Historically, quality measurement analyses utilize manual chart abstraction from data collected primarily for administrative purposes. These methods are resource-intensive, time-delayed, and often lack clinical relevance. Electronic Medical Records (EMRs) have increased data availability and opportunities for quality measurement. However, little is known about the effectiveness of Measurement Feedback Systems (MFSs) in utilizing EMR data. This study explores the effectiveness and characteristics of EMR-enabled MFSs in tertiary care. The search strategy guided by the PICO Framework was executed in four databases. Two reviewers screened abstracts and manuscripts. Data on effect and intervention characteristics were extracted using a tailored version of the Cochrane EPOC abstraction tool. Due to study heterogeneity, a narrative synthesis was conducted and reported according to PRISMA guidelines. A total of 14 unique MFS studies were extracted and synthesized, of which 12 had positive effects on outcomes. Findings indicate that quality measurement using EMR data is feasible in certain contexts and successful MFSs often incorporated electronic feedback methods, supported by clinical leadership and action planning. EMR-enabled MFSs have the potential to reduce the burden of data collection for quality measurement but further research is needed to evaluate EMR-enabled MFSs to translate and scale findings to broader implementation contexts. Quality measurement is essential to systematically identify unwarranted variation in care delivery. Over the last 20 years, measurement-feedback systems (MFSs) such as Audit and Feedback have been widely used in quality improvement programs to provide health professionals with information that reflects the care delivered. These MFSs are based on the theory that health professionals are prompted to improve care when the gap between current practice and optimal practice is highlighted ,2. UnlikThere is a paucity of research on the specific aspects of MFSs that may influence their impact, reporting a wide range of factors associated with feedback utilization including data sources for analysis, feedback content and display, and implementation context ,6,7. HisThe increasing quality reporting requirements expected of healthcare organizations have resulted in additional siloed data collection, duplication of effort, measurement burden, and increased expense ,14,15. TDespite this growing opportunity, little is known about the feasibility and effectiveness of EMR-enabled MFSs in tertiary care. Recent literature has explored electronic audit and feedback in primary care , theoretThe search strategy was guided by the PICO Framework . StudiesCitations retrieved from the search were imported into the reference manager software program EndNote X9 for de-duplication, then imported into Covidence Systematic Review software a web-based platform for screening.Two authors (CD and ES) independently screened the titles and abstracts against the exclusion criteria in The methodological quality of included studies was conducted by one reviewer (CD). The Quality Appraisal for Diverse Studies (QuADS)  tool wasOne author (CD) extracted data relevant to both intervention effect and design. A data abstraction template was developed in Microsoft Excel v. 16.34 to extract data. Guided by Cochrane’s EPOC extraction tool ,26 inclup values) were synthesized where possible and otherwise outcomes were descriptively reported. The intervention characteristics were descriptively reported at the study level. Studies were grouped by key intervention characteristics, i.e., aim of intervention, feedback methods to explore any correlation. Tables were used to summarize study characteristics and reported outcomes, and intervention characteristics.This manuscript follows the PRISMA reporting guidelines where possible to discuss the synthesis of results . This reThe literature search identified 785 records as demonstrated in A summary of key study characteristics are described in Almost all of the MFSs were part of a wider multifaceted quality improvement program (n = 12). Concurrent quality improvement strategies included new models of care, protocols and guidelines, education and training, clinical decision support tools, and EMR modifications, including implementation of pharmacy order sets. The study aims were well reported but highly varied. Both Hester et al., 2019  and Dowlp < 0.05, 95% CI) for each study are reported in Details on outcomes, effect direction, and statistical significance * (The majority of studies reported a positive effect on the primary outcome (n = 12), of which nine provided statistically significant results. Of the nine studies with statistically significant improvement, all had <70 participants, five were single-center and four were multi-center studies. All three ITS studies, and two CRCTs showed statistically significant improvement. In the two studies reporting null or negative effect, one reported no effect on blood pressure control  and the Key intervention characteristics were summarized in In accordance with the inclusion criteria, all studies utilized EMR data as the primary source for analysis, however, additional data sources were used in four MFSs, including national registry data (n = 1), existing databases used in previous QI projects (n = 2), and patient satisfaction data (n = 1). All MFSs conducted quality measurements, mostly using quality indicators. Some MFSs used data to analyze a single quality indicator, guideline or behavior (n = 4), whereas others measured multiple quality indicators in a clinical focus area (n = 10). There was a relatively even mix of MFSs that measured care and outcomes on an individual provider level only (n = 7) and team or department level only (n = 3), and those that measured at both the individual and team, department or hospital level (n = 4).Across the 14 studies, the most common feedback recipients were ED clinicians (n = 3) and pediatric ED clinicians (n = 2). Some MFSs delivered feedback to specialty clinicians (n = 4) including cardiologists, palliative care clinicians, anesthetists, rheumatologists, and specialty teams (n = 3) including internal medicine teams, a cardiology multidisciplinary team (MDT) and neuro-oncology MDTs. Other feedback recipients included hospitalists (n = 1) and nurses (n = 1) across different hospital departments. The content of feedback was typically presented as quality indicators including rates of adherence with best-practice or trend data over time. Many MFSs used peer comparison with individuals or with other teams/hospitals (n = 9), as well as benchmarks of a regional or national standard. The majority of MFSs used reports to deliver feedback (n = 8). These reports were either emailed (n = 5) or hand-delivered (n = 2), one study did not specify. The remaining studies used electronic dashboards to provide a more visual and interactive feedback solution (n = 7). The interventions that used emailed reports displayed static data, whereas dashboard interventions updated and displayed the measurement data in near real-time (<24 h). Feedback reports were delivered in either quarterly (n = 1), monthly (n = 6), or weekly (n = 1) intervals, and dashboards were accessible throughout the intervention period.Six studies utilized a theoretical framework/model used to guide the design of the MFSs including the Plan-Do-Study-Act (PDSA) cycle (n = 2) ,52, VisiThis systematic review identified 16 articles describing the results of 14 EMR-enabled MFSs delivered to healthcare professionals and teams within hospitals. The primary objective of this review was to identify the effect EMR-enabled MFSs have on the quality of care and patient outcomes. Overall, 12 of the 14 MFSs (86%) demonstrated a positive effect on various outcome measures. Although, as almost all studies implemented an MFS within a multifaceted quality improvement program, contamination exists in the measured effects. Three studies, however, did use interrupted time series studies  and wereCommon characteristics which supported the included MFSs pertains to measurement of quality indicators at individual and team levels, the use of technology and tools in feedback , benchmarking , and facilitating action with leadership  and active clinical engagement . These characteristics of EMR-enabled MFSs are aligned with those found in previous reviews of characteristics of audit and feedback. Although studies in this review were not included in Tuti et al.’s  review oWhilst the findings discussed in this manuscript provide a broader range of feedback methods to the dashboard focus of Bucalon et al.’s  review, In addition to the design of the MFSs, many of the included studies actively engaged health professionals and clinical teams in both measurement and feedback components using formal leadership roles and clinical champions. All MFSs that used team review meetings and action planning in conjunction with feedback had positive outcomes. In Patel’s study  that incThis review focused on EMR data for quality improvement contributes to the growing literature on the secondary use of routinely collected data. A key finding from this review was an articulation of the challenges that need to be overcome when using EMR data for quality measurement and improvement. All studies in this review highlighted that MFS utilizing EMR data requires both technical knowledge and skills to extract data and a clinical understanding of decision-making, clinical pathways, and processes to manipulate data appropriately. Such efforts are dependent on the project timelines, IT capacity, or ability to collaborate with the EMR vendor to access proprietary databases. This is a commonly reported issue across secondary use of EMR data more broadly . These cTwo EMR vendors, Epic System Corporation and Cerner Corporation were reported across the six studies which specified the specific EMR package. These two vendors hold a share of over 55% of the market in the US where the majority of studies were conducted ,57. ThisAlthough EMR data was the primary source for analysis in all studies, additional data sources were utilized in five MFSs. Not all data required for measurement calculation existed in a single database, and therefore access to multiple databases was required to support MFSs. This suggests that EMR data alone may not capture sufficient data required for quality measurement and improvement. This review found clinical registries were the most commonly used data source to supplement EMR data. Clinical registries may provide access to additional longitudinal information such as death data, pertinent to the measurement of quality survival and mortality quality indicators. The automated extraction of EMR data into clinical registries has been explored in the literature and whilst it found the integration to be viable, complex challenges remain in the lack of standardization, quality of EMR data, and data completeness ,60,61.A commonly reported issue of EMRs is a lack of interoperability between systems used in different services, making consolidation of data across