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OBJECTIVES: to construct and validate the content of a checklist for the management of totally implanted catheters in hospitalized children and adolescents. METHODS: methodological research conducted from October 2021 to December 2022 in two stages: development of the instrument with care guidelines and content validation of the checklist. The instrument, containing 23 items presented in Likert format, was evaluated online by specialists in two rounds. The Content Validity Index was applied, considering indices above 0.8 as valid. RESULTS: the final checklist included four domains and 22 checklist items, validated with a Content Validity Index of 0.98. The overall evaluation of the instrument presented a global score of 9.9. CONCLUSIONS: the validation and application of instruments that standardize procedures, in addition to supporting professionals, promote autonomy and quality of care for children and adolescents using this device.
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Catéteres de Permanencia , Lista de Verificación , Humanos , Lista de Verificación/métodos , Lista de Verificación/normas , Lista de Verificación/instrumentación , Niño , Adolescente , Catéteres de Permanencia/normas , Catéteres de Permanencia/estadística & datos numéricos , Reproducibilidad de los Resultados , Masculino , Femenino , Encuestas y Cuestionarios , PreescolarRESUMEN
Neuroimaging plays a crucial role in understanding brain structure and function, but the lack of transparency, reproducibility, and reliability of findings is a significant obstacle for the field. To address these challenges, there are ongoing efforts to develop reporting checklists for neuroimaging studies to improve the reporting of fundamental aspects of study design and execution. In this review, we first define what we mean by a neuroimaging reporting checklist and then discuss how a reporting checklist can be developed and implemented. We consider the core values that should inform checklist design, including transparency, repeatability, data sharing, diversity, and supporting innovations. We then share experiences with currently available neuroimaging checklists. We review the motivation for creating checklists and whether checklists achieve their intended objectives, before proposing a development cycle for neuroimaging reporting checklists and describing each implementation step. We emphasize the importance of reporting checklists in enhancing the quality of data repositories and consortia, how they can support education and best practices, and how emerging computational methods, like artificial intelligence, can help checklist development and adherence. We also highlight the role that funding agencies and global collaborations can play in supporting the adoption of neuroimaging reporting checklists. We hope this review will encourage better adherence to available checklists and promote the development of new ones, and ultimately increase the quality, transparency, and reproducibility of neuroimaging research.
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Lista de Verificación , Neuroimagen , Humanos , Neuroimagen/métodos , Neuroimagen/normas , Lista de Verificación/normas , Lista de Verificación/métodos , Reproducibilidad de los Resultados , Proyectos de Investigación/normasRESUMEN
BACKGROUND: The Head and Neck Patient Symptom Checklist (HNSC) is a validated 2-part instrument used to ask patients with head and neck cancer about the nutrition impact symptoms they experience (part 1) and how these interfere with their eating (part 2). PURPOSE: The purpose of this work was to translate and culturally adapt the HNSC into Swedish in accordance with the guidelines of the International Society for Health Economics and Outcomes Research (ISPOR). METHODS: The ISPOR guidelines include 10 steps, and these were thoroughly followed. In step 7, 9 health care professionals from the field of head and neck cancer assessed the perceived relevance (content validity) of each item in the HNSC, as well as the full HNSC. A total of 522 participants with head and neck cancer were included and followed up on 7 occasions using the HNSC to assess internal consistency. RESULTS: The HNSC was translated from English into Swedish, ensuring accuracy through forward and backward translation and harmonization in the research team. Content validity for each part of the HNSC was rated excellent (scale content validity index 0.96). Internal consistency demonstrated a good Cronbach's alpha score (>0.8) across the 7 follow-up time points (from baseline [before the start of treatment] and up to 24 months posttreatment). CONCLUSIONS: The HNSC has been successfully translated and culturally adapted into Swedish. The HNSC can be used in both clinical practice and research to screen for nutrition impact symptoms and symptoms that interfere with eating in patients with head and neck cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03343236 (date of registration: November 17, 2017).
