Reporting of equity in observational epidemiology: A methodological review.

Background: Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods: We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results: The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions: Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0-95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline.

Motivations for investigating health inequities in observational epidemiology: a content analysis of 320 studies.

OBJECTIVES: To enhance equity in clinical and epidemiological research, it is crucial to understand researcher motivations for conducting equity-relevant studies. Therefore, we evaluated author motivations in a randomly selected sample of equity-relevant observational studies published during the COVID-19 pandemic. STUDY DESIGN AND SETTING: We searched MEDLINE for studies from 2020 to 2022, resulting in 16,828 references. We randomly selected 320 studies purposefully sampled across income setting (high vs low-middle-income), COVID-19 topic (vs non-COVID-19), and focus on populations experiencing inequities. Of those, 206 explicitly mentioned motivations which we analyzed thematically. We used discourse analysis to investigate the reasons behind emerging motivations. RESULTS: We identified the following motivations: (1) examining health disparities, (2) tackling social determinants to improve access, and (3) addressing knowledge gaps in health equity. Discourse analysis showed motivations stem from commitments to social justice and recognizing the importance of highlighting it in research. Other discourses included aspiring to improve health-care efficiency, wanting to understand cause-effect relationships, and seeking to contribute to an equitable evidence base. CONCLUSION: Understanding researchers' motivations for assessing health equity can aid in developing guidance that tailors to their needs. We will consider these motivations in developing and sharing equity guidance to better meet researchers' needs.

Optimizing Outpatient Radiation Oncology Consult Workflow by Using Time-Driven Activity-Based Costing: Efficiency and Financial Impacts.

PURPOSE: Clinical efficiency is a key component of value-based health care. Our objective here was to identify workflow inefficiencies by using time-driven activity-based costing (TDABC) and evaluate the implementation of a new clinical workflow in high-volume outpatient radiation oncology clinics. METHODS: Our quality improvement study was conducted with the Departments of GI, Genitourinary (GU), and Thoracic Radiation Oncology at a large academic cancer center and four community network sites. TDABC was used to create process maps and optimize workflow for outpatient consults. Patient encounter metrics were captured with a real-time status function in the electronic medical record. Time metrics were compared using Mann-Whitney U tests. RESULTS: Individual patient encounter data for 1,328 consults before the intervention and 1,234 afterward across all sections were included. The median overall cycle time was reduced by 21% in GI (19 minutes), 18% in GU (16 minutes), and 12% at the community sites (9 minutes). The median financial savings per consult were $52 in US dollars (USD) for the GI, $33 USD for GU, $30 USD for thoracic, and $42 USD for the community sites. Patient satisfaction surveys (from 127 of 228 patients) showed that 99% of patients reported that their providers spent adequate time with them and 91% reported being seen by a care provider in a timely manner. CONCLUSION: TDABC can effectively identify opportunities to improve clinical efficiency. Implementing workflow changes on the basis of our findings led to substantial reductions in overall encounter cycle times across several departments, as well as high patient satisfaction and significant financial savings.

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

SAFE™ Initiative: A Step Closer to Positive Safety Culture and Improved Patient Experience.

