A strategy for minimising the time and obstacles to accessing systematic reviews of health system evidence is to collect them in a freely available database and make them easy to find through a simple ‘Google-style’ search interface. PDQ-Evidence was developed in this way. The objective of this study was to compare PDQ-Evidence to six other databases, namely Cochrane Library, EVIPNet VHL, Google Scholar, Health Systems Evidence, PubMed and Trip.We recruited healthcare policy-makers, managers and health researchers in low-, middle- and high-income countries. Participants selected one of six pre-determined questions. They searched for a systematic review that addressed the chosen question and one question of their own in PDQ-Evidence and in two of the other six databases which they would normally have searched. We randomly allocated participants to search PDQ-Evidence first or to search the two other databases first. The primary outcomes were whether a systematic review was found and the time taken to find it. Secondary outcomes were perceived ease of use and perceived time spent searching. We asked open-ended questions about PDQ-Evidence, including likes, dislikes, challenges and suggestions for improvements.A total of 89 people from 21 countries completed the study; 83 were included in the primary analyses and 6 were excluded because of data errors that could not be corrected. Most participants chose PubMed and Cochrane Library as the other two databases. Participants were more likely to find a systematic review using PDQ-Evidence than using Cochrane Library or PubMed for the pre-defined questions. For their own questions, this difference was not found. Overall, it took slightly less time to find a systematic review using PDQ-Evidence. Participants perceived that it took less time, and most participants perceived PDQ-Evidence to be slightly easier to use than the two other databases. However, there were conflicting views about the design of PDQ-Evidence.PDQ-Evidence is at least as efficient as other databases for finding health system evidence. However, using PDQ-Evidence is not intuitive for some people.ISRCTN12742235.The trial was prospectively registered in the ISRCTN registry 17 April 2015. Registration number: The online version of this article (10.1186/s12961-018-0299-8) contains supplementary material, which is available to authorized users. Research evidence is essential, although insufficient for making well-informed decisions about health systems. Nevertheless, healthcare policy-makers, managers and those who support them have limited time and resources to access research when it is needed and may resort to selective use of research, such as relying on the results of primary studies rather than a more comprehensive and reliable body of evidence , 2.Systematic reviews have the potential to save policy-makers and their staff the time it takes to retrieve, evaluate and synthesise results from many primary studies. Overviews of systematic reviews, where these exist, can be even more time saving, and both these document types help avoid selective use of research results. However, despite the steady increase of synthesised evidence for making well-informed decisions about health systems, many decision-makers still lack access to, awareness of, and familiarity with systematic reviews and overviews of reviews .A number of existing databases and search engines provide access to systematic reviews. Cochrane Library, EVIPNet VHL, Google Scholar, Health Systems Evidence, PubMed, PDQ-Evidence and Trip, all provide access to systematic reviews that can inform healthcare decisions about how to organise, finance and govern health systems, and strategies for implementing changes. However, the comprehensiveness and ease of use differ across these resources. One strategy for minimising time and obstacles to accessing systematic reviews and overviews of reviews for policy-makers is to collect these documents in a freely available single source, and make them easy to find, through a simple ‘Google-style’ search interface. PDQ-Evidence was developed in this way to provide rapid and easy access to the best available evidence for decisions about health systems.PDQ-Evidence is intended for anyone who seeks evidence to inform health system decisions. It was launched in 2012, and is a database that facilitates rapid access to the best available evidence for decisions about health systems. PDQ-Evidence includes the four topics of delivery arrangements, financial arrangements, governance arrangements and implementation strategies. It also included evidence for decisions about public (population) health up until 2016, but no longer does. It was developed and is currently maintained by having searched the list of sources reported in Box 1, using the search strategies reported in Additional file Box 1. PDQ-Evidence previously searched the following databases. Please see the PDQ-Evidence website for an updated list of databases currently being searchedPDQ-Evidence has the same functionalities as Epistemonikos, from which PDQ-Evidence is derived. As of Febuary 2018, PDQ-Evidence includes about 4500 records. Epistemonikos has a broader scope and includes over 200,000 systematic reviews, predominantly on clinical topics. A central and unique feature of both of these databases is the connection they provide between systematic reviews, overviews and the primary studies that are included in these reviews. While the main focus is to provide access to systematic reviews through a multilingual search, these connections provide a highly efficient method for searching across various document types that relate to the same topic, like primary studies included in reviews and reviews included in overviews. Once a relevant title is located, it is easy to move upward to more synthesised evidence, a systematic review or an overview, or to move downward to investigate each primary study that is included in a systematic review  to access the evidence.For simple searches, the current design of PDQ-Evidence is modelled after a ‘Google-style’ single search field. In addition, an advanced search function enables searching in specific fields – Results are presented as records in English. Each record includes information on document type, title, authors, journal, year, link to full text and information/links to connected documents (e.g. ‘This article includes 59 Primary studies’).The abstract can also be viewed directly from the results list by clicking on an arrow on the right side of a record Fig. . The seaPDQ-Evidence is a work in progress, with planned improvements including further work on translations, save searches, automatic updates, print and email search results or abstracts, browsing functions, filtering by country or groups of countries, further developments of the matrix functionality and notifications of new evidence. Being a work in progress, PDQ-Evidence may, at the time of publication, differ from how we have described it in this evaluation.Gabriel Rada, Evidence-Based Health Care Program, Pontificia Universidad Católica de Chile. Director of Epistemonikos ProjectDaniel Pérez, CTO Epistemonikos and other members of the Epistemonikos teamSusan Munabi Babigumira, Simon Lewin, Jenny Moberg, Andy Oxman, Sarah Rosenbaum, Global Health Cluster Norwegian Institute of Public HealthShaun Treweek, Health Services Research Unit, University of Aberdeen, ScotlandThe following people have contributed to the development of PDQ-Evidence:Most of the technical developments rely on the software and collaborators of the Epistemonikos project . InitialWe recruited a convenience sample of participants. Members of the Supporting Use of Research Evidence (SURE) collaboration, the Evidence-Informed Health Policy Network (EVIPNet), and the Cochrane review group Effective Practice and Organisation of Care (EPOC) identified and recruited healthcare policy-makers, managers and health researchers to evaluate the PDQ-Evidence database.To evaluate PDQ-Evidence, participants searched for systematic reviews in PDQ-Evidence and we compared its performance to searches for systematic reviews in the three databases and three search engines  described below.Cochrane Library is a collection of seven databases where six of the seven contain different types of high-quality, independent evidence to inform healthcare decision-making.The EVIPNet Virtual Health Library supports country teams in evidence-informed health policy-making and provides evidence and tools for the activities of knowledge translation platforms, particularly in low- and middle-income countries.Google Scholar provides a simple way to broadly search for scholarly literature.Health Systems Evidence is a continuously updated repository of syntheses of research evidence about governance, financial and delivery arrangements within health systems, and about implementation strategies that can support change in health systems.PubMed comprises more than 28 million citations for biomedical literature from MEDLINE, life science journals and online books.Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice or care.All participants were asked to search three databases – PDQ-Evidence and two of the six databases listed above in which they would normally have searched or which they believe would be most likely to enable them to quickly find a relevant review. To avoid ‘learning bias’ we randomised the search order of the databases. Either PDQ-Evidence was searched first and then the two self-selected databases in any order as the second and third database, or PDQ-Evidence was searched last after the two selected databases in any order as the first and second database.All participants were asked to try to find an answer to two health system questions in all three databases. Participants were asked to search for one predefined question and one question of their choice ? For the comparison databases (the two databases selected by the participants) this outcome was defined as: “Was a systematic review that addresses the question found in either of the two databases?”Time taken to find a systematic review that addresses the question3.Ease of use (from very difficult to very easy)Time spent on searching (from much too much time to very little time)Assessments of the databases with four response options:4.Likes5.Dislikes6.Challenges7.Suggestions for improvementsAdditional outcomes We used SurveyGizmo to collect data. A printed version of the questionnaire that we used can be found in Additional file All quantitative analyses of the primary outcomes were conducted separately for the predefined question and the question chosen by the participants themselves. Data for the first outcome (whether a review was found) were analysed using McNemar’s test for agreement between paired frequencies by comparing the proportion of searches that yield a relevant answer to the question. Data for the second outcome (time taken to find a review) were analysed using Generalised Estimation Equations allowing for repeated observations  for each participant; the link-function was the identity  and the database used was an independent variable (PDQ-Evidence was the reference to which the other databases were compared) in the model. The main analyses included only participants that found a systematic review that answered the question. Sensitivity analyses including all participants were performed, where the time was set to 10 minutes for all databases if a relevant systematic review was not found.We compiled all the comments received in response to the secondary outcomes and prepared a table summarising these.We calculated the sample size based on McNemar’s test for agreement using Miettinen’s approximation to the normal distribution. We wanted to be able to detect a difference compared to finding the answer to the predefined question in PDQ-Evidence of at least 20 percentage points, with a power of 80%, and α = 0.05. We assumed a 50/50 chance of participants finding the answer to a predefined question in at least one of the databases they selected. We also assumed that the binary correlation of the results from the sources searched (PDQ-Evidence and the two self-selected databases) was 0 .Based on these assumptions, we estimated that we would need 94 participants.We recruited participants between 16 October and 6 February 2015. A total of 89 people completed the study  and Cochrane Library  as the other two databases that they searched Table .Table 2DParticipants were more likely to find a systematic