Development Of Reporting Guidelines Research Articles

Study protocol for developing, piloting and disseminating the PRISMA-COSMIN guideline: a new reporting guideline for systematic reviews of outcome measurement instruments

BackgroundSystematic reviews of outcome measurement instruments are important tools in the evidence-based selection of these instruments. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) has developed a comprehensive and widespread guideline to conduct systematic reviews of outcome measurement instruments, but key information is often missing in published reviews. This hinders the appraisal of the quality of outcome measurement instruments, impacts the decisions of knowledge users regarding their appropriateness, and compromises reproducibility and interpretability of the reviews’ findings. To facilitate sufficient, transparent, and consistent reporting of systematic reviews of outcome measurement instruments, an extension of the PRISMA (Preferred Reporting of Items for Systematic reviews and Meta-Analyses) 2020 guideline will be developed: the PRISMA-COSMIN guideline.MethodsThe PRISMA-COSMIN guideline will be developed in accordance with recommendations for reporting guideline development from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. First, a candidate reporting item list will be created through an environmental literature scan and expert consultations. Second, an international Delphi study will be conducted with systematic review authors, biostatisticians, epidemiologists, psychometricians/clinimetricians, reporting guideline developers, journal editors as well as patients, caregivers, and members of the public. Delphi panelists will rate candidate items for inclusion on a 5-point scale, suggest additional candidate items, and give feedback on item wording and comprehensibility. Third, the draft PRISMA-COSMIN guideline and user manual will be iteratively piloted by applying it to systematic reviews in several disease areas to assess its relevance, comprehensiveness, and comprehensibility, along with usability and user satisfaction. Fourth, a consensus meeting will be held to finalize the PRISMA-COSMIN guideline through roundtable discussions and voting. Last, a user manual will be developed and the final PRISMA-COSMIN guideline will be disseminated through publications, conferences, newsletters, and relevant websites. Additionally, relevant journals and organizations will be invited to endorse and implement PRISMA-COSMIN. Throughout the project, evaluations will take place to identify barriers and facilitators of involving patient/public partners and employing a virtual process.DiscussionThe PRISMA-COSMIN guideline will ensure that the reports of systematic reviews of outcome measurement instruments are complete and informative, enhancing their reproducibility, ease of use, and uptake.

PNS154 THE PRISMA 2020 STATEMENT: DEVELOPMENT OF AND KEY CHANGES IN AN UPDATED GUIDELINE FOR REPORTING SYSTEMATIC REVIEWS AND META-ANALYSES

Systematic reviews (SR) require transparent reporting to maximize their utility for decision-makers including patients, providers, payers and policy makers. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement was published in 2009 to help authors improve the reporting of SRs and meta-analyses. PRISMA has been widely adopted as evidenced by ∼50,000 citations and endorsement from over 400 journals. Many advancements in SRs have taken place since 2009 and updated guidance is needed to reflect current methodology, technology and publication practices. To update the PRISMA 2009 Statement for reporting SRs and meta-analyses. The PRISMA Statement update began in late 2017 and followed recommended methods for reporting guideline development including: 1) a comprehensive review (60 select guidance sources) 2) an online survey (methodologists, authors and journal editors from 23 countries); 3) an expert panel consensus meeting (22-members); 4) checklist development and refinement (based on feedback from the PRISMA Group); 5) and pilot testing (authors and journal editors). To facilitate uptake of the guideline internationally, translations are planned. The PRISMA 2020 Statement comprises updated guidance to facilitate transparent reporting of SRs and meta-analyses. It integrates current evidence with stakeholder expertise and reflects advances in SR methods to identify, select, appraise and synthesize studies. We will highlight the methodology and results of the development process and key recommended changes to upcoming guidance. The PRISMA 2020 Statement is intended to benefit researchers, policy makers, guideline developers, payers, editors and peer reviewers involved in conducting or using SRs and meta-analyses. We hope that uptake of the guidance will lead to more transparent reporting of SRs to facilitate applicability and validity assessments for decision-makers, enable more efficient updates and reduce research waste.

