Checklist Approach Research Articles

Brokering responsible research and innovation in in silico medicine

ABSTRACT The implementation of Responsible Research and Innovation (RRI) in research projects has increased the need for interdisciplinary collaboration. This article presents our RRI approach within the Horizon 2020 ‘In Silico World' project, which aims to accelerate the adoption of in silico medicine through computer modeling and simulation tools in healthcare. To address the shortcomings of the ‘checklist approach' for integrating ethics and the risk of becoming checkboxes ourselves, we introduce the term ‘RRI brokers.’ It serves as a lens for evaluating the project's RRI activities and the dynamics that can be faced by Social Science and Humanities scholars (SSH), and as a means to acquire agency in our own positioning. We suggest that to strengthen RRI, more consideration is needed on how we present our expertise in these collaborations, and awareness of how we, as RRI brokers, move between translating, balancing, and shaping worlds, affecting what we broker and ourselves.

Implementation of a High-Level Isolation Unit Readiness Checklist in the Irish Setting.

A high-level isolation unit (HLIU) is a specially designed biocontainment unit for suspected or confirmed high-consequence infectious diseases. For most HLIUs, maintaining readiness during times of inactivity is a challenge. In this case study, we describe a checklist approach to assess HLIU readiness to rapidly operate upon activation. This checklist includes readiness criteria in several domains, such as infrastructure, human resources, and material supplies, that are required to safely activate the unit at any time. The checklist audit tool was derived from a novel activation readiness checklist published by the biocontainment unit at The Johns Hopkins Hospital in Baltimore, Maryland. It was then adapted for the Irish healthcare setting and implemented at the Mater Misericordiae University Hospital, Ireland's current isolation facility. Results from the audit were also used to inform recommendations for the construction of a new HLIU to open in 2025. The audit tool is user friendly, practical, and focuses on the essential elements of readiness to ensure a successful rapid operation.

A standard to report biological variation data studies- based on an expert opinion.

There is a need for standards for generation and reporting of Biological Variation (BV) reference data. The absence of standards affects the quality and transportability of BV data, compromising important clinical applications. To address this issue, international expert groups under the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have developed an online resource (https://tinyurl.com/bvmindmap) in the form of an interactive mind map that serves as a guideline for researchers planning, performing and reporting BV studies. The mind map addresses study design, data analysis, and reporting criteria, providing embedded links to relevant references and resources. It also incorporates a checklist approach, identifying a Minimum Data Set (MDS) to enable the transportability of BV data and incorporates the Biological Variation Data Critical Appraisal Checklist (BIVAC) to assess study quality. The mind map is open to access and is disseminated through the EFLM BV Database website, promoting accessibility and compliance to areporting standard, thereby providing a tool to be used toensure data quality, consistency, and comparability of BV data. Thus, comparable to the STARD initiative for diagnostic accuracy studies, the mind map introduces a Standard for Reporting Biological Variation Data Studies (STARBIV), which can enhance the reporting quality of BV studies, foster user confidence, provide better decision support, and be used as a tool for critical appraisal. Ongoing refinement is expected toadapt to emerging methodologies, ensuring a positive trajectory toward improving the validity and applicability of BV data in clinical practice.

Periodontal outcomes of surgically exposed and orthodontically aligned buccally impacted maxillary canines: A systematic review and meta-analysis.