review using PDQ-Evidence than using Cochrane Library or PubMed for the pre-defined questions . For their own questions, the proportion of participants who found a systematic review was similar for the three databases .Overall, when comparing PDQ-Evidence to searches using two other databases (combined), participants were more likely to find a systematic review using PDQ-Evidence when searching for an answer to a predefined question Table , and lesWhen searching for a systematic review for a predefined question, 72 (87%) participants found a systematic review using PDQ-Evidence compared to 62 (75%) participants using the two other databases they chose to search   participants found a systematic review using PDQ-Evidence compared to 59 (71%) participants using the two other databases they chose to search   participants chose to search PubMed, 57 (69%) chose to search Cochrane Library and 21 or fewer (less than 25%) of the participants chose to search any of the other four databases  chose to search four of the databases. Therefore, the estimates of the perceived ease of use are not robust Table . On a foThe 65 participants that searched PubMed rated the ease of use to be between easy and difficult, (mean 2.18). This indicates that, on average, they found PubMed to be slightly more difficult to use than PDQ-Evidence .The 57 participants that searched Cochrane Library rated the ease of use to be between easy and difficult (mean 2.04), indicating that, on average, they also found Cochrane Library to be slightly more difficult to use than PDQ-Evidence .Participants rated how much time they spent searching each database on a four-point scale (from 1 = very little time to 4 = much too much time). The 83 participants that searched PDQ-Evidence rated the time spent searching to be between very little time and not too much time (mean 1.5) Table .Table 10The 65 participants that searched PubMed rated the time spent between not too much time and too much time (mean 2.2), indicating that, on average, they perceived PubMed to take slightly more time to search than PDQ-Evidence .The 57 participants that searched Cochrane Library rated the time spent searching to be between very little time and not too much time (mean 1.9), indicating that, on average, they also found Cochrane Library to take slightly more time to search than PDQ-Evidence .We asked the 89 participants four open-ended questions about PDQ-Evidence regarding what they liked, what they disliked, challenges and suggestions for improvements Table . OverallAll 89 participants gave feedback on what they liked about PDQ-Evidence. Of the 153 individual comments, we excluded eight, categorised as ‘general’ or ‘other’. These comments were too general, did not refer to PDQ-Evidence, referred to the survey itself, gave too little information, or the feedback was unclear.“Clear uncluttered screen…”“The best is that we can find the included primary studies from this database”“The filter search results presentation on the left is clear and practical”“It is straight forward”Positive feedback referred mainly to two categories, structure and searching. Typical comments included:Participants also liked the use of colour codes, the variety of topics covered, the inclusion of publication types, such as systematic reviews and structured summaries, with links to related evidence (including primary studies), and that the summaries seemed to be up-to-date. In addition, participants liked the search functionality, the geographic distribution of records, the display of the search history, the quick response when searching PDQ-Evidence, how PDQ-Evidence displays search results and records, the possibility to export records, that records seem to be relevant, and the not overwhelming number of search results.Fifty-eight participants gave feedback on what they did not like about PDQ-Evidence. Of the 64 individual comments, we excluded five, categorised as ‘general’ or ‘other’. These comments gave too little information, the feedback was unclear, or referred to technical issues not related to PDQ-Evidence.“If you cannot put all combinations in one sentence it is too cumbersome, a red plus is easy to mix up with the blue one – better with a minus …”“Not sensitive to spelling variations”“I would prefer to use MESH terms”Negative feedback referred mainly to the searching category. Typical comments included:“It could be easy to get lost when you start ‘navigation’ through the net of evidence (where I started?? Where I am now??)”Some participants also did not find the layout very user friendly and disliked the colours used for colour codes. Although some participants appreciated the linking to related evidence, others found this way of structuring the database confusing:“I did find more relevant publications in PubMed …”“I was surprised my initial ‘financial incentives breast feeding’ search found 0 articles when there were clearly articles there.”Some participants could not find information on the database content. Others disliked that PDQ-Evidence excluded clinical topics and would have liked to find additional primary studies, not only those included in PDQ-Evidence’s systematic reviews. Some were disappointed they could not find full text articles, were concerned the database was not up-to-date, found the filter option unsatisfactory, and found the search help unclear. Others felt that PDQ-Evidence was not intuitive and easy to use, and that it was time consuming to search. Some were unhappy with how PDQ-Evidence displayed the search results, and others could not find how to save records to file. Two comments on the relevance of records were:Comments on the number of hits retrieved or displayed varied from too few to too many hits.Fifty-four participants gave feedback on challenges related to PDQ-Evidence. Of the 63 individual comments, we excluded 11, categorised as ‘general’ or ‘other’. These comments were too general, referred to the survey itself, gave too little information, the feedback was unclear, or referred to technical issues not related to PDQ-Evidence. However, one of the general, but legitimate comments worth mentioning, questioned the existence of PDQ-Evidence, asking “Why yet another database?”“To compete against existing search engines, a better and more comprehensive system is required.”Some participants referred to challenges they ran into during the evaluation, others to challenges for PDQ-Evidence’s developers and providers. Comments referred to a not so user-friendly layout, confusing links to a large amount of related evidence and unclear information about the database content. PDQ-Evidence does not seem to be comprehensive, which was found challenging, as additional databases need to be searched. Knowing which topics and publication types are covered is a challenge, and so is the lack of full text. Keeping the database up to date, and making sure the content is quality assessed was perceived as being challenging for the database developers. Regarding the search functionality, one of the participants had the following comment:“New to me; need to get used to it.”“Had never used this database before, so it was challenging, but I guess with more frequent use it will get better.”Other comments mentioned the need to provide better filter option techniques, the lack of specific guidance on how to search and problems with navigating back to the search history. Comments on the ease of use that suggest searching PDQ-Evidence was not intuitive to some first-time users included:Other challenges included the fact that only a few records were displayed at a time thus ‘hiding’ the additional records found, that many irrelevant records were retrieved, and that there was a huge number or a paucity of hits.Sixty-one participants had suggestions for how to improve PDQ-Evidence. Of the 77 individual comments, we excluded eight, categorised as ‘general’ or ‘other’. These suggestions were too general, gave too little information, the feedback was unclear, or it referred to technical issues not related to PDQ-Evidence.Participants suggested improvements to the layout. For example, it should be more colourful and use bigger fonts. It was suggested that linking to related evidence should be less extensive, the information about PDQ-Evidence should give clear examples of evidence included, the database should include additional resources to make it more comprehensive, the inclusion criteria for publication types should be broader, full-text publications should be made available, the search functionality should preferably include predefined keywords or MeSH terms, an extended filter option would be an improvement, sorting hits based on relevancy, and a PICO-format search option should be included.“… a ‘route map’ option when you get lost.”“A three minute, once-off orientation video.”“… some prompts or auto-suggestion in search screen, or an ‘online chat assistance’ in return for membership or a fee.”Participants had specific suggestions for how to improve the search help, including:It was also suggested that PDQ-Evidence should be easier to use, it should be possible to display more than 10 records at a time, abstracts should be available in different languages and include author contact details, it should be possible to export records easily, and records retrieved should be relevant to the search question.Participants were more likely to find a systematic review using PDQ-Evidence than using any of the other databases to which it was compared. When searching for an answer to a predefined question, they were more likely to find a review using PDQ-Evidence than using any two other databases. However, when searching for an answer to their own questions, they were less likely to find a systematic review when compared to using any two other databases. A possible explanation for this difference is that some of the questions that participants asked were not within the scope of PDQ-Evidence, whereas all the pre-defined questions were within the scope of all seven databases. In addition, the order in which the databases were searched might have affected the results since participants were more likely to find a systematic review when PDQ-Evidence was searched first than when it was searched last. This finding is difficult to explain; yet, given the small numbers, it is possible that it is a spurious finding.Overall, it took slightly less time to find a systematic review using PDQ-Evidence. Participants perceived that it took less time, and most participants perceived PDQ-Evidence to be slightly easier to use than the two other databases that were searched. There were conflicting views about the design of PDQ-Evidence.Participants selected databases with which they were familiar. Few listed PDQ-Evidence as a database they normally would use, and our primary analyses compared PDQ-Evidence alone to two other self-selected databases. Thus, the design of the study favoured the databases to which PDQ-Evidence was compared.Strengths of this study include diverse participants from low-, middle-, and high-income countries, direct comparisons with other databases using both predefined and their own questions, and allowing participants to select the comparison databases based on what they would normally have searched or what they believed would be most likely to enable them to quickly find a relevant review.Weaknesses of this study include that we had difficulty recruiting participants and did not achieve the estimated required sample size. In addition, few participants selected four of the databases, so that it was not possible to draw reliable conclusions about PDQ-Evidence compared to those databases.This is the first study that has evaluated PDQ-Evidence. As far as we are aware, no other studies have been published that compare the use of different databases or search engines for finding health system evidence. Other studies have described the databases to which we compared PDQ-Evidence, but not specifically in relation to health system evidence, other than for Health Systems Evidence and EVIPNet VHL –6, both We conclude that PDQ-Evidence is at least as efficient as other databases and search engines for finding health system evidence and is probably more efficient. However, as with any search tool, there may be a learning curve and using PDQ-Evidence is not intuitive for some people. Moreover, preferences may vary. For example, some users value a focused database with limited content, such as PDQ-Evidence, whereas others prefer databases with a broader scope.We believe that PDQ-Evidence is a useful tool for policy-makers, managers, their support staff, researchers and others with an interest in health system evidence. It has several unique features that help make it easy to use and easy to find a systematic review when one is available.Additional file 1:PDQ-Evidence search strategies for PubMed, EMBASE, CINAHL, LILACS and PsycINFO. (DOCX 12 kb)Additional file 2:Predefined and own questions. (DOCX 25 kb)Additional file 3:Questionnaire: a comparative evaluation of PDQ-Evidence (PDQ first). (DOCX 24 kb)


