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Abstract Simulation studies are essential tools to assess statistical methods. Functioning as controlled experiments, simulations generate data from known underlying processes. However, unclear or incomplete reporting of simulation studies can impact their interpretability and reproducibility, potentially leading to the misuse of statistical methods. While Morris et al. (2019, Stat Med, 38, p. 2074) recently provided guidance on the planning and conduct of simulation studies for statistical method evaluation, there is currently no comprehensive set of reporting guidelines in ecology and evolutionary biology. Here, we propose 11 reporting items for statistical simulation studies extending on Morris and colleagues' guidance. These items span across three stages: planning, coding and analysis. We also clarify the terminology related to statistical components and the broad purposes of statistical simulation studies. To highlight our proposed reporting items with current practices, we surveyed 100 articles in ecology and evolution journals that included a simulation study evaluating a statistical method. Our survey found room for improvement in more transparent reporting to ensure clear evaluation of statistical methods. Most notably, only a small proportion of articles reported a Monte Carlo uncertainty (17%; 17 out of 98), and 32% (32 out of 100) articles did not provide code. Beyond the proposed reporting items, we discuss the benefits of open science tools to enhance the reproducibility of simulation studies. Specifically, we propose the registration of statistical simulation studies to enhance planning, reporting and collaboration. We aim to instigate discussions to improve the reporting of simulation studies for statistical method research. The reporting items we propose, along with open science tools, serve as a template for developing standards and guidelines for simulation studies evaluating statistical methods. These reporting guidelines will help enhance reproducibility and indirectly encourage more consideration in the design and conduct of these simulation studies.

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Objectives: A recent applicability study highlighted the need for the existing checklist for reporting research using a simulated patient methodology (CRiSP) to be clearer and user-friendly. The aim of this study was to update the checklist to address these concerns. Methods: A fourth round of the Delphi consensus study, used in the original checklist development work, was conducted. Previous participants, who had expertise in SP methodology, were invited to complete a questionnaire including a list of 13 checklist items developed in the previous study and revised following applicability testing. Closed questions were analysed for frequency. Consensus was predefined as >80% agreement. All items were discussed in a roundtable meeting and further modified as necessary. Responses to open questions were content analysed. Key findings: Twenty-one authors participated. There was a statistical consensus in 12 out of 13 modified checklist items. Conclusions: A final reporting checklist for studies in health research using SP methodology has been developed using a consensus approach. Further refinements may be needed to increase the generalizability of the checklist in different contexts. [ABSTRACT FROM AUTHOR]

Objectives: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." Methods: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. Results: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. Conclusions: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research. [ABSTRACT FROM AUTHOR]

Abstract Background An increasing number of evaluations of social accountability (SA) interventions have been published in the past decade, however, reporting gaps make it difficult to summarize findings. We developed the Social Accountability Reporting for Research (SAR4Research) checklist to support researchers to improve the documentation of SA processes, context, study designs, and outcomes in the peer reviewed literature and to enhance application of findings. Methods We used a multi-step process, starting with an umbrella review of reviews on SA to identify reporting gaps. Next, we reviewed existing guidelines for reporting on behavioral interventions to determine whether one could be used in its current or adapted form. We received feedback from practitioners and researchers and tested the checklist through three worked examples using outcome papers from three SA projects. Results Our umbrella review of SA studies identified reporting gaps in all areas, including gaps in reporting on the context, intervention components, and study methods. Because no existing guidelines called for details on context and the complex processes in SA interventions, we used CONSORT-SPI as the basis for the SAR4Research checklist, and adapted it using other existing checklists to fill gaps. Feedback from practitioners, researchers and the worked examples suggested the need to eliminate redundancies, add explanations for items, and clarify reporting for quantitative and qualitative study components. Conclusions Results of SA evaluations in the peer-reviewed literature will be more useful, facilitating learning and application of findings, when study designs, interventions and their context are described fully in one or a set of papers. This checklist will help authors report better in peer-reviewed journal articles. With sufficient information, readers will better understand whether the results can inform accountability strategies in their own contexts. As a field, we will be better able to identify emerging findings and gaps in our understanding of SA.

• Traditional, Complementary and Integrative Medicine (TCIM) research is challenging. • Modifications to clinical trial designs are required to reflect TCIM clinical practice. • Patient-reported outcome measures need adaptation/development for TCIM contexts. • TCIM-specific guidelines can enhance research quality and relevance. • Machine learning that deals with complexity is advancing TCIM research. [ABSTRACT FROM AUTHOR]