To compare the periodontal outcomes of surgically exposed and orthodontically aligned buccally impacted maxillary canines to spontaneously erupted maxillary canines. An unrestricted search was carried out of indexed databases (Medline, EMBASE, Web of Science and Scopus), reference lists of included studies, and grey literature published until December 2023. Observational and experimental studies that addressed the focused question 'Do periodontal outcomes of buccally impacted maxillary canines that were surgically exposed and subsequently extruded and aligned using orthodontic alignment, differ from those of spontaneously erupted maxillary canines?' were included. Study screening, selection and data extraction were performed independently by two authors, with disagreement resolved by a third reviewer. The risk of bias was assessed using the JBI Critical Appraisal Checklist and GRADE approach. A total of 857 citations were found and five studies were eligible for inclusion. Supragingival plaque accumulation and gingival inflammation were similar between impacted canines and their contralaterals in most studies. Meta-analyses revealed no significant differences in keratinised tissue width (prospective studies: MD = -0.28, 95% confidence interval [CI] = -1.13-0.56, I² = 78%; retrospective studies: MD = 0.61, 95% CI = -1.51-2.72, I² = 94%). However, a meta-analysis of prospective studies showed slightly greater mean probing depth for impacted canines compared to their contralateral canines (prospective studies: MD = 0.16, 95% CI = 0.04-0.28, I² = 0%). The evidence certainty for keratinised tissue width and probing depth outcomes was low. Surgically exposed and orthodontically aligned buccally impacted canines have slightly greater probing depths, potential bone loss and increased clinical crown length, compared to their counterparts. However, these small differences (<1 mm) are unlikely to be clinically significant.

Teaching clinical phenomenology in a post-graduate medical training program

IntroductionPatient care suffers when practitioners do not understand the patient’s experience of the illness. This is especially true in psychiatry relative to patients having learned the jargon and studying the diagnostic criteria for various mental disorders using internet search engines, especially Google. Patients more commonly present with a list of symptoms that match the checklist for their self-diagnosis. Their experience may be quite different from the words they use to present their symptoms to medical personnel. More than ever, psychiatric providers need to unpack the words their patients use to discover the actual experience. K. Toombs has written exquisitely about clinical phenomenology in the context of her diagnosis of multiple sclerosis and her negotiation of a medical system that largely ignored her lived experience. This algorithmic, checklist approach to human suffering derives from an understanding of clinical practice in which the practitioner applies scientific knowledge of the bodily processes of diseases, recognizing those diseases by inquiring about the presence of symptoms characterizing those diseases and then rendering treatments based upon statistical studies (preferably randomized, controlled trials) of large groups of individuals. Within this approach, little need exists to encounter the person with the disease as an actual human being, an Other in the sense of Levinas. This approach suffers because even history-taking requires an encounter with an Other in which the internal, private experience of this Other must be heard and made part of the clinical process. This approach can ignore the role of the doctor-patient relationship and the clinical encounter in symptom relief.ObjectivesTo describe an educational program in clinical phenomenology that was well received by trainees who rated that it improved their practice.MethodsIn this presentation, we will describe our efforts at teaching clinical phenomenology and psychiatry within a residency training program, in which we encourage trainees to develop deeper listening skills through conducting life story interviews, motivational interviewing techniques, and narrative approaches in which they search for the metaphors underlying the patients’ illness. We will describe factors influencing trainees’ acceptance or rejection of these approaches and the change in the culture of our training program and clinic that have arisen from their implementation.ResultsOne hundred and twenty residents have taken this course. Eighty-eight percent reported improved clinical skills and ability to relate to patients.ConclusionsThe practice of medicine does not exist independently from the relationships in which medicine is practiced and a thorough understanding of the lived experience and experience of the patient is necessary for accurate diagnosis, psychiatric or medical, and for discovery of a treatment approach with the patient.Disclosure of InterestNone Declared

Medical Care as Flea Market Bargaining? An International Interdisciplinary Study of Varieties of Shared Decision Making in Physician–Patient Interactions

