Guidelines in Practice: A Safe Environment of Care.

Creating a safe environment for performing surgical procedures is essential to achieve successful patient outcomes and protect the perioperative personnel who are providing care. Numerous factors challenge the provision of a safe environment of care and create a complex setting for perioperative nurses to manage. The updated AORN "Guideline for a safe environment of care" provides perioperative nurses with recommendations for establishing a safe environment for both patients and personnel. This article provides an overview of the guideline and discusses recommendations for implementing fire safety protocols, using warming cabinets, and creating a latex-safe environment. It also includes a scenario describing the care of a patient with an unidentified latex allergy who is undergoing a laparoscopic sleeve gastrectomy and hiatal hernia repair. Perioperative nurses should review the guideline in its entirety and implement recommendations as applicable in operative and other procedural settings.

Guidelines for conscientious objection in Spain: a proposal involving prerequisites and protocolized procedure.

Healthcare professionals often face ethical conflicts and challenges related to decision-making that have necessitated consideration of the use of conscientious objection (CO). No current guidelines exist within Spain's healthcare system regarding acceptable rationales for CO, the appropriate application of CO, or practical means to support healthcare professionals who wish to become conscientious objectors. As such, a procedural framework is needed that not only assures the appropriate use of CO by healthcare professionals but also demonstrates its ethical validity, legislative compliance through protection of moral freedoms and patients' rights to receive health care. Our proposal consists of prerequisites of eligibility for CO (individual reference, specific clinical context, ethical justification, assurance of non-discrimination, professional consistency, attitude of mutual respect, assurance of patient rights and safety) and a procedural process (notification and preparation, documentation and confidentiality, evaluation of prerequisites, non-abandonment, transparency, allowance for unforeseen objection, compensatory responsibilities, access to guidance and/or consultative advice, and organizational guarantee of professional substitution). We illustrate the real-world utility of the proposed framework through a case discussion in which our guidelines are applied.

First steps towards the deinstitutionalization of older adults: A protocol for the implementation of a complex intervention / Primeros pasos en la desinstitucionalización de adultos mayores: protocolo para la implementación de una intervención compleja

Background: Nursing homes are becoming increasingly important as end-of-life care facilities. However, many older adults want to stay in their homes as they age. Objective: To assess the feasibility of a deinstitutionalization process on selected institutionalized older adults who are willing to initiate the process. Methods: This study, divided into two phases, will be carried out over 15 months on 241 residents living in two nursing homes in Navarra (Spain). The first phase has a cross-sectional design. We will identify the factors and covariates associated with feasibility and willingness to participate in a deinstitutionalization process by bivariate analysis, essential resources for the process and residents to participate in the process. The second phase has a complex interventional design to implement a deinstitutionalization process. An exploratory descriptive and comparative analysis will be carried out to characterize the participants, prescribed services and the impact deinstitutionalization intervention will have over time (quality of life will be the main outcome; secondary variables will be health, psychosocial, and resource use variables). This study will be accompanied by a pseudo-qualitative and emergent sub-study to identify barriers and facilitators concerning the implementation of this process and understand how intervention components and context influence the outcomes of the main study. Intervention components and the way the intervention is implemented will be of great relevance in the analysis. Discussion: Alternatives to institutionalization with adapted accommodation and community support can allow people who wish to return to the community.(AU)

