Accuracy and reliability of forensic handwriting comparisons.

Forensic handwriting examination involves the comparison of writing samples by forensic document examiners (FDEs) to determine whether or not they were written by the same person. Here we report the results of a large-scale study conducted to assess the accuracy and reliability of handwriting comparison conclusions. Eighty-six practicing FDEs each conducted up to 100 handwriting comparisons, resulting in 7,196 conclusions on 180 distinct comparison sets, using a five-level conclusion scale. Erroneous "written by" conclusions (false positives) were reached in 3.1% of the nonmated comparisons, while 1.1% of the mated comparisons yielded erroneous "not written by" conclusions (false negatives). False positive rates were markedly higher for nonmated samples written by twins (8.7%) compared to nontwins (2.5%). Notable associations between training and performance were observed: FDEs with less than 2 y of formal training generally had higher error rates, but they also had higher true positive and true negative rates because they tended to provide more definitive conclusions; FDEs with at least 2 y of formal training were less likely to make definitive conclusions, but those definitive conclusions they made were more likely to be correct (higher positive predictive and negative predictive values). We did not observe any association between writing style (cursive vs. printing) and rates of errors or incorrect conclusions. This report also provides details on the repeatability and reproducibility of conclusions, and reports how conclusions are affected by the quantity of writing and the similarity of content.

Evaluation and systematic review of guidance documents for status epilepticus.

Guidance documents play a pivotal role in shaping the management of status epilepticus (SE). However, the methodological quality of these documents remains uncertain. In this systematic review, we comprehensively searched 12 literature and guideline databases to assess the quality of clinical practice guidelines and consensus statements related to SE management using the AGREE II methodology. Additionally, we summarized the associated recommendations. We identified a total of 14 clinical practice guidelines and 11 consensus statements spanning the period from 1993 to 2022. The median score for clarity of presentation was 71.8% (ranging from 15.3% to 91.7%), indicating generally good clarity. However, the aspect of editorial independence received poor ratings, with a median score of 32.1% (ranging from 0% to 83.3%). Notably, the 2016 guideline published by the American Epilepsy Society in Epilepsy (AES) received the highest overall scores. Across these guidance documents, there was consistency in the definition and diagnosis of SE. However, significant variability was observed in therapeutic recommendations, particularly in terms of the timing for adding or changing medications. The methodological approaches used in most SE guidance documents require improvement, and the disparities in recommendations highlight existing gaps in evidence. Enhanced methodological rigor results in increased standardization of the guideline, consequently augmenting its reference value. Given the urgency of SE as an emergency condition, it is imperative that these documents also address relevant management strategies before admission.

Document analysis of the Foundation for a Smoke-Free World's scientific outputs and activities: a case study in contemporary tobacco industry agnogenesis.

BACKGROUND: Tobacco corporation Philip Morris International launched the Foundation for a Smoke-Free World (FSFW), a purportedly independent scientific organisation, in 2017. We aimed to systematically investigate FSFW's activities and outputs, comparing these with previous industry attempts to influence science, as identified in the recently developed typology of corporate influence on science, the Science for Profit Model (SPM). DESIGN: We prospectively collected data on FSFW over a 4-year period, 2017-2021, and used document analysis to assess whether FSFW's activities mirror practices tobacco and other industries have historically used to shape science in their own interests. We used the SPM as an analytical framework, working deductively to search for use of the strategies it identifies, and inductively to search for any additional strategies. RESULTS: Marked similarities between FSFW's practices and previous corporate attempts to influence science were observed, including: producing tobacco industry-friendly research and opinion; obscuring industry involvement in science; funding third parties which denigrate science and scientists that may threaten industry profitability; and promoting tobacco industry credibility. CONCLUSIONS: Our paper identifies FSFW as a new vehicle for agnogenesis, indicating that, over 70 years since the tobacco industry began to manipulate science, efforts to protect science from its interference remain inadequate. This, combined with growing evidence that other industries are engaging in similar practices, illustrates the urgent need to develop more robust systems to protect scientific integrity.

Peer creation and sharing of mnemonics in collaborative documents for pathology education: a pilot study.

