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Susanne Wieschowski, William Wei Lim Chin, Carole Federico, Sören Sievers, Jonathan Kimmelman, Daniel Strech
Human protection policies require favorable risk-benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures [IBs]) presented for ethics review for phase I and II trials to assess the content and properties of PCESs contained in them. Using a sample of 109 IBs most recently approved at 3 institutional review boards based at German Medical Faculties between the years 2010-2016, we identified 708 unique PCESs...
April 2018: PLoS Biology
Constantin Streche, Diana Mariana Cocârţă, Irina-Aura Istrate, Adrian Alexandru Badea
Currently, there are different remediation technologies for contaminated soils, but the selection of the best technology must be not only the treatment efficiency but also the energy consumption (costs) during its application. This paper is focused on assessing energy consumption related to the electrochemical treatment of polluted soil with petroleum hydrocarbons. In the framework of a research project, two types of experiments were conducted using soil that was artificially contaminated with diesel fuel at the same level of contamination...
February 19, 2018: Scientific Reports
Stuart McLennan, Hannes Kahrass, Susanne Wieschowski, Daniel Strech, Holger Langhof
Purpose: To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). Data sources: The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. Study selection: The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict...
April 1, 2018: International Journal for Quality in Health Care
Kimberly A Mc Cord, Rustam Al-Shahi Salman, Shaun Treweek, Heidi Gardner, Daniel Strech, William Whiteley, John P A Ioannidis, Lars G Hemkens
BACKGROUND: Routinely collected health data (RCD) are increasingly used for randomized controlled trials (RCTs). This can provide three major benefits: increasing value through better feasibility (reducing costs, time, and resources), expanding the research agenda (performing trials for research questions otherwise not amenable to trials), and offering novel design and data collection options (e.g., point-of-care trials and other designs directly embedded in routine care). However, numerous hurdles and barriers must be considered pertaining to regulatory, ethical, and data aspects, as well as the costs of setting up the RCD infrastructure...
January 11, 2018: Trials
Marcel Mertz, Daniel Strech, Hannes Kahrass
BACKGROUND: (Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available...
December 19, 2017: Systematic Reviews
Stuart McLennan, Daniel Strech, Andrea Meyer, Hannes Kahrass
BACKGROUND: Physician rating websites (PRWs) allow patients to rate, comment, and discuss physicians' quality. The ability of PRWs to influence patient decision making and health care quality is dependent, in part, on sufficient awareness and usage of PRWs. However, previous studies have found relatively low levels of awareness and usage of PRWs, which has raised concerns about the representativeness and validity of information on PRWs. OBJECTIVE: The objectives of this study were to examine (1) participants' awareness, use, and contribution of ratings on PRWs and how this compares with other rating websites; (2) factors that predict awareness, use, and contribution of ratings on PRWs; and (3) participants' attitudes toward PRWs in relation to selecting a physician...
November 9, 2017: Journal of Medical Internet Research
Lucas de Paula Oliveira, Luiz Henrique Palucci Vieira, Rodrigo Aquino, João Paulo Vieira Manechini, Paulo Roberto Pereira Santiago, Enrico Fuini Puggina
The aim of the present study was to compare the acute effects of active (AC), ballistic (BA), passive (PA), proprioceptive neuromuscular facilitation stretching (PNF) methods on performance in vertical jumping, sit and reach, and sprinting in young soccer players. Twelve trained soccer players (17.67 ± 0.87 years) participated in the study. The jump height (H), peak power (PP), and relative power (RP) in the squat jump (SJ) and countermovement jump (CMJ), the range of motion (ROM), the rate of perceived exertion (RPE), and time (s) in 10-20-30 m sprints were evaluated...
October 27, 2017: Journal of Strength and Conditioning Research
Sabine Bossert, Daniel Strech
BACKGROUND: The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. METHODS: In this paper, we will outline and systematize some of these challenges...
October 17, 2017: Trials
Stuart McLennan, Daniel Strech, Swantje Reimann
BACKGROUND: Physician rating websites (PRWs) have been developed to allow all patients to rate, comment, and discuss physicians' quality online as a source of information for others searching for a physician. At the beginning of 2010, a sample of 298 randomly selected physicians from the physician associations in Hamburg and Thuringia were searched for on 6 German PRWs to examine the frequency of ratings and evaluation tendencies. OBJECTIVE: The objective of this study was to examine (1) the number of identifiable physicians on German PRWs; (2) the number of rated physicians on German PRWs; (3) the average and maximum number of ratings per physician on German PRWs; (4) the average rating on German PRWs; (5) the website visitor ranking positions of German PRWs; and (6) how these data compare with 2010 results...
August 25, 2017: Journal of Medical Internet Research
Hannes Kahrass, Daniel Strech, Marcel Mertz
OBJECTIVES: Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. METHODS: Literature was searched in Medline, EBSCO and others...
