External Subject Matter Experts Research Articles

Enhancing diverse representation in clinical studies: Recommendations from external subject matter experts (SMEs) and patients to optimize protocols, informed consent and study designs.

e23004 Background: Well-characterized disparities in clinical research have disproportionately affected patients of color, particularly in underserved communities. To tackle these barriers, the Roche-Genentech U.S. Advancing Inclusive Research Site Alliance solicited feedback from external SMEs about recommendations for strategies and tactics to increase Black, Hispanic/Latinx and older adult patient clinical research participation. Methods: Feedback was received virtually and via 1:1 interviews from 13 external SMEs defined as investigators, study coordinators or other clinical research roles that engage directly with patients regarding a Phase III small-cell lung cancer protocol as a use case. Two patients provided recommendations for future clinical study protocols and designs. Additionally, multiple healthcare providers from International Society of Geriatric Oncology provided recommendations for the inclusion of older adults in study protocols. A cross-functional, pan-Roche-Genentech team reviewed the feedback and finalized all materials. Results: Six key themes emerged: (a) use lay terms and humanizing language in patient materials; (b) integrate patient lifestyle realities by allowing flexibility in protocol inclusion/exclusion criteria; (c) improve the ease of patient participation and seek only what is clinically necessary for study assessment; (d) incorporate options for sites to enable them to make the right, and fastest, decision(s) for patients without sacrificing safety or data quality; (e) show commitment to diversity in words and actions such as including target enrollment goals in protocols and incorporating patient input on protocols before protocol finalization; (f) include older patients > 70 years. Patient feedback reinforced the SME themes, except for inclusion of older patients. Patients suggested efficiency, clarity and local community realities be factored into future study designs. Some examples are fewer clinic visits, remote visit options, providing patient transportation and food support in connection with protocol-required visits. Patients also highlighted the importance of explaining the probability of side-effects, clinics being present in the community and the need for greater education and awareness regarding barriers to clinical trial enrollment. One patient relayed the importance of early trial education through general physician offices before a trial is actually needed for a given patient. Conclusions: These SME recommendations provide actionable insights to inform protocol design and patient recruitment strategy and tactics to enhance future protocols from an inclusivity-specific lens. Study teams can use these recommendations to address barriers that make enrollment/retention by underrepresented patient populations difficult.

First and Second Stage Labor Management: ACOG Clinical Practice Guideline No. 8.

The purpose of this document is to define labor and labor arrest and provide recommendations for the management of dystocia in the first and second stage of labor and labor arrest. Pregnant individuals in the first or second stage of labor. This guideline was developed using an a priori protocol in conjunction with a writing team consisting of one maternal-fetal medicine subspecialist appointed by the ACOG Committee on Clinical Practice Guidelines-Obstetrics and two external subject matter experts. ACOG medical librarians completed a comprehensive literature search for primary literature within Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. Studies that moved forward to the full-text screening stage were assessed by the writing team based on standardized inclusion and exclusion criteria. Included studies underwent quality assessment, and a modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation) evidence-to-decision framework was applied to interpret and translate the evidence into recommendation statements. This Clinical Practice Guideline includes definitions of labor and labor arrest, along with recommendations for the management of dystocia in the first and second stages of labor and labor arrest. Recommendations are classified by strength and evidence quality. Ungraded Good Practice Points are included to provide guidance when a formal recommendation could not be made because of inadequate or nonexistent evidence.