Phenomenon: Shared decision making (SDM) is a core ideal in the interaction between healthcare providers and patients, but the implementation of the SDM ideal in clinical routines has been a relatively slow process. Approach: In a sociological study, 71 interactions between physicians and simulated patients enacting chronic heart failure were video-recorded in China, Germany, the Netherlands, and Turkey as part of a quasi-experimental research design. Participating physicians varied in specialty and level of experience. The secondary analysis presented in this article used content analysis to study core components of SDM in all of the 71 interactions and a grounded theory approach to observe how physicians responded actively to patients even though they did not actively employ the SDM ideal. Findings: Full realization of the SDM ideal remains an exception, but various aspects of SDM in physician–patient interaction were observed in all four locations. Analyses of longer interactions show dynamic processes of interaction that sometimes surprised both patient and physician. We observed varieties of SDM that differ from the SDM ideal but arguably achieve what the SDM ideal is intended to achieve. Our analysis suggests a need to revisit the SDM ideal—to consider whether varieties of SDM may be acceptable, even valuable, in their own right. Insights: The gap between the SDM ideal and SDM as implemented in clinical practice may in part be explained by the tendency of medicine to define and teach SDM through a narrow lens of checklist evaluations. The authors support the argument that SDM defies a checklist approach. SDM is not uniform, but nuanced, dependent on circumstances and setting. As SDM is co-produced by patients and physicians in a dynamic process of interaction, medical researchers should consider and medical learners should be exposed to varieties of SDM-related practice rather than a single idealized model. Observing and discussing worked examples contributes to the physician’s development of realistic expectations and personal professional growth.

Technical Brief: Safeguardability Analysis of a Molten Salt Sampling System Design

Abstract Challenges with safeguarding molten salt reactor (MSR) designs have prompted the search for enhanced safeguards technologies and revised safeguards materials control &amp; accountancy (MC&amp;A) approaches. A molten salt sampling system is a subsystem being developed to help support facility MC&amp;A in future MSRs by removing salt samples from the primary fuel and/or coolant salt loop of an MSR for chemical and isotopic analysis. To consider the safeguards implications of this molten salt sampling system early in the design process, we employed a safeguards by design approach during the development of a prototype molten salt sampling system. Specifically, we identified and tailored a checklist approach to systematically evaluate the design against recognized safeguards and security attributes. This technical brief describes the molten salt sampling system design and operational concept upon which we applied the safeguards by design methodology, conveys the methods we used to employ the safeguards by design approach on the molten salt sampling system design, and discusses the preliminary results and design insights gained from this safeguards by design assessment.

Reimagining human dissection in preclinical medical education using studio-based learning: A retrospective pilot study.

Human dissections in the current medical curriculum are conducted using a checklist approach to prioritize the exposure of anatomical structures. In this setting, anatomy educators are labored to enhance their engagement during the dissection. To address this issue, we considered the current medical education pedagogies and identified a novel approach of studio-based learning (SBL) for application in a Human Dissection Workshop. This study aimed to (1) evaluate students' perceptions of SBL, (2) appraise the impact of SBL on anatomical knowledge learning, and (3) interpret the results of a validated questionnaire. Workshop participants were recruited from Year 2 medical students at the Chinese University of Hong Kong from the 2020 and 2021 cohorts. Fifty-one students participated in the workshop (N = 24 [2020], N = 27 [2021]), and 50 of them completed the postworkshop questionnaire rated on a 5-point Likert scale. Nineteen items were validated using a factor analysis. The interpretation of the questionnaire results demonstrated the different learning outcomes of the workshop, which included (1) enhancing students' knowledge and spatial understanding of anatomical structures, (2) strengthening students' appreciation of gross pathologies and clinical relevance, and (3) promoting higher-order thinking skills. To our knowledge, this is the first study to introduce SBL in medical education. The successful implementation of the workshop reflects the promising potential of SBL for enhancing human dissection and supplementing the medical curriculum.