To facilitate cross‐sector integration of surveillance data it is necessary to improve and harmonize the meta‐information provided in surveillance data reports. Cross‐sector integration of surveillance results in sector‐specific reports is frequently difficult as reports with a focus on a single sector often lack aspects of the relevant meta‐information necessary to clarify the surveillance context. Such reporting deficiencies reduce the value of surveillance reports to the One Health community. The One Health Consensus Report Annotation Checklist (OH‐CRAC), described in this paper along with potential application scenarios, was developed to improve the current practice of annotating data presented in surveillance data reports. It aims to provide guidance to researchers and reporting officers on what meta‐information should be collected and provided to improve the completeness and transparency of surveillance data reports. The OH‐CRAC can be adopted by all One Health‐related sectors and due to its cross‐sector design, it supports the mutual mapping of surveillance meta‐information from sector‐specific surveillance reports on federal, national and international levels. To facilitate the checklist completion, OH‐CRAC is also available as an online resource that allows the collection of surveillance meta‐information in an easy and user‐friendly manner. Completed OH‐CRAC checklists can be attached as annexes to the corresponding surveillance data reports or even to individual data files regardless of the data source. In this way, reports and data become better interpretable, usable and comparable to information from other sectors, improving their value for all surveillance actors and providing a better foundation for advice to risk managers. [ABSTRACT FROM AUTHOR]

Background: An increasing number of evaluations of social accountability (SA) interventions have been published in the past decade, however, reporting gaps make it difficult to summarize findings. We developed the Social Accountability Reporting for Research (SAR4Research) checklist to support researchers to improve the documentation of SA processes, context, study designs, and outcomes in the peer reviewed literature and to enhance application of findings. Methods: We used a multi-step process, starting with an umbrella review of reviews on SA to identify reporting gaps. Next, we reviewed existing guidelines for reporting on behavioral interventions to determine whether one could be used in its current or adapted form. We received feedback from practitioners and researchers and tested the checklist through three worked examples using outcome papers from three SA projects. Results: Our umbrella review of SA studies identified reporting gaps in all areas, including gaps in reporting on the context, intervention components, and study methods. Because no existing guidelines called for details on context and the complex processes in SA interventions, we used CONSORT-SPI as the basis for the SAR4Research checklist, and adapted it using other existing checklists to fill gaps. Feedback from practitioners, researchers and the worked examples suggested the need to eliminate redundancies, add explanations for items, and clarify reporting for quantitative and qualitative study components. Conclusions: Results of SA evaluations in the peer-reviewed literature will be more useful, facilitating learning and application of findings, when study designs, interventions and their context are described fully in one or a set of papers. This checklist will help authors report better in peer-reviewed journal articles. With sufficient information, readers will better understand whether the results can inform accountability strategies in their own contexts. As a field, we will be better able to identify emerging findings and gaps in our understanding of SA. [ABSTRACT FROM AUTHOR]

Background: Critical appraisal aids in assessing the quality of scientific literature, which is central to the practice of evidence-based medicine. Several tools and guidelines are available for critiquing and assessing the quality of specific study types. However, limited guidance exists for critical appraisal of clinical pharmacokinetic studies. Aim: We aimed to achieve experts' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool. Method: Quality markers related to clinical pharmacokinetic studies, were derived from the published literature and categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion, and conclusion). Questions that aid in appraising pharmacokinetic studies were formulated from these quality markers. Experts were involved in a modified Delphi process to achieve a consensus regarding the formulated questions. The proposed tool was pilot tested on 30 recently published clinical pharmacokinetic studies. Inter-observer agreement was measured to determine the reliability of the included items. Results: Twenty-five experts consented to participate. Three rounds of a modified Delphi survey were required to generate a consensus for a 21-item tool aimed at appraising the quality of clinical pharmacokinetic studies. When applied to 30 recently published clinical pharmacokinetic studies, most items scored fair to moderate levels of agreement (61.90–95.24%). Conclusion: The clinical pharmacokinetic critical appraisal tool (CACPK) developed in this study consisted of 21 items aimed at helping an end-user to determine the quality of a pharmacokinetic study. Further studies are warranted to reaffirm the validity and reliability of the CACPK tool. [ABSTRACT FROM AUTHOR]

Abstract Background Public or patient versions of guidelines (PVGs) are derivative documents that “translate” recommendations and their rationale from clinical guidelines for health professionals into a more easily understandable and usable format for patients and the public. PVGs from different groups and organizations vary considerably in terms of quality of their reporting. In order to address this issue, we aimed to develop a reporting checklist for developers of PVGs and other potential users. Methods First, we collected a list of potential items through reviewing a sample of PVGs, existing guidance for developing and reporting PVGs or other similar evidence-based patient tools, as well as qualitative studies on original studies of patients’ needs about the content and/or reporting of information in PVGs or similar evidence-based patient tools. Second, we conducted a two-round Delphi consultation to determine the level of consensus on the items to be included in the final reporting checklist. Third, we invited two external reviewers to provide comments on the checklist. Results We generated the initial list of 45 reporting items based on a review of a sample of 30 PVGs, four PVG guidance documents, and 46 relevant studies. After the two-round Delphi consultation, we formed a checklist of 17 items grouped under 12 topics for reporting PVGs. Conclusion The RIGHT-PVG reporting checklist provides an international consensus on the important criteria for reporting PVGs.