Advances in neuroscientific techniques have found increasingly broader applications, including in legal neuroscience (or “neurolaw”), where experts in the brain sciences are called to testify in the courtroom. But does the incursion of neuroscience into the legal sphere constitute a threat to individual liberties? And what legal protections are there against such threats? In this paper, we outline individual rights as they interact with neuroscientific methods. We then proceed to examine the current uses of neuroscientific evidence, and ultimately determine whether the rights of the individual are endangered by such approaches. Based on our analysis, we conclude that while federal evidence rules constitute a substantial hurdle for the use of neuroscientific evidence, more ethical safeguards are needed to protect against future violations of fundamental rights. Finally, we assert that it will be increasingly imperative for the legal and neuroscientific communities to work together to better define the limits, capabilities, and intended direction of neuroscientific methods applicable for use in law. Terms like “intent,” “knowingly,” and “purposefully” figure prominently in courtroom decisions, and have alternately served to extenuate or implicate countless individuals  What are the rights of the individual vis-à-vis the acquisition and use of neuroscientific investigation? (2) Is (and how is) neuroscientific evidence currently accepted and used in criminal courts? and (3) Are the ethical injunctions established in (1) violated by uses outlined in (2)?In this light, the focus of this paper can be summarized by a single question: Regarding the rights of the individual, we will use the U.S. Constitution's Bill of Rights as primary reference, given that this document has become a benchmark for basic constructs of human rights in modern democratic societies. We also review a number of landmark court cases that have helped to elucidate how these rights have been interpreted. For the second question, we will inquire into the most viable neuroscientific techniques currently projected toward—or employed in—legal use. Finally, we address whether current protections are likely to persist despite technological change, and how the neuroscientific and legal communities can (and perhaps should) work to safeguard the rights of the individual.What precedent is there for establishing the “neuro-cognitive” rights of the individual? Shen  has commshould be inviolable, but that it inherently is—for instance, the Opelika decision claims that “freedom to think is absolute of its own nature; the most tyrannical government is powerless to control the inward workings of the mind” (316 U.S. 618). Techniques for (blunt) external modulation of cognitive processes—ranging from the pharmacological . That case further reinforces the notion from Schmerber that not all biological evidence is sacrosanct (384 U.S. 757). But it also includes the justification that since DNA samples can help determine an individual's criminal history, their collection serves “legitimate government interest” in determining whether an individual might pose a danger to society (133 S. Ct. 1959). This argument seems to open the door for other procedures that would establish the level of danger an individual poses to society; procedures that might eventually incorporate neuroimaging and perhaps other forms of neuro-cognitive assessment. Such decisions seem to reflect a desire to balance the rights of the individual with concerns about the safety of the society . The court ruled that the use of this evidence, although taken from the defendant's own person, did not constitute a violation of the Fifth Amendment protections, because the evidence was not “testimonial or communicative” in nature (384 U.S. 761). In that same decision, the court remarked that “to compel a person to submit to testing in which an effort will be made to determine his guilt or innocence on the basis of physiological responses, whether willed or not, is to evoke the spirit and history of the Fifth Amendment” (384 U.S. 764). While this assertion was ostensibly directed toward the contemporary use of the polygraph, it seems to have serious implications for use of  neuroscientific methods of deception detection in the courtroom.The legal definition of “self-incrimination,” however, has proven to be somewhat ambiguous. One early challenge to the principles of One of the most fundamental provisions in the Bill of Rights is the “due process” clause of the Fifth and Fourteenth Amendments; it assures the right to a fair trial and stipulates that no individual may be convicted or otherwise deprived of “life, liberty, [or] property” without proper procedure. The “due process” clause has been flexibly interpreted to incorporate basic principles of common law, which include stipulations about the kind of evidence that should be admissible in court. For instance, in State of New Jersey v. Michaels , the couDaubert v Merrell Dow Pharmaceuticals . These two decisions are especially relevant in the case of neuroscientific evidence, because they established a framework by which the admissibility of expert testimony in this field might be judged. While this framework is not completely standardized across state lines, it has been codified at the federal level in the revised Rule 702  measured by electroencephalography (EEG). Most of these techniques center on the detection of “guilty knowledge” via P300 recognition signatures . Nevertheless, these issues have not prevented the emergence of commercial entities purporting to provide reliable fMRI-based deception detection  provides a three-dimensional image of both cortical and sub-cortical activity of the brain , it has greater descriptive potential. However, fMRI is also constrained by practical parameters  that impair its descriptive capability and power , and it was disallowed from the proceedings  of subjects' visual experience  admissible in court? Such problems are inherent to a technology that provides more information than is warranted by the legal system.In a similar vein, Wolpe et al.  suggesteSchmerber established precedent for a tendentious dichotomy between “physical” or “biological” evidence and “testimony”. In its place, she proposed a spectrum of evidence, beginning with “identifying” information like height and appearance, and ranging through “automatic,” “memorialized,” and “uttered” domains (368–389). Where would neurological information fall on the spectrum? Given that complex ideas and semantic information cannot currently be reliably detected by available neurotechnology, neurological evidence probably would not be in the “uttered” category. Deception detection methods would produce evidence in the “memorialized” category, while basic structural information about an individual's brain would fall in the “automatic” category. Using this approach, she concluded that the extant legal framework protecting against self-incrimination would produce a result that is “deeply unsatisfying and at odds with ordinary intuitions about mental autonomy” when applied to memorialized neurological evidence (389).The determination of whether neurological evidence constitutes a violation of Fifth Amendment protections hinges on the classification of such evidence. As Farahany  has arguper se, provided that both the prosecution and the defense consent to its use . A more recent example of gatekeeping in action is the previously mentioned United States v Semrau  present a formidable challenge to legally-oriented uses of neurotechnology. Keckler  just as effectively as Frye v United States , but rather that they should foster a working relationship with subject matter experts in neuroscience, in order to maintain an understanding of the limits and capabilities of contemporary tools and methods of brain science.We assert that such vulnerabilities should prompt the legal and neuroscientific communities to take action. On the side of the courts, the decision must be made as to whether the vulnerabilities described in the previous section are to be treated casuistically, as per tradition, or perhaps more prescriptively, as in the case of France's updated Civil Code. Additionally, judges and lawyers should remain abreast of developments in neuroscience and technology so as to properly consider admitting or excluding neurotechnologically-derived evidence  of the techniques that are being developed; to develop an understanding of the legal and ethical limitations on broader applications of brain science; and finally , to work to avoid misrepresentation of neurotechnological capabilities to the public Morse, . CommercUS v Scheffer). Rather, expert testimony should simply provide evidence that will assist the judge and/or jury in their final decision  the lack of guidelines on informed consent for the use of neurological evidence. Less clear but equally pertinent is the effect of use of such evidence by the defense on legal definitions and social intuitions of guilt. In reaching this conclusion, we have not developed a conception of individual “neuro-cognitive rights” beyond those outlined in the US Constitution, nor have we thoroughly examined the state of affairs in countries other than the United States. These ventures require a broader philosophical outlook, extensive research in international law, and have been well engaged by others  the ambiguous definition of the private sphere; (2) the lack of clarity in the Scientific methods and social norms are constantly changing. And it may be that such international perspectives, discourses, guidelines and laws will need to be considered and engaged if and as brain science continues to be advanced, and to be proposed for use in legal processes. Perhaps then the integrative approach should encompass not only a scientific and ethical effort (Giordano, CK and JG conceived and developed the idea for this manuscript; CK and JG wrote and reviewed the manuscript and CK and JG are responsible for its content.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


To the editor,Dr. de Jesus in his elegant commentary on our recent published article in the Int Braz J Urol  dwelled The diagnosis of PMSD in our patient was based on the presence of Mullerian duct derivatives - a fallopian tube, a bicornuate uterus with a more prominent right horn, and an enlarged cervix possibly hydrocolpos -with the presence of normal 46,XY karyotyping. The patient's mother provided the history of undescended testes with an ambiguity of genitalia, with no clear documentation, as the medical records are no longer available for perusal. However, there was no substantial evidence to support the ambiguity of genitalia. As for the authors’ remark that PMSD patients do not exhibit testicular failure, Claranette et al. suggested that such patients can be classified into three subgroups according to the position of reproductive organs: (i) Intra-abdominal Mullerian structures and testes in a position simulating that of the ovaries, (ii) one testis in a hernial sac or scrotum together with Mullerian, and (iii) both testes located in the same hernia sac along with the Fallopian tubes and uterus . During The typical features of PMDS include undescended testes and the presence of a small, underdeveloped uterus in an XY infant or adult, which both were found in our patient. This condition is usually caused by a deficiency of fetal anti-Mullerian hormone (AMH) effect due to mutations in the gene for AMH or the anti-Mullerian hormone receptor, however, may also be seen as a result of insensitivity to AMH of the target organ . UnfortuAlthough mixed gonadal dysgenesis (MGD) is similar in some ways to PMDS, the conditions can be distinguished histologically and by karyotyping. In our case, the chromosomal analysis was clearly 46,XY with no mosaicism. Unfortunately, a gonadal biopsy was not made as the diagnosis with karyotyping was thought to be sufficient in this case.