Introducción: Las residencias de personas mayores cobran cada vez más importancia como centros de atención al final de la vida. Sin embargo, muchos adultos mayores desean permanecer en sus casas mientras envejecen. Objetivo: Se pretende evaluar la viabilidad de un proceso de desinstitucionalización en adultos mayores seleccionados que viven en las residencias y que expresen la voluntad para iniciar el proceso. Métodos: Este estudio, dividido en dos fases, se llevará a cabo durante 15 meses en 241 sujetos que viven en dos residencias de personas mayores en Navarra (España). La primera fase tiene un diseño transversal en donde se identificarán los factores y covariables asociadas a la viabilidad y voluntad para participar en un proceso de desinstitucionalización a través de un análisis bivariante, los recursos imprescindibles para el proceso y los residentes que quieran participar en él. La segunda fase tiene un diseño de intervención compleja en la que se implementa un proceso de desinstitucionalización. Se realizará un análisis exploratorio descriptivo y comparativo para caracterizar a los participantes, los servicios prescritos y el efecto de la intervención de desinstitucionalización a lo largo del tiempo (la calidad de vida será la variable principal; las secundarias serán las referentes a la salud, las psicosociales y de uso de recursos). Este estudio irá acompañado de un subestudio pseudocualitativo y emergente para identificar las barreras y los elementos facilitadores relativos a la implementación de este proceso y comprender cómo los componentes de la intervención y el contexto influyen en los resultados del estudio principal. Los componentes de la intervención y su ejecución serán de gran relevancia en el análisis. Discusión: Las alternativas a la institucionalización con viviendas adaptadas y apoyos comunitarios pueden permitir a las personas que así lo desean el retorno a la comunidad.(AU)

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

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

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

Shirin Heidari.

Dr. Shirin Heidari is the lead author of the Sex and Gender Equity in Research (SAGER) guidelines. In this interview with Dr. Isabel Goldman at Cell, she discusses her research, GENDRO, the SAGER guidelines and importance of considering sex- and gender-related variables in research, and her work on sexual and reproductive health in forced displacement.

Terapia Cognitivo Conductual presencial y remota para adultos con pánico en Servicios de Emergencias: tres estudios de caso / Face-to-face and remote Cognitive Behavioral Therapy for adults with panic in Emergency Services: study of three cases

Most patients with panic attacks or panic disorder who seek emergency department care go unnoticed and do not receive appropriate treatment. Although first-line psychological treatments exist for these patients, they may be insensitive and inaccessible to their characteristics. The aim of this study was to describe three different brief protocols based on Cognitive Behavioral Therapy that were adapted for face-to-face or videoconferencing application for patients with panic attacks or panic disorder seeking care in emergency department. Three cases of adult patients, two diagnosed with panic disorder and one with panic attacks, are presented to show the implementation and outcomes of the protocols on diagnostic severity, anxiety sensitivity, quality of life, health services utilization, and patient satisfaction with the protocols. As well as the use of a panic screening diagram designed for the initial evaluation of these patients. After one to seven sessions, a decrease in panic disorder severity or frequency of panic attacks, and anxiety sensitivity was observed. Quality of life improved, patients stopped using emergency department and showed satisfaction with the intervention they received. Brief interventions based on Cognitive Behavioral Therapy, both face-to-face and remote, can be implemented in emergency department to overcome some barriers to mental health access and fit the diverse care possibilities of panic patients. (AU)

Transdiagnostic Unified Protocol for Women with Breast Cancer: A Preliminary Study

This article aimed to explore the feasibility and clinical utility of the online Unified Protocol to improve emotional regulation with women diagnosed with breast cancer. Method. Research with a quantitative, exploratory, descriptive, and interactive approach, with a quasi-experimental design, pre-posttest for paired samples. Nine women with an average age of 53 years (SD= 9.5; range from 41 to 71) participated in a psychological intervention of 12 weekly 90-minute sessions. A statistically significant change (p < 0.05) between pre and post-test measurements in Anxiety (t= 2.777; p=.024), Quality of life (Z= -2.670; p=.008), Optimism (t= -2.785; p= .024) and Positive Affect (t= -3.834; p=.005) were found. The size of the effect was moderate in Optimism and big in Anxiety, Quality of life and Positive Affect. High levels of treatment satisfaction were found. The intervention was useful to improve the emotional regulation of women with a medical condition in a pandemic context. (AU)

Level of Awareness about Air Pollution among Decision-makers in Jordan: Unveiling Important COPD Etiology