organizations difficult . WhereasIn order for EMR data to further support MFSs and reduce the overall data collection burden, implementation of data standards across pertinent data elements should be carefully considered for meaningful secondary EMR data use in quality improvement. Some studies noted a lack of trust or time required to build trust in the data used within the MFS. A method used to build trust included engaging health professionals in the data from the outset of the project planning. One study incorporated initial team meetings using data for open discussion, to establish a common understanding of EMR documentation expectations, which data elements would be extracted for the MFS, and how the feedback reports or dashboard interfaces would be created. Studies that utilized these mechanisms reported trust as an enabler of clinical behavior change and fostered a non-judgmental culture of quality measurement.Secondary use of EMR data is a rapidly developing area of research, and many studies may not yet be at the development stage of higher quality studies. The number of studies may also be limited by a lack of formal interventions in health service quality improvement activities or that there are a number of barriers to translating an MFS from proof-of-concept to a final product for evaluation. Therefore, a limitation of this review is the exclusion of earlier stage research such as conference proceedings, and studies that had an outcome of user testing. Including this research may be useful in understanding the development and application of EMR data for MFSs and increased the number of studies included in this review. Another limitation of this review is the restriction of the period of time 2009–2022). Although this contemporary time period was selected as relevant to implementation of modern EMRs and levels of adoption, publications pre-dating this period may have been missed. These limitations may provide additional insight into the lower number of studies. This review also excluded studies where medical students or trainee clinicians were the recipients of feedback. The large number of studies in this area may be attributed the learning context and culture of clinicians at this career level. The decision to exclude these studies was based on the difference in this context to ongoing professional development as a fully qualified clinician. Therefore, results may not be transferrable or comparable. Given a large number of studies in the student clinician context, there may be some learnings to glean from studies including students/trainee clinicians in a future review. Finally, this review excluded studies that utilized only registry data but it is important to note that in countries such as Sweden, Denmark, and the Netherlands, registries for certain clinical conditions have been integrated with automated EMR exports and have much shorter time delays than other clinical registries –2022. Al,69. MoreEMRs contain rich information related to clinical care delivery that could be used in quality improvement programs. Overall, utilizing EMR data to drive MFSs has been demonstrated as feasible and is associated with some studies which show positive changes in care delivery, particularly in multicomponent quality improvement interventions. However, evidence of EMR-enabled MFS impact on patient outcomes is limited, highlighting the need for future high quality studies that would enable causal inferences to be drawn. Common characteristics of successful EMR-enabled MFSs, included additional data sources to supplement EMR data , transparency in data use and quality measurement calculation, technology-enabled feedback methods (dashboards and emailed reports), and support of clinical leadership, goal setting and action planning to facilitate practice change. Our findings highlight the need to improve the quality and implementation of future studies designed to enable causal inferences to be drawn in secondary EMR data use for quality measurement and feedback.


V. Subba Reddy et al., RSC Adv., 2016, 6, 50497–50499.Correction for ‘Rhodium-catalyzed cycloaddition of carbonyl ylides for the synthesis of spiro[furo[2,3- In the original manuscript, an incorrect CCDC number was given for the crystallographic data, and incorrect crystal structure data was provided as Electronic Supplementary Data for the manuscript. The correct CCDC number is 1451304 and the corresponding crystal structure data CIF file has been corrected for the original manuscript.The Royal Society of Chemistry apologises for these errors and any consequent inconvenience to authors and readers.


Aging is expressed as a deterioration and frailty of various tissues, accompanied by dysregulation of the pathways essential for homeostasis, resilience, and maintenance . Under nCellular senescence is an irreversible process occurring during the aging of an organism. Cell cycle withdrawal, macromolecular damage, dysregulated metabolism, and senescence-associated secretory phenotype (SASP) are all major phenomena occurring during cellular senescence . The rolIn this research topic, we received one original research article and three reviews that focused on the role of cellular senescence and aging-related cellular microenvironments at several levels, including molecular, cellular, and tissue. These works uncovered a relatively comprehensive understanding of aging, and provided future perspectives for research on aging and aging interventions.Loss of Growth Differentiation Factor 11 Shortens Telomere Length by Downregulating Telomerase Activity”  reported novel roles of GDF11 in telomere maintenance and cellular senescence in vitro, shedding light on new research directions in the field of rejuvenation and aging.At the molecular level, cellular senescence exhibits various failures of biomolecule maintenance, including shortening of telomere length. The article “Dynamic Aging: Channeled Through Microenvironment” , authors summarized the factors that promote bone fragility during aging and diabetes, including AGEs, inflammatory RAGE signaling and cell senescence. Interventions based on the therapy of aging such as caloric restriction and clearance of senescent cells are promised to improve health in relevant ageing-related diseases. The most prominent feature of aging is reflected by a large number of seemingly independent diseases in different kinds of tissues and organs. As a result, how it may be possible to target cellular senescence and cellular communications within the tissue microenvironment to prevent these diseases is extremely urgent and warrant further attention.Two reviews also summarized the findings related to aging from the perspective of specific organs: brain and bone. In the review entitled “n Aging” , authorsAlmost every cell in the body goes through the process of senescence, and the contribution of senescent cells to the body’s unavoidable aging (we coined this “senescaging”) cannot be ignored. In addition to cellular senescence, more biological events in the microenvironment are included in the aging process of the body . Therefo


Trauma-informed (TI) approach is a framework for a system change intervention that transforms the organizational culture and practices to address the high prevalence and impact of trauma on patients and healthcare professionals, and prevents re-traumatization in healthcare services. Review of TI approaches in primary and community mental healthcare identified limited evidence for its effectiveness in the UK, however it is endorsed in various policies. This study aimed to investigate the UK-specific context through exploring how TI approaches are represented in health policies, and how they are understood and implemented by policy makers and healthcare professionals.A qualitative study comprising of a document analysis of UK health policies followed by semi-structured interviews with key informants with direct experience of developing and implementing TI approaches. We used the Ready Extract Analyse Distil (READ) approach to guide policy document review, and the framework method to analyse data.We analysed 24 documents and interviewed 11 professionals from healthcare organizations and local authorities. TI approach was included in national, regional and local policies, however, there was no UK- or NHS-wide strategy or legislation, nor funding commitment. Although documents and interviews provided differing interpretations of TI care, they were aligned in describing the integration of TI principles at the system level, contextual tailoring to each organization, and addressing varied challenges within health systems. TI care in the UK has had piecemeal implementation, with a nation-wide strategy and leadership visible in Scotland and Wales and more disjointed implementation in England. Professionals wanted enhanced coordination between organizations and regions. We identified factors affecting implementation of TI approaches at the level of organization  and wider context . Professionals had conflicting views on the future of TI approaches, however all agreed that government backing is essential for implementing policies into practice.A coordinated, more centralized strategy and provision for TI healthcare, increased funding for evaluation, and education through professional networks about evidence-based TI health systems can contribute towards evidence-informed policies and implementation of TI approaches in the UK.The online version contains supplementary material available at 10.1186/s12913-022-08461-w. Individual, interpersonal and collective trauma is a highly prevalent and costly public health problem . The WHOCumulative trauma across the lifespan is associated with multiple health consequences . The linIf the high prevalence and negative impacts of trauma are not recognised and addressed in healthcare services, there may be negative consequences for patients and healthcare professionals. Patients may not disclose trauma or recognise the impact of trauma on their health . Patient. Other authors proposed similar constructs for the framework of TI approach, often using slightly differing terminology [Over last 20 years, several frameworks for a trauma-informed (TI) approach at the health systems level have been developed , 23–28. minology , 30. TheHow are TI approaches represented in UK health policies?How are TI approaches understood by policy makers and healthcare professionals?How are TI approaches implemented in the UK?Despite a 20-year history of the TI approach framework, several reviews have found limited evidence for their effectiveness in health systems, with most studies conducted in North America and only one qualitative study in the UK –33. DespThis study of UK policy and practice will help us understand what TI approaches mean for policy makers and professionals to inform future UK-specific policy and TI approaches in healthcare.To answer our research questions, and consider perspectives from different standpoints, we conducted a multi-method qualitative study comprised of a document analysis of UK health policies followed by semi-structured interviews