Abstract Background Health Services Research findings (HSR) reported in scientific publications may become part of the decision-making process on healthcare. This study aimed to explore associations between researcher’s individual, institutional, and scientific environment factors and the occurrence of questionable research practices (QRPs) in the reporting of messages and conclusions in scientific HSR publications. Methods We employed a mixed-methods study design. We identified factors possibly contributing to QRPs in the reporting of messages and conclusions through a literature review, 14 semi-structured interviews with HSR institutional leaders, and 13 focus-groups amongst researchers. A survey corresponding with these factors was developed and shared with 172 authors of 116 scientific HSR publications produced by Dutch research institutes in 2016. We assessed the included publications for the occurrence of QRPs. An exploratory factor analysis was conducted to identify factors within individual, institutional, and environmental domains. Next, we conducted bivariate analyses using simple Poisson regression to explore factors’ association with the number of QRPs in the assessed HSR publications. Factors related to QRPs with a p-value < .30 were included in four multivariate models tested through a multiple Poisson regression. Results In total, 78 (45%) participants completed the survey (51.3% first authors and 48.7% last authors). Twelve factors were included in the multivariate analyses. In all four multivariate models, a higher score of “pressure to create societal impact” (Exp B = 1.28, 95% CI [1.11, 1.47]), was associated with higher number of QRPs. Higher scores on “specific training” (Exp B = 0.85, 95% CI [0.77–0.94]) and “co-author conflict of interest” (Exp B = 0.85, 95% CI [0.75–0.97]) factors were associated with a lower number of QRPs. Stratification between first and last authors indicated different factors were related to the occurrence of QRPs for these groups. Conclusion Experienced pressure to create societal impact is associated with more QRPs in the reporting of messages and conclusions in HSR publications. Specific training in reporting messages and conclusions and awareness of co-author conflict of interests are related to fewer QRPs. Our results should stimulate awareness within the field of HSR internationally on opportunities to better support reporting in scientific HSR publications.

This study aims to establish the implementation standard of health technology assessment(HTA) in traditional Chinese medicine(TCM), so as to promote the scientific and standardized implementation and application of HTA in TCM for high-quality decision-making. Based on the published HTA method guidelines, the literature analysis and expert consensus method were used to establish the implementation standard of HTA in TCM with implementation steps, assessment domains, and reporting checklists as the main content. A total of 41 HTA guidelines were included. After statistical induction and 4 consensus meetings, the preliminary standard of HTA in TCM was formed, and a complete TCM HTA implementation standard was established after two rounds of Delphi method, including 10 implementation steps(1 optional step and 9 necessary steps), 7 assessment domains(7 domains, 19 criteria and 37 sub-criteria, with 2 specific criteria and 5 specific sub-criteria for TCM diagnosis and treatment equipment or protocol health technologies), and 16 items in the reporting checklists. This study constructed a universal HTA implementation standard in TCM and incorporated patient perspectives. The implementation standard was normative, scientific, compatible, and considering the particularity of TCM. At the same time, the implementation standard was explained in detail, providing a reference for the practical application of HTA in TCM.

What is known and objective: Robust critical appraisal tools for clinical pharmacokinetic studies are limited. Before development of such a tool is possible, quality markers (items deemed important for credibility of study results) must be identified. We aim to create an inventory of quality markers intended for the appraisal of clinical pharmacokinetic studies and to categorize identified markers into associated domains of study quality. Methods: Medline via ProQuest central (1946–Sep 2020, EMBASE (1974–Sep 2020), Cochrane database of systematic reviews, Google and Google Scholar were searched using the following search categories: pharmacokinetics, reporting guidelines and quality markers. Reference lists of the identified articles were searched manually. Any article (review, study or guideline) reporting quality markers related to the appraisal of pharmacokinetic literature was eligible for inclusion. Articles were further screened and limited to those reported in English on human subjects only. Cell‐based and animal‐based pharmacokinetic studies were excluded. Extracted data from included articles included identified or perceived markers of quality and baseline article data. Identified quality markers were then categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion and conclusion). Results and discussion: Of 789 studies identified, 17 articles were included for extraction of quality markers. A total of 35 quality markers were identified across eight categories. The most frequently reported quality markers were related to method (13/35) and result sections (6/35). Quality markers encompassed all aspects of study design and reporting and were both similar and different to established reporting checklists for clinical pharmacokinetic studies. What is new and conclusion: The inventory of quality markers is now suitable to undergo further testing for inclusion in a tool designed for the appraisal of clinical pharmacokinetic studies. [ABSTRACT FROM AUTHOR]