BACKGROUND: Mnemonic techniques are memory aids that could help improve memory encoding, storage, and retrieval. Using the brain's natural propensity for pattern recognition and association, new information is associated with something familiar, such as an image, a structure, or a pattern. This should be particularly useful for learning complex medical information. Collaborative documents have the potential to revolutionize online learning because they could increase the creativity, productivity, and efficiency of learning. The purpose of this study was to investigate the feasibility of combining peer creation and sharing of mnemonics with collaborative online documents to improve pathology education. METHODS: We carried out a prospective, quasi-experimental, pretest-posttest pilot study. The intervention group was trained to create and share mnemonics in collaborative documents for pathological cases, based on histopathological slides. The control group compared analog and digital microscopy. RESULTS: Both groups consisted of 41 students and did not reveal demographic differences. Performance evaluations did not reveal significant differences between the groups' pretest and posttest scores. Our pilot study revealed several pitfalls, especially in instructional design, time on task, and digital literacy, that could have masked possible learning benefits. CONCLUSIONS: There is a gap in evidence-based research, both on mnemonics and on CD in pathology didactics. Even though, the combination of peer creation and sharing of mnemonics is very promising from a cognitive neurobiological standpoint, and collaborative documents have great potential to promote the digital transformation of medical education and increase cooperation, creativity, productivity, and efficiency of learning. However, the incorporation of such innovative techniques requires meticulous instructional design by teachers and additional time for students to become familiar with new learning methods and the application of new digital tools to promote also digital literacy. Future studies should also take into account validated high-stakes testing for more reliable pre-posttest results, a larger cohort of students, and anticipate technical difficulties regarding new digital tools.

Pass or fail: Teachers' experience of assessment of postgraduate critical care nursing students' competence in placement. A qualitative study.

BACKGROUND: Learning in placement is essential to postgraduate critical care nursing students' education. Assessment of students' competence in placement is important to ensure highly qualified postgraduate critical care nurses. The placement model applied in Norway involves students being assessed by a preceptor in practice and a teacher from the university. The teacher has a more distant role in placement, and the aim of this study was to explore how the teachers experience the assessment of postgraduate critical care nursing students' competence in placement. Additionally, to explore the content of assessment documents used for postgraduate critical care nursing placement education in Norway. METHODS: This study has a qualitative design with main data collection from individual interviews with 10 teachers from eight universities and colleges in Norway. Additionally, we performed a document analysis of assessment documents from all 10 universities and colleges providing postgraduate critical care nursing education in Norway. We followed the Consolidated Criteria for Reporting Qualitative Research. RESULTS: The teachers experienced the assessment of postgraduate critical care nursing students' competence in placement as important but complex, and some found it difficult to determine what critical care nursing competence is at advanced level. A thematic analysis resulted in one main theme: "Teacher facilitates the bridging between education and practice." Furthermore, three themes were identified: "Assessment based on trust and shared responsibility"; "The teacher's dual role as judge and supervisor"; and "A need for common, clear and relevant assessment criteria". CONCLUSIONS: Teachers have a key role in placement as they contribute to the bridging between education and practice by providing valuable pedagogical and academic input to the assessment process. We suggest that more teachers should be employed in joint university and clinical positions to enhance the collaboration between practice and education. Clear and relevant assessment criteria are essential for providing assessment support for both students and educators. Education and practice should collaborate on developing assessment criteria. Further, there is a need to collaborate on developing, both nationally and internationally, common, clear, relevant and user-friendly assessment tools.

Social justice in Canadian nursing professional documents: A Foucauldian discourse analysis.

Social justice is widely advanced as a central nursing value, and yet conceptual understandings of social justice remain inconsistent and vague. Further, despite persistently articulated commitments to upholding social justice, the profession of nursing has been implicated in perpetuating inequities in health and health care. In this context, it is essential to establish both conceptual clarity and tangible guidance for nurses in enacting practices to advance social justice-particularly through regulatory, education and accreditation documents that shape the nursing profession. This Foucauldian discourse analysis examines how social justice is discursively positioned within nursing professional documents in Canada, and illustrates that social justice was largely discursively excluded from these texts. Where social justice discourses were invoked, we identified that four central discursive patterns obscured and de-centred this nursing value: (i) Vague language undermined professional commitments to social justice; (ii) Constructions of knowledge and awareness de-emphasized practice; (iii) Individualism discourses minimized institutional/professional responsibility; and (iv) Aspirational language obscured present action. Extending from this analysis, we contend that the nursing profession must re-examine how social justice is understood and articulated, and call for a re-conceptualization of social justice grounded in nursing practice toward remediating inequities in health and health care.