Dear Colleagues, it is a great pleasure for me to present this special issue that was written by experts of our discipline and published at the occasion of the 87th Annual Meeting of the German Society of Otolaryngology, Head and Neck Surgery. The annual meeting of 2016 has the heading of “Evidence and transparence in Otolaryngology – ENT, quo vadis?” which aims at defining the position of our discipline. Among the different diseases diagnosed and treated in otolaryngology, there are quite some, where therapy is not performed on the basis of the results of modern evidence-based medicine but on extensive experience. Of course, criticism is often justified when dealing with the topic of evidence-base, however, it is essential that we define the position of our discipline also in this context. With this background, I invited 9 experts of this field to analyze important areas of otolaryngology, head and neck surgery under the mentioned aspects. The introduction includes the definition of the terms of evidence and evidence gaps, then a detailed analysis of a meanwhile performed qualitative survey about the identification of evidence gaps in daily routine will follow. Only when we identify evidence gaps as such – and this applies to practice and clinic – we will be able to define topics that have to be dealt with in multicenter trials with high priority. Those two introductory chapters are followed by 6 articles that focus on definable evidence and evidence gaps, i.e. on non-tumorous diseases of the tonsils, nasal obstruction and rhinosinusitis, disturbed middle ear ventilation and otitis media, furthermore on the treatment of tinnitus, surgery of laryngeal carcinomas, and pharmacotherapy of non-tumorous diseases of the head and neck. This issue ends with an intensive description of the inclusion of study results in practical guidelines and their implementation in the clinic. I want to cordially thank all authors for their enormous efforts to create those articles and I am convinced that the present issue will turn out to be a useful source of information and provide supporting arguments in order to justify certain procedures and to initiate study projects. Prof. Dr. Jochen A. WernerPresident of the German Society of Otolaryngology, Head and Neck SurgeryFigure 1


Genetics is an important piece of every individual health puzzle. The completion of the Human Genome Project sequence has deeply changed the research of life sciences including nutrition. The analysis of the genome is already part of clinical care in oncology, pharmacology, infectious disease and, rare and undiagnosed diseases. The implications of genetic variations in shaping individual nutritional requirements have been recognised and conclusively proven, yet routine use of genetic information in nutrition and dietetics practice is still far from being implemented. This article sets out the path that needs to be taken to build a framework to translate gene–nutrient interaction studies into best-practice guidelines, providing tools that health professionals can use to understand whether genetic variation affects nutritional requirements in their daily clinical practice.  It is common for nutrition professionals to experience that the same dietary intervention and management strategy produce very different outcomes in different people. An overwhelming number of observations support the evidence that genetic background has a key role to play in individual response to diet and life-style, and in shaping individual nutritional requirements . Proof oPhenylketonuria (PKU) is a rare inborn syndrome caused by a mutation in a single gene that encodes for the enzyme phenylalanine hydroxylase. The liver of PKU mutation carriers in homozygosis are unable to break down phenylalanine and are consequently unable to metabolise food that contains this amino acid. PKU was one of the first genetic conditions to be identified, and it is the result of a mutation in gene coding for an enzyme involved in a key step of a metabolic pathway; to date, the only effective management for PKU patients is a carefully tailored low protein diet . Common The completion of the Human Genome Project (HGP)  held theTo translate genetic information into evidence-based nutritional recommendations, clear summaries and critical analysis of the current evidence base of identified polymorphisms and their interaction with nutrition and health need to be provided, including their effect size. This will allow healthcare professionals to more easily understand the relationship with nutrient metabolism, and whether there is any robust evidence for an intervention. First, the results in systematic reviews and meta-analysis need to be collated and second, user-friendly computational tools that can integrate the complex genetic and epigenetics information need to be built, integrating it with clinical and biochemical biomarkers. This approach has achieved a promising step toward with Eran Segal’s group at Weizemann Institute. This important study developed an algorithm that integrates blood parameters, dietary habits, anthropometrics, physical activity, and gut microbiota to predict blood glucose response to meals with different contents of carbohydrates . HoweverA limited number of papers have reviewed the evidence in regards to specific areas of nutrigenetics in an attempt to collate and build the literature base ,17,18,19Health professionals require clear best-practice guidelines to be able to translate the evidence into nutrition advice. In general, to guide nutrition and dietetic practice, nutrition research is regularly reviewed and analysed by experts to provide summaries of the latest evidence to guide practice. For example, the National Health and Medical Research Council in Australia provides guidance for the recommended nutrient intake along with summaries of the latest available evidence . These aNutritionists and dietitians were identified as prime candidates to provide advice on nutrition and genetics, but the development of guidelines and evidence summaries for these professionals has been scarce . CurrentWhile the science of nutritional genomics continues to demonstrate potential individual responses to nutrition, the complex nature of gene, nutrition and health interactions continues to provide a challenge for healthcare professionals to analyse, interpret and apply to patient recommendations. Evidenced-based summaries and interpretations of the current literature base urgently need to be developed by expert working teams of both genetic experts and nutrition experts. These summaries can then provide the basis for the development of best-practice guidelines for nutrition professionals for use in clinical practice.


