governments of both Ecuador and...not reflect the official policy or position of the Department of Defense or the U.S. Government . IRB Protocol number: N/A. 12a. DISTRIBUTION...Revolucionarias de Colombia) FBI Federal Bureau of Investigation GAO Government Accountability Office HRK Kurdistan Freedom Brigade (Hazen Rizgariya Kurdistan

Evidentiary Foundations.

DTIC Science & Technology

1986-01-01

STI . DI MARA RFrONE STATEMEI 86 3 11072 INTRODUCTION Presenting or opposing evidence is at the heart of all trial work. Wile there can be no...witness spouse in prescribed immoral conduct (e.g., transportation of the witness spouse in interstate commerce for purposes of prostitution ...divorce proceedings or legal separation proceedings have ever been begun by you since your marriage to Seaman Accused? 4.. f. There has never been an

Laboratory Information Management Systems for Forensic Laboratories: A White Paper for Directors and Decision Makers

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

Anthony Hendrickson; Brian Mennecke; Kevin Scheibe

2005-10-01

Modern, forensics laboratories need Laboratory Information Management Systems (LIMS) implementations that allow the lab to track evidentiary items through their examination lifecycle and also serve all pertinent laboratory personnel. The research presented here presents LIMS core requirements as viewed by respondents serving in different forensic laboratory capacities as well as different forensic laboratory environments. A product-development methodology was employed to evaluate the relative value of the key features that constitute a LIMS, in order to develop a set of relative values for these features and the specifics of their implementation. In addition to the results of the product development analysis,more » this paper also provides an extensive review of LIMS and provides an overview of the preparation and planning process for the successful upgrade or implementation of a LIMS. Analysis of the data indicate that the relative value of LIMS components are viewed differently depending upon respondents' job roles (i.e., evidence technicians, scientists, and lab management), as well as by laboratory size. Specifically, the data show that: (1) Evidence technicians place the most value on chain of evidence capabilities and on chain of custody tracking; (2) Scientists generally place greatest value on report writing and generation, and on tracking daughter evidence that develops during their analyses; (3) Lab. Managers place the greatest value on chain of custody, daughter evidence, and not surprisingly, management reporting capabilities; and (4) Lab size affects LIMS preference in that, while all labs place daughter evidence tracking, chain of custody, and management and analyst report generation as their top three priorities, the order of this prioritization is size dependent.« less

The advent of clinical standards for professional liability.

PubMed

Holzer, J F

1990-02-01

The development of clinically based written standards to reduce the frequency and severity of medical malpractice loss appears to be gaining in popularity among provider specialty groups and professional liability underwriters. To date, such standards have addressed problems in specialties such as obstetrics and anesthesia where dollar losses associated with malpractice claims have been high. Guidelines can be developed and used by providers on a purely voluntary basis or mandated on an involuntary basis by third parties such as malpractice insurance companies or legislators. Because the advent of risk-control standards is a relatively new phenomenon, formal scientific studies on the long-term benefits of such guidelines have not yet been published. However, it appears that sharp reductions of malpractice losses in specialties such as anesthesia have coincided with the implementation of formal written standards specifically designed for liability control. This has led some liability insurance carriers to decrease premiums associated with specialists following such standards. Many providers are understandably concerned about the potential use of written standards by plaintiff attorneys in medical malpractice suits. Although it is possible that such policies and guidelines could be admitted into evidence to show that a provider breached the legal duty or standard of care owed to a patient, it is uncertain whether these risk-control standards could ultimately pass the evidentiary rules of relevancy or materiality in a given lawsuit. It is clear, however, that the consensus-based process of creating clinical standards and guidelines specifically for controlling professional liability losses is itself a powerful and emerging standard for health care risk management programs.

Using anecdotal occurrence data for rare or elusive species: the illusion of reality and a call for evidentiary standards

Treesearch

Kevin S. McKelvey; Keith B. Aubry; Michael K. Schwartz

2008-01-01

Anecdotal occurrence data (unverifiable observations of organisms or their sign) and inconclusive physical data are often used to assess the current and historical ranges of rare or elusive species. However, the use of such data for species conservation can lead to large errors of omission and commission, which can influence the allocation of limited funds and the...

Using anecdotal occurrence data for rare or elusive species: The illusion of reality and a call for evidentiary standards

Treesearch

Kevin S. McKelvey; Keith B. Aubry; Michael K. Schwartz

2008-01-01

Anecdotal occurrence data (unverifiable observations of organisms or their sign) and inconclusive physical data are often used to assess the current and historical ranges of rare or elusive species. However, the use of such data for species conservation can lead to large errors of omission and commission, which can influence the allocation of limited funds and the...

UPTAKE OF RADIONUCLIDE METALS BY SPME FIBERS

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

Duff, M; S Crump, S; Robert02 Ray, R

2006-08-28

The Federal Bureau of Investigation (FBI) Laboratory currently does not have on site facilities for handling radioactive evidentiary materials and there are no established FBI methods or procedures for decontaminating high explosive (HE) and fire debris (FD) evidence while maintaining evidentiary value. One experimental method for the isolation of HE and FD residue involves using solid phase microextraction or SPME fibers to remove residue of interest. Due to their high affinity for organics, SPME fibers should have little affinity for most metals. However, no studies have measured the affinity of radionuclides for SPME fibers. The focus of this research wasmore » to examine the affinity of dissolved radionuclide ({sup 239/240}Pu, {sup 238}U, {sup 237}Np, {sup 85}Sr, {sup 133}Ba, {sup 137}Cs, {sup 60}Co and {sup 226}Ra) and stable radionuclide surrogate metals (Sr, Co, Ir, Re, Ni, Ba, Cs, Nb, Zr, Ru, and Nd) for SPME fibers at the exposure conditions that favor the uptake of HE and FD residues. Our results from radiochemical and mass spectrometric analyses indicate these metals have little measurable affinity for these SPME fibers during conditions that are conducive to HE and FD residue uptake with subsequent analysis by liquid or gas phase chromatography with mass spectrometric detection.« less

SOLID PHASE MICROEXTRACTION SAMPLING OF HIGH EXPLOSIVE RESIDUES IN THE PRESENCE OF RADIONUCLIDES AND RADIONUCLIDE SURROGATE METALS

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

Duff, M; S Crump, S; Robert02 Ray, R

2007-04-13

The Federal Bureau of Investigation (FBI) Laboratory currently does not have on site facilities for handling radioactive evidentiary materials and there are no established FBI methods or procedures for decontaminating high explosive (HE) evidence while maintaining evidentiary value. One experimental method for the isolation of HE residue involves using solid phase microextraction or SPME fibers to remove residue of interest. Due to their high affinity for organics, SPME fibers should have little affinity for most metals. However, no studies have measured the affinity of radionuclides for SPME fibers. The focus of this research was to examine the affinity of dissolvedmore » radionuclide ({sup 239/240}Pu, {sup 238}U, {sup 237}Np, {sup 85}Sr, {sup 133}Ba, {sup 137}Cs, {sup 60}Co and {sup 226}Ra) and stable radionuclide surrogate metals (Sr, Co, Ir, Re, Ni, Ba, Cs, Nb, Zr, Ru, and Nd) for SPME fibers at the exposure conditions that favor the uptake of HE residues. Our results from radiochemical and mass spectrometric analyses indicate these metals have little measurable affinity for these SPME fibers during conditions that are conducive to HE residue uptake with subsequent analysis by liquid or gas phase chromatography with mass spectrometric detection.« less

An evidence-based clinical guideline for the use of antithrombotic therapies in spine surgery.

PubMed

Bono, Christopher M; Watters, William C; Heggeness, Michael H; Resnick, Daniel K; Shaffer, William O; Baisden, Jamie; Ben-Galim, Peleg; Easa, John E; Fernand, Robert; Lamer, Tim; Matz, Paul G; Mendel, Richard C; Patel, Rajeev K; Reitman, Charles A; Toton, John F

2009-12-01

The objective of the North American Spine Society (NASS) Evidence-Based Clinical Guideline on antithrombotic therapies in spine surgery was to provide evidence-based recommendations to address key clinical questions surrounding the use of antithrombotic therapies in spine surgery. The guideline is intended to address these questions based on the highest quality clinical literature available on this subject as of February 2008. The goal of the guideline recommendations was to assist in delivering optimum, efficacious treatment with the goal of preventing thromboembolic events. To provide an evidence-based, educational tool to assist spine surgeons in minimizing the risk of deep venous thrombosis (DVT) and pulmonary embolism (PE). Systematic review and evidence-based clinical guideline. This report is from the Antithrombotic Therapies Work Group of the NASS Evidence-Based Guideline Development Committee. The work group was composed of multidisciplinary spine care specialists, all of whom were trained in the principles of evidence-based analysis. Each member of the group was involved in formatting a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subject of this report. A literature search addressing each question and using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional, evidence-based databases. The relevant literature was then independently rated by at least three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final grades of recommendation for the answers to each clinical question were arrived at via Web casts among members of the work group using standardized grades of recommendation. When Level I to IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. Fourteen clinical questions were formulated, addressing issues of incidence of DVT and PE in spine surgery and recommendations regarding utilization of mechanical prophylaxis and chemoprophylaxis in spine surgery. The answers to these 14 clinical questions are summarized in this article. The respective recommendations were graded by the strength of the supporting literature that was stratified by levels of evidence. A clinical guideline addressing the use of antithrombotic therapies in spine surgery has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to assist spine surgeons in minimizing the risk of DVT and PE. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

PubMed

Kreiner, D Scott; Baisden, Jamie; Mazanec, Daniel J; Patel, Rakesh D; Bess, Robert S; Burton, Douglas; Chutkan, Norman B; Cohen, Bernard A; Crawford, Charles H; Ghiselli, Gary; Hanna, Amgad S; Hwang, Steven W; Kilincer, Cumhur; Myers, Mark E; Park, Paul; Rosolowski, Karie A; Sharma, Anil K; Taleghani, Christopher K; Trammell, Terry R; Vo, Andrew N; Williams, Keith D

2016-12-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

Forensic Taxonomy of Android Social Apps.

PubMed

Azfar, Abdullah; Choo, Kim-Kwang Raymond; Liu, Lin

2017-03-01

An Android social app taxonomy incorporating artifacts that are of forensic interest will enable users and forensic investigators to identify the personally identifiable information (PII) stored by the apps. In this study, 30 popular Android social apps were examined. Artifacts of forensic interest (e.g., contacts lists, chronology of messages, and timestamp of an added contact) were recovered. In addition, images were located, and Facebook token strings used to tie account identities and gain access to information entered into Facebook by a user were identified. Based on the findings, a two-dimensional taxonomy of the forensic artifacts of the social apps is proposed. A comparative summary of existing forensic taxonomies of different categories of Android apps, designed to facilitate timely collection and analysis of evidentiary materials from Android devices, is presented. © 2016 American Academy of Forensic Sciences.

Method overtness, forensic autopsy, and the evidentiary suicide note: A multilevel National Violent Death Reporting System analysis.

PubMed

Rockett, Ian R H; Caine, Eric D; Stack, Steven; Connery, Hilary S; Nolte, Kurt B; Lilly, Christa L; Miller, Ted R; Nelson, Lewis S; Putnam, Sandra L; Nestadt, Paul S; Jia, Haomiao

2018-01-01

Higher prevalence of suicide notes could signify more conservatism in accounting and greater proneness to undercounting of suicide by method. We tested two hypotheses: (1) an evidentiary suicide note is more likely to accompany suicides by drug-intoxication and by other poisoning, as less violent and less forensically overt methods, than suicides by firearm and hanging/suffocation; and (2) performance of a forensic autopsy attenuates any observed association between overtness of method and the reported presence of a note. This multilevel (individual/county), multivariable analysis employed a generalized linear mixed model (GLMM). Representing the 17 states participating in the United States National Violent Death Reporting System throughout 2011-2013, the study population comprised registered suicides, aged 15 years and older. Decedents totaled 32,151. The outcome measure was relative odds of an authenticated suicide note. An authenticated suicide note was documented in 31% of the suicide cases. Inspection of the full multivariable model showed a suicide note was more likely to manifest among drug intoxication (adjusted odds ratio [OR], 1.70; 95% CI, 1.56, 1.85) and other poisoning suicides (OR, 2.12; 1.85, 2.42) than firearm suicides, the referent. Respective excesses were larger when there was no autopsy or autopsy status was unknown (OR, 1.86; 95% CI, 1.61, 2.14) and (OR, 2.25; 95% CI, 1.86, 2.72) relative to the comparisons with a forensic autopsy (OR, 1.62, 95% CI, 1.45, 1.82 and OR, 2.01; 95% CI, 1.66, 2.43). Hanging/suffocation suicides did not differ from the firearm referent given an autopsy. Suicide requires substantial affirmative evidence to establish manner of death, and affirmation of drug intoxication suicides appears to demand an especially high burden of proof. Findings and their implications argue for more stringent investigative standards, better training, and more resources to support comprehensive and accurate case ascertainment, as the foundation for developing evidence-based suicide prevention initiatives.

The American Psychological Association Task Force assessment of violent video games: Science in the service of public interest.

PubMed

Calvert, Sandra L; Appelbaum, Mark; Dodge, Kenneth A; Graham, Sandra; Nagayama Hall, Gordon C; Hamby, Sherry; Fasig-Caldwell, Lauren G; Citkowicz, Martyna; Galloway, Daniel P; Hedges, Larry V

2017-01-01

A task force of experts was convened by the American Psychological Association (APA) to update the knowledge and policy about the impact of violent video game use on potential adverse outcomes. This APA Task Force on Media Violence examined the existing literature, including the meta-analyses in the field, since the last APA report on media violence in 2005. Because the most recent meta-analyses were published in 2010 and reflected work through 2009, the task force conducted a search of the published studies from 2009-2013. These recently published articles were scored and assessed by a systematic evidentiary review, followed by a meta-analysis of the high utility studies, as documented in the evidentiary review. Consistent with the literature that we reviewed, we found that violent video game exposure was associated with: an increased composite aggression score; increased aggressive behavior; increased aggressive cognitions; increased aggressive affect, increased desensitization, and decreased empathy; and increased physiological arousal. The size of the effects was similar to that in prior meta-analyses, suggesting a stable result. Our task force concluded that violent video game use is a risk factor for adverse outcomes, but found insufficient studies to examine any potential link between violent video game use and delinquency or criminal behavior. Our technical report is the basis of this article. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Criminal profiling as expert witness evidence: The implications of the profiler validity research.

PubMed

Kocsis, Richard N; Palermo, George B

The use and development of the investigative tool colloquially known as criminal profiling has steadily increased over the past five decades throughout the world. Coupled with this growth has been a diversification in the suggested range of applications for this technique. Possibly the most notable of these has been the attempted transition of the technique from a tool intended to assist police investigations into a form of expert witness evidence admissible in legal proceedings. Whilst case law in various jurisdictions has considered with mutual disinclination the evidentiary admissibility of criminal profiling, a disjunction has evolved between these judicial examinations and the scientifically vetted research testing the accuracy (i.e., validity) of the technique. This article offers an analysis of the research directly testing the validity of the criminal profiling technique and the extant legal principles considering its evidentiary admissibility. This analysis reveals that research findings concerning the validity of criminal profiling are surprisingly compatible with the extant legal principles. The overall conclusion is that a discrete form of crime behavioural analysis is supported by the profiler validity research and could be regarded as potentially admissible expert witness evidence. Finally, a number of theoretical connections are also identified concerning the skills and qualifications of individuals who may feasibly provide such expert testimony. Copyright © 2016 Elsevier Ltd. All rights reserved.

Walter Bouldin Dam failure and reconstruction

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

None

1978-09-01

Walter Bouldin is one of several hydroelectric developments of Alabama Power Company. On February 10, 1975, an earth embankment section of Walter Bouldin Dam was breached, causing total evacuation of the forebay reservoir and rendering the 225-MW power plant inoperable. The Federal Power Commission instituted an investigation of the dam failure, and a report on the investigation was published in February 1976. Subsequently, an evidentiary hearing was held before an administrative law judge who issued his initial decision on August 19, 1976. The Commission, on April 21, 1977, issued its Opinion No. 795 in which it adopted the initial decisionmore » with modifications and terminated the investigation of failure of Walter Bouldin Dam. Opinion No. 795 directs the staff of the Bureau of Power to prepare, for the future guidance of the Commission, a report on the deficiencies which were found in its investigation, together with advice as to how such deficiencies have been and should be remedied. Also, it directs the staff of the Bureau of Power to address certain general recommendations included in the initial decision. This report was prepared in response to that directive and summaries information on the dam failure and its investigation; the evidentiary hearing; the judge's recommendations, the reconstruction of the Bouldin Dam; and the evalution and status of the Federal Energy Regulatory Commission Dam safety program. (LCL)« less

Estimation of gestational age from hand and foot length.

PubMed

Kumar, G P; Kumar, U K

1994-01-01

Abortion, foeticide and infanticide have been practised from time immemorial by both primitive and civilized societies. Establishing the precise duration of gestation is an important point in the total medical evidentiary picture of infanticide. In this study, an attempt has been made to establish the gestational age of the foetus using foot and hand length. This study will be of help in establishing the gestational age when the foetus is fragmented. Results obtained were significant in establishing the gestational age.

SOLID PHASE MICROEXTRACTION SAMPLING OF FIRE DEBRIS RESIDUES IN THE PRESENCE OF RADIONUCLIDE SURROGATE METALS

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

Duff, M; Keisha Martin, K; S Crump, S

2007-03-23

The Federal Bureau of Investigation (FBI) Laboratory currently does not have on site facilities for handling radioactive evidentiary materials and there are no established FBI methods or procedures for decontaminating highly radioactive fire debris (FD) evidence while maintaining evidentiary value. One experimental method for the isolation of FD residue from radionuclide metals involves using solid phase microextraction (SPME) fibers to remove the residues of interest. Due to their high affinity for organics, SPME fibers should have little affinity for most (radioactive) metals. The focus of this research was to develop an examination protocol that was applicable to safe work inmore » facilities where high radiation doses are shielded from the workers (as in radioactive shielded cells or ''hot cells''). We also examined the affinity of stable radionuclide surrogate metals (Co, Ir, Re, Ni, Ba, Cs, Nb, Zr and Nd) for sorption by the SPME fibers. This was done under exposure conditions that favor the uptake of FD residues under conditions that will provide little contact between the SPME and the FD material (such as charred carpet or wood that contains commonly-used accelerants). Our results from mass spectrometric analyses indicate that SPME fibers show promise for use in the room temperature head space uptake of organic FD residue (namely, diesel fuel oil, kerosene, gasoline and paint thinner) with subsequent analysis by gas chromatography (GC) with mass spectrometric (MS) detection. No inorganic forms of ignitable fluids were included in this study.« less

The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

PubMed

Wallach, Joshua D; Ross, Joseph S; Naci, Huseyin

2018-06-01

The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration's expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration's expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic "real-world" design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

Internal validation of STRmix™ for the interpretation of single source and mixed DNA profiles.

PubMed

Moretti, Tamyra R; Just, Rebecca S; Kehl, Susannah C; Willis, Leah E; Buckleton, John S; Bright, Jo-Anne; Taylor, Duncan A; Onorato, Anthony J

2017-07-01

The interpretation of DNA evidence can entail analysis of challenging STR typing results. Genotypes inferred from low quality or quantity specimens, or mixed DNA samples originating from multiple contributors, can result in weak or inconclusive match probabilities when a binary interpretation method and necessary thresholds (such as a stochastic threshold) are employed. Probabilistic genotyping approaches, such as fully continuous methods that incorporate empirically determined biological parameter models, enable usage of more of the profile information and reduce subjectivity in interpretation. As a result, software-based probabilistic analyses tend to produce more consistent and more informative results regarding potential contributors to DNA evidence. Studies to assess and internally validate the probabilistic genotyping software STRmix™ for casework usage at the Federal Bureau of Investigation Laboratory were conducted using lab-specific parameters and more than 300 single-source and mixed contributor profiles. Simulated forensic specimens, including constructed mixtures that included DNA from two to five donors across a broad range of template amounts and contributor proportions, were used to examine the sensitivity and specificity of the system via more than 60,000 tests comparing hundreds of known contributors and non-contributors to the specimens. Conditioned analyses, concurrent interpretation of amplification replicates, and application of an incorrect contributor number were also performed to further investigate software performance and probe the limitations of the system. In addition, the results from manual and probabilistic interpretation of both prepared and evidentiary mixtures were compared. The findings support that STRmix™ is sufficiently robust for implementation in forensic laboratories, offering numerous advantages over historical methods of DNA profile analysis and greater statistical power for the estimation of evidentiary weight, and can be used reliably in human identification testing. With few exceptions, likelihood ratio results reflected intuitively correct estimates of the weight of the genotype possibilities and known contributor genotypes. This comprehensive evaluation provides a model in accordance with SWGDAM recommendations for internal validation of a probabilistic genotyping system for DNA evidence interpretation. Copyright © 2017. Published by Elsevier B.V.

Medical examiners, coroners, and biologic terrorism: a guidebook for surveillance and case management.

PubMed

Nolte, Kurt B; Hanzlick, Randy L; Payne, Daniel C; Kroger, Andrew T; Oliver, William R; Baker, Andrew M; McGowan, Dennis E; DeJong, Joyce L; Bell, Micahel R; Guarner, Jeannette; Shieh, Wun-Ju; Zaki, Sherif R

2004-06-11

Medical examiners and coroners (ME/Cs) are essential public health partners for terrorism preparedness and response. These medicolegal investigators support both public health and public safety functions and investigate deaths that are sudden, suspicious, violent, unattended, and unexplained. Medicolegal autopsies are essential for making organism-specific diagnoses in deaths caused by biologic terrorism. This report has been created to 1) help public health officials understand the role of ME/Cs in biologic terrorism surveillance and response efforts and 2) provide ME/Cs with the detailed information required to build capacity for biologic terrorism preparedness in a public health context. This report provides background information regarding biologic terrorism, possible biologic agents, and the consequent clinicopathologic diseases, autopsy procedures, and diagnostic tests as well as a description of biosafety risks and standards for autopsy precautions. ME/Cs' vital role in terrorism surveillance requires consistent standards for collecting, analyzing, and disseminating data. Familiarity with the operational, jurisdictional, and evidentiary concerns involving biologic terrorism-related death investigation is critical to both ME/Cs and public health authorities. Managing terrorism-associated fatalities can be expensive and can overwhelm the existing capacity of ME/Cs. This report describes federal resources for funding and reimbursement for ME/C preparedness and response activities and the limited support capacity of the federal Disaster Mortuary Operational Response Team. Standards for communication are critical in responding to any emergency situation. This report, which is a joint collaboration between CDC and the National Association of Medical Examiners (NAME), describes the relationship between ME/Cs and public health departments, emergency management agencies, emergency operations centers, and the Incident Command System.

Establishing a database of Canadian feline mitotypes for forensic use.

PubMed

Arcieri, M; Agostinelli, G; Gray, Z; Spadaro, A; Lyons, L A; Webb, K M

2016-05-01

Hair shed by pet animals is often found and collected as evidence from crime scenes. Due to limitations such as small amount and low quality, mitochondrial DNA (mtDNA) is often the only type of DNA that can be used for linking the hair to a potential contributor. mtDNA has lower discriminatory power than nuclear DNA because multiple, unrelated individuals within a population can have the same mtDNA sequence, or mitotype. Therefore, to determine the evidentiary value of a match between crime scene evidence and a suspected contributor, the frequency of the mitotype must be known within the regional population. While mitotype frequencies have been determined for the United States' cat population, the frequencies are unknown for the Canadian cat population. Given the countries' close proximity and similar human settlement patterns, these populations may be homogenous, meaning a single, regional database may be used for estimating cat population mitotype frequencies. Here we determined the mitotype frequencies of the Canadian cat population and compared them to the United States' cat population. The two cat populations are statistically homogenous, however mitotype B6 was found in high frequency in Canada and extremely low frequency in the United States, meaning a single database would not be appropriate for North America. Furthermore, this work calls attention to these local spikes in frequency of otherwise rare mitotypes, instances of which exist around the world and have the potential to misrepresent the evidentiary value of matches compared to a regional database. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

PubMed

Matz, Paul G; Meagher, R J; Lamer, Tim; Tontz, William L; Annaswamy, Thiru M; Cassidy, R Carter; Cho, Charles H; Dougherty, Paul; Easa, John E; Enix, Dennis E; Gunnoe, Bryan A; Jallo, Jack; Julien, Terrence D; Maserati, Matthew B; Nucci, Robert C; O'Toole, John E; Rosolowski, Karie; Sembrano, Jonathan N; Villavicencio, Alan T; Witt, Jens-Peter

2016-03-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

America’s Air Force, The Future Calls: An Evidentiary and Theoretical Analysis Of The Roles And Missions Of A USAF Astronaut Corps

DTIC Science & Technology

2016-06-01

wT0S8qQLCOqh. ; Keith Wagstaff, “ Elon Musk Says SpaceX Will Send People to Mars By 2025,” NBC News, 29 January 2016, Accessed 22 February 2016...http://www.nbcnews.com/tech/tech-news/ elon - musk -says-spacex-will-send-people- mars-2025-n506891. 76. “About Mars One,” Mars-One.com, 2016, Accessed 22...January 2014. Accessed 22 February 2016. https://www.stratcom.mil/factsheets/11/Space_Control_and_Space_Surveillan ce/. Wagstaff, Keith. “ Elon Musk Says

Utilizing DNA analysis to combat the world wide plague of present day slavery – trafficking in persons

PubMed Central

Palmbach, Timothy; Blom, Jeffrey; Hoynes, Emily; Primorac, Dragan; Gaboury, Mario

2014-01-01

A study was conducted to determine if modern forensic DNA typing methods can be properly employed throughout the world with a final goal of increasing arrests, prosecutions, and convictions of perpetrators of modern day trafficking in persons while concurrently reducing the burden of victim testimony in legal proceedings. Without interruption of investigations, collection of samples containing DNA was conducted in a variety of settings. Evidentiary samples were analyzed on the ANDE Rapid DNA system. Many of the collected swabs yielded informative short tandem repeat profiles with Rapid DNA technology. PMID:24577820

Utilizing DNA analysis to combat the world wide plague of present day slavery--trafficking in persons.

PubMed

Palmbach, Timothy M; Blom, Jeffrey; Hoynes, Emily; Primorac, Dragan; Gaboury, Mario

2014-02-01

A study was conducted to determine if modern forensic DNA typing methods can be properly employed throughout the world with a final goal of increasing arrests, prosecutions, and convictions of perpetrators of modern day trafficking in persons while concurrently reducing the burden of victim testimony in legal proceedings. Without interruption of investigations, collection of samples containing DNA was conducted in a variety of settings. Evidentiary samples were analyzed on the ANDE Rapid DNA system. Many of the collected swabs yielded informative short tandem repeat profiles with Rapid DNA technology.

Analysis of the Digital Evidence Presented in the Yahoo! Case

NASA Astrophysics Data System (ADS)

Kwan, Michael; Chow, Kam-Pui; Lai, Pierre; Law, Frank; Tse, Hayson

The “Yahoo! Case” led to considerable debate about whether or not an IP address is personal data as defined by the Personal Data (Privacy) Ordinance (Chapter 486) of the Laws of Hong Kong. This paper discusses the digital evidence presented in the Yahoo! Case and evaluates the impact of the IP address on the verdict in the case. A Bayesian network is used to quantify the evidentiary strengths of hypotheses in the case and to reason about the evidence. The results demonstrate that the evidence about the IP address was significant to obtaining a conviction in the case.

Scientific Versus Experiential Evidence: Discourse Analysis of the Chronic Cerebrospinal Venous Insufficiency Debate in a Multiple Sclerosis Forum.

PubMed

Koschack, Janka; Weibezahl, Lara; Friede, Tim; Himmel, Wolfgang; Makedonski, Philip; Grabowski, Jens

2015-07-01

The vascular hypothesis of multiple sclerosis (MS), called chronic cerebrospinal venous insufficiency (CCSVI), and its treatment (known as liberation therapy) was immediately rejected by experts but enthusiastically gripped by patients who shared their experiences with other patients worldwide by use of social media, such as patient online forums. Contradictions between scientific information and lay experiences may be a source of distress for MS patients, but we do not know how patients perceive and deal with these contradictions. We aimed to understand whether scientific and experiential knowledge were experienced as contradictory in MS patient online forums and, if so, how these contradictions were resolved and how patients tried to reconcile the CCSVI debate with their own illness history and experience. By using critical discourse analysis, we studied CCSVI-related posts in the patient online forum of the German MS Society in a chronological order from the first post mentioning CCSVI to the time point when saturation was reached. For that time period, a total of 117 CCSVI-related threads containing 1907 posts were identified. We analyzed the interaction and communication practices of and between individuals, looked for the relation between concrete subtopics to identify more abstract discourse strands, and tried to reveal discourse positions explaining how users took part in the CCSVI discussion. There was an emotionally charged debate about CCSVI which could be generalized to 2 discourse strands: (1) the "downfall of the professional knowledge providers" and (2) the "rise of the nonprofessional treasure trove of experience." The discourse strands indicated that the discussion moved away from the question whether scientific or experiential knowledge had more evidentiary value. Rather, the question whom to trust (ie, scientists, fellow sufferers, or no one at all) was of fundamental significance. Four discourse positions could be identified by arranging them into the dimensions "trust in evidence-based knowledge," "trust in experience-based knowledge," and "subjectivity" (ie, the emotional character of contributions manifested by the use of popular rhetoric that seemed to mask a deep personal involvement). By critical discourse analysis of the CCSVI discussion in a patient online forum, we reconstruct a lay discourse about the evidentiary value of knowledge. We detected evidence criteria in this lay discourse that are different from those in the expert discourse. But we should be cautious to interpret this dissociation as a sign of an intellectual incapability to understand scientific evidence or a naïve trust in experiential knowledge. Instead, it might be an indication of cognitive dissonance reduction to protect oneself against contradictory information.

Evidence based vaccinology.

PubMed

Nalin, David R

2002-02-22

Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

Neuroprediction, Violence, and the Law: Setting the Stage.

PubMed

Nadelhoffer, Thomas; Bibas, Stephanos; Grafton, Scott; Kiehl, Kent A; Mansfield, Andrew; Sinnott-Armstrong, Walter; Gazzaniga, Michael

2012-04-01

In this paper, our goal is to (a) survey some of the legal contexts within which violence risk assessment already plays a prominent role, (b) explore whether developments in neuroscience could potentially be used to improve our ability to predict violence, and (c) discuss whether neuropredictive models of violence create any unique legal or moral problems above and beyond the well worn problems already associated with prediction more generally. In "Violence Risk Assessment and the Law", we briefly examine the role currently played by predictions of violence in three high stakes legal contexts: capital sentencing ("Violence Risk Assessment and Capital Sentencing"), civil commitment hearings ("Violence Risk Assessment and Civil Commitment"), and "sexual predator" statutes ("Violence Risk Assessment and Sexual Predator Statutes"). In "Clinical vs. Actuarial Violence Risk Assessment", we briefly examine the distinction between traditional clinical methods of predicting violence and more recently developed actuarial methods, exemplified by the Classification of Violence Risk (COVR) software created by John Monahan and colleagues as part of the MacArthur Study of Mental Disorder and Violence [1]. In "The Neural Correlates of Psychopathy", we explore what neuroscience currently tells us about the neural correlates of violence, using the recent neuroscientific research on psychopathy as our focus. We also discuss some recent advances in both data collection ("Cutting-Edge Data Collection: Genetically Informed Neuroimaging") and data analysis ("Cutting-Edge Data Analysis: Pattern Classification") that we believe will play an important role when it comes to future neuroscientific research on violence. In "The Potential Promise of Neuroprediction", we discuss whether neuroscience could potentially be used to improve our ability to predict future violence. Finally, in "The Potential Perils of Neuroprediction", we explore some potential evidentiary ("Evidentiary Issues"), constitutional ("Constitutional Issues"), and moral ("Moral Issues") issues that may arise in the context of the neuroprediction of violence.

Systematic review of strategies to manage and allocate scarce resources during mass casualty events.

PubMed

Timbie, Justin W; Ringel, Jeanne S; Fox, D Steven; Pillemer, Francesca; Waxman, Daniel A; Moore, Melinda; Hansen, Cynthia K; Knebel, Ann R; Ricciardi, Richard; Kellermann, Arthur L

2013-06-01

Efficient management and allocation of scarce medical resources can improve outcomes for victims of mass casualty events. However, the effectiveness of specific strategies has never been systematically reviewed. We analyze published evidence on strategies to optimize the management and allocation of scarce resources across a wide range of mass casualty event contexts and study designs. Our literature search included MEDLINE, Scopus, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Global Health, Web of Science, and the Cochrane Database of Systematic Reviews, from 1990 through late 2011. We also searched the gray literature, using the New York Academy of Medicine's Grey Literature Report and key Web sites. We included both English- and foreign-language articles. We included studies that evaluated strategies used in actual mass casualty events or tested through drills, exercises, or computer simulations. We excluded studies that lacked a comparison group or did not report quantitative outcomes. Data extraction, quality assessment, and strength of evidence ratings were conducted by a single researcher and reviewed by a second; discrepancies were reconciled by the 2 reviewers. Because of heterogeneity in outcome measures, we qualitatively synthesized findings within categories of strategies. From 5,716 potentially relevant citations, 74 studies met inclusion criteria. Strategies included reducing demand for health care services (18 studies), optimizing use of existing resources (50), augmenting existing resources (5), implementing crisis standards of care (5), and multiple categories (4). The evidence was sufficient to form conclusions on 2 strategies, although the strength of evidence was rated as low. First, as a strategy to reduce demand for health care services, points of dispensing can be used to efficiently distribute biological countermeasures after a bioterrorism attack or influenza pandemic, and their organization influences speed of distribution. Second, as a strategy to optimize use of existing resources, commonly used field triage systems do not perform consistently during actual mass casualty events. The number of high-quality studies addressing other strategies was insufficient to support conclusions about their effectiveness because of differences in study context, comparison groups, and outcome measures. Our literature search may have missed key resource management and allocation strategies because of their extreme heterogeneity. Interrater reliability was not assessed for quality assessments or strength of evidence ratings. Publication bias is likely, given the large number of studies reporting positive findings. The current evidence base is inadequate to inform providers and policymakers about the most effective strategies for managing or allocating scarce resources during mass casualty events. Consensus on methodological standards that encompass a range of study designs is needed to guide future research and strengthen the evidence base. Evidentiary standards should be developed to promote consensus interpretations of the evidence supporting individual strategies. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Optimal use of atherectomy in critical limb ischemia.

PubMed

Rundback, John H; Herman, Kevin Chaim

2014-09-01

Critical limb ischemia (CLI) is the most severe and debilitating form of peripheral arterial disease and is associated with high rates of limb loss and cardiovascular mortality. The unique physical environment of tibial occlusive disease underlying most CLI cases limits treatment options and long-term durability, with resulting frequent rates of persistent obstruction, restenosis, and reintervention. Atherectomy represents a potential strategy to improve acute and late results when treating patients with CLI. Available atherectomy devices each have specific performance characteristics, evidentiary rationale, and limitations that mandate a clear understanding of the optimal albeit evolving use of this category of interventional tools. Copyright © 2014 Elsevier Inc. All rights reserved.

Good epidemiology, good ethics: empirical and ethical dimensions of global public health.

PubMed

Rentmeester, Christy A; Dasgupta, Rajib

2012-01-01

This paper examines the following ethically and epidemiologically relevant challenges, as yet neglected in public health ethics: how to distribute resources and health risks and benefits, how to define evidentiary criteria that justify public health interventions, and how to define terms in which programme goals, successes, and failures will be assessed and monitored. We illuminate critical intersections of empirical and ethical dimensions of public health work, drawing upon three global public health interventions-inclusion of the Hepatitis B vaccine in the Universal Immunisation Programme, Universal Salt Iodisation, and the Global Polio Eradication Initiative-and suggest strategies for addressing and responding to them.

Medicare and Amyloid PET Imaging: The Battle Over Evidence.

PubMed

Maschke, Karen J; Gusmano, Michael K

2017-01-01

We examine a recent dispute regarding the Centers for Medicare and Medicaid Services' (CMS) refusal to unconditionally pay for amyloid positron emission tomography (PET) imaging for Medicare beneficiaries being assessed for Alzheimer's disease. CMS will only pay for amyloid PET imaging when patients are enrolled in clinical trials that meet certain criteria. The dispute reflects CMS's willingness in certain circumstances to require effectiveness evidence that differs from the Food and Drug Administration's standard for pre-market approval of a medical intervention and reveals how stakeholders with differing perspectives about evidentiary standards have played a role in attempting to shape the Medicare program's coverage policies.

Coma Recovery Scale-Revised: evidentiary support for hierarchical grading of level of consciousness.

PubMed

Gerrard, Paul; Zafonte, Ross; Giacino, Joseph T

2014-12-01

To investigate the neurobehavioral pattern of recovery of consciousness as reflected by performance on the subscales of the Coma Recovery Scale-Revised (CRS-R). Retrospective item response theory (IRT) and factor analysis. Inpatient rehabilitation facilities. Rehabilitation inpatients (N=180) with posttraumatic disturbance in consciousness who participated in a double-blinded, randomized, controlled drug trial. Not applicable. Scores on CRS-R subscales. The CRS-R was found to fit factor analytic models adhering to the assumptions of unidimensionality and monotonicity. In addition, subscales were mutually independent based on residual correlations. Nonparametric IRT reaffirmed the finding of monotonicity. A highly constrained confirmatory factor analysis model, which imposed equal factor loadings on all items, was found to fit the data well and was used to estimate a 1-parameter IRT model. This study provides evidence of the unidimensionality of the CRS-R and supports the hierarchical structure of the CRS-R subscales, suggesting that it is an effective tool for establishing diagnosis and monitoring recovery of consciousness after severe traumatic brain injury. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Dissemination of physical activity promotion interventions in underserved populations.

PubMed

Yancey, Antronette K; Ory, Marcia G; Davis, Sally M

2006-10-01

Achieving minimum physical activity levels of 30 or more minutes per day will require a variety of intervention strategies to engage each segment of an aging and increasingly ethnically diverse U.S. population. This article presents a focused review of the sparse literature on the diffusion of evidence-based physical activity interventions that are culturally appropriate for underserved populations. Related literature and experiential insights inform this discussion, because so few published studies report outcome data beyond the first diffusion phase of intervention development and evaluation. Three brief case studies are presented to further illustrate and exemplify key concepts and processes at several different stages in diffusing physical activity interventions. Successful engagement of underserved populations reflects a delicate balance between embracing group customs and values and recognizing the nonmonolithic nature of any sociodemographically defined group. The costs of failing to promulgate effective physical activity interventions in these groups continue to mount, in dollars, health, and lives. Researchers, practitioners, decision makers, and policymakers must partner to bridge the evidentiary gap so that the physically active lifestyle choices become the easier choices.

'We hold these truths to be self-evident': deconstructing 'evidence-based' medical practice.

PubMed

Devisch, Ignaas; Murray, Stuart J

2009-12-01

Rationale, aims and objectives Evidence-based medicine (EBM) claims to be based on 'evidence', rather than 'intuition'. However, EBM's fundamental distinction between quantitative 'evidence' and qualitative 'intuition' is not self-evident. The meaning of 'evidence' is unclear and no studies of quality exist to demonstrate the superiority of EBM in health care settings. This paper argues that, despite itself, EBM holds out only the illusion of conclusive scientific rigour for clinical decision making, and that EBM ultimately is unable to fulfil its own structural criteria for 'evidence'. Methods Our deconstructive analysis of EBM draws on the work of the French philosopher, Jacques Derrida. Deconstruction works in the name of justice to lay bare, to expose what has been hidden from view. In plain language, we deconstruct EBM's paradigm of 'evidence', the randomized controlled trial (RCT), to demonstrate that there cannot be incontrovertible evidence for EBM as such. We argue that EBM therefore 'auto-deconstructs' its own paradigm, and that medical practitioners, policymakers and patients alike ought to be aware of this failure within EBM itself. Results EBM's strict distinction between admissible evidence (based on RCTs) and other supposedly inadmissible evidence is not itself based on evidence, but rather, on intuition. In other words, according to EBM's own logic, there can be no 'evidentiary' basis for its distinction between admissible and inadmissible evidence. Ultimately, to uphold this fundamental distinction, EBM must seek recourse in (bio)political ideology and an epistemology akin to faith.

Scientific Versus Experiential Evidence: Discourse Analysis of the Chronic Cerebrospinal Venous Insufficiency Debate in a Multiple Sclerosis Forum

PubMed Central

Weibezahl, Lara; Friede, Tim; Himmel, Wolfgang; Makedonski, Philip; Grabowski, Jens

2015-01-01

Background The vascular hypothesis of multiple sclerosis (MS), called chronic cerebrospinal venous insufficiency (CCSVI), and its treatment (known as liberation therapy) was immediately rejected by experts but enthusiastically gripped by patients who shared their experiences with other patients worldwide by use of social media, such as patient online forums. Contradictions between scientific information and lay experiences may be a source of distress for MS patients, but we do not know how patients perceive and deal with these contradictions. Objective We aimed to understand whether scientific and experiential knowledge were experienced as contradictory in MS patient online forums and, if so, how these contradictions were resolved and how patients tried to reconcile the CCSVI debate with their own illness history and experience. Methods By using critical discourse analysis, we studied CCSVI-related posts in the patient online forum of the German MS Society in a chronological order from the first post mentioning CCSVI to the time point when saturation was reached. For that time period, a total of 117 CCSVI-related threads containing 1907 posts were identified. We analyzed the interaction and communication practices of and between individuals, looked for the relation between concrete subtopics to identify more abstract discourse strands, and tried to reveal discourse positions explaining how users took part in the CCSVI discussion. Results There was an emotionally charged debate about CCSVI which could be generalized to 2 discourse strands: (1) the “downfall of the professional knowledge providers” and (2) the “rise of the nonprofessional treasure trove of experience.” The discourse strands indicated that the discussion moved away from the question whether scientific or experiential knowledge had more evidentiary value. Rather, the question whom to trust (ie, scientists, fellow sufferers, or no one at all) was of fundamental significance. Four discourse positions could be identified by arranging them into the dimensions “trust in evidence-based knowledge,” “trust in experience-based knowledge,” and “subjectivity” (ie, the emotional character of contributions manifested by the use of popular rhetoric that seemed to mask a deep personal involvement). Conclusions By critical discourse analysis of the CCSVI discussion in a patient online forum, we reconstruct a lay discourse about the evidentiary value of knowledge. We detected evidence criteria in this lay discourse that are different from those in the expert discourse. But we should be cautious to interpret this dissociation as a sign of an intellectual incapability to understand scientific evidence or a naïve trust in experiential knowledge. Instead, it might be an indication of cognitive dissonance reduction to protect oneself against contradictory information. PMID:26133525

Public healthcare interests require strict competition enforcement.