Using inner speech checklists to nurture L2 discussion task fluency: Reactions from within Japanese university classrooms

This study investigates how inner speech practice, facilitated by checklists, can be used to nurture English discussion fluency of Japanese university students, addressing challenges posed by silence in Japanese classrooms (Harumi, 2023; King, 2013a; Stroud, 2017a). Integrating innovative methods to enhance cognitive and utterance fluency, the study utilizes checklists centered on speech acts for silent mental rehearsal, self-assessment, and discussion task fluency development. Positive student responses reveal motivation, increased confidence, and a desire for future checklist use. However, nuanced perspectives underscore the necessity for further investigation. The study highlights the efficacy of checklists in improving English proficiency, self-assessment, and sentence creation, fostering interaction. Yet, students' preferences for more guidance, freedom, practice, adaptable difficulty, writing activities, and increased interaction time, offering avenues for instructional refinement. Pioneering an integrative inner speech checklist approach, this study contributes to the discourse on spoken task fluency in Second Language Acquisition (SLA).

Coastal Dune Restoration: A Checklist Approach to Site Selection

Coastal dune systems around the world have been severely degraded by human activities, especially in the last century. This has resulted in severe structural and functional damage to these dynamic yet fragile transitional ecosystems and a net loss of important ecosystem services, especially in the face of climate change threats. The implementation of measures for sustainable coastal management and the restoration of degraded ecosystems are urgently needed. In this context, we revised and used several indicators and indices on the geomorphology, biology, and ecology of the dune systems along the Venetian coast to define the current conservation status and assess the feasibility of dune restoration measures. The application of the indices provided important information about the sites and the measures needed to improve the functionality of the coastal dune systems. In addition, the indices provided useful insights for the implementation of management strategies aimed at ensuring the current and future provision of ecosystem services by coastal dune systems and promoting their sustainable use by translating scientific knowledge into management and restoration practices, which has been a bottleneck in ecosystem conservation and restoration so far.

Software Developer Perspectives on Work-Life Balance

This study aims to explore work-life balance (WLB) dimensions that Nepalese software developers prefer. The present study was carried out in ten IT companies situated in Kathmandu Valley. A sample of 50 software developers was chosen to collect data. The convenience sampling method was used. Only primary data were used to reach acceptable results. Such data was acquired using the checklist approach. These developers were given a checklist that included several WLB dimensions. They answered to checklist used for data analysis. Their responses were used for data analysis. WLB is becoming a concern for all employees in today's rapidly changing workplace, particularly in information technology (IT) companies. The results indicate that all of the software developers give first priority to physical and mental health as the key dimensions of WLB. They also prefer parental and family leave, flexible work hours, recognition and reward, team collaboration, reasonable workload, managerial support, and work and family support as important aspects of WLB. They also have given priority to career growth opportunities, boundary management, efficient tools and systems, organizational culture, and remote work options as the important dimensions of WLB. If IT companies can manage these dimensions, software developers can, too.

Application of the LCA approach to the citrus production chain – A systematic review

The citrus sector represents one of the main agri-food supply chains in Italy, which today is the second largest producer of citrus fruits in Europe. Consequently, its impact from an environmental, economic and social point of view can be considerable and it is therefore necessary to assess the sustainability performance of this supply chain. Life Cycle Assessment (LCA) studies are nowadays an important tool for the improvement of production standards and for better decision support by entrepreneurs and public decision makers. This work aims to review in a systematic way the scientific literature on LCA applied to the citrus fruit sector and was conducted following the STARR-LCA checklist approach. The survey was conducted through the main bibliographic databases: Scopus, Web Of Science and Google Scholar, adopting specific search criteria depending on the tool used; the search led to a final selection of 42 articles. The analysis of the papers was conducted using various parameters such as: topic, methodology applied, system boundaries, functional units, allocation criteria, inventory analysis and impact assessment. The analysis of the results shows an overview of the state of the art of LCA approach applied to the citrus sector and can provide useful data and information for practitioners as well as a basis for further methodological developments.

Stressful life events and depressive symptoms during COVID-19: A gender comparison.