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Lista de Verificación , Neoplasias de Cabeza y Cuello , Humanos , Suecia , Neoplasias de Cabeza y Cuello/complicaciones , Lista de Verificación/métodos , Lista de Verificación/normas , Femenino , Encuestas y Cuestionarios , Masculino , Reproducibilidad de los Resultados , Persona de Mediana Edad , Traducciones , Anciano , Psicometría/instrumentación , Psicometría/métodos , Traducción , AdultoRESUMEN
OBJECTIVES: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, first published in 2009, has been widely endorsed and compliance is high in systematic reviews (SRs) of intervention studies. SRs of prevalence studies are increasing in frequency, but their characteristics and reporting quality have not been examined in large studies. Our objectives were to describe the characteristics of SRs of prevalence studies in adults, evaluate the completeness of reporting, and explore study-level characteristics associated with the completeness of reporting. STUDY DESIGN AND SETTING: We did a metaresearch study. We searched 5 databases from January 2010 to December 2020 to identify SRs of prevalence studies in adult populations. We used the PRISMA 2009 checklist to assess completeness of reporting and recorded additional characteristics. We conducted a descriptive analysis of review characteristics and linear regression to assess the relationship between compliance with PRISMA and publication characteristics. RESULTS: We included 1172 SRs of prevalence studies. The number of reviews increased from 25 in 2010 to 273 in 2020. The median PRISMA score for SRs without meta-analysis was 17.5 of a maximum of 23, and for SRs with meta-analysis, 22 of a maximum of 25. Completeness of reporting, particularly for key items in the methods section, was suboptimal. SRs that included a meta-analysis or reported using a reporting or conduct guideline were the factors most strongly associated with increased compliance with PRISMA 2009. CONCLUSION: Reporting of SRs of prevalence was adequate for many PRISMA items. Nonetheless, this study highlights aspects for which special attention is needed. Development of a specific tool to assess the risk of bias in prevalence studies and an extension to the PRISMA statement could improve the conduct and reporting of SRs of prevalence studies.
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Revisiones Sistemáticas como Asunto , Humanos , Revisiones Sistemáticas como Asunto/normas , Revisiones Sistemáticas como Asunto/métodos , Prevalencia , Adulto , Metaanálisis como Asunto , Lista de Verificación/normas , Proyectos de Investigación/normasRESUMEN
OBJECTIVES: To demonstrate how researchers can identify and translate reporting gaps from a systematic review into checklist items for reporting guidelines. STUDY DESIGN AND SETTING: Good quality research reporting ensures transparency, reproducibility, and utility, facilitated by reporting guidelines. Conducting a systematic review is an essential step in the development of these guidelines. The Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network's toolkit (2010) assists researchers in this process and is due for an update to address current gaps and evolving research methods. One significant gap is the translation of systematic review findings into checklist items. Reflecting on our experience developing the ACcurate Consensus Reporting Document, we illustrate this translation process aiming to empower researchers developing reporting guidelines to address potential biases and promote transparency. We highlight the challenges faced and how they were addressed. RESULTS: The systematic review search process was iterative, involving multiple adjustments to balance precision and sensitivity. Excessively stringent exclusion criteria may lead to missed valuable insights, especially when studies offer relevant content. An information specialist was invaluable in developing the search strategy. Key lessons learned include the necessity of maintaining flexibility and openness during data extraction, continuous adaptation based on panelist feedback, and promoting clear communication through understandable language. These principles can guide the development of future reporting guidelines and the updating of the EQUATOR toolkit, promoting transparency and robustness in research reporting. CONCLUSION: Maintaining flexibility, capturing evolving insights, clear communication, and accommodating changes in research and technologies are key to translating systematic review findings into effective reporting checklists.
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Lista de Verificación , Revisiones Sistemáticas como Asunto , Lista de Verificación/normas , Humanos , Revisiones Sistemáticas como Asunto/normas , Revisiones Sistemáticas como Asunto/métodos , Proyectos de Investigación/normas , Guías como Asunto , Reproducibilidad de los Resultados , Informe de Investigación/normasRESUMEN
PURPOSE: Participant characteristics are underreported; however, they impact swallowing impairments and subsequent access to assessment and intervention. Standards for rigorous and transparent reporting of dysphagia research are required. The Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS) offers a critical appraisal tool for dysphagia research. This article outlines questions for participant characteristics in dysphagia research as part of the larger FRONTIERS tool. METHOD: An exploratory literature review was conducted to determine how participant characteristics, eligibility criteria, and definitions of health and dysphagia are reported in the literature. Findings were cross-referenced with other relevant critical appraisal tools. A list of questions was generated and refined iteratively with the entire FRONTIERS collaborative until consensus was met. RESULTS: The participant characteristics portion of the FRONTIERS tool includes eight questions and 16 possible subquestions. Examples for how the tool might be used, as well as rationales for inclusion of all questions, are included. CONCLUSIONS: Including detailed characteristics of research participants may support understanding of how best to serve marginalized and underrepresented populations more effectively. Critical appraisal tools, such as FRONTIERS, may help to improve the rigor and transparency in dysphagia research, ultimately improving patient care.