Nutrition literacy is linked to health via its influence on dietary intake. There is a need for a tool to assess nutrition literacy in research and dietetic practice. We sought guidance from nutrition professionals on topic areas and features of an electronic nutrition literacy assessment tool for Australian adults. 28 experienced nutrition professionals engaged in a range of nutrition and dietetic work areas participated in six focus groups using a semi-structured interview schedule. Data were analysed using an inductive approach using NVivo 10 . Key areas identified to assess nutrition literacy included specific nutrients versus foods, labels and packaging, construction of the diet, knowledge of the Australian Dietary Guidelines and Australian Guide to Healthy Eating, understanding of serve and portion sizes, ability to select healthier foods, and demographics such as belief systems and culture. Exploitation of electronic features to enhance visual and auditory displays, including interactive animations such as “drag and drop” and virtual reality situations, were discussed. This study provided insight into the most relevant topic areas and presentation format to assess the nutrition literacy of adult Australians. The visual, auditory, and interactive capacity of the available technology could enhance the assessment of nutrition literacy. Understanding health and nutrition information requires adequate literacy and numeracy skills, which are collectively referred to as health literacy . The WorHealth literacy is associated with health behaviours and outcomes ,6,7,8. INutrition literacy is analogous to health literacy, as it is defined by the ability of individuals to obtain, process, and understand basic nutrition information and services they require to make suitable dietary selections . Sound hThere is a need for a more specific tool to evaluate nutrition literacy at a population and individual level and to measure the impact of activities, interventions, and policies that are in place to promote healthy eating. A range of tools has been developed to measure health literacy ; howeverMost of the other existing instruments designed to assess general nutrition knowledge or literacy in adults have minimal validation, are now dated, and are not specific to Australian foods or culture. There have been few new tools developed since 2007, with most of these adaptations from previous instruments. One of the key limitations of existing tools is that the readability and comprehension level required to complete the questions has not been undertaken; lower scores on existing nutrition literacy tools may reflect a lower reading level rather than poor nutrition knowledge. The average reading ability of the Australian population (not including migrants educated in non-English speaking countries) is approximately equivalent to a year 8 level (or 13 years of age) , and neaThe aim of this study was to obtain the guidance of dietetic professionals from a larger range of work settings on key nutrition areas that should be included in an electronic nutrition literacy assessment tool (e-NutLit) specifically for Australian adults. Nutrition literacy in this context was limited to the knowledge and skill components required for the selection of a healthy diet for everyday life, rather than an assessment of knowledge or skills in cooking, budgeting, or knowledge of where foods come from. The study also aimed to capture opinion on how to present these item areas within the electronic tool.www.doodle.com) or asked for broad availability (days/times) to be supplied by e-mail.Participants were purposively selected by the research team based on their expertise and experience in a range of work areas in nutrition and dietetics and snowball sampling . A targeParticipants attended one of six focus groups . Each group consisted of 4–6 participants and ran for a duration of approximately 60–90 min. Experienced/trained facilitators  who were also Accredited Practising Dietitians led all sessions. The focus groups were conducted using a semi-structured interview schedule asking participants to describe their experience working with individuals using existing nutrition guidelines , Australian Guide to Healthy Eating (AGHE)) ; the maiFocus groups were recorded and then transcribed by either a project investigator (one focus group was transcribed verbatim by (A.M.C.) or a professional transcription service). Transcripts were de-identified by assigning pseudonyms for each participant and removing identifying information such as place of work. These were returned to participants for verification and correction (within two weeks). Participants were instructed to amend the text to ensure the transcription correctly summarised the content of their specific group discussion. All comments and corrections returned by participants for each focus group were compiled in to a single document for analysis. All focus groups were conducted prior to thematic analysis due to time restrictions within the university research semester for data collection personnel. Past and present work areas identified by participants at the beginning of the interview were classified according to defined Dietetics Association of Australia (DAA) work areas .Data analysis was conducted using a general inductive analysis procedure . AnalysiEthical approval was granted by the University of Sydney Human Ethics Committee (Project No. 2013/633). All participants provided informed consent prior to participation.Twenty-eight (74%) of the 38 invited professionals agreed to participate. Five (13%) declined , and the remaining five invitations (13%) failed to elicit a response. Participants were recruited from all DAA work areas  32]..32].There were six main themes discussed by participants for inclusion in a tool to assess nutrition literacy. Diet-disease relationships were also discussed but did not emerge as a major theme. Exemplar quotes for each theme are provided in Discussion about assessment of knowledge of nutrients versus whole foods was evident across all focus groups. Although there has been a recent emphasis on considering foods rather than nutrients in making recommendations , some paParticipants indicated that knowledge of the AGHE should be assessed, with emphasis placed on assessing the understanding of appropriate serve sizes, basic food groups, and discretionary foods. Participants also discussed addressing knowledge and understanding of the ADG with the recommendation to assess general awareness of the ADG and the messages they convey.Testing the respondents’ ability to read, understand, and interpret food packaging was a predominant theme across all focus groups. Assessment of Nutrition Information Panels (NIP) drew a substantial amount of this discussion across the groups. Participants also commented that the ingredients list should also be featured in an e-NutLit and indicated that it would be important to evaluate awareness of the ingredients list, its purpose, and if it influenced their food choices. The importance of determining if there were specific populations more likely to use ingredient lists was also raised.The ability to construct a healthy diet was nominated as a key area to include in the e-NutLit, particularly regarding skills in selecting a balanced intake  and skills in selecting appropriate portion sizes.Discussion pertaining to assessment of skills in making healthier food choices focused predominantly on recognition of healthier foods, including selection of these within each food group (for example grading the foods) and adapting recipes. Grading foods as a method of assessing whether the individual can select or rank foods that are healthier and more consistent with dietary guidelines was a common subtheme.Although this is not an area that can be “assessed” as such, participants considered these an important inclusion an instrument to assess nutrition literacy. Along with general descriptors , cultural and individual beliefs  expected to have a strong influence on nutrition literacy were discussed.Three main categories related to electronic tool presentation features were identified: visual representation, audio, and other (miscellaneous) features. Discussion on audio did not feature heavily, but was discussed as an option to assist participants to recognise images or words, for those with visual impairments or for specific languages. Other general suggestions were in relation to cultural considerations, order of presentation, and consideration of industry influence (packaging) on perception of food images. Exemplar quotes for each theme are given in When probed with potential animation features, “drag and drop” was discussed positively with supporting for its specific suitability in lower literacy groups. Other potentially valuable interactive features included virtual reality situations  and expand and fill images.This theme included subcategories: relationship of AGHE serves to everyday food presentation and single versus multi-ingredient or prepared foods. There was substantial cross-over between talk on the relationship of AGHE serves to everyday food presentation and talk on presentation of single versus multi-ingredient or prepared foods; the abundance of mixed meals or pre-prepared foods in everyday life and the potential need to identify serves or ingredients for the tool was frequently discussed concurrently.This category included the idea of building meals and recipes or diets, having multiple choice questions, and using pictures instead of words.Aspects of food images were discussed, including the use of common items for scale , ensuring accurate and realistic portion sizes in images, and using realistic and clear food images.This study identified key elements for inclusion in an electronic nutrition literacy assessment tool for adults specific to the Australian context and informed by nutrition professionals from a broader range of work settings than that of previous work. Several main elements were identified within the context of assessing competency in making everyday decisions regarding selection of a healthy diet. Recommendations for the design features of the tool strongly supported use of visual images of real foods, fiduciary markers to indicate portion size, interactive components such as ‘drag and drop’, and the potential capacity for auditory item stems.One of the key deliberations of the focus groups revolved around the benefits of assessing knowledge of nutrients versus knowledge of foods. There was support for assessing key nutrients  and energy, as well as knowledge of food groups and healthier food choices. The healthfulness of food choice was also referenced with specific nutrients . Gibbs et al. suggest that greater knowledge of some nutrients may be important for people with particular conditions such as diabetes ,16. AlthParticipants favoured assessment of ADG concepts rather than having knowledge of its wording. Together with knowledge of the AGHE, assessment of understanding appropriate serve sizes, knowledge of the food groups, and discretionary foods were discussed most. This confirms the work of Gibbs et al. who suggest that competence with household measurements and understanding good groups are important nutrition literacy skills ,16. All Other major themes identified discussed assessment of interpretive or functional nutrition literacy rather than knowledge. Labels and packaging were discussed by all groups. Many references to labelling were about the NIP; participants generally supported the assessment of participants’ ability to read an NIP in an e-NutLit, particularly interpreting information about specific nutrients, and being able to make an informed choice. The ingredient list was also favoured as an item for the assessment of nutrition literacy. Being able to apply numeracy and literacy skills to reading and comparing labels may be important in making healthier food choices ,39. ThisThe ability to differentiate between an AGHE serve, serving size on a package, and portion size at an eating occasion may all present difficulties to the average consumer. A major challenge for the general population in reading food labels/packaging appears to be interpretation and application of the serve size on the label; this can lead to either an over- or under- estimation of the amount of nutrients consumed . NutritiThe need for nutrition literacy assessment instruments to support a greater range of literacy levels evident in the Australian population suggests the potential benefit of using an electronic platform to assess nutrition literacy. Use of pictures when communicating health information can provide significant benefits to attention, comprehension recall, and intention/adherence . Simple Innovative question types that incorporate the interactive drag and drop feature, supported by the participants in the current study, and problem-solving simulations also allow examination of the respondents’ knowledge, skills, and capabilities . VirtualReferences were made to visual representation of accurate and realistic images of food and portion sizes. Indication of scale was also raised as a consideration when presenting images in this tool. Examples given included comparing a piece of meat to the size of a hand or using a fork near a plate to show the size of the plate to allow participants to gain a better understanding of the serve or portion size being displayed in the image. Respondents may be better able to respond to questions on portion size by ensuring that a standard reference is included . MeasureAudio or language features may facilitate utility across a larger number of respondents including those with English as a second language or those with lower levels of literacy. Hahn et al. (2004) developed a ‘Talking Touchscreen’ to accommodate varying literacy levels and computer skills to enable cancer patients to complete a quality of life assessment. The tool was developed so that one item was presented at a time on the computer touchscreen, supported by a recording of the question . VariousThe main strength of this study was recruitment of a diverse range of expert dietetic professionals from all DAA work areas. The inclusion of input from a broader range of nutrition work areas  supports assessment of nutrition literacy in both clinical and non-clinical contexts as suggested by Velardo . It alsoThis study gathered valuable insights from focus groups of experienced nutrition professionals regarding the assessment of nutrition literacy . Key areas identified by participants included knowledge of specific nutrients and foods, knowledge of the ADG and AGHE, appropriate serve and portion sizes, reading and interpreting food labels and packaging, and the ability to select healthier foods. Existing nutrition literacy assessment tools have minimal validation, are dated, and are not specific to Australian culture and foods. Many do not use visual aids and only incorporate some of these themes. Using currently available technology should enhance the assessment and usability of a nutrition literacy instrument, especially for low-literacy groups. This study will inform items and a format for an e-NutLit suitable for adult Australians.