with key informants. Document analysis explored how TI approaches are represented in UK health policy while interviews explored professional views on how they are understood and implemented. We used the Ready Extract Analyse Distil (READ) approach , to guidData collection occurred between October 2020 and June 2021, with researchers and interviewees based in remote settings due to social distancing restrictions during the COVID-19 pandemic. Sample size was informed by the concept of information power , and resWe defined policy as ‘a statement of the government’s position, intent or action’ , and conWe conducted virtual semi-structured interviews with professionals at decision making levels who have direct experience of developing and implementing TI approaches in the UK healthcare system. We agreed to recruit up to 10 professionals from national and local governments and healthcare organisations. Researchers sent an expression of interest letter via email and Twitter to: (i) individuals and professional networks of policy makers, (ii) authors of included policy documents, (iii) individuals recommended by interview participants. Interested individuals contacted study researchers who checked their eligibility, sent participant information leaflets, answered questions, and arranged interviews with those eligible and willing to proceed. Interviews were conducted over the Zoom video call platform. Researchers obtained verbal informed consent, asked demographic questions, and followed a flexible topic guide to ensure primary issues were covered during all interviews but allowing participants to introduce unanticipated issues. The topic guide explored participant experiences of developing and implementing TI approaches and their views on how TI approaches have come to be represented in policy and implementation  agreed to use purposive sampling to gather 24 documents representing a broad range of document categories including primary legislation, parliamentary documents, NHS and Public Health England strategy and planning documents, service-user perspectives, evaluation reports, and guidance on ‘how to do’ TI approach . EE ordeIn step three, we imported all included documents and interview transcripts into NVivo R project and applied the framework method . To addrIn step four, we stopped document review when we reached the pre-specified number of documents and discussed common findings. First, we illustrated how TI approaches have developed in the UK over time by creating an integrated timeline with document publication dates, the years when interview participants began working in this area, and broader contextual factors from national news and related media. Then we integrated findings from the analysis of documents and interviews through three iterative cycles of developing final analytical themes cutting across documents and interviews. Researchers produced written accounts of the themes, and tables with illustrative quotes that explained how TI approaches have been represented in policy documents, understood, and implemented in the UK.We identified 50 documents and selected 24 policy documents at national, local, and organizational levels. The remaining 26 documents provided context and a background on TI approaches. The documents included were published over nine years 2012–2021) and considered all UK nations, multiple sectors, government policy and service-user voices. The documents either mentioned a TI approach or discussed related concepts such as a patient choice and safety of services (Table 2–2021 ann = 24), followed by women’s health (n = 11), healthcare for rough-sleepers (n = 7), primary care (n = 4) and major incident management (n = 1). The level of application of the TI approach varied from one organization [n = 10) to regional application (n = 24). Scotland emerged as a leading region with the TI knowledge and skills framework for the Scottish Workforce [Mirroring the historical development of TI approaches from mental health services , 29, acrnization , to a punization , to NHS-nization , 50. Theorkforce .The timeline of TI approaches and related concepts in the UK showed a steady growth between 2012 and 2021 with parallel developments from top-down and bottom-up . We achieved a maximum variation sample representing diversity of gender , organizations , professional role (frontline to leadership positions), and direct experience of developing and/or implementing TI approaches in healthcare (from 2 to 25 years). Most participants developed and implemented TI approaches in England, at the level of organizations and local authorities . However, some participants considered standalone TI practices to be a TI approach. Documents and most interviewees differentiated TI approach from a good clinical practice by incorporation of the TI assumptions and principles .In line with the SAMHSA guidance , documenIn all policy documents and in nine interviews, TI approaches were presented as a remedy to a variety of problems within health systems. Sixteen of twenty-five documents justified a TI approach as a way for addressing the high prevalence and negative impact of violence and trauma on patients, with eleven documents considering its impact on staff. The growing international evidence base for the impact of psychological trauma and the need for service response was used in documents and interviews to justify TI approaches as a pragmatic solution to these concerns. However, the documents and interview participants justified the need for TI care by citing US and Welsh epidemiological studies on ACEs, DVA and patient accounts of being re-traumatized in services. We found no references to intervention studies that demonstrated effectiveness, cost-effectiveness, or acceptability of TI approaches in the UK.In the NHS Long Term Plan, TI care was also identified as a component of a new model of integrated care . A TI apInterviewees confirmed the piecemeal implementation of TI approaches in the UK and felt that a shared national vision would be beneficial. Participants agreed that the implementation of TI approaches varied across the UK, with Scotland having more strategic coordinated implementation . Another interviewee called for a united parliamentary leadership recognised by government and capable of influencing policy.At the wider context level, documents highlighted the value of political support capable of influencing practice nationally . Some inInadequate funding and commissioning of services was also described as a barrier, partly explaining regional differences in implementation of TI care  and wider context . The evidence-policy gap in TI care implementation can be explained by limited funding and evaluation capacity. Professionals had differing views on the future of TI approaches, however all agreed that without political backing at the government level, policy endorsement will not translate into meaningful implementation.Our finding of a marked difference in the landscape of TI approaches in healthcare systems between the devolved nations, with evidence of a unified national strategy emerging in Scotland and Wales and notably absent in England could have several explanations. These include smaller territories, populations, and governments in devolved nations, with clear buy-in from government-level leadership in Scotland. Our analysis highlighted the initiatives of local decision-makers in England who have developed and implemented TI approaches in their own organizations and local authorities. The absence of a national strategy in England contributed to the piecemeal implementation, with some regions leading the way, and others silent. As local TI leads have been left to ‘find their own way’, they may not always have been aware of similar initiatives in other organizations and regions. A proposed solution was bottom-up initiatives aiming to bring the local TI leads together to share resources and good practice. This finding indicates the need for a leader on TI approaches within or linked to the UK government who can support and strengthen the bottom-up initiatives.Another important finding is confirmation of the evidence-policy gap, with proposed reasons emerging in the analysis. Interview participants explained an absence of UK evidence on the effectiveness of TI approaches by a need for more interest from commissioners and funders, as well as a lack of physical and methodological capacity to evaluate system-level TI approaches. The former can be resolved through funding calls and comprehensive, transparent evaluation. The latter can be addressed by funding evaluations and raising awareness regarding available methodologies and tools for evaluating TI system change interventions , 33.Our finding of differing understanding of TI-approaches is in line with prior literature . We founThese misunderstandings can be explained by the conceptual mutability of a TI approach framework, lack of awareness about existing frameworks, and a need for coordinated working led by experts in TI approaches. The evidence of emerging working groups and UK-wide professional networks on TI care is promising. However, these initiatives require adequate funding and coordination to sustain momentum and develop further. These professional networks can become the platform for education about evidence-based TI approaches contributing to increasing value and reducing waste in research and implementation in this field.This study is methodologically robust with perspectives drawn from UK policy documents and professionals, who have direct experience of developing and implementing TI approaches. Data analysis occurred alongside data collection, to help refine and guide further data collection. The limitations include no professional informants from devolved nations and no participants at the level of UK government. Due to time and funding restrictions, we could only recruit 11 professionals and did not interview patients including those with lived experience of trauma. Our small sample size could have resulted in underrepresentation of views of some stakeholders. Future research should recruit informants from these groups to draw a complete picture of the landscape of TI approaches in the UK.Although health policies endorse implementation of TI approaches in the UK, they do not provide specific legislation, strategy or funding and are not supported by evidence of effectiveness. Understanding and implementation of TI approaches varies between regions, organizations, and individual professionals; however, all agree that if implemented at the system level and contextually tailored, TI approaches can mitigate varied problems withing NHS. The implementation of TI approaches in the UK is driven by local experts in TI care. A coordinated, more centralized strategy and enhanced provisioning for TI healthcare, including increased funding for evaluation and education through TI professional networks, can contribute towards evidence-informed policies and implementation of TI approaches in the UK.Additional file 1. Interview topic guide.Additional file 2. Analytical themes with subthemes and supporting quotes.