Abstract Background Statistics are frequently used in health advocacy to attract attention, but are often misinterpreted. The Figure Interpretation Assessment Tool–Health (FIAT-Health) 1.0 was developed to support systematic assessment of the interpretation of figures on health and health care. This study aimed to test and evaluate the FIAT-Health 1.0 amongst its intended user groups, and further refine the tool based on our results. Methods Potential users (N = 32) were asked to assess one publicly reported figure using the FIAT-Health 1.0, and to justify their assessments and share their experience in using the FIAT-Health. In total four figures were assessed. For each figure, an expert on the specific topic (N = 4) provided a comparative assessment. The consistency of the answers was calculated, and answers to the evaluation questions were qualitatively analysed. A qualitative comparative analysis of the justifications for assessment by the experts and potential users was made. Based on the results, a new version of the FIAT-Health was developed and tested by employees (N = 27) of the National Institute for Public Health and the Environment (RIVM), and approved by the project’s advisory group. In total sixty-three participants contributed. Results Potential users using the FIAT-Health 1.0 and experts gave similar justifications for their assessments. The justifications provided by experts aligned with the items of the FIAT-Health. Seventeen out of twenty-six dichotomous questions were consistently answered by the potential users. Numerical assessment questions showed inconsistencies in how potential users responded. In the evaluation, potential users most frequently mentioned that thanks to its structured approach, the FIAT-Health contributed to their awareness of the main characteristics of the figure (n = 14), but they did find the tool complex (n = 11). The FIAT-Health 1.0 was revised from a scoring instrument into a critical appraisal tool: the FIAT-Health 2.0, which was tested and approved by employees of the RIVM and the advisory group. Conclusion The tool was refined according to the results of the test and evaluation, transforming the FIAT-Health from a quantitative scoring instrument into an online qualitative appraisal tool that has the potential to aid the better interpretation and public reporting of statistics on health and healthcare.

Objectives: Simulated patients are increasingly used to measure outcomes in health services but reporting is suboptimal. This study aims to create a checklist for the reporting of simulated patient (SP) methodology. Methods: This was a Delphi study. The authors of health service research studies using SP methodology were invited to participate. Round 1 questionnaire assessed the applicability of the TIDieR (Template for Intervention Description and Replication) reporting checklist for SP methodology and asked for rewording of/additional items. Responses were thematically analysed to generate Round 2 items in which participants rated each item for importance (seven-point Likert scale) and median, mode and IQR were calculated. In Round 3, participants were invited to rescore their Round 2 responses. Consensus was defined as an IQR = 1 (Extremely important) and median = 2 (Very important). All consensus items were considered for inclusion in the checklist. Similarly, worded items were rationalised and items not specific to SP methodology or other existing checklists were excluded. Key findings: Twenty-nine authors participated in Round 1 and a further seven for Rounds 2 and 3. Twenty-six responses were analysed for Round 1, 30 for Round 2 and 28 for Round 3. There was consensus on 29 of 54 items in Round 2 and 45 of 63 items in Round 3. The final checklist comprised 28 items. Conclusions: A new reporting checklist to guide the reporting of studies, using simulated patients, complementary to CONSORT or STROBE, has been developed and will now be tested for usability. [ABSTRACT FROM AUTHOR]

Background: Public or patient versions of guidelines (PVGs) are derivative documents that "translate" recommendations and their rationale from clinical guidelines for health professionals into a more easily understandable and usable format for patients and the public. PVGs from different groups and organizations vary considerably in terms of quality of their reporting. In order to address this issue, we aimed to develop a reporting checklist for developers of PVGs and other potential users.Methods: First, we collected a list of potential items through reviewing a sample of PVGs, existing guidance for developing and reporting PVGs or other similar evidence-based patient tools, as well as qualitative studies on original studies of patients' needs about the content and/or reporting of information in PVGs or similar evidence-based patient tools. Second, we conducted a two-round Delphi consultation to determine the level of consensus on the items to be included in the final reporting checklist. Third, we invited two external reviewers to provide comments on the checklist.Results: We generated the initial list of 45 reporting items based on a review of a sample of 30 PVGs, four PVG guidance documents, and 46 relevant studies. After the two-round Delphi consultation, we formed a checklist of 17 items grouped under 12 topics for reporting PVGs.Conclusion: The RIGHT-PVG reporting checklist provides an international consensus on the important criteria for reporting PVGs. [ABSTRACT FROM AUTHOR]

Lung ultrasound is a useful tool for the assessment of patients with both acute and chronic heart failure, but the use of different image acquisition methods, inconsistent reporting of the technique employed and variable quantification of 'B-lines,' have all made it difficult to compare published reports. We therefore need to ensure that future studies utilizing lung ultrasound in the assessment of heart failure adopt a standardized approach to reporting the quantification of pulmonary congestion. Strategies to improve patient care by use of lung ultrasound in the assessment of heart failure have been difficult to develop. In the present document, key aspects of standardization are discussed, including equipment used, number of chest zones assessed, the method of quantifying B-lines, the presence and timing of additional investigations (e.g. natriuretic peptides and echocardiography) and the impact of therapy. This consensus report includes a checklist to provide standardization in the preparation, review and analysis of manuscripts. This will serve as a guide for investigators and clinicians and enhance the quality and transparency of lung ultrasound research. [ABSTRACT FROM AUTHOR]