Sugar sweetened beverages (SSB) are a major source of sugar in the diet. Although trends in consumption vary across regions, in many countries, particularly LMICs, their consumption continues to increase. In response, a growing number of governments have introduced a tax on SSBs. SSB manufacturers have opposed such taxes, disputing the role that SSBs play in diet-related diseases and the effectiveness of SSB taxation, and alleging major economic impacts. Given the importance of evidence to effective regulation of products harmful to human health, we scrutinised industry submissions to the South African government’s consultation on a proposed SSB tax and examined their use of evidence.Corporate submissions were underpinned by several strategies involving the misrepresentation of evidence. First, references were used in a misleading way, providing false support for key claims. Second, raw data, which represented a pliable, alternative evidence base to peer reviewed studies, was misused to dispute both the premise of targeting sugar for special attention and the impact of SSB taxes on SSB consumption. Third, purposively selected evidence was used in conjunction with other techniques, such as selective quoting from studies and omitting important qualifying information, to promote an alternative evidential narrative to that supported by the weight of peer-reviewed research. Fourth, a range of mutually enforcing techniques that inflated the effects of SSB taxation on jobs, public revenue generation, and gross domestic product, was used to exaggerate the economic impact of the tax. This “hyperbolic accounting” included rounding up figures in original sources, double counting, and skipping steps in economic modelling.Our research raises fundamental questions concerning the bona fides of industry information in the context of government efforts to combat diet-related diseases. The beverage industry’s claims against SSB taxation rest on a complex interplay of techniques, that appear to be grounded in evidence, but which do not observe widely accepted approaches to the use of either scientific or economic evidence. These techniques are similar, but not identical, to those used by tobacco companies and highlight the problems of introducing evidence-based policies aimed at managing the market environment for unhealthful commodities.The online version of this article (10.1186/s12992-019-0495-5) contains supplementary material, which is available to authorized users. Sugar sweetened beverages (SSB) are a major source of sugar in the diet. Although trends in consumption vary across regions, in many countries, particularly LMICs, their consumption continues to increase . In respBy agnogenic practices we refer to methods of representing, communicating, and producing scientific research and evidence which work to create ignorance or doubt irrespective of the strength of the underlying evidence . AgnogenIn addition, much of the existing literature examining the interface between corporations and policy- relevant science either simply describes industry influence on science and its communication or demonstrates its effects , 30–33, Our selection of SSB taxation as a case study is based on three observations. First, efforts by governments internationally to use fiscal levers as a means of addressing rising levels of type 2 diabetes, obesity, and associated cardiovascular disease have met with fierce industry opposition , 41. ThiA desk based approach was taken to collating written responses to the South African National Treasury’s policy paper on a taxation of sugar sweetened beverages , 57 by cn = 3) to seek clarification of specific points, but received no replies.We used several methods to collate evidence cited in the submissions and Oxford Economics report. Peer-reviewed research was identified via Web of Science and PubMed Central. Searches of authors’ institutional web-sites were used to identify research consultant, company, and (non-peer reviewed) academic reports. Where this proved unsuccessful, we performed general internet searches using the search engine Google and requested copies from authors via email. The same protocol was used where the cited (primary) source was not the ultimate (secondary) source of the evidence claimed in the submission reviewed (see Results). Peer-reviewed research articles on the effects of SSB taxation on consumer behaviour based on calculations of cross-price elasticities were collated to strengthen our evaluation of Oxford Economics’ modelling. These were identified using relevant search terms via Web of Science and PubMed Central and by hand searches of reference lists of studies identified as relevant  to determine availability at both the time of publication and immediately after the deadline for consultation submissions. A sub-sample (10%) of the results of this analysis was coded by SW. Disagreements over differences in coding were resolved through discussion and consensus.We undertook three analyses. First, we performed a source analysis of industry submissions, which involved: identifying policy relevant propositions within submissions (executive summaries and introductory sections were excluded); assessing whether propositions were substantiated with reference to an ostensibly validating source; classifying the type (e.g. method of funding and publication) and availability of the source. We defined “relevant propositions” as statements or assertions that expressed an anticipated effect of, or judgement of fact supportive of an anticipated effect of, the policy beyond the intended direct effects of SSB taxation (encouraging a substantive decline in consumption of SSBs), but excluding assertions relating to the industry’s pre-levy contribution to the economy, such as employment associated with the non-alcoholic beverage industry. Evidence availability was examined by transposing the search strategies used to collate the evidence (outlined above) into thematic codes. Where evidence was obtained directly from authors we used a web-archiving tool  with their supporting sources to examine how they had been used. Where the supporting (primary) source was not the original source of evidence for the proposition, we applied the same approach to the underlying (secondary) source. The results of this process were thematically analysed (by GF) using the techniques of constructivist grounded theory , 60: sysThird, the critical appraisal of Oxford Economics’ report  was undeIndustry submissions set out a metanarrative of “policy dystopia” . Predicafalse attribution of focus and selective quotation) or are linked by a common theme (e.g. cryptic references and faux sources) we group them together under related practices (i.e. misleading summaries and and confounding references.). We go on to discuss our results under two meta-practices: mimicked scientific reasoning and hyperbolic accounting. We use the term mimicked scientific reasoning to describe practices and techniques that misrepresent, and work to circumvent, the weight of evidence concerning the effects of SSBs and SSB taxes on obesity and diet-related diseases, including, for instance, misrepresenting the focus and objectives of studies and omitting important qualifying information. Scientific reasoning is mimicked in the sense that evidence use and appraisal appears, on the face of it, to take an unprejudiced, evidence-informed assessment of the relevant science. In practice, however, the approach fails to observe accepted principles of deductive and inductive reasoning, does not observe accepted conventions associated with how to accurately support evidence-based claims, and does not appropriately take into account weight or strength of evidence approaches to evidence appraisal. Hyperbolic Accounting, by comparison, encompasses techniques and practices that exaggerate the stated economic impact of proposed policies , such as failing to fully articulate key steps in economic modelling (syncopated estimation) or counting economic impacts more than once (double counting). Although we deal with these meta-practices separately for ease of understanding, in practice, agnogenic techniques cut across efforts to misrepresent the weight of evidence concerning the effects of SSBs and SSB taxes on obesity and diet-related diseases and exaggerate the economic impacts of SSB taxes  and faux sources  gave a misleading impression of the breadth of sources and evidence supporting claims .Industry submissions took a misleading approach to referencing sources. Techniques such as Source laundering (Table Information Asymmetries below). By creating an additional step in the process of assessing the methodology of original sources and verifying that their findings have been accurately reported, the technique complicated the process of evidence appraisal. In the present case, Oxford Economics’ 2013 report had cited the DI Fødevarer factsheet to support the contention that a Danish family could save at least US$455 (EUR350) a year by shopping in Germany, despite the factsheet containing no such claim (see faux source below and Table and beer combined and that the Danish government had introduced higher taxes on beer (amongst other things) in the January of the year the survey was conducted   work [were] consistent with those reported in the National Treasury’s SSB tax policy paper” . This imncrease” . In facthyperbolic accounting was enabled by reliance on privately held data in economic assessments (inaccessible data) and opaque, unverifiable steps in economic modelling (black box computation). Although not strictly agnogenic practices, both phenomena increase the obstacles involved in substantiating the bona fides of industry estimates of projected economic impacts and, as such, expand the opportunities for corporate agnogenesis. For example, Oxford Economics’ estimates of lost spaza jobs and store closures rested on the assumption that post-tax employment would fall in proportion to the decline in revenue generated by soft drink sales. Its projections were, therefore, tied to baseline estimates for both employment and store numbers and the proportion of spaza revenue (and profit margins) derived from SSB sales. In relation to the former, estimates for both employment and store numbers drew on unpublished, industry-funded research by PwC  sing industry specific productivity estimates derived from Statistics South Africa data and published by Oxford Economics the core industry [was] estimated to support around 107,500 jobs indirectly and a further 66,500 via the induced impact channel” without outlining how they had been derived [Finally, the scope for h by PwC  and “conh by PwC , which hh by PwC . Likewis derived .Finally, focusing exclusively on information asymmetries in respect of Oxford Economics’ estimates belies