Purpose: The complete awareness of policymakers about air pollution can play a significant role in dealing with this environmental threat. This study aimed to examine the awareness and perception among the policymakers regarding air pollution in Jordan. Methods: This is a cross-sectional study conducted in Jordan. The participants included in this study were governmental and non-governmental officials from different sectors. An interview and questionnaire were used to examine the extent of knowledge of these decision-makers regarding air pollution types, sources, and threats. Results: Most participants acknowledged that air pollution in Jordan was a huge problem. Most participants (90%) were familiar with the term air pollution, and regularly read about different contaminants that cause air pollution. However, most of the participants had a low level of knowledge about air contaminant types in Jordan. The least known pollutants were PM2.5 (Particulate Matter 2.5 microns in width) and PM10 (Particulate Matter 10 microns in width). Only 7.5% of the participants knew about PM2.5, while 12.5% knew about PM10. Conclusion: Policymakers have the full authority to initiate and implement policies that intend to limit air pollution. Their complete awareness of air pollution can result in conducting certain protocols to approve new policies and legislations that can improve the air quality in Jordan. Unfortunately, no previous studies were conducted to analyze policymakers’ knowledge regarding air pollution in Jordan, and this study’s results hoped to reflect the importance of air pollutants and their greater significance on public health. (AU)

Addressing Privacy Concerns Surrounding Oocyte Donation in the United States: Gone With Anonymity.

Oocyte donation has greatly expanded in the past several decades since the first procedure was performed in 1983. According to the Centers for Disease Control, the number of cycles using donor oocytes increased from 18,011 cycles in 2010 to 27,131 cycles in 2019. Oocyte donation has become an important reproductive option for women with diminished ovarian reserve, recurrent failed in vitro fertilization, or heritable genetic conditions. It is also particularly important for single men, same-sex male couples, and men with a transgender woman partner. More recently, societal changes accompanying the expansion of social media and broader access to direct-to-consumer DNA testing have raised concerns about privacy and anonymity. In this article, we review two specific aspects of donor privacy: privacy related to personal identifiers provided by clinics or donor egg bank websites and privacy related to direct-to-consumer genetic testing. We also provide clinical recommendations specific to the United States for working with oocyte donors and donor oocyte recipients.

"How to article:" guidelines for serving on an expert panel.

Academics in medicine are frequently asked to serve on panels to discuss their clinical, research, education, administrative or personal expertise. While panel discussions are often the highlight of a conference or event, in the medical literature, there is very little published on how an individual can effectively prepare and present as an expert panelist. This paper offers guidelines that will enable academics to prepare, deliver, and engage in active dialogue during a panel discussion. Specific tactics include how to accept invitations to serve on a panel, conducting pre-panel conference meetings and background research, preparing concise opening statements and new insights, connecting with the audience, answering questions in a collaborative spirit, and debriefing after the panel. These guidelines will be valuable to any individual invited to serve on a panel discussion and will promote future panelists in engaging in constructive and fulfilling dialogue, with the ultimate goal of leaving the audience with a greater understanding of the topic of discourse.

Endorsement of open science practices by dental journals: A meta-research study.

OBJECTIVES: This study evaluates the endorsement of open science practices by dental journals. MATERIALS AND METHODS: This was a meta-research study that included journals listed in the 2021 Journal Citation Reports under Dentistry. A comprehensive evaluation was performed by accessing journal websites to ascertain the availability of publicly accessible instructions to authors in Portuguese, English, or Spanish. A researcher extracted information from the "Instructions for Authors" section, encompassing the journal's impact factor, mention of any reporting guidelines, details on data sharing, acceptance of articles in preprint format, and information regarding study protocol registration. Descriptive data analysis was conducted using the Stata 14.0 program, and an Open Science Score (OSS) (ranging from 0 to 100 %) was calculated for each journal by considering five open science practices. Pearson's correlation test was conducted to determine the relationship between the OSS score and journal impact factor. RESULTS: Ninety journals were included in the study. Most journals (70 %) indicated the mandatory use of reporting guidelines, while 60 % recommended data sharing. Conversely, 46.7 % did not provide information on study protocol registration, and 44.4 % stipulated them as mandatory for authors. Regarding preprints, 50 % of the journals did not provide any information, but 46.7 % confirmed their acceptance. The mean OSS was 52.9 % (standard deviation 26.2). There was a weak correlation (Pearson's correlation coefficient of 0.221) between the journal impact factor and OSS (P-value=0.036). CONCLUSION: This study found varying degrees of endorsement of open science practices among dental journals. CLINICAL SIGNIFICANCE: Dental practitioners rely on high-quality, evidence-based research for informed decision-making. By assessing the endorsement of open science practices, our study contributes to improving the quality and reliability of dental research, ultimately enhancing the evidence base for clinical practice.