Background: Existing reporting guidelines pay insufficient attention to the detail and comprehensiveness reporting of surgical technique. The Surgical techniqUe rePorting chEcklist and standaRds (SUPER) aims to address this gap by defining reporting standards for surgical technique. The SUPER guideline intends to apply to articles that encompass surgical technique in any study design, surgical discipline, and stage of surgical innovation., Methods: Following the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach, 16 surgeons, journal editors, and methodologists reviewed existing reporting guidelines relating to surgical technique, reviewed papers from 15 top journals, and brainstormed to draft initial items for the SUPER. The initial items were revised through a three-round Delphi survey from 21 multidisciplinary Delphi panel experts from 13 countries and regions. The final SUPER items were formed after an online consensus meeting to resolve disagreements and a three-round wording refinement by all 16 SUPER working group members and five SUPER consultants., Results: The SUPER reporting guideline includes 22 items that are considered essential for good and informative surgical technique reporting. The items are divided into six sections: background, rationale, and objectives (items 1 to 5); preoperative preparations and requirements (items 6 to 9); surgical technique details (items 10 to 15); postoperative considerations and tasks (items 16 to 19); summary and prospect (items 20 and 21); and other information (item 22)., Conclusions: The SUPER reporting guideline has the potential to guide detailed, comprehensive, and transparent surgical technique reporting for surgeons. It may also assist journal editors, peer reviewers, systematic reviewers, and guideline developers in the evaluation of surgical technique papers and help practitioners to better understand and reproduce surgical technique., Trial Registration: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#SUPER., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://hbsn.amegroups.com/article/view/10.21037/hbsn-22-509/coif). KZ, GSL, XT and SDW are full-time employees of AME Publishing Company, the publisher of Hepatobiliary Surgery and Nutrition. RHP has received speaker fees from Medtronic, AMBU, Medela and AstraZeneca and is the Advisory Board member of AstraZeneca, MSD and Roche. CSHN has received consulting fees from Medtronic & Johnson and Johnson. AT reports consulting fee from Intuitive. MFJ has received consulting and lecture fees from Medtronic and Intuitive. AYO reports educational and research grants from Artivion and Terumo Aortic to his institution. The other authors have no conflicts of interest to declare., (2023 Hepatobiliary Surgery and Nutrition. All rights reserved.)

Background: Surgical technique plays an essential role in achieving good health outcomes. However, the quality of surgical technique reporting remains heterogeneous. Reporting checklists could help authors to describe the surgical technique more transparently and effectively, as well as to assist reviewers and editors evaluate it more informatively, and promote readers to better understand the technique. We previously developed SUPER (surgical technique reporting checklist and standards) to assist authors in reporting their research that contains surgical technique more transparently. However, further explanation and elaboration of each item are needed for better understanding and reporting practice., Methods: We searched surgical literature in PubMed, Google Scholar and journal websites published up to January 2023 to find multidiscipline examples in various article types for each SUPER item., Results: We explain the 22 items of the SUPER and provide rationales item by item alongside. We provide 69 examples from 53 literature that present optimal reporting of the 22 items. Article types of examples include pure surgical technique, and case reports, observational studies and clinical trials that contain surgical technique. Examples are multidisciplinary, including general surgery, orthopaedical surgery, cardiac surgery, thoracic surgery, gastrointestinal surgery, neurological surgery, oncogenic surgery, and emergency surgery etc., Conclusions: Along with SUPER article, this explanation and elaboration file can promote deeper understanding on the SUPER items. We hope that the article could further guide surgeons and researchers in reporting, and assist editors and peer reviewers in reviewing manuscripts related to surgical technique., Competing Interests: (I) Specify any potential conflicts of interest; (II) include the ethics committee or institutional review board approval (and the number when applicable); and (III) provide the informed consent for publication. Conflicts of interest disclosures have the potential to reduce bias, yet the current disclosure of conflicts of interest is worrying (65,66). Every author should disclose their conflicts of interest, both financial and non-financial, as defined by the International Committee of Medical Journal Editors (67) and as required by each journal. For example, if a new device is introduced in a surgical technique, the relationship between the manufacturer and the authors should be disclosed (Appendix 2, Example 66). Another example is that if the project is supported by a funder, the funder’s involvement and role in the development of the project should be disclosed (Appendix 2, Example 67). The authors need to ensure that the ethics committee has approved the project and provided an ethics approval number (Appendix 2, Example 68). Research has found that in the field of surgical technique, many surgeons underestimate the importance of obtaining and reporting ethical approval and that there is much room for improving the reporting of ethical approval (66,68,69). Research conducted without ethical approval or even falsified ethical approval documents is at great risk (70). Authors should also obtain informed consent signed by the patient for writing and publishing the article (Appendix 2, Example 69). If this cannot be obtained from the patient, it should be obtained from the patient’s relatives, when local regulations permit. The article should clearly give the statement ‘Signed informed consent was obtained from the patients’. When informed consent could not be obtained, the author needs to ensure that all possible attempts have been made and clearly give the reason and the statement ‘Signed informed consent was not obtained after all possible attempts were made’ or ‘Signed informed consent was not obtained due to ...’.Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-23-76/coif). KZ, GSL, XT and SDW are staffs of AME publishing company (the publisher of Gland Surgery). The other authors have no conflicts of interest to declare., (2023 Gland Surgery. All rights reserved.)