the true extent of the problem in corporate submissions. Some sources  referred to directly in corporate submissions to support other points, for example, were not publicly available either during the consultation period or at the time of writing. The same applied to other sources that underpinned claims in cited references (e.g the survey by the Danish Grocer’s Trade Organisation - see under Cryptic Referencing).Figure Observational Selection above) have the effect of “wholesale discounting of evidence” [’s study.Some techniques and practices identified in our data overlap with those outlined in Ulucanlar et al’s study of the tobacco industry: notably, the tweezers method, the conflation of absence of evidence with evidence of absence, and evidential landscaping . The indvidence”  also reptweezers method and false attribution of focus, for example, were used to conflate absence of evidence with evidence of absence. Second, the same technique can be used to produce different effects. Out-of-place citations, for example, were used to support illicit generalisations and misleading summaries. Third, agnogenic techniques can operate as a series of steps in a process or a chain of agnogenesis. For instance, key qualifying information was omitted from studies which worked to misrepresent their focus and objectives and, ultimately, provided a platform to present contradictory findings on the extent to which food taxes led to improvements in health (an absence of consistent evidence) as evidence that the research had found no improvements (evidence of absence). Fourth, agnogenic techniques can also combine in more complex ways. Coca-Cola’s and BEVSA’s practice of cherry-picking studies to support their preferred theory of substitution effects, for example, rested on an illicit generalisation and relied heavily on selective quoting and the omission of qualifying information of the selected studies, as well as strategic ignorance of the findings and observations in studies relied on elsewhere in their submissions. In this respect, agnogenesis is produced via a mutually reinforcing network of agnogenic techniques that produce superficially coherent descriptions of evidence that support the industry’s overarching dystopic narrative.In addition, the model outlines four qualities of corporate agnogenesis that illustrate its plasticity and the interdependence between different techniques and practices. First, different techniques can produce the same effect. Both the selective quotations, for example, constitute classic agnogenic techniques in so far as they misrepresent the underlying evidence. Others, however, such as cryptic references, inaccessible data and black box computation perform a more ancillary role: not misleading in themselves, but, nonetheless, potentially instrumental to more direct agnogenic practices in so far as they work to obstruct evidence appraisal. Equally, strategic ignorance is neither strictly misleading  nor obstructive of evidence appraisal. However, it represents a necessary strategy in building agnogenic narratives where the weight of evidence suggests a policy is broadly likely to work as intended.Finally, account needs to be taken of the different roles that agnogenic practices perform in corporate evidence claims. Some, such as Corporate agnogenesis represents a major problem for health actors and the general population. Addressing the global non-communicable disease epidemic requires fundamental changes in markets: what products are sold, at what price, how and to whom . It setsThis political potential of corporate agnogenesis has been strengthened by the emergence of new forms of policy-making governance, which draw heavily on the US cost-benefit approach to policy formation. These new forms of governance have elevated the importance of evidence in areas of policy-making in which corporate and public interests clash and enhanced the effective political power of economics which has created a receptive milieu for industry commissioned economic impact analyses that translate diverse and complex processes into a single figure with the sense of precision and neutrality widely accorded to numbers . ProvidiThese uncertainties highlight the structural vulnerability of modern modes of evidence-based policy-making to corporate agnogenesis. Scientific uncertainty arises in part because new evidence is constantly emerging and because new methods are regularly developed to gather and analyse evidence. No scientific claim is entirely free from evidential challenge , 126. CoStructural weaknesses inherent in contemporary forms of evidence-based policy-making are exacerbated by diagnostic problems in unpicking corporate agnogenic techniques. On first inspection, these appear to be softened by broad similarities between agnogenic techniques identified in studies of corporations’ use of evidence in different sectors, which is providing an emerging inventory of sharp evidential practices . DespiteThe policy implications of our findings need to be set against the spread internationally of regulatory impact assessments and mandatory public consultations through Better Regulation/Good Governance agenda  , as well as in respect of different polices relevant to diet-related diseases (e.g. restrictions on marketing to children). More generally, our findings point to the importance of further research on the political-psychology of corporate agnogenesis. The obvious explanation for corporate agnogenesis is that it represents a necessary protective strategy for business actors where the evidence-base necessary to contest commercially prejudicial policies is weak or unhelpful. However, submissions were characterised by a form of le point , which rle point . In our Additional file 1:Table S1. Peer reviewed research articles on SSB taxes (published prior to 2016) containing analyses based on calculated cross-price elasticities. (DOCX 16 kb)


There is uncertainty about the variation in infection prevention practices for central venous catheters (CVC) in neonatal units (NNUs) and how practices relate to national guidance.To evaluate evidence supporting infection prevention practices for CVCs recommended in national guidelines and to compare with reported practices for peripherally inserted central catheters (PICC), a type of CVC widely used in NNUs.We searched national guidelines for neonates and children to identify infection prevention practices for CVCs and conducted an overview of studies to determine the quality of evidence underpinning recommendations. We surveyed 134 NNUs in England and Wales to ascertain reported practice.We found low quality evidence supporting CVC care bundles and use of 2% alcoholic chlorhexidine to decontaminate catheter ports and skin before insertion. Moderate quality evidence supported recommendations against routinely replacing CVCs and against chlorhexidine-impregnated dressings. 90% (44/49) of NICUs and 40% (34/85) of LNUs responded. 66% (48/73) of NNUs reported using CVC care bundles for insertion; 62% (45/73) used bundles for maintenance. 63% (32/51) of those using bundles reported monitoring adherence. 85% (61/72) of NNUs did not routinely replace PICCs and 89% (63/71) did not use chlorhexidine-impregnated dressings. Antiseptic use varied with alcoholic 2% chlorhexidine used for skin preparation in 33% (23/71) of NNUs and for catheter ports in 52% (37/71).Lack of consistency across NNUs in antiseptic use and low rates of reported CVC care bundle use may reflect the low quality of evidence of the effectiveness and safety of these interventions in NNUs. Clinical trials are needed to quantify benefits and harms of infection prevention practices in NNUs. Central venous catheters (CVCs) allow the administration of parenteral nutrition, fluids and medication in neonatal units (NNUs). Peripherally inserted central catheters (PICCs) are a type of CVC often used in NNUs because they can be inserted at the bedside and can remain in situ for many days. However, CVCs increase the risk of bloodstream infection (BSI)., 2 NeonaIn the UK, consensus guidelines for CVC care that reduce the risk of BSI are based mainly on evidence in adults. GuidelinIn this study, we conducted an overview of national and international guidance, systematic reviews, randomised controlled trials (RCTs) and observational studies to determine the strength of evidence supporting infection prevention practices for CVCs in neonates. We also surveyed NNUs in England and Wales to determine reported adoption of these practices. We hypothesised that variation in adoption of PICC infection prevention practices would be greatest for those practices with the lowest quality supporting evidence or where evidence is uncertain or suggests the practice is potentially harmful for neonates.Five CVC infection prevention practices relevant to NNU practice and likely to be measurable by a short survey were selected from the EPIC3 UK guidelines by two neonatologists  .13] We  We 13] WWe developed a short questionnaire about PICC care practices to be completed by neonatologists or senior neonatal nursing staff in NNUs in England and Wales . QuestioAfter piloting the survey at four neonatal intensive care units (NICUs), the original survey contained 23 questions. We distributed the survey to a consultant contact at each of 134 NNUs: 49 NICUs which provide care for the most unwell or unstable babies and 85 local neonatal units (LNUs) which provide high dependency care to babies who require highly skilled staff but require a lower staff to patient ratios. Special To improve the response rate, we condensed the survey into a printable 2-page document containing 10 questions, prioritising questions judged clinically important, previously well completed, describing measurable practices or covered by existing systematic reviews. In May 2016 we re-sent the survey to NNUs that had not yet provided a complete response. In June 2016, we sent a personalised final email reminder to complete the condensed survey non-responding NICUs, which was addressed to a consultant known at the unit by the clinical investigator for the study (SO). NICUs were prioritised as they use PICCs most frequently.We counted responses from NNUs with no questions answered as non-respondents, but responses that answered at least one question were included. Where we received multiple responses from the same NNU, we included answers from the first responding consultant in the main analysis. An additional duplicate analysis compared multiple responses from the same NNU to assess consistency of answers. We classified multiple responses as in agreement if more than one professional from a NNU provided the same answer.This study did not require Research Ethics Approval as we asked staff about their usual practice. InformedThe practices selected