The COVID-19 pandemic precipitated a wide range of public health, economic, social, and political shocks, setting in motion life events that reverberated to affect individuals' mental health. Moving beyond a checklist approach, this study drew on individuals' own words to identify both conventional and novel sources of stress during COVID-19 and examine the role of stressful life events in producing gender disparities in depressive symptoms. Drawing on a 2021 U.S. nationally representative survey, we coded text responses to an open-ended question on stressful life events and conducted descriptive and regression analyses (n=1733). The analyses revealed three key findings. First, men were more likely to report having experienced no stressful life events or else mention politics as a source of stress. Women, by comparison, were more likely to report the following as stressful-inability to socialize, paid work, care work, health, or the death of loved ones. Second, for both women and men, respondents reporting no stressful life events had the lowest, and those reporting finances as the most stressful life event had the highest, depressive symptoms. Third, women had higher depressive symptoms than men, and mediation analysis showed that stressful life events explained approximately a third of the gender gap in depressive symptoms. The findings indicate that policies attending to people's financial stress are important for mitigating mental health risks in turbulent times. Interventions that reduce women's exposure to stressful life events are also crucial to bridging gender disparities in mental health.

LITERATURE REVIEW: TELENURSING ON ADHERENCE OF HEMODIALYSIS PATIENTS

Background: A health problem in hemodialysis patients is non-compliance with fluid restrictions. The country with the highest incidence of end-stage renal disease in 2018 was the Jalisco region in Mexico, with 594 people per million. One of the efforts to improve patient compliance is through education and monitoring. Telenursing is one of the modern information and communication technology systems in the health sector that can be used for patient monitoring and providing nursing services. Purpose: To determine telenursing's effect on dialysis patients' adherence. Methods: The research articles were obtained from three databases, ProQuest, PubMed, and Google Scholar, with 27 articles. Search literature using keywords (Bahasa and English), telenursing OR text messaging OR telephone Follow-up OR short message system OR mobile phone text messaging AND adherence OR Compliance AND hemodialysis OR dialysis with the inclusion criteria of research articles from 2016-2020, primary articles, full text, and research subjects were hemodialysis patients (either primary or secondary). The seven articles obtained were critically assessed and analyzed using Duffy's Research Appraisal Checklist Approach. Results: Telenursing research showed increased adherence in the presence of hemodialysis, fluid restriction, medicine, dietary, physical activity, and intention to quit smoking also increased knowledge, quality of life, and self-efficacy of a dialysis patient. Conclusion: Telenursing increases adherence to care and treatment of dialysis patients and improves health status in chronic diseases.

Development of a novel observed structured clinical exam to assess clinical ultrasound proficiency in undergraduate medical education

ObjectivesA pilot study was performed to develop and test an observed structured clinical exam (OSCE) for clinical ultrasound in second-year medical students. The goal was to assess a longitudinal clinical ultrasound curriculum for medical students and to help determine readiness to perform ultrasound during clinical clerkships.MethodsThe OSCE contained 40 tasks over 30 min in a one-to-one examiner to examinee environment using standardized patients covering cardiac, pulmonary, and inferior vena cava (IVC) ultrasound exams along with 6 critical diagnoses. Examinees were assessed using a binary checklist approach. A two-way ANOVA analysis was performed to determine if there were differences between the day and session the OSCE was administered. Results are presented as mean ± standard deviation.ResultsOne hundred fifty-two students were tested with an overall mean score of 64.9 ± 17.6%. Scores between the cardiac, IVC, and lung sections varied—67.8% ± 18.8%, 62.4% ± 26.2%, and 57.1% ± 20.6%, respectively. One hundred twenty-six (82.9%) answered at least one critical diagnosis incorrectly. Students in the late session performed better than the early session (1: 60% vs 2: 69%, p = .001).ConclusionsStudents performed better in later sessions. Additionally, the number of questions left blank at the end of the exam suggests that the length of the OSCE should be evaluated. Incorporating critical diagnoses was challenging for examinees. The proposed OSCE is a valuable assessment tool that could be adapted to assess student’s readiness to use clinical ultrasound prior to clerkships.

How can human factors close the gender data gap?