PubMed

Loozen, Edith M H

2015-07-01

Several countries have introduced competition in their health systems in order to maintain the supply of high quality health care in a cost-effective manner. The introduction of competition triggers competition enforcement. Since healthcare is characterized by specific market failures, many favor healthcare-specific competition enforcement in order not only to account for the competition interest, but also for the healthcare interests. The question is whether healthcare systems based on competition can succeed when competition enforcement deviates from standard practice. This paper analyzes whether healthcare-specific competition enforcement is theoretically sound and practically effective. This is exemplified by the Dutch system that is based on regulated competition and thus crucially depends on getting competition enforcement right. Governments are responsible for correcting market failures. Markets are responsible for maximizing the public healthcare interests. By securing sufficient competitive pressure, competition enforcement makes sure they do. When interpreted according to welfare-economics, competition law takes into account both costs and benefits specific market behavior may have for healthcare. Competition agencies and judiciary are not legitimized to deviate from standard evidentiary requirements. Dutch case law shows that healthcare-specific enforcement favors the healthcare undertakings concerned, but to the detriment of public health care. Healthcare-specific competition enforcement is conceptually flawed and counterproductive. In order for healthcare systems based on competition to succeed, competition enforcement should be strict. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Nature and Utilization of Civil Commitment for Substance Abuse in the United States.

PubMed

Christopher, Paul P; Pinals, Debra A; Stayton, Taylor; Sanders, Kellie; Blumberg, Lester

2015-09-01

Substance abuse is a leading cause of morbidity and mortality in the United States. Although civil commitment has been used to address substance abuse for more than a century, little is known today about the nature and use of substance-related commitment laws in the United States. We examined statutes between July 2010 and October 2012 from all 50 states and the District of Columbia for provisions authorizing civil commitment of adults for substance abuse and recorded the criteria and evidentiary standard for commitment and the location and the maximum duration of commitment orders. High-level state representatives evaluated these data and provided information on the use of commitment. Thirty-three states have statutory provisions for the civil commitment of persons because of substance abuse. The application of these statutes ranged from a few commitment cases to thousands annually. Although dangerousness was the most common basis for commitment, many states permitted it in other contexts. The maximum duration of treatment ranged from less than 1 month to more than 1 year for both initial and subsequent civil commitment orders. These findings show wide variability in the nature and application of civil commitment statutes for substance abuse in the United States. Such diversity reflects a lack of consensus on the role that civil commitment should play in managing substance abuse and the problems associated with it. © 2015 American Academy of Psychiatry and the Law.

Population screening for genetic disorders in the 21st century: evidence, economics, and ethics.

PubMed

Grosse, S D; Rogowski, W H; Ross, L F; Cornel, M C; Dondorp, W J; Khoury, M J

2010-01-01

Proposals for population screening for genetic diseases require careful scrutiny by decision makers because of the potential for harms and the need to demonstrate benefits commensurate with the opportunity cost of resources expended. We review current evidence-based processes used in the United States, the United Kingdom, and the Netherlands to assess genetic screening programs, including newborn screening programs, carrier screening, and organized cascade testing of relatives of patients with genetic syndromes. In particular, we address critical evidentiary, economic, and ethical issues that arise in the appraisal of screening tests offered to the population. Specific case studies include newborn screening for congenital adrenal hyperplasia and cystic fibrosis and adult screening for hereditary hemochromatosis. Organizations and countries often reach different conclusions about the suitability of screening tests for implementation on a population basis. Deciding when and how to introduce pilot screening programs is challenging. In certain cases, e.g., hereditary hemochromatosis, a consensus does not support general screening although cascade screening may be cost-effective. Genetic screening policies have often been determined by technological capability, advocacy, and medical opinion rather than through a rigorous evidence-based review process. Decision making should take into account principles of ethics and opportunity costs. Copyright 2009 S. Karger AG, Basel.

The landscape of knowledge translation interventions in cancer control: What do we know and where to next? A review of systematic reviews

PubMed Central

2011-01-01

Background Effective implementation strategies are needed to optimize advancements in the fields of cancer diagnosis, treatment, survivorship, and end-of-life care. We conducted a review of systematic reviews to better understand the evidentiary base of implementation strategies in cancer control. Methods Using three databases, we conducted a search and identified English-language systematic reviews published between 2005 and 2010 that targeted consumer, professional, organizational, regulatory, or financial interventions, tested exclusively or partially in a cancer context (primary focus); generic or non-cancer-specific reviews were also considered. Data were extracted, appraised, and analyzed by members of the research team, and research ideas to advance the field were proposed. Results Thirty-four systematic reviews providing 41 summaries of evidence on 19 unique interventions comprised the evidence base. AMSTAR quality ratings ranged between 2 and 10. Team members rated most of the interventions as promising and in need of further research, and 64 research ideas were identified. Conclusions While many interventions show promise of effectiveness in the cancer-control context, few reviews were able to conclude definitively in favor of or against a specific intervention. We discuss the complexity of implementation research and offer suggestions to advance the science in this area. PMID:22185329

Judging sex.

PubMed

Tuerkheimer, Deborah

2012-09-01

This Article explores the curious jurisprudence of sexual patterns and how it constructs female sexuality. In modern rape law, the "unchaste character inference" expressly prohibited by the rape shield endures. Though the boundaries that circumscribe appropriate sexual conduct have shifted over time, courts persist in making normative judgments about women's sexuality. Cloaked in the legitimizing rhetoric of sexual patterns, retrograde notions of deviancy are substituting for rational deliberation on the question of consent. As rape shield law enters its fourth decade, it continues to defy reason, both in application and in theory. The proposed evidentiary approach promises to improve judicial decision making in rape cases, while reorienting the law toward the female sexual subject and the contingency of her consent.

Our Environment in Miniature: Dust and the Early Twentieth-Century Forensic Imagination

PubMed Central

BURNEY, IAN

2013-01-01

This article explores the articulation of the crime scene as a distinct space of theory and practice in the early twentieth century. In particular it focuses on the evidentiary hopes invested in what would at first seem an unpromising forensic object: dust. Ubiquitous and, to the uninitiated, characterless, dust nevertheless featured as an exemplary object of cutting-edge forensic analysis in two contemporary domains: writings of criminologists and works of detective fiction. The article considers how in these texts dust came to mark the furthest reach of a new forensic capacity they were promoting, one that drew freely upon the imagination to invest crime scene traces with meaning. PMID:23766552

Neuroprediction, Violence, and the Law: Setting the Stage

PubMed Central

Bibas, Stephanos; Grafton, Scott; Kiehl, Kent A.; Mansfield, Andrew; Sinnott-Armstrong, Walter; Gazzaniga, Michael

2014-01-01

In this paper, our goal is to (a) survey some of the legal contexts within which violence risk assessment already plays a prominent role, (b) explore whether developments in neuroscience could potentially be used to improve our ability to predict violence, and (c) discuss whether neuropredictive models of violence create any unique legal or moral problems above and beyond the well worn problems already associated with prediction more generally. In “Violence Risk Assessment and the Law”, we briefly examine the role currently played by predictions of violence in three high stakes legal contexts: capital sentencing (“Violence Risk Assessment and Capital Sentencing”), civil commitment hearings (“Violence Risk Assessment and Civil Commitment”), and “sexual predator” statutes (“Violence Risk Assessment and Sexual Predator Statutes”). In “Clinical vs. Actuarial Violence Risk Assessment”, we briefly examine the distinction between traditional clinical methods of predicting violence and more recently developed actuarial methods, exemplified by the Classification of Violence Risk (COVR) software created by John Monahan and colleagues as part of the MacArthur Study of Mental Disorder and Violence [1]. In “The Neural Correlates of Psychopathy”, we explore what neuroscience currently tells us about the neural correlates of violence, using the recent neuroscientific research on psychopathy as our focus. We also discuss some recent advances in both data collection (“Cutting-Edge Data Collection: Genetically Informed Neuroimaging”) and data analysis (“Cutting-Edge Data Analysis: Pattern Classification”) that we believe will play an important role when it comes to future neuroscientific research on violence. In “The Potential Promise of Neuroprediction”, we discuss whether neuroscience could potentially be used to improve our ability to predict future violence. Finally, in “The Potential Perils of Neuroprediction”, we explore some potential evidentiary (“Evidentiary Issues”), constitutional (“Constitutional Issues”), and moral (“Moral Issues”) issues that may arise in the context of the neuroprediction of violence. PMID:25083168

What implementation interventions increase cancer screening rates? a systematic review

PubMed Central

2011-01-01

Background Appropriate screening may reduce the mortality and morbidity of colorectal, breast, and cervical cancers. However, effective implementation strategies are warranted if the full benefits of screening are to be realized. As part of a larger agenda to create an implementation guideline, we conducted a systematic review to evaluate interventions designed to increase the rate of breast, cervical, and colorectal cancer (CRC) screening. The interventions considered were: client reminders, client incentives, mass media, small media, group education, one-on-one education, reduction in structural barriers, reduction in out-of-pocket costs, provider assessment and feedback interventions, and provider incentives. Our primary outcome, screening completion, was calculated as the overall median post-intervention absolute percentage point (PP) change in completed screening tests. Methods Our first step was to conduct an iterative scoping review in the research area. This yielded three relevant high-quality systematic reviews. Serving as our evidentiary foundation, we conducted a formal update. Randomized controlled trials and cluster randomized controlled trials, published between 2004 and 2010, were searched in MEDLINE, EMBASE and PSYCHinfo. Results The update yielded 66 studies new eligible studies with 74 comparisons. The new studies ranged considerably in quality. Client reminders, small media, and provider audit and feedback appear to be effective interventions to increase the uptake of screening for three cancers. One-on-one education and reduction of structural barriers also appears effective, but their roles with CRC and cervical screening, respectively, are less established. More study is required to assess client incentives, mass media, group education, reduction of out-of-pocket costs, and provider incentive interventions. Conclusion The new evidence generally aligns with the evidence and conclusions from the original systematic reviews. This review served as the evidentiary foundation for an implementation guideline. Poor reporting, lack of precision and consistency in defining operational elements, and insufficient consideration of context and differences among populations are areas for additional research. PMID:21958556

Addiction, 12-Step Programs, and Evidentiary Standards for Ethically and Clinically Sound Treatment Recommendations: What Should Clinicians Do?

PubMed

Mendola, Annette; Gibson, Richard L

2016-06-01

Addiction is a complex phenomenon characterized by a loss of control and compulsive, habitual behavior. Since there is no single, specific cause for addiction, there is no single, standard treatment for it. A variety of approaches are used, including counseling, psychotherapy, medications, and mutual help groups (MHG). The best known and most widely available approach to addiction is 12-step (TS) programs of recovery, a variety of MHG. These have been lauded as lifesaving by some and criticized by others. We argue that TS programs are an appropriate mode of help for those seeking to quit an addiction but should not be the only approach considered. © 2016 American Medical Association. All Rights Reserved. ISSN 2376-6980.

From public health genomics to precision public health: a 20-year journey.

PubMed

Khoury, Muin J; Bowen, M Scott; Clyne, Mindy; Dotson, W David; Gwinn, Marta L; Green, Ridgely Fisk; Kolor, Katherine; Rodriguez, Juan L; Wulf, Anja; Yu, Wei

2018-06-01

In this paper, we review the evolution of the field of public health genomics in the United States in the past two decades. Public health genomics focuses on effective and responsible translation of genomic science into population health benefits. We discuss the relationship of the field to the core public health functions and essential services, review its evidentiary foundation, and provide examples of current US public health priorities and applications. We cite examples of publications to illustrate how Genetics in Medicine reflected the evolution of the field. We also reflect on how public-health genomics is contributing to the emergence of "precision public health" with near-term opportunities offered by the US Precision Medicine (AllofUs) Initiative.

FDA: Evidentiary Standards for Drug Development and Approval

PubMed Central

Katz, Russell

2004-01-01

Summary: The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. PMID:15717032

Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan.

PubMed

Munsie, Megan; Lysaght, Tamra; Hendl, Tereza; Tan, Hui-Yin Lynn; Kerridge, Ian; Stewart, Cameron

2017-11-10

This article examines online marketing practices of Japanese and Australian clinics offering putative autologous stem cell treatments. We conducted google searches for keywords related to stem cell therapy and stem cell clinics in English and Japanese. We identified websites promoting 88 point-of-sale clinics in Japan and 70 in Australia. Our findings provide further evidence of the rapid global growth in clinics offering unproven stem cell interventions. We also show that these clinics adopt strategies to promote their services as though they are consistent with evidentiary and ethical standards of science, research and medicine. Unless addressed, these practices risk harming not only vulnerable patients but also undermining public trust in science and medicine.

Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care.

PubMed

Swift, Brandon; Jain, Lokesh; White, Craig; Chandrasekaran, Vasu; Bhandari, Aman; Hughes, Dyfrig A; Jadhav, Pravin R

2018-05-16

While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review provides an overview of real-world data (RWD) and related advances in the regulatory framework, and discusses their impact on clinical research and development. A framework for linking drug development decisions with the value proposition of the drug, utilizing pharmacokinetic-pharmacodynamic-pharmacoeconomic models, is introduced. The summary presented here is based on the presentations and discussion at the symposium entitled Innovation at the Intersection of Clinical Trials and Real-World Data to Advance Patient Care at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting. © 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Colorectal Cancer Screening in Average Risk Populations: Evidence Summary.

PubMed

Tinmouth, Jill; Vella, Emily T; Baxter, Nancy N; Dubé, Catherine; Gould, Michael; Hey, Amanda; Ismaila, Nofisat; McCurdy, Bronwen R; Paszat, Lawrence

2016-01-01

Introduction. The objectives of this systematic review were to evaluate the evidence for different CRC screening tests and to determine the most appropriate ages of initiation and cessation for CRC screening and the most appropriate screening intervals for selected CRC screening tests in people at average risk for CRC. Methods. Electronic databases were searched for studies that addressed the research objectives. Meta-analyses were conducted with clinically homogenous trials. A working group reviewed the evidence to develop conclusions. Results. Thirty RCTs and 29 observational studies were included. Flexible sigmoidoscopy (FS) prevented CRC and led to the largest reduction in CRC mortality with a smaller but significant reduction in CRC mortality with the use of guaiac fecal occult blood tests (gFOBTs). There was insufficient or low quality evidence to support the use of other screening tests, including colonoscopy, as well as changing the ages of initiation and cessation for CRC screening with gFOBTs in Ontario. Either annual or biennial screening using gFOBT reduces CRC-related mortality. Conclusion. The evidentiary base supports the use of FS or FOBT (either annual or biennial) to screen patients at average risk for CRC. This work will guide the development of the provincial CRC screening program.

Spanish language proficiency among providers and Latino clients' engagement in substance abuse treatment.

PubMed

Guerrero, Erick G; Khachikian, Tenie; Kim, Tina; Kong, Yinfei; Vega, William A

2013-12-01

Quality of care, such as provision of services in Spanish, is a common factor believed to improve treatment engagement among Spanish-speaking Latinos in health care. However, there is little evidence that Spanish language proficiency among providers increases treatment access and retention in publicly funded substance abuse treatment. We analyzed client and program data collected in 2010-2011 from publicly funded treatment programs in Los Angeles County, California. An analytic sample of 1903 Latino clients nested within 40 treatment programs located in minority communities was analyzed using multilevel negative binomial regressions on days to initiate and spent in treatment. As hypothesized, Spanish language proficiency was negatively associated with client wait time and positively associated with retention in treatment, after controlling for individual and program characteristics. The path analysis models showed that Spanish language proficiency played a mediating role between professional accreditation and client wait time and retention. These preliminary findings provide an evidentiary base for the role of providers' Spanish language proficiency and Latino engagement in treatment for a population at high risk of treatment dropout. Implications related to health care reform legislation, which seeks to enhance linguistically competent care, are discussed. © 2013.

Electronic Health Record Design and Implementation for Pharmacogenomics: a Local Perspective

PubMed Central

Peterson, Josh F.; Bowton, Erica; Field, Julie R.; Beller, Marc; Mitchell, Jennifer; Schildcrout, Jonathan; Gregg, William; Johnson, Kevin; Jirjis, Jim N; Roden, Dan M.; Pulley, Jill M.; Denny, Josh C.

2014-01-01

Purpose The design of electronic health records (EHR) to translate genomic medicine into clinical care is crucial to successful introduction of new genomic services, yet there are few published guides to implementation. Methods The design, implemented features, and evolution of a locally developed EHR that supports a large pharmacogenomics program at a tertiary care academic medical center was tracked over a 4-year development period. Results Developers and program staff created EHR mechanisms for ordering a pharmacogenomics panel in advance of clinical need (preemptive genotyping) and in response to a specific drug indication. Genetic data from panel-based genotyping were sequestered from the EHR until drug-gene interactions (DGIs) met evidentiary standards and deemed clinically actionable. A service to translate genotype to predicted drug response phenotype populated a summary of DGIs, triggered inpatient and outpatient clinical decision support, updated laboratory records, and created gene results within online personal health records. Conclusion The design of a locally developed EHR supporting pharmacogenomics has generalizable utility. The challenge of representing genomic data in a comprehensible and clinically actionable format is discussed along with reflection on the scalability of the model to larger sets of genomic data. PMID:24009000

An Android Communication App Forensic Taxonomy.

PubMed

Azfar, Abdullah; Choo, Kim-Kwang Raymond; Liu, Lin

2016-09-01

Due to the popularity of Android devices and applications (apps), Android forensics is one of the most studied topics within mobile forensics. Communication apps, such as instant messaging and Voice over IP (VoIP), are one popular app category used by mobile device users, including criminals. Therefore, a taxonomy outlining artifacts of forensic interest involving the use of Android communication apps will facilitate the timely collection and analysis of evidentiary materials from such apps. In this paper, 30 popular Android communication apps were examined, where a logical extraction of the Android phone images was collected using XRY, a widely used mobile forensic tool. Various information of forensic interest, such as contact lists and chronology of messages, was recovered. Based on the findings, a two-dimensional taxonomy of the forensic artifacts of the communication apps is proposed, with the app categories in one dimension and the classes of artifacts in the other dimension. Finally, the artifacts identified in the study of the 30 communication apps are summarized using the taxonomy. It is expected that the proposed taxonomy and the forensic findings in this paper will assist forensic investigations involving Android communication apps. © 2016 American Academy of Forensic Sciences.

Microchip-based cell lysis and DNA extraction from sperm cells for application to forensic analysis.

PubMed

Bienvenue, Joan M; Duncalf, Natalie; Marchiarullo, Daniel; Ferrance, Jerome P; Landers, James P

2006-03-01

The current backlog of casework is among the most significant challenges facing crime laboratories at this time. While the development of next-generation microchip-based technology for expedited forensic casework analysis offers one solution to this problem, this will require the adaptation of manual, large-volume, benchtop chemistry to small volume microfluidic devices. Analysis of evidentiary materials from rape kits where semen or sperm cells are commonly found represents a unique set of challenges for on-chip cell lysis and DNA extraction that must be addressed for successful application. The work presented here details the development of a microdevice capable of DNA extraction directly from sperm cells for application to the analysis of sexual assault evidence. A variety of chemical lysing agents are assessed for inclusion in the extraction protocol and a method for DNA purification from sperm cells is described. Suitability of the extracted DNA for short tandem repeat (STR) analysis is assessed and genetic profiles shown. Finally, on-chip cell lysis methods are evaluated, with results from fluorescence visualization of cell rupture and DNA extraction from an integrated cell lysis and purification with subsequent STR amplification presented. A method for on-chip cell lysis and DNA purification is described, with considerations toward inclusion in an integrated microdevice capable of both differential cell sorting and DNA extraction. The results of this work demonstrate the feasibility of incorporating microchip-based cell lysis and DNA extraction into forensic casework analysis.

A ranking index for quality assessment of forensic DNA profiles forensic DNA profiles

PubMed Central

2010-01-01

Background Assessment of DNA profile quality is vital in forensic DNA analysis, both in order to determine the evidentiary value of DNA results and to compare the performance of different DNA analysis protocols. Generally the quality assessment is performed through manual examination of the DNA profiles based on empirical knowledge, or by comparing the intensities (allelic peak heights) of the capillary electrophoresis electropherograms. Results We recently developed a ranking index for unbiased and quantitative quality assessment of forensic DNA profiles, the forensic DNA profile index (FI) (Hedman et al. Improved forensic DNA analysis through the use of alternative DNA polymerases and statistical modeling of DNA profiles, Biotechniques 47 (2009) 951-958). FI uses electropherogram data to combine the intensities of the allelic peaks with the balances within and between loci, using Principal Components Analysis. Here we present the construction of FI. We explain the mathematical and statistical methodologies used and present details about the applied data reduction method. Thereby we show how to adapt the ranking index for any Short Tandem Repeat-based forensic DNA typing system through validation against a manual grading scale and calibration against a specific set of DNA profiles. Conclusions The developed tool provides unbiased quality assessment of forensic DNA profiles. It can be applied for any DNA profiling system based on Short Tandem Repeat markers. Apart from crime related DNA analysis, FI can therefore be used as a quality tool in paternal or familial testing as well as in disaster victim identification. PMID:21062433

Enhancing access and retention in substance abuse treatment: the role of Medicaid payment acceptance and cultural competence.

PubMed

Guerrero, Erick G

2013-10-01

Health insurance coverage and quality of care are common factors believed to improve access for and retention of racial and ethnic minority groups in health care. However, there is little evidence that acceptance of public insurance and provision of culturally responsive care decrease wait time and retention of minority populations in community-based substance abuse treatment. We analyzed client and program data collected in 2010-2011 from publicly funded treatment programs in Los Angeles County, CA. An analytical sample of 13,328 primarily African American and Latino clients nested within 104 treatment programs located in minority communities was analyzed using multilevel negative binomial regressions on count measures of days to initiate and days spent in treatment. Programs that accepted public insurance (p<.001) and in which staff reported personal involvement (p<.01) and linkages and resources with minority communities (p<.001) were negatively associated with client wait time. Similarly, programs with culturally responsive policies and assessment and treatment practices (p<.05) were positively associated with retention in treatment, after controlling for individual and program characteristics. These preliminary findings provide an evidentiary base for the role of community-based financial and cultural practices in improving accessibility and treatment adherence in a population at high risk of treatment dropout. Implications related to health care reform legislation, which seeks to expand public insurance and enhance culturally competent care, are discussed. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A systematic review of the evidence concerning the economic impact of employee-focused health promotion and wellness programs.

PubMed

Lerner, Debra; Rodday, Angie Mae; Cohen, Joshua T; Rogers, William H

2013-02-01

To assess the evidence regarding the economic impact of worker health promotion programs. Peer-reviewed research articles were identified from a database search. Included articles were published between January 2000 and May 2010, described a study conducted in the United States that used an experimental or quasi-experimental study design and analyzed medical, pharmacy (direct), and/or work productivity (indirect) costs. A multidisciplinary review team, following specific criteria, assessed research quality. Of 2030 retrieved articles, 44 met study inclusion criteria. Of these, 10 were of sufficient quality to be considered evidentiary. Only three analyzed direct and indirect costs. Evidence regarding economic impact is limited and inconsistent. Higher-quality research is needed to demonstrate the value of specific programs.

Balancing Vaccine Science and National Policy Objectives: Lessons From the National Vaccine Injury Compensation Program Omnibus Autism Proceedings

PubMed Central

Keelan, Jennifer

2011-01-01

The US Court of Federal Claims, which adjudicates cases for the National Vaccine Injury Compensation Program, has been confronted with more than 5000 cases submitted on behalf of children with autism spectrum disorders, seeking to link the condition to vaccination. Through a test case process, the Omnibus Autism Proceedings have in every instance found no association between autism spectrum disorders and vaccines. However, vaccine advocates have criticized the courts for having an overly permissive evidentiary test for causation and for granting credence to insupportable accusations of vaccine harm. In fact, the courts have functioned as intended and have allowed for a fair hearing of vaccine concerns while maintaining confidence in vaccines and providing protection to vaccine manufacturers. PMID:21940934

A prospective multiple case study of the impact of emerging scientific evidence on established colorectal cancer screening programs: a study protocol.

PubMed

Geddie, Hannah; Dobrow, Mark J; Hoch, Jeffrey S; Rabeneck, Linda

2012-06-01

Health-policy decision making is a complex and dynamic process, for which strong evidentiary support is required. This includes scientifically produced research, as well as information that relates to the context in which the decision takes place. Unlike scientific evidence, this "contextual evidence" is highly variable and often includes information that is not scientifically produced, drawn from sources such as political judgement, program management experience and knowledge, or public values. As the policy decision-making process is variable and difficult to evaluate, it is often unclear how this heterogeneous evidence is identified and incorporated into "evidence-based policy" decisions. Population-based colorectal cancer screening poses an ideal context in which to examine these issues. In Canada, colorectal cancer screening programs have been established in several provinces over the past five years, based on the fecal occult blood test (FOBT) or the fecal immunochemical test. However, as these programs develop, new scientific evidence for screening continues to emerge. Recently published randomized controlled trials suggest that the use of flexible sigmoidoscopy for population-based screening may pose a greater reduction in mortality than the FOBT. This raises the important question of how policy makers will address this evidence, given that screening programs are being established or are already in place. This study will examine these issues prospectively and will focus on how policy makers monitor emerging scientific evidence and how both scientific and contextual evidence are identified and applied for decisions about health system improvement. This study will employ a prospective multiple case study design, involving participants from Ontario, Alberta, Manitoba, Nova Scotia, and Quebec. In each province, data will be collected via document analysis and key informant interviews. Documents will include policy briefs, reports, meeting minutes, media releases, and correspondence. Interviews will be conducted in person with senior administrative leaders, government officials, screening experts, and high-level cancer system stakeholders. The proposed study comprises the third and final phase of an Emerging Team grant to address the challenges of health-policy decision making and colorectal cancer screening decisions in Canada. This study will contribute a unique prospective look at how policy makers address new, emerging scientific evidence in several different policy environments and at different stages of program planning and implementation. Findings will provide important insight into the various approaches that are or should be used to monitor emerging evidence, the relative importance of scientific versus contextual evidence for decision making, and the tools and processes that may be important to support challenging health-policy decisions.

Developing the evidentiary basis for family medicine in the global context

PubMed Central

Ponka, David; Rouleau, Katherine; Arya, Neil; Redwood-Campbell, Lynda; Woollard, Robert; Siedlecki, Basia; Dunikowski, Lynn

2015-01-01

Abstract Objective To provide an overview of the main methodologic challenges to finding definitive evidence of the positive effects of family medicine and family medicine training on a global scale. Composition of the committee In 2012, 2013, and 2014, the College of Family Physicians of Canada hosted the Besrour Conferences to reflect on its role in advancing the discipline of family medicine globally. The Besrour Papers Working Group, which was struck at the 2013 conference, was tasked with developing a series of papers to highlight the key issues, lessons learned, and outcomes emerging from the various activities of the Besrour collaboration. The working group comprised members of various academic departments of family medicine in Canada and abroad who attended the conferences. Methods We performed a scoping review to determine the methodologic obstacles to understanding the positive effects of family medicine globally. Report The main obstacle to evaluating family medicine globally is that one of its core dimensions and assets is its local adaptability. Family medicine takes on very different roles in different health systems, making aggregation of data difficult. In many countries family medicine competes with other disciplines rather than performing a gatekeeping role. Further, most research that has been conducted thus far comes from industrialized contexts, and patient continuity and its benefits might not be achievable in the short term in developing countries when clinical demands are great. We must find frameworks to permit strengthening the evidentiary basis of the discipline across different contexts without sacrificing its beneficial adaptability. Conclusion We believe that developing family medicine and its attributes is one of the keys to achieving global health. These attributes—including its comprehensiveness, adaptability, and attention to both local and patient needs—are key to advancing global health priorities, but make common evaluative frameworks for the discipline a challenge. The spread of family medicine over the past decades is indirect evidence of its utility, but we need to generate more evidence. We present some of the initial challenges to a broader and more rigorous evaluative framework. PMID:26380849

Developing the evidentiary basis for family medicine in the global context: The Besrour Papers: a series on the state of family medicine in the world.

PubMed

Ponka, David; Rouleau, Katherine; Arya, Neil; Redwood-Campbell, Lynda; Woollard, Robert; Siedlecki, Basia; Dunikowski, Lynn

2015-07-01

To provide an overview of the main methodologic challenges to finding definitive evidence of the positive effects of family medicine and family medicine training on a global scale. In 2012, 2013, and 2014, the College of Family Physicians of Canada hosted the Besrour Conferences to reflect on its role in advancing the discipline of family medicine globally. The Besrour Papers Working Group, which was struck at the 2013 conference, was tasked with developing a series of papers to highlight the key issues, lessons learned, and outcomes emerging from the various activities of the Besrour collaboration. The working group comprised members of various academic departments of family medicine in Canada and abroad who attended the conferences. We performed a scoping review to determine the methodologic obstacles to understanding the positive effects of family medicine globally. The main obstacle to evaluating family medicine globally is that one of its core dimensions and assets is its local adaptability. Family medicine takes on very different roles in different health systems, making aggregation of data difficult. In many countries family medicine competes with other disciplines rather than performing a gatekeeping role. Further, most research that has been conducted thus far comes from industrialized contexts, and patient continuity and its benefits might not be achievable in the short term in developing countries when clinical demands are great. We must find frameworks to permit strengthening the evidentiary basis of the discipline across different contexts without sacrificing its beneficial adaptability. We believe that developing family medicine and its attributes is one of the keys to achieving global health. These attributes—including its comprehensiveness, adaptability, and attention to both local and patient needs—are key to advancing global health priorities, but make common evaluative frameworks for the discipline a challenge. The spread of family medicine over the past decades is indirect evidence of its utility, but we need to generate more evidence. We present some of the initial challenges to a broader and more rigorous evaluative framework.

Reducing the Density and Number of Tobacco Retailers: Policy Solutions and Legal Issues

PubMed Central

Ackerman, Amy; Etow, Alexis; Bartel, Sara

2017-01-01

Introduction: Because higher density of tobacco retailers is associated with greater tobacco use, U.S. communities seek ways to reduce the density and number of tobacco retailers. This approach can reduce the concentration of tobacco retailers in poorer communities, limit youth exposure to tobacco advertising, and prevent misleading associations between tobacco and health messaging. Methods: Communities can reduce the density and number of tobacco retailers by imposing minimum distance requirements between existing retailers, capping the number of retailers in a given geographic area, establishing a maximum number of retailers proportional to population size, and prohibiting sales at certain types of establishments, such as pharmacies, or within a certain distance of locations serving youth. Local governments use direct regulation, licensing, or zoning laws to enact these changes. We analyze each approach under U.S. constitutional law to assist communities in selecting and implementing one or more of these methods. There are few published legal opinions that address these strategies in the context of tobacco control. But potential constitutional challenges include violations of the Takings Clause of the Fifth Amendment, which protects property owners from onerous government regulations, and under the Fourteenth Amendment’s Equal Protection and Due Process Clauses, which protect business owners from arbitrary or unreasonable regulations that do not further a legitimate government interest. Conclusion: Because there is an evidentiary basis linking the density of tobacco retailers to smoking rates in a community, courts are likely to reject constitutional challenges to carefully crafted laws that reduce the number of tobacco retailers. Implications: Our review of the relevant constitutional issues confirms that local governments have the authority to utilize laws and policies to reduce the density and number of tobacco retailers in their communities, given existing public health data. The analysis guides policy makers in crafting laws that comply with constitutional requirements by outlining the most important procedures and evidentiary justifications to use in development, implementation, and enforcement. This perspective also highlights the importance of reviewing state constitutions, statutes, and municipal codes and getting local input from attorneys and community stakeholders to assess the likely success of some methods over others. PMID:27127232

Evidence-Base Update of Psychosocial Treatments for Child and Adolescent Depression

PubMed Central

Weersing, V. Robin; Jeffreys, Megan; Do, Minh-Chau T.; Schwartz, Karen T. G.; Bolano, Carl

2017-01-01

Depression in youth is prevalent and disabling and tends to presage a chronic and recurrent course of illness and impairment in adulthood. Clinical trial research in youth depression has a 30 year history, and evidence-based treatment reviews appeared in 1998 and 2008. The current review of 42 randomized controlled trials (RCTs) updates these reviews to include RCTs published between 2008 and 2014 (N = 14) and re-evaluates previously reviewed literature. Given the growing maturity of the field, this review utilized a stringent set of methodological criteria for trial inclusion, most notable for excluding trials based in sub-clinical samples of youth that had been included in previous reviews (N = 12) and including well-designed RCTs with null and negative findings (N = 8). Findings from the current review suggest that evidence for child treatments is notably weaker than for adolescent interventions, with no child treatments achieving well-established status and the evidentiary basis of treatments downgraded from previous reports. Cognitive behavioral therapy (CBT) for clinically depressed children appears to be possibly efficacious, with mixed findings across trials. For depressed adolescents, both CBT and Interpersonal Psychotherapy (IPT) are well-established interventions, with evidence of efficacy in multiple trials by independent investigative teams. This positive conclusion is tempered by the small size of the IPT literature (N = 6) and concern that CBT effects may be attenuated in clinically complicated samples and when compared against active control conditions. In conclusion, data on predictors, moderators, and mediators are examined and priorities for future research discussed. PMID:27870579

Proper assessment of the JFK assassination bullet lead evidence from metallurgical and statistical perspectives.

PubMed

Randich, Erik; Grant, Patrick M

2006-07-01

The bullet evidence in the JFK assassination investigation was reexamined from metallurgical and statistical standpoints. The questioned specimens are comprised of soft lead, possibly from full-metal-jacketed Mannlicher-Carcano (MC), 6.5-mm ammunition. During lead refining, contaminant elements are removed to specified levels for a desired alloy or composition. Microsegregation of trace and minor elements during lead casting and processing can account for the experimental variabilities measured in various evidentiary and comparison samples by laboratory analysts. Thus, elevated concentrations of antimony and copper at crystallographic grain boundaries, the widely varying sizes of grains in MC bullet lead, and the 5-60 mg bullet samples analyzed for assassination intelligence effectively resulted in operational sampling error for the analyses. This deficiency was not considered in the original data interpretation and resulted in an invalid conclusion in favor of the single-bullet theory of the assassination. Alternate statistical calculations, based on the historic analytical data, incorporating weighted averaging and propagation of experimental uncertainties also considerably weaken support for the single-bullet theory. In effect, this assessment of the material composition of the lead specimens from the assassination concludes that the extant evidence is consistent with any number between two and five rounds fired in Dealey Plaza during the shooting.

Proper Assessment of the JFK Assassination Bullet Lead Evidence from Metallurgical and Statistical Perspectives

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

Randich, E; Grant, P M

2006-08-29

The bullet evidence in the JFK assassination investigation was reexamined from metallurgical and statistical standpoints. The questioned specimens are comprised of soft lead, possibly from full-metal-jacketed Mannlicher-Carcano, 6.5-mm ammunition. During lead refining, contaminant elements are removed to specified levels for a desired alloy or composition. Microsegregation of trace and minor elements during lead casting and processing can account for the experimental variabilities measured in various evidentiary and comparison samples by laboratory analysts. Thus, elevated concentrations of antimony and copper at crystallographic grain boundaries, the widely varying sizes of grains in Mannlicher-Carcano bullet lead, and the 5-60 mg bullet samples analyzedmore » for assassination intelligence effectively resulted in operational sampling error for the analyses. This deficiency was not considered in the original data interpretation and resulted in an invalid conclusion in favor of the single-bullet theory of the assassination. Alternate statistical calculations, based on the historic analytical data, incorporating weighted averaging and propagation of experimental uncertainties also considerably weaken support for the single-bullet theory. In effect, this assessment of the material composition of the lead specimens from the assassination concludes that the extant evidence is consistent with any number between two and five rounds fired in Dealey Plaza during the shooting.« less

Qualitative research and the politics of knowledge in an age of evidence: developing a research-based practice of immanent critique.

PubMed

Mykhalovskiy, Eric; Armstrong, Pat; Armstrong, Hugh; Bourgeault, Ivy; Choiniere, Jackie; Lexchin, Joel; Peters, Suzanne; White, Jerry

2008-07-01

This paper offers an expository discussion of an approach to qualitative health research we call immanent critique. The central analytic move of immanent critique, as we have practiced it, is to explore how claims that are internal to authoritative discourse are experienced by those who have been excluded from their formulation. This paper contributes to the discussion of the politics of qualitative research methods in an age of evidence. We do so by responding to a recent call to move beyond the micro-politics of the qualitative research encounter to consider the overall political effects of qualitative research. We argue that the political effects of research are partly enabled by mundane practices internal to the research process. We explore how this is so by considering one formulation of immanent critique--a qualitative study of the introduction of continuous quality improvement in Ontario hospitals. We emphasize how practices internal to our research--trade union collaboration, our orientation to authoritative claims, and procedures for generating and representing health care workers' experiences--helped shape the political effects of our research. The latter include challenges to managerial claims about neo-liberal health reform and broadening the evidentiary terrain upon which interlocutors can participate in public debate about health care restructuring.

Real World Evidence for Regulatory Decisions: Concomitant Administration of Zoster Vaccine Live and Pneumococcal Polysaccharide Vaccine.

PubMed

Bruxvoort, Katia; Sy, Lina S; Luo, Yi; Tseng, Hung Fu

2018-04-11

The US Food and Drug Administration is charged with expanding the use of real world evidence (RWE) for regulatory decisions. As a test case for RWE to support regulatory decisions, we present the scenario of concomitant vaccination with zoster vaccine live (ZVL) and 23-valent pneumococcal polysaccharide vaccine (PPSV23). The prescribing information states that these vaccines should not be given concurrently, based on a small trial using varicella zoster virus antibody levels as a correlate of ZVL efficacy, even though ZVL protects against herpes zoster via cell-mediated immunity. We conducted an observational cohort study involving >30,000 members of Kaiser Permanente Southern California receiving concomitant ZVL and PPSV23 versus PPSV23 prior to ZVL. Occurrence of herpes zoster was assessed through electronic health records from January 1, 2007 to June 30, 2016. The adjusted hazard ratio comparing incidence rates of herpes zoster in the concomitant vaccination cohort and the prior vaccination cohort was 1.04 (95% CI: 0.92, 1.16). This RWE study provides direct evidence for a lack of vaccine interference, relying on herpes zoster occurrence rather than an intermediate marker of immunity. RWE is essential for regulators and policy makers in addressing evidentiary gaps regarding safety, effectiveness, compliance, and vaccine interactions for the new recombinant zoster vaccine.

2007 Wholesale Power Rate Adjustment Proceeding (WP-07) : Administrator's Final Record of Decision.

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

United States. Bonneville Power Administration.

2006-07-01

This Record of Decision (ROD) contains the decisions of the Bonneville Power Administration (BPA), based on the record compiled in this rate proceeding, with respect to the adoption of power rates for the three-year rate period commencing October 1, 2006, through September 30, 2009. This ''2007 Wholesale Power Rate Adjustment Proceeding'' is designed to establish replacement rate schedules and General Rate Schedule Provisions (GRSPs) for those that expire on September 30, 2006. This power rate case also establishes the General Transfer Agreement (GTA) Delivery Charge for the period of October 1, 2007, through September 30, 2009. BPA's Power Subscription Strategymore » and Record of Decision (Subscription Strategy), as well as other Agency processes, provide much of the policy context for this rate case and are described in Section 2. This ROD follows a full evidentiary hearing and briefing, including an Oral Argument before the BPA Administrator. Sections 3 through 18, including any appendices or attachments, present the issues raised by parties in this proceeding, the parties positions, BPA staff positions on the issues, BPA's evaluations of the positions, and the Administrator's decisions. Parties had the opportunity to file briefs on exceptions to the Draft ROD, before issuance of this Final Record of Decision.« less

Looking for race in all the wrong places: analyzing the lack of productivity in the ongoing debate about race and genetics.

PubMed

Foster, Morris W

2009-09-01

The ongoing debate about the relationship between race and genetics is more than a century old and has yet to be resolved. Recent emphasis on population-based patterns in human genetic variation and the implications of those for disease susceptibility and drug response have revitalized that long-standing debate. Both sides in the debate use the same rhetorical device of treating geographic, ancestral, population-specific, and other categories as surrogates for race, but otherwise share no evidentiary standards, analytic frameworks, or scientific goals that might resolve the debate and result in some productive outcome. Setting a common goal of weighing the scientific benefits of using racial and other social heuristics with testable estimates of the potential social harms of racialization can reduce both the unreflexive use of race and other social identities in biological analyses as well as the unreflexive use of racialization in social critiques of genetics. Treating social identities used in genetic studies as objects for investigation rather than artifacts of participant self-report or researcher attribution also will reduce the extent to which genetic studies that report social identities imply that membership in social categories can be defined or predicted using genetic features.