Interfacing legitimacy - health and social care integration in Scotland.

As people, particularly those ageing and living with disabilities, struggle with how care is enacted, integrated care has gained policy purchase in the United Kingdom. Despite integration's apparent popularity, its contribution to improved care for people has been questioned, exposing uncertainties about its associated benefits. Nonetheless, over decades a remarkably consistent approach to integrated care has advanced partnerships between the NHS and local government. Accordingly, in 2014 the Scottish Government mandated Health and Social Care Integration (HSCI) via the Scottish Public Bodies (Joint Working) (Scotland) Act. Emerging from an interorganisational ethnography of the implementation of a Health and Social Care Partnership in 2016, in a place I call 'Kintra', I interrogated what happened when NHS Kintra and Kintra Council endeavoured to implement HSCI according to the precepts of 'the Act'. Immersed in the everyday arrangements in the spaces of governance, I attended to how these policy actors worked to both (re)configure and held things together behind care frontiers, and away from the bodywork of direct care. I charted their efforts to comply with regulations, plan, and build governance apparatuses through documents. In following documents, I show the ways in which HSCI was materialised through documentation. I reveal how, in the mundane mattering of document manufacturing, possibilities for (re)forming the carescape emerged. I deploy a posthuman practice stance to show not only the way in which 'papery' partnerships between the NHS and local government 'enact' care, but also how they make worlds through a sociomaterial politics of anticipation.

Exome and genome sequencing for rare genetic disease diagnosis: A scoping review and critical appraisal of clinical guidance documents produced by genetics professional organizations.

PURPOSE: Exome and genome sequencing have rapidly transitioned from research methods to widely used clinical tests for diagnosing rare genetic diseases. We sought to synthesize the topics covered and appraise the development processes of clinical guidance documents generated by genetics professional organizations. METHODS: We conducted a scoping review of guidance documents published since 2010, systematically identified in peer-reviewed and gray literature, using established methods and reporting guidelines. We coded verbatim recommendations by topic using content analysis and critically appraised documents using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool. RESULTS: We identified 30 guidance documents produced by 8 organizations (2012-2022), yielding 611 recommendations covering 21 topics. The most common topic related to findings beyond the primary testing indication. Mean AGREE II scores were low across all 6 quality domains; scores for items related to rigor of development were among the lowest. More recently published documents generally received higher scores. CONCLUSION: Guidance documents included a broad range of recommendations but were of low quality, particularly in their rigor of development. Developers should consider using tools such as AGREE II and basing recommendations on living knowledge syntheses to improve guidance development in this evolving space.

Effectiveness of behavioural interventions to influence COVID-19 outcomes: A scoping review.

Behavioural non-pharmaceutical interventions (NPIs) (e.g., mask wearing, quarantine, restriction on gatherings, physical distancing) have been used to interrupt transmission of COVID-19 and to reduce the impacts of the pandemic. The aim of this scoping review was to document the efficacy of behavioural NPIs to positively influence COVID-19 outcomes. Following PRISMA guidelines, a systematic search was conducted of PubMed, ScienceDirect, Psych INFO, Medline, CINAHL and Scopus for studies published between January 2020 and February 2023. Seventy -seven studies were eligible to be included in the review. Majority of the studies were conducted in high-income countries, with fewer studies in low- or middle-income countries. School closure, mask wearing, and non-essential business closure and shelter-in-place orders were the most prevalent NPIs investigated. School closure and mask wearing reported high effectiveness while shelter-in-place orders reported less effectiveness. Shelter-in-place orders when used in conjunction with other measures, did not enhance effectiveness. Public event bans, physical distancing, handwashing, and travel restrictions were largely effective, while the effectiveness of gathering restrictions depended on the limitation on numbers. Early implementation was associated with a higher effectiveness in reducing COVID-19 cases and deaths, the use of behavioural NPIs in combinations was reported to yield more effective results. Moreover, behavioural NPIs were reported to be dependent on their consistent use and were difficult behaviours to maintain, highlighting the need for behavioural change. This review highlighted the effectiveness of behavioural NPIs to positively influence COVID-19 reduction outcomes. Further research to promote country- and context-specific documents that will enhance the effectiveness of behavioural NPIs.