This issue of Cancer Biology & Medicine, a premium Chinese international scientific journal in this field, focuses on cooperation between Chinese and German cancer research, particularly between the Tianjin Medical University Cancer Institute & Hospital and the German Cancer Research Center (DKFZ) with its networking partners. This editorial provides a brief overview on DKFZ’s research strategy with a focus on how a national integrated cancer research and care ecosystem is evolving that benefits patients and society.1 , and malignant diseases are the leading cause of years of life lost (YLL) in this country (accounting for 35% of YLL)2. Cancer incidence in Germany is expected to grow by 20% within the next decade. For Europe, current estimates suggest an increase in the annual incidence of cancer, from 4.4 million in 2020 to 5.3 million in 2040 (+21%)3, and globally from 19 million people today to about 30 million in 2040 (+50%). Growing and aging societies, unhealthy lifestyles, and environmental factors are the causes of the increasing cancer burden. There are enormous disparities in incidence and treatment outcome between countries and, albeit to a lesser extent, within nations. Even in the most advanced health systems, including Germany, the 5-year cancer survival rate is only about 65%. 4.65 million people in Germany are living with or after a cancer diagnosis (2017)4 and are at risk of developing progressive disease, recurrence, or secondary cancers1. Many of them suffer from treatment-related morbidity, sequelae of treatment, or struggle with a reduced quality of life and disadvantages in their professional lives. These alarming global and national trends pose enormous medical, societal and economic challenges that require increased investment in cancer research and care.Although considerable progress has been made over the past few decades, cancer continues to be a major and growing health challenge worldwide. In Germany with its population of 83 million, 498,000 people are newly diagnosed with cancer every yearFigure 1)5:Major challenges need to be tackled to reduce the burden of cancer and improve cancer treatment. Fundamental discoveries in basic research are pushing the frontiers of knowledge towards a better understanding of cancer biology or for the basis of new technologies, diagnostics or medications. To achieve substantial clinical progress, these new discoveries must be applied through translational and clinical research in three main areas (7 (i.e. primary prevention). New risk factors and pathogenetic mechanisms leading to cancer need to be uncovered in order to further develop strategies counteracting the rising cancer incidence. Preventive measures offered to patients with or after cancer can reduce the risk of recurrence or unwarranted sequelae (i.e. tertiary prevention).Cancer prevention: up to 40% of cancer cases can be avoided by minimizing or eliminating known risk factorsEarly detection: new diagnostic methods and strategies need to be developed to recognize tumors at earlier, and thus potentially curable stages (i.e. secondary prevention). Such strategies can be biomarker-based  or image-based; often both modalities are necessary to obtain a lab-test warning sign, which is followed-up by imaging.Novel and improved clinical treatments: increasingly efficient and precise diagnostics and treatments are expected to further improve cancer cure rates. In addition, new treatments have the potential to transform advanced cancers from an acutely lethal disease into a chronic, manageable disease. Novel strategies of personalized precision oncology in an integrated multidisciplinary and participatory clinical setting promise higher anti-tumor efficacy, fewer side effects and an overall better quality of life for patients.Cancer is a uniqueIy heterogenous disease. Significant biological differences exist not only between tumor entities but equally between different patients, between different lesions of the same patient, within each individual lesion in a single patient and at different time points during disease progression and therapy. Therefore, all three broad anticancer research strategies increasingly require personalized approaches, are highly dependent on progress in data-science, and benefit from global cooperation.Finally, once new anti-cancer strategies have been developed in clinical or basic prevention research, society needs concepts for their efficient implementation in the health system to make these innovations widely available. In addition, the benefits of such innovations need to be constantly monitored and scrutinized through health economic and outcome research.8.The mission of the DKFZ is to make a significant contribution to decrease new cancer cases and cancer deaths – through transformative research, education of the next generation of leaders, and the transfer of results into the health system, society, and innovative products. DKFZ is primarily funded by the German Federal Ministry of Education and Research (BMBF) and the federal states in which the main center or its branches are located. DKFZ is a member of the Helmholtz Association, the largest German research organizationFigure 2)10. The DKFZ has particular strength in areas such as stem cell research; cancer genomics; cancer prevention; tumor immunology, inflammation and infection; imaging, radiooncology and image-guided therapies. As transformative innovations often originate at the interface between different areas, DKFZ promotes an increasing number of temporary or long-term ‘horizontal’ cross topic programs including single-cell approaches, digital oncology including AI-driven approaches, or disease-specific areas such as neuro-oncology or pediatric oncology. The DKFZ Cancer Research Academy hosts the International PhD Program, one of Europe’s largest graduate programs in the biomedical field, the International Postdoc Program and the International Clinician Scientist Program as well as specialized further activities, to educate, train and mentor the next generation of leaders for tomorrow’s needs. Several advisories help the DKFZ to formulate and continuously adapt its strategy, including scientific advisory boards, a patient advisory board, and a council assembling members from industry, politics, the public sphere and communication experts.Currently, more than 3,000 staff members, including more than 1,300 scientists, doctoral researchers and clinician scientists, are performing basic, preclinical and clinical translational research at the DKFZ. Additionally, more than 1,500 associated or guest scientists have access to research facilities at the center in Heidelberg or at branch locations. Research covers the entire translational continuum from discovery of fundamental causes of cancer to the development of disruptive, preventive, diagnostic and therapeutic approaches, and to innovative clinical studies/trials  in Germany in recent years. These include bilateral platforms such as the Helmholtz Institute for Translational Oncology Mainz (HI-TRON Mainz), and the DKFZ-Hector Cancer Institute in Mannheim as well as multi-site networks: The German Cancer Consortium (DKTK) and the National Center for Tumor Diseases (NCT) 10. The emerging cooperative network is increasingly comprehensive, although there are still open areas, particularly in northern Germany. With the National Decade against Cancer (2019–2028), the BMBF has launched a unique initiative with the aim to significantly advance cancer research in Germany, to create strong and sustainable structures necessary for future challenges and to ensure that all people in Germany have access to high-quality oncological care and to innovations in cancer research – regardless of where they live.Discovery and basic cancer research at universities and academic research centers in Germany have been at the international forefront for decades. For example, the discovery of Human Papillomaviruses (HPV) as a cause of cervical cancer by 2008 Nobel laureate Harald zur Hausen in the 1970s and early 80s laid the ground for later efforts outside of Germany in vaccine development and vaccination trials that have since provided clear evidence for the prevention of this disease. Another example is the theranostic agent 13.The DKTK was initiated by the BMBF in 2012 to provide significant contributions to bridging the gap  between basic cancer research and clinical cancer research/clinical prevention research using state-of-the-art translational and reverse translational approaches. For this, DKFZ, as the consortium’s core center, together with local university hospitals and further partners, has established translation hubs at eight sites  all of which are in cancer research and care. The aim is to further develop personalized oncology approaches and to improve early detection, diagnosis and therapy of cancer. Since its inception, DKTK has implemented long-term sustained programs, innovative research platforms, and established new full professorships and junior research groups at the eight partner sites. The DKTK network trains tomorrow’s leaders in translational cancer research, with a particular focus on clinician scientists and medical scientists. In addition, DKTK has established an intramural Joint Funding Program to launch annual competitive calls for site-overarching research activities. DKTK has evolved into a powerful innovation hub that actively integrates its bridging role in the translational research continuum, and provides a platform bringing together the best cancer researchers in the country. An impressive example of success is the very prominent role played by DKTK scientists in the development of new molecular classifications for brain tumors and pediatric cancers, which have been adopted by the WHO and are now globally used in clinical practiceThe next step within the translational research chain, namely innovative clinical translational cancer research, is still a critical bottleneck in Germany. To address this bottleneck, the NCT was founded to integrate patient-centered and translational-driven clinical cancer research with top-notch multidisciplinary cancer care. The NCT has the potential to overcome current shortcomings by creating powerful and interconnected clinical translational trial infrastructures and expertise.Deutsche Krebshilfe (foundation). The NCT integrates a number of central activities “under one roof” in a dedicated building, including the most important elements of multidisciplinary outpatient care and innovative clinical trial activities, particularly