Background Positive safety culture is a key characteristic of a high-reliability organization; it is the leading service excellence standard and highest priority of The University of Texas MD Anderson Cancer Center. However, understanding the importance and impact of safety event reporting was limited at the MD Anderson campus in Sugar Land, Texas. Therefore, we implemented the Secure, Attentive, Focused, Engaged (SAFE™) initiative to create, foster, and continuously improve safety culture throughout the campus, with a secondary goal of impacting patient experience. Here, we review the SAFE™ initiative and its impact on our safety culture and patient experience. Methods The SAFE™ initiative was conceptualized and implemented in April 2017 by the leadership team at MD Anderson Cancer Center in Sugar Land. This initiative completely restructured our safety reporting and follow-up processes through leading by example, open safety meetings, transparent communication, emphasis on processes rather than people, and follow-up on any safety event entered or issue raised. We recorded quantitative measures and qualitative improvements, such as increased engagement and improved staff morale, using the results of institutional safety surveys in 2018 and 2020, which included a comparison to Agency for Healthcare Research and Quality's (AHRQ) national benchmarks and Press Ganey® patient experience scores. The AHRQ national benchmarks are based on the culture of safety surveys that measure staff views on safety, while the Press Ganey® patient experience scores measure patient perception. The SAFE™ initiative was then implemented at three additional MD Anderson Cancer Center campuses. Results During the data collection period of April 2017 to December 2021, we observed a sustained increase in safety event reporting at our campus, from 7.17 to 15.49 reports per month. We also observed a qualitative increase in safety meeting engagement and a higher participation rate in the institution-wide safety survey compared to MD Anderson Cancer Center overall. MD Anderson Cancer Center in Sugar Land scored above the national benchmarks in nine of the 13 domains in 2018 and all domains surveyed in 2020. Patient experience scores, measured by Press Ganey®, increased annually, with 2017, 2018, 2019, and 2020 fiscal year top box scores averaging 80.6%, 83.9%, 85.9%, and 86.4%, respectively. Two of the additional locations showed improvement from 2018 to 2020 in the institution-wide Culture of Safety Employee Survey and scored above the AHRQ's national benchmarks in all the domains. The third location showed improvement from 2018 to 2020 on the institution-wide Culture of Safety Employee Survey in 11 of 15 domains and scored above the AHRQ's national benchmarks in all except one domain. The greatest improvements were error feedback, employee safety, and communication openness. Conclusions Positive safety culture is a requirement for a health care organization to be designated as a high-reliability organization. At MD Anderson Cancer Center in Sugar Land, we implemented an initiative that had a meaningful impact on the creation of a positive safety culture and was successfully scaled to additional locations.

Validation studies of rheumatoid arthritis patient-reported outcome measures in populations at risk for inequity: A systematic review and analysis using the OMERACT summary of measurement properties equity table.

BACKGROUND: Existing patient-reported outcome measures (PROMs) in rheumatoid arthritis (RA) may be limited in their applicability to populations that are at risk for inequities. We conducted a systematic review to identify and rate evidence in the validation studies for PROMs in populations at risk for inequity. METHODS: A systematic review of MEDLINE and EMBASE was completed. The search strategy was developed to identify measurement property studies for PROMs of interest (selected pain, disease activity, global evaluation and quality of life scales) in patients with RA. We identified experimental, observational, and qualitative studies reporting analysis of feasibility, construct validity and discriminant ability metrics for populations at risk for inequity by various factors including race, ethnicity, culture or language; employment status; sex and gender identity; education level; socioeconomic status; social support; age; health literacy and disability. These were rated based on the OMERACT Summary of Measurement Properties Equity table. RESULTS: From 19,786 titles and abstracts screened, we identified 14 unique studies reporting validation metrics for pain (n = 3), DAS28-ESR or DAS28-CRP (n = 2), ACR20 (n = 1), patient global assessment (n = 2), EQ5D (n = 4), and PROMIS® (n = 3) by race (n = 10 studies), age (n = 6 studies), sex (n = 5 studies), education level (n = 2 studies), and disability, literacy, employment status, social support level and socioeconomic status (n = 1 study each). Five studies reported on feasibility, 12 reported construct validity metrics, and 4 studies reported on discriminant validity metrics. All studies by culture or language were rated as having good measurement property metrics. There was limited assessment of measurement property metrics for other populations at risk for inequity. CONCLUSION: Our study highlights important gaps in patient representation in rheumatology research for accepted outcome measures. New outcome measures being developed for research purposes and clinical practice should ensure and report representation of patients from populations at risk for inequities in the testing of metrics of feasibility, construct validity and discriminant ability metrics.

Guidance relevant to the reporting of health equity in observational research: a scoping review protocol.