Background: Ecological momentary assessment (EMA) is a method of collecting real-time data based on careful timing, repeated measures, and observations that take place in a participant's typical environment. Due to methodological advantages and rapid advancement in mobile technologies in recent years, more studies have adopted EMA in addressing topics of nutrition and physical activity in youth.Objective: The aim of this systematic review is to describe EMA methodology that has been used in studies addressing nutrition and physical activity in youth and provide a comprehensive checklist for reporting EMA studies.Methods: Thirteen studies were reviewed and analyzed for the following 5 areas of EMA methodology: (1) sampling and measures, (2) schedule, (3) technology and administration, (4) prompting strategy, and (5) response and compliance.Results: Results of this review showed a wide variability in the design and reporting of EMA studies in nutrition and physical activity among youth. The majority of studies (69%) monitored their participants during one period of time, although the monitoring period ranged from 4 to 14 days, and EMA surveys ranged from 2 to 68 times per day. More than half (54%) of the studies employed some type of electronic technology. Most (85%) of the studies used interval-contingent prompting strategy. For studies that utilized electronic devices with interval-contingent prompting strategy, none reported the actual number of EMA prompts received by participants out of the intended number of prompts. About half (46%) of the studies failed to report information about EMA compliance rates. For those who reported, compliance rates ranged from 44-96%, with an average of 71%.Conclusions: Findings from this review suggest that in order to identify best practices for EMA methodology in nutrition and physical activity research among youth, more standardized EMA reporting is needed. Missing the key information about EMA design features and participant compliance might lead to misinterpretation of results. Future nutrition and physical activity EMA studies need to be more rigorous and thorough in descriptions of methodology and results. A reporting checklist was developed with the goal of enhancing reliability, efficacy, and overall interpretation of the findings for future studies that use EMAs. [ABSTRACT FROM AUTHOR]

Transparent reporting of nutrition research promotes rigor, reproducibility, and relevance to human nutrition. We performed a scoping review of recent articles reporting dietary folate interventions in mice as a case study to determine the reporting frequency of generic study design items (i.e., sex, strain, and age) and nutrition-specific items (i.e., base diet composition, intervention doses, duration, and exposure verification) in basic nutrition research. We identified 798 original research articles in the EMBASE, Medline, Food Science and Technology Abstracts (FSTA), Global Health, and International Pharmaceutical Abstracts (IPA) databases published between January 2009 and July 2021 in which a dietary folic acid (FA) intervention was used in mice. We identified 312 original peer-reviewed articles including 191 studies in nonpregnant and 126 in pregnant mice. Most studies reported sex (99%), strain (99%), and age (83%). The majority of studies used C57BL/6 (53%) or BALB/c (11%) mice aged 3-9 wk. Nonpregnancy studies were more likely to use only male mice (57%). Dietary FA interventions varied considerably and overlapped: deficiency (0-3 mg/kg), control (0-16 mg/kg), and supplemented (0-50 mg/kg). Only 63% of studies used an open-formula base diet with a declared FA content and 60% of studies verified FA exposure using folate status biomarkers. The duration of intervention ranged from 1 to 104 wk for nonpregnancy studies. The duration of intervention for pregnancy studies was 1-19 wk, occurring variably before pregnancy and/or during pregnancy and/or lactation. Overall, 17% of studies did not report ≥1 generic study design item(s) and 40% did not report ≥1 nutrition-specific study design item(s). The variability and frequent lack of reporting of important generic and nutrition-specific study design details in nutrition studies limit their generalizability, reproducibility, and interpretation. The use of reporting checklists for animal research would enhance reporting quality of key study design and conduct factors in animal-based nutrition research., (© Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2022.)

Background: Influenced by an important paper by Michie et al., outlining the rationale and requirements for detailed reporting of behavior change interventions now required by Implementation Science, we created and refined a checklist to operationalize the Workgroup for Intervention Development and Evaluation Research (WIDER) recommendations in systematic reviews. The WIDER recommendations provide a framework to identify and provide detailed reporting of the essential components of behavior change interventions in order to facilitate replication, further development, and scale-up of the interventions. Findings: The checklist was developed, applied, and improved over the course of four systematic reviews of knowledge translation (KT) strategies in a variety of healthcare settings conducted by Scott and associates. The checklist was created as one method of operationalizing the work of the WIDER in order to facilitate comparison across heterogeneous studies included in these systematic reviews. Numerous challenges were encountered in the process of creating and applying the checklist across four stages of development. The resulting improvements have produced a 'user-friendly' and replicable checklist to assess the quality of reporting of KT interventions in systematic reviews using the WIDER recommendations. Conclusions: With journals, such as Implementation Science, using the WIDER recommendations as publication requirements for evaluation reports of behavior change intervention studies, it is crucial to find methods of examining, measuring, and reporting the quality of reporting. This checklist is one approach to operationalize the WIDER recommendations in systematic review methodology. [ABSTRACT FROM AUTHOR]