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Lista de Verificación , Trastornos de Deglución , Humanos , Investigación Biomédica/normas , Lista de Verificación/normas , Deglución/fisiología , Trastornos de Deglución/diagnóstico , Trastornos de Deglución/terapia , Trastornos de Deglución/fisiopatología , Proyectos de Investigación/normasRESUMEN
PURPOSE: The videofluoroscopic swallowing study (VFSS) is used widely in dysphagia research. However, variations exist in the conduct and interpretation of VFSS, including differences in contrast agents, food and fluid consistencies tested, patient positioning, intervention strategies trialed, fluoroscopy settings, resolution, and image storage solutions. It cannot be assumed that VFSS exams yield directly comparable results across different studies. It is essential that relevant elements of VFSS be clearly reported in research. The goal of this article is to outline optimal VFSS reporting as part of the Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS), a critical appraisal tool intended to promote rigor and transparency in dysphagia research. METHOD: We developed a set of 27 questions regarding the rigor and transparency of VFSS reporting, based on review of previous research articles. These were reviewed by all members of the FRONTIERS Framework collaborative, to determine which questions were mandatory, unnecessary, or needed revision, prior to inclusion in the final critical appraisal tool. RESULTS: The final FRONTIERS Framework tool contains 20 questions and seven subquestions regarding VFSS. These are grouped into four themes: patient/participant positioning, equipment and recording settings, contrast agents, and rating methods, including operational definitions and reliability. CONCLUSIONS: The VFSS section of the FRONTIERS Framework tool is intended to facilitate and promote rigorous and transparent reporting of all elements that may influence the interpretation of VFSS in research. This critical appraisal tool can also be used to guide research design and the evaluation of study outcomes contributing to best practices in the field of dysphagia research.
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Lista de Verificación , Trastornos de Deglución , Deglución , Grabación en Video , Humanos , Trastornos de Deglución/fisiopatología , Trastornos de Deglución/diagnóstico por imagen , Trastornos de Deglución/diagnóstico , Deglución/fisiología , Lista de Verificación/normas , Fluoroscopía/métodos , Reproducibilidad de los Resultados , Valor Predictivo de las Pruebas , Proyectos de Investigación/normasRESUMEN
PURPOSE: In the field of dysphagia research, there is a need to establish a framework for the critical appraisal of methodological reporting. A working group was formed to develop a tool to aid in such critical appraisal across various domains of dysphagia research (called the FRONTIERS [Framework for RigOr aNd Transparency In REseaRch on Swallowing] Framework). The goal of the current paper is to present and describe one domain of this tool: noninstrumental assessment and screening tools. METHOD: Methods describing the development of the FRONTIERS Framework and the associated tool are detailed in the prologue of this series. RESULTS: A set of questions specific to the critical appraisal of transparency and rigor of research involving noninstrumental screening and assessment tools was developed. This included 13 "yes/no" questions, each of which is presented with a rationale for its inclusion and an example of its implementation. CONCLUSIONS: The use of this framework will serve researchers and those appraising the quality of research that uses noninstrumental dysphagia assessment and screening tools. More broadly, the FRONTIERS Framework will facilitate improved rigor and transparency across dysphagia research. Special considerations and future goals are discussed.
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Lista de Verificación , Trastornos de Deglución , Trastornos de Deglución/diagnóstico , Humanos , Lista de Verificación/normas , Deglución , Tamizaje Masivo/métodos , Tamizaje Masivo/normas , Valor Predictivo de las Pruebas , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. METHODS: Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls. RESULTS: According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively. CONCLUSION: The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.
