German emergency department measures in 2018: a status quo based on the Utstein reporting standard.

BACKGROUND: Compelling data on clinical emergency medicine is required for healthcare system management. The aim of this survey was to describe the nationwide status quo of emergency care in Germany at the healthcare system level using the Utstein reporting template as the guideline to measure the data collected. METHODS: This cross-sectional survey collected standardized data from German EDs in 2018. All 759 of the EDs listed in a previously collected ED Directory were contacted in November 2019 using the online-survey tool SoSci Survey. Exclusively descriptive statistical analyses were performed. Absolute as well as relative frequencies, medians, means, ranges, standard deviations (SD) and interquartile ranges (IQR) were reported depending on distribution. MAIN RESULTS: A total of 150 questionnaires of contacted EDs were evaluated (response rate: 19.8%). Hospitals had a median of 403 inpatient beds (n=147). The EDs recorded a median of 30,000 patient contacts (n=136). Eighty-three EDs (55%) had observation units with a median of six beds. The special patient groups were pediatric patients (< 5 years) and older patients (> 75 years) with a median of 1.7% and 25%, respectively. Outpatients accounted for 55%, while 45% were admitted (intensive care unit 5.0%, standard care unit 32.3%, observation unit 6.3%) and 1.2% transferred to another hospital. CONCLUSIONS: The use of the Utstein reporting template enabled the collection of ED descriptive parameters in Germany. The data can provide a baseline for upcoming reforms on German emergency medicine, and for international comparisons on admission rates, initial triage categories, and patient populations.

Adding Toxicological Context to Nanotoxicity Study Reporting Using the NanoTox Metadata List.

This paper proposes a list of specifications (NanoTox metadata list) to be reported about nanotoxicity experiments (metadata) together with resultant data to add toxicological context to reported studies. In areas involving nanomaterials (NMs), existing metadata reporting standards include the reporting of experimental conditions and protocols (MIRIBEL) and material characteristics (MINChar and MIAN), as well as reporting focused on specific experiments (MINBE). NanoCRED is a similarly transparent and structured framework, however, it is developed to guide risk assessors in evaluating the reliability and relevance of NM ecotoxicity studies. There is no reporting standard which would include interpretation of the aims and outcomes of nanotoxicity studies beyond regulatory purposes. The proposed NanoTox metadata reporting checklist is elaborated to extend reporting toward describing nanotoxicological context and thus is a logical complement to technology/material-assay focused reporting checklists. It is further designed to allow for NM toxicity data and knowledge integration, reuse, and communication. Its ultimate goal is to adhere to the basic rules of toxicology when taking a stand on the toxicity of NMs and to limit speculations on safety. As nanotoxicology becomes more interdisciplinary with the advent of new tools and new materials to be tested, reporting standards will contribute to cross-disciplinary communication.

Reporting items for capillaroscopy in clinical research on musculoskeletal diseases: a systematic review and international Delphi consensus.

OBJECTIVES: The level of detail included when describing nailfold videocapillaroscopy (NVC) methods varies among research studies, making interpretation and comparison of results challenging. The overarching objective of the present study was to seek consensus on the reporting standards in NVC methodology for clinical research in rheumatic diseases and to propose a pragmatic reporting checklist. METHODS: Based on the items derived from a systematic review focused on this topic, a three-step web-based Delphi consensus on minimum reporting standards in NVC was performed among members of the European League against Rheumatism (EULAR) Study Group on Microcirculation in Rheumatic Diseases and the Scleroderma Clinical Trials Consortium. RESULTS: A total of 319 articles were selected by the systematic review, and 46 items were proposed in the Delphi process. This Delphi exercise was completed by 80 participants from 31 countries, including Australia and countries within Asia, Europe, North America and South America. Agreement was reached on items covering three main areas: patient preparation before NVC (15 items), device description (5 items) and examination details (13 items). CONCLUSION: Based on the available evidence, the description of NVC methods was highly heterogeneous in the identified studies and differed markedly on several items. A reporting checklist of 33 items, based on practical suggestions made (using a Delphi process) by international participants, has been developed to provide guidance to improve and standardize the NVC methodology to be applied in future clinical research studies.

A biological perspective towards a standard for information exchange and reporting in XAS.

The complex structural landscape of biological samples and their sensitivity to X-ray exposure leads to specific challenges in biological X-ray absorption spectroscopy (bio-XAS) research, which in turn has necessitated standardization of various aspects of bio-XAS data measurement, analysis and interpretation. The bio-XAS community is therefore well suited for the development of a data-reporting standard with the specific aim of creating a feedback loop for improving/standardizing data analysis protocols and optionally to make published data available to collaborators/researchers in a meaningful and quantitative format. The XIF (XAFS information file) reporting format presented here contains key experimental and analysis parameters, useful in developing a consistent platform for bio-XAS research worldwide. Such a reporting standard, enforced by the user community and publishing groups alike, can be an important step towards the standardization of data measurement and analysis techniques in bio-XAS.