Preventing sexual violence in Vietnam: qualitative findings from high school, university, and civil society key informants across regions

BackgroundSexual violence by young men against women is common, but efficacious primary prevention interventions tailored to men are limited in low- and middle-income settings like Vietnam. GlobalConsent, a web-based sexual violence prevention intervention tailored to university men in Hanoi, is efficacious. Implementation research is needed to understand facilitators and barriers to scaling GlobalConsent and prevention programs generally. We conducted qualitative research with key informants from three youth-focused organizational settings to understand the context of implementation in Vietnam.MethodsInterviews with university (n = 15), high-school (n = 15) and non-governmental (n = 15) key informants focused on perceptions about sexual violence among young people and prevention programming. Four focus group discussions with 22 interviewed informants, following the Consolidated Framework for Implementation Research, asked about facilitators and barriers to implementing GlobalConsent. Narratives were transcribed, translated, and coded inductively and deductively to identify salient themes.ResultsOuter-setting influences included greater expectations for sex among young people alongside norms favoring men’s sexual privilege, ostensibly ambiguous and lax laws on sexual violence, government ministries as bureaucratic but potential allies, external subject-matter experts, and the media. Inner-setting influences included variable cultures regarding openness to discuss sexual violence and equitable gender norms, variable departmental coordination, limited funding and ‘red tape’ especially in public institutions, inconsistent student access to technologies, and limited time and competing priorities among students and teachers. Several actors were considered influential, including institutional leaders, human-resource staff, the Youth Union, and student-facing staff. Important characteristics of individuals for implementation included subject-matter expertise, science or social science training, younger age, engagement in social justice related activities, and more open attitudes about sex. Regarding characteristics of sexual violence prevention programming, some participants preferred online formats for busy students while others suggested hybrid or in-person formats, peer education, and incentives. Participants generally accepted the content of GlobalConsent and suggested adding more content for women, ancillary support services, and adapted content for high-school students.ConclusionsImplementation of sexual violence prevention programs in youth-focused organizations in Vietnam requires multilevel strategies that connect outer-setting subject-matter experts with supportive inner-setting leaders and student-facing staff to overcome normative and organizational constraints, and thereby, to deliver institution-wide programming.

Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 5.

To assess the evidence regarding safety and efficacy of psychiatric medications to treat mental health conditions during pregnancy and lactation. The conditions reviewed include depression, anxiety and anxiety-related disorders, bipolar disorder, and acute psychosis. For information on screening and diagnosis, refer to American College of Obstetricians and Gynecologists (ACOG) Clinical Practice Guideline Number 4, "Screening and Diagnosis of Mental Health Conditions During Pregnancy and Postpartum" (1). Pregnant or postpartum individuals with mental health conditions with onset that may have predated the perinatal period or may have occurred for the first time in pregnancy or the first year postpartum or may have been exacerbated in that time. This guideline was developed using an a priori protocol in conjunction with a writing team consisting of one specialist in obstetrics and gynecology and one maternal-fetal medicine subspecialist appointed by the ACOG Committee on Clinical Practice Guidelines-Obstetrics and two external subject matter experts. ACOG medical librarians completed a comprehensive literature search for primary literature within Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. Studies that moved forward to the full-text screening stage were assessed by two authors from the writing team based on standardized inclusion and exclusion criteria. Included studies underwent quality assessment, and a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence-to-decision framework was applied to interpret and translate the evidence into recommendation statements. This Clinical Practice Guideline includes recommendations on treatment and management of perinatal mental health conditions including depression, anxiety, bipolar disorders, and acute postpartum psychosis, with a focus on psychopharmacotherapy. Recommendations are classified by strength and evidence quality. Ungraded Good Practice Points are included to provide guidance when a formal recommendation could not be made because of inadequate or nonexistent evidence.

Screening and Diagnosis of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 4.