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Terapia por Acupuntura , Depresión , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia por Acupuntura/normas , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Depresión/terapia , Lista de Verificación/normas , Proyectos de Investigación/normasRESUMEN
BACKGROUND: There is a growing awareness of the need to adequately integrate sex and gender into health-related research. Although it is widely known that the entangled dimensions sex/gender are not comprehensively considered in most studies to date, current publications of conceptual considerations and guidelines often only give recommendations for certain stages of the research process and - to the best of our knowledge - there is a lack of a detailed guidance that accompanies each step of the entire research process. The interdisciplinary project "Integrating gender into environmental health research" (INGER) aimed to fill this gap by developing a comprehensive checklist that encourages sex/gender transformative research at all stages of the research process of quantitative health research. In the long term this contributes to a more sex/gender-equitable research. METHODS: The checklist builds on current guidelines on sex/gender in health-related research. Starting from important key documents, publications from disciplines involved in INGER were collected. Furthermore, we used a snowball method to include further relevant titles. The identification of relevant publications was continued until saturation was reached. 55 relevant publications published between 2000 and 2021 were identified, assessed, summarised and included in the developed checklist. After noticing that most publications did not cover every step of the research process and often considered sex/gender in a binary way, the recommendations were modified and enriched based on the authors' expertise to cover every research step and to add further categories to the binary sex/gender categories. RESULTS: The checklist comprises 67 items in 15 sections for integrating sex/gender in quantitative health-related research and addresses aspects of the whole research process of planning, implementing and analysing quantitative health studies as well as aspects of appropriate language, communication of results to the scientific community and the public, and research team composition. CONCLUSION: The developed comprehensive checklist goes beyond a binary consideration of sex/gender and thus enables sex/gender-transformative research. Although the project INGER focused on environmental health research, no aspects that were specific to this research area were identified in the checklist. The resulting comprehensive checklist can therefore be used in different quantitative health-related research fields.
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Lista de Verificación , Humanos , Lista de Verificación/métodos , Lista de Verificación/normas , Masculino , Femenino , Factores Sexuales , Proyectos de Investigación/normas , Investigación Biomédica/métodos , Investigación Biomédica/normas , Identidad de GéneroRESUMEN
BACKGROUND: Whiplash-associated disorders are a common sequela of road traffic accidents. Exercise therapy is considered an effective intervention, and it is recommended for the management of such condition. However, the application of research findings to everyday clinical practice is dependent on sufficient details being reported. OBJECTIVES: To explore the quality of reporting in studies investigating the effectiveness of exercise for whiplash-associated disorders. METHODS: A literature search was conducted to identify studies testing the effectiveness of exercise for whiplash-associated disorders. Two reporting checklists were used to evaluate reporting completeness. The median positive scores for each study and overall percentage of positive scores for each item were calculated. Percentage agreement and the Cohen's Kappa coefficient were calculated. RESULTS: Twenty-one studies were included. According to the Template for Intervention Description and Replication checklist, items were reported appropriately with a median of 29% (range 0-95%, IQR 40.5). The median number of adequately reported items per study was 5 (range 1-10, IQR 3). For the Consensus on Exercise Reporting Template checklist, items were reported appropriately with a median of 29% (range 0-57%, IQR 29). The median number of adequately reported items per study was 4 (range 0-16, IQR 8). Percentage agreement ranged from 57% to 100% while Cohen's Kappa from -0.17 to 1.00. CONCLUSIONS: The study reveals significant gaps in the quality of reporting in studies investigating exercise for whiplash-associated disorders as both checklists showed a median reporting adequacy of only 29%. Overall, the inter-rater agreement for both checklists was acceptable.