Stakeholder Assessment of the Evidence for Cancer Genomic Tests: Insights from Three Case Studies

PubMed Central

Deverka, Patricia A.; Schully, Sheri D.; Ishibe, Naoko; Carlson, Josh J.; Freedman, Andrew; Goddard, Katrina A.B.; Khoury, Muin J.; Ramsey, Scott D.

2015-01-01

Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Purpose Understanding stakeholders’ assessment of the current evidence base for clinical practice and coverage decisions should be a critical step to influence research, policy, and practice. Methods Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision-making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test. Results At baseline, the level of confidence on the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for EGFR mutation and Lynch Syndrome (LS) testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX and EGFR testing, but not LS. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach. Conclusion Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis. PMID:22481130

The Empirical Foundations of Telepathology: Evidence of Feasibility and Intermediate Effects

PubMed Central

Krupinski, Elizabeth A.; Weinstein, Ronald S.; Dunn, Matthew R.; Bashshur, Noura

2017-01-01

Abstract Introduction: Telepathology evolved from video microscopy (i.e., “television microscopy”) research in the early 1950s to video microscopy used in basic research in the biological sciences to a basic diagnostic tool in telemedicine clinical applications. Its genesis can be traced to pioneering feasibility studies regarding the importance of color and other image-based parameters for rendering diagnoses and a series of studies assessing concordance of virtual slide and light microscopy diagnoses. This article documents the empirical foundations of telepathology. Methods: A selective review of the research literature during the past decade (2005–2016) was conducted using robust research design and adequate sample size as criteria for inclusion. Conclusions: The evidence regarding feasibility/acceptance of telepathology and related information technology applications has been well documented for several decades. The majority of evidentiary studies focused on intermediate outcomes, as indicated by comparability between telepathology and conventional light microscopy. A consistent trend of concordance between the two modalities was observed in terms of diagnostic accuracy and reliability. Additional benefits include use of telepathology and whole slide imaging for teaching, research, and outreach to resource-limited countries. Challenges still exist, however, in terms of use of telepathology as an effective diagnostic modality in clinical practice. PMID:28170313

Commercial host (dram shop) liability: current status and trends.

PubMed

Mosher, James F; Cohen, Elena N; Jernigan, David H

2013-09-01

Commercial host liability (CHL, also called dram shop liability) holds alcohol retailers liable for alcohol-attributable harm caused by serving alcohol, illegally, to a patron who is already intoxicated (adult liability) or underage (underage liability). The Community Preventive Services Task Force, based on a systematic research literature review, concluded that CHL is an effective strategy for reducing excessive alcohol consumption. The current article describes the key components of CHL, its grounding in American jurisprudence, its adoption in the 50 states, and changes since 1989, when a similar assessment of these policies was conducted. The current paper focuses on three legislatively enacted restrictions: (1) increased evidentiary requirements; (2) limitations on damage awards; and (3) limitations on who may be sued. Data were collected in 2011 and analyzed in 2012 and 2013. There has been substantial erosion of CHL during the past 2 decades. Fewer states recognized CHL in 2011 than in 1989, and more statutory restrictions were imposed during the study period among states that did recognize CHL; states are more likely to recognize underage than adult liability; and six states recognized a Responsible Beverage Services Practices affirmative defense in both 1989 and 2011. Implications of these findings for public health practitioners are discussed. Copyright © 2013 American Journal of Preventive Medicine. All rights reserved.

Understanding current causes of women's underrepresentation in science.

PubMed

Ceci, Stephen J; Williams, Wendy M

2011-02-22

Explanations for women's underrepresentation in math-intensive fields of science often focus on sex discrimination in grant and manuscript reviewing, interviewing, and hiring. Claims that women scientists suffer discrimination in these arenas rest on a set of studies undergirding policies and programs aimed at remediation. More recent and robust empiricism, however, fails to support assertions of discrimination in these domains. To better understand women's underrepresentation in math-intensive fields and its causes, we reprise claims of discrimination and their evidentiary bases. Based on a review of the past 20 y of data, we suggest that some of these claims are no longer valid and, if uncritically accepted as current causes of women's lack of progress, can delay or prevent understanding of contemporary determinants of women's underrepresentation. We conclude that differential gendered outcomes in the real world result from differences in resources attributable to choices, whether free or constrained, and that such choices could be influenced and better informed through education if resources were so directed. Thus, the ongoing focus on sex discrimination in reviewing, interviewing, and hiring represents costly, misplaced effort: Society is engaged in the present in solving problems of the past, rather than in addressing meaningful limitations deterring women's participation in science, technology, engineering, and mathematics careers today. Addressing today's causes of underrepresentation requires focusing on education and policy changes that will make institutions responsive to differing biological realities of the sexes. Finally, we suggest potential avenues of intervention to increase gender fairness that accord with current, as opposed to historical, findings.

Neuropsychologist experts and neurolaw: cases, controversies, and admissibility challenges.

PubMed

Kaufmann, Paul M

2013-01-01

Clinical neuropsychologists engage increasingly in forensic consulting activities because such expert opinions are generally relevant, reliable and helpful in resolving certain legal claims, especially those related to traumatic brain injury. Consequently, practitioners of law, medicine and psychology would benefit from understanding the nature of neuropsychological evidence, the standards for its admissibility, and its expanding role in neurolaw. This article reviews important evidentiary rules regulating relevance, preliminary questions, and expert testimony, while tracing federal key court decisions and progeny. Civil and criminal cases are detailed to illustrate the application of these rules and case law to neuropsychological evidence, with suggestions for overcoming motions to exclude such evidence. Expert neuropsychologists have a role in forensic consultation on brain trauma cases, even as the interdisciplinary dialog and understanding among law, medicine, and psychology continues to expand. Copyright © 2013 John Wiley & Sons, Ltd.

Incarceration, restitution, and lifetime debarment: legal consequences of scientific misconduct in the Eric Poehlman case: Commentary on: "Scientific forensics: how the office of research integrity can assist institutional investigations of research misconduct during oversight review".

PubMed

Tilden, Samuel J

2010-12-01

Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter and punish wrongdoers. This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result.

Renegotiating forensic cultures: between law, science and criminal justice.

PubMed

Roberts, Paul

2013-03-01

This article challenges stereotypical conceptions of Law and Science as cultural opposites, arguing that English criminal trial practice is fundamentally congruent with modern science's basic epistemological assumptions, values and methods of inquiry. Although practical tensions undeniably exist, they are explicable-and may be neutralised-by paying closer attention to criminal adjudication's normative ideals and their institutional expression in familiar aspects of common law trial procedure, including evidentiary rules of admissibility, trial by jury, adversarial fact-finding, cross-examination and the ethical duties of expert witnesses. Effective partnerships between lawyers and forensic scientists are indispensable for integrating scientific evidence into criminal proceedings, and must be renegotiated between individual practitioners on an on-going basis. Fruitful interdisciplinary collaboration between scholars with a shared interest in forensic science should dispense with reductive cultural stereotypes of Science and Law. Copyright © 2013. Published by Elsevier Ltd.

The Failed Feminist Challenge to `Fundamental Epistemology'

NASA Astrophysics Data System (ADS)

Pinnick, Cassandra L.

Despite volumes written in the name of the new and fundamental feminist project in philosophy of science, and conclusions drawn on the strength of the hypothesis that the feminist project will boost progress toward cognitive aims associated with science and rationality (and, one might add, policy decisions enacted in the name of these aims), the whole rationale for the project remains (after 20 years, plus) wholly unsubstantiated. We must remain agnostic about its evidentiary merits or demerits. This is because we are without evidence to test the hypothesis: certainly, we have no data that would test the strength of the hypothesis as asserting a causal relationship between women and cognitive ends. Thus, any self-respecting epistemologist who places a premium on evidence-driven belief and justification ought not to accept the hypothesis. By extension, there is no reasoned basis to draw any definitive conclusion about the project itself. No matter how self-evidently correct.

On the presumption of evidentiary independence: can confessions corrupt eyewitness identifications?

PubMed

Hasel, Lisa E; Kassin, Saul M

2009-01-01

A confession is potent evidence, persuasive to judges and juries. Is it possible that a confession can also affect other evidence? The present study tested the hypothesis that a confession will alter eyewitnesses' identification decisions. Two days after witnessing a staged theft and making an identification decision from a lineup that did not include the thief, participants were told that certain lineup members had confessed or denied guilt during a subsequent interrogation. Among those participants who had made a selection but were told that another lineup member confessed, 61% changed their identifications. Among those participants who had not made an identification, 50% went on to select the confessor when his identity was known. These findings challenge the presumption in law that different forms of evidence are independent and suggest an important overlooked mechanism by which innocent confessors are wrongfully convicted: Potentially exculpatory evidence is corrupted by a confession itself.

The Role of Scientific Collections in Scientific Preparedness

PubMed Central

2015-01-01

Building on the findings and recommendations of the Interagency Working Group on Scientific Collections, Scientific Collections International (SciColl) aims to improve the rapid access to science collections across disciplines within the federal government and globally, between government agencies and private research institutions. SciColl offered a novel opportunity for the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, to explore the value of scientific research collections under the science preparedness initiative and integrate it as a research resource at each stage in the emergence of the infectious diseases cycle. Under the leadership of SciColl’s executive secretariat at the Smithsonian Institution, and with multiple federal and international partners, a workshop during October 2014 fully explored the intersections of the infectious disease cycle and the role scientific collections could play as an evidentiary scientific resource to mitigate risks associated with emerging infectious diseases. PMID:26380390

Rational and irrational clinical strategies for collaborative medicine.

PubMed

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

Forensic archaeology and anthropology : An Australian perspective.

PubMed

Oakley, Kate

2005-09-01

Forensic archaeology is an extremely powerful investigative discipline and, in combination with forensic anthropology, can provide a wealth of evidentiary information to police investigators and the forensic community. The re-emergence of forensic archaeology and anthropology within Australia relies on its diversification and cooperation with established forensic medical organizations, law enforcement forensic service divisions, and national forensic boards. This presents a unique opportunity to develop a new multidisciplinary approach to forensic archaeology/anthropology within Australia as we hold a unique set of environmental, social, and cultural conditions that diverge from overseas models and require different methodological approaches. In the current world political climate, more forensic techniques are being applied at scenes of mass disasters, genocide, and terrorism. This provides Australian forensic archaeology/anthropology with a unique opportunity to develop multidisciplinary models with contributions from psychological profiling, ballistics, sociopolitics, cultural anthropology, mortuary technicians, post-blast analysis, fire analysis, and other disciplines from the world of forensic science.

Eliciting probabilistic expectations: Collaborations between psychologists and economists

PubMed Central

Bruine de Bruin, Wändi

2017-01-01

We describe two collaborations in which psychologists and economists provided essential support on foundational projects in major research programs. One project involved eliciting adolescents’ expectations regarding significant future life events affecting their psychological and economic development. The second project involved eliciting consumers’ expectations regarding inflation, a potentially vital input to their investment, saving, and purchasing decisions. In each project, we sought questions with the precision needed for economic modeling and the simplicity needed for lay respondents. We identify four conditions that, we believe, promoted our ability to sustain these transdisciplinary collaborations and coproduce the research: (i) having a shared research goal, which neither discipline could achieve on its own; (ii) finding common ground in shared methodology, which met each discipline’s essential evidentiary conditions, but without insisting on its culturally acquired tastes; (iii) sharing the effort throughout, with common language and sense of ownership; and (iv) gaining mutual benefit from both the research process and its products. PMID:28270610

Solid-state acquisition of fingermark topology using dense columnar thin films.

PubMed

Lakhtakia, Akhlesh; Shaler, Robert C; Martín-Palma, Raúl J; Motyka, Michael A; Pulsifer, Drew P

2011-05-01

Various vacuum techniques are employed to develop fingermarks on evidentiary items. In this work, a vacuum was used to deposit columnar thin films (CTFs) on untreated, cyanoacrylate-fumed or dusted fingermarks on a limited selection of nonporous surfaces (microscope glass slides and evidence tape). CTF deposition was not attempted on fingermarks deposited on porous surfaces. The fingermarks were placed in a vacuum chamber with the fingermark side facing an evaporating source boat containing either chalcogenide glass or MgF(2). Thermal evaporation of chalcogenide glass or MgF(2) under a 1 μTorr vacuum for 30 min formed dense CTFs on fingermark ridges, capturing the topographical features. The results show that it is possible to capture fingermark topology using CTFs on selected untreated, vacuumed cyanoacrylate-fumed or black powder-dusted nonporous surfaces. Additionally, the results suggested this might be a mechanism to help elucidate the sequence of deposition. © 2011 American Academy of Forensic Sciences.

Standards and Stories: The Interactional Work of Informed Choice in Ontario Midwifery Care

PubMed Central

Spoel, Philippa; Mckenzie, Pamela; James, Susan; Hobberlin, Jessica

2013-01-01

This paper uses a discourse-rhetorical approach to analyze how Ontario midwives and their clients interactionally accomplish the healthcare communicative process of «informed choice.» Working with four excerpts from recorded visits between Ontario midwives and women, the analysis focuses on the discursive rendering during informed choice conversations of two contrasting kinds of evidence — professional standards and story-telling — related to potential interventions during labour. We draw on the concepts of discursive hybridity (Sarangi and Roberts 1999) and recontextualization (Linell 1998; Sarangi 1998) to trace the complex and creative ways in which the conversational participants reconstruct the meanings of these evidentiary sources to address their particular care contexts. This analysis shows how, though very different in their forms, both modes of evidence function as hybrid and flexible discursive resources that perform both instrumental and social-relational healthcare work. PMID:24289941

Factors related to drug approvals: predictors of outcome?

PubMed

Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Hubert

2017-06-01

There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters': evidentiary support; product or indication characteristics; company experience or strategy; social and regulatory factors. We observed a heterogeneous mix of technical factors (e.g., study designs, clinical evidence of efficacy) and less studied social factors (e.g., company-regulator interactions). We confirmed factors known to be of relevance to drug approval decisions (imperative) and a cohort of less understood (compensatory) social factors. Having robust supportive clinical evidence, addressing rare or serious illness, following scientific advice and prior company experience were associated with positive outcomes, which illustrated the multifactorial nature of regulatory decision making and factors need to be considered holistically while having varying, context-dependent importance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Eliciting probabilistic expectations: Collaborations between psychologists and economists.

PubMed

Bruine de Bruin, Wändi; Fischhoff, Baruch

2017-03-28

We describe two collaborations in which psychologists and economists provided essential support on foundational projects in major research programs. One project involved eliciting adolescents' expectations regarding significant future life events affecting their psychological and economic development. The second project involved eliciting consumers' expectations regarding inflation, a potentially vital input to their investment, saving, and purchasing decisions. In each project, we sought questions with the precision needed for economic modeling and the simplicity needed for lay respondents. We identify four conditions that, we believe, promoted our ability to sustain these transdisciplinary collaborations and coproduce the research: ( i ) having a shared research goal, which neither discipline could achieve on its own; ( ii ) finding common ground in shared methodology, which met each discipline's essential evidentiary conditions, but without insisting on its culturally acquired tastes; ( iii ) sharing the effort throughout, with common language and sense of ownership; and ( iv ) gaining mutual benefit from both the research process and its products.

Interpretation guidelines of a standard Y-chromosome STR 17-plex PCR-CE assay for crime casework.

PubMed

Roewer, Lutz; Geppert, Maria

2012-01-01

Y-STR analysis is an invaluable tool to examine evidence in sexual assault cases and in other forensic casework. Unambiguous detection of the male component in DNA mixtures with a high female background is still the main field of application of forensic Y-STR haplotyping. In the last years, powerful technologies including a 17-locus multiplex PCR assay have been introduced in the forensic laboratories. At the same time, statistical methods have been developed and adapted for interpretation of a nonrecombining, linear marker as the Y-chromosome which shows a strongly clustered geographical distribution due to the linear inheritance and the patrilocality of ancestral groups. Large population databases, namely the Y-STR Haplotype Reference Database (YHRD), have been established to assess the evidentiary value of Y-STR matches by means of frequency estimation methods (counting and extrapolation).

An ethical exploration of barriers to research on controlled drugs

PubMed Central

ANDREAE, Michael H; RHODES, Evelyn; BOURGOISE, Tylor; CARTER, George; WHITE, Robert S.; INDYK, Debbie; SACKS, Henry; RHODES, Rosamond

2016-01-01

We examine the ethical, social and regulatory barriers that may hamper research on therapeutic potential of certain controversial controlled substances like marijuana, heroin or ketamine. Hazards for individuals and society, and their potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of certain substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may hinder research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns of undue inducement, informed consent, risk to participants, researchers and institutions, justice and liberty germane to the research with illicit and addictive substances. We debate the disparate research stakeholder perspectives and why they are likely to be infected with bias. We propose an empirical research agenda to provide a more evidentiary basis for ethical reasoning. PMID:26982922

Loss of possession: concussions, informed consent, and autonomy.

PubMed

Robeson, Richard; King, Nancy M P

2014-01-01

The recent explosion of publicity about the dangers of concussion in contact sports - particularly in football - represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. © 2014 American Society of Law, Medicine & Ethics, Inc.

Of spheres and squares: Can Sloterdijk help us rethink the architecture of climate science?

PubMed

Skrydstrup, Martin

2016-12-01

This article explores how different visions and values of science translate into different architectural shapes. I bring Peter Sloterdijk's 'spherology' to bear on my ethnographic fieldwork at the NEEM ice core base in Greenland, a significant node in the global infrastructure of climate science. I argue that the visual form of the geodesic dome of the camp materializes specific values and visions of this branch of paleoclimate science, which I elaborate vis-a-vis the pragmatic claims of the scientists/designers and the particular architectural history of Danish ice core drilling in Greenland. I argue that this aesthetic history articulates with Buckminster Fuller's ideas of a 'new nature' and 'scalar connections' encapsulated in his geodesic form. Second, I argue that the aesthetic production of space in the camp replicates the modern distinction between science and society, in so far as the lab space is rectangular and the recreational space is spherical. Third, I argue that NEEM scientists and Sloterdijk are essentially engaged in a common project: the scientists work hard to align air bubbles in the cores with atmospheric fluctuations in the hemisphere on the evidentiary terrain of ice, and Sloterdijk attempts to connect micro-uteri with macro-uteri in an attempt to fundamentally rethink space. Fuller's notion of 'Spaceship Earth', appropriated by Sloterdijk in his thinking about anthropogenic climate change, lends itself well to capturing the scalar alignments and the isolated NEEM base - on a mission to save planet Earth. In conclusion, I argue that Sloterdijk's spherology may serve as a point of departure for rethinking the aesthetic grammar of the architecture of science.

Understanding current causes of women's underrepresentation in science

PubMed Central

Williams, Wendy M.

2011-01-01

Explanations for women's underrepresentation in math-intensive fields of science often focus on sex discrimination in grant and manuscript reviewing, interviewing, and hiring. Claims that women scientists suffer discrimination in these arenas rest on a set of studies undergirding policies and programs aimed at remediation. More recent and robust empiricism, however, fails to support assertions of discrimination in these domains. To better understand women's underrepresentation in math-intensive fields and its causes, we reprise claims of discrimination and their evidentiary bases. Based on a review of the past 20 y of data, we suggest that some of these claims are no longer valid and, if uncritically accepted as current causes of women's lack of progress, can delay or prevent understanding of contemporary determinants of women's underrepresentation. We conclude that differential gendered outcomes in the real world result from differences in resources attributable to choices, whether free or constrained, and that such choices could be influenced and better informed through education if resources were so directed. Thus, the ongoing focus on sex discrimination in reviewing, interviewing, and hiring represents costly, misplaced effort: Society is engaged in the present in solving problems of the past, rather than in addressing meaningful limitations deterring women's participation in science, technology, engineering, and mathematics careers today. Addressing today's causes of underrepresentation requires focusing on education and policy changes that will make institutions responsive to differing biological realities of the sexes. Finally, we suggest potential avenues of intervention to increase gender fairness that accord with current, as opposed to historical, findings. PMID:21300892

Multiple perpetrator rape among girls evaluated at a hospital-based Child Advocacy Center: Seven years of reviewed cases

PubMed Central

Edinburgh, Laurel; Pape-Blabolil, Julie; Harpin, Scott B.; Saewyc, Elizabeth

2015-01-01

The aim of this study was to describe contextual events, abuse experiences, and disclosure processes of adolescents who presented to a hospital-based Child Advocacy Center for medical evaluation and evidentiary collection as indicated after experiencing multiple perpetrator rape during a single event (n = 32) and to compare these findings to a group of single perpetrator sexual assaults (n = 534). This study used a retrospective mixed-methods design with in-depth, forensic interviews and complete physical examinations of gang-raped adolescents. Patients ranged from 12 to 17 years (M = 14 years). Girls who experienced multiple perpetrator rape during a single event were more likely to have run away, to have drunk alcohol in the past month, and to have participated in binge drinking in the past 2 weeks. Acute presentation of these victims were rare but 30% had hymenal transections and 38% had sexually transmitted infections (STIs). Forensic interviews revealed alcohol was a common weapon used by offenders, and its use resulted in victims experiencing difficulty in remembering and reporting details for police investigation or physical and mental health care. Most victims were raped at parties they attended with people they thought they could trust, and they felt let down by witnesses who could have helped but did not intervene. Although relatively rare, multiple perpetrator rape during a single event is a type of severe sexual assault experience and has significant risks for deleterious health outcomes. These victims require health care by trained providers to diagnose physical findings, treat STIs, screen for trauma, and support victims. PMID:24933707

Research-to-policy translation for prevention of disordered weight and shape control behaviors: A case example targeting dietary supplements sold for weight loss and muscle building.

PubMed

Austin, S Bryn; Yu, Kimberly; Tran, Alvin; Mayer, Beth

2017-04-01

New approaches to universal eating disorders prevention and interventions targeting macro-environmental change are greatly needed, and research-to-policy translation efforts hold promise for advancing both of these goals. This paper describes as a policy-translation case example an academic-community-government partnership of the Strategic Training Initiative for the Prevention of Eating Disorders, Multi-Service Eating Disorders Association, and the office of Massachusetts Representative Kay Khan, all based in Massachusetts, USA. The partnership's research-to-policy translation project focused on dietary supplements sold for weight loss and muscle building, which have been linked with serious injury and death in consumers. Youth and people of all ages with eating disorders and body dysmorphic disorder may be especially vulnerable to use these products due to deceptive promises of fast and safe weight loss and muscle gain. The research-to-policy translation project was informed by a triggers-to-action framework to establish the evidentiary base of harm to consumers, operationalize policy solutions to mitigate harm through legislation, and generate political will to support action through legislation introduced in the Massachusetts legislature to restrict sales of weight-loss and muscle-building dietary supplements. The paper concludes with lessons learned from this unique policy translation effort for the prevention of disordered weight and shape control behaviors and offers recommendations for next steps for the field to advance research and practice for universal, macro-environmentally targeted prevention. Copyright © 2016 Elsevier Ltd. All rights reserved.

Reducing the Density and Number of Tobacco Retailers: Policy Solutions and Legal Issues.

PubMed

Ackerman, Amy; Etow, Alexis; Bartel, Sara; Ribisl, Kurt M

2017-02-01

Because higher density of tobacco retailers is associated with greater tobacco use, U.S. communities seek ways to reduce the density and number of tobacco retailers. This approach can reduce the concentration of tobacco retailers in poorer communities, limit youth exposure to tobacco advertising, and prevent misleading associations between tobacco and health messaging. Communities can reduce the density and number of tobacco retailers by imposing minimum distance requirements between existing retailers, capping the number of retailers in a given geographic area, establishing a maximum number of retailers proportional to population size, and prohibiting sales at certain types of establishments, such as pharmacies, or within a certain distance of locations serving youth. Local governments use direct regulation, licensing, or zoning laws to enact these changes. We analyze each approach under U.S. constitutional law to assist communities in selecting and implementing one or more of these methods. There are few published legal opinions that address these strategies in the context of tobacco control. But potential constitutional challenges include violations of the Takings Clause of the Fifth Amendment, which protects property owners from onerous government regulations, and under the Fourteenth Amendment's Equal Protection and Due Process Clauses, which protect business owners from arbitrary or unreasonable regulations that do not further a legitimate government interest. Because there is an evidentiary basis linking the density of tobacco retailers to smoking rates in a community, courts are likely to reject constitutional challenges to carefully crafted laws that reduce the number of tobacco retailers. Our review of the relevant constitutional issues confirms that local governments have the authority to utilize laws and policies to reduce the density and number of tobacco retailers in their communities, given existing public health data. The analysis guides policy makers in crafting laws that comply with constitutional requirements by outlining the most important procedures and evidentiary justifications to use in development, implementation, and enforcement. This perspective also highlights the importance of reviewing state constitutions, statutes, and municipal codes and getting local input from attorneys and community stakeholders to assess the likely success of some methods over others. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Delphi Technology Foresight Study: Mapping Social Construction of Scientific Evidence on Metagenomics Tests for Water Safety

PubMed Central

Birko, Stanislav; Dove, Edward S.; Özdemir, Vural

2015-01-01

Access to clean water is a grand challenge in the 21st century. Water safety testing for pathogens currently depends on surrogate measures such as fecal indicator bacteria (e.g., E. coli). Metagenomics concerns high-throughput, culture-independent, unbiased shotgun sequencing of DNA from environmental samples that might transform water safety by detecting waterborne pathogens directly instead of their surrogates. Yet emerging innovations such as metagenomics are often fiercely contested. Innovations are subject to shaping/construction not only by technology but also social systems/values in which they are embedded, such as experts’ attitudes towards new scientific evidence. We conducted a classic three-round Delphi survey, comprised of 107 questions. A multidisciplinary expert panel (n = 24) representing the continuum of discovery scientists and policymakers evaluated the emergence of metagenomics tests. To the best of our knowledge, we report here the first Delphi foresight study of experts’ attitudes on (1) the top 10 priority evidentiary criteria for adoption of metagenomics tests for water safety, (2) the specific issues critical to governance of metagenomics innovation trajectory where there is consensus or dissensus among experts, (3) the anticipated time lapse from discovery to practice of metagenomics tests, and (4) the role and timing of public engagement in development of metagenomics tests. The ability of a test to distinguish between harmful and benign waterborne organisms, analytical/clinical sensitivity, and reproducibility were the top three evidentiary criteria for adoption of metagenomics. Experts agree that metagenomic testing will provide novel information but there is dissensus on whether metagenomics will replace the current water safety testing methods or impact the public health end points (e.g., reduction in boil water advisories). Interestingly, experts view the publics relevant in a “downstream capacity” for adoption of metagenomics rather than a co-productionist role at the “upstream” scientific design stage of metagenomics tests. In summary, these findings offer strategic foresight to govern metagenomics innovations symmetrically: by identifying areas where acceleration (e.g., consensus areas) and deceleration/reconsideration (e.g., dissensus areas) of the innovation trajectory might be warranted. Additionally, we show how scientific evidence is subject to potential social construction by experts’ value systems and the need for greater upstream public engagement on metagenomics innovations. PMID:26066837

Neuroscience and Brain Death Controversies: The Elephant in the Room.

PubMed

Verheijde, Joseph L; Rady, Mohamed Y; Potts, Michael

2018-06-21

The conception and the determination of brain death continue to raise scientific, legal, philosophical, and religious controversies. While both the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1981 and the President's Council on Bioethics in 2008 committed to a biological definition of death as the basis for the whole-brain death criteria, contemporary neuroscientific findings augment the concerns about the validity of this biological definition. Neuroscientific evidentiary findings, however, have not yet permeated discussions about brain death. These findings have critical relevance (scientifically, medically, legally, morally, and religiously) because they indicate that some core assumptions about brain death are demonstrably incorrect, while others lack sufficient evidential support. If behavioral unresponsiveness does not equate to unconsciousness, then the philosophical underpinning of the definition based on loss of capacity for consciousness as well as the criteria, and tests in brain death determination are incongruent with empirical evidence. Thus, the primary claim that brain death equates to biological death has then been de facto falsified. This conclusion has profound philosophical, religious, and legal implications that should compel respective authorities to (1) reassess the philosophical rationale for the definition of death, (2) initiate a critical reappraisal of the presumed alignment of brain death with the theological definition of death in Abrahamic faith traditions, and (3) enact new legislation ratifying religious exemption to death determination by neurologic criteria.

Impact of computer-mediated, obesity-related nutrition education interventions for adolescents: a systematic review.

PubMed

Ajie, Whitney N; Chapman-Novakofski, Karen M

2014-06-01

The purpose of this systematic review was to evaluate recent research regarding the use of computer-based nutrition education interventions targeting adolescent overweight and obesity. Online databases were systematically searched using key words, and bibliographies of related articles were manually searched. Inclusion/exclusion criteria were applied and included studies evaluated for their ability to achieve their objectives and for quality using the Nutrition Evidence Library appraisal guidelines for research design and implementation. Of the 15 studies included, 10 were randomized controlled trials. Two studies targeted weight loss, 2 targeted weight maintenance, and 11 targeted dietary improvement with or without physical activity. At least half of in-school (60%) and nonschool interventions (80%) exhibited significantly positive effects on nutrition- or obesity-related variables. Small changes in diet, physical activity, knowledge, and self-efficacy were shown; however, few results were sustained long term. Recommendations included application of health behavior theory and computer tailoring for feedback messages. Future research should include thorough description of intervention content (messages, theory, multimedia, etc.), application of rigorous methodology, as well as consideration of covariates such as parental involvement and gender. With further research and evidentiary support, this approach to obesity-related nutrition education has the potential to be successful. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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

Malone, Elizabeth L.; Sanquist, Tom; Wolfe, Amy K.

This document is part of a larger, programmatic effort to assist federal agencies in taking action and changing their institutions to achieve and maintain federal sustainability goals, while meeting their mission goals. FEMP is developing guidance for federal agency efforts to enable institutional behavior change for sustainability, and for making sustainability “business as usual.” The driving requirement for this change is Executive Order (EO) 13514, Federal Leadership in Environmental, Energy, and Economic Performance. FEMP emphasizes strategies for increasing energy efficiency and renewable energy utilization as critical components of attaining sustainability, and promotes additional non-energy action pathways contained in EO 13514.more » This report contributes to the larger goal by laying out the conceptual and evidentiary underpinnings of guidance to federal agencies. Conceptual frameworks focus and organize the development of guidance. We outline a series of progressively refined conceptual frameworks, including a multi-layer approach, key steps in sustainability implementation, a process view of specific approaches to institutional change, the agency Strategic Sustainability Performance Plans (SSPPs), and concepts related to context-specific rules, roles and tools for sustainability. Additionally, we tap pertinent bodies of literature in drawing eight evidence-based principles for behavior change. These principles are important foundations upon which to build in selecting strategies to effect change in organizations. Taken together, this report presents a suite of components that inform the training materials, presentations, web site, and other products that provide guidance to federal agencies.« less

Direct and comprehensive analysis of dyes based on integrated molecular and structural information via laser desorption laser postionization mass spectrometry.

PubMed

Liu, Rong; Yin, Zhibin; Leng, Yixin; Hang, Wei; Huang, Benli

2018-01-01

Laser desorption laser postionization time-of-flight mass spectrometry (LDPI-TOFMS) was employed for direct analysis and determination of typical basic dyes. It was also used for the analysis and comprehensive understanding of complex materials such as blue ballpoint pen inks. Simultaneous emergences of fragmental and molecular information largely simplify and facilitate unambiguous identification of dyes via variable energy of 266nm postionization laser. More specifically, by optimizing postionization laser energy with the same energy of desorption laser, the structurally significant results show definite differences in the fragmentation patterns, which offer opportunities for discrimination of isomeric species with identical molecular weight. Moreover, relatively high spectra resolution can be acquired without the expense of sensitivity. In contrast to laser desorption/ionization mass spectrometry (LDI-MS), LDPI-MS simultaneously offers valuable molecular information about dyes in traces, solvents and additives about inks, thereby offering direct determination and comprehensive understanding of blue ballpoint inks and giving a high level of confidence to discriminate the complicated evidentiary samples. In addition, direct analysis of the inks not only allows the avoidance of the tedious sample preparation processes, significantly shortening the overall analysis time and improving throughput, but allows minimized sample consumption which is important for rare and precious samples. Copyright © 2017 Elsevier B.V. All rights reserved.

ESDA®-Lite collection of DNA from latent fingerprints on documents.

PubMed

Plaza, Dane T; Mealy, Jamia L; Lane, J Nicholas; Parsons, M Neal; Bathrick, Abigail S; Slack, Donia P

2015-05-01

The ability to detect and non-destructively collect biological samples for DNA processing would benefit the forensic community by preserving the physical integrity of evidentiary items for more thorough evaluations by other forensic disciplines. The Electrostatic Detection Apparatus (ESDA®) was systemically evaluated for its ability to non-destructively collect DNA from latent fingerprints deposited on various paper substrates for short tandem repeat (STR) DNA profiling. Fingerprints were deposited on a variety of paper substrates that included resume paper, cotton paper, magazine paper, currency, copy paper, and newspaper. Three DNA collection techniques were performed: ESDA collection, dry swabbing, and substrate cutting. Efficacy of each collection technique was evaluated by the quantity of DNA present in each sample and the percent profile generated by each sample. Both the ESDA and dry swabbing non-destructive sampling techniques outperformed the destructive methodology of substrate cutting. A greater number of full profiles were generated from samples collected with the non-destructive dry swabbing collection technique than were generated from samples collected with the ESDA; however, the ESDA also allowed the user to visualize the area of interest while non-destructively collecting the biological material. The ability to visualize the biological material made sampling straightforward and eliminated the need for numerous, random swabbings/cuttings. Based on these results, the evaluated non-destructive ESDA collection technique has great potential for real-world forensic implementation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Short hypervariable microhaplotypes: A novel set of very short high discriminating power loci without stutter artefacts.

PubMed

van der Gaag, Kristiaan J; de Leeuw, Rick H; Laros, Jeroen F J; den Dunnen, Johan T; de Knijff, Peter

2018-07-01

Since two decades, short tandem repeats (STRs) are the preferred markers for human identification, routinely analysed by fragment length analysis. Here we present a novel set of short hypervariable autosomal microhaplotypes (MH) that have four or more SNPs in a span of less than 70 nucleotides (nt). These MHs display a discriminating power approaching that of STRs and provide a powerful alternative for the analysis;1;is of forensic samples that are problematic when the STR fragment size range exceeds the integrity range of severely degraded DNA or when multiple donors contribute to an evidentiary stain and STR stutter artefacts complicate profile interpretation. MH typing was developed using the power of massively parallel sequencing (MPS) enabling new powerful, fast and efficient SNP-based approaches. MH candidates were obtained from queries in data of the 1000 Genomes, and Genome of the Netherlands (GoNL) projects. Wet-lab analysis of 276 globally dispersed samples and 97 samples of nine large CEPH families assisted locus selection and corroboration of informative value. We infer that MHs represent an alternative marker type with good discriminating power per locus (allowing the use of a limited number of loci), small amplicon sizes and absence of stutter artefacts that can be especially helpful when unbalanced mixed samples are submitted for human identification. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Rapid and inexpensive body fluid identification by RNA profiling-based multiplex High Resolution Melt (HRM) analysis

PubMed Central

Hanson, Erin K.; Ballantyne, Jack

2014-01-01

Positive identification of the nature of biological material present on evidentiary items can be crucial for understanding the circumstances surrounding a crime. However, traditional protein-based methods do not permit the identification of all body fluids and tissues, and thus molecular based strategies for the conclusive identification of all forensically relevant biological fluids and tissues need to be developed. Messenger RNA (mRNA) profiling is an example of such a molecular-based approach. Current mRNA body fluid identification assays involve capillary electrophoresis (CE) or quantitative RT-PCR (qRT-PCR) platforms, each with its own limitations. Both platforms require the use of expensive fluorescently labeled primers or probes. CE-based assays require separate amplification and detection steps thus increasing the analysis time. For qRT-PCR assays, only 3-4 markers can be included in a single reaction since each requires a different fluorescent dye. To simplify mRNA profiling assays, and reduce the time and cost of analysis, we have developed single- and multiplex body fluid High Resolution Melt (HRM) assays for the identification of common forensically relevant biological fluids and tissues. The incorporated biomarkers include IL19 (vaginal secretions), IL1F7 (skin), ALAS2 (blood), MMP10 (menstrual blood), HTN3 (saliva) and TGM4 (semen).  The HRM assays require only unlabeled PCR primers and a single saturating intercalating fluorescent dye (Eva Green). Each body-fluid-specific marker can easily be identified by the presence of a distinct melt peak. Usually, HRM assays are used to detect variants or isoforms for a single gene target. However, we have uniquely developed duplex and triplex HRM assays to permit the simultaneous detection of multiple targets per reaction. Here we describe the development and initial performance evaluation of the developed HRM assays. The results demonstrate the potential use of HRM assays for rapid, and relatively inexpensive, screening of biological evidence. PMID:24715968

Rapid and inexpensive body fluid identification by RNA profiling-based multiplex High Resolution Melt (HRM) analysis.

PubMed

Hanson, Erin K; Ballantyne, Jack

2013-01-01

Positive identification of the nature of biological material present on evidentiary items can be crucial for understanding the circumstances surrounding a crime. However, traditional protein-based methods do not permit the identification of all body fluids and tissues, and thus molecular based strategies for the conclusive identification of all forensically relevant biological fluids and tissues need to be developed. Messenger RNA (mRNA) profiling is an example of such a molecular-based approach. Current mRNA body fluid identification assays involve capillary electrophoresis (CE) or quantitative RT-PCR (qRT-PCR) platforms, each with its own limitations. Both platforms require the use of expensive fluorescently labeled primers or probes. CE-based assays require separate amplification and detection steps thus increasing the analysis time. For qRT-PCR assays, only 3-4 markers can be included in a single reaction since each requires a different fluorescent dye. To simplify mRNA profiling assays, and reduce the time and cost of analysis, we have developed single- and multiplex body fluid High Resolution Melt (HRM) assays for the identification of common forensically relevant biological fluids and tissues. The incorporated biomarkers include IL19 (vaginal secretions), IL1F7 (skin), ALAS2 (blood), MMP10 (menstrual blood), HTN3 (saliva) and TGM4 (semen).  The HRM assays require only unlabeled PCR primers and a single saturating intercalating fluorescent dye (Eva Green). Each body-fluid-specific marker can easily be identified by the presence of a distinct melt peak. Usually, HRM assays are used to detect variants or isoforms for a single gene target. However, we have uniquely developed duplex and triplex HRM assays to permit the simultaneous detection of multiple targets per reaction. Here we describe the development and initial performance evaluation of the developed HRM assays. The results demonstrate the potential use of HRM assays for rapid, and relatively inexpensive, screening of biological evidence.

Characteristics of binge eating disorder in relation to diagnostic criteria

PubMed Central

Wilfley, Denise E; Citrome, Leslie; Herman, Barry K

2016-01-01

The objective of this review was to examine the evidentiary basis for binge eating disorder (BED) with reference to the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) diagnostic criteria for BED. A PubMed search restricted to titles and abstracts of English-language reviews, meta-analyses, clinical trials, randomized controlled trials, journal articles, and letters using human participants was conducted on August 7, 2015, using keywords that included “binge eating disorder,” DSM-5, DSM-IV, guilt, shame, embarrassment, quantity, psychological, behavior, and “shape and weight concerns.” Of the 257 retrieved publications, 60 publications were considered relevant to discussions related to DSM-5 diagnostic criteria and were included in the current review, and 20 additional references were also included on the basis of the authors’ knowledge and/or on a review of the reference lists from relevant articles obtained through the literature search. Evidence supports the duration/frequency criterion for BED and the primary importance of loss of control and marked distress in identifying individuals with BED. Although overvaluation of shape/weight is not a diagnostic criterion, its relationship to the severity of BED psychopathology may identify a unique subset of individuals with BED. Additionally, individuals with BED often exhibit a clinical profile consisting of psychiatric (eg, mood, obsessive–compulsive, and impulsive disorders) and medical (eg, gastrointestinal symptoms, metabolic syndrome, and type 2 diabetes) comorbidities and behavioral profiles (eg, overconsumption of calories outside of a binge eating episode and emotional eating). Future revisions of the BED diagnostic criteria should consider the inclusion of BED subtypes, perhaps based on the overvaluation of shape/weight, and an evidence-based reassessment of severity criteria. PMID:27621631

Integration and timing of basic and clinical sciences education.

PubMed

Bandiera, Glen; Boucher, Andree; Neville, Alan; Kuper, Ayelet; Hodges, Brian

2013-05-01

Medical education has traditionally been compartmentalized into basic and clinical sciences, with the latter being viewed as the skillful application of the former. Over time, the relevance of basic sciences has become defined by their role in supporting clinical problem solving rather than being, of themselves, a defining knowledge base of physicians. As part of the national Future of Medical Education in Canada (FMEC MD) project, a comprehensive empirical environmental scan identified the timing and integration of basic sciences as a key pressing issue for medical education. Using the literature review, key informant interviews, stakeholder meetings, and subsequent consultation forums from the FMEC project, this paper details the empirical basis for focusing on the role of basic science, the evidentiary foundations for current practices, and the implications for medical education. Despite a dearth of definitive relevant studies, opinions about how best to integrate the sciences remain strong. Resource allocation, political power, educational philosophy, and the shift from a knowledge-based to a problem-solving profession all influence the debate. There was little disagreement that both sciences are important, that many traditional models emphasized deep understanding of limited basic science disciplines at the expense of other relevant content such as social sciences, or that teaching the sciences contemporaneously rather than sequentially has theoretical and practical merit. Innovations in integrated curriculum design have occurred internationally. Less clear are the appropriate balance of the sciences, the best integration model, and solutions to the political and practical challenges of integrated curricula. New curricula tend to emphasize integration, development of more diverse physician competencies, and preparation of physicians to adapt to evolving technology and patients' expectations. Refocusing the basic/clinical dichotomy to a foundational/applied model may yield benefits in training widely competent future physicians.

Multiple perpetrator rape among girls evaluated at a hospital-based child advocacy center: seven years of reviewed cases.