To review evidence on the current understanding of mental health conditions in pregnancy and postpartum, with a focus on mood and anxiety disorders, and to outline guidelines for screening and diagnosis that are consistent with best available scientific evidence. The conditions or symptoms reviewed include depression, anxiety and anxiety-related disorders, bipolar disorder, suicidality, and postpartum psychosis. For information on psychopharmacologic treatment and management, refer to American College of Obstetricians and Gynecologists (ACOG) Clinical Practice Guideline Number 5, "Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum" (1). Pregnant or postpartum individuals with mental health conditions. Onset of these conditions may have predated the perinatal period or may have occurred for the first time in pregnancy or the first year postpartum or may have been exacerbated in that time. This guideline was developed using an a priori protocol in conjunction with a writing team consisting of one specialist in obstetrics and gynecology and one maternal-fetal medicine subspecialist appointed by the ACOG Committee on Clinical Practice Guidelines-Obstetrics and two external subject matter experts. ACOG medical librarians completed a comprehensive literature search for primary literature within Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. Studies that moved forward to the full-text screening stage were assessed by two authors from the writing team based on standardized inclusion and exclusion criteria. Included studies underwent quality assessment, and a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence-to-decision framework was applied to interpret and translate the evidence into recommendation statements. This Clinical Practice Guideline includes recommendations on the screening and diagnosis of perinatal mental health conditions including depression, anxiety, bipolar disorder, acute postpartum psychosis, and the symptom of suicidality. Recommendations are classified by strength and evidence quality. Ungraded Good Practice Points are included to provide guidance when a formal recommendation could not be made because of inadequate or nonexistent evidence.

Expanding advanced work packaging to include commissioning and startup for industrial projects

PurposeThe purpose of this paper is to present a comprehensive analysis on how the advanced work packaging (AWP) managerial paradigm could be advanced by incorporating and integrating the post-construction commissioning and startup (CSU) phases.Design/methodology/approachThis study was implemented with the support of consolidated knowledge from industry subject matter experts and an exhaustive literature review to provide a knowledge foundation for the developments. The findings were further validated and strengthened by external subject matter experts.FindingsA new operating system-oriented work package, systems work package (SWP), is devised with a set of definitions and models of how it relates to AWPs with three-dimensional visualizations. SWP-related constraints, key roles and responsibilities are thoroughly investigated.Research limitations/implicationsA new SWP concept would pose potential challenges for its adoption because of inherent organizational culture and hesitation to change. A systematic reorganization of existing practices is considered as a key strategy to alleviate the limitation, and short- and long-term validity of SWP is currently being investigated by organizations.Practical implicationsThis research provides practical implementation strategies on CSU integration which lead to benefits including: better alignment and collaboration of stakeholders, reduced costs for associating AWPs to SWP and improved predictability.Originality/valueAWP-related studies have primarily focused on the construction phase, with minimal integration of CSU considerations. Highlighting the importance of the philosophy “start with the end in mind,” this research describes how the AWP managerial paradigm can be expanded to include CSU, by placing a strong emphasis on understanding CSU priorities, sequences and constraints.

Reimagining probation and parole for young adults in the United States

The aim of this article is to propose an overhaul in how young adults (approximately aged 15–25 years) should be supervised in the community while serving probation or parole sentences. Using a pilot model implemented in the Pacific Northwest in the United States, we describe the development of a new specialized caseload focused on the developmental needs of this age group. Once established, an ambitious training program using external subject matter experts was used to educate supervising officers and integrate best practices across four emerging areas in the literature: trauma informed care, brain development science, an Equity and Empowerment Lens with a racial justice focus, and the case management approach Effective Practices in Community Supervision. Results show the potential of this approach to change the trajectory of the life course of participants, as well as promote systematic and systemic reform in the participating jurisdiction.

High Cost, High Need Populations Data‐Driven Decision Making for Interventions with Complex Needs’ Patients: Identifying the Right Target Population