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Terapia por Ejercicio , Ensayos Clínicos Controlados Aleatorios como Asunto , Lesiones por Latigazo Cervical , Humanos , Lista de Verificación/normas , Terapia por Ejercicio/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Lesiones por Latigazo Cervical/terapiaRESUMEN
The transversus abdominis plane (TAP) block is a regional anesthesia technique used as part of a multimodal pain management plan in patients undergoing abdominal surgery. There are numerous approaches and techniques described in the literature, resulting in a lack of consistency in block performance. This potentially reduces efficacy while increasing risk to the patient. Competency assessment tools have been shown to lower patient risk and improve outcomes by improving provider skill. Checklists are used as formative and summative assessment tools throughout healthcare education, however, there is no validated tool for ultrasound-guided TAP blocks. The purpose of this evidence-based project was to develop a checklist using a modified Delphi method. The primary outcome measure was validation of the assessment tool, established by an expert panel consensus and guided by Messick's validity framework. A 43-item checklist was validated by six certified registered nurse anesthesiologists throughout the United States with expertise in regional anesthesia. Three rounds of feedback were required to exceed the threshold of consensus (0.8), establishing a method of evaluation that may allow future research in educational settings through improved skill assessment among providers performing TAP blocks.
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Músculos Abdominales , Técnica Delphi , Bloqueo Nervioso , Enfermeras Anestesistas , Ultrasonografía Intervencional , Humanos , Bloqueo Nervioso/métodos , Enfermeras Anestesistas/educación , Músculos Abdominales/diagnóstico por imagen , Lista de Verificación/normas , Competencia Clínica/normas , Reproducibilidad de los ResultadosRESUMEN
Evidence-based medicine drives patient care decision-making; thus, accurate and complete reporting in scientific publications is paramount. A checklist for complete reporting of veterinary radiation therapy was proposed in 2012 using the recommendations of the International Commission of Radiation Units and Measurements (ICRU). The purpose of this study is to review the 2012 checklist and propose updates based on changes in technology. Significant technology advancements have gained traction in veterinary medicine, including intensity-modulated radiation therapy (IMRT) and stereotactic radiation therapy (SRT), both of which have related modality-specific ICRU reporting recommendations. The 2012 checklist and proposed 2024 checklist are then used to assess the completeness of reporting in veterinary radiation oncology publications between 2015 and 2022, of which one hundred and eight publications met the inclusion criteria. Prior to the publication of the 2012 checklist (2005-2010), only nine checklist items showed a good level of completeness in reporting, and from 2015 to 2022, this increased to 16 items. Encouraging and/or requiring the use of reporting checklists at the time of manuscript submission may be responsible for this improvement in reporting. Using the 2024 checklist, which is more relevant to publications discussing IMRT and SRT treatments, only 14 of the analyzed checklist items (34%) show a good level of completeness in reporting, suggesting there is a need for updated guidelines to capture the nuances of advanced techniques. This study proposes a 2024 checklist that can be used as a guideline for future reporting of radiation therapy in veterinary medicine.
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Lista de Verificación , Medicina Veterinaria , Medicina Veterinaria/normas , Lista de Verificación/normas , Animales , Medicina Basada en la Evidencia/normas , Radioterapia/veterinaria , Radioterapia/normas , Oncología por Radiación/normas , Guías de Práctica Clínica como Asunto , Radioterapia de Intensidad Modulada/veterinaria , Radioterapia de Intensidad Modulada/normas , Radioterapia de Intensidad Modulada/métodosRESUMEN
BACKGROUND AND OBJECTIVE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: This paper was jointly developed by Journal of Clinical Epidemiology, Quality of Life Research, Journal of Patient Reported Outcomes, Health and Quality of Life Outcomes and jointly published by Elsevier Inc, Springer Nature Switzerland AG, and BioMed Central Ltd., part of Springer Nature. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article.