Informing the development of the SUCCEED reporting guideline for studies on the scaling of health interventions: A systematic review.

BACKGROUND: Quality reporting contributes to effective translation of health research in practice and policy. As an initial step in the development of a reporting guideline for scaling, the Standards for reporting stUdies of sCaling evidenCEd-informED interventions (SUCCEED), we performed a systematic review to identify relevant guidelines and compile a list of potential items. METHODS: We conducted a systematic review according to Cochrane method guidelines. We searched the following databases: MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Web of Science, from their respective inceptions. We also searched websites of relevant organizations and Google. We included any document that provided instructions or recommendations, e.g., reporting guideline, checklist, guidance, framework, standard; could inform the design or reporting of scaling interventions; and related to the health sector. We extracted characteristics of the included guidelines and assessed their methodological quality using a 3-item internal validity assessment tool. We extracted all items from the guidelines and classified them according to the main sections of reporting guidelines (title, abstract, introduction, methods, results, discussion and other information). We performed a narrative synthesis based on descriptive statistics. RESULTS: Of 7704 records screened (published between 1999 and 2019), we included 39 guidelines, from which data were extracted from 57 reports. Of the 39 guidelines, 17 were for designing scaling interventions and 22 for reporting implementation interventions. At least one female author was listed in 31 guidelines, and 21 first authors were female. None of the authors belonged to the patient stakeholder group. Only one guideline clearly identified a patient as having participated in the consensus process. More than half the guidelines (56%) had been developed using an evidence-based process. In total, 750 items were extracted from the 39 guidelines and distributed into the 7 main sections. CONCLUSION: Relevant items identified could inform the development of a reporting guideline for scaling studies of evidence-based health interventions. This and our assessment of guidelines could contribute to better reporting in the science and practice of scaling.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Endorsements of five reporting guidelines for biomedical research by journals of prominent publishers.

Biomedical research reporting guidelines provide a framework by which journal editors and the researchers who conduct studies can ensure that the reported research is both complete and transparent. With more than 16 different guidelines for the 11 major study types of medical and health research, authors need to be familiar with journal reporting standards. To assess the current endorsements of reporting guidelines for biomedical and health research, this study examined the instructions for authors (IFAs) of 559 biomedical journals by 11 prominent publishers that publish original research or systematic reviews/meta-analyses. Data from the above original sources were cleaned and restructured, and analyzed in a database and text miner. Each journal's instructions or information for authors were examined to code if any of five prominent reporting guidelines were mentioned and what form the guideline adherence demonstration took. Seventeen journals published the reporting guidelines. Four of the five reporting guidelines listed journals as endorsers. For journals with open peer review reports, a sample of journals and peer reviews was analyzed for mention of adherence to reporting guidelines. The endorsement of research guidelines by publishers and their associated journals is inconsistent for some publishers, with only a small number of journals endorsing relevant guidelines. Based on the analysis of open peer reviews, there is evidence that some reviewers check the adherence to the endorsed reporting guidelines. Currently, there is no universal endorsement of reporting guidelines by publishers nor ways of demonstrating adherence to guidelines. Journals may not directly inform authors of their guideline endorsements, making it more difficult for authors to adhere to endorsed guidelines. Suggestions derived from the findings are provided for authors, journals, and reporting guidelines to ensure increased adequate use of endorsed reporting guidelines.

Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during the lifecycle of a trial, protocol deviations may occur. Under ICH efficacy guidelines, protocol deviations are divided into non-important (minor) or important (major), and the latter can jeopardise the participant's rights, safety or the quality of data generated by the study. Existing guidelines on protocol deviation management do not detail or standardise actions to be taken for participants, investigational products, data or samples as part of a holistic management of important protocol deviations. Herein, we propose guidelines to address the current literature gap and promote the standardisation of actions to address important protocol deviations in clinical trials. The advised actions should complement the existing local institutional review board and national regulatory authority requirements.