Development of best evidence-based practice protocols for central venous catheter placement and maintenance to reduce CLABSI.

Although evidence-based interventions can reduce the incidence of central line-associated bloodstream infection (CLABSI), there is a large gap between evidence-based interventions and the actual practice of central venous catheter (CVC) care. Evidence-based interventions are needed to reduce the incidence of CLABSI in intensive care units (ICU) in China. Professional association, guidelines, and database websites were searched for data relevant to CLABSI in the adult ICUs from inception to February 2020. Checklists were developed for both CVC placement and maintenance. Based on the Integrated Promoting Action on Research Implementation in Health Services framework, a questionnaire collected the cognition and practice of ICU nursing and medical staff on the CLABSI evidence-based prevention guidelines. From January 2018 to December 2021, ICU CLABSI rates were collected monthly. Ten clinical guidelines were included after the screening and evaluation process and used to develop the best evidence-based protocols for CVC placement and maintenance. The CLABSI rates in 2018, 2019, and 2020 were 2.98‰ (9/3021), 1.83‰ (6/3276), and 1.69‰ (4/2364), respectively. Notably, the CLABSI rate in 2021 was 0.38‰ (1/2607). In other words, the ICU CLABSI rate decreased from 1.69‰ to 0.38‰ after implementation of the new protocols. Additionally, our data suggested that the use of ultrasound-guidance for catheter insertion, chlorhexidine body wash, and the use of a checklist for CVC placement and maintenance were important measures for reducing the CLABSI rate. The evidence-based processes developed for CVC placement and maintenance were effective at reducing the CLABSI rate in the ICU.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: 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: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: 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: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Reporting guidelines for precision medicine research of clinical relevance: the BePRECISE checklist.

Precision medicine should aspire to reduce error and improve accuracy in medical and health recommendations by comparison with contemporary practice, while maintaining safety and cost-effectiveness. The etiology, clinical manifestation and prognosis of diseases such as obesity, diabetes, cardiovascular disease, kidney disease and fatty liver disease are heterogeneous. Without standardized reporting, this heterogeneity, combined with the diversity of research tools used in precision medicine studies, makes comparisons across studies and implementation of the findings challenging. Specific recommendations for reporting precision medicine research do not currently exist. The BePRECISE (Better Precision-data Reporting of Evidence from Clinical Intervention Studies & Epidemiology) consortium, comprising 23 experts in precision medicine, cardiometabolic diseases, statistics, editorial and lived experience, conducted a scoping review and participated in a modified Delphi and nominal group technique process to develop guidelines for reporting precision medicine research. The BePRECISE checklist comprises 23 items organized into 5 sections that align with typical sections of a scientific publication. A specific section about health equity serves to encourage precision medicine research to be inclusive of individuals and communities that are traditionally under-represented in clinical research and/or underserved by health systems. Adoption of BePRECISE by investigators, reviewers and editors will facilitate and accelerate equitable clinical implementation of precision medicine.

Design and construct of an assessment tool for the handover of critical patient the in urgent care and emergency setting.

OBJECTIVES: To design and construct an assessment tool for the handover of critical patients in the urgent care and emergency setting. RESEARCH METHODOLOGY: This metric and descriptive study comprised two phases in accordance with the Clinical practice guidelines for A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist. In the first phase, the identification and selection of items related to the handover of critical patients were performed by consensus of a group of experts. The second phase consisted of two stages. In the first stage, the items were selected by applying the e-Delphi technique across two assessment rounds and in the second stage, the items were subjected a pilot test in a real critical patient handover scenario. Professionals from different disciplines and work areas (hospital and prehospital) caring for critically ill patients in the urgency and emergency setting participated in each of the phases. RESULTS: A total of 58 critical patient care, and urgent and emergency care professionals participated in the design and construction of the assessment tool. The initial list consisted of 14 categories and 57 items, which were reduced to 28 items grouped into five categories after the intervention of the participants. The content validity index (CVI) of the instrument was 0.966. CONCLUSIONS: This study describes an assessment tool developed in Spanish-language designed to assess the handover of critical patients in the urgent care and emergency setting. This tool has a high CVI, and is the only currently available tool that consider all of the dimensions and characteristics of the handover process. IMPLICATIONS FOR CLINICAL PRACTICE: The assessment tool developed in this study could enable critical care professionals in their clinical practice to work in a systematic way, universalizing the handover of critically ill patients in the urgent care and emergency setting through scientifically proven guidelines.

An observer tool to enhance learning of medical students during simulation training of cardiopulmonary resuscitation: a randomised controlled trial.