INTRODUCTION: Health inequities are defined as unfair and avoidable differences in health between groups within a population. Most health research is conducted through observational studies, which are able to offer real-world insights about etiology, healthcare policy/programme effectiveness and the impacts of socioeconomic factors. However, most published reports of observational studies do not address how their findings relate to health equity. Our team seeks to develop equity-relevant reporting guidance as an extension of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. This scoping review will inform the development of candidate items for the STROBE-Equity extension. We will operationalise equity-seeking populations using the PROGRESS-Plus framework of sociodemographic factors. As part of a parallel stream of the STROBE-Equity project, the relevance of candidate guideline items to Indigenous research will be led by Indigenous coinvestigators on the team. METHODS AND ANALYSIS: We will follow the Joanna Briggs Institute method for conducting scoping reviews. We will evaluate the extent to which the identified guidance supports or refutes our preliminary candidate items for reporting equity in observational studies. These candidate items were developed based on items from equity-reporting guidelines for randomised trials and systematic reviews, developed by members of this team. We will consult with our knowledge users, patients/public partners and Indigenous research steering committee to invite suggestions for relevant guidance documents and interpretation of findings. If the identified guidance suggests the need for additional candidate items, they will be developed through inductive thematic analysis. ETHICS AND DISSEMINATION: We will follow a principled approach that promotes ethical codevelopment with our community partners, based on principles of cultural safety, authentic partnerships, addressing colonial structures in knowledge production and the shared ownership, interpretation, and dissemination of research. All products of this research will be published as open access.

Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership.

BACKGROUND: Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. OBJECTIVE: We aimed to develop factors for health research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership, with the aim of forming equitable and informed teams. DESIGN: Consensus development. PARTICIPANTS: We involved 16 stakeholders from the international Multi-Stakeholder Engagement (MuSE) Consortium, including patients and the public, providers, payers of health services/purchasers, policy makers, programme managers, peer review editors, and principal investigators. APPROACH: We engaged stakeholders in factor development and as co-authors of this manuscript. Using a modified Delphi approach, we gathered stakeholder views concerning a preliminary list of 18 factors. Over two feedback rounds, using qualitative and quantitative analysis, we concentrated these into ten factors. KEY RESULTS: We present seven highly desirable factors: 'expertise or experience', 'ability and willingness to represent the stakeholder group', 'inclusivity (equity, diversity and intersectionality)', 'communication skills', 'commitment and time capacity', 'financial and non-financial relationships and activities, and conflict of interest', 'training support and funding needs'. Additionally, three factors are desirable: 'influence', 'research relevant values', 'previous stakeholder engagement'. CONCLUSIONS: We present factors for research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership. Policy makers and guideline developers may benefit from considering the factors in stakeholder identification and invitation. Research funders may consider stipulating consideration of the factors in funding applications. We outline how these factors can be implemented and exemplify how their use has the potential to improve the quality and relevancy of health research.

Public Health and Health Care Partnerships for Improved Tobacco Cessation.

CONTEXT: Tobacco use remains a leading cause of preventable death and disease. While most tobacco users are interested in quitting, few receive professional assistance. PROGRAM: This state health department-led project leveraged partnerships to build capacity and support 9 health care organizations in implementing system-level initiatives to improve delivery of tobacco cessation. IMPLEMENTATION: Participating organizations' initiatives targeted 3 focus areas: implementing best practices for tobacco cessation; quality improvement; and utilization of the electronic health record. EVALUATION: A qualitative study was conducted to examine facilitators and barriers to tobacco cession systems change among participating health care organizations. Common barriers included time constraints, staffing issues, and organizational structure. These factors often differed by organization type (eg, large vs small). Facilitators included leadership buy-in, organizational priority, technical assistance, teams/teamwork, and IT support. DISCUSSION: Initial findings suggest that this type of partnership model can be leveraged to gain organizational support, build capacity, address key barriers, and ensure that systems change strategies align with best practices for tobacco cessation across a diverse set of health care organizations. Findings presented in this report provide insights for other public health and health care organizations looking to implement similar initiatives.

Development of an extension of the OMERACT Summary of Measurement Properties table to capture equity considerations: SOMP-Equity.