Increasing the Clinical Psychiatric Knowledge Base About Pathogenic Copy Number Variation.

Specific copy number variants (CNVs) have been robustly associated with intellectual disability, autism, and schizophrenia. Most of the literature focus has been on documenting the existence of these phenomena. There are few data to guide therapeutic choices for these “orphan” diseases. We call for systematic and longitudinal case reports which, if carefully conducted, may provide crucial initial knowledge to guide therapeutics. We provide a step-by-step overview, a tailored set of consensus criteria for high-quality case reports, and a specific set of learning resources.

Evaluation of the Clarity and Completeness of Reporting in Orthopedic Clinical Practice Guidelines.

Clinical practice guidelines (CPGs) can positively affect the quality of patient care offered by physicians because they decrease variability in clinical practice and may help reduce unnecessary testing, promoting a more responsible use of resources. Building on existing framework for reporting guideline development, including the work of the Enhancing the Quality and Transparency of Health Research Network, the Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group created a 2016 checklist of 35 items considered essential for high-quality reporting of CPGs. To evaluate how many previously published CPGs in orthopedic surgery met the RIGHT criteria and assess how improvements can be made in future orthopedic CPGs based on any found deficiencies. All 18 CPGs published before January 1, 2018, by the American Academy of Orthopedic Surgeons (AAOS) are publicly available on orthoguidelines.org. Two authors downloaded each file and both of those authors independently scored each CPG using piloted abstraction RIGHT checklist forms. Of the 35 RIGHT criteria outlined in 22 checklist items, 23 (65.7%) were met across all AAOS guidelines, 6 (17.1%) were not met by any of the AAOS guidelines, and 6 (17.2%) were met by some of the AAOS guidelines. Overall, the AAOS guidelines addressed many important recommendations within the RIGHT checklist. Assessing adherence to the RIGHT checklist can help ensure that future guidelines are more effectively communicated, hopefully assisting end users in efficient implementation and increasing the level of evidence-based patient care.

Phenytoin Induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Case Report

Background: Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a rare and potentially life-threatening condition. It presents a long prodromal period, extensive rash, fever, lymphadenopathy, hematologic abnormalities (eosinophilia with or without atypical lymphocytosis), and internal organ involvement. Purpose: To describe a case of phenytoin induced DRESS syndrome, presenting diagnostic and management challenges of clinical interest. Methods: The Consensus-based Clinical Case Reporting Guideline Development (CARE) was observed for data analysis in case reports. Case Report: A 22-year-old man, using phenytoin for 60 days, sought medical attention due to fever and maculopapular cutaneous lesions. He presented lymphocytosis with eosinophilia and severe acute hepatitis 24 hours after admission day. Hepatic transaminases returned to reference levels after phenytoin withdrawal, and eosinophilia and cutaneous manifestations did not respond well to systemic steroids. A forearm biopsy showed findings suggestive of severe cutaneous adverse reaction. The patient’s microscopic and clinical characteristics meet all criteria in the scoring systems of Bocquet et al., Registry of Severe Cutaneous Adverse Reaction (RegiSCAR), and Japanese Research Committee on Severe Cutaneous Adverse Reaction (J-SCAR), being highly suggestive of DRESS syndrome very probably caused by phenytoin. The complete remission of symptoms was achieved weeks after admission. Conclusions: DRESS syndrome is a defiant reaction. Clinicians must be aware of potential causative drugs and perform a complete clinical examination using the available resources, including laboratory tests and histopathological assessment. The clinical remission relies on the withdrawal of the culprit drug. Particular attention should be given to the involvement of internal organs.

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)

BackgroundInadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines.MethodsThe InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities.DiscussionInsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Should editors be more involved in the development of reporting guidelines?

Should editors be more involved in the development of reporting guidelines?