BACKGROUND: Simulation training in cardiopulmonary resuscitation (CPR) is effective but active practice time is limited given the large number of students and the learning effect size remains small. To improve learning during observation, the use of an observer tool (OT) has been advocated. The aim was to assess the value of OT to improve medical students' learning outcomes during CPR simulation training. METHODS: This prospective, randomized study took place during CPR training of medical students. The workshop targeted recognition of unconsciousness, absence of breathing, call for help, cardiac massage and defibrillation. Students practicing in dyads were randomized to use an OT (i.e., a checklist summarizing CPR skills and step-by-step actions) (OT +) or not (OT-) when observing others. At the end of the training, the global performance of the dyad was assessed by an evaluator using the OT checklist (primary outcome). The non-technical skills (NTS), chest compression quality, perceived improvement in knowledge and skills and knowledge score (MCQ) were also recorded. RESULTS: The student dyads were included (OT + : n = 40 and OT-: n = 41). Immediately after training, the global performance was similar between the two groups: OT + : 24 [23-25] and OT-: 23 [21-24] (out of 25), p = 0.052. However, better learning of breathing assessment and cardiac massage performance, as well as a better knowledge score, were found in the OT + group. No significant difference was observed for NTS or perceived improvement in knowledge and skills. Satisfaction was higher in the OT- group. CONCLUSIONS: The use of an OT during CPR simulation did not show any pedagogical benefit on the global performance of medical students. However, a potential benefit was found for several important secondary outcomes. Further studies are needed to confirm these positive results.

Still to ARRIVE at adequate reporting of orthodontic studies involving animal models.

BACKGROUND: The ARRIVE 2.0 guidelines were introduced to improve the reporting of animal studies. The aim of this study was to assess the reporting adherence of orthodontic speciality animal studies in relation to ARRIVE 2.0 guidelines. Associations between the reporting and study characteristics were explored. MATERIALS AND METHOD: An electronic database search was undertaken using Medline via PubMed (www.pubmed.ncbi.nlm.nih.gov) to identify studies meeting the eligibility criteria published between 1 January 2018 and 31 December 2023. Data extraction was performed in duplicate and independently. Descriptive statistics and frequency distributions for the responses to each checklist item were calculated. Mean values for adequate reporting per ARRIVE item were calculated. A sum score was calculated by adding the responses (0 = not reported, 1 = inadequate reporting, 2 = adequate reporting) per item and sub-questions. On an exploratory basis, univariable linear regression between summary score and study characteristics (year of publication, continent of authorship, type of centre, and number of authors) was performed. RESULTS: Three hundred and eighty-four studies were analysed. Variability in the adequate reporting of the ARRIVE 2.0 guideline items was evident. In particular, in 32% of studies, there was a lack of reporting of the priori sample size calculation. Overall, the mean reporting score for the sample was 57.9 (SD 6.7 and range 34-74). There were no associations between score and study characteristics except for a weak association for year of publication with a small improvement over time (each additional year). CONCLUSIONS: The reporting of animal studies relevant to the speciality of orthodontics is sub-optimal in relation to the ARRIVE 2.0 guidelines. There was a tendency for the non-reporting of items pertaining to study sample size, eligibility, methods to reduce bias and interpretation/scientific implications. Greater awareness and reporting adherence to the ARRIVE 2.0 guidelines are required to reduce research waste involving animal models.

Translation to Portuguese and cross-cultural adaptation of the epilepsy transition readiness checklist for use in Brazil.

OBJECTIVES: Planning for the child and adolescent to have a safe handling in the epilepsy transition process is essential. In this work, the authors translated the "Readiness Checklists" and applied them to a group of patients and their respective caregivers in the transition process to assess the possibility of using them as a monitoring and instructional instrument. METHODS: The "Readiness Checklists" were applied to thirty adolescents with epilepsy and their caregivers. The original English version of this instrument underwent a process of translation and cultural adaptation by a translator with knowledge of English and epilepsy. Subsequently, it was carried out the back-translation and the Portuguese version was compared to the original, analyzing discrepancies, thus obtaining the final version for the Brazilian population. RESULTS: Participants were able to answer the questions. In four questions there was an association between the teenagers' educational level and the response pattern to the questionnaires. The authors found a strong positive correlation between the responses of adolescents and caregivers (RhoSpearman = 0.837; p < 0.001). The application of the questionnaire by the health team was feasible for all interviewed patients and their respective caregivers. CONCLUSION: The translation and application of the "Readiness Checklists" is feasible in Portuguese. Patients with lower educational levels felt less prepared for the transition than patients with higher educational levels, independently of age. Adolescents and caregivers showed similar perceptions regarding patients' abilities. The lists can be very useful tools to assess and plan the follow-up of the population of patients with epilepsy in the process of transition.

Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force.

This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.

Formulating policies and procedures for managing diving related deaths: a whole of state engagement from frontline and hospital services in Tasmania.

Introduction: Tasmania is a small island state off the southern edge of Australia where a comparatively high proportion of the 558,000 population partake in recreational or occupational diving. While diving is a relatively safe sport and occupation, Tasmania has a significantly higher diving death rate per head of population than other States in Australia (four times the national diving mortality rate). Methods: Three compressed gas diving deaths occurred in seven months between 2021-2022 prompting a review of the statewide approach for the immediate response of personnel to diving-related deaths. The review engaged first responders including the Police Marine and Rescue Service, hospital-based departments including the Department of Hyperbaric and Diving Medicine, and the mortuary and coroner's office. Results: An aide-mémoire for all craft groups, digitalised checklists for first responders (irrespective of diving knowledge), and a single-paged algorithm to highlight inter-agency communication pathways in the event of a diving death were designed to enhance current practices and collaboration. Conclusions: If used, these aids for managing diving related deaths should ensure that time-critical information is appropriately captured and stored to optimise information provided for the coronial investigation.

Feedback in an Entrustment-Based Objective Structured Clinical Examination: Analysis of Content and Scoring Methods.

Background The integration of entrustable professional activities (EPAs) within objective structured clinical examinations (OSCEs) has yielded a valuable avenue for delivering timely feedback to residents. However, concerns about feedback quality persist. Objective This study aimed to assess the quality and content alignment of verbal feedback provided by examiners during an entrustment-based OSCE. Methods We conducted a progress test OSCE for internal medicine residents in 2022, assessing 7 EPAs. The immediate 2-minute feedback provided by examiners was recorded and analyzed using the Quality of Assessment of Learning (QuAL) score. We also analyzed the degree of alignment with EPA learning objectives: competency milestones and task-specific abilities. In a randomized crossover experiment, we compared the impact of 2 scoring methods used to assess residents' clinical performance (3-point entrustability scales vs task-specific checklists) on feedback quality and alignment. Results Twenty-one examiners provided feedback to 67 residents. The feedback demonstrated high quality (mean QuAL score 4.3 of 5) and significant alignment with the learning objectives of the EPAs. On average, examiners addressed in their feedback 2.5 milestones (61%) and 1.2 task-specific abilities (46%). The scoring methods used had no significant impact on QuAL scores (95% CI -0.3, 0.1, P=.28), alignment with competency milestones (95% CI -0.4, 0.1, P=.13), or alignment with task-specific abilities (95% CI -0.3, 0.1, P=.29). Conclusions In our entrustment-based OSCE, examiners consistently offered valuable feedback aligned with intended learning outcomes. Notably, we explored high-quality feedback and alignment as separate dimensions, finding no significant impact from our 2 scoring methods on either aspect.

Cognitive aid and performance for simulated umbilical venous catheter placement: A randomized trial.

INTRODUCTION: Neonatal resuscitation may require urgent umbilical venous catheter (UVC) placement. Complications can be observed with umbilical venous catheterization, especially in a stressful context. Inspired by the aeronautic environment, medical routine checklists, also called "cognitive aids," secure the equipment and environment for the patients once they are admitted to the operating room. We hypothesized that reading a cognitive aid for UVC placement in the delivery room during neonatal resuscitation simulation scenarios can (a) improve the performance in reducing catheterization duration and (b) can limit complications. METHODS: This was a prospective single-center randomized study. A total of 23 dyads for a simulation scenario were included: 12 in the control group and 11 in the cognitive aid group. In the cognitive aid group, the cognitive aid was read by the same facilitator for every scenario. RESULTS: No significant difference concerning the duration of the procedure was identified between the cognitive aid and control groups: 412 s [342; 420] vs. 374 s [338;402], respectively (p = 0.781). Nevertheless, there were significantly fewer deviations from hygiene guidelines and improved prevention of air embolism in the cognitive aid group compared with the control group. CONCLUSION: The UVC insertion time was similar between the control and cognitive aid groups. Moreover, cognitive aid can limit infectious complications or air embolism by allowing caregivers to follow UVC placement standards.

Rationale and Study Checklist for Ethical Rejection of Participants on Crowdsourcing Research Platforms.

Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs.

Measurement properties of the Iranian version of the breast cancer perception scale (BCPS) according to the COSMIN checklist.