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Técnica Delphi , Evaluación de Resultado en la Atención de Salud , Revisiones Sistemáticas como Asunto , Humanos , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/normas , Guías como Asunto , Proyectos de Investigación/normas , Lista de Verificación/normas , ConsensoRESUMEN
BACKGROUND: Operating room (OR) handoffs are not universally standardized, although standardized sign outs have been proven to provide effective communication in other aspects of healthcare. We hypothesize that creating a standardized handoff will improve communication between OR staff. STUDY DESIGN: A frontline stakeholder approached our quality improvement team with concern regarding inadequate quality surgical technician handoffs during staff changes. An audit tool was created for a pilot cohort of 23 cases to evaluate surgical technician handoffs from May 2022 to November 2022. Handoffs occurred in 82.6% of cases. Elements of handoff varied significantly, with an average of 34.4% completion of critical handoff elements. Audits were reviewed with stakeholders to develop a standardized communication checklist, including domains regarding sponges, sharps, hidden items, replaced items, instruments, implants, medications, procedure overview, and specimens. An acronym of these domains, SHRIMPS, was affixed to each OR wall. RESULTS: In the initial Plan-Do-Study-Act cycle, piloted in urology, general surgery, and neurosurgery, 100% of the 15 observed cases included handoff, averaging 76 seconds per handoff. Additionally, 100% of cases announced a handoff to the surgeon, and all elements were addressed 99.6% of the time. Plan-Do-Study-Act cycle 2 involved implementation to all service lines. Of the 68 cases observed, 100% included handoff, averaging 69.4 seconds per handoff, with 98.2% of elements addressed, though only 97.1% of handoffs were announced. CONCLUSIONS: Little communication standardization exists within the OR, especially regarding intraoperative staff changes. Implementation of a standardized handoff between surgical technicians resulted in substantial improvement in critical communication during staff changes.
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Quirófanos , Pase de Guardia , Mejoramiento de la Calidad , Pase de Guardia/normas , Humanos , Quirófanos/normas , Comunicación , Lista de Verificación/normas , Proyectos PilotoRESUMEN
The perioperative setting is a complex environment requiring interdisciplinary team collaboration to avoid adverse events. To protect the safety of patients and perioperative team members, communication among personnel should be clear and effective. The recently updated AORN "Guideline for team communication" provides perioperative nurses with recommendations on the topic. To promote effective communication in perioperative areas, all personnel should value and commit to a culture of safety. This article discusses recommendations for supporting a culture of safety, developing and implementing an effective hand-off process and surgical safety checklist, and developing education strategies for team communication. It also includes a scenario describing the implementation of a standardized, electronic surgical safety checklist in the OR. Perioperative nurses should review the guideline in its entirety and apply the recommendations for team communication in their working environments.
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Comunicación , Grupo de Atención al Paciente , Grupo de Atención al Paciente/normas , Humanos , Enfermería Perioperatoria/normas , Guías como Asunto , Lista de Verificación/métodos , Lista de Verificación/normas , Seguridad del Paciente/normas , Guías de Práctica Clínica como AsuntoRESUMEN
BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting. RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated ß = 0.14, p < 0.01) and the multicenter trials (estimated ß = 2.22, p < 0.01) were associated with better reporting. CONCLUSION: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Humanos , Proyectos de Investigación/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Lista de Verificación/métodos , Lista de Verificación/normas , Ensayos Clínicos Fase II como Asunto/métodos , Ensayos Clínicos Fase II como Asunto/estadística & datos numéricos , Ensayos Clínicos Fase II como Asunto/normasRESUMEN
OBJECTIVES: The objectives of this study are to assess reporting of evidence-based healthcare (EBHC) e-learning interventions using the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) checklist and explore factors associated with compliant reporting. DESIGN: Methodological cross-sectional study. METHODS: Based on the criteria used in an earlier systematic review, we included studies comparing EBHC e-learning and any other form of EBHC training or no EBHC training. We searched Medline, Embase, ERIC, CINAHL, CENTRAL, SCOPUS, Web of Knowledge, PsycInfo, ProQuest and Best Evidence Medical Education up to 4 January 2023. Screening of titles, abstracts, full-text articles and data extraction was done independently by two authors. For each study, we assessed adherence to each of the 17 GREET items and extracted information on possible predictors. Adequacy of reporting for each item of the GREET checklist was judged with yes (provided complete information), no (provided no information), unclear (when insufficient information was provided), or not applicable, when the item was clearly of no relevance to the intervention described (such as for item 8-details about the instructors-in the studies which used electronic, self-paced intervention, without any tutoring). Studies' adherence to the GREET checklist was presented as percentages and absolute numbers. We performed univariate analysis to