PubMed

Edinburgh, Laurel; Pape-Blabolil, Julie; Harpin, Scott B; Saewyc, Elizabeth

2014-09-01

The aim of this study was to describe contextual events, abuse experiences, and disclosure processes of adolescents who presented to a hospital-based Child Advocacy Center for medical evaluation and evidentiary collection as indicated after experiencing multiple perpetrator rape during a single event (n=32) and to compare these findings to a group of single perpetrator sexual assaults (n=534). This study used a retrospective mixed-methods design with in-depth, forensic interviews and complete physical examinations of gang-raped adolescents. Patients ranged from 12 to 17 years (M=14 years). Girls who experienced multiple perpetrator rape during a single event were more likely to have run away, to have drunk alcohol in the past month, and to have participated in binge drinking in the past 2 weeks. Acute presentation of these victims were rare but 30% had hymenal transections and 38% had sexually transmitted infections (STIs). Forensic interviews revealed alcohol was a common weapon used by offenders, and its use resulted in victims experiencing difficulty in remembering and reporting details for police investigation or physical and mental health care. Most victims were raped at parties they attended with people they thought they could trust, and they felt let down by witnesses who could have helped but did not intervene. Although relatively rare, multiple perpetrator rape during a single event is a type of severe sexual assault experience and has significant risks for deleterious health outcomes. These victims require health care by trained providers to diagnose physical findings, treat STIs, screen for trauma, and support victims. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: report from a joint US-/Canadian-sponsored working group123

PubMed Central

Yetley, Elizabeth A; MacFarlane, Amanda J; Greene-Finestone, Linda S; Garza, Cutberto; Ard, Jamy D; Atkinson, Stephanie A; Bier, Dennis M; Carriquiry, Alicia L; Harlan, William R; Hattis, Dale; King, Janet C; Krewski, Daniel; O’Connor, Deborah L; Prentice, Ross L; Rodricks, Joseph V; Wells, George A

2017-01-01

Dietary Reference Intakes (DRIs) are used in Canada and the United States in planning and assessing diets of apparently healthy individuals and population groups. The approaches used to establish DRIs on the basis of classical nutrient deficiencies and/or toxicities have worked well. However, it has proved to be more challenging to base DRI values on chronic disease endpoints; deviations from the traditional framework were often required, and in some cases, DRI values were not established for intakes that affected chronic disease outcomes despite evidence that supported a relation. The increasing proportions of elderly citizens, the growing prevalence of chronic diseases, and the persistently high prevalence of overweight and obesity, which predispose to chronic disease, highlight the importance of understanding the impact of nutrition on chronic disease prevention and control. A multidisciplinary working group sponsored by the Canadian and US government DRI steering committees met from November 2014 to April 2016 to identify options for addressing key scientific challenges encountered in the use of chronic disease endpoints to establish reference values. The working group focused on 3 key questions: 1) What are the important evidentiary challenges for selecting and using chronic disease endpoints in future DRI reviews, 2) what intake-response models can future DRI committees consider when using chronic disease endpoints, and 3) what are the arguments for and against continuing to include chronic disease endpoints in future DRI reviews? This report outlines the range of options identified by the working group for answering these key questions, as well as the strengths and weaknesses of each option. PMID:27927637

Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications: guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain.

PubMed

Narouze, Samer; Benzon, Honorio T; Provenzano, David A; Buvanendran, Asokumar; De Andres, José; Deer, Timothy R; Rauck, Richard; Huntoon, Marc A

2015-01-01

Interventional spine and pain procedures cover a far broader spectrum than those for regional anesthesia, reflecting diverse targets and goals. When surveyed, interventional pain and spine physicians attending the American Society of Regional Anesthesia and Pain Medicine (ASRA) 11th Annual Pain Medicine Meeting exhorted that existing ASRA guidelines for regional anesthesia in patients on antiplatelet and anticoagulant medications were insufficient for their needs. Those surveyed agreed that procedure-specific and patient-specific factors necessitated separate guidelines for pain and spine procedures. In response, ASRA formed a guidelines committee. After preliminary review of published complication reports and studies, committee members stratified interventional spine and pain procedures according to potential bleeding risk as low-, intermediate-, and high-risk procedures. The ASRA guidelines were deemed largely appropriate for the low- and intermediate-risk categories, but it was agreed that the high-risk targets required an intensive look at issues specific to patient safety and optimal outcomes in pain medicine. The latest evidence was sought through extensive database search strategies and the recommendations were evidence-based when available and pharmacology-driven otherwise. We could not provide strength and grading of these recommendations as there are not enough well-designed large studies concerning interventional pain procedures to support such grading. Although the guidelines could not always be based on randomized studies or on large numbers of patients from pooled databases, it is hoped that they will provide sound recommendations and the evidentiary basis for such recommendations.

Toward a child-centered approach to evaluating claims of alienation in high-conflict custody disputes.

PubMed

Nichols, Allison M

2014-02-01

Theories of parental alienation abound in high-conflict custody cases. The image of one parent brainwashing a child against the other parent fits with what we think we know about family dynamics during divorce. The concept of a diagnosable "Parental Alienation Syndrome" ("PAS") developed as an attempt to explain this phenomenon, but it has been widely discredited by mental health professionals and thus fails the standard for evidentiary admissibility. Nevertheless, PAS and related theories continue to influence the decisions of family courts, and even in jurisdictions that explicitly reject such theories, judges still face the daunting task of resolving these volatile cases. In the midst of this highly adversarial process, children deserve independent representation to ensure that their interests remain front and center. Mandating the appointment of guardians ad litem in cases involving allegations of abuse or alienation will assist courts in conducting individualized, fact-specific investigations into such allegations to craft custody orders that serve the best interests of children.

Meeting a Forensic Podiatry Admissibility Challenge: A Daubert Case Study.

PubMed

Nirenberg, Michael

2016-05-01

This article is an introduction to the United States Supreme Court's standard of admissibility of forensic evidence and testimony at trial, known as the Daubert standard, with emphasis on how this standard applies to the field of forensic podiatry. The author, a forensic podiatrist, provided law enforcement with evidence tying a bloody sock-clad footprint found at the scene of a homicide to the suspect. In 2014, the author testified at a pretrial hearing, known as "a Daubert hearing," to address the admissibility of this evidence in court. This was the first instance of forensic podiatry being the primary subject of a Daubert hearing. The hearing resulted in the court ordering this evidence admissible. The expert's testimony contributed to the suspect's conviction. This article serves as a reference for forensic podiatrists and experts in similar fields that involve impression evidence, providing evidentiary standards and their impact on expert evidence and testimony. © 2016 American Academy of Forensic Sciences.

An Optimized Centrifugal Method for Separation of Semen from Superabsorbent Polymers for Forensic Analysis.

PubMed

Camarena, Lucy R; Glasscock, Bailey K; Daniels, Demi; Ackley, Nicolle; Sciarretta, Marybeth; Seashols-Williams, Sarah J

2017-03-01

Connection of a perpetrator to a sexual assault is best performed through the confirmed presence of semen, thereby proving sexual contact. Evidentiary items can include sanitary napkins or diapers containing superabsorbent polymers (SAPs), complicating spermatozoa visualization and DNA analysis. In this report, we evaluated the impact of SAPS on the current forensic DNA workflow, developing an efficient centrifugal protocol for separating spermatozoa from SAP material. The optimized filtration method was compared to common practices of excising the top layer only, resulting in significantly higher sperm yields when a core sample of the substrate was taken. Direct isolation of the SAP-containing materials without filtering resulted in 20% sample failure; additionally, SAP material was observed in the final eluted DNA samples, causing physical interference. Thus, use of the described centrifugal-filtering method is a simple preliminary step that improves spermatozoa visualization and enables more consistent DNA yields, while also avoiding SAP interference. © 2016 American Academy of Forensic Sciences.

McGovern's Senate Select Committee on Nutrition and Human Needs Versus the: Meat Industry on the Diet-Heart Question (1976–1977)

PubMed Central

Oppenheimer, Gerald M.; Benrubi, I. Daniel

2014-01-01

For decades, public health advocates have confronted industry over dietary policy, their debates focusing on how to address evidentiary uncertainty. In 1977, enough consensus existed among epidemiologists that the Senate Select Committee on Nutrition and Human Need used the diet–heart association to perform an extraordinary act: advocate dietary goals for a healthier diet. During its hearings, the meat industry tested that consensus. In one year, the committee produced two editions of its Dietary Goals for the United States, the second containing a conciliatory statement about coronary heart disease and meat consumption. Critics have characterized the revision as a surrender to special interests. But the senators faced issues for which they were professionally unprepared: conflicts within science over the interpretation of data and notions of proof. Ultimately, it was lack of scientific consensus on these factors, not simply political acquiescence, that allowed special interests to secure changes in the guidelines. PMID:24228658

Forensic Stable Isotope Biogeochemistry

NASA Astrophysics Data System (ADS)

Cerling, Thure E.; Barnette, Janet E.; Bowen, Gabriel J.; Chesson, Lesley A.; Ehleringer, James R.; Remien, Christopher H.; Shea, Patrick; Tipple, Brett J.; West, Jason B.

2016-06-01

Stable isotopes are being used for forensic science studies, with applications to both natural and manufactured products. In this review we discuss how scientific evidence can be used in the legal context and where the scientific progress of hypothesis revisions can be in tension with the legal expectations of widely used methods for measurements. Although this review is written in the context of US law, many of the considerations of scientific reproducibility and acceptance of relevant scientific data span other legal systems that might apply different legal principles and therefore reach different conclusions. Stable isotopes are used in legal situations for comparing samples for authenticity or evidentiary considerations, in understanding trade patterns of illegal materials, and in understanding the origins of unknown decedents. Isotope evidence is particularly useful when considered in the broad framework of physiochemical processes and in recognizing regional to global patterns found in many materials, including foods and food products, drugs, and humans. Stable isotopes considered in the larger spatial context add an important dimension to forensic science.

Screening Test for Shed Skin Cells by Measuring the Ratio of Human DNA to Staphylococcus epidermidis DNA.

PubMed

Nakanishi, Hiroaki; Ohmori, Takeshi; Hara, Masaaki; Takahashi, Shirushi; Kurosu, Akira; Takada, Aya; Saito, Kazuyuki

2016-05-01

A novel screening method for shed skin cells by detecting Staphylococcus epidermidis (S. epidermidis), which is a resident bacterium on skin, was developed. Staphylococcus epidermidis was detected using real-time PCR. Staphylococcus epidermidis was detected in all 20 human skin surface samples. Although not present in blood and urine samples, S. epidermidis was detected in 6 of 20 saliva samples, and 5 of 18 semen samples. The ratio of human DNA to S. epidermidisDNA was significantly smaller in human skin surface samples than in saliva and semen samples in which S. epidermidis was detected. Therefore, although skin cells could not be identified by detecting only S. epidermidis, they could be distinguished by measuring the S. epidermidis to human DNA ratio. This method could be applied to casework touch samples, which suggests that it is useful for screening whether skin cells and human DNA are present on potential evidentiary touch samples. © 2016 American Academy of Forensic Sciences.

Phenolphthalein false-positive reactions from legume root nodules.

PubMed

Petersen, Daniel; Kovacs, Frank

2014-03-01

Presumptive tests for blood play a critical role in the examination of physical evidence and in the determination of subsequent analysis. The catalytic power of hemoglobin allows colorimetric reactions employing phenolphthalein (Kastle-Meyer test) to indicate "whether" blood is present. Consequently, DNA profiles extracted from phenolphthalein-positive stains are presumed to be from blood on the evidentiary item and can lead to the identification of "whose" blood is present. Crushed nodules from a variety of legumes yielded phenolphthalein false-positive reactions that were indistinguishable from true bloodstains both in color quality and in developmental time frame. Clothing and other materials stained by nodules also yielded phenolphthalein false-positive reactivity for several years after nodule exposure. Nodules from leguminous plants contain a protein (leghemoglobin) which is structurally and functionally similar to hemoglobin. Testing of purified leghemoglobin confirmed this protein as a source of phenolphthalein reactivity. A scenario is presented showing how the presence of leghemoglobin from nodule staining can mislead investigators. © 2013 American Academy of Forensic Sciences.

Organizational downsizing and age discrimination litigation: the influence of personnel practices and statistical evidence on litigation outcomes.

PubMed

Wingate, Peter H; Thornton, George C; McIntyre, Kelly S; Frame, Jennifer H

2003-02-01

The present study examined relationships between reduction-in-force (RIF) personnel practices, presentation of statistical evidence, and litigation outcomes. Policy capturing methods were utilized to analyze the components of 115 federal district court opinions involving age discrimination disparate treatment allegations and organizational downsizing. Univariate analyses revealed meaningful links between RIF personnel practices, use of statistical evidence, and judicial verdict. The defendant organization was awarded summary judgment in 73% of the claims included in the study. Judicial decisions in favor of the defendant organization were found to be significantly related to such variables as formal performance appraisal systems, termination decision review within the organization, methods of employee assessment and selection for termination, and the presence of a concrete layoff policy. The use of statistical evidence in ADEA disparate treatment litigation was investigated and found to be a potentially persuasive type of indirect evidence. Legal, personnel, and evidentiary ramifications are reviewed, and a framework of downsizing mechanics emphasizing legal defensibility is presented.

The Potential of Cosmetic Applicators as a Source of DNA for Forensic Analysis.

PubMed

Adamowicz, Michael S; Labonte, Renáe D; Schienman, John E

2015-07-01

Personal products, such as toothbrushes, have been used as both known reference and evidentiary samples for forensic DNA analysis. This study examined the viability of a broad selection of cosmetic applicators for use as targets for human DNA extraction and short tandem repeat (STR) analysis using standard polymerase chain reaction (PCR) conditions. Applicator types included eyeliner smudgers, pencils and crayons, eye shadow sponges, mascara wands, concealer wands, face makeup sponges, pads and brushes, lipsticks and balms, and lip gloss wands. The quantity and quality of DNA extracted from each type of applicator were examined by assessing the number of loci successfully amplified and the peak balance of the heterozygous alleles in each full STR profile. While degraded DNA, stochastic amplification, and PCR inhibition were observed for some items, full STR profiles were developed for 14 of 76 applicators. The face makeup sponge applicators yielded the highest proportional number of full STR profiles (4/7). © 2015 American Academy of Forensic Sciences.

Linguistic Traces of a Scientific Fraud: The Case of Diederik Stapel

PubMed Central

Markowitz, David M.; Hancock, Jeffrey T.

2014-01-01

When scientists report false data, does their writing style reflect their deception? In this study, we investigated the linguistic patterns of fraudulent (N  =  24; 170,008 words) and genuine publications (N  =  25; 189,705 words) first-authored by social psychologist Diederik Stapel. The analysis revealed that Stapel's fraudulent papers contained linguistic changes in science-related discourse dimensions, including more terms pertaining to methods, investigation, and certainty than his genuine papers. His writing style also matched patterns in other deceptive language, including fewer adjectives in fraudulent publications relative to genuine publications. Using differences in language dimensions we were able to classify Stapel's publications with above chance accuracy. Beyond these discourse dimensions, Stapel included fewer co-authors when reporting fake data than genuine data, although other evidentiary claims (e.g., number of references and experiments) did not differ across the two article types. This research supports recent findings that language cues vary systematically with deception, and that deception can be revealed in fraudulent scientific discourse. PMID:25153333

Linguistic traces of a scientific fraud: the case of Diederik Stapel.

PubMed

Markowitz, David M; Hancock, Jeffrey T

2014-01-01

When scientists report false data, does their writing style reflect their deception? In this study, we investigated the linguistic patterns of fraudulent (N  =  24; 170,008 words) and genuine publications (N  =  25; 189,705 words) first-authored by social psychologist Diederik Stapel. The analysis revealed that Stapel's fraudulent papers contained linguistic changes in science-related discourse dimensions, including more terms pertaining to methods, investigation, and certainty than his genuine papers. His writing style also matched patterns in other deceptive language, including fewer adjectives in fraudulent publications relative to genuine publications. Using differences in language dimensions we were able to classify Stapel's publications with above chance accuracy. Beyond these discourse dimensions, Stapel included fewer co-authors when reporting fake data than genuine data, although other evidentiary claims (e.g., number of references and experiments) did not differ across the two article types. This research supports recent findings that language cues vary systematically with deception, and that deception can be revealed in fraudulent scientific discourse.

USB Storage Device Forensics for Windows 10.

PubMed

Arshad, Ayesha; Iqbal, Waseem; Abbas, Haider

2018-05-01

Significantly increased use of USB devices due to their user-friendliness and large storage capacities poses various threats for many users/companies in terms of data theft that becomes easier due to their efficient mobility. Investigations for such data theft activities would require gathering critical digital information capable of recovering digital forensics artifacts like date, time, and device information. This research gathers three sets of registry and logs data: first, before insertion; second, during insertion; and the third, after removal of a USB device. These sets are analyzed to gather evidentiary information from Registry and Windows Event log that helps in tracking a USB device. This research furthers the prior research on earlier versions of Microsoft Windows and compares it with latest Windows 10 system. Comparison of Windows 8 and Windows 10 does not show much difference except for new subkey under USB Key in registry. However, comparison of Windows 7 with latest version indicates significant variances. © 2017 American Academy of Forensic Sciences.

Proceedings of the 2016 Clinical Nutrition Week Research Workshop-The Optimal Dose of Protein Provided to Critically Ill Patients.

PubMed

Heyland, Daren K; Rooyakers, Olav; Mourtzakis, Marina; Stapleton, Renee D

2017-02-01

Recent literature has created considerable confusion about the optimal amount of protein/amino acids that should be provided to the critically ill patient. In fact, the evidentiary basis that directly tries to answer this question is relatively small. As a clinical nutrition research community, there is an urgent need to develop the optimal methods to assess the impact of exogenous protein/amino acid administration in the intensive care unit setting. That assessment can be conducted at various levels: (1) impact on stress response pathways, (2) impact on muscle synthesis and protein balance, (3) impact on muscle mass and function, and (4) impact on the patient's recovery. The objective of this research workshop was to review current literature relating to protein/amino acid administration for the critically ill patient and clinical outcomes and to discuss the key measurement and methodological features of future studies that should be done to inform the optimal protein/amino acid dose provided to critically ill patients.

DNA fingerprinting of Chinese melon provides evidentiary support of seed quality appraisal.

PubMed

Gao, Peng; Ma, Hongyan; Luan, Feishi; Song, Haibin

2012-01-01

Melon, Cucumis melo L. is an important vegetable crop worldwide. At present, there are phenomena of homonyms and synonyms present in the melon seed markets of China, which could cause variety authenticity issues influencing the process of melon breeding, production, marketing and other aspects. Molecular markers, especially microsatellites or simple sequence repeats (SSRs) are playing increasingly important roles for cultivar identification. The aim of this study was to construct a DNA fingerprinting database of major melon cultivars, which could provide a possibility for the establishment of a technical standard system for purity and authenticity identification of melon seeds. In this study, to develop the core set SSR markers, 470 polymorphic SSRs were selected as the candidate markers from 1219 SSRs using 20 representative melon varieties (lines). Eighteen SSR markers, evenly distributed across the genome and with the highest contents of polymorphism information (PIC) were identified as the core marker set for melon DNA fingerprinting analysis. Fingerprint codes for 471 melon varieties (lines) were established. There were 51 materials which were classified into17 groups based on sharing the same fingerprint code, while field traits survey results showed that these plants in the same group were synonyms because of the same or similar field characters. Furthermore, DNA fingerprinting quick response (QR) codes of 471 melon varieties (lines) were constructed. Due to its fast readability and large storage capacity, QR coding melon DNA fingerprinting is in favor of read convenience and commercial applications.

DNA Fingerprinting of Chinese Melon Provides Evidentiary Support of Seed Quality Appraisal

PubMed Central

Gao, Peng; Ma, Hongyan; Luan, Feishi; Song, Haibin

2012-01-01

Melon, Cucumis melo L. is an important vegetable crop worldwide. At present, there are phenomena of homonyms and synonyms present in the melon seed markets of China, which could cause variety authenticity issues influencing the process of melon breeding, production, marketing and other aspects. Molecular markers, especially microsatellites or simple sequence repeats (SSRs) are playing increasingly important roles for cultivar identification. The aim of this study was to construct a DNA fingerprinting database of major melon cultivars, which could provide a possibility for the establishment of a technical standard system for purity and authenticity identification of melon seeds. In this study, to develop the core set SSR markers, 470 polymorphic SSRs were selected as the candidate markers from 1219 SSRs using 20 representative melon varieties (lines). Eighteen SSR markers, evenly distributed across the genome and with the highest contents of polymorphism information (PIC) were identified as the core marker set for melon DNA fingerprinting analysis. Fingerprint codes for 471 melon varieties (lines) were established. There were 51 materials which were classified into17 groups based on sharing the same fingerprint code, while field traits survey results showed that these plants in the same group were synonyms because of the same or similar field characters. Furthermore, DNA fingerprinting quick response (QR) codes of 471 melon varieties (lines) were constructed. Due to its fast readability and large storage capacity, QR coding melon DNA fingerprinting is in favor of read convenience and commercial applications. PMID:23285039

Long-Term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD)

PubMed Central

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Objective The objective of this health technology assessment was to determine the effectiveness, cost-effectiveness, and safety of long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD). Clinical Need: Condition and Target Population Oxygen therapy is used in patients with COPD with hypoxemia, or very low blood oxygen levels, because they may have difficulty obtaining sufficient oxygen from inspired air. Technology Long-term oxygen therapy is extended use of oxygen. Oxygen therapy is delivered as a gas from an oxygen source. Different oxygen sources are: 1) oxygen concentrators, electrical units delivering oxygen converted from room air; 2) liquid oxygen systems, which deliver gaseous oxygen stored as liquid in a tank; and 3) oxygen cylinders, which contain compressed gaseous oxygen. All are available in portable versions. Oxygen is breathed in through a nasal cannula or through a mask covering the mouth and nose. The treating clinician determines the flow rate, duration of use, method of administration, and oxygen source according to individual patient needs. Two landmark randomized controlled trials (RCTs) of patients with COPD established the role of LTOT in COPD. Questions regarding the use of LTOT, however, still remain. Research Question What is the effectiveness, cost-effectiveness, and safety of LTOT compared with no LTOT in patients with COPD, who are stratified by severity of hypoxemia? Research Methods Literature Search Search Strategy A literature search was performed on September 8, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, the Cochrane Library, and INAHTA for studies published from January 1, 2007 to September 8, 2010. A single clinical epidemiologist reviewed the abstracts, obtained full-text articles for studies meeting the eligibility criteria, and examined reference lists for additional relevant studies not identified through the literature search. A second clinical epidemiologist and then a group of epidemiologists reviewed articles with an unknown eligibility until consensus was established. Inclusion Criteria patients with mild, moderate, or severe hypoxemia; English-language articles published between January 1, 2007 and September 8, 2010; journal articles reporting on effectiveness, cost-effectiveness, or safety for the comparison of interest; clearly described study design and methods; health technology assessments, systematic reviews, RCTs, or prospective cohort observational studies; any type of observational study for the evaluation of safety. Exclusion Criteria no hypoxemia non-English papers animal or in vitro studies case reports, case series, or case-case studies studies comparing different oxygen therapy regimens studies on nocturnal oxygen therapy studies on short-burst, palliative, or ambulatory oxygen (supplemental oxygen during exercise or activities of daily living) Outcomes of Interest mortality/survival hospitalizations readmissions forced expiratory volume in 1 second (FEV1) forced vital capacity (FVC) FEV1/FVC pulmonary hypertension arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2) end-exercise dyspnea score endurance time health-related quality of life Note: Outcomes of interest were formulated according to existing studies, with arterial pressure of oxygen and carbon dioxide as surrogate outcomes. Summary of Findings Conclusions Based on low quality of evidence, LTOT (~ 15 hours/day) decreases all-cause mortality in patients with COPD who have severe hypoxemia (PaO2 ~ 50 mm Hg) and heart failure. The effect for all-cause mortality had borderline statistical significance when the control group was no LTOT: one study. Based on low quality of evidence, there is no beneficial effect of LTOT on all-cause mortality at 3 and 7 years in patients with COPD who have mild-to-moderate hypoxemia (PaO2 ~ 59-65 mm Hg)1 Based on very low quality of evidence, there is some suggestion that LTOT may have a beneficial effect over time on FEV1 and PaCO2 in patients with COPD who have severe hypoxemia and heart failure: improved methods are needed. Based on very low quality of evidence, there is no beneficial effect of LTOT on lung function or exercise factors in patients with COPD who have mild-to-moderate hypoxemia, whether survivors or nonsurvivors are assessed. Based on low to very low quality of evidence, LTOT does not prevent readmissions in patients with COPD who have severe hypoxemia. Limited data suggest LTOT increases the risk of hospitalizations. Limited work has been performed evaluating the safety of LTOT by severity of hypoxemia. Based on low to very low quality of evidence, LTOT may have a beneficial effect over time on health-related quality of life in patients with COPD who have severe hypoxemia. Limited work using disease-specific instruments has been performed. Ethical constraints of not providing LTOT to eligible patients with COPD prohibit future studies from examining LTOT outcomes in an ideal way. PMID:23074435

Newly graduated nurses' use of knowledge sources in clinical decision-making: an ethnographic study.

PubMed

Voldbjerg, Siri Lygum; Grønkjaer, Mette; Wiechula, Rick; Sørensen, Erik Elgaard

2017-05-01

To explore which knowledge sources newly graduated nurses' use in clinical decision-making and why and how they are used. In spite of an increased educational focus on skills and competencies within evidence-based practice, newly graduated nurses' ability to use components within evidence-based practice with a conscious and reflective use of research evidence has been described as being poor. To understand why, it is relevant to explore which other knowledge sources are used. This may shed light on why research evidence is sparsely used and ultimately inform approaches to strengthen the knowledgebase used in clinical decision-making. Ethnographic study using participant-observation and individual semistructured interviews of nine Danish newly graduated nurses in medical and surgical hospital settings. Newly graduates use of knowledge sources was described within three main structures: 'other', 'oneself' and 'gut feeling'. Educational preparation, transition into clinical practice and the culture of the setting influenced the knowledge sources used. The sources ranged from overt easily articulated knowledge sources to covert sources that were difficult to articulate. The limited articulation of certain sources inhibited the critical reflection on the reasoning behind decisions. Reflection is a prerequisite for an evidence-based practice where decisions should be transparent in order to consider if other evidentiary sources could be used. Although there is a complexity and variety to knowledge sources used, there is an imbalance with the experienced nurse playing a key role, functioning both as predominant source and a role model as to which sources are valued and used in clinical decision-making. If newly graduates are to be supported in an articulate and reflective use of a variety of sources, they have to be allocated to experienced nurses who model a reflective, articulate and balanced use of knowledge sources. © 2016 John Wiley & Sons Ltd.

[RET/PTC Gene Rearrangements in the Sporadic and Radiogenic Thyroid Tumors: Molecular Genetics, Radiobiology and Molecular Epidemiology].

PubMed

Ushenkova, L N; Koterov, A N; Biryukov, A P

2015-01-01

A review of molecular genetic, radiobiological and molecular epidemiological studies of gene (chromosome) rearrangements RET/PTC in the cells of the thyroid gland as well as the laws in relation to radiation exposure in vitro, in vivo and human populations identified with them are submitted. The data on the c-RET gene and its chimeric constructs with the gene-donors (RET/PTC rearrangements) are considered. The information about the history of the RET/PTC discovery, their types, carcinogenic potential and specificity both to tumor and non-tumor thyroid disease especially for papillary thyroid carcinoma are provided. The data (seven studies) on the induction of RET/PTC after irradiation of tumor and normal thyroid cells in vitro and mice are reviewed. The mechanisms of RET/PTC induction may be associated with DNA double strand breaks and oxidative stress. Some information (three publications) about the possibility of RET/PTC induction by low doses of radiation with low LET (to 0.1 Gy) is given and it is concluded that their potential evidentiary is generally weak. The achievements in the molecular epidemiology of RET/PTC frequency for exposed and unexposed cohorts are stated. At the same time it is noted that, despite the vast array. of data accumulated from 30 countries of the world and more than 20 years of research, the formed provisions are weakly confirmed statistically and have no base corresponding to the canons of evidence-based medicine. The possibility of use of the RET/PTC presence or their frequencies as markers of the papillary thyroid carcinomas and, specifically, their radiogenic forms, is considered. In the first case the answer may be positive, while in the second, the situation is characterized by uncertainty. Based to the above mentioned we came to a conclusion about the need of a pooled or meta-analysis of the totality of the published data.

The problem of epistemic jurisdiction in global governance: The case of sustainability standards for biofuels.

PubMed

Winickoff, David E; Mondou, Matthieu

2017-02-01

While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies 'epistemic jurisdiction' - the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory - as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union's Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives - including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.

Psychiatric/ psychological forensic report writing.

PubMed

Young, Gerald

Approaches to forensic report writing in psychiatry, psychology, and related mental health disciplines have moved from an organization, content, and stylistic framework to considering ethical and other codes, evidentiary standards, and practice considerations. The first part of the article surveys different approaches to forensic report writing, including that of forensic mental health assessment and psychiatric ethics. The second part deals especially with psychological ethical approaches. The American Psychological Association's Ethical Principles and Code of Conduct (2002) provide one set of principles on which to base forensic report writing. The U.S. Federal Rules of Evidence (2014) and related state rules provide another basis. The American Psychological Association's Specialty Guidelines for Forensic Psychology (2013) provide a third source. Some work has expanded the principles in ethics codes; and, in the third part of this article, these additions are applied to forensic report writing. Other work that could help with the question of forensic report writing concerns the 4 Ds in psychological injury assessments (e.g., conduct oneself with Dignity, avoid the adversary Divide, get the needed reliable Data, Determine interpretations and conclusions judiciously). One overarching ethical principle that is especially applicable in forensic report writing is to be comprehensive, scientific, and impartial. As applied to forensic report writing, the overall principle that applies is that the work process and product should reflect integrity in its ethics, law, and science. Four principles that derive from this meta-principle concern: Competency and Communication; Procedure and Protection; Dignity and Distance; and Data Collection and Determination. The standards or rules associated with each of these principles are reviewed. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

The case-control design in veterinary sciences: A survey.

PubMed

Cullen, Jonah N; Sargeant, Jan M; Makielski, Kelly M; O'Connor, Annette M

2016-11-01

The case-control study design is deceptively simple. However, many design considerations influence the estimated effect measure. An investigation of case-control studies in the human health literature suggested that some of these considerations are not described in reports of case-control studies. Our hypothesis was that the majority of veterinary studies labeled as case-controls would be incident density designs, and many would not interpret the effect measure obtained from those studies as the rate ratio rather than the odds ratio. Reference databases were searched for author-designated case-control studies. A survey of 100 randomly selected studies was conducted to examine the different design options described and estimated effect measures. Of the 100 author-identified case-control studies, 83 assessed an exposure-outcome association and, of those, only 54 (65.1%) sampled the study population based on an outcome and would thus be considered case-control designs. Twelve studies were incidence density designs but none used this terminology. Of the studies that reported an odds ratio as the effect measure, none reported on additional considerations that would have enabled a more interpretable result. This survey indicated many case-control-labeled studies were not case-control designs and among case-control studies, key design aspects were not often described. The absence of information about study design elements and underlying assumptions in case-control studies limits the ability to establish the effect measured by the study and the evidentiary value of the study might be underestimated. Copyright © 2016 Elsevier B.V. All rights reserved.

Adverse Drug Event Causality Analysis (ADECA): A Process for Evaluating Evidence and Assigning Drugs to Risk Categories for Sudden Death.

PubMed

Woosley, Raymond L; Romero, Klaus; Heise, Craig W; Gallo, Tyler; Tate, Jared; Woosley, Raymond David; Ward, Sophie

2017-06-01

Growing evidence indicates that many drugs have the ability to cause a potentially lethal cardiac arrhythmia, torsades de pointes (TdP). This necessitates the development of a compilation of drugs that have this potential toxicity. Such a list is helpful in identifying the etiology of TdP in patients taking multiple drugs and assists decision making by those caring for patients at high risk of TdP. The Arizona Center for Education and Research on Therapeutics (AZCERT) has developed a process to standardize the identification of drugs and place them in risk categories for their clinical ability to cause TdP and QT prolongation. AZCERT's Adverse Drug Event Causality Analysis (ADECA) utilizes 16 types of data drawn from four sources to compile an open-source knowledge base, QTdrugs, which is maintained on the CredibleMeds.org website. Because the evidence for most drugs is incomplete, the ADECA process is used to place drugs into one of three categories that represent different levels of certainty: known TdP risk, possible TdP risk, and conditional TdP risk. Each category has strict evidentiary requirements for clinical evidence of TdP and/or QT prolongation. These are described in this paper. Because evidence can evolve over time, the ADECA process includes the continuous gathering and analysis of newly emerging evidence to revise the lists. The QTdrugs lists have proven to be a valued, readily available, commercial influence-free resource for healthcare providers, patients, researchers, and authors of consensus guidelines for the safe use of medicines.

Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

PubMed Central

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Objective The objective of this health technology assessment was to determine the effectiveness and cost-effectiveness of noninvasive ventilation for stable chronic obstructive pulmonary disease (COPD). Clinical Need: Condition and Target Population Noninvasive ventilation is used for COPD patients with chronic respiratory failure. Chronic respiratory failure in COPD patients may be due to the inability of the pulmonary system to coordinate ventilation, leading to adverse arterial levels of oxygen and carbon dioxide. Noninvasive ventilation in stable COPD patients has the potential to improve quality of life, prolong survival, and improve gas exchange and sleep quality in patients who are symptomatic after optimal therapy, have hypercapnia or nocturnal hypoventilation and mild hypercapnia, and are frequently hospitalized. Technology Noninvasive positive pressure ventilation (NPPV) is any form of positive ventilatory support without the use of an endotracheal tube. For stable COPD, the standard of care when using noninvasive ventilation is bilevel positive airway pressure (BiPAP). Bilevel positive airway pressure involves both inspiratory and expiratory pressure, high during inspiration and lower during expiration. It acts as a pressure support to accentuate a patient’s inspiratory efforts. The gradient between pressures maintains alveolar ventilation and helps to reduce carbon dioxide levels. Outpatients typically use BiPAP at night. Additional advantages of using BiPAP include resting of respiratory muscles, decreased work of breathing, and control of obstructive hypopnea. Research Question What is the effectiveness and cost-effectiveness of noninvasive ventilation, compared with no ventilation while receiving usual care, for stable COPD patients? Research Methods Literature Search Search Strategy A literature search was performed on December 3, 2010, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database for studies published from January 1, 2004 to December 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. When the reviewer was unsure of the eligibility of articles, a second clinical epidemiologist and then a group of epidemiologists reviewed these until consensus was reached. Inclusion Criteria full-text English language articles, studies published between January 1, 2004 and December 3, 2010, journal articles that report on the effectiveness or cost-effectiveness of noninvasive ventilation, clearly described study design and methods, and health technology assessments, systematic reviews, meta-analyses, randomized controlled trials (RCTs). Exclusion Criteria non-English papers animal or in vitro studies case reports, case series, or case-case studies cross-over RCTs studies on noninvasive negative pressure ventilation (e.g., iron lung) studies that combine ventilation therapy with other regimens (e.g., daytime NPPV plus exercise or pulmonary rehabilitation) studies on heliox with NPPV studies on pulmonary rehabilitation with NPPV Outcomes of Interest mortality/survival hospitalizations/readmissions length of stay in hospital forced expiratory volume arterial partial pressure of oxygen arterial partial pressure of carbon dioxide dyspnea exercise tolerance health-related quality of life Note: arterial pressure of oxygen and carbon dioxide are surrogate outcomes. Statistical Methods A meta-analysis and an analysis of individual studies were performed using Review Manager Version 5. For continuous data, a mean difference was calculated, and for dichotomous data, a relative risk ratio was calculated for RCTs. For continuous variables with mean baseline and mean follow-up data, a change value was calculated as the difference between the 2 mean values. Quality of Evidence The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence: High Further research is very unlikely to change confidence in the estimate of effect. Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Very Low Any estimate of effect is very uncertain Summary of Findings Conclusions The following conclusions refer to stable, severe COPD patients receiving usual care. Short-Term Studies Based on low quality of evidence, there is a beneficial effect of NPPV compared with no ventilation on oxygen gas exchange, carbon dioxide gas exchange, and exercise tolerance measured using the 6 Minute Walking Test. Based on very low quality of evidence, there is no effect of NPPV therapy on lung function measured as forced expiratory volume in 1 second (Type II error not excluded). Long-Term Studies Based on moderate quality of evidence, there is no effect of NPPV therapy for the outcomes of mortality, lung function measured as forced expiratory volume in 1 second, and exercise tolerance measured using the 6 Minute Walking Test. Based on low quality of evidence, there is no effect of NPPV therapy for the outcomes of oxygen gas exchange and carbon dioxide gas exchange (Type II error not excluded). Qualitative Assessment Based on low quality of evidence, there is a beneficial effect of NPPV compared with no ventilation for dyspnea based on reduced Borg score or Medical Research Council dyspnea score. Based on moderate quality of evidence, there is no effect of NPPV therapy for hospitalizations. Health-related quality of life could not be evaluated. PMID:23074437

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine.

PubMed

Gibson, Shannon; Raziee, Hamid R; Lemmens, Trudo

2015-03-01

Pharmaceutical research and development is increasingly focused on niche markets, most notably treatments for rare diseases and "personalized" medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in niche markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different-and sometimes conflicting-views on the reasons for and extent of the shift toward niche markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of niche markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies.

The Israel DNA database--the establishment of a rapid, semi-automated analysis system.

PubMed

Zamir, Ashira; Dell'Ariccia-Carmon, Aviva; Zaken, Neomi; Oz, Carla

2012-03-01

The Israel Police DNA database, also known as IPDIS (Israel Police DNA Index System), has been operating since February 2007. During that time more than 135,000 reference samples have been uploaded and more than 2000 hits reported. We have developed an effective semi-automated system that includes two automated punchers, three liquid handler robots and four genetic analyzers. An inhouse LIMS program enables full tracking of every sample through the entire process of registration, pre-PCR handling, analysis of profiles, uploading to the database, hit reports and ultimately storage. The LIMS is also responsible for the future tracking of samples and their profiles to be expunged from the database according to the Israeli DNA legislation. The database is administered by an in-house developed software program, where reference and evidentiary profiles are uploaded, stored, searched and matched. The DNA database has proven to be an effective investigative tool which has gained the confidence of the Israeli public and on which the Israel National Police force has grown to rely. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Medical tourism's impact on health care equity and access in low- and middle-income countries: making the case for regulation.

PubMed

Chen, Y Y Brandon; Flood, Colleen M

2013-01-01

There is currently an evidentiary gap in the scholarship concerning medical tourism's impact on low- and middle-income destination countries (LMICs). This article reviews relevant evidence that exists and concludes that there are signs of correlation between medical tourism and the expansion of private, technology- intensive health care in LMICs, which has largely remained out of reach for the majority of the local patients. In light of this health care inequity between local residents and medical tourists in LMICs, we argue that the presumption should not be in favor of medical tourism and that governments have a legitimate interest in seeking to regulate this industry to ensure that the net effects for their citizens is positive. Moreover, sending countries, particularly those in the developed world, have the responsibility to adopt public policies to diminish demand on the part of their citizens for medical tourism and to work with LMICs to ensure that the growth of medical tourism does not occur at the expense of the poorest of the poor. © 2013 American Society of Law, Medicine & Ethics, Inc.

Trace detection of meglumine and diatrizoate from Bacillus spore samples using liquid chromatography/mass spectrometry.

PubMed

Swider, Catherine; Maguire, Kelly; Rickenbach, Michael; Montgomery, Madeline; Ducote, Matthew J; Marhefka, Craig A

2012-07-01

Following the September 11, 2001 terrorist attacks, letters containing Bacillus anthracis were distributed through the United States postal system killing five people. A complex forensic investigation commenced to identify the perpetrator of these mailings. A novel liquid chromatography/mass spectrometry protocol for the qualitative detection of trace levels of meglumine and diatrizoate in dried spore preparations of B. anthracis was developed. Meglumine and diatrizoate are components of radiographic imaging products that have been used to purify bacterial spores. Two separate chromatographic assays using multiple mass spectrometric analyses were developed for the detection of meglumine and diatrizoate. The assays achieved limits of detection for meglumine and diatrizoate of 1.00 and 10.0 ng/mL, respectively. Bacillus cereus T strain spores were effectively used as a surrogate for B. anthracis spores during method development and validation. This protocol was successfully applied to limited evidentiary B. anthracis spore material, providing probative information to the investigators. 2012 American Academy of Forensic Sciences. Published 2012. This article is a U.S. Government work and is in the public domain in the U.S.A.

Detection of the Spermicide Nonoxynol-9 Via GC-MS

NASA Astrophysics Data System (ADS)

Musah, Rabi A.; Vuong, Angela L.; Henck, Colin; Shepard, Jason R. E.

2012-05-01

The spermicide nonoxynol-9 is actually a complex mixture of dozens of closely related amphiphilic compounds, and the chemical properties of this assortment significantly hamper its characterization by GC-MS. The inability to perform routine GC-MS testing on nonoxynol-9 has limited its evidentiary value in forensic casework, which relies heavily on this technique for analysis. A disturbing trend in sexual assault is the use of condoms by assailants, to avoid leaving behind DNA evidence that can connect a perpetrator to a victim. This observation necessitates the development of alternative methods for the analysis of trace evidence that can show causal links between a victim and a suspect. Detection of lubricants associated with sexual assault is one such way to establish this connection. The development of GC-MS methods that permit facile detection of both nonoxynol-9 alone and nonoxynol-9 extracted from other complex matrices that have potential as trace evidence in sexual assault is reported. A detection limit of 2.14 μg of nonoxynol-9 is demonstrated, and a detailed mass spectral profile that elaborates on what is known of its structure is provided.