OBJECTIVE: To develop an equity extension of the OMERACT Summary of Measurement Properties (SOMP) Table, SOMP Equity to describe whether a patient reported outcome measure (PROM) works well among patients of diverse languages and cultures, education levels, and other population characteristics. METHODS: We used the PROGRESS-Plus framework to categorize equity characteristics assessed in trials of PROM. PROGRESS refers to Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social Capital, while the 'plus' captures additional characteristics, such as age. We pilot tested our SOMP Equity Extension using the Health Assessment Questionnaire (HAQ) as a prototypical PROM. RESULTS: The SOMP Equity Extension retains the same columns as the original OMERACT SOMP (domain match, feasibility, construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, thresholds of meaning) but uses the PROGRESS-Plus characteristics as rows. We found several examples of studies of the HAQ which had assessed one or more PROGRESS-Plus characteristics. CONCLUSIONS: The most commonly reported equity considerations were related to language. OMERACT Equity virtual meeting participants were polled and they indicated that the SOMP Equity Extension is useful for highlighting and tracking equity considerations for OMERACT Core Outcome Measurement Instruments.

Improving Social Justice in COVID-19 Health Research: Interim Guidelines for Reporting Health Equity in Observational Studies.

The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes.

Neonatal Organ and Tissue Donation for Research: Options Following Death by Natural Causes.

The donation of organs and tissues from neonates (birth to 28 days) for transplantation has been a relatively infrequent occurrence. Less common has been the use of neonatal organs and tissues for research. Specific ethical and legal questions beg for rational and transparent guidelines with which to evaluate referrals of potential donors. Donation of organs and tissues from a neonate can play a key role in the care and support provided to families by health care professionals around the time of a neonate's death. We report on the recovery of neonatal organs and tissues for research. A working group made up of bioethicists, neonatologists, lawyers, obstetric practioners as well as organ procurement and tissue banking professionals evaluated legal, ethical and medical issues. Neonatal donor family members were also consulted. Our primary goals were (a) to ensure that referrals were made in compliance with all applicable federal and state laws, regulations and institutional protocols, and (b) to follow acceptable ethical standards. Algorithms and policies designed to assist in the evaluation of potential neonatal donors were developed. Neonatal donation is proving increasingly valuable for research into areas including diabetes, pulmonary, gastrointestinal, genitourinary and neurological development, rheumatoid arthritis, autism, childhood psychiatric and neurologic disorders, treatment of MRSA infection and pediatric emergency resuscitation. The development of policies and procedures will assist medical professionals who wish to offer the option of donation to family members anticipating the death of a neonate.

Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation.

BACKGROUND: Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.

Community-Initiated Research Engagement: Equitable Partnership Delivering Research-Ready Faith-Based Ambassadors.

BACKGROUND: Faith-based communities supporting diverse and underserved communities are increasingly being recognized by health researchers as valued partners for research engagement. Although the "why engage" is clearly documented, the how and lessons learned is less well evidenced. OBJECTIVES: This article describes community-academic collaboration initiated by African American faith-based church leaders to foster equitable partnership, engagement and shared decision making in patient-centered health research initiatives. METHODS: A phased process of relationship and capacity building was used to found and operationalize a mixed stakeholder community advisory board (CAB). Core phases presented in this article are (1) pre-CAB capacity building, (2) developing the CAB vision and mission, (3) extending CAB capacity, and (4) sustaining CAB capacity. LESSONS LEARNED: Collaborative governance and shared goal setting delivers research engagement which supports the data needs and aspirations of faith-based communities. CONCLUSIONS: Faith-based communities have the capacity to design and deliver community appropriate governance for research engagement.

Proceedings of the 2017 Advancing the Science of Community Engaged Research (CEnR) Conference.