• Finite element analysis has multitude of applications in biomechanics and biophysics to study the mechanical behaviour of tissues or organs. • Inconsistencies in reporting such studies have been thereby affecting their reliability and reproducibility. • We have developed standard reporting-guidelines for biomechanical studies to bring about a consistency in reporting such studies so that no significant information related to the FE model or FE analysis is missed. • These reporting guidelines can help in improving the details of these studies so as to facilitate ease in understanding and extrapolation of the results in clinical scenario. To the best of our knowledge, there are no reporting guidelines for design, conduct and reporting of Finite Element studies in health sciences. We intend to propose specific and detailed guidelines for reporting these studies. After recognizing the need to have uniform guidelines for reporting of finite element analysis in medicine and dentistry, a group of 5 researchers working on FEA as their research area met in the summer of 2020 and drafted the methodology for the development of such guidelines. Each researcher individually made a list of major headings required for reporting these studies and met again in September 2020 to finalize the domains. Subsequently, sub headings and details were charted. The draft list of items for reporting the guidelines were presented to a larger team of 15 experts and some changes were further made based on their inputs. The guidelines entail seven major domains and their sub-domains, including parameters for model structure, segmentation, mesh structure, force application and model validation, etc. This checklist aims to improvise the reporting and consistency of FEA studies. We hope that the usage and adoption of these guidelines by the scientific community would result in more thoughtful and uniform documentation. Also, the confidence in the results would be enhanced through model reproducibility, reusability and accountability. The proposed guidelines were named as 'Reporting of in-silico studies using finite element analysis in medicine' and the term 'RIFEM' was used as acronym. [ABSTRACT FROM AUTHOR]

Coincident with the tsunami of COVID-19-related publications, there has been a surge of studies using real-world data, including those obtained from the electronic health record (EHR). Unfortunately, several of these high-profile publications were retracted because of concerns regarding the soundness and quality of the studies and the EHR data they purported to analyze. These retractions highlight that although a small community of EHR informatics experts can readily identify strengths and flaws in EHR-derived studies, many medical editorial teams and otherwise sophisticated medical readers lack the framework to fully critically appraise these studies. In addition, conventional statistical analyses cannot overcome the need for an understanding of the opportunities and limitations of EHR-derived studies. We distill here from the broader informatics literature six key considerations that are crucial for appraising studies utilizing EHR data: data completeness, data collection and handling (eg, transformation), data type (ie, codified, textual), robustness of methods against EHR variability (within and across institutions, countries, and time), transparency of data and analytic code, and the multidisciplinary approach. These considerations will inform researchers, clinicians, and other stakeholders as to the recommended best practices in reviewing manuscripts, grants, and other outputs from EHR-data derived studies, and thereby promote and foster rigor, quality, and reliability of this rapidly growing field. [ABSTRACT FROM AUTHOR]

Background: Health Services Research findings (HSR) reported in scientific publications may become part of the decision-making process on healthcare. This study aimed to explore associations between researcher's individual, institutional, and scientific environment factors and the occurrence of questionable research practices (QRPs) in the reporting of messages and conclusions in scientific HSR publications.Methods: We employed a mixed-methods study design. We identified factors possibly contributing to QRPs in the reporting of messages and conclusions through a literature review, 14 semi-structured interviews with HSR institutional leaders, and 13 focus-groups amongst researchers. A survey corresponding with these factors was developed and shared with 172 authors of 116 scientific HSR publications produced by Dutch research institutes in 2016. We assessed the included publications for the occurrence of QRPs. An exploratory factor analysis was conducted to identify factors within individual, institutional, and environmental domains. Next, we conducted bivariate analyses using simple Poisson regression to explore factors' association with the number of QRPs in the assessed HSR publications. Factors related to QRPs with a p-value < .30 were included in four multivariate models tested through a multiple Poisson regression.Results: In total, 78 (45%) participants completed the survey (51.3% first authors and 48.7% last authors). Twelve factors were included in the multivariate analyses. In all four multivariate models, a higher score of "pressure to create societal impact" (Exp B = 1.28, 95% CI [1.11, 1.47]), was associated with higher number of QRPs. Higher scores on "specific training" (Exp B = 0.85, 95% CI [0.77-0.94]) and "co-author conflict of interest" (Exp B = 0.85, 95% CI [0.75-0.97]) factors were associated with a lower number of QRPs. Stratification between first and last authors indicated different factors were related to the occurrence of QRPs for these groups.Conclusion: Experienced pressure to create societal impact is associated with more QRPs in the reporting of messages and conclusions in HSR publications. Specific training in reporting messages and conclusions and awareness of co-author conflict of interests are related to fewer QRPs. Our results should stimulate awareness within the field of HSR internationally on opportunities to better support reporting in scientific HSR publications. [ABSTRACT FROM AUTHOR]

Introduction: The use of observational data to assess drug effectiveness and safety can provide relevant information, much of which may not be feasible to obtain through randomized clinical trials. Because observational studies provide critical drug safety and effectiveness information that influences drug policy and prescribing practices, transparent, consistent, and accurate reporting of these studies is critical., Areas Covered: We provide recommendations to extend existing reporting guidelines, covering the main components of primary research studies (methods, results, discussion)., Expert Opinion: Our recommendations include extending drug safety and effectiveness guidelines to include explicit checklist items on: study registration, causal diagrams, rationale for measures of effect, comprehensive assessment of bias, comprehensive data cleaning steps, drug equivalents, subject-level drug data visualization, sex and gender-based analyses and results, patient-oriented outcomes, and patient involvement in research.