Ethnography, fidelity, and the evidence that anthropology adds: supplementing the fidelity process in a clinical trial of supported employment.

PubMed

Smith-Morris, Carolyn; Lopez, Gilberto; Ottomanelli, Lisa; Goetz, Lance; Dixon-Lawson, Kimberly

2014-06-01

This discussion considers the role and findings of ethnographic research within a clinical trial of supported employment for veterans with spinal cord injury. Contributing to qualitative evaluation research and to debates over anthropological evidence vis-à-vis clinical trials, we demonstrate how enactors of a randomized controlled trial can simultaneously attend to both the trial's evidentiary and procedural requirements and to the lived experiences and needs of patients and clinicians. Three major findings are described: (1) contextual information essential to fidelity efforts within the trial; (2) the role of human interrelationships and idiosyncratic networks in the trial's success; and (3) a mapping of the power and authority structures relevant to the staff's ability to perform the protocol. We emphasize strengths of anthropological ethnography in clinical trials that include the provision of complementary, qualitative data, the capture of otherwise unmeasured parts of the trial, and the realization of important information for the translation of the clinical findings into new settings. © 2014 by the American Anthropological Association.

Identification of a killer by a definitive sneaker pattern and his beating instruments by their distinctive patterns.

PubMed

Zugibe, F T; Costello, J; Breithaupt, M

1996-03-01

A 39-year-old male service station attendant was found murdered on the floor of a gasoline service area by a passing motorist who had stopped for gas. The victim had been brutally beaten all over his entire body. After carefully examining the body and scene and taking selective photographs, special procedures were implemented in an attempt to preserve and transport the body without disturbing any items of evidence. In addition, specific evidentiary items were noted and collected for processing. The victim was meticulously examined externally at autopsy using a special protocol to locate clues that might assist in identifying a suspect or instrument of injury or death. Patterned impressions and subsequent DNA analysis proved successful in identifying the perpetrator of the crime and the instruments used in inflicting the beating. It is the purpose of this paper to show how a meticulous examination of the body for the presence of patterned injuries and critical studies of these patterns and impressions led to the identification of a killer and the instruments he used in a brutal beating.

FORENSIC RADIOLOGY AND IMAGING FOR VETERINARY RADIOLOGISTS.

PubMed

Watson, Elizabeth; Heng, Hock Gan

2017-05-01

Imaging studies are often of evidentiary value in medicolegal investigations involving animals and the role of the veterinary radiologist is to interpret those images for courts as an expert or opinion witness. With progressing interest in prosecuting animal crimes and strengthening of penalties for crimes against animals, the participation of veterinary radiologists in medicolegal investigations is expected to increase. Veterinary radiologists who are aware of radiographic and imaging signs that result in animal suffering, abuse, or neglect; knowledgeable in ways radiology and imaging may support cause of death determinations; conversant in postmortem imaging; comfortable discussing mechanisms and timing of blunt or sharp force and projectile trauma in imaging; and prepared to identify mimics of abuse can assist court participants in understanding imaging evidence. The goal of this commentary review is to familiarize veterinary radiologists with the forensic radiology and imaging literature and with the advantages and disadvantages of various imaging modalities utilized in forensic investigations. Another goal is to provide background information for future research studies in veterinary forensic radiology and imaging. © 2017 American College of Veterinary Radiology.

A note on Hardy-Weinberg equilibrium of VNTR data by using the Federal Bureau of Investigation's fixed-bin method

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

Devlin, B.; Risch, N.

1992-09-01

To fully utilize the information of VNTR data for forensic inference, the probability of observing the matching suspect and evidentiary profile in a reference population is estimated, usually by assuming independence of alleles within and between loci. This assumption has been challenged on the basis of the observation that there is frequently an excess of single-band phenotypes (SBP) in forensic data bases, which could indicate lack of independence. Nevertheless, another explanation is that the excess SBP are artifacts of laboratory methods. In this report the authors examine the excess of SBP for three VNTR loci studied by the FBI (D17S79more » and D2S44, for blacks, and D14S13, for Caucasians). The FBI claims that the excess is due to the effect of null alleles; the null alleles are suspected to be small to be detected. The authors estimate the frequency of null alleles for two loci (D17S79 and D14A13) by comparing, for these loci, the data from the FBI data base and the data from the Lifecodes data base. These comparisons yield information on small fragments because Lifecodes uses the restriction enzyme PstI, which yields larger fragments than does HaeIII, which the FBI uses. For D17S19 in blacks, the authors estimate a null allele frequency of 4.4%, and, for D14S13 in Caucasians, they estimate a frequency of 3.0%. The null-allele frequency for D2S44 in blacks is derived similarly, again being based on analysis of DNA cut with HaeIII and PstI; the estimate of the null-allele frequency for this locus is 1.5%. Using these null-allele frequency estimates and a goodness-of-fit test, the authors show that there is no evidence for deviations from Hardy-Weinberg expectations of genotype probabilities at these loci. 20 refs., 1 fig.« less

High-energy contact sports and cervical spine neuropraxia injuries: what are the criteria for return to participation?

PubMed

Dailey, Andrew; Harrop, James S; France, John C

2010-10-01

Clinically based systematic review. To define optimal clinical care for patients after sport-related neuropraxic injuries using a systematic review supported with expert opinion. Athletes who participate in contact sports may experience cervical cord neuropraxia, with bilateral motor or sensory symptoms such as burning, numbness, or loss of sensation referable to the cervical spinal cord. The symptoms last from minutes to hours, but recovery is usually believed to be complete. The underlying condition is cervical spinal stenosis that predisposes the athlete to a transient compression or concussive injury to the spinal cord. Focused questions on the treatment of cervical spine sport-related injuries resulting in transient neuropraxia were refined by a panel of spine traumatology surgeons consisting of fellowship-trained neurologic and orthopedic surgeons. Medical subject heading keywords were searched through MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews to identify pertinent English-language abstracts and articles whose focus was human subjects. The quality of literature was rated as high, moderate, low, or very low. The proposed questions were answered using the Grading of Recommendations Assessment, Development and Evaluation evidence-based review system. These treatment recommendations were rated as either strong or weak based on the quality of evidence and clinical expertise. The literature searches revealed low and very low quality evidence with no prospective or randomized studies. One hundred fifty-three pertinent articles were identified; these were supplemented with additional articles to form an evidentiary table with 17 original articles containing unique patient data. Literature regarding the optimal treatment of patients with transient neuropraxia is of low quality. On the basis of expert opinion, there was a recommendation that a return to full participation in high-energy contact sports could be based on radiographic findings: patients with transient neuropraxia without stenosis could return as a strong recommendation, whereas stenotic patients could not return as a weak recommendation. Furthermore, a strong recommendation was made to permit players to return to full participation after decompression with a single-level anterior cervical fusion.

Pulmonary Rehabilitation for Patients With Chronic Pulmonary Disease (COPD)

PubMed Central

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Objective The objective of this evidence-based review was to determine the effectiveness and cost-effectiveness of pulmonary rehabilitation in the management of chronic obstructive pulmonary disease (COPD). Technology Pulmonary rehabilitation refers to a multidisciplinary program of care for patients with chronic respiratory impairment that is individually tailored and designed to optimize physical and social performance and autonomy. Exercise training is the cornerstone of pulmonary rehabilitation programs, though they may also include components such as patient education and psychological support. Pulmonary rehabilitation is recommended as the standard of care in the treatment and rehabilitation of patients with COPD who remain symptomatic despite treatment with bronchodilators. For the purpose of this review, the Medical Advisory Secretariat focused on pulmonary rehabilitation programs as defined by the Cochrane Collaboration—that is, any inpatient, outpatient, or home-based rehabilitation program lasting at least 4 weeks that includes exercise therapy with or without any form of education and/or psychological support delivered to patients with exercise limitations attributable to COPD. Research Questions What is the effectiveness and cost-effectiveness of pulmonary rehabilitation compared with usual care (UC) for patients with stable COPD? Does early pulmonary rehabilitation (within 1 month of hospital discharge) in patients who had an acute exacerbation of COPD improve outcomes compared with UC (or no rehabilitation)? Do maintenance or postrehabilitation programs for patients with COPD who have completed a pulmonary rehabilitation program improve outcomes compared with UC? Research Methods Literature Search Search Strategy For Research Questions 1and 2, a literature search was performed on August 10, 2010 for studies published from January 1, 2004 to July 31, 2010. For Research Question 3, a literature search was performed on February 3, 2011 for studies published from January 1, 2000 to February 3, 2011. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists and health technology assessment websites were also examined for any additional relevant studies not identified through the systematic search. Inclusion Criteria Research questions 1 and 2: published between January 1, 2004 and July 31, 2010 randomized controlled trials, systematic reviews, and meta-analyses COPD study population studies comparing pulmonary rehabilitation with UC (no pulmonary rehabilitation) duration of pulmonary rehabilitation program ≥ 6 weeks pulmonary rehabilitation program had to include at minimum exercise training Research question 3: published between January 1, 2000 and February 3, 2011 randomized controlled trials, systematic reviews, and meta-analyses COPD study population studies comparing a maintenance or postrehabilitation program with UC (standard follow-up) duration of pulmonary rehabilitation program ≥ 6 weeks initial pulmonary rehabilitation program had to include at minimum exercise training Exclusion Criteria Research questions 1, 2, and 3: grey literature duplicate publications non-English language publications study population ≤ 18 years of age studies conducted in a palliative population studies that did not report primary outcome of interest Additional exclusion criteria for research question 3: studies with ≤ 2 sessions/visits per month Outcomes of Interest The primary outcomes of interest for the stable COPD population were exercise capacity and health-related quality of life (HRQOL). For the COPD population following an exacerbation, the primary outcomes of interest were hospital readmissions and HRQOL. The primary outcomes of interest for the COPD population undertaking maintenance programs were functional exercise capacity and HRQOL. Quality of Evidence The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence: High Further research is very unlikely to change confidence in the estimate of effect. Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Very Low Any estimate of effect is very uncertain. Summary of Findings Research Question 1: Effect of Pulmonary Rehabilitation on Outcomes in Stable COPD Seventeen randomized controlled trials met the inclusion criteria and were included in this review. The following conclusions are based on moderate quality of evidence. Pulmonary rehabilitation including at least 4 weeks of exercise training leads to clinically and statistically significant improvements in HRQOL in patients with COPD.1 Pulmonary rehabilitation also leads to a clinically and statistically significant improvement in functional exercise capacity2 (weighted mean difference, 54.83 m; 95% confidence interval, 35.63–74.03; P < 0.001). Research Question 2: Effect of Pulmonary Rehabilitation on Outcomes Following an Acute Exacerbation of COPD Five randomized controlled trials met the inclusion criteria and are included in this review. The following conclusion is based on moderate quality of evidence. Pulmonary rehabilitation (within 1 month of hospital discharge) after acute exacerbation significantly reduces hospital readmissions (relative risk, 0.50; 95% confidence interval, 0.33–0.77; P = 0.001) and leads to a statistically and clinically significant improvement in HRQOL.3 Research Question 3: Effect of Pulmonary Rehabilitation Maintenance Programs on COPD Outcomes Three randomized controlled trials met the inclusion criteria and are included in this review. The conclusions are based on a low quality of evidence and must therefore be considered with caution. Maintenance programs have a nonsignificant effect on HRQOL and hospitalizations. Maintenance programs have a statistically but not clinically significant effect on exercise capacity (P = 0.01). When subgrouped by intensity and quality of study, maintenance programs have a statistically and marginally clinically significant effect on exercise capacity. PMID:23074434

Use of Anecdotal Occurrence Data in Species Distribution Models: An Example Based on the White-Nosed Coati (Nasua narica) in the American Southwest

PubMed Central

Frey, Jennifer K.; Lewis, Jeremy C.; Guy, Rachel K.; Stuart, James N.

2013-01-01

Simple Summary We evaluated the influence of occurrence records with different reliability on predicted distribution of a unique, rare mammal in the American Southwest, the white-nosed coati (Nasua narica). We concluded that occurrence datasets that include anecdotal records can be used to infer species distributions, providing such data are used only for easily-identifiable species and based on robust modeling methods such as maximum entropy. Use of a reliability rating system is critical for using anecdotal data. Abstract Species distributions are usually inferred from occurrence records. However, these records are prone to errors in spatial precision and reliability. Although influence of spatial errors has been fairly well studied, there is little information on impacts of poor reliability. Reliability of an occurrence record can be influenced by characteristics of the species, conditions during the observation, and observer’s knowledge. Some studies have advocated use of anecdotal data, while others have advocated more stringent evidentiary standards such as only accepting records verified by physical evidence, at least for rare or elusive species. Our goal was to evaluate the influence of occurrence records with different reliability on species distribution models (SDMs) of a unique mammal, the white-nosed coati (Nasua narica) in the American Southwest. We compared SDMs developed using maximum entropy analysis of combined bioclimatic and biophysical variables and based on seven subsets of occurrence records that varied in reliability and spatial precision. We found that the predicted distribution of the coati based on datasets that included anecdotal occurrence records were similar to those based on datasets that only included physical evidence. Coati distribution in the American Southwest was predicted to occur in southwestern New Mexico and southeastern Arizona and was defined primarily by evenness of climate and Madrean woodland and chaparral land-cover types. Coati distribution patterns in this region suggest a good model for understanding the biogeographic structure of range margins. We concluded that occurrence datasets that include anecdotal records can be used to infer species distributions, providing such data are used only for easily-identifiable species and based on robust modeling methods such as maximum entropy. Use of a reliability rating system is critical for using anecdotal data. PMID:26487405

Educating adult females for leadership roles in an informal science program for girls

NASA Astrophysics Data System (ADS)

McCreedy, Dale

The purpose of this study is to gain an understanding of and an evidentiary warrant for, how a community of practice focused on informal science learning, can engage and promote active participation that offers adult female members and the community opportunities for legitimacy and transformation. This study is a qualitative, ethnographic research study that documents how adult female volunteers, historically inexperienced and/or excluded from traditional practices of science, come to engage in science activities through an informal, community-based context that helps them to appreciate science connections in their lives that are ultimately empowering and agentic. I begin to understand the ways in which such informal contexts, often thought to be marginal to dominant educational beliefs and practices, can offer adults outside of the field of science, education, or both, an entree into science learning and teaching that facilitate female's participation in legitimate and empowering ways. Using descriptive analyses, I first identify the characteristics of peripheral and active program participants. Through phenomenological analyses, I then develop an understanding of participation in an informal science program by focusing on three adult female members' unique trajectories of participation leading to core member status. Each draws on different aspects of the program that they find most salient, illustrating how different elements can serve as motivators for participation, and support continuation along the trajectory of participation reflecting personal and political agency. Through a purposeful ethnographic case-study analysis, I then explore one core member's transformation, evidenced by her developing identities as someone who enjoys science, engages in science activities, and, enacts a role as community old timer and door opener to science learning. This study: (1) contributes to the limited knowledge base in fields of informal learning, science education, and feminist research; (2) provides data that lead to assertions about the impact of NSP participation; and (3) takes advantage of a unique context in which to study adults and the interaction of gender, science, and informal learning.

Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

PubMed

Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

2016-10-01

The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product labeling. As such, the development of a new FD symptom PRO instrument is supported.

Lumbar Spinous Process Fixation and Fusion: A Systematic Review and Critical Analysis of an Emerging Spinal Technology.

PubMed

Lopez, Alejandro J; Scheer, Justin K; Dahdaleh, Nader S; Patel, Alpesh A; Smith, Zachary A

2017-11-01

A systematic review. The available literature on interspinous rigid fixation/fusion devices (IFD) was systematically reviewed to explore the devices' efficacy and complication profile. The clinical application of new spinal technologies may proceed without well-established evidence, as is the case with IFDs. IFDs are plate-like devices that are attached to the lateral aspects of 2 adjacent spinous processes to promote rigidity at that segment. Despite almost a decade since the devices' introduction, the literature regarding efficacy and safety is sparse. Complications have been reported but no definitive study is known to the authors. A systematic review of the past 10 years of English literature was conducted according to PRISMA guidelines. The timeframe was chosen based on publication of the first study containing a modern IFD, the SPIRE, in 2006. All PubMed publications containing MeSH headings or with title or abstract containing any combination of the words "interspinous," "spinous process," "fusion," "fixation," "plate," or "plating" were included. Exclusion criteria consisted of dynamic stabilization devices (X-Stop, DIAM, etc.), cervical spine, pediatrics, and animal models. The articles were blinded to author and journal, assigned a level of evidence by Oxford Centre of Evidence-Based Medicine (OCEBM) criteria, and summarized in an evidentiary table. A total of 293 articles were found in the initial search, of which 15 remained after examination for exclusion criteria. No class I or class II evidence regarding IFDs was found. IFDs have been shown by methodologically flawed and highly biased class III evidence to reduce instability at 1 year, without statistical comparison of complication rates against other treatment modalities. Although IFDs are heavily marketed and commonly applied in modern practice, data on safety and efficacy are inadequate. The paucity of evidence warrants reexamination of these devices' value and indications by the spine surgery community.

Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications (Second Edition): Guidelines From the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain.

PubMed

Narouze, Samer; Benzon, Honorio T; Provenzano, David; Buvanendran, Asokumar; De Andres, José; Deer, Timothy; Rauck, Richard; Huntoon, Marc A

2018-04-01

The American Society of Regional Anesthesia and Pain Medicine (ASRA) 2012 survey of meeting attendees showed that existing ASRA anticoagulation guidelines for regional anesthesia were insufficient for their needs. Those surveyed agreed that procedure-specific and patient-specific factors required separate guidelines for pain and spine procedures. In response, a guidelines committee was formed. After preliminary review of published complications reports and studies, the committee stratified interventional spine and pain procedures according to potential bleeding risk: low-, intermediate-, and high-risk procedures. The ASRA regional anesthesia anticoagulation guidelines were largely deemed appropriate for the low- and intermediate-risk categories, but the high-risk category required further investigation. The first guidelines specific to interventional spine and pain procedures were published in 2015. Recent reviews evaluating bleeding complications in patients undergoing specific interventional pain procedures, the development of new regional anesthesia and acute pain guidelines, and the development of new anticoagulants and antiplatelet medications necessitate complementary updated guidelines. The authors desired coordination with the authors of the recently updated regional and acute pain anticoagulation guidelines. The latest evidence was sought through extensive database search strategies and the recommendations were evidence based when available and pharmacology driven otherwise. We could not provide strength and grading of these recommendations because there are not enough well-designed large studies concerning interventional pain procedures to support such grading. Although the guidelines could not always be based on randomized studies or on large numbers of patients from pooled databases, it is hoped that they will provide sound recommendations and the evidentiary basis for such recommendations. This publication is intended as a living document to be updated periodically with consideration of new evidence.

Exploring the controversy in child abuse pediatrics and false accusations of abuse.

PubMed

Gabaeff, Steven C

2016-01-01

There is a controversy in child abuse pediatrics between an established corps of child abuse pediatricians aligned with hospital colleagues and law enforcement, and a multi-specialty challenger group of doctors and other medical professionals working with public interest lawyers. The latter group questions the scientific validity of the core beliefs of child abuse pediatricians and believes that there are a substantial number of false accusations of abuse occurring. An unproven primary hypothesis, crafted around 1975 by a small group of pediatricians with an interest in child abuse, lies at the foundation of child abuse pediatrics. With no scientific study, it was hypothesized that subdural hemorrhage (SDH) and retinal hemorrhage (RH) were diagnostic of shaking abuse. That hypothesis became the so-called "shaken baby syndrome." Through the period 1975-1985, in a coordinated manner, these child abuse specialists coalesced under the American Academy of Pediatrics and began working with district attorneys and social workers, informing them of the ways in which their hypothesis could be applied to prosecutions of child abuse and life-altering social service interventions. In a legal context, using then-prevailing evidentiary rules which treated scientific expert testimony as valid if it was "generally accepted" in the field, they represented falsely that there was general acceptance of their hypothesis and therefore it was valid science. As the ability to convict based on this unproven prime hypothesis (SDH and RH equals abuse) increased, some defense attorneys were professionally compelled by their own doubts to reach out to experts from other fields with experience with SDH and RH, trauma, and biomechanics, for second opinions. Medical and legal challenges to the established thinking soon emerged, based on both old and new evidenced-based literature. As the intensity of the controversy increased, the probability of false accusation became more apparent and the need to address the issue more pressing. Since false accusations of child abuse are themselves abusive, efforts to eliminate such false accusations must continue. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

A 17-month time course study of human RNA and DNA degradation in body fluids under dry and humid environmental conditions.

PubMed

Sirker, Miriam; Schneider, Peter M; Gomes, Iva

2016-11-01

Blood, saliva, and semen are some of the forensically most relevant biological stains commonly found at crime scenes, which can often be of small size or challenging due to advanced decay. In this context, it is of great importance to possess reliable knowledge about the effects of degradation under different environmental conditions and to use appropriate methods for retrieving maximal information from limited sample amount. In the last decade, RNA analysis has been demonstrated to be a reliable approach identifying the cell or tissue type of an evidentiary body fluid trace. Hence, messenger RNA (mRNA) profiling is going to be implemented into forensic casework to supplement the routinely performed short tandem repeat (STR) analysis, and therefore, the ability to co-isolate RNA and DNA from the same sample is a prerequisite. The objective of this work was to monitor and compare the degradation process of both nucleic acids for human blood, saliva, and semen stains at three different concentrations, exposed to dry and humid conditions during a 17-month time period. This study also addressed the question whether there are relevant differences in the efficiency of automated, magnetic bead-based single DNA or RNA extraction methods compared to a manually performed co-extraction method using silica columns. Our data show that mRNA, especially from blood and semen, can be recovered over the entire time period surveyed without compromising the success of DNA profiling; mRNA analysis indicates to be a robust and reliable technique to identify the biological source of aged stain material. The co-extraction method appears to provide mRNA and DNA of sufficient quantity and quality for all different forensic investigation procedures. Humidity and accompanied mold formation are detrimental to both nucleic acids.

A non-linear dynamical approach to belief revision in cognitive behavioral therapy

PubMed Central

Kronemyer, David; Bystritsky, Alexander

2014-01-01

Belief revision is the key change mechanism underlying the psychological intervention known as cognitive behavioral therapy (CBT). It both motivates and reinforces new behavior. In this review we analyze and apply a novel approach to this process based on AGM theory of belief revision, named after its proponents, Carlos Alchourrón, Peter Gärdenfors and David Makinson. AGM is a set-theoretical model. We reconceptualize it as describing a non-linear, dynamical system that occurs within a semantic space, which can be represented as a phase plane comprising all of the brain's attentional, cognitive, affective and physiological resources. Triggering events, such as anxiety-producing or depressing situations in the real world, or their imaginal equivalents, mobilize these assets so they converge on an equilibrium point. A preference function then evaluates and integrates evidentiary data associated with individual beliefs, selecting some of them and comprising them into a belief set, which is a metastable state. Belief sets evolve in time from one metastable state to another. In the phase space, this evolution creates a heteroclinic channel. AGM regulates this process and characterizes the outcome at each equilibrium point. Its objective is to define the necessary and sufficient conditions for belief revision by simultaneously minimizing the set of new beliefs that have to be adopted, and the set of old beliefs that have to be discarded or reformulated. Using AGM, belief revision can be modeled using three (and only three) fundamental syntactical operations performed on belief sets, which are expansion; revision; and contraction. Expansion is like adding a new belief without changing any old ones. Revision is like adding a new belief and changing old, inconsistent ones. Contraction is like changing an old belief without adding any new ones. We provide operationalized examples of this process in action. PMID:24860491

Adjunctive nutraceuticals with standard pharmacotherapies in bipolar disorder: a systematic review of clinical trials.

PubMed

Sarris, Jerome; Mischoulon, David; Schweitzer, Isaac

2011-01-01

  Studies using augmentation of pharmacotherapies with nutraceuticals in bipolar disorder (BD) have been conducted and preliminary evidence in many cases appears positive. To date, however, no specialized systematic review of this area has been conducted. We present the first systematic review of clinical trials using nutrient-based nutraceuticals in combination with standard pharmacotherapies to treat BD. A subsequent aim of this report was to discuss posited underlying mechanisms of action.   PubMed, CINAHL, Web of Science, and Cochrane Library databases, and grey literature were searched during mid-2010 for human clinical trials in English using nutraceuticals such as omega-3, N-acetyl cysteine (NAC), inositol, and vitamins and minerals, in combination with pharmacotherapies to treat bipolar mania and bipolar depression. A review of the results including an effect size analysis (Cohen's d) was subsequently conducted.   In treating bipolar depression, positive evidence with large effect sizes were found for NAC (d=1.04) and a chelated mineral and vitamin formula (d=1.70). On the outcome of bipolar mania, several nutraceuticals reduced mania with strong clinical effects: a chelated mineral formula (d=0.83), L-tryptophan (d=1.47), magnesium (d=1.44), folic acid (d=0.40), and branched-chain amino acids (d=1.60). Mixed, but mainly positive, evidence was found for omega-3 for bipolar depression, while no evidentiary support was found for use in mania. No significant effect on BD outcome scales was found for inositol (possibly due to small samples).   BD treatment outcomes may potentially be improved by additional use of certain nutraceuticals with conventional pharmacotherapies. However, caution should be extended in interpreting the large effects of several isolated studies, as they have not yet been replicated in larger trials. © 2011 John Wiley and Sons A/S.

An inconclusive study comparing the effect of concrete and abstract descriptions of belief-inconsistent information.

PubMed

Collins, Katherine A; Clément, Richard

2018-01-01

Linguistic bias is the differential use of linguistic abstraction (as defined by the Linguistic Category Model) to describe the same behaviour for members of different groups. Essentially, it is the tendency to use concrete language for belief-inconsistent behaviours and abstract language for belief-consistent behaviours. Having found that linguistic bias is produced without intention or awareness in many contexts, researchers argue that linguistic bias reflects, reinforces, and transmits pre-existing beliefs, thus playing a role in belief maintenance. Based on the Linguistic Category Model, this assumes that concrete descriptions reduce the impact of belief-inconsistent behaviours while abstract descriptions maximize the impact of belief-consistent behaviours. However, a key study by Geschke, Sassenberg, Ruhrmann, and Sommer [2007] found that concrete descriptions of belief-inconsistent behaviours actually had a greater impact than abstract descriptions, a finding that does not fit easily within the linguistic bias paradigm. Abstract descriptions (e.g. the elderly woman is athletic) are, by definition, more open to interpretation than concrete descriptions (e.g. the elderly woman works out regularly). It is thus possible that abstract descriptions are (1) perceived as having less evidentiary strength than concrete descriptions, and (2) understood in context (i.e. athletic for an elderly woman). In this study, the design of Geschke et al. [2007] was modified to address this possibility. We expected that the differences in the impact of concrete and abstract descriptions would be reduced or reversed, but instead we found that differences were largely absent. This study did not support the findings of Geschke et al. [2007] or the linguistic bias paradigm. We encourage further attempts to understand the strong effect of concrete descriptions for belief-inconsistent behaviour.

Metagenomic analyses of bacteria on human hairs: a qualitative assessment for applications in forensic science.

PubMed

Tridico, Silvana R; Murray, Dáithí C; Addison, Jayne; Kirkbride, Kenneth P; Bunce, Michael

2014-01-01

Mammalian hairs are one of the most ubiquitous types of trace evidence collected in the course of forensic investigations. However, hairs that are naturally shed or that lack roots are problematic substrates for DNA profiling; these hair types often contain insufficient nuclear DNA to yield short tandem repeat (STR) profiles. Whilst there have been a number of initial investigations evaluating the value of metagenomics analyses for forensic applications (e.g. examination of computer keyboards), there have been no metagenomic evaluations of human hairs-a substrate commonly encountered during forensic practice. This present study attempts to address this forensic capability gap, by conducting a qualitative assessment into the applicability of metagenomic analyses of human scalp and pubic hair. Forty-two DNA extracts obtained from human scalp and pubic hairs generated a total of 79,766 reads, yielding 39,814 reads post control and abundance filtering. The results revealed the presence of unique combinations of microbial taxa that can enable discrimination between individuals and signature taxa indigenous to female pubic hairs. Microbial data from a single co-habiting couple added an extra dimension to the study by suggesting that metagenomic analyses might be of evidentiary value in sexual assault cases when other associative evidence is not present. Of all the data generated in this study, the next-generation sequencing (NGS) data generated from pubic hair held the most potential for forensic applications. Metagenomic analyses of human hairs may provide independent data to augment other forensic results and possibly provide association between victims of sexual assault and offender when other associative evidence is absent. Based on results garnered in the present study, we believe that with further development, bacterial profiling of hair will become a valuable addition to the forensic toolkit.

Econometrics as evidence? Examining the 'causal' connections between financial speculation and commodities prices.

PubMed

Williams, James W; Cook, Nikolai M

2016-10-01

One of the lasting legacies of the financial crisis of 2008, and the legislative energies that followed from it, is the growing reliance on econometrics as part of the rulemaking process. Financial regulators are increasingly expected to rationalize proposed rules using available econometric techniques, and the courts have vacated several key rules emanating from Dodd-Frank on the grounds of alleged deficiencies in this evidentiary effort. The turn toward such econometric tools is seen as a significant constraint on and challenge to regulators as they endeavor to engage with such essential policy questions as the impact of financial speculation on food security. Yet, outside of the specialized practitioner community, very little is known about these techniques. This article examines one such econometric test, Granger causality, and its role in a pivotal Dodd-Frank rulemaking. Through an examination of the test for Granger causality and its attempts to distill the causal connections between financial speculation and commodities prices, the article argues that econometrics is a blunt but useful tool, limited in its ability to provide decisive insights into commodities markets and yet yielding useful returns for those who are able to wield it.

Legal and ethical aspects of deliberate G-induced loss of consciousness experiments.

PubMed

Euretig, J G

1991-07-01

Informed consent is both a legal and accepted ethical prerequisite to nontherapeutic human experimentation. The informed consent obtained from the subject in G-LOC experimentation is in the same form as the risk disclosures used in high-G acceleration experiments. However, in high acceleration protocols G-LOC is a potential risk while in G-LOC experiments it is the result. The case law embodies three modern evidentiary standards (the "professional," "material fact," and "possible risks" tests) employed by common law courts when deciding whether the risk disclosures are sufficient to elicit the informed consent of the subject. Each standard is applied against the disclosures in the G-LOC protocol to determine if the elements of the requirement are met. The risk disclosures are wanting in specific identification under the three tests. The deficiency is the failure to inform the subject that G-LOC may result in a pathologic state of unconsciousness about which little is known. Without complete disclosure of this lacking state of medical knowledge, it is questionable whether informed consent can be given. If subjected to judicial scrutiny, the disclosures stated in the G-LOC protocol used in government sponsored research will probably be found deficient.

Variability in the blood/breath alcohol ratio and implications for evidentiary purposes.

PubMed

Jaffe, Dena H; Siman-Tov, Maya; Gopher, Asher; Peleg, Kobi

2013-09-01

The breath analyzer is an indispensable tool for identifying alcohol levels among drivers. While numerous studies have shown high correlations between blood and breath alcohol concentrations, most are limited by the study design. This study seeks to assess this relationship by minimizing potential measurement bias, document time from alcohol consumption to testing, and adjusting for potential confounders. A blinded study was performed using conditions closely resembling those in the field. The Draeger 7110 MKIII IL breath analyzer was used to assess breath alcohol concentrations (BrAC). Participants were 61 healthy volunteers aged 21-37 years with body mass index ≤30 and no history of alcoholism. A total of 242 valid blood/breath tests were performed in four test sets. The study results showed a high correlation coefficient between BrAC and blood alcohol concentration (BAC) levels (r = 0.983) with high sensitivity (97%) and specificity (93%). This strong association between the breath analyzer and BAC persisted even after adjustment for various stages of alcohol absorption. These results illustrate the high diagnostic sensitivity of the breath analyzer in field-tested conditions. © 2013 American Academy of Forensic Sciences.

Analytical Validation of a Portable Mass Spectrometer Featuring Interchangeable, Ambient Ionization Sources for High Throughput Forensic Evidence Screening

NASA Astrophysics Data System (ADS)

Lawton, Zachary E.; Traub, Angelica; Fatigante, William L.; Mancias, Jose; O'Leary, Adam E.; Hall, Seth E.; Wieland, Jamie R.; Oberacher, Herbert; Gizzi, Michael C.; Mulligan, Christopher C.

2017-06-01

Forensic evidentiary backlogs are indicative of the growing need for cost-effective, high-throughput instrumental methods. One such emerging technology that shows high promise in meeting this demand while also allowing on-site forensic investigation is portable mass spectrometric (MS) instrumentation, particularly that which enables the coupling to ambient ionization techniques. While the benefits of rapid, on-site screening of contraband can be anticipated, the inherent legal implications of field-collected data necessitates that the analytical performance of technology employed be commensurate with accepted techniques. To this end, comprehensive analytical validation studies are required before broad incorporation by forensic practitioners can be considered, and are the focus of this work. Pertinent performance characteristics such as throughput, selectivity, accuracy/precision, method robustness, and ruggedness have been investigated. Reliability in the form of false positive/negative response rates is also assessed, examining the effect of variables such as user training and experience level. To provide flexibility toward broad chemical evidence analysis, a suite of rapidly-interchangeable ion sources has been developed and characterized through the analysis of common illicit chemicals and emerging threats like substituted phenethylamines. [Figure not available: see fulltext.

Abortion, breast cancer, and informed consent.

PubMed

Kindley, J

2000-01-01

The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering induced abortion. The article examines the relationship between this evidence and the elements of a medical malpractice claim alleging failure to obtain informed consent. The first part focuses on the elements of informed consent, which require the plaintiff to establish that the physician had a duty to disclose information, which he failed to disclose, that this failure to disclose was a legal cause of the plaintiff's decision to undergo the procedure, and the procedure was a legal cause of the plaintiff's injury. The second part compares two prevalent standards for determining which risks a physician has a duty to disclose. Part three reviews the scientific evidence of the abortion/breast cancer (ABC) link and explains why it survives both the Frye and the Daubert tests for admissibility of expert testimony. The fourth part assesses the materiality of the risk posed by the ABC link. Parts five and six discuss evidentiary issues and the possibility of punitive damage awards.

John Woolman and Ethical Progress in Kitcher's Pragmatic Naturalism.

PubMed

Barresi, John

2017-01-01

The development of John Woolman’s views on slavery plays an important evidentiary role in Philip Kitcher’s recent book, The ethical project (Kitcher 2011). In this work Kitcher takes what he calls a “pragmatic naturalist” approach to ethics and claims that the discovery of ethical truth plays no role in the emergence of ethical progress. To support his view, he argues that Woolman’s contribution was not due to his discovery of an ethical truth about slavery, not previously known, but due to his sensitivity to slavery and his influence on others, which contributed to collective progressive change in moral norms involving slavery. While not disputing Kitcher’s ethical theory, I argue that personal discoveries of a moral psychological nature made by Woolman served both as insights and motivations for his contribution. Thus, even if there are no such things as independent ethical truths that can be discovered by individuals, a fully naturalistic approach to ethical progress requires that we make room not only for group-level progressive evolution of norms, but also for individual discoveries of a moral psychological nature that can sometimes cause an individual to play a significant initiating role in progressive ethical transitions that occur at a group level.

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

PubMed

Hemmerich, Natalie; Klein, Elizabeth G; Berman, Micah

2017-08-01

Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation. Copyright © 2017 by Duke University Press.

Case study: using infrared technology for evidentiary purposes

NASA Astrophysics Data System (ADS)

Jolivet, Noel D.; Hansen, Joel; Miller, John Lester; Beniga, Rico; Austria, Rich

2014-06-01

Infrared technology and imaging systems are already used extensively by the law enforcement (LE) community, typically to gain a tactical advantage or obtain immediate situational awareness. As the use of infrared technology becomes more affordable and widespread, LE is finding new ways to use it and leverage the results in the courtroom as evidence. A case study will be presented where infrared imagery was used to support the Portland Police Bureau (PPB) in prosecuting an individual for a crime where a conviction might not have been assured without said imagery. Tests conducted at FLIR Systems, combined with expert witness testimony by a FLIR employee, helped a jury understand the significance of a key piece of infrared evidence, resulting in a conviction of the criminal. This case was the first Federal case of its kind where infrared imagery was used forensically as evidence and, as such, established precedence. Prior to this, infrared imagery has been offered and debated in court only as to whether it constitutes a legal search. Courtroom observations and lessons learned from this trial have shown that both industry and LE can do a better job of making the prosecution's cases stronger utilizing infrared technology and thus taking criminals off the street.

Global Learning Communities: A Comparison of Online Domestic and International Science Class Partnerships

NASA Astrophysics Data System (ADS)

Kerlin, Steven C.; Carlsen, William S.; Kelly, Gregory J.; Goehring, Elizabeth

2013-08-01

The conception of Global Learning Communities (GLCs) was researched to discover potential benefits of the use of online technologies that facilitated communication and scientific data sharing outside of the normal classroom setting. 1,419 students in 635 student groups began the instructional unit. Students represented the classrooms of 33 teachers from the USA, 6 from Thailand, 7 from Australia, and 4 from Germany. Data from an international environmental education project were analyzed to describe grades 7-9 student scientific writing in domestic US versus international-US classroom online partnerships. The development of an argument analytic and a research model of exploratory data analysis followed by statistical testing were used to discover and highlight different ways students used evidence to support their scientific claims about temperature variation at school sites and deep-sea hydrothermal vents. Findings show modest gains in the use of some evidentiary discourse components by US students in international online class partnerships compared to their US counterparts in domestic US partnerships. The analytic, research model, and online collaborative learning tools may be used in other large-scale studies and learning communities. Results provide insights about the benefits of using online technologies and promote the establishment of GLCs.

Medicare is scrutinizing evidence more tightly for national coverage determinations.

PubMed

Chambers, James D; Chenoweth, Matthew; Cangelosi, Michael J; Pyo, Junhee; Cohen, Joshua T; Neumann, Peter J

2015-02-01

We examined Medicare national coverage determinations for medical interventions to determine whether or not they have become more restrictive over time. National coverage determinations address whether particular big-ticket medical items, services, treatment procedures, and technologies can be paid for under Medicare. We found that after we adjusted for the strength of evidence and other factors known to influence the determinations of the Centers for Medicare and Medicaid Services (CMS), the evidentiary bar for coverage has risen. More recent coverage determinations (from mid-March 2008 through August 2012) were twenty times less likely to be positive than earlier coverage determinations (from February 1999 through January 2002). Furthermore, coverage during the study period was increasingly and positively associated both with the degree of consistency of favorable findings in the CMS reviewed clinical evidence and with recommendations made in clinical guidelines. Coverage policy is an important payer tool for promoting the appropriate use of medical interventions, but CMS's rising evidence standards also raise questions about patients' access to new technologies and about hurdles for the pharmaceutical and device industries as they attempt to bring innovations to the market. Project HOPE—The People-to-People Health Foundation, Inc.

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine

PubMed Central

Gibson, Shannon; Raziee, Hamid R; Lemmens, Trudo

2015-01-01

Pharmaceutical research and development is increasingly focused on niche markets, most notably treatments for rare diseases and “personalized” medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in niche markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different—and sometimes conflicting—views on the reasons for and extent of the shift toward niche markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of niche markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies. PMID:25914853

Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges

PubMed Central

Knowles, Lori; Luth, Westerly; Bubela, Tania

2017-01-01

Abstract Personalized medicine (PM) aims to harness a wave of ‘omics’ discoveries to facilitate research and discovery of targeted diagnostics and therapies and increase the efficiency of healthcare systems by predicting and treating individual predispositions to diseases or conditions. Despite significant investment, limited progress has been made bringing PM to market. We describe the major perceived regulatory, intellectual property, and reimbursement challenges to the development, translation, adoption, and implementation of PM products into clinical care. We conducted a scoping review to identify (i) primary challenges for the development and implementation of PM identified in the academic literature; (ii) solutions proposed in the academic literature to address these challenges; and (iii) gaps that exist in that literature. We identified regulatory barriers to PM development and recommendations in 344 academic papers. Regulatory uncertainty was a cross-cutting theme that appeared in conjunction with other themes including: reimbursement; clinical trial regulation; regulation of co-development; unclear evidentiary requirements; insufficient incentives for research and development; incompatible information systems; and different regulation of different diagnostics. To fully realize the benefits of PM for healthcare systems and patients, regulatory, intellectual property, and reimbursement challenges need to be addressed in lock step with scientific advances. PMID:29868182

A novel framework for analyzing conservation impacts: evaluation, theory, and marine protected areas.

PubMed

Mascia, Michael B; Fox, Helen E; Glew, Louise; Ahmadia, Gabby N; Agrawal, Arun; Barnes, Megan; Basurto, Xavier; Craigie, Ian; Darling, Emily; Geldmann, Jonas; Gill, David; Holst Rice, Susie; Jensen, Olaf P; Lester, Sarah E; McConney, Patrick; Mumby, Peter J; Nenadovic, Mateja; Parks, John E; Pomeroy, Robert S; White, Alan T

2017-07-01

Environmental conservation initiatives, including marine protected areas (MPAs), have proliferated in recent decades. Designed to conserve marine biodiversity, many MPAs also seek to foster sustainable development. As is the case for many other environmental policies and programs, the impacts of MPAs are poorly understood. Social-ecological systems, impact evaluation, and common-pool resource governance are three complementary scientific frameworks for documenting and explaining the ecological and social impacts of conservation interventions. We review key components of these three frameworks and their implications for the study of conservation policy, program, and project outcomes. Using MPAs as an illustrative example, we then draw upon these three frameworks to describe an integrated approach for rigorous empirical documentation and causal explanation of conservation impacts. This integrated three-framework approach for impact evaluation of governance in social-ecological systems (3FIGS) accounts for alternative explanations, builds upon and advances social theory, and provides novel policy insights in ways that no single approach affords. Despite the inherent complexity of social-ecological systems and the difficulty of causal inference, the 3FIGS approach can dramatically advance our understanding of, and the evidentiary basis for, effective MPAs and other conservation initiatives. © 2017 New York Academy of Sciences.

Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD)

PubMed Central

Franek, J

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Objective The objective of this analysis was to conduct an evidence-based assessment of home telehealth technologies for patients with chronic obstructive pulmonary disease (COPD) in order to inform recommendations regarding the access and provision of these services in Ontario. This analysis was one of several analyses undertaken to evaluate interventions for COPD. The perspective of this assessment was that of the Ontario Ministry of Health and Long-Term Care, a provincial payer of medically necessary health care services. Clinical Need: Condition and Target Population Canada is facing an increase in chronic respiratory diseases due in part to its aging demographic. The projected increase in COPD will put a strain on health care payers and providers. There is therefore an increasing demand for telehealth services that improve access to health care services while maintaining or improving quality and equality of care. Many telehealth technologies however are in the early stages of development or diffusion and thus require study to define their application and potential harms or benefits. The Medical Advisory Secretariat (MAS) therefore sought to evaluate telehealth technologies for COPD. Technology Telemedicine (or telehealth) refers to using advanced information and communication technologies and electronic medical devices to support the delivery of clinical care, professional education, and health-related administrative services. Generally there are 4 broad functions of home telehealth interventions for COPD: to monitor vital signs or biological health data (e.g., oxygen saturation), to monitor symptoms, medication, or other non-biologic endpoints (e.g., exercise adherence), to provide information (education) and/or other support services (such as reminders to exercise or positive reinforcement), and to establish a communication link between patient and provider. These functions often require distinct technologies, although some devices can perform a number of these diverse functions. For the purposes of this review, MAS focused on home telemonitoring and telephone only support technologies. Telemonitoring (or remote monitoring) refers to the use of medical devices to remotely collect a patient’s vital signs and/or other biologic health data and the transmission of those data to a monitoring station for interpretation by a health care provider. Telephone only support refers to disease/disorder management support provided by a health care provider to a patient who is at home via telephone or videoconferencing technology in the absence of transmission of patient biologic data. Research Questions What is the effectiveness, cost-effectiveness, and safety of home telemonitoring compared with usual care for patients with COPD? What is the effectiveness, cost-effectiveness, and safety of telephone only support programs compared with usual care for patients with COPD? Research Methods Literature Search Search Strategy A literature search was performed on November 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2000 until November 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, and then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low, or very low according to GRADE methodology. Inclusion Criteria – Question #1 frequent transmission of a patient’s physiological data collected at home and without a health care professional physically present to health care professionals for routine monitoring through the use of a communication technology; monitoring combined with a coordinated management and feedback system based on transmitted data; telemonitoring as a key component of the intervention (subjective determination); usual care as provided by the usual care provider for the control group; randomized controlled trials (RCTs), controlled clinical trials (CCTs), systematic reviews, and/or meta-analyses; published between January 1, 2000 and November 3, 2010. Inclusion Criteria – Question #2 scheduled or frequent contact between patient and a health care professional via telephone or videoconferencing technology in the absence of transmission of patient physiological data; monitoring combined with a coordinated management and feedback system based on transmitted data; telephone support as a key component of the intervention (subjective determination); usual care as provided by the usual care provider for the control group; RCTs, CCTs, systematic reviews, and/or meta-analyses; published between January 1, 2000 and November 3, 2010. Exclusion Criteria published in a language other than English; intervention group (and not control) receiving some form of home visits by a medical professional, typically a nurse (i.e., telenursing) beyond initial technology set-up and education, to collect physiological data, or to somehow manage or treat the patient; not recording patient or health system outcomes (e.g., technical reports testing accuracy, reliability or other development-related outcomes of a device, acceptability/feasibility studies, etc.); not using an independent control group that received usual care (e.g., studies employing historical or periodic controls). Outcomes of Interest hospitalizations (primary outcome) mortality emergency department visits length of stay quality of life other […] Subgroup Analyses (a priori) length of intervention (primary) severity of COPD (primary) Quality of Evidence The quality of evidence assigned to individual studies was determined using a modified CONSORT Statement Checklist for Randomized Controlled Trials. (1) The CONSORT Statement was adapted to include 3 additional quality measures: the adequacy of control group description, significant differential loss to follow-up between groups, and greater than or equal to 30% study attrition. Individual study quality was defined based on total scores according to the CONSORT Statement checklist: very low (0 to < 40%), low (≥ 40 to < 60%), moderate (≥ 60 to < 80%), and high (≥ 80 to 100%). The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence: High Further research is very unlikely to change confidence in the estimate of effect. Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Very Low Any estimate of effect is very uncertain. Summary of Findings Six publications, representing 5 independent trials, met the eligibility criteria for Research Question #1. Three trials were RCTs reported across 4 publications, whereby patients were randomized to home telemonitoring or usual care, and 2 trials were CCTs, whereby patients or health care centers were nonrandomly assigned to intervention or usual care. A total of 310 participants were studied across the 5 included trials. The mean age of study participants in the included trials ranged from 61.2 to 74.5 years for the intervention group and 61.1 to 74.5 years for the usual care group. The percentage of men ranged from 40% to 64% in the intervention group and 46% to 72% in the control group. All 5 trials were performed in a moderate to severe COPD patient population. Three trials initiated the intervention following discharge from hospital. One trial initiated the intervention following a pulmonary rehabilitation program. The final trial initiated the intervention during management of patients at an outpatient clinic. Four of the 5 trials included oxygen saturation (i.e., pulse oximetry) as one of the biological patient parameters being monitored. Additional parameters monitored included forced expiratory volume in one second, peak expiratory flow, and temperature. There was considerable clinical heterogeneity between trials in study design, methods, and intervention/control. In relation to the telemonitoring intervention, 3 of the 5 included studies used an electronic health hub that performed multiple functions beyond the monitoring of biological parameters. One study used only a pulse oximeter device alone with modem capabilities. Finally, in 1 study, patients measured and then forwarded biological data to a nurse during a televideo consultation. Usual care varied considerably between studies. Only one trial met the eligibility criteria for Research Question #2. The included trial was an RCT that randomized 60 patients to nurse telephone follow-up or usual care (no telephone follow-up). Participants were recruited from the medical department of an acute-care hospital in Hong Kong and began receiving follow-up after discharge from the hospital with a diagnosis of COPD (no severity restriction). The intervention itself consisted of only two 10-to 20-minute telephone calls, once between days 3 to 7 and once between days 14 to 20, involving a structured, individualized educational and supportive programme led by a nurse that focused on 3 components: assessment, management options, and evaluation. Regarding Research Question #1: Low to very low quality evidence (according to GRADE) finds non-significant effects or conflicting effects (of significant or non-significant benefit) for all outcomes examined when comparing home telemonitoring to usual care. There is a trend towards significant increase in time free of hospitalization and use of other health care services with home telemonitoring, but these findings need to be confirmed further in randomized trials of high quality. There is severe clinical heterogeneity between studies that limits summary conclusions. The economic impact of home telemonitoring is uncertain and requires further study. Home telemonitoring is largely dependent on local information technologies, infrastructure, and personnel, and thus the generalizability of external findings may be low. Jurisdictions wishing to replicate home telemonitoring interventions should likely test those interventions within their jurisdictional framework before adoption, or should focus on home-grown interventions that are subjected to appropriate evaluation and proven effective. Regarding Research Question #2: Low quality evidence finds significant benefit in favour of telephone-only support for self-efficacy and emergency department visits when compared to usual care, but non-significant results for hospitalizations and hospital length of stay. There are very serious issues with the generalizability of the evidence and thus additional research is required. PMID:23074421

Bruised Witness: Bernard Spilsbury and the Performance of Early Twentieth-Century English Forensic Pathology

PubMed Central

BURNEY, IAN; PEMBERTON, NEIL

2011-01-01

This article explores the status, apparatus and character of forensic pathology in the inter-war period, with a special emphasis on the ‘people’s pathologist’, Bernard Spilsbury. The broad expert and public profile of forensic pathology, of which Spilsbury was the most prominent contemporary representative, will be outlined and discussed. In so doing, close attention will be paid to the courtroom strategies by which he and other experts translated their isolated post-mortem encounters with the dead body into effective testimony. Pathologists built a high-profile practice that transfixed the popular, legal and scientific imagination, and this article also explores, through the celebrated 1925 murder trial of Norman Thorne, how Spilsbury’s courtroom performance focused critical attention on the practices of pathology itself, which threatened to destabilise the status of forensic pathology. In particular, the Thorne case raised questions about the interrelation between bruising and putrefaction as sources of interpretative anxiety. Here, the question of practice is vital, especially in understanding how Spilsbury’s findings clashed with those of rival pathologists whose autopsies centred on a corpse that had undergone further putrefactive changes and that had thereby mutated as an evidentiary object. Examining how pathologists dealt with interpretative problems raised by the instability of their core investigative object enables an analysis of the ways in which pathological investigation of homicide was inflected with a series of conceptual, professional and cultural difficulties stemming in significant ways from the materiality of the corpse itself. This article presents early findings of a larger study of twentieth-century English homicide investigation which focuses on the interaction between two dominant forensic regimes: the first, outlined in part here, is a body-centred forensics, associated with the lone, ‘celebrity’ pathologist, his scalpel and the mortuary slab; the second is a ‘forensics of things’ centred on the laboratory and its associated technologies of trace analysis (hair, blood, fibres), deployed in closed technician-dominated spaces and in the regimentally managed crime scene. Future work will seek to illuminate the shifting landscape of English forensics by following the historical interplay between these two powerful investigative models. PMID:23752864

Bruised witness: Bernard Spilsbury and the performance of early twentieth-century English forensic pathology.

PubMed

Burney, Ian; Pemberton, Neil

2011-01-01

This article explores the status, apparatus and character of forensic pathology in the inter-war period, with a special emphasis on the 'people's pathologist', Bernard Spilsbury. The broad expert and public profile of forensic pathology, of which Spilsbury was the most prominent contemporary representative, will be outlined and discussed. In so doing, close attention will be paid to the courtroom strategies by which he and other experts translated their isolated post-mortem encounters with the dead body into effective testimony. Pathologists built a high-profile practice that transfixed the popular, legal and scientific imagination, and this article also explores, through the celebrated 1925 murder trial of Norman Thorne, how Spilsbury's courtroom performance focused critical attention on the practices of pathology itself, which threatened to destabilise the status of forensic pathology. In particular, the Thorne case raised questions about the interrelation between bruising and putrefaction as sources of interpretative anxiety. Here, the question of practice is vital, especially in understanding how Spilsbury's findings clashed with those of rival pathologists whose autopsies centred on a corpse that had undergone further putrefactive changes and that had thereby mutated as an evidentiary object. Examining how pathologists dealt with interpretative problems raised by the instability of their core investigative object enables an analysis of the ways in which pathological investigation of homicide was inflected with a series of conceptual, professional and cultural difficulties stemming in significant ways from the materiality of the corpse itself. This article presents early findings of a larger study of twentieth-century English homicide investigation which focuses on the interaction between two dominant forensic regimes: the first, outlined in part here, is a body-centred forensics, associated with the lone, 'celebrity' pathologist, his scalpel and the mortuary slab; the second is a 'forensics of things' centred on the laboratory and its associated technologies of trace analysis (hair, blood, fibres), deployed in closed technician-dominated spaces and in the regimentally managed crime scene. Future work will seek to illuminate the shifting landscape of English forensics by following the historical interplay between these two powerful investigative models.

Age Estimation with DNA: From Forensic DNA Fingerprinting to Forensic (Epi)Genomics: A Mini-Review.

PubMed

Parson, Walther

2018-01-01

Forensic genetics developed from protein-based techniques a quarter of a century ago and became famous as "DNA fingerprinting," this being based on restriction fragment length polymorphisms (RFLPs) of high-molecular-weight DNA. The amplification of much smaller short tandem repeat (STR) sequences using the polymerase chain reaction soon replaced RFLP analysis and advanced to become the gold standard in genetic identification. Meanwhile, STR multiplexes have been developed and made commercially available which simultaneously amplify up to 30 STR loci from as little as 15 cells or fewer. The enormous information content that comes with the large variety of observed STR genotypes allows for genetic individualisation (with the exception of identical twins). Carefully selected core STR loci form the basis of intelligence-led DNA databases that provide investigative leads by linking unsolved crime scenes and criminals through their matched STR profiles. Nevertheless, the success of modern DNA fingerprinting depends on the availability of reference material from suspects. In order to provide new investigative leads in cases where such reference samples are absent, forensic scientists started to explore the prediction of phenotypic traits from the DNA of the evidentiary sample. This paradigm change now uses DNA and epigenetic markers to forecast characteristics that are useful to triage further investigative work. So far, the best investigated externally visible characteristics are eye, hair and skin colour, as well as geographic ancestry and age. Information on the chronological age of a stain donor (or any sample donor) is elemental for forensic investigations in a number of aspects and has, therefore, been explored by researchers in some detail. Among different methodological approaches tested to date, the methylation-sensitive analysis of carefully selected DNA markers (CpG sites) has brought the most promising results by providing prediction accuracies of ±3-4 years, which can be comparable to, or even surpass those from, eyewitness reports. This mini-review puts recent developments in age estimation via (epi)genetic methods in the context of the requirements and goals of forensic genetics and highlights paths to follow in the future of forensic genomics. © 2018 S. Karger AG, Basel.

Improving access to emergent spinal care through knowledge translation: an ethnographic study.

PubMed

Webster, Fiona; Fehlings, Michael G; Rice, Kathleen; Malempati, Harsha; Fawaz, Khaled; Nicholls, Fred; Baldeo, Navindra; Reeves, Scott; Singh, Anoushka; Ahn, Henry; Ginsberg, Howard; Yee, Albert J

2014-04-14

For patients and family members, access to timely specialty medical care for emergent spinal conditions is a significant stressor to an already serious condition. Timing to surgical care for emergent spinal conditions such as spinal trauma is an important predictor of outcome. However, few studies have explored ethnographically the views of surgeons and other key stakeholders on issues related to patient access and care for emergent spine conditions. The primary study objective was to determine the challenges to the provision of timely care as well as to identify areas of opportunities to enhance care delivery. An ethnographic study of key administrative and clinical care providers involved in the triage and care of patients referred through CritiCall Ontario was undertaken utilizing standard methods of qualitative inquiry. This comprised 21 interviews with people involved in varying capacities with the provision of emergent spinal care, as well as qualitative observations on an orthopaedic/neurosurgical ward, in operating theatres, and at CritiCall Ontario's call centre. Several themes were identified and organized into categories that range from inter-professional collaboration through to issues of hospital-level resources and the role of relationships between hospitals and external organizations at the provincial level. Underlying many of these issues is the nature of the medically complex emergent spine patient and the scientific evidentiary base upon which best practice care is delivered. Through the implementation of knowledge translation strategies facilitated from this research, a reduction of patient transfers out of province was observed in the one-year period following program implementation. Our findings suggest that competing priorities at both the hospital and provincial level create challenges in the delivery of spinal care. Key stakeholders recognized spinal care as aligning with multiple priorities such as emergent/critical care, medical through surgical, acute through rehabilitative, disease-based (i.e. trauma, cancer), and wait times initiatives. However, despite newly implemented strategies, there continues to be increasing trends over time in the number of spinal CritiCall Ontario referrals. This reinforces the need for ongoing inter-professional efforts in care delivery that take into account the institutional contexts that may constrain individual or team efforts.

Late lessons from early warnings: towards precaution and realism in research and policy.

PubMed

Gee, D; Krayer von Krauss, M P

2005-01-01

This paper focuses on the evidentiary aspects of the precautionary principle. Three points are highlighted: (i) the difference between association and causation; (ii) how the strength of scientific evidence can be considered; and (iii) the reasons why regulatory regimes tend to err in the direction of false negatives rather than false positives. The point is made that because obtaining evidence of causation can take many decades of research, the precautionary principle can be invoked to justify action when evidence of causation is not available, but there is good scientific evidence of an association between exposures and impacts. It is argued that the appropriate level of proof is context dependent, as "appropriateness" is based on value judgements about the acceptability of the costs, about the distribution of the costs, and about the consequences of being wrong. A complementary approach to evaluating the strength of scientific evidence is to focus on the level of uncertainty. If decision makers are made aware of the limitations of the knowledge base, they can compensate by adopting measures aimed at providing early warnings of un-anticipated effects and mitigating their impacts. The point is made that it is often disregarded that the Bradford Hill criteria for evaluating evidence are asymmetrical, in that the applicability of a criterion increases the strength of evidence on the presence of an effect, but the inapplicability of a criterion does not increase the strength of evidence on the absence of an effect. The paper discusses the reason why there are so many examples of regulatory "false negatives" as opposed to "false positives". Two main reasons are put forward: (i) the methodological bias within the health and environmental sciences; and (ii) the dominance within decision-making of short term economic and political interests. Sixteen features of methods and culture in the environmental and health sciences are presented. Of these, only three features tend to generate "false positives". It is concluded that although the different features of scientific methods and culture produce robust science, they can lead to poor regulatory decisions on hazard prevention.

Community Pharmacists' Views and Practices Regarding Natural Health Products Sold in Community Pharmacies.

PubMed

Ogbogu, Ubaka; Necyk, Candace

Reports of regulatory and evidentiary gaps have raised concerns about the marketing and use of natural health products (NHPs). The majority of NHPs offered for sale are purchased at a community pharmacy and pharmacists are "front-line" health professionals involved in the marketing and provision of NHPs. To date, the involvement of pharmacists in pharmacy care involving NHPs and the degree to which concerns over the safety, efficacy, marketing and regulation of NHPs are addressed in pharmacy care in Canada have not been studied. Using Qualtrics, a web-based data collection and analysis software, and a study instrument made up of fifteen (15) open-ended, closed and rating scale questions, we surveyed the attitudes and practices of 403 community pharmacists in the Canadian province of Alberta regarding NHPs offered for sale in community pharmacies. The majority of pharmacists surveyed (276; 68%) recommend NHPs to clients sometimes to very often. Vitamin D, calcium, multivitamins, prenatal vitamins, probiotics and fish oil and omega-3 fatty acids were the most frequently recommended NHPs. The most common indications for which NHPs are recommended include bone and musculoskeletal disorders, maintenance of general health, gastrointestinal disorders and pregnancy. Review articles published in the Pharmacist's Letter and Canadian Pharmacists Journal were the primary basis for recommending NHPs. The majority of pharmacists surveyed (339; 84%) recommend the use of NHPs concurrently with conventional drugs, while a significant number and proportion (125; 31%) recommend alternative use. Pharmacists in the study overwhelmingly reported providing counselling on NHPs to clients based on information obtained mainly from the Natural Medicines Comprehensive Database. The study findings indicate a high prevalence of pharmacy care relating to NHPs among study participants. Although pharmacists' practices around NHPs are consistent with the existing licensing framework, we found some involvement in problematic practices that necessitate further research and potential policy scrutiny. The study also uncovered patterns of recommendations, including sources relied on in recommending NHPs and in providing counselling to patients, that raise concerns about the quality and credibility of NHP-related care provided to pharmacy patrons.

Designing EvoRoom: An Immersive Simulation Environment for Collective Inquiry in Secondary Science

NASA Astrophysics Data System (ADS)

Lui, Michelle Mei Yee

This dissertation investigates the design of complex inquiry for co-located students to work as a knowledge community within a mixed-reality learning environment. It presents the design of an immersive simulation called EvoRoom and corresponding collective inquiry activities that allow students to explore concepts around topics of evolution and biodiversity in a Grade 11 Biology course. EvoRoom is a room-sized simulation of a rainforest, modeled after Borneo in Southeast Asia, where several projected displays are stitched together to form a large, animated simulation on each opposing wall of the room. This serves to create an immersive environment in which students work collaboratively as individuals, in small groups and a collective community to investigate science topics using the simulations as an evidentiary base. Researchers and a secondary science teacher co-designed a multi-week curriculum that prepared students with preliminary ideas and expertise, then provided them with guided activities within EvoRoom, supported by tablet-based software as well as larger visualizations of their collective progress. Designs encompassed the broader curriculum, as well as all EvoRoom materials (e.g., projected displays, student tablet interfaces, collective visualizations) and activity sequences. This thesis describes a series of three designs that were developed and enacted iteratively over two and a half years, presenting key features that enhanced students' experiences within the immersive environment, their interactions with peers, and their inquiry outcomes. Primary research questions are concerned with the nature of effective design for such activities and environments, and the kinds of interactions that are seen at the individual, collaborative and whole-class levels. The findings fall under one of three themes: 1) the physicality of the room, 2) the pedagogical script for student observation and reflection and collaboration, and 3) ways of including collective visualizations in the activity. Discrete findings demonstrate how the above variables, through their design as inquiry components (i.e., activity, room, scripts and scaffolds on devices, collective visualizations), can mediate the students' interactions with one another, with their teacher, and impact the outcomes of their inquiry. A set of design recommendations is drawn from the results of this research to guide future design or research efforts.

Appeal to fear in health care: appropriate or inappropriate?

PubMed

Simpson, J Keith

2017-01-01

This paper examines appeal to fear in general: its perceived positive aspects, its negative characteristics, its appropriate as well as its fallacious use. Appeal to fear is a commonly used marketing method that attempts to change behaviour by creating anxiety in those receiving a fearful message. It is regularly used in public health initiatives such as anti-smoking, anti-drunk driving campaigns as well as in hypertension awareness campaigns. Some chiropractors appear to use appeal to fear to promote subluxation awareness and thereby encourage the use of chiropractic treatment. Research supporting its use is equivocal; nevertheless, when used judiciously, appeal to fear probably has sufficient strengths to warrant its continued conditional use. When used to promote care for which there is no supporting evidence, its use is fallacious. Appeal to fear has been used in health promotion campaigns for sixty years or more with the intent of modifying behaviours. While there is evidence to suggest that appeal to fear may motivate some individuals to modify offending behaviour or adopt recommended behaviour there is growing resistance to the use of appeal to fear on ethical and psychological grounds. Using appeal to fear as a tool of persuasion can be valid or fallacious depending on the truth of the premises within the argument. When used to raise awareness about genuine health concerns such as smoking, drunk driving and hypertension appeal to fear is considered to be a valid approach with certain caveats. However, when appeal to fear, not based on evidence or reason, is used as motivator to get others to accept unnecessary interventions for unproven disorders, the use of appeal to fear is fallacious. In spite of the evidence against its use, it seems likely that appeal to fear will continue to be used in conjunction with other public awareness initiatives to modify recognized detrimental behaviours such as smoking and drunk driving as well as silent killers such as hypertension. However, when used to promote a treatment that has no evidentiary basis such as subluxation based practice in chiropractic the appeal to fear is a fallacy and must be stopped.

The insanity defense: Related issues.

PubMed

Asokan, T V

2016-12-01

For the past 150 years, there is no change in the understanding and knowledge other than autonomy and capacity to choose the right and wrong for criminal liability. The alternative concept that human behavior is the result of an interaction between biological and environmental factors other than free choice failed to impress the criminal justice system because of a direct threat to a society's deep seated need to blame someone than themselves for criminal harms that occur. The insanity defense has a long history, and is evolved after many tests that have been tried and tested. McNaughton's rules stressed on "understandability of right and wrong" and "intellectual" rather than a moral or affective definition dominated in its formulation. Lack of control and irresistible drives or impulses were neglected Going by the current understanding of neurological evidences of compulsion and lack of impulse control, rationality tests without the inclusion of lack of control, seem to be outdated. Separate "Control determination" than the "Rationality determination" by the jurors may improve the accuracy of Juror's categorizations. There is a suggestion that Relevance ratio is ideal for 'Evidentiary relevance" and there should be a quality control on expert testimonies. With progress in neuroscience, the law may need to abandon or alter some of its current assumptions about the nature of voluntary conduct, which underlies various defenses.

Standards of Evidence for Behavioral Counseling Recommendations.

PubMed

McNellis, Robert J; Ory, Marcia G; Lin, Jennifer S; O'Connor, Elizabeth A

2015-09-01

Behavioral counseling interventions to promote healthy behaviors can significantly reduce leading causes of disease and death. Recommendations for delivery of these interventions in primary care have been and continue to be an important part of the U.S. Preventive Services Task Force's portfolio of clinical preventive services recommendations. However, primary and secondary research on the effectiveness of behavioral counseling interventions can be more complex than recommendations for screening or use of preventive medications. The nature of behavior change and interventions to promote it can lead to unique challenges. This paper summarizes and expands upon an extensive discussion held at the U.S. Preventive Services Task Force's Expert Forum on behavioral counseling interventions held in November 2013. The paper describes the foundational challenges for using behavioral outcomes as evidence to support a Task Force recommendation. The paper discusses research design and reporting characteristics needed by behavioral counseling intervention researchers in order for their research to contribute to the evidentiary basis of a Task Force recommendation. Finally, the paper identifies critical issues that need to be considered by the Task Force and other stakeholders to maintain confidence and credibility in the standards of evidence for behavioral counseling recommendations. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The impact of multiple show-ups on eyewitness decision-making and innocence risk.

PubMed

Smith, Andrew M; Bertrand, Michelle; Lindsay, R C L; Kalmet, Natalie; Grossman, Deborah; Provenzano, Daniel

2014-09-01

If an eyewitness rejects a show-up, police may respond by finding a new suspect and conducting a second show-up with the same eyewitness. Police may continue finding suspects and conducting show-ups until the eyewitness makes an identification (Study 1). Relatively low criterion-setting eyewitnesses filter themselves out of the multiple show-ups procedure by choosing the first suspect with whom they are presented (Studies 2 and 3). Accordingly, response bias was more stringent on the second show-up when compared with the first, but became no more stringent with additional show-ups. Despite this stringent shift in response bias, innocence risk increased with additional show-ups, as false alarms cumulate (Studies 2 and 3). Although unbiased show-up instructions decreased innocent suspect identifications, the numbers were still discouraging (Study 4). Given the high number of innocent suspects who would be mistakenly identified through the use of multiple show-up procedures, using such identifications as evidence of guilt is questionable. Although evidence of guilt is limited to identifications from a single show-up, practical constraints might sometimes require police to use additional show-ups. Accordingly, we propose a stronger partition between evidentiary and investigative procedures. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Molecular identification of python species: development and validation of a novel assay for forensic investigations.

PubMed

Ciavaglia, Sherryn A; Tobe, Shanan S; Donnellan, Stephen C; Henry, Julianne M; Linacre, Adrian M T

2015-05-01

Python snake species are often encountered in illegal activities and the question of species identity can be pertinent to such criminal investigations. Morphological identification of species of pythons can be confounded by many issues and molecular examination by DNA analysis can provide an alternative and objective means of identification. Our paper reports on the development and validation of a PCR primer pair that amplifies a segment of the mitochondrial cytochrome b gene that has been suggested previously as a good candidate locus for differentiating python species. We used this DNA region to perform species identification of pythons, even when the template DNA was of poor quality, as might be the case with forensic evidentiary items. Validation tests are presented to demonstrate the characteristics of the assay. Tests involved the cross-species amplification of this marker in non-target species, minimum amount of DNA template required, effects of degradation on product amplification and a blind trial to simulate a casework scenario that provided 100% correct identity. Our results demonstrate that this assay performs reliably and robustly on pythons and can be applied directly to forensic investigations where the presence of a species of python is in question. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Economics of pediatric burns.

PubMed

Bass, Michael J; Phillips, Linda G

2008-07-01

Sustaining a burn injury sets in motion a cycle of pain, disfigurement, and a search for survival. In pediatric burns, the injury extends to the parents where fear, ignorance, and helplessness forever change their lives. Pediatric burn injuries are caused by fire, hot liquids, clothing irons, hair curlers, caustic substances like drain cleaner, the grounding of an electrical source, and exposure to radiation. Efficiency in the delivery of pediatric burn care is critical. Maximizing resource utilization means continual self-evaluation and economic analysis of therapeutic modalities. Griffiths et al found that most childhood burns are due to scalds, which can be treated for $1061 per percent burn. Paddock et al reduced the cost of treating superficial pediatric burns and reduced the length of stay in hospital using silver-impregnated gauze over traditional methods. Barrett et al found improved cosmesis of skin grafts using cultured epithelial autografts but at a substantially increased cost. Corpron et al showed that pediatric burn units that treat burns >10% total body surface area and operative treatment of pediatric burns regardless of size generate positive revenue. There is a paucity of evidentiary pediatric burn economic data. More research is needed to address areas of pediatric burn care inefficiency. Improving knowledge of cost in all health care endeavors will create competition and drive down expenditures.

Factual causation in medical negligence.

PubMed

Manning, Joanna

2007-12-01

The conventional approach to causation in negligence is the "but for" test, decided on the balance of probabilities. Even when supplemented by the "material contribution" principle, satisfying the onus of proof of causation can be an insuperable obstacle for plaintiffs, particularly in medical cases. Yet, having found a breach of duty, a court's sympathies may gravitate toward the plaintiff at this point in the case. Accordingly, courts have sometimes accepted a relaxation of strict causation principles. The judicial devices are described: a special principle of causation in particular duties of care; a shifting burden of proof; "bridging the evidentiary gap" by drawing a robust inference of causation; treating a material increase in risk as sufficient proof of causation; and permitting causation to be established on the basis of the loss of a material chance of achieving a better outcome and discounting damages. In Accident Compensation Corp v Ambros [2007] NZCA 304 the New Zealand Court of Appeal recognised the need for a legal device to ameliorate the injustice sometimes caused by the strict rules of causation, and preferred the "inferential reasoning" approach favoured by the Canadian common law for use in the context of the accident compensation scheme. It is hoped that the New Zealand Supreme Court approves Ambros if the opportunity arises.

Evidence for frozen melts in the mid-lithosphere detected from active-source seismic data.

PubMed

Ohira, Akane; Kodaira, Shuichi; Nakamura, Yasuyuki; Fujie, Gou; Arai, Ryuta; Miura, Seiichi

2017-11-17

The interactions of the lithospheric plates that form the Earth's outer shell provide much of the evidentiary basis for modern plate tectonic theory. Seismic discontinuities in the lithosphere arising from mantle convection and plate motion provide constraints on the physical and chemical properties of the mantle that contribute to the processes of formation and evolution of tectonic plates. Seismological studies during the past two decades have detected seismic discontinuities within the oceanic lithosphere in addition to that at the lithosphere-asthenosphere boundary (LAB). However, the depth, distribution, and physical properties of these discontinuities are not well constrained, which makes it difficult to use seismological data to examine their origin. Here we present new active-source seismic data acquired along a 1,130 km profile across an old Pacific plate (148-128 Ma) that show oceanic mid-lithosphere discontinuities (oceanic MLDs) distributed 37-59 km below the seafloor. The presence of the oceanic MLDs suggests that frozen melts that accumulated at past LABs have been preserved as low-velocity layers within the current mature lithosphere. These observations show that long-offset, high-frequency, active-source seismic data can be used to image mid-lithospheric structure, which is fundamental to understanding the formation and evolution of tectonic plates.

Drugged Driving in Wisconsin: Oral Fluid Versus Blood.

PubMed

Edwards, Lorrine D; Smith, Katherine L; Savage, Theodore

2017-07-01

A pilot project was conducted in Dane County, Wisconsin, to evaluate the frequency of individuals driving under the influence of drugs (DUID). Evidentiary blood specimens, collected from subjects arrested for Operating While Intoxicated (OWI), were compared to oral fluid (OF) results obtained with the Alere DDS2®, a handheld screening device. The project objectives were to evaluate (i) the Alere DDS2® for use by police officers in the field, (ii) the frequency of individuals DUID and drugs combined with alcohol among OWI cases, (iii) the differences between detecting drugs in OF and in blood, and (iv) the effect of the laboratory drug testing cancellation policy (LCP) when the blood alcohol concentration (BAC) exceeds 0.100 g/100 mL. Following the arrest and collection of blood, subjects were asked to voluntarily participate in the project and provide an OF specimen. The OF was presumptively screened with the Alere DDS2® for six drug categories including (ng/mL) amphetamine (50), benzodiazepines (temazepam, 20), cocaine (benzoylecgonine, 30), methamphetamine (50), opioids (morphine, 40) and THC (delta-9-THC, 25). Results obtained with the OF screening instrument were not confirmed. A total of 104 subjects (22 female, 82 male), ages 18-72, were included in the project. Blood specimens were tested by gas chromatography-headspace (GCHS-FID) for volatiles, enzyme immunoassay (Siemens Viva-E Drug Testing System), and an alkaline basic drug screen with gas chromatography-mass spectrometry (GCMS) analysis. To compensate for differences between the EIA and the Alere DDS2® drug categories, results from the enzyme immunoassay and the alkaline basic drug screen were combined for purposes of comparing OF to blood. Seventy-six of 104 (73%) subjects arrested for OWI were driving under the influence of alcohol; 71 of the 76 had a BAC exceeding 0.10 g/100 mL. Subjects with a BAC exceeding the LCP, screened positive for drugs in both OF (n = 29) and blood (n = 28). Overall, one or more positive drug screening result was observed in 57 (55%) and 50 (48%) subjects for OF and blood specimens, respectively. THC was the most frequently detected drug category in both OF (n = 46) and whole blood (n = 44). Drug Recognition Expert (DRE) evaluations were performed on 18 subjects. In general, the Alere DDS2® results were consistent with the combined screening results observed in evidentiary blood specimens. This project was limited in scope as a second OF specimen was not collected for confirmation of drugs, however it did demonstrate that nearly 40% of the subjects with concentrations of alcohol exceeding 0.10 g/100 mL, screened positive for one or more drug categories in both OF and blood. The Alere DDS2® portable OF screening instrument may be useful in assisting law enforcement with identifying individuals driving under the influence of drugs and establishing probable cause at roadside for making DUID arrests. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A study of the transferability of influenza case detection systems between two large healthcare systems

PubMed Central

Wagner, Michael M.; Cooper, Gregory F.; Ferraro, Jeffrey P.; Su, Howard; Gesteland, Per H.; Haug, Peter J.; Millett, Nicholas E.; Aronis, John M.; Nowalk, Andrew J.; Ruiz, Victor M.; López Pineda, Arturo; Shi, Lingyun; Van Bree, Rudy; Ginter, Thomas; Tsui, Fuchiang

2017-01-01

Objectives This study evaluates the accuracy and transferability of Bayesian case detection systems (BCD) that use clinical notes from emergency department (ED) to detect influenza cases. Methods A BCD uses natural language processing (NLP) to infer the presence or absence of clinical findings from ED notes, which are fed into a Bayesain network classifier (BN) to infer patients’ diagnoses. We developed BCDs at the University of Pittsburgh Medical Center (BCDUPMC) and Intermountain Healthcare in Utah (BCDIH). At each site, we manually built a rule-based NLP and trained a Bayesain network classifier from over 40,000 ED encounters between Jan. 2008 and May. 2010 using feature selection, machine learning, and expert debiasing approach. Transferability of a BCD in this study may be impacted by seven factors: development (source) institution, development parser, application (target) institution, application parser, NLP transfer, BN transfer, and classification task. We employed an ANOVA analysis to study their impacts on BCD performance. Results Both BCDs discriminated well between influenza and non-influenza on local test cases (AUCs > 0.92). When tested for transferability using the other institution’s cases, BCDUPMC discriminations declined minimally (AUC decreased from 0.95 to 0.94, p<0.01), and BCDIH discriminations declined more (from 0.93 to 0.87, p<0.0001). We attributed the BCDIH decline to the lower recall of the IH parser on UPMC notes. The ANOVA analysis showed five significant factors: development parser, application institution, application parser, BN transfer, and classification task. Conclusion We demonstrated high influenza case detection performance in two large healthcare systems in two geographically separated regions, providing evidentiary support for the use of automated case detection from routinely collected electronic clinical notes in national influenza surveillance. The transferability could be improved by training Bayesian network classifier locally and increasing the accuracy of the NLP parser. PMID:28380048

A study of the transferability of influenza case detection systems between two large healthcare systems.

PubMed

Ye, Ye; Wagner, Michael M; Cooper, Gregory F; Ferraro, Jeffrey P; Su, Howard; Gesteland, Per H; Haug, Peter J; Millett, Nicholas E; Aronis, John M; Nowalk, Andrew J; Ruiz, Victor M; López Pineda, Arturo; Shi, Lingyun; Van Bree, Rudy; Ginter, Thomas; Tsui, Fuchiang

2017-01-01

This study evaluates the accuracy and transferability of Bayesian case detection systems (BCD) that use clinical notes from emergency department (ED) to detect influenza cases. A BCD uses natural language processing (NLP) to infer the presence or absence of clinical findings from ED notes, which are fed into a Bayesain network classifier (BN) to infer patients' diagnoses. We developed BCDs at the University of Pittsburgh Medical Center (BCDUPMC) and Intermountain Healthcare in Utah (BCDIH). At each site, we manually built a rule-based NLP and trained a Bayesain network classifier from over 40,000 ED encounters between Jan. 2008 and May. 2010 using feature selection, machine learning, and expert debiasing approach. Transferability of a BCD in this study may be impacted by seven factors: development (source) institution, development parser, application (target) institution, application parser, NLP transfer, BN transfer, and classification task. We employed an ANOVA analysis to study their impacts on BCD performance. Both BCDs discriminated well between influenza and non-influenza on local test cases (AUCs > 0.92). When tested for transferability using the other institution's cases, BCDUPMC discriminations declined minimally (AUC decreased from 0.95 to 0.94, p<0.01), and BCDIH discriminations declined more (from 0.93 to 0.87, p<0.0001). We attributed the BCDIH decline to the lower recall of the IH parser on UPMC notes. The ANOVA analysis showed five significant factors: development parser, application institution, application parser, BN transfer, and classification task. We demonstrated high influenza case detection performance in two large healthcare systems in two geographically separated regions, providing evidentiary support for the use of automated case detection from routinely collected electronic clinical notes in national influenza surveillance. The transferability could be improved by training Bayesian network classifier locally and increasing the accuracy of the NLP parser.

A public health approach to eating disorders prevention: it's time for public health professionals to take a seat at the table.

PubMed

Austin, S Bryn

2012-10-09

The societal burden of eating disorders is clear, and though there is a compelling need for a public health approach to eating disorders prevention, public health professionals have yet to take up the challenge. The article lays out an argument for what steps need to be taken to bring a public health approach to eating disorders prevention. First, stock is taken of what the field has achieved so far, using tools from the prevention science literature, and, second, a research plan of action is offered that plays to the unique strengths of public health, drawing on a triggers-to-action framework from public health law. Minimal participation was found from public health professionals in eating disorders prevention research, and the vast majority of prevention research to date was found to be concentrated within the disciplines of psychology and psychiatry. Extreme disciplinary concentration of the research has led to a preponderance of individually targeted prevention strategies with little research focused on environmental targets, particularly at the macro level. New environmental initiatives are now emerging, such as a government-sponsored mass media anti-dieting campaign, and legal bans on extremely thin models in advertising, but for the most part, they have yet to be evaluated. A triggers-to-action framework, which focuses on evidentiary base, practical considerations, and political will, developed in public health law provides a basis for a strategic research plan for a public health approach to eating disorders prevention. There is enormous potential for growth in the scope and diversity of eating disorder prevention research strategies, particularly those targeting the macro environment. A public health approach will require a strategic plan for research that leverages the macro environment for prevention. The full engagement of public health professionals will bring to the field the much broader range of preventive strategies and perspectives needed to tackle the problem of eating disorders.

A public health approach to eating disorders prevention: It’s time for public health professionals to take a seat at the table

PubMed Central

2012-01-01

Background The societal burden of eating disorders is clear, and though there is a compelling need for a public health approach to eating disorders prevention, public health professionals have yet to take up the challenge. Discussion The article lays out an argument for what steps need to be taken to bring a public health approach to eating disorders prevention. First, stock is taken of what the field has achieved so far, using tools from the prevention science literature, and, second, a research plan of action is offered that plays to the unique strengths of public health, drawing on a triggers-to-action framework from public health law. Minimal participation was found from public health professionals in eating disorders prevention research, and the vast majority of prevention research to date was found to be concentrated within the disciplines of psychology and psychiatry. Extreme disciplinary concentration of the research has led to a preponderance of individually targeted prevention strategies with little research focused on environmental targets, particularly at the macro level. New environmental initiatives are now emerging, such as a government-sponsored mass media anti-dieting campaign, and legal bans on extremely thin models in advertising, but for the most part, they have yet to be evaluated. A triggers-to-action framework, which focuses on evidentiary base, practical considerations, and political will, developed in public health law provides a basis for a strategic research plan for a public health approach to eating disorders prevention. Summary There is enormous potential for growth in the scope and diversity of eating disorder prevention research strategies, particularly those targeting the macro environment. A public health approach will require a strategic plan for research that leverages the macro environment for prevention. The full engagement of public health professionals will bring to the field the much broader range of preventive strategies and perspectives needed to tackle the problem of eating disorders. PMID:23043459

Source Attribution of Cyanides Using Anionic Impurity Profiling, Stable Isotope Ratios, Trace Elemental Analysis and Chemometrics.