for our study were: use of CVC care bundles for insertion and maintenance, monitoring of bundle compliance, use of chlorhexidine impregnated dressing, routine removal or replacement of CVCs, and use of 2% chlorhexidine in alcohol for skin preparation and port disinfection.We found low quality evidence supporting the use of care bundles, and cleaning catheter ports with 2% chlorhexidine in alcohol and moderate quality evidence to support recommendations to avoid use of chlorhexidine impregnated foam dressings and to avoid routine replacement of CVCs . The remWe obtained at least one response to the original survey from 28% (24/85) of LNUs and 55% (27/49) of NICUs in England and Wales . InitialForty eight responses from 21 units were analysed in the duplicate analysis. Duplicate respondents from the same NNU gave consistent answers for questions concerning use of bundles, monitoring compliance of bundles and routine replacement or removal of PICCs . HoweverTwo thirds of NNUs reported using care bundles for PICC insertion and maintenance . There wAll NNUs reported using a form of chlorhexidine for skin disinfection prior to insertion but the concentration and use of alcohol vs aqueous solutions varied with one-third using 2% chlorhexidine in alcohol . Ten res2% chlorhexidine in alcohol was the most commonly used antiseptic for cleaning catheter ports, followed by 70% isopropyl alcohol . Nine reThere was no difference in use of 2% chlorhexidine in alcohol to clean catheter ports between NNUs that use bundles and those that did not, but use of 2% chlorhexidine in alcohol as skin preparation was more common in bundle users than non-users .We found variation in adherence to recommended care practices, and a lack of high quality evidence supporting these in neonates. Reported practice from the majority of NNUs was in accordance with recommendations against routine replacement of PICCs and against use of chlorhexidine-impregnated foam dressing, supported by moderate quality evidence. Despite only low quality evidence to support the use of care bundles in neonates, the majority of NNUs reported using insertion and maintenance bundles.A strength of the study was the response rate of 88% for NICUs. The lower response rate from LNUs may reflect fewer PICC insertions in LNUs or a higher level research engagement among NICU practitioners. The high response rate from NICUs was achieved after reducing the questionnaire length and repeated personal reminders. Other studies have highlighted the importance of personal contact. A limitaVariation in chlorhexidine solutions may reflect differing interpretations of case studies that report burns for aqueous and alcoholic chlorhexidine in very preterm babies., 48, 49 Use of 2% chlorhexidine in alcohol was more common in NNUs that used care bundles than those that did not. This practice is included in the Department of Health Saving Lives care bundle and the NHS England Matching Michigan programme, both of which were evidence based interventions to reduce BSI rates in adult and paediatric intensive care., 53 TherPractices with small effect sizes may have a greater value to neonates compared to other populations due to the higher rate of BSI in NNU, therefore all practices would benefit from neonate specific evidence., 55 Antiwww.prevail.org.uk). Our findings of inconsistent practice underline the need for adequately powered RCTs to determine the effectiveness and safety of skin antiseptic agents.Further research is needed to determine the effectiveness and safety of CVC care practices for reducing BSI in neonates. A multicentre UK RCT evaluating antimicrobial impregnated versus standard PICCs for preventing BSI in preterm neonates is in progress Click here for additional data file.S1 File(DOCX)Click here for additional data file.S2 File(DOCX)Click here for additional data file.S3 File(XLSX)Click here for additional data file.


Metascience refers to the systematic process that uncovers, builds, evaluates, organizes and disseminates scientific advances. It is the principal tool at the disposal of thesociety to combat the debilitating effects of “false information” on health related data and its constituents. The roots of Western science are to be found in the philosophers of antiquity, and their observations of the matter, energy, phenomena, and the interaction between them, which together constituted their surrounding world. They called it the study of nature, or physics. Soon, they expanded their inquisitive horizon to the identification of what lied behind, or above the physical forces of nature; that is, what was "meta"-physical. With the centuries, metaphysics broke new frontiers in characterizing the fundamental nature of reality, the relationship between mind and matter, between substance and attribute, and between potentiality and actuality. But the prefix "meta" continued to be used to indicate the study of the principles that drive a given domain of inquiry. Case in point, modern cognitive psychology has two principal domains: the study of cognition and memory, and the study of the processes that drives and determines cognition and memory, and that are de facto "above" cognition and memory in se, that is meta-cognition. In brief, meta cognition is cognition about cognition, thinking about thinking, awareness of higher intellectual skills and processes.In the same vein, science can be defined as the systematic enterprise that uncovers, builds, organizes and disseminates knowledge by means of testable explanations, analyses and predictions about our psycho-physiological nature and the environment that surrounds us. Metascience is, by extension, our scientific inquiry into science itself. Metascience  is the In the last two decades, since the establishment of evidence-based medicine and evidence-based dentistry, metascience has developed, tested, verified and established a stringent methodological strategy .For everThis process results in the generation of certain key words and phrases that aid in pinpointing the exact scientific evidence that pertains to the research question. The pertinence of each uncovered report to the research question is then verified by two independent assessors. The resulting short-list of evidentiary documentation –the "bibliome"–, which is directly and uniquely pertinent to the research question, is evaluated for the level and quality of the evidence it purports to present. In brief, the level of the evidence refers to the type of study - cf. observational correlative, such as the recent report that hair dyeing seems to be associated with breast cancer risk; observational longitudinal, in which patients serve as their own control, or clinical trials, the highest producible "level of evidence". By contrast, the quality of the evidence refers to the nature of the data obtained, the structure of the sample that generated the data, the validity and reliability of the measuring instruments that produced the data, and the exactness of the statistical analysis of the data.One of great utilities of statistical analysis is its ability to dive within the information to elucidate the truth principally by minimizing that which is erroneous . The "beMetascience, like all science, is grounded not only on the stringency of its methodology and data analysis, but also of the replicability of its findings. Systematic reviews of the research literature as outlined above are the core of metascience, and must be both peer-reviewed before dissemination, and replicated before conclusions are taken as "the best available" evidence in support or in refuting the original research hypothesis.Metascience is disseminated by several means and at several levels . Formal However, neither systematic reviews nor critical summaries serve to disseminate the "best available" evidence to the patient, stakeholders, and general lay population. To achieve that most critical step in metascience dissemination, it is timely and critical "to translate" the metascientific jargon into lay language. This is an important pillar of the greater, translational model of healthcare, which is the inevitable future. The ease of communication and understanding plays a critical role in services that aid a patient-centered approach, such as telehealth and its encompassing applications -6.Today, the weakest step in the metascience endeavoris its translation to stakeholders. Scientists willing and capable of translating systematic reviews or critical summaries into easy-reading documents that coherently reflect the stringency and validity of the reported "best available" evidence are few and far between. But, no system of validation for such translations has yet been developed, standardized, validated and widely accepted in the field.Metascience involves the use of new and stringent scientific methodology to study science itself for raising the overall quality of scientific knowledge, and of ensuring the highest possible effectiveness in its patient-centered clinical applications. Metascience is research on research: the science of science in all fields from astrophysics and psychology to molecular biology; from the social and political sciences to the health sciences. In the context of health care, metascience is often referred to as evidence-based medicine/dentistry/nursing, and seeks primarily to ensure the highest possible effectiveness of evidence-based treatment in a personalized patient-centered model of clinical intervention. This translational model of healthcare stresses active involvement of the patient and stakeholders in the clinical-decision making process, and is therefore anchored in the optimization of precise and accurate, factual evidence .The very goal of metascience is to ensure that scientific progress and information grow from accurate, systematically verified, statically incontrovertible, and unquestionably true facts. It is no longer enough for our quests of minimizing false information to be limited to misinformation, i.e., inaccurate information that was made by honest error. Now, we must lend a keen eye to and actively search out disinformation – inaccurate information used intentionally to deceive. Metascience is the principal tool we have now, and must continue to develop and strengthen in the next decade to combat the undermining effects of "false information" in science in general - cf. creationism vs. evolution theory -, or in the health sciences specifically - cf., root canals cause breast cancer; anti-vaccination movement, etc. Surely, there are few greater dangers than scientific information - which is, in effect, information for the ultimate benefit of society - that is falsified, whether intentionally or not.Allen Khakshooy is currently a medical pre MD student. Ms. Quyen Bach and Vandan Kasar are currently dental pre D.D.S. students.