in the field of personalized oncology. In 2014, the BMBF decided to fund the existing NCT site in Heidelberg and a second NCT site in Dresden. These NCT sites have proved to be successful models for fostering innovative clinical cancer research, including clinical trials fueled by own preclinical pipelines. As a central element of the National Decade Against Cancer, the federal government therefore decided to expand the NCT by up to four new sites to create greater critical mass and comprehensiveness as well as to facilitate improved access to innovative clinical trials for patients nationwide. The UMCs of (i) Berlin (NCT Berlin), (ii) Cologne and Essen (NCT West), (iii) Tuebingen-Stuttgart with Ulm (NCT SouthWest), and (iv) Wuerzburg with Erlangen, Regensburg and Augsburg (NCT WERA) were selected by international peer review as candidates for the expanded NCT. They are currently working with the two existing NCTs and DKFZ on a joint strategy and implementation plan which will undergo peer-review before start of the program.In 2003, the DKFZ established a first NCT site in Heidelberg in collaboration with the University Hospital Heidelberg and the Deutsche Krebshilfe, will pilot an innovative concept of personalized cancer prevention. The concept is modeled on the experience of the Comprehensive Cancer Centers, which have shown that integration of research and multidisciplinary clinical services significantly promote translation, innovation and quality of care as well as of research. Located in a new dedicated building which will be constructed at the DKFZ Heidelberg campus, the NCPC will combine biological research on mechanisms of oncogenesis and biomarkers with translational, clinical and outcome prevention and early detection research. Consultation offices and laboratories for citizens and patients seeking advice or wishing to participate in interventional prevention trials will be next door to research laboratories. Prototypic evidence-based workflows, a digital prevention unit, database and biomaterial archives, and comprehensive education programs for the next generation of prevention experts will feed into large-scale nationwide outreach initiatives.The NCPC, which is currently being established in a strategic partnership between the DKFZ and the The DKFZ’s strategy for internationalization aims to create synergies by teaming up with strategically selected cancer and cancer research centers of excellence around the world that ideally complement the DKFZ cancer research program. In addition to a wide spectrum or multitude of international collaborative efforts among individual scientists and within international research networks, DKFZ supports several major international partnerships at a formalized institutional level. Examples are the long-lasting bi-national DKFZ-MOST (Ministry of Science and Technology) program between scientists from the DKFZ and academic institutions in Israel, the collaboration between DKFZ and INSERM with a joint research unit in Heidelberg, the sister institution relationship with the MD Anderson Cancer Center in Houston, or joint initiatives with the US National Cancer Institute NCI, the International Agency for Research and Cancer (IARC), Cancer Research UK, Tianjin Medical University Cancer Institute & Hospital, King Hussein Cancer Center in Jordan, University and Health Ministry of Namibia, or the emerging Athens Cancer Center. DKFZ is also a key partner in leading European consortia like Cancer Core Europe and Cancer Prevention Europe. Examples for joint international efforts in education and training are a joint research school with the Weizmann Institute of Science in Israel or the International Clinician and Medical Scientist exchange program with the Princess Margaret Cancer Center in Toronto.DKFZ, together with its partners at the UMCs and further institutions, works towards a coherent and high-performing cancer research landscape in Germany that spans the entire translational continuum and can effectively support excellent cancer researchers to generate impact for cancer patients and society. This long-term national investment into an integrated cancer research and care environment also serves as a powerful basis for close international partnerships to effectively fight cancer on a global scale.


Growing research on transgender youth is accounting for the variety of ways in which young people define their genders and sexualities. Because of this growing representation, more research is needed to understand how intersectional identities and stigma affect risk for HIV acquisition along the HIV care continuum and engagement in mental and physical health care. Little is known about accessibility to HIV-related prevention services of nonbinary and transmasculine youth, and further understanding of the impacts on transfeminine people—those who have historically faced the highest prevalence of HIV positivity—is crucial.The overarching aims of the Trans Youth of Color Study are to conduct longitudinal research with a cohort of transgender minority youth (TGMY), explore factors that aid in the prevention of new HIV infection and transmission, and reduce HIV- and AIDS-related disparities by focusing on successful engagement in care. Findings from this research will be used to inform the development of new interventions designed to engage TGMY in the HIV prevention and care continua.Longitudinal research (baseline and follow-up assessments every 6 months for 3 waves of data collection) followed a cohort (N=108) of transgender youth of color recruited in Los Angeles, California, United States. Participants were recruited using multiple community-informed strategies, such as from local venues, social media, and participant referral. In addition to self-report surveys, urine was collected to assess recent use of illicit drugs, and blood, rectal, and throat swabs were collected to test for current sexually transmitted infection and HIV infection. Additional blood and plasma samples  were collected and stored for future research.Participants in the Trans Youth of Color Study were recruited between May 25, 2018, and December 7, 2018. Baseline and longitudinal data are being analyzed as of August 2022.The findings from this research will inform adaptations to existing evidence-based HIV prevention interventions and help to guide new interventions designed to engage TGMY, especially those who are Black, Indigenous, or people of color, in the HIV prevention and care continua.DERR1-10.2196/39207 The lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA) community comprises an incredibly diverse community of people from many races, ethnicities, religions, and socioeconomic backgrounds who also share a wide variety of sexual identity– and gender-related experiences. Specifically, transgender individuals seem to experience unique and complex patterns of gender-related experiences throughout the life course ,2.Some transgender people may identify with a gender that differs from the sex that they were assigned at birth, and others may identify as being beyond the gender binary, such as nonbinary, genderqueer, gender nonconforming, agender, or other combinations of identities that reflect their personal experience .Data on the prevalence of nonbinary individuals in the transgender community varies across studies, from 52% of 14,320 transgender survey respondents in the United Kingdom to 35% of 27,715 transgender survey respondents in the United States . HoweverRacial and ethnic minorities who also identify as transgender and nonbinary remain particularly underexplored, and this is evident in the lack of available resources designed to help these individuals achieve a higher quality of life ,9. SpeciBecause of their experiences with multiple identities—for example, gender identity, sexual identity, and racial and ethnic identity—TGMY face more complex patterns of intersectionality, which may lead to greater experience of various forms of stigma . These experiences, in turn, systemically place stress on TGMY, placing them at higher risk for mental health conditions ; substance use; and sexual health risk, including HIV transmission and acquisition ,9,13-17.Regarding sexual health, data show that 14% of transgender women and 3% of transgender men live with HIV compared with <0.5% of the general American population ,19; 36% Because of this increased risk for violence and victimization and the necessity to enhance our contextual understanding of multiple forms of stigma faced by TGMY in relation to their increased risk for HIV , we applThe Trans Youth of Color (TRUTH) Study aimed to expand the research of our parent grant, the Healthy Young Men’s (HYM) Cohort Study (U01DA036926). As a supplement to this parent project, the TRUTH Study proposed to recruit a sample of 125 African American and Latinx young transgender women and collect 2 waves of data. Herein, we highlight the process of expanding our eligibility criteria and aims through iterative community-informed research. The overarching aim of the project is to better understand the unique challenges and opportunities regarding engaging these young transgender people in primary care and the HIV prevention care continuum.The specific aims are as follows:Aim 1: Conduct qualitative research (focus groups and one-on-one interviews) with transgender youth of color to better understand what linkage, engagement, retention to primary health, pre-exposure prophylaxis (PrEP), and antiretroviral therapy care and adherence mean to them to identify potential strategies for intervention.Aim 2: Characterize transgender youth of color on measures of (1) alcohol and illicit drug use; (2) sexual risk behaviors, including sex work; (3) use of HIV testing and prevention services; (4) incidence of HIV and sexually transmitted infections (STIs); (5) use of hormone therapy (physician prescribed or obtained in other ways); (6) insurance status and access to health care services, including primary care and HIV and AIDS treatment services; (7) engagement in, and use of, health care and HIV and AIDS treatment services; and (8) use of PrEP. We harmonized data collection with the HYM Cohort Study for some measures and administered additional transgender individual–specific measures. This will allow us to compare the responses of transgender youth of color with those of YMSM.Aim 3: Identify transgender individual–specific barriers and facilitators to engagement in primary health and HIV-related care, including transgender individuals’ coping and adjustment