Background: Statistics are frequently used in health advocacy to attract attention, but are often misinterpreted. The Figure Interpretation Assessment Tool-Health (FIAT-Health) 1.0 was developed to support systematic assessment of the interpretation of figures on health and health care. This study aimed to test and evaluate the FIAT-Health 1.0 amongst its intended user groups, and further refine the tool based on our results.Methods: Potential users (N = 32) were asked to assess one publicly reported figure using the FIAT-Health 1.0, and to justify their assessments and share their experience in using the FIAT-Health. In total four figures were assessed. For each figure, an expert on the specific topic (N = 4) provided a comparative assessment. The consistency of the answers was calculated, and answers to the evaluation questions were qualitatively analysed. A qualitative comparative analysis of the justifications for assessment by the experts and potential users was made. Based on the results, a new version of the FIAT-Health was developed and tested by employees (N = 27) of the National Institute for Public Health and the Environment (RIVM), and approved by the project's advisory group. In total sixty-three participants contributed.Results: Potential users using the FIAT-Health 1.0 and experts gave similar justifications for their assessments. The justifications provided by experts aligned with the items of the FIAT-Health. Seventeen out of twenty-six dichotomous questions were consistently answered by the potential users. Numerical assessment questions showed inconsistencies in how potential users responded. In the evaluation, potential users most frequently mentioned that thanks to its structured approach, the FIAT-Health contributed to their awareness of the main characteristics of the figure (n = 14), but they did find the tool complex (n = 11). The FIAT-Health 1.0 was revised from a scoring instrument into a critical appraisal tool: the FIAT-Health 2.0, which was tested and approved by employees of the RIVM and the advisory group.Conclusion: The tool was refined according to the results of the test and evaluation, transforming the FIAT-Health from a quantitative scoring instrument into an online qualitative appraisal tool that has the potential to aid the better interpretation and public reporting of statistics on health and healthcare. [ABSTRACT FROM AUTHOR]

To introduce the application status of network Meta-analysis( NMA) in the field of traditional Chinese medicine,and to discuss the application value of NMA in the field of traditional Chinese medicine,this study comprehensively reviewed the systematic reviews with application of NMA in the field of traditional Chinese medicine. CNKI,Wan Fang,Sino Med,VIP,Embase,PubMed and Cochrane Library and the reference list of previous studies were searched. The AMSTAR scale was used to evaluate the quality of literature methodology,and PRISMA-NMA checklist was used to measure the degree of report specification. Overall,122 articles were included,including 80 in Chinese and 42 in English. The included studies centered on cancer,bone and joint disease,cardiovascular disease,respiratory disease,mental disease and digestive disease. Additionally,the intervention can be categorized into three groups,traditional Chinese medicine injection,oral Chinese medicine or prescription,and traditional physical therapy including acupuncture.Nearly one-third of the researches&apos; intervention program is aimed at comparing the effect of Chinese and Western combined therapy and monotherapy. The overall methodology quality grade is medium and the report quality is average,with methodology reporting and result reporting especially need to be improved. The subgroup analysis shows that the methodology quality of the English literatures is evidently higher than Chinese literatures,and the quality of the literatures published after 2015 is higher than those published in or before 2015.This study indicates that the NMA can compare multiple treatments simultaneously,which accords with characteristics of the clinical practice in traditional Chinese medicine that is complex and individual. NMA in the field of traditional Chinese medicine is still in the process of development. With higher level of quality control and reporting as well as the improvement of the statistical methodology and the accumulation of original researches,NMA application in the field of traditional Chinese medicine will be promising.

Background: There has been a growing interest around the world in developing country-specific scoring algorithms for the EQ-5D. This study systematically reviews all existing EQ-5D valuation studies to highlight their strengths and limitations, explores heterogeneity in observed utilities using meta-regression, and proposes a methodological checklist for reporting EQ-5D valuation studies., Methods: . We searched Medline, EMBASE, the National Health Service Economic Evaluation Database (NHS EED) via Wiley's Cochrane Library, and Wiley's Health Economic Evaluation Database from inception through November 2012, as well as bibliographies of key papers and the EuroQol Plenary Meeting Proceedings from 1991 to 2012 for English-language reports of EQ-5D valuation studies. Two reviewers independently screened the titles and abstracts for relevance. Three reviewers performed data extraction and compared the characteristics and scoring algorithms developed in the included valuation studies., Results: . Of the 31 studies included in the review, 19 used the time trade-off (TTO) technique, 10 used the visual analogue scale (VAS) technique, and 2 used both TTO and VAS. Most studies included respondents from the general population selected by random or quota sampling and used face-to-face interviews or postal surveys. Studies valued between 7 and 198 total states, with 1-23 states valued per respondent. Different model specifications have been proposed for scoring. Some sample or demographic factors, including gender, education, percentage urban population, and national health care expenditure, were associated with differences in observed utilities for moderate or severe health states., Conclusions: . EQ-5D valuation studies conducted to date have varied widely in their design and in the resulting scoring algorithms. Therefore, we propose the Checklist for Reporting Valuation Studies of the EQ-5D (CREATE) for those conducting valuation studies.