AbstractThis commentary paper will describe how the discipline of human factors and ergonomics (HFE) can help to close the gender data gap, which is prevalent across many domains and arises due to a lack of data capturing female metrics and viewpoints. HFE is a domain‐independent discipline that seeks to understand human performance and well‐being with respect to the interactions that humans engage in and the environments that they inhabit. HFE therefore presents an opportunity to understand how gender influences human performance, effective design, social interactions, and environmental factors. This paper argues that a sociotechnical systems approach is essential when reviewing equality, diversity, and inclusivity issues, without which attempts to close the gender data gap will not go far enough. Following the sociotechnical systems approach in HFE, the micro‐, meso‐, and macro‐levels of system design with respect to closing the gender data gap are reviewed. We discuss these issues in relation to a case study example of a crash test dummy. A checklist approach for researchers is presented, which identifies key questions that prompt where gender should be considered in the research process across these levels of sociotechnical systems.

Examining the association between exposure to major stressful life events and non-suicidal self-injury

Experiencing major stressful life events (SLEs) may contribute to risk for non-suicidal self-injury (NSSI). Prior research has established that a higher number of SLEs is linked with more frequent NSSI episodes among young adults. However, life stress is typically assessed with checklist approaches; these methods introduce frequent idiosyncratic misinterpretations of stress categories (e.g., major illness). Coupled with the unclear boundary of what constitutes SLEs, relying on participants’ subjective appraisals of stress severity attenuates validity. Specifically, individuals with a history of NSSI may have certain cognitive characteristics that contribute to an over-appraisal of event severity. Interview-based, contextual life stress systems overcome these limitations by having third-party raters blind to participant characteristics determine stress severity based on a standardized set of circumstances. Accordingly, this study used the Life Events and Difficulties Schedule 2 (LEDS-II), which is a gold-standard, semi-structured life stress interview and rating system. Specifically, we focused on the cumulative severity of episodic stressors (i.e., SLEs whose major features occur within a 2-week period). In preliminary analyses of 53 participants (Mage= 20.17, SDage= 2.51), cumulative stress severity (M =2.96, SD =3.20) was not significantly associated with the number of NSSI episodes participants reported in the past year (M = 22.75, SD = 67.46), r(53) = .13 p = .370. Data collection is ongoing, and we anticipate adding 30 participants (total n=83) to the analyses. Current findings do not align with previous literature on the association between SLEs and NSSI. However, they provide a methodological foundation for how to improve future research on SLEs and NSSI in young adults through the application of gold-standard life stress measures.

An investigation of linked data catalogue features in libraries, archives, and museums: a checklist approach

PurposeIn this study, the distinctive functional features of linked data (LD) catalogues were investigated to contrast with existing online public access catalogues (OPACs) and discovery systems using a checklist approach. The checklist was derived from a literature review and is composed of 10 items as follows: self-descriptive and dynamic content for resource description, linkage to external LD sources and online services, aggregation of knowledge contexts into knowledge graphs (KGs), URI-based link discovery, representation and query of LD relationships, URI-based serendipitous discovery, keyword recommendation, faceted limitation and browsing, visualization and openness of data.Design/methodology/approachTen functional features derived from the literature were checked against existing LD catalogues offered by libraries, archives and museums (LAMs). The LD catalogues were regarded as qualified subjects if they offered functional features that were distinct from current OPACs and discovery systems through URI-based enrichment and aggregation from various LD sources. In addition to individual organizations, LD union catalogues were also included. However, LD hubs, such as ISNI, OCLC WorldCat Entities, VIAF and Wikidata, were excluded. In total, six LD catalogues from LAMs were selected as subjects for examination.FindingsFirst, LD catalogues provide similar KG information through URI combination, and KGs also facilitate information serendipity, including social-document, intellectual, conceptual, spatial and temporal contexts and networks of corporate bodies, persons and families (CPFs). Second, LD catalogues have transformed the “seek first and browse later” paradigm into a “seek or browse” paradigm by refreshing the browsing function of traditional card catalogues with preview and new options to facilitate LD identification and discovery. Third, LD catalogues have refined keyword recommendation with the addition of the following fields: person’s title, CPF relationships, entity type and LD source. Lastly, a virtual union LD catalogue is offered.Research limitations/implicationsThe proposed checklist revealed the unique/improved functional features of LD catalogues, allowing further investigation and comparison. More cases from the fields of medicine, engineering science and so on will be required to make revisions to fine-tune the proposed checklist approach.Originality/valueTo the best of the author’s knowledge, this is the first study to propose a checklist of functional features for LD catalogues and examine what the results and features of LD catalogues have achieved and are supported by from ontologies across LAMs. The findings suggest that LD provides a viable alternative to catalogues. The proposed checklist and results pave the way for the future development of LD catalogues and next-generation catalogues and also provide a basis for the future study of LD catalogues from other fields to refine the proposed checklist.