strategies, gender identity, gender-related stigma, self-esteem, empowerment, lack of culturally competent providers, and use of services for transgender individuals.Our HYM Cohort Study found that YMSM of color experience the highest rates of risk factors as framed by syndemic theory, which posits that accumulations of health problems can potentially compound and amplify the negative impact of other health problems -26. For The proposed analyses will examine syndemic risk factors as predictors of HIV infection among transgender youth of color as well as engagement in care, including HIV prevention, testing, and treatment. The TRUTH Study will focus on areas affecting the health and wellness of transgender youth, such as engagement and retention to primary health care, access to PrEP and antiretroviral therapy, alcohol and substance use, and sexual health behaviors. Through understanding the impacts of intersectional stigma on this cohort, we also hope to observe possible facilitators to care and wellness, such as coping and adjustment, self-esteem, community belongingness, and positive transgender identity.The purpose of this paper is to describe the protocol for the TRUTH Study: the community-informed method of study design, research methods, and longitudinal recruitment and retention.As a supplemental study to our longitudinal HYM Cohort Study, which involves following a cohort of 450 Black or African American, Latinx, and multiracial YMSM in Los Angeles , the TRUwhere they are at, meaning conducting field-based, face-to-face consent visits at locations most convenient to participants. All participants provided written informed consent after reviewing consent documents with research field staff. Participants were provided with infographics explaining the consent process (assent process for participants aged <18 years) and the process of participating in the project.As a community-oriented research project, an important component of the informed consent process was meeting participants All participants were identified, screened for eligibility, and, if eligible, invited to participate in the study, as described in the following sections. All participants provided written informed consent during a face-to-face consenting visit. A certificate of confidentiality was obtained from the National Institute on Drug Abuse, and a waiver of parental consent was obtained for participants aged 16 to 17 years.Foundational research with the HYM Cohort Study informed the creation and implementation of the TRUTH Study design . OriginaModified self-report surveys using scales from the HYM Cohort Study were used to assess social, behavioral, and health concerns specific to TGMY and their intersectional lived experiences. In addition to these measures, data collection also included biological markers for recent illicit substance use via urine analysis, rapid HIV testing, and STI testing. Following our protocol for the original HYM Cohort Study, we collected additional samples of blood  and a rectal swab to be stored in a biorepository for future analysis. These samples were collected once during the project . Care waAlthough we had initially proposed to recruit young Black or African American or Latinx transgender women, our community advisory board (CAB), youth CAB (YCAB), and scientific advisory group strongly encouraged us to broaden our recruitment strategy to include transgender women, transgender men, and gender nonbinary youth . They also advised us to expand our eligibility to include all Black, Indigenous, and other youth of color. Although much previous research has focused on transgender women and their risk for HIV acquisition because they experience intersectional forms of discrimination, there is growing understanding that research needs to be conducted to understand HIV and STI risk among all transgender people experiencing these overlapping stigmas.Youth were eligible if they (1) were aged 16 to 24 years; (2) self-identified as transgender, gender nonconforming, or nonbinary; (3) spoke English (because interviews were conducted in English); (4) identified as Black or African American, Latinx, Asian or Pacific Islander, Indigenous, or multiracial; and (5) lived in Los Angeles. Ultimately, we recruited 108 TGMY between May 25, 2018, and December 7, 2018.On the basis of the lessons learned during recruitment for the HYM Cohort Study, the research staff determined that a wide variety of recruitment techniques would be necessary to reach TGMY of color in the Los Angeles area. Conversations with our community partners, including members of our provider CAB and YCAB as well as service providers at local clinics, informed our methods for connecting with potential participants. In total, 281 potential participants were screened for eligibility, of whom 108 (38.4%) consented to participate in the project and completed a baseline assessment.One of the difficulties that arose when recruiting TGMY was that it was impossible to know someone’s gender without asking them. At LGBTQIA youth events, any youth may have met the eligibility criteria; therefore, many participants at these events needed to be screened so that we could know more about their identity and experiences. Although there are spaces dedicated to the LGBTQIA community in Los Angeles, the number of spaces intended exclusively for transgender youth is limited. Although LGBTQIA youth events were identified and attended by study staff members, venue-based outreach programs conducted at several of these events and clinics across our 6-month recruitment timeline only accounted for 19.4% (21/108) of the recruited participants.Because of the challenges associated with the in-person recruitment of TGMY, as well as the lessons learned from the recruitment of the HYM Cohort Study, our community partners and research team understood that web-based advertising through social media might be an effective method of recruitment. We used paid advertising with images of gender-diverse youth alongside transgender imagery (such as the transgender pride flag and transgender symbol) to recruit participants on Facebook and Instagram. These sites were identified by our YCAB as places that TGMY frequent and feel most comfortable fully expressing themselves. Participants filled out a screener with their name, demographic information, and contact information. If they met the eligibility criteria for the TRUTH Study, a member of the research field team contacted them to verify their eligibility and invite them to participate in the project. This recruitment strategy accounted for 48.1% (52/108) of the total enrolled participants.Participant referrals were recommended by both our CAB and YCAB as an effective strategy for connecting with TGMY, and 24.1% (26/108) of the enrolled participants were recruited using this respondent-driven sampling design. YCAB members and study participants could earn a cash incentive of US $10 for each eligible participant they referred, for up to 5 participants, and US $50 in incentives.Community partnerships were fostered by the TRUTH Study field team through outreach to LGBTQIA-specific organizations across the Los Angeles area. Specialty clinics in the Los Angeles area served as eligibility screening locations. Several high school and college Genders and Sexualities Alliances were identified, and they expressed interest in disseminating recruitment materials. Recruitment scripts were sent via email to college email listserves as well as community organizations. Although 79 participants were recruited using this community venue–based sampling, only 21 (27%) enrolled into the project. The TRUTH Study also ran advertisements via Craigslist to reach potential participants. Although previous outreach through sites that post sex work–related advertisements has been demonstrated to be successful, the passing of the Stop Enabling Sex Traffickers Act and the Fight Online Sex Trafficking Act and removal of these advertisements from Craigslist and other sites have significantly decreased the activity of these sites. Longitudinal research conducted with participants experiencing intersecting, stigmatized identities requires specific thoughtfulness and strategies. The TRUTH Study used techniques previously demonstrated to be effective in the HYM Cohort Study for participant tracking and retention . This prCommunity-informed research was essential to building a project that facilitated a safe and inclusive environment for a population with various gender experiences. These steps were important for collecting sensitive information. This involved not only meeting with community members and forming working advisory boards but also hiring research teams with a variety of experiences and identities that represented the population under study. Representation within our field and research staff was necessary to demonstrate our commitment to well-informed practices and to allow our research participants to see themselves reflected within the project team.A key component of the retention strategy for the TRUTH Study was to pair a field team member with each participant throughout their duration in the project. From the initial eligibility confirmation telephone call to consent visits, study visits, and STI and HIV testing, participants work with the same field team member. This allows the participant to build trust and rapport in the project and ensures that communication about the project is from a single, trusted source. Staff changes may occur; therefore, specific protocols were established to ease the transition. New staff members are introduced by the existing researcher either via the participant’s preferred method of communication  or, preferably, during an in-person visit. Consistently updated participant records with contact information, preferred pronouns, insurance status, and day-to-day information help to facilitate these changes as well as eliminate the need for participants to share this information repeatedly with different study staff members.In addition, the protocol involves obtaining consent to gather multiple forms of contact information. Participants are asked to provide as much of their information as they feel comfortable sharing, including their mobile phone numbers, email addresses, and social media handles, as well as address information, relevant school or work information, and a trusted family or friend contact. Contact information often shifts; therefore, participants are incentivized US $10 to update their contact information with their interviewer, reaching out