PubMed

Mirjankar, Nikhil S; Fraga, Carlos G; Carman, April J; Moran, James J

2016-02-02

Chemical attribution signatures (CAS) for chemical threat agents (CTAs), such as cyanides, are being investigated to provide an evidentiary link between CTAs and specific sources to support criminal investigations and prosecutions. Herein, stocks of KCN and NaCN were analyzed for trace anions by high performance ion chromatography (HPIC), carbon stable isotope ratio (δ(13)C) by isotope ratio mass spectrometry (IRMS), and trace elements by inductively coupled plasma optical emission spectroscopy (ICP-OES). The collected analytical data were evaluated using hierarchical cluster analysis (HCA), Fisher-ratio (F-ratio), interval partial least-squares (iPLS), genetic algorithm-based partial least-squares (GAPLS), partial least-squares discriminant analysis (PLSDA), K nearest neighbors (KNN), and support vector machines discriminant analysis (SVMDA). HCA of anion impurity profiles from multiple cyanide stocks from six reported countries of origin resulted in cyanide samples clustering into three groups, independent of the associated alkali metal (K or Na). The three groups were independently corroborated by HCA of cyanide elemental profiles and corresponded to countries each having one known solid cyanide factory: Czech Republic, Germany, and United States. Carbon stable isotope measurements resulted in two clusters: Germany and United States (the single Czech stock grouped with United States stocks). Classification errors for two validation studies using anion impurity profiles collected over five years on different instruments were as low as zero for KNN and SVMDA, demonstrating the excellent reliability associated with using anion impurities for matching a cyanide sample to its factory using our current cyanide stocks. Variable selection methods reduced errors for those classification methods having errors greater than zero; iPLS-forward selection and F-ratio typically provided the lowest errors. Finally, using anion profiles to classify cyanides to a specific stock or stock group for a subset of United States stocks resulted in cross-validation errors ranging from 0 to 5.3%.

Barriers to primary care responsiveness to poverty as a risk factor for health.

PubMed

Bloch, Gary; Rozmovits, Linda; Giambrone, Broden

2011-06-29

Poverty is widely recognized as a major determinant of poor health, and this link has been extensively studied and verified. Despite the strong evidentiary link, little work has been done to determine what primary care health providers can do to address their patients' income as a risk to their health. This qualitative study explores the barriers to primary care responsiveness to poverty as a health issue in a well-resourced jurisdiction with near-universal health care insurance coverage. One to one interviews were conducted with twelve experts on poverty and health in primary care in Ontario, Canada. Participants included family physicians, specialist physicians, nurse practitioners, community workers, advocates, policy experts and researchers. The interviews were analysed for anticipated and emergent themes. This study reveals provider- and patient-centred structural, attitudinal, and knowledge-based barriers to addressing poverty as a risk to health. While many of its findings reinforce previous work in this area, this study's findings point to a number of areas front line primary care providers could target to address their patients' poverty. These include a lack of provider understanding of the lived reality of poverty, leading to a failure to collect adequate data about patients' social circumstances, and to the development of inappropriate care plans. Participants also pointed to prejudicial attitudes among providers, a failure of primary care disciplines to incorporate approaches to poverty as a standard of care, and a lack of knowledge of concrete steps providers can take to address patients' poverty. While this study reinforces, in a well-resourced jurisdiction such as Ontario, the previously reported existence of significant barriers to addressing income as a health issue within primary care, the findings point to the possibility of front line primary care providers taking direct steps to address the health risks posed by poverty. The consistent direction and replicability of these findings point to a refocusing of the research agenda toward an examination of interventions to decrease the health impacts of poverty.

Development of quality indicators for low-risk labor care provided by midwives using a RAND-modified Delphi method.

PubMed

Ueda, Kayo; Ohtera, Shosuke; Kaso, Misato; Nakayama, Takeo

2017-09-22

In childbirth, most deliveries are low-risk, defined as spontaneous labor at full term without special high-risk facts or complications, especially in high-resource countries where maternal and perinatal mortality rates are very low. Indeed, the majority of mothers and infants have no serious conditions during labor. However, the quality of care provided is not assured, and performance may vary by birthing facility and provider. The overuse of technology in childbirth in some parts of the world is almost certainly based on assumptions like, "something can go wrong at any minute." There is a need to assess the quality of care provided for mothers and infants in low-risk labor. We aimed to develop specific quality indicators for low-risk labor care provided primarily by midwives in Japan. We used a RAND-modified Delphi method, which integrates evidence review with expert consensus development. The procedure comprises five steps: (1) literature review, including clinical practice guidelines, to extract and develop quality indicator candidates; (2) formation of a multidisciplinary panel; (3) independent panel ratings (Round 1); (4) panel meeting and independent panel ratings (Round 2); and (5) independent panel ratings (Round 3). The three independent panel ratings (Rounds 1-3) were held between July and December 2012. The assembled multidisciplinary panel comprised eight clinicians (two pediatricians, three obstetricians, and three midwives) and three mothers who were nonclinicians. Evidentiary review extracted 166 key recommendations from 32 clinical practice guidelines, and 31 existing quality indicators were added. After excluding duplicate recommendations and quality indicators, the panel discussed 25 candidate indicators. Of these, 18 were adopted, one was modified, six were not adopted, and four were added during the meeting, respectively. We established 23 quality indicators for low-risk labor care provided by midwives in labor units in Japan.

Detection and localization of copy-paste forgeries in digital videos.

PubMed

Singh, Raahat Devender; Aggarwal, Naveen

2017-12-01

Amidst the continual march of technology, we find ourselves relying on digital videos to proffer visual evidence in several highly sensitive areas such as journalism, politics, civil and criminal litigation, and military and intelligence operations. However, despite being an indispensable source of information with high evidentiary value, digital videos are also extremely vulnerable to conscious manipulations. Therefore, in a situation where dependence on video evidence is unavoidable, it becomes crucial to authenticate the contents of this evidence before accepting them as an accurate depiction of reality. Digital videos can suffer from several kinds of manipulations, but perhaps, one of the most consequential forgeries is copy-paste forgery, which involves insertion/removal of objects into/from video frames. Copy-paste forgeries alter the information presented by the video scene, which has a direct effect on our basic understanding of what that scene represents, and so, from a forensic standpoint, the challenge of detecting such forgeries is especially significant. In this paper, we propose a sensor pattern noise based copy-paste detection scheme, which is an improved and forensically stronger version of an existing noise-residue based technique. We also study a demosaicing artifact based image forensic scheme to estimate the extent of its viability in the domain of video forensics. Furthermore, we suggest a simplistic clustering technique for the detection of copy-paste forgeries, and determine if it possess the capabilities desired of a viable and efficacious video forensic scheme. Finally, we validate these schemes on a set of realistically tampered MJPEG, MPEG-2, MPEG-4, and H.264/AVC encoded videos in a diverse experimental set-up by varying the strength of post-production re-compressions and transcodings, bitrates, and sizes of the tampered regions. Such an experimental set-up is representative of a neutral testing platform and simulates a real-world forgery scenario where the forensic investigator has no control over any of the variable parameters of the tampering process. When tested in such an experimental set-up, the four forensic schemes achieved varying levels of detection accuracies and exhibited different scopes of applicabilities. For videos compressed using QFs in the range 70-100, the existing noise residue based technique generated average detection accuracy in the range 64.5%-82.0%, while the proposed sensor pattern noise based scheme generated average accuracy in the range 89.9%-98.7%. For the aforementioned range of QFs, average accuracy rates achieved by the suggested clustering technique and the demosaicing artifact based approach were in the range 79.1%-90.1% and 83.2%-93.3%, respectively. Copyright © 2017 Elsevier B.V. All rights reserved.

The effect of growth medium on B. anthracis Sterne spore carbohydrate content.

PubMed

Colburn, Heather A; Wunschel, David S; Antolick, Kathryn C; Melville, Angela M; Valentine, Nancy B

2011-06-01

The expressed characteristics of biothreat agents may be impacted by variations in the culture environment, including growth medium formulation. The carbohydrate composition of B. anthracis spores has been well studied, particularly for the exosporium, which is the outermost spore structure. The carbohydrate composition of the exosporium has been demonstrated to be distinct from the vegetative form containing unique monosaccharides. We have investigated the carbohydrate composition of B. anthracis Sterne spores produced using four different medium types formulated with different sources of medium components. The amount of rhamnose, 3-O-methyl rhamnose and galactosamine was found to vary significantly between spores cultured using different medium formulations. The relative abundance of these monosaccharides compared to other monosaccharides such as mannosamine was also found to vary with medium type. Specific medium components were also found to impact the carbohydrate profile. Xylose has not been previously described in B. anthracis spores but was detected at low levels in two media. This may represent residual material from the brewery yeast extract used to formulate these two media. These results illustrate the utility of this method to capture the impact of growth medium on carbohydrate variation in spores. Detecting carbohydrate profiles in B. anthracis evidentiary material may provide useful forensic information on the growth medium used for sporulation. Copyright © 2011 Elsevier B.V. All rights reserved.

Differential reporting of mixed DNA profiles and its impact on jurists' evaluation of evidence. An international analysis.

PubMed

de Keijser, Jan W; Malsch, Marijke; Luining, Egge T; Weulen Kranenbarg, Marleen; Lenssen, Dominique J H M

2016-07-01

While DNA analysis is considered by many the gold standard in forensic science, there is ample room for variation in interpretation and reporting. This seems especially the case when working with (complex) mixed DNA profiles. Two consecutive studies on differential DNA reporting were conducted. In Study 1, we first examined type and magnitude of differences when forensic DNA experts across institutes and jurisdictions are handed an identical forensic case with mixed profiles. In Study 2, we explore the impact of the observed differential reporting on jurists' evaluation of the DNA evidence. 19 DNA expert reports from forensic institutes across Western jurisdictions were obtained. Differences between the reports were many and include extensiveness of the reports, explanations of technical issues, use of explanatory appendices, level of reporting, use of context information, and, most markedly, type and substantive content of the conclusions. In Study 2, a group of criminal law students judged a selection of these reports in a quasi experimental study design. Findings show that these differing reports have quite different evidentiary value for jurists, depending on which expert authored the report. It is argued that the impact of differential reporting on jurists' evaluation was so fundamental and substantive that it is seems reasonable to claim that in an actual court case it could make the difference between acquittal and conviction. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The insanity defense: Related issues

PubMed Central

Asokan, T. V.

2016-01-01

For the past 150 years, there is no change in the understanding and knowledge other than autonomy and capacity to choose the right and wrong for criminal liability. The alternative concept that human behavior is the result of an interaction between biological and environmental factors other than free choice failed to impress the criminal justice system because of a direct threat to a society's deep seated need to blame someone than themselves for criminal harms that occur. The insanity defense has a long history, and is evolved after many tests that have been tried and tested. McNaughton's rules stressed on “understandability of right and wrong” and “intellectual” rather than a moral or affective definition dominated in its formulation. Lack of control and irresistible drives or impulses were neglected Going by the current understanding of neurological evidences of compulsion and lack of impulse control, rationality tests without the inclusion of lack of control, seem to be outdated. Separate “Control determination” than the “Rationality determination” by the jurors may improve the accuracy of Juror's categorizations. There is a suggestion that Relevance ratio is ideal for ‘Evidentiary relevance” and there should be a quality control on expert testimonies. With progress in neuroscience, the law may need to abandon or alter some of its current assumptions about the nature of voluntary conduct, which underlies various defenses PMID:28216769

Potential effects of ionizing radiation on the evidentiary value of DNA, latent fingerprints, hair, and fibers: A comprehensive review and new results.

PubMed

Monson, Keith L; Ali, Sherine; Brandhagen, Michael D; Duff, Martine C; Fisher, Constance L; Lowe, Karen K; Meyer, Carna E; Roberts, Maria A; Tom, Kyle R; Washington, Aaron L

2018-03-01

An extensive literature review and new post-irradiation experimental results are presented of genotyping blood stains and hair, and physical examinations of latent fingerprints, hairs, and fibers. Results indicate that successful development of nuclear short tandem repeat (STR) and mitochondrial DNA sequence profiles from human blood and hair evidence is possible-up to a point-following exposure to gamma, neutron, beta, and alpha radiation at several levels that would most likely be present at this type of crime scene (i.e., a "dirty bomb," etc.). Commencing at gamma radiation levels between 90 and 900kGy, DNA analysis using conventional DNA techniques was unsuccessful. In general, irradiation negatively affected the quality of latent fingerprints. All four radiation types degraded most fingerprint samples at all doses; nevertheless, many fingerprints remained of value for potential use in comparison. Although variable from one hair to another, microscopic changes observed for all types and levels of irradiation could potentially result in false exclusions. Negligible microscopic changes were observed in papers and fibers (used as substrates for fingerprints and bloodstains) up to 90kGy gamma, but fluorescence of fibers began to change above that dose. Paper and fibers, as well as plastic evidence enclosures, became extremely brittle leading to breakage after a gamma dose of 900kGy. Published by Elsevier B.V.

The Dimensionality of Reasoning: Inductive and Deductive Inference can be Explained by a Single Process.

PubMed

Hayes, Brett K; Stephens, Rachel G; Ngo, Jeremy; Dunn, John C

2018-02-01

Three-experiments examined the number of qualitatively different processing dimensions needed to account for inductive and deductive reasoning. In each study, participants were presented with arguments that varied in logical validity and consistency with background knowledge (believability), and evaluated them according to deductive criteria (whether the conclusion was necessarily true given the premises) or inductive criteria (whether the conclusion was plausible given the premises). We examined factors including working memory load (Experiments 1 and 2), individual working memory capacity (Experiments 1 and 2), and decision time (Experiment 3), which according to dual-processing theories, modulate the contribution of heuristic and analytic processes to reasoning. A number of empirical dissociations were found. Argument validity affected deduction more than induction. Argument believability affected induction more than deduction. Lower working memory capacity reduced sensitivity to argument validity and increased sensitivity to argument believability, especially under induction instructions. Reduced decision time led to decreased sensitivity to argument validity. State-trace analyses of each experiment, however, found that only a single underlying dimension was required to explain patterns of inductive and deductive judgments. These results show that the dissociations, which have traditionally been seen as supporting dual-processing models of reasoning, are consistent with a single-process model that assumes a common evidentiary scale for induction and deduction. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Real-World Evidence, Public Participation, and the FDA.

PubMed

Schwartz, Jason L

2017-11-01

For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD)

PubMed Central

2012-01-01

Executive Summary In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions. After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses. The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html. Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty member_giacomini.htm. For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx. The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact. Objective The objective of this evidence-based analysis was to determine the effectiveness and cost-effectiveness of smoking cessation interventions in the management of chronic obstructive pulmonary disease (COPD). Clinical Need: Condition and Target Population Tobacco smoking is the main risk factor for COPD. It is estimated that 50% of older smokers develop COPD and more than 80% of COPD-associated morbidity is attributed to tobacco smoking. According to the Canadian Community Health Survey, 38.5% of Ontarians who smoke have COPD. In patients with a significant history of smoking, COPD is usually present with symptoms of progressive dyspnea (shortness of breath), cough, and sputum production. Patients with COPD who smoke have a particularly high level of nicotine dependence, and about 30.4% to 43% of patients with moderate to severe COPD continue to smoke. Despite the severe symptoms that COPD patients suffer, the majority of patients with COPD are unable to quit smoking on their own; each year only about 1% of smokers succeed in quitting on their own initiative. Technology Smoking cessation is the process of discontinuing the practice of inhaling a smoked substance. Smoking cessation can help to slow or halt the progression of COPD. Smoking cessation programs mainly target tobacco smoking, but may also encompass other substances that can be difficult to stop smoking due to the development of strong physical addictions or psychological dependencies resulting from their habitual use. Smoking cessation strategies include both pharmacological and nonpharmacological (behavioural or psychosocial) approaches. The basic components of smoking cessation interventions include simple advice, written self-help materials, individual and group behavioural support, telephone quit lines, nicotine replacement therapy (NRT), and antidepressants. As nicotine addiction is a chronic, relapsing condition that usually requires several attempts to overcome, cessation support is often tailored to individual needs, while recognizing that in general, the more intensive the support, the greater the chance of success. Success at quitting smoking decreases in relation to: a lack of motivation to quit, a history of smoking more than a pack of cigarettes a day for more than 10 years, a lack of social support, such as from family and friends, and the presence of mental health disorders (such as depression). Research Question What are the effectiveness and cost-effectiveness of smoking cessation interventions compared with usual care for patients with COPD? Research Methods Literature Search Search Strategy A literature search was performed on June 24, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations (1950 to June Week 3 2010), EMBASE (1980 to 2010 Week 24), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the Centre for Reviews and Dissemination for studies published between 1950 and June 2010. A single reviewer reviewed the abstracts and obtained full-text articles for those studies meeting the eligibility criteria. Reference lists were also examined for any additional relevant studies not identified through the search. Data were extracted using a standardized data abstraction form. Inclusion Criteria English-language, full reports from 1950 to week 3 of June, 2010; either randomized controlled trials (RCTs), systematic reviews and meta-analyses, or non-RCTs with controls; a proven diagnosis of COPD; adult patients (≥ 18 years); a smoking cessation intervention that comprised at least one of the treatment arms; ≥ 6 months’ abstinence as an outcome; and patients followed for ≥ 6 months. Exclusion Criteria case reports case series Outcomes of Interest ≥ 6 months’ abstinence Quality of Evidence The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence: High Further research is very unlikely to change confidence in the estimate of effect. Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Very Low Any estimate of effect is very uncertain. Summary of Findings Nine RCTs were identified from the literature search. The sample sizes ranged from 74 to 5,887 participants. A total of 8,291 participants were included in the nine studies. The mean age of the patients in the studies ranged from 54 to 64 years. The majority of studies used the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD staging criteria to stage the disease in study subjects. Studies included patients with mild COPD (2 studies), mild-moderate COPD (3 studies), moderate–severe COPD (1 study) and severe–very severe COPD (1 study). One study included persons at risk of COPD in addition to those with mild, moderate, or severe COPD, and 1 study did not define the stages of COPD. The individual quality of the studies was high. Smoking cessation interventions varied across studies and included counselling or pharmacotherapy or a combination of both. Two studies were delivered in a hospital setting, whereas the remaining 7 studies were delivered in an outpatient setting. All studies reported a usual care group or a placebo-controlled group (for the drug-only trials). The follow-up periods ranged from 6 months to 5 years. Due to excessive clinical heterogeneity in the interventions, studies were first grouped into categories of similar interventions; statistical pooling was subsequently performed, where appropriate. When possible, pooled estimates using relative risks for abstinence rates with 95% confidence intervals were calculated. The remaining studies were reported separately. Abstinence Rates Table ES1 provides a summary of the pooled estimates for abstinence, at longest follow-up, from the trials included in this review. It also shows the respective GRADE qualities of evidence. Table ES1: Summary of Results* Intervention Comparison Number of Studies Abstinence Rate Pooled Relative Risk (95% CI) GRADE Counselling Usual Care 2 5.85 (3.81−8.97)† Moderate Intensive Counselling ≥ 90 minutes Usual Care 1 7.70 (4.64−12.79)† Minimal Counselling < 90 minutes Usual Care 1 1.56 (0.65−3.72) Counselling + NRT Usual Care 3 4.28 (3.51−5.20)† Moderate Intensive Counselling ≥ 90 minutes + Usual Care     NRT Usual Care 1 4.41 (3.60−5.39)† Minimal Counselling < 90 minutes +   2 2.11 (0.90−4.91) NRT         Minimal Counselling < 90 minutes + Antidepressant Usual Care 1 1.91 (0.65−5.61) Low Minimal Counselling < 90 minutes + NRT + Antidepressant Usual Care 1 2.25 (0.87−5.85) Low NRT Placebo 1 3.01 (1.02−8.89)† Moderate Antidepressant Placebo‡ 2 2.09 (1.35−3.24)† Moderate Nortriptyline Placebo 1 2.54 (0.87−7.44) Moderate Bupropion Placebo 2 2.01 (1.24−3.24)†   * Abbreviations: CI, confidence interval; NRT, nicotine replacement therapy. † Statistically significant (P < 0.05). ‡ One trial used in this comparison had 2 treatment arms each examining a different antidepressant. Conclusions Based on a moderate quality of evidence, compared with usual care, abstinence rates are significantly higher in COPD patients receiving intensive counselling or a combination of intensive counselling and NRT. Based on limited and moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving NRT compared with placebo. Based on a moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving the antidepressant bupropion compared to placebo. PMID:23074432

[Gaps of Evidence in ENT-Surgery - a Qualitative Survey].

PubMed

Löhler, J; Akcicek, B; Müller, F; Dreier, G; Meerpohl, J J; Vach, W; Werner, J

2016-04-01

As in other disciplines, the burgeoning knowledge in ENT medicine long ago surpassed our ability to adequately absorb it and maintain a proper overview. This can give rise to actual or assumed knowledge gaps that can impede the progress of the discipline and evidence-based treatment of patients. Clinics and medical practices also hold to traditional doctrines that shape day-to-day medicine, without these schools being challenged based on evidence. Between February and June 2015, 160 ENT clinics, including 34 university hospitals, and 2,670 ENT practices took part in a two-arm online survey on existing or perceived evidentiary gaps in ENT medicine using a previously development questionnaire. The survey used for half the participants was open in form; the other half were given a closed survey with systematics of the field for orientation. The survey was augmented with additional data such as the number of publications and focus areas in the clinics and the age and type of practice of the established physicians. The return rate from the clinics was 39.7%; the return rate of the closed surveys was 29.3%. Of the physicians in medical practice, 14.6% responded to the closed and 18.6% to the open survey. There were no major differences between the two forms of survey. Otological and oncological issues comprised approximately 30% of the list of answers from clinics. Corresponding questions were formulated regarding the current diagnostic and therapeutic problems, such as with stage-related tumor treatment or implantable hearing aids. Diagnostic procedures, e.g., special new procedures in audiology and vestibulogy, dominated the surveys from the practices. However clinics and practices alike cited marginal areas of the discipline that are of daily relevance. The cited knowledge gaps then needed to be verified or refuted and clarified based on research of the literature as to whether the existing evidence actually reached healthcare providers in the form of guidelines, publications, conferences or continuing training for application in daily practice. Other steps would include prioritizing future research, evidence mapping, deciding on further systematic reviews, and targeted studies in conjunction with procuring third-party funding and in cooperation with patient associations. The knowledge thus gained should ultimately be transferred in improved form for application in daily clinical practice. Ten questions of key importance each needed to be formulated for the hospitals and practices. © Georg Thieme Verlag KG Stuttgart · New York.

Internet of Things technology-based management methods for environmental specimen banks.

PubMed

Peng, Lihong; Wang, Qian; Yu, Ang

2015-02-01

The establishment and management of environmental specimen banks (ESBs) has long been a problem worldwide. The complexity of specimen environment has made the management of ESB likewise complex. Through an analysis of the development and management of ESBs worldwide and in light of the sophisticated Internet of Things (IOT) technology, this paper presents IOT technology-based ESB management methods. An IOT technology-based ESB management system can significantly facilitate ESB ingress and egress management as well as long-term storage management under quality control. This paper elaborates on the design of IOT technology-based modules, which can be used in ESB management to achieve standardized, smart, information-based ESB management. ESB management has far-reaching implications for environmental management and for research in environmental science.

Application of the BioMek 2000 Laboratory Automation Workstation and the DNA IQ System to the extraction of forensic casework samples.

PubMed

Greenspoon, Susan A; Ban, Jeffrey D; Sykes, Karen; Ballard, Elizabeth J; Edler, Shelley S; Baisden, Melissa; Covington, Brian L

2004-01-01

Robotic systems are commonly utilized for the extraction of database samples. However, the application of robotic extraction to forensic casework samples is a more daunting task. Such a system must be versatile enough to accommodate a wide range of samples that may contain greatly varying amounts of DNA, but it must also pose no more risk of contamination than the manual DNA extraction methods. This study demonstrates that the BioMek 2000 Laboratory Automation Workstation, used in combination with the DNA IQ System, is versatile enough to accommodate the wide range of samples typically encountered by a crime laboratory. The use of a silica coated paramagnetic resin, as with the DNA IQ System, facilitates the adaptation of an open well, hands off, robotic system to the extraction of casework samples since no filtration or centrifugation steps are needed. Moreover, the DNA remains tightly coupled to the silica coated paramagnetic resin for the entire process until the elution step. A short pre-extraction incubation step is necessary prior to loading samples onto the robot and it is at this step that most modifications are made to accommodate the different sample types and substrates commonly encountered with forensic evidentiary samples. Sexual assault (mixed stain) samples, cigarette butts, blood stains, buccal swabs, and various tissue samples were successfully extracted with the BioMek 2000 Laboratory Automation Workstation and the DNA IQ System, with no evidence of contamination throughout the extensive validation studies reported here.

Munchausen Syndrome by Proxy/Fabricated and Induced Illness: does the diagnosis serve economic vested interests, rather than the interests of children?

PubMed

Wrennall, Lynne

2007-01-01

The discourse of Munchausen Syndrome by Proxy/Fabricated and Induced Illness posits the widespread incidence of a highly dangerous form of child abuse in which illness and developmental delay in children, is caused by their parents or carers. The discourse has been linked to false allegations of child abuse, hostile adoptions and miscarriages of justice. It has also stimulated concerns that the children's real medical and developmental needs are neglected when their conditions are misdiagnosed as child abuse. This study examines the critical claims that have been levelled against the Munchausen discourse. They provide explanations of the children's problems that compete with the discourse. The claim of the discourse to scientific validity is thereby shown to be questionable. The explanations have been distilled into specific hypotheses, to stimulate further research. The literature from which the hypotheses were derived, identifies problems in the MSbP/FII discourse in five broad areas of science, regarding: the test validity of techniques; construct validity; statistical methods; evidentiary standards and adverse impacts. The main conclusion is that the detailed critical hypotheses, cohere around the central claim that the discourse of Munchausen Syndrome by Proxy/Fabricated and Induced Illness serves economic vested interests, rather than the interests of children. The hypotheses predict adverse health and social outcomes, as a result of the discourse. Consequently, the continued deployment of the discourse would probably be "unsafe and therefore unwise".

The Terri Schiavo case: legal, ethical, and medical perspectives.

PubMed

Perry, Joshua E; Churchill, Larry R; Kirshner, Howard S

2005-11-15

Although tragic, the plight of Terri Schiavo provides a valuable case study. The conflicts and misunderstandings surrounding her situation offer important lessons in medicine, law, and ethics. Despite media saturation and intense public interest, widespread confusion lingers regarding the diagnosis of persistent vegetative state, the judicial processes involved, and the appropriateness of the ethical framework used by those entrusted with Terri Schiavo's care. First, the authors review the current medical understanding of persistent vegetative state, including the requirements for patient examination, the differential diagnosis, and the practice guidelines of the American Academy of Neurology regarding artificial nutrition and hydration for patients with this diagnosis. Second, they examine the legal history, including the 2000 trial, the 2002 evidentiary hearing, and the subsequent appeals. The authors argue that the law did not fail Terri Schiavo, but produced the highest-quality evidence and provided the most judicial review of any end-of-life guardianship case in U.S. history. Third, they review alternative ethical frameworks for understanding the Terri Schiavo case and contend that the principle of respect for autonomy is paramount in this case and in similar cases. Far from being unusual, the manner in which Terri Schiavo's case was reviewed and the basis for the decision reflect a broad medical, legal, and ethical consensus. Greater clarity regarding the persistent vegetative state, less apprehension of the presumed mysteries of legal proceedings, and greater appreciation of the ethical principles at work are the chief benefits obtained from studying this provocative case.

From Nutrition Plus to Nutrition Driven: how to realize the elusive potential of agriculture for nutrition?

PubMed

Haddad, Lawrence

2013-03-01

Agriculture has the potential to have a bigger impact on nutrition status than it currently does. The pathways between agriculture and nutrition are well known. Yet the evidence on how to increase the impact of agriculture on nutrition is weak. To outline some of the possible reasons for the weak evidentiary link between agriculture and income and to highlight some approaches to incentivizing agriculture to give nutrition a greater priority. A review of literature reviews and other studies. Agriculture does not have a strong poverty and nutrition impact culture, the statistical links between aggregate agriculture and nutrition data are weak, literature reviews to date have not been sufficiently clear on the quality of evidence admitted, and the evidence for the impact of biofortification on nutrition status is positive, but small. Some tools are proposed and described that may be helpful in raising the profile of nutrition outcomes, building nutrition outcomes into impact assessments of agriculture, measuring the commitment to undernutrition reduction, and helping to prioritize nutrition-relevant actions within agriculture. Leadership in agriculture and nutrition is also an understudied issue. Agriculture has a vast potential to increase its impact on nutrition outcomes. We don't know if this potential is being fully realized as yet. I suspect it is not. Tools that help promote the visibility of nutrition within agriculture and the accountability of agriculture toward nutrition can possibly contribute to moving "from Nutrition Plus to Nutrition Driven" agriculture.

Should consultation recording use be a practice standard? A systematic review of the effectiveness and implementation of consultation recordings.

PubMed

Rieger, Kendra L; Hack, Thomas F; Beaver, Kinta; Schofield, Penelope

2018-04-01

To conduct a systematic review of the effectiveness of consultation recordings and identify factors contributing to their successful implementation in health-care settings. A systematic review was conducted for quantitative studies examining the effectiveness of consultation recordings in health care. Two independent reviewers assessed the relevance and quality of retrieved quantitative studies by using standardized criteria. Study findings were examined to determine consultation recording effectiveness and to identify barriers and facilitators to implementation. A supplementary review of qualitative evidence was performed to further explicate implementation factors. Of the 3373 articles retrieved in the quantitative search, 26 satisfied the standardized inclusion criteria (12 randomized controlled trials, 1 quasi-experiment, and 13 cross-sectional studies). Most patients found consultation recordings beneficial. Statistically significant evidentiary support was found for the beneficial impact of consultation recordings on the following patient reported outcomes: knowledge, perception of being informed, information recall, decision-making factors, anxiety, and depression. Implementation barriers included strength of evidence concerns, patient distress, impact of the recording on consultation quality, clinic procedures, medico-legal issues, and resource costs. Facilitators included comfort with being recorded, clinical champions, legal strategies, efficient recording procedures, and a positive consultation recording experience. Consultation recordings are valuable to patients and positively associated with patient-reported outcomes. Successful integration of consultation recording use into clinical practice requires an administratively supported, systematic approach to addressing implementation factors. Copyright © 2017 John Wiley & Sons, Ltd.

Feline mitochondrial DNA sampling for forensic analysis: when enough is enough!

PubMed

Grahn, Robert A; Alhaddad, Hasan; Alves, Paulo C; Randi, Ettore; Waly, Nashwa E; Lyons, Leslie A

2015-05-01

Pet hair has a demonstrated value in resolving legal issues. Cat hair is chronically shed and it is difficult to leave a home with cats without some level of secondary transfer. The power of cat hair as an evidentiary resource may be underused because representative genetic databases are not available for exclusionary purposes. Mitochondrial control region databases are highly valuable for hair analyses and have been developed for the cat. In a representative worldwide data set, 83% of domestic cat mitotypes belong to one of twelve major types. Of the remaining 17%, 7.5% are unique within the published 1394 sample database. The current research evaluates the sample size necessary to establish a representative population for forensic comparison of the mitochondrial control region for the domestic cat. For most worldwide populations, randomly sampling 50 unrelated local individuals will achieve saturation at 95%. The 99% saturation is achieved by randomly sampling 60-170 cats, depending on the numbers of mitotypes available in the population at large. Likely due to the recent domestication of the cat and minimal localized population substructure, fewer cats are needed to meet mitochondria DNA control region database practical saturation than for humans or dogs. Coupled with the available worldwide feline control region database of nearly 1400 cats, minimal local sampling will be required to establish an appropriate comparative representative database and achieve significant exclusionary power. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The statistical evaluation of duct tape end match as physical evidence

NASA Astrophysics Data System (ADS)

Chan, Ka Lok

Duct tapes are often submitted to crime laboratories as evidence associated with abductions, homicides, or construction of explosive devices. As a result, trace evidence examiners are often asked to analyze and compare commercial duct tapes so that they can establish possible evidentiary links. Duct tape end matches are believed to be the strongest association between exemplar and question samples because they are considered as evidence with unique individual characteristics. While end match analysis and comparison have long been undertaken by trace evidence examiners, there is a significant lack of scientific research for associating two or more segments of duct tapes. This study is designed to obtain statistical inferences on the uniqueness of duct tape tears. Three experiments were devised to compile the basis for a statistical assessment of the probability of duct tape end matches along with a proposed error rate. In one experiment, we conducted the equivalent of 10,000 end match examinations with an error rate of 0%. In the second experiment, we performed 2,704 end match examinations having 0% error rate. In the third experiment, using duct tape by an Elmendorf Tear tester, we conducted 576 end match examinations with an error rate of 0% and having all samples correctly associated. The results of this study indicate that end matches are distinguishable among a single roll of duct tape and between two different rolls of duct tape having very similar surface features and weave pattern.

Classification of footwear outsole patterns using Fourier transform and local interest points.

PubMed

Richetelli, Nicole; Lee, Mackenzie C; Lasky, Carleen A; Gump, Madison E; Speir, Jacqueline A

2017-06-01

Successful classification of questioned footwear has tremendous evidentiary value; the result can minimize the potential suspect pool and link a suspect to a victim, a crime scene, or even multiple crime scenes to each other. With this in mind, several different automated and semi-automated classification models have been applied to the forensic footwear recognition problem, with superior performance commonly associated with two different approaches: correlation of image power (magnitude) or phase, and the use of local interest points transformed using the Scale Invariant Feature Transform (SIFT) and compared using Random Sample Consensus (RANSAC). Despite the distinction associated with each of these methods, all three have not been cross-compared using a single dataset, of limited quality (i.e., characteristic of crime scene-like imagery), and created using a wide combination of image inputs. To address this question, the research presented here examines the classification performance of the Fourier-Mellin transform (FMT), phase-only correlation (POC), and local interest points (transformed using SIFT and compared using RANSAC), as a function of inputs that include mixed media (blood and dust), transfer mechanisms (gel lifters), enhancement techniques (digital and chemical) and variations in print substrate (ceramic tiles, vinyl tiles and paper). Results indicate that POC outperforms both FMT and SIFT+RANSAC, regardless of image input (type, quality and totality), and that the difference in stochastic dominance detected for POC is significant across all image comparison scenarios evaluated in this study. Copyright © 2017 Elsevier B.V. All rights reserved.

Adaptationism--how to carry out an exaptationist program.

PubMed

Andrews, Paul W; Gangestad, Steven W; Matthews, Dan

2002-08-01

Adaptationism is a research strategy that seeks to identify adaptations and the specific selective forces that drove their evolution in past environments. Since the mid-1970s, paleontologist Stephen J. Gould and geneticist Richard Lewontin have been critical of adaptationism, especially as applied toward understanding human behavior and cognition. Perhaps the most prominent criticism they made was that adaptationist explanations were analogous to Rudyard Kipling's Just So Stories (outlandish explanations for questions such as how the elephant got its trunk). Since storytelling (through the generation of hypotheses and the making of inferences) is an inherent part of science, the criticism refers to the acceptance of stories without sufficient empirical evidence. In particular, Gould, Lewontin, and their colleagues argue that adaptationists often use inappropriate evidentiary standards for identifying adaptations and their functions, and that they often fail to consider alternative hypotheses to adaptation. Playing prominently in both of these criticisms are the concepts of constraint, spandrel, and exaptation. In this article we discuss the standards of evidence that could be used to identify adaptations and when and how they may be appropriately used. Moreover, building an empirical case that certain features of a trait are best explained by exaptation, spandrel, or constraint requires demonstrating that the trait's features cannot be better accounted for by adaptationist hypotheses. Thus, we argue that the testing of alternatives requires the consideration, testing, and systematic rejection of adaptationist hypotheses. Where possible, we illustrate our points with examples taken from human behavior and cognition.

Evaluation of a novel material, Diomics X-Swab™, for collection of DNA.

PubMed

Marshall, Pamela L; Stoljarova, Monika; Larue, Bobby L; King, Jonathan L; Budowle, Bruce

2014-09-01

Success of DNA typing is related to the amount of target material recovered from an evidentiary item. Generally, the more DNA that is recovered, the better the chance is of obtaining a typing result that will be robust and reliable. One method of collecting stain materials is by swabbing. Recovery of DNA from a number of commercially available swabs is not an efficient process. The X-Swab™ (Diomics Corporation, La Jolla, CA) is a unique bio-specimen collection material with highly absorptive properties and can be dissolved during certain extraction conditions. Therefore, more DNA may be collected from a substrate and be released from the swab matrix than other swabs. The ability to recover DNA from X-Swab material and success in STR typing were compared with the Copan 4N6FLOQSwab™ (Brescia, Italy), a device which utilizes a proprietary flocked-swab technology to maximize DNA collection and elution efficiency. Both types of swabs were impregnated with known amounts of DNA and body fluids and allowed to air dry. In addition, blood was placed onto glass slides, allowed to dry and collected using both types of swabs. DNA recovery was assessed by DNA quantitation and by STR typing. Results suggested that X-Swab material yielded greater DNA recovery, particularly of low quantity samples (defined as diluted neat samples), compared with the 4N6FLOQSwab. Results also indicated that X-Swab material itself enhances yield of PCR products. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer's Disease: Comparison of Efficacy and Effectiveness Studies

PubMed Central

Atri, Alireza; Rountree, Susan D.; Lopez, Oscar L.; Doody, Rachelle S.

2012-01-01

Background Randomized controlled efficacy trials (RCTs), the scientific gold standard, are required for regulatory approval of Alzheimer's disease (AD) interventions, yet provide limited information regarding real-world therapeutic effectiveness. Objective: To compare the nature of evidence regarding the combination of approved AD treatments from RCTs versus long-term observational controlled studies (LTOCs). Methods Comparisons of strengths, limitations, and evidence level for monotherapy [cholinesterase inhibitor (ChEI) or memantine] and combination therapy (ChEI + memantine) in RCTs versus LTOCs. Results RCTs examined highly selected populations over months. LTOCs collected data across multiple AD stages in large populations over many years. RCTs and LTOCs show similar patterns favoring combination over monotherapy over placebo/no treatment. Long-term combination therapy compared to monotherapy reduced cognitive and functional decline and delayed time to nursing home admission. Persistent treatment was associated with slower decline. While LTOCs used control groups, adjusted for multiple covariates, had higher external validity, and favorable ethical, practical and cost considerations, their limitations included potential selection bias due to lack of placebo comparisons and randomization. Conclusions Naturalistic LTOCs provide complementary long-term level II evidence to complement level I evidence from short-term RCTs regarding therapeutic effectiveness in AD that may otherwise be unobtainable. A coordinated strategy/consortium to pool LTOC data from multiple centers to estimate long-term comparative effectiveness, risks/benefits, and costs of AD treatments is needed. PMID:22327239

Management Data Base Development.

ERIC Educational Resources Information Center

Dan, Robert L.

1975-01-01

A management data base is seen as essential for a management information system, program budgeting, program costing, management by objectives, program evaluation, productivity measures, and accountability in institutions of higher education. The necessity of a management data base is addressed, along with the benefits and limitations it may have…

Integrating School-Based and Therapeutic Conflict Management Models at School.

ERIC Educational Resources Information Center

D'Oosterlinck, Franky; Broekaert, Eric

2003-01-01

Explores the possibility of integrating school-based and therapeutic conflict management models, comparing two management models: a school-based conflict management program, "Teaching Students To Be Peacemakers"; and a therapeutic conflict management program, "Life Space Crisis Intervention." The paper concludes that integration might be possible…

Computer-assisted engineering data base

NASA Technical Reports Server (NTRS)

Dube, R. P.; Johnson, H. R.

1983-01-01

General capabilities of data base management technology are described. Information requirements posed by the space station life cycle are discussed, and it is asserted that data base management technology supporting engineering/manufacturing in a heterogeneous hardware/data base management system environment should be applied to meeting these requirements. Today's commercial systems do not satisfy all of these requirements. The features of an R&D data base management system being developed to investigate data base management in the engineering/manufacturing environment are discussed. Features of this system represent only a partial solution to space station requirements. Areas where this system should be extended to meet full space station information management requirements are discussed.

Evidence-based practice beliefs and behaviors of nurses providing cancer pain management: a mixed-methods approach.

PubMed

Eaton, Linda H; Meins, Alexa R; Mitchell, Pamela H; Voss, Joachim; Doorenbos, Ardith Z

2015-03-01

To describe evidence-based practice (EBP) beliefs and behaviors of nurses who provide cancer pain management. Descriptive, cross-sectional with a mixed-methods approach. Two inpatient oncology units in the Pacific Northwest. 40 RNs.
 Data collected by interviews and web-based surveys. EBP beliefs, EBP implementation, evidence-based pain management. Nurses agreed with the positive aspects of EBP and their implementation ability, although implementation level was low. They were satisfied with their pain management practices. Oncology nursing certification was associated with innovativeness, and innovativeness was associated with EBP beliefs. Themes identified were (a) limited definition of EBP, (b) varied evidence-based pain management decision making, (c) limited identification of evidence-based pain management practices, and (d) integration of nonpharmacologic interventions into patient care. Nurses' low level of EBP implementation in the context of pain management was explained by their trust that standards of care and medical orders were evidence-based. Nurses' EBP beliefs and behaviors should be considered when developing strategies for sustaining evidence-based pain management practices. Implementation of the EBP process by nurses may not be realistic in the inpatient setting; therefore, hospital pain management policies need to be evidence-based and reinforced with nurses.

Disturbance dynamics and ecosystem-based forest management

Treesearch

Kalev Jogiste; W. Keith Moser; Malle Mandre

2005-01-01

Ecosystem-based management is intended to balance ecological, social and economic values of sustainable resource management. The desired future state of forest ecosystem is usually defined through productivity, biodiversity, stability or other terms. However, ecosystem-based management may produce an unbalanced emphasis on different components. Although ecosystem-based...

VHBuild.com: A Web-Based System for Managing Knowledge in Projects.

ERIC Educational Resources Information Center

Li, Heng; Tang, Sandy; Man, K. F.; Love, Peter E. D.

2002-01-01

Describes an intelligent Web-based construction project management system called VHBuild.com which integrates project management, knowledge management, and artificial intelligence technologies. Highlights include an information flow model; time-cost optimization based on genetic algorithms; rule-based drawing interpretation; and a case-based…

36 CFR 1237.30 - How do agencies manage records on nitrocellulose-base and cellulose-acetate base film?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false How do agencies manage records on nitrocellulose-base and cellulose-acetate base film? 1237.30 Section 1237.30 Parks, Forests..., CARTOGRAPHIC, AND RELATED RECORDS MANAGEMENT § 1237.30 How do agencies manage records on nitrocellulose-base...