An open source corpus and automatic tool for section identification in Spanish health records.

BACKGROUND: Electronic Clinical Narratives (ECNs) store valuable individual's health information. However, there are few available open-source data. Besides, ECNs can be structurally heterogeneous, ranging from documents with explicit section headings or titles to unstructured notes. This lack of structure complicates building automatic systems and their evaluation. OBJECTIVE: The aim of the present work is to provide the scientific community with a Spanish open-source dataset to build and evaluate automatic section identification systems. Together with this dataset, the purpose is to design and implement a suitable evaluation measure and a fine-tuned language model adapted to the task. MATERIALS AND METHODS: A corpus of unstructured clinical records, in this case progress notes written in Spanish, was annotated with seven major section types. Existing metrics for the presented task were thoroughly assessed and, based on the most suitable one, we defined a new B2 metric better tailored given the task. RESULTS: The annotated corpus, as well as the designed new evaluation script and a baseline model are freely available for the community. This model reaches an average B2 score of 71.3 on our open source dataset and an average B2 of 67.0 in data scarcity scenarios where the target corpus and its structure differs from the dataset used for training the LM. CONCLUSION: Although section identification in unstructured clinical narratives is challenging, this work shows that it is possible to build competitive automatic systems when both data and the right evaluation metrics are available. The annotated data, the implemented evaluation scripts, and the section identification Language Model are open-sourced hoping that this contribution will foster the building of more and better systems.

Tobacco company agreements with tobacco retailers for price discounts and prime placement of products and advertising: a scoping review.

OBJECTIVE: The objectives of this scoping review are to examine existing research on the often-secretive contracts between tobacco manufacturers and retailers, to identify contract requirements and incentives, and to assess the impact of contracts on the sales and marketing of tobacco products in the retail setting. DATA SOURCES: The systematic search was conducted in PubMed/MEDLINE, Web of Science, Scopus, ProQuest Political Science Database, Business Source Premier, ProQuest Agricultural & Environmental Science Collection, and Global Health through December 2020. STUDY SELECTION: We included studies that collected and analysed empirical data related to tobacco contracts, tobacco manufacturers, and tobacco retailers. Two reviewers independently screened all 2786 studies, excluding 2694 titles and abstracts and 65 full texts resulting in 27 (0.97%) included studies. DATA EXTRACTION: Study characteristics, contract prevalence, contract requirements and incentives, and the influence of contracts on the retail environment were extracted from each study. DATA SYNTHESIS: We created an evidence table and conducted a narrative review of included studies. CONCLUSIONS: Contracts are prevalent around the world and handsomely incentivise tobacco retailers in exchange for substantial manufacturer control of tobacco product availability, placement, pricing and promotion in the retail setting. Contracts allow tobacco companies to promote their products and undermine tobacco control efforts in the retail setting through discounted prices, promotions and highly visible placement of marketing materials and products. Policy recommendations include banning tobacco manufacturer contracts and retailer incentives along with more transparent reporting of contract incentives given to retailers.

Variations in cigarette brand characteristics: can consumers tell the difference?

OBJECTIVES: Sensory experience is an important determinant of smoking initiation, brand choice and harm perception, but little is known about how cigarette design shapes sensory experience. This study reports which variations in tobacco blend and design characteristics available on the market are likely to be perceived as different by consumers. METHODS: Truth Tobacco Industry Documents was reviewed for studies showing noticeable sensory differences resulting from variations in tobacco blend and design characteristics. These differences were compared with tobacco product data as available in the Dutch section of the European Common Entry Gate (EU-CEG) system on 30 April 2020. RESULTS: Industry documents identified discrimination thresholds for ventilation, pressure drop, tobacco weight, filter length, and tar and nicotine levels in smoke while evidence for other design characteristics was less conclusive. In the 103 different cigarette varieties in the EU-CEG database, five main types of cigarettes could be identified by principal component analysis, differing in (combinations of) design characteristics. The most significant differences between brand varieties were tar, nicotine and carbon monoxide emissions and associated parameters filter ventilation, filter length, cigarette length and tobacco weight. CONCLUSIONS: While some clusters of brand varieties provided a noticeably different product for consumers, in many cases design differences within these clusters did not exceed the expected discrimination threshold. This indicates that many products on the market are not discernibly different for consumers, and that proliferation of brand varieties has a non-sensory purpose, such as marketing. Policy makers should consider limiting available brand varieties and regulating design characteristics to reduce product appeal.