Factors that Influence Women's Decision on the Mode of Birth After a Previous Caesarean Section: A Meta-ethnography.

Caesarean section (CS) rates are continuing to rise worldwide. Elective repeat CS (ERCS) greatly contribute to the rising rate which increases unnecessary risks of maternal and neonatal morbidity and mortality. Vaginal birth after caesarean (VBAC) is a safe mode of birth for most women; however, uptake remains low. Our objective is to find the factors that influence women's decision-making to support informed choices for the mode of next birth after caesarean section (NBAC). A literature search was conducted in CINAHL, Maternity and Infant Care, Embase, EmCare, Cochrane Library and Medline databases. Primary, qualitative, peer reviewed, English language research articles were assessed according to inclusion/exclusion criteria. Articles were systematically assessed for inclusion or exclusion. Included studies were assessed using the Critical Appraisal Skills Programme qualitative studies checklist, Noblit and Hare's seven-step meta-ethnography approach synthesised themes. Fourteen primary research articles were included. Six studies on 287 women focused on VBAC, and eight studies examined both VBAC and ERCS with 1861 women and 311 blogs. Thematic analysis yielded four primary themes: Influence of health professionals, impact of previous birth experience, optimal experience, and being in control. This meta-ethnography highlights health professionals' influence on women's decision making. To assist in decision-making, women need supportive health professionals who provide the current evidence-informed information about risks and benefits of each mode of birth. Health professionals need skills to provide supportive shared decision-making, debrief women regarding indications for their primary caesarean, and address issues of safety, fear, and expectations of childbirth.

A “Do No Harm” Novel Safety Checklist and Research Approach to Determine Whether to Launch an Artificial Intelligence–Based Medical Technology: Introducing the Biological-Psychological, Economic, and Social (BPES) Framework

Given the impact artificial intelligence (AI)-based medical technologies (hardware devices, software programs, and mobile apps) can have on society, debates regarding the principles behind their development and deployment are emerging. Using the biopsychosocial model applied in psychiatry and other fields of medicine as our foundation, we propose a novel 3-step framework to guide industry developers of AI-based medical tools as well as health care regulatory agencies on how to decide if a product should be launched-a "Go or No-Go" approach. More specifically, our novel framework places stakeholders' (patients, health care professionals, industry, and government institutions) safety at its core by asking developers to demonstrate the biological-psychological (impact on physical and mental health), economic, and social value of their AI tool before it is launched. We also introduce a novel cost-effective, time-sensitive, and safety-oriented mixed quantitative and qualitative clinical phased trial approach to help industry and government health care regulatory agencies test and deliberate on whether to launch these AI-based medical technologies. To our knowledge, our biological-psychological, economic, and social (BPES) framework and mixed method phased trial approach are the first to place the Hippocratic Oath of "Do No Harm" at the center of developers', implementers', regulators', and users' mindsets when determining whether an AI-based medical technology is safe to launch. Moreover, as the welfare of AI users and developers becomes a greater concern, our framework's novel safety feature will allow it to complement existing and future AI reporting guidelines.