Research ObjectiveWhile existing taxonomies describe the major groups of complex patients (prominently, the National Academy of Medicine [NAM] taxonomy), these are often at a conceptual level. Healthcare organizations often select patients for CN interventions using structured criteria based on administrative data, and program designers must make critical decisions in defining target populations. Our study aimed to provide insights to inform decisions about selecting CN populations for interventions, by conducting a review of approaches being used to operationalize CN populations in practice, and implementing various definitions in a large health plan member population to compare the characteristics of the resulting patient cohorts.Study DesignOur study involved multiple methods to identify and implement data‐driven definitions of CN patients. We interviewed internal and external subject matter experts to inform our research approach. We conducted a pragmatic literature review of studies published 2000‐2018 which used data‐driven definitions of CN populations. We conducted thematic analysis of the results to identify core concepts and variations in criteria used to define CN populations. We implemented variations of the core concepts and calculated descriptive statistics to understand the characteristics of patients within each of the resulting CN populations, including size of the population, demographics, chronic illness, health care utilization, spending, and survival.Population StudiedPatients with complex needs defined using criteria applied to the membership population of Kaiser Permanente Southern California (KPSC), a large, population‐based health plan with more than 4 million members.Principal FindingsOur literature review yielded 90 examples of CN populations; we cataloged population criteria for each. We grouped observed criteria into domains: age (reflected in 59 CN population definitions), income (12), costs (45), utilization (39), health status (35), and subjective criteria (15). We constructed a framework for classifying approaches to selecting CN populations (Figure 1). We then used KPSC data to assemble populations representing five CN patient concepts (high cost, high emergency department utilization, high inpatient utilization, multiple chronic conditions, and frail elderly); in each concept, we compared multiple population specifications. We observed within‐ and across‐concept differences in the characteristics of the resulting populations. Data presented during the session will include CN population size, demographics, utilization, comorbidity, costs, and survival.ConclusionsOur results illustrate tremendous variation in how CN populations are defined. Nearly every CN population identified through our literature review was unique in the criteria used to select patients. Furthermore, when we implemented a variety of definitional approaches in our membership, we found substantial variation in the cohorts that resulted from different approaches to patient selection. These findings have important implications for both research and health care operations. In a world of limited resources, it is imperative that we use available data to identify, understand, and target resources to the right CN populations.Implications for Policy or PracticeThese findings offer important considerations for intervention planning and implementation. Program planners should select population criteria after exploring the impact of their draft criteria and comparing alternate approaches to understand the implications of those decisions.Primary Funding SourceThe Garfield Memorial Fund.

Implementation of sexual and gender minority health curricula in health care professional schools: a qualitative study

BackgroundLesbian, gay, bisexual, transgender, queer, and intersex people—inclusively termed “sexual and gender minorities”—have unique health and health care needs that are not being met by most healthcare providers due to lack of training in health care professional schools. The purpose of this qualitative study was to examine implementation factors for advancing sexual and gender minority health professional student curricula in academic settings.MethodsSemi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) were conducted with sixteen curricular champions to identify factors relevant to curricular adoption, integration, and sustainment. Themes were coded using a hybrid of deductive and inductive approaches and reported using major CFIR domains.ResultsFacilitators supporting implementation of sexual and gender minority health curricula included collaboration among multiple stakeholders, alignment of formal and hidden curricula, fostering an organizational culture that valued inclusion and diversity, engagement with external subject matter experts or faculty with content expertise, and thoughtful and inclusive planning.ConclusionThis study contributes to health care professional education research as well as to implementation science. Facilitators that were identified in this study can be used to increase the adoption, integration, and sustainment of sexual and gender minority health curricula in diverse academic settings.

Examining “best practices” for literacy coaching and monitoring: Evidence from Northern Nigeria and Ghana

Abstract Evidence-based ‘best practices’ from high-resource contexts have motivated some early grade literacy programs in developing countries to hire private literacy specialists as coaches for teachers, rather than build coaching into the job description of existing system actors, such as school inspectors. This study poses the question, can education system actors with supervisory responsibilities for schools, who are not necessarily literacy specialists, become effective literacy coaches? Using secondary data from a reading program in Nigeria, we use a fixed-effects regression framework to evaluate the relative effectiveness of external subject matter experts and system actors on teaching and learning outcomes. We find that in Nigeria, system actors are as effective at improving both program implementation and teacher performance as externally hired reading experts. Qualitative data from contrasting coaching models in Nigeria and Ghana provide insight into the reasons why school inspectors may be well-suited for coaching.

Examining the readiness of best evidence in medical education guides for integration into educational practice: Ameta-synthesis.