BACKGROUND: To address an urgent need to advance the field of community engaged research, faculty at Vanderbilt University Medical Center and Meharry Medical College organized the national meeting "Advancing the Science of Community Engaged Research (CEnR): Innovative & Effective Methods of Stakeholder Engagement in Translational Research, Washington, DC September 14-15, 2017 (See Additional file 1). These meetings brought together a diverse group of stakeholders to share community engaged research evidence and practical knowledge for implementing new and enhancing existing research programs. The conference series' goals were: 1) to expand the scientific basis for the community engaged research field by convening researchers, community partners, patient advocacy organizations, and others to share innovative methods and strategies; 2) to engage community representatives and patient advocates in the development of new approaches in community engaged research by meaningfully involving them in the planning, as speakers and presenters, and as conference participants; and 3) to catalyze innovative community engaged research using interactive meeting methods that promote learning, support collective problem solving, and encourage new conceptual frameworks. These conferences have advanced community engagement across the translational research spectrum in biomedical research. For the 2017 meeting, described here, the overarching theme was Innovative and Effective Methods of Stakeholder Engagement in Translational Research. METHODS: The forum was attended by over 210 participants. This conference used novel approaches to fulfill its objectives of participant diversity, meaningful stakeholder engagement, and eliciting varied distinct perspectives to advance the science of community engaged research. Innovative strategies for the conference included: Think Tanks focused on emerging community engaged research topics or topics in need of urgent attention. These dynamic group sessions provided for freely sharing ideas with the purpose of creating change and facilitating new research collaborations. Learning Labs offered unique opportunities to gain practical knowledge regarding innovative methods in community engaged research. Learning Labs also facilitated the wide broadcast of locally successful engagement methods with the goal of speeding the uptake and implementation of community engaged methods. Travel Scholarships were provided for twenty community and patient representatives to participate in the conference. The lack of travel funds was a significant barrier to stakeholder participation in prior community engaged research meetings. The scholarships expanded the role of community and patient representatives in setting research priorities and promoting methods development. Meaningful Engagement meant that community members and patients participated in decision making on all aspects of the conference planning, including the selection of themes, topics, and speakers, and were fully integrated into the conference as speakers, panelists, and moderators. CONCLUSIONS: Community and stakeholder engagement can directly impact research by enhancing clinical trial design, increasing relevance, and increasing recruitment, accrual and retention (Staley K.: Exploring Impact: Public 53 Involvement in NHS, Public Health and Social Care Research - INVOLVE.; 2009, Johnson et al Clin Transl Sci 8:388-54 390, 2015, Joosten et al Acad Med 90:1646-1650, 2015). The 2017 Advancing the Science of Community Engaged Research meeting, Innovative and Effective Methods of Stakeholder Engagement in Translational Research facilitated meaningful engagement of diverse stakeholder groups including racial and ethnic minorities, community and patient representatives, and junior investigators. Of 210 attendees, 72 completed the evaluation, and, of those, 36% self-affiliated as community members, and 21% as patient/caregiver advocacy, faith-based, or tribal organization members. This conference 1) represented a step toward expanding the scientific basis for the community engaged research (CEnR) field; 2) catalyzed innovative community engaged research; and 3) enhanced the reach and impact of the scientific developments emerging from pioneering work in community engagement.

Practical Guidance for Involving Stakeholders in Health Research.

Stakeholder engagement is increasingly common in health research, with protocols for engaging multiple stakeholder groups becoming normative in patient-centered outcomes research. Previous work has focused on identifying relevant stakeholder groups with whom to work and on working with stakeholders in evidence implementation. This paper draws on the expertise of a team from four countries-Canada, Australia, the UK, and the USA-to provide researchers with practical guidance for carrying out multi-stakeholder-engaged projects: we present a list of questions to assist in selecting appropriate roles and modes of engagement; we introduce a matrix to help summarize engagement activities; and we provide a list of online resources. This guidance, matrix, and list of resources can assist researchers to consider more systematically which stakeholder groups to involve, in what study roles, and by what modes of engagement. By documenting how stakeholders are paired up with specific roles, the matrix also provides a potential structure for evaluating the impact of stakeholder engagement.

Considerations and guidance in designing equity-relevant clinical trials.

Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequities is important to inform the design, conduct and reporting of trials so that research can build evidence to more effectively address health inequities and importantly, ensure that inequities are not aggravated. In this paper, we discuss approaches to integrating health equity-considerations in randomized trials by using the PROGRESS Plus framework (Place of residence, Race/ethnicity/culture/language, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and "Plus" that includes other context specific factors) and cover: (i) formulation of research questions, (ii) two specific scenarios relevant to trials about health equity and (iii) describe how the PROGRESS Plus characteristics may influence trial design, conduct and analyses. This guidance is intended to support trialists designing equity-relevant trials and lead to better design, conduct, analyses and reporting, by addressing two main issues: how to avoid aggravating inequity among research participants and how to produce information that is useful to decision-makers who are concerned with health inequities.