36 CFR 1237.30 - How do agencies manage records on nitrocellulose-base and cellulose-acetate base film?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 false How do agencies manage records on nitrocellulose-base and cellulose-acetate base film? 1237.30 Section 1237.30 Parks, Forests..., CARTOGRAPHIC, AND RELATED RECORDS MANAGEMENT § 1237.30 How do agencies manage records on nitrocellulose-base...

36 CFR 1237.30 - How do agencies manage records on nitrocellulose-base and cellulose-acetate base film?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 36 Parks, Forests, and Public Property 3 2012-07-01 2012-07-01 false How do agencies manage records on nitrocellulose-base and cellulose-acetate base film? 1237.30 Section 1237.30 Parks, Forests..., CARTOGRAPHIC, AND RELATED RECORDS MANAGEMENT § 1237.30 How do agencies manage records on nitrocellulose-base...

Comparison of tiered formularies and reference pricing policies: a systematic review

PubMed Central

Morgan, Steve; Hanley, Gillian; Greyson, Devon

2009-01-01

Objectives To synthesize methodologically comparable evidence from the published literature regarding the outcomes of tiered formularies and therapeutic reference pricing of prescription drugs. Methods We searched the following electronic databases: ABI/Inform, CINAHL, Clinical Evidence, Digital Dissertations & Theses, Evidence-Based Medicine Reviews (which incorporates ACP Journal Club, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, Database of Abstracts of Reviews of Effectiveness, Health Technology Assessments and NHS Economic Evaluation Database), EconLit, EMBASE, International Pharmaceutical Abstracts, MEDLINE, PAIS International and PAIS Archive, and the Web of Science. We also searched the reference lists of relevant articles and several grey literature sources. We sought English-language studies published from 1986 to 2007 that examined the effects of either therapeutic reference pricing or tiered formularies, reported on outcomes relevant to patient care and cost-effectiveness, and employed quantitative study designs that included concurrent or historical comparison groups. We abstracted and assessed potentially appropriate articles using a modified version of the data abstraction form developed by the Cochrane Effective Practice and Organisation of Care Group. Results From an initial list of 2964 citations, 12 citations (representing 11 studies) were deemed eligible for inclusion in our review: 3 studies (reported in 4 articles) of reference pricing and 8 studies of tiered formularies. The introduction of reference pricing was associated with reduced plan spending, switching to preferred medicines, reduced overall drug utilization and short-term increases in the use of physician services. Reference pricing was not associated with adverse health impacts. The introduction of tiered formularies was associated with reduced plan expenditures, greater patient costs and increased rates of non-compliance with prescribed drug therapy. From the data available, we were unable to examine the hypothesis that tiered formulary policies result in greater use of physician services and potentially worse health outcomes. Conclusion The available evidence does not clearly differentiate between reference pricing and tiered formularies in terms of policy outcomes. Reference pricing appears to have a slight evidentiary advantage, given that patients’ health outcomes under tiered formularies have not been well studied and that tiered formularies are associated with increased rates of medicine discontinuation. PMID:21603047

Complementary medicine, self-help, and lifestyle interventions for obsessive compulsive disorder (OCD) and the OCD spectrum: a systematic review.

PubMed

Sarris, Jerome; Camfield, David; Berk, Michael

2012-05-01

In Obsessive Compulsive Disorder (OCD) current standard pharmacotherapies may be of limited efficacy. Non-conventional interventions such as Complementary and Alternative Medicine (CAM), self-help techniques, and lifestyle interventions are commonly used by sufferers of OCD, however to date no systematic review of this specific area exists. We conducted a systematic review of studies using CAM, self-help, and lifestyle interventions for treatment of OCD and trichotillomania (TTM). PubMed, PsycINFO, China Academic Journals Full-text Database, The Cochrane Library and CINAHL were searched (up to Jan 11th 2011), for controlled clinical trials using non-conventional interventions for OCD. A quality analysis using a purpose-designed scale and an estimation of effect sizes (Cohen's d) where data was available, were also calculated. The literature search revealed 14 studies that met inclusion criteria. Methodological quality of nutraceutical studies (nutrients and herbal medicines) were rated as high (mean 8.6/10), whereas mind-body or self-help studies were poorer (mean 6.1/10). In OCD, tentative evidentiary support from methodologically weak studies was found for mindfulness meditation (d=0.63), electroacupuncture (d=1.16), and kundalini yoga (d=1.61). Better designed studies using the nutrient glycine (d=1.10), and traditional herbal medicines milk thistle (insufficient data for calculating d) and borage (d=1.67) also revealed positive results. A rigorous study showed that N-acetylcysteine (d=1.31) was effective in TTM, while self-help technique "movement decoupling" also demonstrated efficacy (d=0.94). Mixed evidence was found for myo-inositol (mean d=0.98). Controlled studies suggest that St John's wort, EPA, and meridian-tapping are ineffective in treating OCD. While several studies were positive, these were un-replicated and commonly used small samples. This precludes firm confidence in the strength of clinical effect. Preliminary evidence however is encouraging, and more rigorous research of some of the more hypothesis-based interventions in the treatment of OCD and TTM may be indicated. Copyright © 2011 Elsevier B.V. All rights reserved.

Home telemonitoring for type 2 diabetes: an evidence-based analysis.

PubMed

2009-01-01

In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry's newly released Diabetes Strategy.After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM: Summary of Evidence-Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based AnalysisBehavioural Interventions for Type 2 Diabetes: An Evidence-Based AnalysisBARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY: An Evidence-Based SummaryCommunity-Based Care for the Management of Type 2 Diabetes: An Evidence-Based AnalysisHome Telemonitoring for Type 2 Diabetes: An Evidence-Based AnalysisApplication of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario The objective of this report is to determine whether home telemonitoring and management of blood glucose is effective for improving glycemic control in adults with type 2 diabetes. An aging population coupled with a shortage of nurses and physicians in Ontario is increasing the demand for home care services for chronic diseases, including diabetes. In recent years, there has also been a concurrent rise in the number of blood glucose home telemonitoring technologies available for diabetes management. The Canadian Diabetes Association (CDA) currently recommends self-monitoring of blood glucose for patients with type 2 diabetes, particularly for individuals using insulin. With the emergence of home telemonitoring, there is potential for improving the impact of self-monitoring by linking patients with health care professionals who can monitor blood glucose values and then provide guided recommendations remotely. The MAS has, therefore, conducted a review of the available evidence on blood glucose home telemonitoring and management technologies for type 2 diabetes. EVIDENCE-BASED ANALYSIS OF EFFECTIVENESS: Is home telemonitoring of blood glucose for adults with type 2 diabetes more efficacious in improving glycemic control (i.e. can it reduce HbA1c levels) in comparison to usual care? Must involve the frequent transmission of remotely-collected blood glucose measurements by patients to health care professionals for routine monitoring through the use of home telemonitoring technology. Monitoring must be combined with a coordinated management and feedback system based on transmitted data. Usual diabetes care as provided by the usual care provider (usual care largely varies by jurisdiction and study). Adults ≥18 years of age with type 2 diabetes. ≥6 months. ≥30 patients total.PUBLICATION TYPE: Randomized controlled trials (RCTs), systematic reviews, and/or meta-analyses.PUBLICATION DATE RANGE: January 1, 1998 to January 31, 2009. Studies with a control group other than usual care.Studies published in a language other than English.Studies in which there is indication that the monitoring of patients' diabetic measurements by a health care professional(s) was not occurring more frequently in intervention patients than in control patients receiving usual care. The primary outcome of interest was a reduction in glycosylated hemoglobin (HbA1c) levels. A comprehensive literature search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, The Cochrane Library, and INAHTA for studies published between January 1, 2007 and January 31, 2009. The search was designed as a continuation of a search undertaken for a systematic review by the Canadian Agency for Drugs and Technologies in Health, originally encompassing studies published from 1950 up until July of 2008 and which reviewed home telemonitoring in comparison to usual care for the management of type 1 and type 2 diabetes. A total of eight studies identified by the literature search were eligible for inclusion (one was excluded post-hoc from analysis). Studies varied considerably on characteristics of design, population, and intervention/control. Of note, few trials limited populations to type 2 diabetics only, thus trials with mixed populations (type 1 and type 2) were included, though in such cases, the majority of patients (>60%) had type 2 diabetes. No studies restricted inclusion or analyses by diabetes treatment type (i.e. populations were mixed with respect to those on insulin therapy vs. not) and studies further varied on whether intervention was provided in addition to usual care or as a replacement. Lastly, trials often included blood glucose home telemonitoring as an adjunct to other telemedicine components and thus the incremental value of adding home telemonitoring remains unclear. The overall grading of the quality of evidence was low, indicating that there is uncertainty in the findings. Meta-analysis of the seven trials identified a moderate but significant reduction in HbA1c levels (~0.5% reduction) in favour blood glucose home telemonitoring compared to usual care for adults with type 2 diabetes). Subgroup analyses suggested differences in effect size depending on the type of intervention, however, these findings should be held under caution as the analyses were exploratory in nature and intervention components overlapped between subgroups. Executive Summary Table 1:Meta-Analyses of Reduction in HbA(1c) Values for Analyzed StudiesGroupEstimate of effect(95% Confidence Interval)Statistical Heterogeneity (I(2))FOLLOW-UP values     All studies-0.48 [-0.70 to -0.26]45%     Upload studies-0.39 [-0.66 to -0.13]48%     Web entry studies-0.66 [-0.99 to -0.33]0%Change-from-baseline values (p=0.5)     All studies-0.50 [-0.80 to -0.19]65%     Upload studies-0.26 [-0.55 to 0.02]45%     Web entry studies-0.78 [-1.14 to -0.43]0%Change-from-baseline values (p=0.65)     All studies-0.52 [-0.82 to -0.21]73%     Upload studies-0.25 [-0.51 to 0.01]46%     Web entry studies-0.78 [-1.08 to -0.48]0%Change-from-baseline values (p=0.85)     All studies-0.54 [-0.84 to -0.24]85%     Upload studies-0.21 [-0.41 to 0.00]47%     Web entry studies-0.81 [-1.11 to -0.51]49% Based on low quality evidence, blood glucose home telemonitoring technologies confer a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.Exploratory analysis suggests differences in effect sizes for the primary outcome when analyzing by subgroup; however, this should only be viewed as exploratory or hypothesis-generating only.Significant limitations and/or sources of clinical heterogeneity are present in the available literature, generating great uncertainty in conclusions.More robust trials in type 2 diabetics only, utilizing more modern technologies, preferably performed in an Ontario or a similar setting (given the infrastructure demands and that the standard comparator is usual care), while separating out the effects of other telemedicine intervention components, are needed to clarify the effect of emerging remote blood glucose monitoring technologies.

Strategies for Teaching Evidence-Based Management: What Management Educators Can Learn from Medicine

ERIC Educational Resources Information Center

Wright, April L.; Middleton, Stuart; Greenfield, Geoffrey; Williams, Julian; Brazil, Victoria

2016-01-01

Evidence-based management (EBMgt) is a growing literature stream in management education which contends that management decision making should be informed by the best available scientific evidence (Rousseau, 2006). Encouraged by the success of evidence-based practice in the field of medicine, advocates of EBMgt have increasingly called for…

75 FR 6208 - Proposed Collection; Comment Request; Web Based Training for Pain Management Providers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... Request; Web Based Training for Pain Management Providers SUMMARY: Under the provisions of Section 3507(a... comment. Proposed Collection Title: Web Based Training for Pain Management Providers. Type of Information... effectiveness of the Web Based Training for Pain Management Providers, via the Web site PainAndAddiction...

Site-Based Management in a Collective Bargaining Environment: Can We Mix Oil and Water?

ERIC Educational Resources Information Center

Fossey, Richard

Site-based management has become a popular school reform strategy. However, conflicts can arise when school districts with collective bargaining try to implement site-based management. Site-based management depends on collaboration and cooperation among educators, both of which conflict with collective bargaining's adversarial nature. There is…

Evidence-based management - healthcare manager viewpoints.

PubMed

Janati, Ali; Hasanpoor, Edris; Hajebrahimi, Sakineh; Sadeghi-Bazargani, Homayoun

2018-06-11

Purpose Hospital manager decisions can have a significant impact on service effectiveness and hospital success, so using an evidence-based approach can improve hospital management. The purpose of this paper is to identify evidence-based management (EBMgt) components and challenges. Consequently, the authors provide an improving evidence-based decision-making framework. Design/methodology/approach A total of 45 semi-structured interviews were conducted in 2016. The authors also established three focus group discussions with health service managers. Data analysis followed deductive qualitative analysis guidelines. Findings Four basic themes emerged from the interviews, including EBMgt evidence sources (including sub-themes: scientific and research evidence, facts and information, political-social development plans, managers' professional expertise and ethical-moral evidence); predictors (sub-themes: stakeholder values and expectations, functional behavior, knowledge, key competencies and skill, evidence sources, evidence levels, uses and benefits and government programs); EBMgt barriers (sub-themes: managers' personal characteristics, decision-making environment, training and research system and organizational issues); and evidence-based hospital management processes (sub-themes: asking, acquiring, appraising, aggregating, applying and assessing). Originality/value Findings suggest that most participants have positive EBMgt attitudes. A full evidence-based hospital manager is a person who uses all evidence sources in a six-step decision-making process. EBMgt frameworks are a good tool to manage healthcare organizations. The authors found factors affecting hospital EBMgt and identified six evidence sources that healthcare managers can use in evidence-based decision-making processes.

Managing geometric information with a data base management system

NASA Technical Reports Server (NTRS)

Dube, R. P.

1984-01-01

The strategies for managing computer based geometry are described. The computer model of geometry is the basis for communication, manipulation, and analysis of shape information. The research on integrated programs for aerospace-vehicle design (IPAD) focuses on the use of data base management system (DBMS) technology to manage engineering/manufacturing data. The objectives of IPAD is to develop a computer based engineering complex which automates the storage, management, protection, and retrieval of engineering data. In particular, this facility must manage geometry information as well as associated data. The approach taken on the IPAD project to achieve this objective is discussed. Geometry management in current systems and the approach taken in the early IPAD prototypes are examined.

36 CFR § 1237.30 - How do agencies manage records on nitrocellulose-base and cellulose-acetate base film?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true How do agencies manage records on nitrocellulose-base and cellulose-acetate base film? § 1237.30 Section § 1237.30 Parks, Forests..., CARTOGRAPHIC, AND RELATED RECORDS MANAGEMENT § 1237.30 How do agencies manage records on nitrocellulose-base...

A Data-Based Financial Management Information System (FMIS) for Administrative Sciences Department

DTIC Science & Technology

1990-12-01

Financial Management Information System that would result in improved management of financial assets, better use of clerical skills, and more detailed...develops and implements a personal computer-based Management Information System for the Management of the many funding accounts controlled by the...different software programs, into a single all-encompassing Management Information System . The system was written using dBASE IV and is currently operational.

Social Networking as a Strategic Tool in the Management of School-Based Violence

ERIC Educational Resources Information Center

Eke, Chidi Idi; Singh, Shakila

2018-01-01

School-based violence is serious, and on the rise in South African schools. The violence affects learners, teachers, communities and the management of schools. Towards finding possible ways to manage school violence, this article presents social networking as a strategic tool in the management of school-based violence in high schools, based on the…

The Developmental Directions and Tasks of the School Based Curriculum Management System in Korea

ERIC Educational Resources Information Center

Kim, Soon Nam

2005-01-01

The purpose of this paper is to inquire into the developmental directions and tasks of the School Based Curriculum Management (SBCM) system. The concept of the School Based Curriculum Management can be considered as a subsystem to School Based Management. The logics behind the SBCM system are autonomy, accountability, effectiveness, creativity,…

Evidence-based financial management.

PubMed

Finkler, Steven A; Henley, Richard J; Ward, David M

2003-10-01

Like the practice of evidence-based medicine, evidence-based financial management can be used by providers to improve results. The concept provides a framework that managers and researchers can use to help direct efforts in gathering and using evidence to support management decisions in health care.

24 CFR 990.255 - Overview.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HOUSING OPERATING FUND PROGRAM Asset Management § 990.255 Overview. (a) PHAs shall manage their properties according to an asset management model, consistent with the management norms in the broader multi-family management industry. PHAs shall also implement project-based management, project-based budgeting, and project...

24 CFR 990.255 - Overview.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HOUSING OPERATING FUND PROGRAM Asset Management § 990.255 Overview. (a) PHAs shall manage their properties according to an asset management model, consistent with the management norms in the broader multi-family management industry. PHAs shall also implement project-based management, project-based budgeting, and project...

Healthcare managers' construction of the manager role in relation to the medical profession.

PubMed

von Knorring, Mia; Alexanderson, Kristina; Eliasson, Miriam A

2016-05-16

Purpose - The purpose of this paper is to explore how healthcare managers construct the manager role in relation to the medical profession in their organisations. Design/methodology/approach - In total, 18 of Sweden's 20 healthcare chief executive officers (CEOs) and 20 clinical department managers (CDMs) were interviewed about their views on management of physicians. Interviews were performed in the context of one aspect of healthcare management; i.e., management of physicians' sickness certification practice. A discourse analysis approach was used for data analysis. Findings - Few managers used a management-based discourse to construct the manager role. Instead, a profession-based discourse dominated and managers frequently used the attributes "physician" or "non-physician" to categorise themselves or other managers in their managerial roles. Some managers, both CEOs and CDMs, shifted between the management- and profession-based discourses, resulting in a kind of "yes, but […]" approach to management in the organisations. The dominating profession-based discourse served to reproduce the power and status of physicians within the organisation, thereby rendering the manager role weaker than the medical profession for both physician and non-physician managers. Research limitations/implications - Further studies are needed to explore the impact of gender, managerial level, and basic profession on how managers construct the manager role in relation to physicians. Practical implications - The results suggest that there is a need to address the organisational conditions for managers' role taking in healthcare organisations. Originality/value - Despite the general strengthening of the manager position in healthcare through political reforms during the last decades, this study shows that a profession-based discourse clearly dominated in how the managers constructed the manager role in relation to the medical profession on the workplace level in their organisations.

Adaptive capacity and community-based natural resource management.

PubMed

Armitage, Derek

2005-06-01

Why do some community-based natural resource management strategies perform better than others? Commons theorists have approached this question by developing institutional design principles to address collective choice situations, while other analysts have critiqued the underlying assumptions of community-based resource management. However, efforts to enhance community-based natural resource management performance also require an analysis of exogenous and endogenous variables that influence how social actors not only act collectively but do so in ways that respond to changing circumstances, foster learning, and build capacity for management adaptation. Drawing on examples from northern Canada and Southeast Asia, this article examines the relationship among adaptive capacity, community-based resource management performance, and the socio-institutional determinants of collective action, such as technical, financial, and legal constraints, and complex issues of politics, scale, knowledge, community and culture. An emphasis on adaptive capacity responds to a conceptual weakness in community-based natural resource management and highlights an emerging research and policy discourse that builds upon static design principles and the contested concepts in current management practice.

Evaluating the effects of ecosystem management: a case study in a Missouri Ozark forest

Treesearch

Wendy K. Gram; Victoria L. Sork; Robert J. Marquis; Rochelle B. Renken; Richard L. Clawson; et. al.

2002-01-01

Many federal and state management agencies have shifted from commodity-based management systems to multiple resource-based management systems that emphasize sustainable ecosystem management. Long-term sustainability of ecosystem functions and processes is at the core of ecosystem management, but a blueprint for assessing sustainability under different management...

Development of a Faith-Based Stress Management Intervention in a Rural African American Community.

PubMed

Bryant, Keneshia; Moore, Todd; Willis, Nathaniel; Hadden, Kristie

2015-01-01

Faith-based mental health interventions developed and implemented using a community-based participatory research (CBPR) approach hold promise for reaching rural African Americans and addressing health disparities. To describe the development, challenges, and lessons learned from the Trinity Life Management, a faith-based stress management intervention in a rural African American faith community. The researchers used a CBPR approach by partnering with the African American faith community to develop a stress management intervention. Development strategies include working with key informants, focus groups, and a community advisory board (CAB). The community identified the key concepts that should be included in a stress management intervention. The faith-based "Trinity Life Management" stress management intervention was developed collaboratively by a CAB and an academic research team. The intervention includes stress management techniques that incorporate Biblical principles and information about the stress-distress-depression continuum.

Decorative Integration or Relevant Learning? A Literature Review of Studio Arts-Based Management Education with Recommendations for Teaching and Research

ERIC Educational Resources Information Center

Katz-Buonincontro, Jen

2015-01-01

This review presents a synthesis of the state of arts-based management education scholarship, with teaching and research recommendations. To begin, the lack of creativity and empathy development in management students is presented. Next, literature-based descriptions of arts-based management exercises focus on how to use improvisational theatre,…

Lessons about Cash and Manager Priorities

ERIC Educational Resources Information Center

Mong, Donald

2013-01-01

Experienced managers know that cash affects virtually every aspect of a company's strategy and operations. Business students and new managers, however, sometimes lose sight of the importance of cash amidst the details of accrual-based accounting courses, formula-based finance courses, and production-based management courses. We therefore use…

Management Principles to be Considered for Implementing a Data Base Management System Aboard U.S. (United States) Naval Ships under the Shipboard Non-Tactical ADP (Automated Data Processing) Program.

DTIC Science & Technology

1982-12-01

Data Base Management System Aboard U.S. Naval Ships Under the Shipboard Non-tactical ADP Program by Robert Harrison Dixon December 1982 Thesis Advisor...OF REPORT a PERIOD COVIAOtt Management Principles to be Considered for Master’s Thesis Implementing a Data Base Management System December 1982 Aboard...NOTES is. KEY s0mas (Coelte on revrs side of 0..e..mp am iNe or "Neo 00111) Data Base Management System , DBMS, SNAP, SNAP I, SNAP II, Information

Family vs Village-Based: Intangible View on the Sustainable of Seaweed Farming

NASA Astrophysics Data System (ADS)

Teniwut, Wellem A.; Teniwut, Yuliana K.; Teniwut, Roberto M. K.; Hasyim, Cawalinya L.

2017-10-01

Compare to other fishery activities for instance fish mariculture and catching fisheries, seaweed farming is considered easier. Also, the market for seaweed is wider and will keep growing. Thus, makes seaweed farming as one of the fastest commodity to improve the welfare of a coastal community. There are technical and non-technical factors in seaweed farming management, for non-technical on this intangible factors vary between family-based and village-based management, therefore aimed of this study was to simulate farmers decision to choose between family-based and village-based on seaweed managing system trigger by intangible factors. We conducted our study in Southeast Maluku, data collecting conducted from October to December 2016 by depth interview and questionnaires on seaweed farmers. We used logistic regression to compare each intangible factors on family and village-based seaweed farming management. The result showed that for family-based management farmers were willing to transfer their knowledge among each member in the household. For village-based revealed that farmers with higher education background tend to work on village-based, also, the result also stated that in village-based management member were those who have better capability and skill, at the same time village-based management had a small probability for conflict to occur compared to family-based.

Unified web-based network management based on distributed object orientated software agents

NASA Astrophysics Data System (ADS)

Djalalian, Amir; Mukhtar, Rami; Zukerman, Moshe

2002-09-01

This paper presents an architecture that provides a unified web interface to managed network devices that support CORBA, OSI or Internet-based network management protocols. A client gains access to managed devices through a web browser, which is used to issue management operations and receive event notifications. The proposed architecture is compatible with both the OSI Management reference Model and CORBA. The steps required for designing the building blocks of such architecture are identified.

The influence of environmental conditions on safety management in hospitals: a qualitative study.

PubMed

Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

2018-05-02

Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced approach is required. A strong focus on control-based management generates extrinsic motivation in employees but may, at the same time, undermine or even diminish intrinsic motivation to work on patient safety. Emphasising commitment-based management may, in contrast, strengthen intrinsic motivation but increases the risk of priorities being set elsewhere. Currently, external pressures frequently lead to the adoption of control-based management. A balanced approach requires a shift towards more trust-based safety demands.

MST radar data-base management

NASA Technical Reports Server (NTRS)

Wickwar, V. B.

1983-01-01

Data management for Mesospheric-Stratospheric-Tropospheric, (MST) radars is addressed. An incoherent-scatter radar data base is discussed in terms of purpose, centralization, scope, and nature of the data base management system.

24 CFR 990.275 - Project-based management (PBM).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Project-based management (PBM). 990... URBAN DEVELOPMENT THE PUBLIC HOUSING OPERATING FUND PROGRAM Asset Management § 990.275 Project-based... of rental housing at the project level. Under PBM, these property management services are arranged...

CAD/CAM data management

NASA Technical Reports Server (NTRS)

Bray, O. H.

1984-01-01

The role of data base management in CAD/CAM, particularly for geometric data is described. First, long term and short term objectives for CAD/CAM data management are identified. Second, the benefits of the data base management approach are explained. Third, some of the additional work needed in the data base area is discussed.

24 CFR 990.275 - Project-based management (PBM).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Project-based management (PBM). 990... URBAN DEVELOPMENT THE PUBLIC HOUSING OPERATING FUND PROGRAM Asset Management § 990.275 Project-based... of rental housing at the project level. Under PBM, these property management services are arranged...

24 CFR 990.275 - Project-based management (PBM).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Project-based management (PBM). 990... URBAN DEVELOPMENT THE PUBLIC HOUSING OPERATING FUND PROGRAM Asset Management § 990.275 Project-based... of rental housing at the project level. Under PBM, these property management services are arranged...

24 CFR 990.275 - Project-based management (PBM).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Project-based management (PBM). 990... URBAN DEVELOPMENT THE PUBLIC HOUSING OPERATING FUND PROGRAM Asset Management § 990.275 Project-based... of rental housing at the project level. Under PBM, these property management services are arranged...

24 CFR 990.275 - Project-based management (PBM).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Project-based management (PBM). 990... URBAN DEVELOPMENT THE PUBLIC HOUSING OPERATING FUND PROGRAM Asset Management § 990.275 Project-based... of rental housing at the project level. Under PBM, these property management services are arranged...

20 CFR 670.515 - What responsibilities do the center operators have in managing work-based learning?

Code of Federal Regulations, 2010 CFR

2010-04-01

... have in managing work-based learning? 670.515 Section 670.515 Employees' Benefits EMPLOYMENT AND... managing work-based learning? (a) The center operator must emphasize and implement work-based learning... arrangements with employers. Work-based learning must be under actual working conditions and must be designed...

Educators' Self-Reported Training, Use, and Perceived Effectiveness of Evidence-Based Classroom Management Practices

ERIC Educational Resources Information Center

Cooper, Justin T.; Gage, Nicholas A.; Alter, Peter J.; LaPolla, Stefanie; MacSuga-Gage, Ashley S.; Scott, Terrance M.

2018-01-01

A survey study of 248 educators in four states was conducted to identify respondents' formal training, use, and perceived effectiveness of 37 evidence-based classroom management practices within four general categories: (a) antecedent-based, (b) instructionally based, (c) consequence-based, and (d) self-management. Results indicated that, on…

20 CFR 670.515 - What responsibilities do the center operators have in managing work-based learning?

Code of Federal Regulations, 2011 CFR

2011-04-01

... have in managing work-based learning? 670.515 Section 670.515 Employees' Benefits EMPLOYMENT AND... managing work-based learning? (a) The center operator must emphasize and implement work-based learning... arrangements with employers. Work-based learning must be under actual working conditions and must be designed...

Improving The Quality of Education through School-Based Management: Learning from International Experiences

ERIC Educational Resources Information Center

De Grauwe, Anton

2005-01-01

School-based management is being increasingly advocated as a shortcut to more efficient management and quality improvement in education. Research, however, has been unable to prove conclusively such a linkage. Especially in developing countries, concerns remain about the possible detrimental impact of school-based management on school quality;…

75 FR 29307 - Web Based Supply Chain Management Commodity Offer Form, Paperwork Collection Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-25

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No FV10-CP-01, AMS-FV-10-0041] Web... collection request is required for the implementation of a new system named Web Based Supply Chain Management...-2782. Mail: David Tuckwiller, Project Manager, Web Based Supply Chain Management System, Agricultural...

Leave islands as refugia for low-mobility species in managed forest mosaics

Treesearch

Stephanie J. Wessell-Kelly; Deanna H. Olson

2013-01-01

In recent years, forest management in the Pacifi c Northwest has shifted from one based largely on resource extraction to one based on ecosystem management principles. Forest management based on these principles involves simultaneously balancing and sustaining multiple forest resource values, including silvicultural, social, economic, and ecological objectives. Leave...

Information-based management mode based on value network analysis for livestock enterprises

NASA Astrophysics Data System (ADS)

Liu, Haoqi; Lee, Changhoon; Han, Mingming; Su, Zhongbin; Padigala, Varshinee Anu; Shen, Weizheng

2018-01-01

With the development of computer and IT technologies, enterprise management has gradually become information-based management. Moreover, due to poor technical competence and non-uniform management, most breeding enterprises show a lack of organisation in data collection and management. In addition, low levels of efficiency result in increasing production costs. This paper adopts 'struts2' in order to construct an information-based management system for standardised and normalised management within the process of production in beef cattle breeding enterprises. We present a radio-frequency identification system by studying multiple-tag anti-collision via a dynamic grouping ALOHA algorithm. This algorithm is based on the existing ALOHA algorithm and uses an improved packet dynamic of this algorithm, which is characterised by a high-throughput rate. This new algorithm can reach a throughput 42% higher than that of the general ALOHA algorithm. With a change in the number of tags, the system throughput is relatively stable.

Statutory Regulation of Traditional Medicine Practitioners and Practices: The Need for Distinct Policy Making Guidelines.

PubMed

Ijaz, Nadine; Boon, Heather

2018-04-01

The World Health Organization (WHO) has called for the increased statutory regulation of traditional and complementary medicine practitioners and practices, currently implemented in about half of nations surveyed. According to recent WHO data, however, the absence of policy guidelines in this area represents a significant barrier to implementation of such professional regulations. This commentary reviews several key challenges that distinguish the statutory regulation of traditional medicine practitioners and practices from biomedical professional regulation, providing a foundation for the development of policy making parameters in this area. Foremost in this regard are the ongoing impacts of the European colonial encounter, which reinforce biomedicine's disproportionate political dominance across the globe despite traditional medicine's ongoing widespread use (particularly in the global South). In this light, the authors discuss the conceptual and historical underpinnings of contemporary professional regulatory structures, the tensions between institutional and informal traditional medicine training pathways, and the policy challenges presented by the prospect of standardizing internally diverse indigenous healing approaches. Epistemic and evidentiary tensions, as well as the policy complexities surrounding the intersection of cultural and clinical considerations, present additional challenges to regulators. Conceptualizing professional regulation as an intellectual property claim under the law, the authors further consider what it means to protect traditional knowledge and prevent misappropriation in this context. Overall, the authors propose that innovative professional regulatory approaches are needed in this area to address safety, quality of care, and accessibility as key public interest concerns, while prioritizing the redress of historical inequities, protection of diverse indigenous knowledges, and delivery of care to underserved populations.

Just a Collection of Recollections: Clinical Ethics Consultation and the Interplay of Evaluating Voices.

PubMed

Bartlett, Virginia L; Bliton, Mark J; Finder, Stuart G

2016-12-01

Despite increased attention to the question of how best to evaluate clinical ethics consultations and emphasis on external evaluation (Hastings Center Report, ASBH Quality Attestation Process), there has been little sustained focus on how we, as clinicians, make sense of and learn from our own experiences in the midst of any one consultation. Questions of how we evaluate the request for, unfolding of, and conclusion of any specific ethics consultation are often overlooked, along with the underlying question of whether it is possible to give an accurate account of clinical ethics consultants' experience as experienced by ethics consultants. Before the challenge of submitting one's accounts or case reports for review and evaluation from others (at one's local institution or in the broader field), there is an underlying challenge of understanding and evaluating our own accounts. To highlight this crucial and deeply challenging dimension of actual clinical ethics practice, we present an account of a complex consultation, explicitly constructed to engage the reader in the unfolding experience of the consultant by emphasizing the multiple perspectives unfolding within the consultant's experience. Written in script format, the three perspectives presented-prototypical clinically descriptive account; didactically reflective and self-evidentiary account often seen in journal presentations; highly self-critical reflective account emphasizing uncertainties inherent to clinical ethics practice-reflect different manners for responding to the ways actual clinical involvement in ethics consultation practice accentuates and refocuses the question of how to understand and evaluate our own work, as well as that of our colleagues.

Complementary medicines (herbal and nutritional products) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD): a systematic review of the evidence.

PubMed

Sarris, Jerome; Kean, James; Schweitzer, Isaac; Lake, James

2011-08-01

Complementary and Alternative Medicines (CAMs) are frequently given to children and adolescents for reputed benefits in the treatment of hyperkinetic and concentration disorders such as Attention Deficit Hyperactivity Disorder (ADHD). In such vulnerable populations high quality evidence is required to support such claims. The aim of the paper is to assess the current evidence of herbal and nutritional interventions for ADHD using a systematic search of clinical trials meeting an acceptable standard of evidence. PubMed, PsycINFO, Cochrane Library and CINAHL were searched up to May 26th, 2011 for randomised, controlled clinical trials using CAM products as interventions to treat ADHD. A quality analysis using a purpose-designed scale, and an estimation of effect sizes (Cohen's d) where data were available, were also calculated. The review revealed that 16 studies met inclusion criteria, with predominant evidentiary support found for zinc, iron, Pinus marinus (French maritime pine bark), and a Chinese herbal formula (Ningdong); and mixed (mainly inconclusive) evidence for omega-3, and l-acetyl carnitine. Current data suggest that Ginkgo biloba (ginkgo), and Hypercium perforatum (St. John's wort) are ineffective in treating ADHD. The research suggests only some CAMs may be beneficial in ADHD, thus clinicians need to be aware of the current evidence. Promising candidates for future research include Bacopa monniera (brahmi) and Piper methysticum (kava), providing potential efficacy in improving attentional and hyperkinetic disorders via a combination of cognitive enhancing and sedative effects. Copyright © 2011 Elsevier Ltd. All rights reserved.

THE CALIFORNIA MEDICAL MALPRACTICE PICTURE

PubMed Central

Rubsamen, David S.

1963-01-01

The California physician's steadily increasing risk of legal liability poses a basic question: Will he ultimately wind up a guarantor of results, carrying a great burden of malpractice insurance in order to pay for every untoward result of medical treatment? This alarming prospect is the result of many years of judicial (and therefore lay) speculation on the legal significance of the injury which brings the patient into court. Does it look as though this injury probably is associated with medical negligence? If so, let the doctor explain. And the explanation must be very complete. The legal instrument which thus reverses the traditional requirements of proof, permitting the patient-plaintiff to remain silent while the doctor-defendant must exculpate himself, is an evidentiary doctrine called res ipsa loquitur—the thing speaks for itself. The application of the doctrine relieves the patient-plaintiff of the necessity of producing an expert witness to point the finger and say, “The medical conduct that produced this injury was sub-standard.” The increased use of the doctrine reflects a judicial conviction that in many parts of California physicians refuse to testify for the patient-plaintiff regardless of the merit to his case. A recent California Supreme Court decision suggests that the Court is not unaware of the adverse social consequences implicit in the irrational expansion of the physician's risk of legal liability. But a reversal of this trend would seem to be contingent on positive conduct from the medical profession in California—conduct demonstrating that no meritorious patient-plaintiff will fail in his malpractice lawsuit for lack of an expert medical witness. PMID:14081771

SOCIO-ETHICAL ISSUES IN PERSONALIZED MEDICINE: A SYSTEMATIC REVIEW OF ENGLISH LANGUAGE HEALTH TECHNOLOGY ASSESSMENTS OF GENE EXPRESSION PROFILING TESTS FOR BREAST CANCER PROGNOSIS.

PubMed

Ali-Khan, Sarah E; Black, Lee; Palmour, Nicole; Hallett, Michael T; Avard, Denise

2015-01-01

There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration. A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis. Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. "Classical" ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients' risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly. Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems.

Capacity Evaluations of Psychiatric Patients Requesting Assisted Death in the Netherlands

PubMed Central

Doernberg, Samuel N.; Peteet, John R.; Kim, Scott Y.H.

2016-01-01

Objective Euthanasia or physician-assisted suicide (EAS) of psychiatric patients is legal in some countries but remains controversial. This study examined a frequently raised concern about the practice: how physicians address the issue of decision-making capacity of persons requesting psychiatric EAS. Methods A review of psychiatric EAS case summaries published by the Dutch Regional Euthanasia Review Committees. Directed content analysis using a capacity-specific 4 abilities model (understanding of facts, applying those facts to self, weighing/reasoning, and evidencing choice) was used to code texts discussing capacity. 66 cases from 2011-2014 were reviewed. Results In 55% (36 of 66) of cases the capacity-specific discussion consisted of only global judgments of patients’ capacity, even in patients with psychotic disorders. 32% (21 of 66) of cases included evidentiary statements regarding capacity-specific abilities; only 5 cases (8%) mentioned all four abilities. Physicians frequently stated that psychosis or depression did or did not impact capacity but provided little explanation regarding their judgments. Physicians in 8 cases (12%) disagreed about capacity; even when no explanation is given for the disagreement, the review committees generally accepted the judgment of the physician performing EAS. In one case, the physicians noted that not all capacity-specific abilities were intact but deemed the patient capable. Conclusion Case summaries of psychiatric EAS in the Netherlands do not show that a high threshold of capacity is required for granting EAS. Although this may reflect limitations in documentation, it likely represents a practice that reflects the normative position of the review committees. PMID:27590345

Prevalence of human cell material: DNA and RNA profiling of public and private objects and after activity scenarios.

PubMed

van den Berge, M; Ozcanhan, G; Zijlstra, S; Lindenbergh, A; Sijen, T

2016-03-01

Especially when minute evidentiary traces are analysed, background cell material unrelated to the crime may contribute to detectable levels in the genetic analyses. To gain understanding on the composition of human cell material residing on surfaces contributing to background traces, we performed DNA and mRNA profiling on samplings of various items. Samples were selected by considering events contributing to cell material deposits in exemplary activities (e.g. dragging a person by the trouser ankles), and can be grouped as public objects, private samples, transfer-related samples and washing machine experiments. Results show that high DNA yields do not necessarily relate to an increased number of contributors or to the detection of other cell types than skin. Background cellular material may be found on any type of public or private item. When a major contributor can be deduced in DNA profiles from private items, this can be a different person than the owner of the item. Also when a specific activity is performed and the areas of physical contact are analysed, the "perpetrator" does not necessarily represent the major contributor in the STR profile. Washing machine experiments show that transfer and persistence during laundry is limited for DNA and cell type dependent for RNA. Skin conditions such as the presence of sebum or sweat can promote DNA transfer. Results of this study, which encompasses 549 samples, increase our understanding regarding the prevalence of human cell material in background and activity scenarios. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Statutory Regulation of Traditional Medicine Practitioners and Practices: The Need for Distinct Policy Making Guidelines

PubMed Central

Boon, Heather

2018-01-01

Abstract The World Health Organization (WHO) has called for the increased statutory regulation of traditional and complementary medicine practitioners and practices, currently implemented in about half of nations surveyed. According to recent WHO data, however, the absence of policy guidelines in this area represents a significant barrier to implementation of such professional regulations. This commentary reviews several key challenges that distinguish the statutory regulation of traditional medicine practitioners and practices from biomedical professional regulation, providing a foundation for the development of policy making parameters in this area. Foremost in this regard are the ongoing impacts of the European colonial encounter, which reinforce biomedicine's disproportionate political dominance across the globe despite traditional medicine's ongoing widespread use (particularly in the global South). In this light, the authors discuss the conceptual and historical underpinnings of contemporary professional regulatory structures, the tensions between institutional and informal traditional medicine training pathways, and the policy challenges presented by the prospect of standardizing internally diverse indigenous healing approaches. Epistemic and evidentiary tensions, as well as the policy complexities surrounding the intersection of cultural and clinical considerations, present additional challenges to regulators. Conceptualizing professional regulation as an intellectual property claim under the law, the authors further consider what it means to protect traditional knowledge and prevent misappropriation in this context. Overall, the authors propose that innovative professional regulatory approaches are needed in this area to address safety, quality of care, and accessibility as key public interest concerns, while prioritizing the redress of historical inequities, protection of diverse indigenous knowledges, and delivery of care to underserved populations. PMID:29359948

Electronic cigarettes. A position statement of the forum of international respiratory societies.

PubMed

Schraufnagel, Dean E; Blasi, Francesco; Drummond, M Bradley; Lam, David C L; Latif, Ehsan; Rosen, Mark J; Sansores, Raul; Van Zyl-Smit, Richard

2014-09-15

Awareness and usage of electronic cigarettes has exponentially increased during the last few years, especially among young people and women in some countries. The rapid acceptance of electronic cigarettes may be attributed in part to the perception created by marketing and the popular press that they are safer than combustible cigarettes. To alert and advise policy makers about electronic cigarettes and their potential hazards. Using The Union's position paper on electronic cigarettes as the starting template, the document was written using an iterative process. Portions of the manuscript have been taken directly from the position papers of participating societies. Because electronic cigarettes generate less tar and carcinogens than combustible cigarettes, use of electronic cigarettes may reduce disease caused by those components. However, the health risks of electronic cigarettes have not been adequately studied. Studies looking at whether electronic cigarettes can aid smoking cessation have had inconsistent results. Moreover, the availability of electronic cigarettes may have an overall adverse health impact by increasing initiation and reducing cessation of combustible nicotine delivery products. The health and safety claims regarding electronic nicotine delivery devices should be subject to evidentiary review. The potential benefits of electronic cigarettes to an individual smoker should be weighed against potential harm to the population of increased social acceptability of smoking and use of nicotine, the latter of which has addictive power and untoward effects. As a precaution, electronic nicotine delivery devices should be restricted or banned until more information about their safety is available. If they are allowed, they should be closely regulated as medicines or tobacco products.