BackgroundTo support evidence-informed education, health professions education (HPE) stakeholders encourage the creation and use of knowledge syntheses or reviews. However, it is unclear if these knowledge syntheses are ready for translation into educational practice. Without understanding the readiness, defined by three criteria—quality, accessibility and relevance—we risk translating weak evidence into practice and/or providing information that is not useful to educators.MethodsA librarian searched Web of Science for knowledge syntheses, specifically Best Evidence in Medical Education (BEME) Guides. This meta-synthesis focuses on BEME Guides because of their explicit goal to inform educational practice and policy. Two authors extracted data from all Guides, guided by the 25-item STructured apprOach to the Reporting In healthcare education of Evidence Synthesis (STORIES).ResultsForty-two Guides published in Medical Teacher between 1999 and 2017 were analyzed. No Guide met all STORIES criteria, but all included structured summaries and most described their literature search (n = 39) and study inclusion/exclusion (n = 40) procedures. Eleven Guides reported the presence of theory and/or educational principles, and eight consulted with external subject matter experts. Accessibility to each Guide’s full-text and supplemental materials was variable.DiscussionFor a subset of HPE knowledge syntheses, BEME Guides, this meta-synthesis identifies factors that support readiness and indicates potential areas of improvement, such as consistent access to Guides and inclusion of external subject matter experts on the review team. This analysis is useful for understanding the current readiness of HPE knowledge syntheses and informing future reviews to evolve so they can catalyze translation of evidence into educational practice.

Implications for educator preparation programs considering competency‐based education

Implications for educator preparation programs considering competency‐based education

Identifying Gaps in Respiratory Syncytial Virus Disease Epidemiology in the United States Prior to the Introduction of Vaccines.

Respiratory syncytial virus (RSV) causes lower respiratory tract illness frequently. No effective antivirals or vaccines for RSV are approved for use in the United States; however, there are at least 50 vaccines and monoclonal antibody products in development, with those targeting older adults and pregnant women (to protect young infants) in phase 2 and 3 clinical trials. Unanswered questions regarding RSV epidemiology need to be identified and addressed prior to RSV vaccine introduction to guide the measurement of impact and future recommendations. The Centers for Disease Control and Prevention (CDC) convened a technical consultation to gather input from external subject matter experts on their individual perspectives regarding evidence gaps in current RSV epidemiology in the United States, potential studies and surveillance platforms needed to fill these gaps, and prioritizing efforts. Participants articulated their individual views, and CDC staff synthesized individuals' input into this report.

Supply Chain–Wide Optimization at TNT Express

The application of operations research (OR) at TNT Express during the past seven years has significantly improved decision-making quality and resulted in cost savings of 207 million euros. The global optimization (GO) program initiative has led to the development of a suite of optimization solutions to assist the operating units of TNT Express to improve their package delivery in road and air networks. To create and deploy these solutions, we established communities of practice (CoPs), at which internal and external subject matter experts meet three times annually at an internal conference. We also created a unique two-year learning environment, the GO academy, where employees of TNT Express are taught the principles, use, and deployment of optimization techniques. As a result of these combined initiatives, OR is now an effective part of the core values at TNT Express.

Training Needs Assessment Data‐gathering Methods:

The fourth in a series of four articles which explores training needs assessment (TNA) data‐gathering methods: survey questionnaires, individual interviews, focus groups, and on‐site observations. Originally presented in a condensed format in an article entitled “Training Needs Assessment: An ‘Open‐systems’ Application” and published in the Journal of European Industrial Training, Vol. 17 No. 1, this article presents the method of using on‐site observations as a means of gathering relevant training needs data. Emphasis is placed on using observations in both production as well as non‐production or administrative environments. Alternatively, presents and discusses the selection and use of subject matter experts (SMEs). Explores the advantages and disadvantages of using internal and external SMEs: stresses analysis of data and recommends that only individuals who are qualified, trained and/or experienced in observations should conduct them. Concludes that a more balanced approach for conducting on‐site observations is in using a combination of both internal as well as external SMEs.