BACKGROUND: Breast cancer is a prevalent cancer characterized by its aggressive nature and potential to cause mortality among women. The rising mortality rates and women's inadequate perception of the disease's severity in developing countries highlight the importance of screening using conventional methods and reliable scales. Since the validity and reliability of the breast cancer perception scale (BCPS) have not been established in the Iranian context. Therefore, this study aimed to determine the measurement properties of the BCPS in women residing in Tabriz, Iran. METHODS: The present study comprised a cross-sectional design, encompassing a sample of 372 Iranian women. The participants were selected through a multi-stage cluster random sampling technique conducted over a period spanning from November 2022 to February 2023. The measurement properties of the Iranian version of BCPS were assessed following the guidelines outlined in the COSMIN checklist. This involved conducting various steps, including the translation process, reliability testing (internal consistency, test-retest reliability, and measurement error), and methodological tests for validity (content validity, face validity, construct validity, and hypothesis testing). The study also investigated the factors of responsiveness and interpretability. The presence of floor and ceiling effects was assessed. RESULTS: The internal consistency of the scale was assessed using Cronbach's alpha, yielding a satisfactory value of 0.68. Additionally, McDonald's omega (95% CI) was computed, resulting in a value of 0.70 (0.66 to 0.74). Furthermore, the test-retest reliability was evaluated, revealing a high intraclass correlation coefficient (ICC) of 0.97 (95% CI: 0.94 to 0.99). The CVI, CVR, and impact scores of the BCPS were determined to be 0.98, 0.95, and 3.70, respectively, indicating favorable levels of content and face validity. To assess construct validity, an examination of the Exploratory Factor Analysis (EFA) was conducted on a set of 24 items. This analysis revealed the presence of six distinct factors, which collectively accounted for 52% of the cumulative variance. The fit indices of the validity model (CFI = 0.91, NFI = 0.96, RFI = 0.94, TLI = 0.90, χ2/df = 2.03, RMSEA = 0.055 and SRMR = 0.055) were confirmed during the confirmatory factor analysis (CFA). The overall score of BCPS exhibited a ceiling effect of 0.3%. The floor effect observed in the overall score (BCPS) was found to be 0.5%. Concerning the validation of the hypothesis, Spearman's correlation coefficient of 0.55 was obtained between the BCPS and the QLICP-BR V2.0. This correlation value signifies a statistically significant association. Furthermore, it is worth noting that the minimum important change (MIC) of 3.92 exhibited a higher value compared to the smallest detectable change (SDC) of 3.70, thus suggesting a satisfactory level of response. CONCLUSIONS: The obtained findings suggest that the Iranian version of the BCPS demonstrates satisfactory psychometric properties for assessing the perception of breast cancer among Iranian women. Furthermore, it exhibits favorable responsiveness to clinical variations. Consequently, it can serve as a screening instrument for healthcare professionals to comprehend breast cancer and as a reliable tool in research endeavors.

A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials.

Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent update to the CONSORT harms checklist aims to improve reporting by providing structure and consistency to the information presented. We propose an extension wherein harms would be reported in conjunction with effectiveness outcome(s) rather than in silo to provide a more complete picture of the evidence acquired within a trial. Benefit-risk methods are designed to simultaneously consider both benefits and risks, and therefore, we believe these methods could be implemented to improve the prominence of adverse events when reporting trials. The aim of this article is to use case studies to demonstrate the practical utility of benefit-risk methods to present adverse events results alongside effectiveness results. Two randomised controlled trials have been selected as case studies, the Option-DM trial and the SANAD II trial. Using a previous review, a shortlist of 17 benefit-risk methods which could potentially be used for reporting RCTs was created. From this shortlist, three benefit-risk methods are applied across the two case studies. We selected these methods for their usefulness to achieve the aim of this paper and which are commonly used in the literature. The methods selected were the Benefit-Risk Action Team (BRAT) Framework, net clinical benefit (NCB), and the Outcome Measures in Rheumatology (OMERACT) 3 × 3 table. Results using the benefit-risk method added further context and detail to the clinical summaries made from the trials. In the case of the SANAD II trial, the clinicians concluded that despite the primary outcome being improved by the treatment, the increase in adverse events negated the improvement and the treatment was therefore not recommended. The benefit-risk methods applied to this case study outlined the data that this decision was based on in a clear and transparent way. Using benefit-risk methods to report the results of trials can increase the prominence of adverse event results by presenting them alongside the primary efficacy/effectiveness outcomes. This ensures that all the factors which would be used to determine whether a treatment would be recommended are transparent to the reader.