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

BackgroundDesigning and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients’ experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients’ views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality.Methods/designThe mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use.DiscussionMeta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

Methodology and reporting quality of reporting guidelines: systematic review.

BackgroundWith increasing attention put on the methodology of reporting guidelines, Moher et al. conducted a review of reporting guidelines up to December 2009. Information gaps appeared on many aspects. Therefore, in 2010, the Guidance for Developers of Health Research Reporting Guidelines was developed. With more than four years passed and a considerable investment was put into reporting guideline development, a large number of new, updated, and expanded reporting guidelines have become available since January 2010. We aimed to systematically review the reporting guidelines published since January 2010, and investigate the application of the Guidance.MethodsWe systematically searched databases including the Cochrane Methodology Register, MEDLINE, and EMBASE, and retrieved EQUATOR and the website (if available) to find reporting guidelines as well as their accompanying documents. We screened the titles and abstracts resulting from searches and extracted data. We focused on the methodology and reporting of the included guidelines, and described information with a series of tables and narrative summaries. Data were summarized descriptively using frequencies, proportions, and medians as appropriate.ResultsTwenty-eight and 32 reporting guidelines were retrieved from databases and EQUATOR network, respectively. Reporting guidelines were designed for a broad spectrum of types of research. A considerable number of reporting guidelines were published and updated in recent years. Methods of initial items were given in 45 (75 %) guidelines. Thirty-eight (63 %) guidelines reported they have reached consensus, and 35 (58 %) described their consensus methods. Only 9 (15 %) guidelines followed the Guidance.ConclusionsOnly few guidelines were developed complying with the Guidance. More attention should be paid to the quality of reporting guidelines.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-015-0069-z) contains supplementary material, which is available to authorized users.

Towards improving the reporting quality of clinical case reports in complementary medicine: Assessing and illustrating the need for guideline development

Case reports have had a varying level of recognition as a source of evidence throughout the history of medicine. In recent years, there has been a revival of interest in clinical case reports in both conventional and complementary medicine. There is a need to further improve the reporting quality of clinical case reports of different Complementary and Alternative Medicine (CAM) therapies. To provide an overview of the different objectives for clinical case reports, identify those that are most relevant for CAM, and to develop a conceptual framework for purpose orientated clinical case reporting guidelines for CAM therapies. To practically illustrate the chosen approach by developing a clinical case reporting guideline for homeopathic cases. The various objectives of clinical case reports were described by Prof. Milos Jenicek, and the potential relevance of these objectives for CAM were discussed and graded by a mixed panel of experts. A conceptual framework for developing clinical case reporting guidelines for CAM treatments with specific objectives is proposed. The aim is to integrate both 'generic' and 'CAM therapy specific' quality items. This framework has been practically applied to the development of a reporting guideline for clinical case reports in homoeopathy which will be reported in a second article. An overview is given of the clinical case reporting literature. The conceptual framework for the development of purpose orientated CAM clinical case reporting guidelines is presented. This framework is based on alignment with the recently published 'generic' CARE guideline for reporting of clinical case reports, whilst addressing the CAM specific elements at the same time. The scope and importance of clinical case reporting guideline development in CAM is illustrated. A conceptual framework for developing CAM specific clinical case reporting guidelines was established. It has been implemented using homoeopathy as an illustration, and this will be reported in a separate article. Further improvements in clinical case reporting in CAM will greatly contribute to CAM research and education, as well as to improved patient care.

The CARE Guidelines: Consensus‐Based Clinical Case Reporting Guideline Development

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

The CARE guidelines: consensus-based clinical case reporting guideline development

BackgroundA case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.Primary Objective. Develop, disseminate, and implement systematic reporting guidelines for case reports.MethodsWe used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.ResultsThis consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.ConclusionsWe believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development

Background:A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.Primary Objective:Develop, disseminate, and implement systematic reporting guidelines for case reports.Methods:We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) postmeeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.Results:This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.Conclusions:We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.