Tactics of the tobacco industry in an Arab nation: a review of tobacco documents in Oman.

BACKGROUND: Few studies have investigated tobacco industry interference in the tobacco control policies of Arab nations. This paper explores the tactics used by the industry to subvert tobacco control policies in Oman and offers lessons on how to prevent such interference in the future. METHODS: We searched the Truth Tobacco Industry Documents Archive using the word 'Oman', names of government institutions, policymakers and local tobacco distributors. Extracted data were noted chronologically by key elements of tobacco control measures. Gulf Cooperation Council (GCC) Health Ministers' Council resolutions on tobacco control were also reviewed. RESULTS: Out of 1020 tobacco documents located, 327 were closely related to policy interference. Documents revealed that the industry met key government officials, offered in-kind services, used local diplomatic missions to influence Omani policymakers, opposed smoking bans, delayed regulations to lower tar and nicotine content of cigarettes, and to require effective health warnings, circumvented a tobacco advertising, promotion and sponsorship ban and provided voluntary codes as an alternative to effective regulations. Additionally, industry representatives lobbied individual countries in the GCC to veto tax increments and defeat consensus on agreed resolutions of the Health Ministers' Council. CONCLUSION: The tobacco industry interfered in all key public health policies aimed to reduce tobacco use in Oman. There is an urgent need for the Omani government to enforce the Civil Code of Conduct and develop guidelines for all policymakers through implementing Article 5.3 of the WHO Framework Convention on Tobacco Control to curb the tobacco epidemic.

'No-Barriers' tobacco product? Selling smokeless tobacco to women, people of colour and the LGBTQ+ community in the USA.

BACKGROUND: In both Sweden and the USA, smokeless tobacco (ST) is legal and used predominantly by men. Starting in the 1970s, US tobacco companies attempted to expand the ST market to women, African Americans, Hispanic Americans and lesbian, gay, bisexual, transgender, queer and other sexual orientation (LGBTQ+) people. DESIGN: We analysed industry documents from the Truth Tobacco Industry Documents Library triangulating findings with recent ST advertising and publicly available literature. FINDINGS: We found tobacco companies used design innovations such as pouched moist snuff, snus and dissolvable products to expand the market. In addition, diverse advertising campaigns targeted women, people of colour (Hispanic, African American) and LGBTQ+ communities with identity-targeted messages emphasising novelty, convenience, cleanliness and use in smoke-free environments. However, stereotypes of ST users as rural white males endured, perpetuated by continued marketing aimed at this customer base, which created cognitive dissonance and stymied marketer's hopes that pouch products would 'democratize' ST. CONCLUSION: These failed campaigns suggest novel products such as nicotine pouch products may provide a 'clean slate' to similarly target women and other low-ST-using groups. Based on this history, the risk of new tobacco and nicotine products to increase health disparities should be closely monitored.

Tobacco industry strategies for flavour capsule cigarettes: analysis of patents and internal industry documents.