proactively in the event of a telephone number or address change.Incentivized monthly check-ins with study staff are built into the study protocol to encourage retention in the study. Between each wave, participants can earn money each month for responding to a check-in inquiry from their assigned field team member. Monthly check-ins are an opportunity for field team members to verify that the contact information is still active and to ask whether participants need referrals to any resources. A rich database of LGBTQIA-specific resources has been created by the field team, and it is available to participants on our study website as well as in an easily distributed PDF file. Participants also use these check-ins as a time to share life updates ranging from difficulties to excitement, such as milestones related to their transition (hormone access or surgery), changes in their access to medical care (through insurance or housing status), or achievements (school graduations and new jobs). If a participant fails to contact their researcher for 2 consecutive check-ins, the provided tracking information and public records  are used to attempt to reconnect.met where they were at. This required the study team to be adaptive and responsive to participants’ needs to reschedule after missing a study visit, extend hours to accommodate participant schedules, and allow for participants to show up late for visits or even walk in for an unscheduled visit. Part of linking 1 research staff member to a participant—for continuity and stability—involved the use of unique mobile phones and numbers for each study staff member. Bidirectional communication between staff members and participants allowed for telephone calls, SMS text messages, emails, and other social media messaging  in a more fluid fashion. As mentioned earlier, participants were incentivized to keep their contact information up to date with their assigned research staff member.Working with multiply marginalized participants highlighted many unique challenges. Our participants needed to be figuratively In addition, all staff members on the project were trained in gender affirmation and competency. All research assistants and coordinators were educated to not assume participants’ pronouns or identities, research nurses conducting specimen testing were instructed on using chosen names that may differ from those in hospital records, and policies governing other hospital personnel who interacted with participants were updated to affirm transgender and nonbinary patients more accurately within their systems.CABs and YCABs play a critical role in supporting community-partnered and community-informed research. When working with research populations who have been historically denied agency in research narratives about themselves, it is essential to demonstrate accountability and to include community partners in meaningful ways.Our CAB was formed by inviting members of the HYM Cohort Study CAB and members of service providers and organizations serving gender-diverse populations to an open house to introduce the study. After providing initial feedback, the members were invited back to future meetings to provide guidance and input on the study. CAB members included service providers in the local community, policy makers who focus on transgender issues, STI and HIV test counselors, and medical leads from clinics specializing in transgender individual–related health care. The CAB met bimonthly leading up to the launch of the study and quarterly thereafter.YCAB members were gender-expansive youth of color recruited from the original HYM Cohort Study as well as youth advocates recommended by existing participants. Study coordinators for the TRUTH Study worked with research assistants on the HYM Cohort Study to identify participants who identified as transgender or nonbinary and invited them to join the YCAB for the TRUTH Study. These YCAB members were also allowed to refer additional members to the YCAB from their social networks. The YCAB met monthly in preparation for the study launch and quarterly during data collection. Before the onset of the COVID-19 pandemic, meetings were held in person, where food as well as stipends worth US $50 were provided to attendees. Meetings moved to the web via videoconferencing software after pandemic lockdown restrictions began. Agendas for the 2 advisory boards often involved study updates, data sharing, data interpretation, and new measure creation. The advisory boards provided information about what data to collect and about the data needs of community organizations. The YCAB provided feedback on proposed new measures and piloted the measures before study launch. Members of the YCAB gave input on which questions could be eliminated to reduce the overall survey length and highlighted and provided suggestions on language that should be updated before being administered to participants.Our CAB and YCAB were created to provide support and feedback for all components of the study, from eligibility criteria through participant recruitment, including the creation and interpretation of survey measures. It is because of the guidance of the YCAB and CAB that we expanded our eligibility for the project and were able to capture valuable information about TGMY of color, particularly nonbinary and transmasculine youth for whom there is little existing HIV-related research.The TRUTH Study measures were adapted from the protocol previously used to conduct the HYM Cohort Study with YMSM of color in the Los Angeles area . The HYMTRUTH Study participants completed 3 study visits, with consecutive visits spaced 6 months apart. Study visits consisted of self-report survey measures, urine collection for substance screening, biorepository specimen collection, and STI and HIV testing. Consistent with the HYM Cohort Study, survey measures were administered by research assistants, with the more sensitive topics being self-administered using a web-based survey ; the goal was to provide additional confidentiality and to encourage honesty in responses ,32. The Survey measures to obtain demographic information were modeled from the HYM Cohort Study protocol. Information collected included age, language spoken inside and outside the home, race and ethnicity, religion, residential stability, educational history and current employment status, access to food and food security, incarceration, and foster care experience . UpdatesSubstance use within the TRUTH Study was measured using the same scales and assessments as the HYM Cohort Study protocol . TRUTH SThe point-of-care biometric urinalysis test administered at survey visits used the Integrated E-Z Split Key Cup II-10 Panel (Alere Toxicology) that measures metabolites of amphetamines, methamphetamines, benzodiazepines, cocaine, ecstasy, phencyclidine, methadone, fentanyl, opiates, and marijuana. This test can detect marijuana use for up to 30 days and other drugs from 1 to 4 days after use ,35. PartAlcohol and marijuana misuse was assessed using standardized measures, including the Alcohol Use Disorders Identification Test ,37, whicpenis and vagina, and these words were populated into the survey module. This functioned to affirm participants’ own language for their bodies and the bodies of their sexual partners, as well as to avoid distress related to dysphoria around gendered words for body parts. Additional types of partners and types of sexual interactions also needed to be added to the questionnaires. Participants preferred to be able to choose their partner’s specific gender (such as genderqueer or trans femme) as opposed to choosing from male, female, or intersex. The specific questions used to assess sexual activity and partners are outlined in the HYM Cohort Study protocol [Survey measures looking at sexual activity, number and genders of sexual partners, and use of protective factors such as PrEP and condoms were adapted from the HYM Cohort Study protocol scales. The TRUTH Study team worked to generate affirming methods of measuring sexual activity for transgender and nonbinary participants because the HYM Cohort Study scales were adapted from the EXPLORE study specifically for YMSM ,40. As lprotocol .HIV and PrEP knowledge was assessed in the self-administered STI and HIV testing section of the survey. HIV knowledge was assessed using a 2-part question from Hou et al  as well Participants self-reported their lifetime and recent history of HIV and STI testing and HIV status. This section of the survey asked about testing behaviors, HIV and STI testing results, access to treatment, as well as any hesitance around HIV and STI testing. Condom use across partners as well as condom self-efficacy were also measured . ParticiNeisseria gonorrheae and Chlamydia trachomatis nucleic acid amplification. Syphilis testing was conducted using whole blood samples collected via venipuncture using rapid plasma regain and treponemal antibody testing. All research staff and nursing staff members associated with the project underwent an LGBTQIA health care training to be able to provide compassionate care.Research staff members administered rapid HIV testing and a complete STI testing panel to participants at each study visit. HIV and STI testing protocols followed the methods used for the HYM Cohort Study , with thParticipants with positive test results were connected to members of the research staff certified in HIV and STI test counseling and then referred to an appropriate community clinical partner for treatment. Research staff members were available to participants via SMS text message, telephone, and email to assist with accessing care.Overall health, well-being, and access to health care were measured using scales adapted from those used with the HYM Cohort Study . QuestioAlthough we hoped to capture the mental well-being of the TRUTH Study cohort using clinical assessments, we also included measures that were hypothesized to be protective factors against negative mental health outcomes. The protective factors included optimism, resilience, and mindfulness. Assessments of these factors were adapted from the HYM Cohort Study protocol with attention to possible life experiences specific to TGMY .Depression, anxiety, and somatization were measured using the 18-item Brief Symptom Inventory, which asks participants to rate, using a 5-point scale, how extensively a symptom or trait has bothered them in the last week . LifetimChildhood abuse and trauma experiences were measured by the Bernstein Childhood Trauma Questionnaire . IPV wasA 43-item