Omission of quality assurance during data entry in public health research from India: Is there an elephant in the room?

As the adage, "Garbage in, Garbage out" goes, data entry errors may lead to erroneous results and conclusions. Quality assurance during data entry is one of the most neglected components of research and is conspicuously missing in most of the reporting standards. In this study, we reviewed research studies published in Indian Journal of Public Health and Indian Journal of Community Medicine during 2014-2016 and determined the proportion of papers reporting on quality assurance during data entry. Of 110 papers, only 6 (5.5%) papers explicitly included a statement about data quality assurance, with two studies reported to have performed double entry and validation, considered the gold standard in quality-assurance of data entry. This is highly unacceptable. We hereby appeal to the community of researchers, peer reviewers, and journal editors in India to pay attention to this important aspect of research and make reporting of quality assurance of data entry mandatory in every published paper.

Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review.

BACKGROUND: The Delphi technique is widely used for the development of guidance in palliative care, having impact on decisions with relevance for patient care. AIM: To systematically examine the application of the Delphi technique for the development of best practice guidelines in palliative care. DESIGN: A methodological systematic review was undertaken using the databases PubMed, CINAHL, Web of Science, Academic Search Complete and EMBASE. DATA SOURCES: Original articles (English language) were included when reporting on empirical studies that had used the Delphi technique to develop guidance for good clinical practice in palliative care. Data extraction included a quality appraisal on the rigour in conduct of the studies and the quality of reporting. RESULTS: A total of 30 empirical studies (1997-2015) were considered for full-text analysis. Considerable differences were identified regarding the rigour of the design and the reporting of essential process and outcome parameters. Furthermore, discrepancies regarding the use of terms for describing the method were observed, for example, concerning the understanding of a 'round' or a 'modified Delphi study'. CONCLUSION: Substantial variation was found concerning the quality of the study conduct and the transparency of reporting of Delphi studies used for the development of best practice guidance in palliative care. Since credibility of the resulting recommendations depends on the rigorous use of the Delphi technique, there is a need for consistency and quality both in the conduct and reporting of studies. To allow a critical appraisal of the methodology and the resulting guidance, a reporting standard for Conducting and REporting of DElphi Studies (CREDES) is proposed.

Key issues in the STRICTA checklist. / 对STRICTAæ¸ å•å‡ ä¸ªå ³é”®é—®é¢˜çš„æ¢³ç†.

The STRICTA checklist is the guideline for reporting clinical trials undertaken using acupuncture intervention. As an extension of the CONSORT checklist, the STRICTA checklist facilitates the reporting quality of acupuncture clinical trials. The clinical research paradigm changes along with the development of science and technology. It is crucial to ensure whether or not the existing STRICTA checklist guides the reporting clinical trials of acupuncture now and in the future as well. This paper introduces the development and the updating procedure of the STRICTA checklist, analyzes the characteristics of utility and the limitation, and proposes several suggestions on the difficulties and challenges encountered in the implementation of the STRICTA checklist of current version so as to advance the further update and improvement.

Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs).

BACKGROUND: Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline. METHODS: An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline. RESULTS: We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains. CONCLUSIONS: The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline. TRIAL REGISTRATION: EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.

Development of a core domain set for nailfold capillaroscopy reporting.

BACKGROUND: The peripheral microangiopathy may be well evaluated and studied by nailfold capillaroscopy (NFC) which is a safe and non-invasive technique. NFC has been reported to have both diagnostic and prognostic values in patients presenting with Raynaud's phenomenon. OBJECTIVE: The overarching objective of this work was to make a consensus on what domains should be included in a capillaroscopy report and that it can be used in daily clinical practice and clinical research in the area of rheumatology. METHODS: A Delphi questionnaire was developed regarding capillaroscopy report from a literature review and expert consensus. The first Delphi round included 14 core areas, its 18 domains with 50 subdomains, derived from a systematic literature review. The level of evidence was determined for each core set using the Oxford Centre for Evidence-based Medicine (CEBM) system. Nine response categories have been set per each item ranging between 1 and 9. Round 2, aimed to reach preliminary consensus "in" or "out" for domains. It included all items that were rated "critical" by at least 80% of the participants as well as any new domains proposed in round 1. RESULTS: The participants to the first, and second round were 11 experts. Fourteen domains were discussed in the two rounds. At the end of the survey, the final report template of NFC in rheumatology reached a consensus. CONCLUSION: A nailfold capillaroscopy report template has been developed by this study, based on outcomes of a Delphi process, by international participants panel. All domains met the 80% voting threshold set in this work. The reporting template can be used for both clinical research as well as day to day practice to provide guidance and standardize the NFC reporting.