BACKGROUND: The global market for flavour capsule variants (FCVs), cigarettes with a crushable flavour capsule, has grown exponentially. To inform further regulatory efforts, it is important to understand tobacco industry strategies for FCVs. METHODS: Analysis of data from 65 patents and 179 internal tobacco industry documents, retrieved via snowball searches in Patsnap and the Truth Tobacco Industry Documents Library, describing tobacco industry developments related to FCVs. We used an inductive coding method to identify themes relating to FCV features or developments. RESULTS: Tobacco companies were developing FCVs since the 1960s, with little market success until the 2000s following the launch of Camel Crush, a brand which targeted millennials (in their teens or early 20s at the time). Tobacco companies have patented, but not yet marketed, FCVs with microcapsule surface coatings, adjustable or heat-triggered flavour release systems, airflow manipulation features, transparent filters to visualise flavour release, and various flavours and additives for capsules including nicotine/tobacco extracts for an on-demand nicotine hit. Tobacco companies developed FCVs purported to be reduced harm, although their own tests showed that FCVs have higher toxicant concentrations. They have also developed loose flavour capsule units designed to fit into cigarettes, packs, or recessed filters to enable users to customise cigarettes and circumvent tobacco flavour bans. CONCLUSIONS: To prevent tobacco companies from targeting young people and exploiting regulatory loopholes, regulations on tobacco products should ban flavours and consider the broad variety of FCV designs, additives and loose products designed to impart flavour into tobacco products.

Tobacco industry's 'behind the scenes' tactics in Singapore.

BACKGROUND: Tobacco companies have maintained a profitable business in Singapore, despite its strong anti-tobacco climate and commitment to protect public health policymaking from tobacco industry interference in line with Framework Convention on Tobacco Control Article 5.3. This study describes how tobacco companies influence policymaking in a highly regulated environment such as Singapore's, where there is a strong government commitment to Article 5.3. METHODS: Analysis of internal tobacco industry documents detailing the industry's lobbying activities in Singapore, retrieved via snowball searches in the Truth Tobacco Industry Documents Library. Subsequently, we conducted one-on-one interviews with key informants from sectors mentioned in the documents (academia, arts, government, public health, media, trade, education) to fill gaps in information and provide context to events described in the documents. RESULTS: In the 1980s and 1990s, tobacco companies observed that, to influence policy within Singapore's 'hostile' environment, they needed to use 'behind the scenes' tactics, targeting influential individuals at social functions or industry-sponsored events. Tobacco companies used arts and education sponsorships primarily for political purposes, to gain visibility with policymakers. Tobacco companies cultivated relationships with academic researchers and the media to avoid smoke-free legislation in the 1990s and, in the 2010s, appear to have used similar tactics to challenge Singapore's e-cigarette ban. CONCLUSIONS: Countries with a strong commitment to Article 5.3 should consider the tobacco industry's potential interference in policymaking beyond relationships in the government sector, particularly in academia, arts, education and the media, and the more subtle or indirect manners in which these relationships are built.

Advance Statements for Black African and Caribbean people (AdStAC): protocol for an implementation study.

BACKGROUND: The UK government committed to legislating for Advance Choice Documents/Advance Statements (ACD/AS) following their recommendation by the Independent Review of the MHA (2018). ACDs/AS are yet to be implemented in routine practice despite evidence and high demand; they are associated with improved therapeutic relationships and a reduction (25%, RR 0.75, CI 0.61-0.93) in compulsory psychiatric admission. Barriers to their implementation are well documented, ranging from low knowledge levels to logistical challenges in accessing the content during episodes of acute care. In the UK this is an issue for Black people, who experience detention rates disproportionately (over three times) higher than those of White British people and have poorer care experiences and outcomes. ACDs/AS allow for Black people to have their concerns heard by mental health professionals in a care system where they often feel their views are ignored. AdStAC aims to improve Black service users' experiences in mental health services in South London by co-producing and testing an ACD/AS implementation resource with Black service users, mental health professionals and carers/supporters of Black service users. METHODS/DESIGN: The study will take place in South London, England over three phases: 1) formative work through stakeholder workshops; 2) co-production of resources through a consensus development exercise and working groups; and 3) testing of the resources using quality improvement (QI) methods. A lived experience advisory group, staff advisory group and project steering committee will support the study throughout. The implementation resources will comprise: advance choice document/advance statement (ACD/AS) documentation, stakeholder trainings, a manual for mental health professionals to facilitate the processes of creating and revising advance statements, and informatics development. DISCUSSION: The implementation resources will help increase the likelihood of the new mental health legislation in England being implemented effectively; through aligning evidence-based medicine, policy and law to effectively provide positive clinical, social and financial outcomes for Black people, the National Health Service (NHS) and wider society. This study will likely benefit a wider group of people with severe mental illness, as when marginalised groups who are least engaged, can be supported with these strategies, then the strategies are likely to work for others.