December 2017: International Journal of Public Health
Kiwoo Jun, Donggyu Kim, Seunghwa Ryu, Il-Kwon Oh
Interest in soft actuators for next-generation electronic devices, such as wearable electronics, haptic feedback systems, rollable flexible displays, and soft robotics, is rapidly growing. However, for more practical applications in diverse electronic devices, soft actuators require multiple functionalities including anisotropic actuation in three-dimensional space, active tactile feedback, and controllable wettability. Herein, we report anisotropic dielectric elastomer actuators with uni- and bi-axially wrinkled carbon black electrodes that are formed through pre-streching and relaxation processes...
July 20, 2017: Scientific Reports
Corinna Klingler, Diego Steven Silva, Christopher Schuermann, Andreas Alois Reis, Abha Saxena, Daniel Strech
BACKGROUND: Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent...
April 4, 2017: BMC Public Health
Holger Langhof, Hannes Kahrass, Sören Sievers, Daniel Strech
Access policies of biobanks specify the governance of sample and data sharing. Basic guidance on relevant access criteria exists, but so far little is known about their public availability and what criteria for access and prioritization they actually include. Access policies were gathered by hand searching the websites of biobanks identified via registries (eg, BBMRI and P3G), and by additional search strategies. Criteria for access and prioritization were synthesized by thematic analysis. Of 523 biobank websites screened, 9% included a publicly available access policy...
February 2017: European Journal of Human Genetics: EJHG
Susanne Wieschowski, Diego S Silva, Daniel Strech
Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs)...
November 2016: PLoS Biology
Marcel Mertz, Hannes Kahrass, Daniel Strech
BACKGROUND: Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed...
October 3, 2016: BMC Medicine
Holger Langhof, Jonas Lander, Daniel Strech
BACKGROUND: The European Union's (EU) Clinical Trials Directive was replaced by an EU-Regulation as of 2016. The policy revision process was subject to a formal impact assessment exercised by the European Commission (EC) from 2008 to 2014. Following the EU principles of Good Governance, deliberation with stakeholders was an integral part of this impact assessment and the policy formulation process. Hence, two public consultations (PCs) were held by the EC in 2009 and 2011, respectively...
September 17, 2016: Health Research Policy and Systems
Ansgar Gerhardus, Heiko Becher, Peter Groenewegen, Ulrich Mansmann, Thorsten Meyer, Holger Pfaff, Milo Puhan, Oliver Razum, Eva Rehfuess, Rainer Sauerborn, Daniel Strech, Frank Wissing, Hajo Zeeb, Eva Hummers-Pradier
Public health research is complex, involves various disciplines, epistemological perspectives and methods, and is rarely conducted in a controlled setting. Often, the added value of a research project lies in its inter- or trans-disciplinary interaction, reflecting the complexity of the research questions at hand. This creates specific challenges when writing and reviewing public health research grant applications. Therefore, the German Research Foundation (DFG), the largest independent research funding organization in Germany, organized a round table to discuss the process of writing, reviewing and funding public health research...
June 13, 2016: Health Research Policy and Systems
Sérgio Takeshi Tatsukawa DE Freitas, Elizângela Márcia DE Carvalho Abreu, Mariane Cecilia Dos Reis, Bruna DE Souza Cunha, Tamires Souza Moreira Prianti, Fernanda Pupio Silva Lima, Mário Oliveira Lima
Spasticity is one of the main causes of contracture, muscle weakness and subsequent functional incapacity. The passive static stretching can be included as having the purpose of increasing musculoskeletal flexibility, however, it also can influence the muscle torque. The objective is to verify the immediate effect of passive static stretching in the muscle strength of healthy and those who present spastic hemiparesis. There were assessed 20 subjects, 10 spastic hemiparetic (EG) and 10 healthy individuals (CG), including both sexes, aged between 22 and 78 years...
2016: Acta of Bioengineering and Biomechanics
D Strech, S Bein, M Brumhard, W Eisenmenger, C Glinicke, T Herbst, R Jahns, S von Kielmansegg, G Schmidt, J Taupitz, H D Tröger
BACKGROUND: Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust...
June 2016: European Journal of Medical Genetics
Jonas Lander, Tobias Hainz, Irene Hirschberg, Sabine Bossert, Daniel Strech
BACKGROUND: Public involvement activities (PIAs) may contribute to the governance of ethically challenging biomedical research and innovation by informing, consulting with and engaging the public in developments and decision-making processes. For PIAs to capture a population's preferences (e.g. on issues in whole genome sequencing, biobanks or genome editing), a central methodological requirement is to involve a sufficiently representative subgroup of the general public. While the existing literature focusses on theoretical and normative aspects of 'representation', this study assesses empirically how such considerations are implemented in practice...
2016: Public Health Genomics
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