Reporting standards for child health research were few and poorly implemented.

OBJECTIVES: This study aims to identify existing reporting standards for child health research, assess the robustness of the standards development process, and evaluate the dissemination of these standards. STUDY DESIGN AND SETTING: We searched MEDLINE, the EQUATOR Network Library, and Google to identify reporting standards for child health research studies. We assessed the adherence of the Guidance for Developers of Health Research Reporting Guidelines (GDHRG) by the identified reporting standards. We also assessed the use of the identified reporting standards by primary research studies, and the endorsement of the included reporting standards by journals. RESULTS: We identified six reporting standards for child health research, including two under development. Among the four available standards their median adherence to the 18 main steps of the GDHRG was 58.35% (range: 27.8%-83.3%). None of these four reporting standards had been endorsed by pediatric journals indexed by the Science Citation Index. Only 26 primary research studies declared that they followed one of the reporting standards. CONCLUSION: There is a quantitative and qualitative paucity of well-developed reporting standards for child health research. The available standards are also poorly implemented. This situation demands an urgent need to develop robust standards and ensure their implementation.

Quality Evaluation and Reporting Specification for Real-World Studies of Traditional Chinese Medicine.

In recent years, the real-world studies (RWS) have attracted extensive attention, and the real-world evidence (RWE) has been accepted to support the drug development in China and abroad. However, there is still a lack of standards for the evaluation of the quality of RWE. It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine (TCM). To this end, under the guidance of China Association of Chinese Medicine, the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine (QUERST) Group, including 24 experts (clinical epidemiologists, clinicians, pharmacologists, ethical reviewer and statisticians), was established to develop the specification. This specification contains the listing of classification of RWS design and RWE, the general principles and methods of RWE quality evaluation (26 tools or scales), 25 types of bias in RWS, the special considerations in evaluating the quality of RWE of TCM, and the 19 reporting standards of RWE. This specification aims to propose the quality evaluation principles and key points of RWE, and provide guidance for the proper use of RWE in the development of TCM new drugs.

Kidney Exchange Program Reporting Standards: Evidence-Based Consensus From Europe.

Background: Kidney Exchange Programs can play an important role to increase access to the life saving and most cost-effective treatment for End Stage Renal Disease. The rise of national KEPs in Europe brings a need for standardized performance reporting to facilitate the development of an international evidence base on program practices. Methods: We systematically searched and reviewed the literature to extract kidney exchange program performance measures. Reported measures were initially categorized as structure, process, and outcome measures. Expert feedback was used to redefine categories and extend the set of measures to be considered. Using the Delphi method and a panel of 10 experts, the resulting measures were subsequently classified as mandatory (Base set), optional (Extended set), or deleted. Results: Out of the initial 1,668 articles identified by systematic literature search, 21 European publications on kidney exchange programs were included to collect performance measures, accompanied by three national program reports. The final measurement categories were Context, Population, Enrollment, Matching, Transplantation, and Outcomes. The set of performance measures resulting from the literature review was modified and classified as mandatory or optional. The resulting Base set and Extended set form the kidney exchange program reporting standard. Conclusions: The evidence-based and consensus-based kidney exchange program reporting standard can harmonize practical and scientific reporting on kidney exchange programs, thus facilitating the advancement of national programs. In addition, the kidney exchange program reporting standard can promote and align cross-national programs.

Spatial Lifecourse Epidemiology Reporting Standards (ISLE-ReSt) statement.

Spatial lifecourse epidemiology is an interdisciplinary field that utilizes advanced spatial, location-based, and artificial intelligence technologies to investigate the long-term effects of environmental, behavioural, psychosocial, and biological factors on health-related states and events and the underlying mechanisms. With the growing number of studies reporting findings from this field and the critical need for public health and policy decisions to be based on the strongest science possible, transparency and clarity in reporting in spatial lifecourse epidemiologic studies is essential. A task force supported by the International Initiative on Spatial Lifecourse Epidemiology (ISLE) identified a need for guidance in this area and developed a Spatial Lifecourse Epidemiology Reporting Standards (ISLE-ReSt) Statement. The aim is to provide a checklist of recommendations to improve and make more consistent reporting of spatial lifecourse epidemiologic studies. The STrengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement for cohort studies was identified as an appropriate starting point to provide initial items to consider for inclusion. Reporting standards for spatial data and methods were then integrated to form a single comprehensive checklist of reporting recommendations. The strength of our approach has been our international and multidisciplinary team of content experts and contributors who represent a wide range of relevant scientific conventions, and our adherence to international norms for the development of reporting guidelines. As spatial, location-based, and artificial intelligence technologies used in spatial lifecourse epidemiology continue to evolve at a rapid pace, it will be necessary to revisit and adapt the ISLE-ReSt at least every 2-3 years from its release.

American College of Radiology Thyroid Imaging Reporting and Data System standardises reporting of thyroid ultrasounds.