From the Integrity of Potency Assays to Safe Clinical Intervention: Legal Perspectives.

Potency assays associated with the efficacy of investigational pharmaceutical products are one of the critical quality attributes that need to be carefully monitored during advanced therapy medicinal product (ATMP) development projects. Ensuring integrity of relevant potency assays for stem cell-based ATMPs is of paramount importance for safety and efficacy of clinical interventions. Yet, due to the complex and heterogeneous nature of stem cell-based ATMPs, creation of an appropriate set of potency assays is associated with a number of specific challenges ranging from intrinsic and operational to legal and regulatory ones. This chapter provides an overview of the EU regulatory landscape for advanced therapies, highlighting important aspects that need to be taken into consideration when preparing a strategic plan to meet the EU regulatory requirements.

Evaluation of Adult and Pediatric Chiari Type 1 Malformation Patients: Do Consensus Documents Fit Everyday Practice?

The management of Chiari 1 malformation (CM1) and Syringomyelia (Syr) has shown many changes in surgical indications and techniques over time. The dedicated neurosurgical and neurological community recently planned to analyze the state of the art and find conduct uniformity. This led to international consensus documents on diagnostic criteria and therapeutic strategies. We aimed to evaluate, in a large, monocentric surgical series of adult and children CM1 patients, if the daily clinical practice reflects the consensus documents. Our series comprises 190 pediatric and 220 adult Chiari patients submitted to surgery from 2000 to 2021. The main indications for the treatment were the presence of Syr and symptoms related to CM1. While there is great correspondence with the statements derived from the consensus documents about what to do for Syr and symptomatic CM1, the accordance is less evident in CM1 associated with craniosynostosis or hydrocephalus, especially when considering the early part of the series. However, we think that performing such studies could increase the homogeneity of surgical series, find a common way to evaluate long-term outcomes, and reinforce the comparability of different strategies adopted in different referral centers.

Assessing the Readability of Online Patient Education Materials in Obstetrics and Gynecology Using Traditional Measures: Comparative Analysis and Limitations.

BACKGROUND: Patient education materials (PEMs) can be vital sources of information for the general population. However, despite American Medical Association (AMA) and National Institutes of Health (NIH) recommendations to make PEMs easier to read for patients with low health literacy, they often do not adhere to these recommendations. The readability of online PEMs in the obstetrics and gynecology (OB/GYN) field, in particular, has not been thoroughly investigated. OBJECTIVE: The study sampled online OB/GYN PEMs and aimed to examine (1) agreeability across traditional readability measures (TRMs), (2) adherence of online PEMs to AMA and NIH recommendations, and (3) whether the readability level of online PEMs varied by web-based source and medical topic. This study is not a scoping review, rather, it focused on scoring the readability of OB/GYN PEMs using the traditional measures to add empirical evidence to the literature. METHODS: A total of 1576 online OB/GYN PEMs were collected via 3 major search engines. In total 93 were excluded due to shorter content (less than 100 words), yielding 1483 PEMs for analysis. Each PEM was scored by 4 TRMs, including Flesch-Kincaid grade level, Gunning fog index, Simple Measure of Gobbledygook, and the Dale-Chall. The PEMs were categorized based on publication source and medical topic by 2 research team members. The readability scores of the categories were compared statistically. RESULTS: Results indicated that the 4 TRMs did not agree with each other, leading to the use of an averaged readability (composite) score for comparison. The composite scores across all online PEMs were not normally distributed and had a median at the 11th grade. Governmental PEMs were the easiest to read amongst source categorizations and PEMs about menstruation were the most difficult to read. However, the differences in the readability scores among the sources and the topics were small. CONCLUSIONS: This study found that online OB/GYN PEMs did not meet the AMA and NIH readability recommendations and would be difficult to read and comprehend for patients with low health literacy. Both findings connected well to the literature. This study highlights the need to improve the readability of OB/GYN PEMs to help patients make informed decisions. Research has been done to create more sophisticated readability measures for medical and health documents. Once validated, these tools need to be used by web-based content creators of health education materials.