Effects of bronchoscopy on lung function in asthmatics.

BACKGROUND: To better understand the changes in pulmonary physiology related to asthma severity following bronchoscopy, we performed scheduled pre- and post-procedure spirometry on subjects undergoing bronchoscopy in our research program. METHODS: Control subjects and asthma subjects were recruited for bronchoscopy. On the day of bronchoscopy, subjects underwent spirometry pre-bronchoscopy and then up to three sets within 2 hour following the completion of bronchoscopy. A subset of patients had a second bronchoscopy after 2 weeks of treatment with oral prednisolone (40mg daily). RESULTS: A total of 92 subjects had at least one bronchoscopy (12 control subjects, 56 nonsevere asthma (NSA), 24 severe asthma (SA)). The SA and NSA groups had similar decreases in forced expiratory volume in 1 second (FEV1) (-20±13% vs.-19±16%, p = 0.92) and forced vital capacity (FVC) (-20±12% vs.-20±14%, p = 0.80), but no change in FEV1/FVC ratio. The control and NSA group had more rapid recovery of both FEV1 and FVC by 2 hour compared to the SA group (p = 0.01). In the subset of 36 subjects (22 NSA, 14 SA) who underwent a second bronchoscopy following the administration of oral prednisolone for 14 days, steroids resulted in more rapid recovery of lung function (p < 0.04). CONCLUSION: Following bronchoscopy the lung function of NSA subjects recovered more quickly than SA subjects. Treatment with oral corticosteroids was associated with a quicker recovery of FEV1 which suggests an inflammatory mechanism for these changes in lung compliance.

Application of programmable bio-nano-chip system for the quantitative detection of drugs of abuse in oral fluids.

OBJECTIVE: There is currently a gap in on-site drug of abuse monitoring. Current detection methods involve invasive sampling of blood and urine specimens, or collection of oral fluid, followed by qualitative screening tests using immunochromatographic cartridges. While remote laboratories then may provide confirmation and quantitative assessment of a presumptive positive, this instrumentation is expensive and decoupled from the initial sampling making the current drug-screening program inefficient and costly. The authors applied a noninvasive oral fluid sampling approach integrated with the in-development chip-based Programmable bio-nano-chip (p-BNC) platform for the detection of drugs of abuse. METHOD: The p-BNC assay methodology was applied for the detection of tetrahydrocannabinol, morphine, amphetamine, methamphetamine, cocaine, methadone and benzodiazepines, initially using spiked buffered samples and, ultimately, using oral fluid specimen collected from consented volunteers. RESULTS: Rapid (∼10min), sensitive detection (∼ng/mL) and quantitation of 12 drugs of abuse was demonstrated on the p-BNC platform. Furthermore, the system provided visibility to time-course of select drug and metabolite profiles in oral fluids; for the drug cocaine, three regions of slope were observed that, when combined with concentration measurements from this and prior impairment studies, information about cocaine-induced impairment may be revealed. CONCLUSIONS: This chip-based p-BNC detection modality has significant potential to be used in the future by law enforcement officers for roadside drug testing and to serve a variety of other settings, including outpatient and inpatient drug rehabilitation centers, emergency rooms, prisons, schools, and in the workplace.

Nurse faculty experiences in problem-based learning: an interpretive phenomenologic analysis.

AIM: This study explored the nurse faculty experience of participating in a problem-based learning (PBL) faculty development program. BACKGROUND: Utilizing PBL as a pedagogical method requires a paradigm shift in the way faculty think about teaching, learning, and the teacher-student relationship. METHOD: An interpretive phenomenological analysis approach was used to explore the faculty experience in a PBL development program. RESULTS: Four themes emerged: change in perception of the teacher-student relationship, struggle in letting go, uncertainty, and valuing PBL as a developmental process. CONCLUSIONS: Epistemic doubt happens when action and intent toward the PBL teaching perspective do not match underlying beliefs. Findings from this study call for ongoing administrative support for education on PBL while faculty take time to uncover hidden epistemological beliefs.