BACKGROUND: Thyroid nodules are common, the majority benign. The small risk of malignancy leads to excessive workup. Thyroid ultrasound is essential for risk stratification and management guidance. Without an organised reporting guideline, reports do not add significant value to referring clinicians. The American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) was developed to aid ultrasound reporting, lessen excessive biopsies and diagnose thyroid cancers. OBJECTIVES: To standardise reporting of thyroid ultrasounds by utilising an organised reporting guideline based on ACR TI-RADS. METHOD: Thyroid ultrasound reports generated by radiology registrars at an academic hospital were studied in two phases. In Phase 1, the reports were generated as free text, and in Phase 2, using a guideline based on ACR TI-RADS. The percentages of reports that described the maximum size, the five ACR TI-RADS features and a management recommendation were compared. RESULTS: A total of 130 reports were studied. Significant improvement was observed in the description of all five ACR TI-RADS categories (p < 0.0001) from Phase 1 to Phase 2. Of all the reports, 89% included a management recommendation. Reports including an ACR TI-RADS-based recommendation increased from 48% to 75% (p < 0.05). Recommendation for biopsy increased from 35.4% to 53.8% (p < 0.05). CONCLUSION: Introduction of an organised reporting guideline based on ACR TI-RADS, standardised reporting of thyroid ultrasounds by increasing description of thyroid nodule features and ensuring appropriate management recommendations. This, in future, will prevent underdiagnosis of thyroid cancer and unnecessary workup of benign nodules.

Investigation and analysis of the current situation of case reporting ethical review and patient informed consent reports in comprehensive journals of clinical medicine in China / 中国医学伦理学

ObjectiveTo investigate and analyze case reporting ethical review and patient informed consent reports published in the comprehensive journals of clinical medicine in China in 2022. MethodsAccording to the data from the 2022 Edition of the Chinese Science and Technology Journal of the Citation Reports （Extended Version），the case reports published in comprehensive journals of clinical medicine in 2022 were selected as the research objects.The information on ethics and patient informed consent was extracted from the case reports that met the selection criteria，and Microsoft Excel 2021 and SPSS 21.0 were used to sort out and analyze the data. ResultsA total of 587 case reporting articles were published in the 42 included journals in 2022，of which 36 （6.13%） reported on science and technology ethics and/or informed consent.Case reports reporting on science and technology ethics and/or informed consent mostly came from the key magazine of China technology （88.89% Vs.65.88%），and the proportion of manuscripts involving science and technology ethics on the official website of the journal was relatively high （86.11% Vs.63.88%），and the difference was statistically significant （P<0.01）. ConclusionThe proportion of case reports of science and technology ethics and/or informed consent in journals of comprehensive discipline classification of clinical medicine was relatively low.Currently，most international journals are required to obtain the informed consent of patients or legal guardians before publishing case reports.Compared with this，there are still certain gaps in China，which need to be paid great attention to.

Computational models for the assessment of manufactured nanomaterials: Development of model reporting standards and mapping of the model landscape.

Different types of computational models have been developed for predicting the biokinetics, environmental fate, exposure levels and toxicological effects of chemicals and manufactured nanomaterials (MNs). However, these models are not described in a consistent manner in the scientific literature, which is one of the barriers to their broader use and acceptance, especially for regulatory purposes. Quantitative structure-activity relationships (QSARs) are in silico models based on the assumption that the activity of a substance is related to its chemical structure. These models can be used to provide information on (eco)toxicological effects in hazard assessment. In an environmental risk assessment, environmental exposure models can be used to estimate the predicted environmental concentration (PEC). In addition, physiologically based kinetic (PBK) models can be used in various ways to support a human health risk assessment. In this paper, we first propose model reporting templates for systematically and transparently describing models that could potentially be used to support regulatory risk assessments of MNs, for example under the REACH regulation. The model reporting templates include (a) the adaptation of the QSAR Model Reporting Format (QMRF) to report models for MNs, and (b) the development of a model reporting template for PBK and environmental exposure models applicable to MNs. Second, we show the usefulness of these templates to report different models, resulting in an overview of the landscape of available computational models for MNs.

Nation-Wide Registry of Vascular Diseases

Incidence of vascular diseases in Korea has been increasing and their researches are undertaken actively. However, experience of single institute about various vascular diseases is to be limited, a nationwide vascular registry is needed for sharing common protocols and experiences. We devolped a customized vascular registry program calling VasBase for nation-wide sharing and analysis. The characteristics of VasBase are as follows; clinician-oriented intuitive software, complete adherence to vascular protocols based on practical experiences, error-free input by presetting numeric codes, data protection, multi-user tasking, integration of graphic data, open source, easy modification of protocol and one-step export to statistical analysis software. We propose this VasBase as a nation-wide vascular registry program.