assess the association of potential adherence predictors with the GREET checklist. We summarised results descriptively. RESULTS: We included 40 studies, the majority of which assessed e-learning or blended learning and mostly involved medical and other healthcare students. None of the studies fully reported all the GREET items. Overall, the median number of GREET items met (received yes) per study was 8 and third quartile (Q3) of GREET items met per study was 9 (min. 4 max. 14). When we used Q3 of the number of items met as cut-off point, adherence to the GREET reporting checklist was poor with 7 out of 40 studies (17.5%) reporting items of the checklist on acceptable level (adhered to at least 10 items out of 17). None of the studies reported on all 17 GREET items. For 3 items, 80% of included studies well reported information (received yes for these items): item 1 (brief description of intervention), item 4 (evidence-based practice content) and item 6 (educational strategies). Items for which 50% of included studies reported complete information (received yes for these items) included: item 9 (modes of delivery), item 11 (schedule) and 12 (time spent on learning). The items for which 70% or more of included studies did not provide information (received no for these items) included: item 7 (incentives) and item 13 (adaptations; for both items 70% of studies received no for them), item 14 (modifications of educational interventions-95% of studies received no for this item), item 16 (any processes to determine whether the materials and the educational strategies used in the educational intervention were delivered as originally planned-93% of studies received no for this item) and 17 (intervention delivery according to schedule-100% of studies received no for this item). Studies published after September 2016 showed slight improvements in nine reporting items. In the logistic regression models, using the cut-off point of Q3 (10 points or above) the odds of acceptable adherence to GREET guidelines were 7.5 times higher if adherence to other guideline (Consolidated Standards of Reporting Trials, Strengthening the Reporting of Observational Studies in Epidemiology, etc) was reported for a given study type (p=0.039), also higher number of study authors increased the odds of adherence to GREET guidance by 18% (p=0.037). CONCLUSIONS: Studies assessing educational interventions on EBHC e-learning still poorly adhere to the GREET checklist. Using other reporting guidelines increased the odds of better GREET reporting. Journals should call for the use of appropriate use of reporting guidelines of future studies on teaching EBHC to increase transparency of reporting, decrease unnecessary research duplication and facilitate uptake of research evidence or result. STUDY REGISTRATION NUMBER: The Open Science Framework (https://doi.org/10.17605/OSF.IO/V86FR).
Asunto(s)
Lista de Verificación , Práctica Clínica Basada en la Evidencia , Adhesión a Directriz , Humanos , Lista de Verificación/normas , Instrucción por Computador/normas , Instrucción por Computador/métodos , Estudios Transversales , Práctica Clínica Basada en la Evidencia/educación , Práctica Clínica Basada en la Evidencia/normasRESUMEN
BACKGROUND AND AIMS: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols. METHODS: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. RESULTS: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [ß = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [ß = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [ß = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [ß = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores. CONCLUSIONS: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.
Asunto(s)
Protocolos de Ensayos Clínicos como Asunto , Dieta , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Lista de Verificación/normas , Proyectos de Investigación/normas , SARS-CoV-2 , Políticas Editoriales , Publicaciones Periódicas como Asunto , Guías como AsuntoRESUMEN
INTRODUCTION: The use of survey methodology in surgical research has proliferated in recent years, but the quality of these surveys and of their reporting is understudied. METHODS: We conducted a comprehensive review of surgical survey literature (January 2022-July 2023) via PubMed in July 2023. Articles which (1) reported data gleaned from a survey, (2) were published in an English language journal, (3) targeted survey respondents in the United States or Canada, and (4) pertained to general surgery specialties were included. We assessed quality of survey reports using the Checklist for Reporting Of Survey Studies (CROSS) guidelines. Articles were evaluated for concordance with CROSS using a dichotomous (yes or no) scale. RESULTS: Initial literature search yielded 481 articles; 57 articles were included in analysis based on the inclusion criteria. The mean response rate was 37% (range 0.62%-98%). The majority of surveys were administered electronically (n = 50, 87.8%). No publications adhered to all 40 CROSS items; on average, publications met 61.2% of items applicable to that study. Articles were most likely to adhere to reporting criteria for title and abstract (mean adherence 99.1%), introduction (99.1%), and discussion (92.4%). Articles were least adherent to items related to methodology (42.6%) and moderately adherent to items related to results (76.6%). Only five articles cited CROSS guidelines or another standardized survey reporting tool (10.5%). CONCLUSIONS: Our analysis demonstrates that CROSS reporting guidelines for survey research have not been adopted widely. Surveys reported in surgical literature may be of variable quality. Increased adherence to guidelines could improve development and dissemination of surveys done by surgeons.