stressful life events scale was adapted from the HYM Cohort Study  and updaspecial person (such as partner or close friend) was measured using a 12-item scale [Perception of general social support among family, friends, and a em scale . Social em scale .Perception of stigma against transgender and gender nonbinary people was measured using a 6-item scale asking participants to rank how they perceive other people’s reactions to transgender people. This scale has been adapted for transgender and gender minority populations .Participants complete a self-administered 54-item scale regarding the interactions they have had of lifetime and recent racism . During Positive sense of self and perceived belongingness within the transgender community were also assessed. Positive transgender identity was measured using a 24-item scale adapted from a scale previously used to measure positive LGBTQIA identity and community belongingness. Questions such as “I embrace my identity” and “I feel a connection to the community” were asked on a 5-point scale. The measure can be scaled to measure different factors associated with positive self-identity, such as authenticity, relationships, commitment to social justice, and self-acceptance and awareness .out to others about their gender identity, several questions were used to assess the age at which the participants first identified as transgender or felt that they had a gender identity that did not align with the sex assigned to them at birth, when they first told someone about their gender, and how often they share about their gender with others. Participants were asked about their pronouns and possible shifts in pronoun use; appropriate pronoun use by friends, family, coworkers, and community members; and how often they had been asked about their pronouns. They were also asked about experiences of gender affirmation and how they felt about achieving affirmation through clothing, social cues, medical procedures, and spirituality.In collaboration with our YCAB and CAB members, we convened regular meetings to determine what research questions would be most beneficial and influential to the community. Feedback from our meetings led to the creation of several new scales. To capture the differing experiences of comfort being Our YCAB encouraged us to use open-ended questions at the end of the second and third waves of data collection. Because of the unique experiences of TGMY of color and their intersectional experiences, the YCAB members believed that open-ended questions would allow for more expression and nuance from participants. In collaboration with the YCAB, the research team developed the following open-ended questions:How has the TGMY community empowered you?What makes you euphoric in your gender?TRUTH Study participants consented to providing biological samples  for our biorepository during one of their study visits. Samples were stored in a freezer maintained at a temperature of –80 °F (–62 °C) for future use.The TRUTH Study cohort was recruited between May 25, 2018, and December 7, 2018. Three waves of data collection occurred between May 25, 2018, and April 9, 2020. Baseline data were presented at the Center for HIV Identification, Prevention, and Treatment Services annual conference in January 2020. Baseline and longitudinal data are being analyzed as of August 2022. In July 2020, we received additional funding from the National Institutes of Health (5U01DA036926) to conduct additional waves of data collection across 5 more years with our existing cohort and to recruit 250 additional TGMY of color to participate. The study team leadership met in September 2022 to review the performance of the measures—especially those measures that were adapted or newly created—and to make recommendations for future measures to include in future waves. The team decided to retain new or adapted measures for at least one additional wave to assess performance over time.This paper describes the addition of a gender-diverse sample complementary to the sample in the HYM Cohort Study . We discTransgender and gender minority youth, particularly those of color, exist at the intersection of multiple complex identities and experiences. From public health reform and social justice advocacy to youth empowerment and positive self-identity, it is imperative to consider the strategies needed to address disparities in health care and other social determinants that place TGMY of color at risk for negative health outcomes. Research conducted with TGMY of color needs to acknowledge the historical hierarchical structures that exist to gatekeep individuals from appropriate care and empowerment and work to heal this through community-informed research practices created by, and for, transgender people.Although our sample experiences a host of systemic barriers, through the guidance of our advisory boards and by engaging in appropriate gender affirmation trainings we were able to create a space that allowed for a retention rate of 97.2% (105/108) across the first 3 waves of data collection. Our advisory boards provided instrumental feedback on where to recruit participants, what data to collect, and how to assess constructs in the survey. Our approach of connecting participants to a single staff member for communication and study visits provided stability across the life of the study. Staff members were provided with mobile phones, which allowed them to have a single source by which participants could contact them to provide updates and stay connected between study visits. We believe that these strategies combined to help us achieve a high level of retention.Researchers looking to engage participants with multiply marginalized identities should strive to ensure that their research procedures do not accidentally further victimize the participants. Making sure that the measures are inclusive and nonjudgmental can reduce stress during the survey process. Any person who may interact with participants during the study process (including those outside the study team) should be trained to understand how the language they use and the tasks they perform may affect participants. Only then can we begin to build trust between research and multiply marginalized communities.


The goal of clinical and translational science (CTS) is to fill gaps in medical knowledge toward improving human health. However, one of our most pressing challenges does not reside within the biological map we navigate to find sustainable cures but rather the moral compass to recognize and overcome racial and ethnic injustices that continue to influence our society and hinder diverse research rigor. The Georgetown-Howard Universities Center for Clinical and Translational Science includes an inter-institutional TL1-funded training program for predoctoral/postdoctoral trainees in Translational Biomedical Science (TBS).In the fall of 2020, the TBS program responded to the national social justice crisis by incorporating a curriculum focused on structural racism in biomedical research. Educational platforms, including movie reviews, Journal Clubs, and other workshops, were threaded throughout the curriculum by ensuring safe spaces to discuss racial and ethnic injustices and providing trainees with practical steps to recognize, approach, and respond to these harmful biases in the CTS. Workshops also focused on why individuals underrepresented in science are vital for addressing and closing gaps in CTS.Paring analysis using REDCap software de-identified participants after invitations were sent and collected in the system to maintain anonymity for pre- and post-analysis. The Likert scale evaluated respondents’ understanding of diverse scientific circumstances. The pre/Fall and post/Spring surveys suggested this curriculum was successful at raising institutional awareness of racial and ethnic biases. Evaluating the effectiveness of our program with other training Clinical and Translational Science Awards (CTSA) consortiums will strengthen both the academic and professional TBS programs. The death of George Floyd in the summer of 2020 instigated a wake-up call heard worldwide that racism continues to plague society. Introspection ensued, including within the medical educator community. Directors of training programs revisited their approach to addressing racism and prejudice in biomedical research. Required training in human subject research includes “The Tuskegee Study of Untreated Syphilis in the Negro Male” as the iconic exemplar of abuse of Blacks by the medical profession . HoweverShortly after the death of George Floyd, Dr. Francis Collins, then Director of the NIH, apologized for longstanding and continuing structural racism in the biomedical sciences. He acknowledged that significant changes at NIH were necessary to effectively address structural racism in biomedical research. Despite all previous efforts to raise awareness of the importance of diversity and inclusivity, the numbers continue to reflect a large discrepancy between Whites and minorities in grant applications, funding rates, and numbers of postdoctoral fellows, staff, and senior scientists . To thisSeveral NIH institute directors followed Dr. Collins’ lead and developed committees to address structural racism. On February 26, 2021, a special meeting of the advisory committee to the director announced the establishment of the UNITE initiative  to bring together all the NIH Institutes and Centers to focus on addressing racism and discrimination in science and advancing the goal of diversity and inclusion throughout the biomedical community through five separate committees including U: Understanding stakeholder experiences through listening and learning; N: New research on health disparities, minority health, and health equity; I: Improving the NIH culture and structure for equity, inclusion, and excellence; T: Transparency, communication, and accountability with our internal and external stakeholders; and E: Extramural research ecosystem: changing policy, culture, and structure to promote workforce diversity .On March 1, 2021, Dr. Joni L. Rutter, then Acting Director of the NCATS, voiced a commitment to join Dr. Collins and “stand alongside the rest of NIH in its commitment to end structural racism in biomedical research” and join the UNITE initiative. Dr. Rutter goes on to say, “At NCATS, we have committed ourselves — in words and in actions — to support diversity, equity and inclusion and to address the scientific, operational, organizational and cultural problems that have contributed to racial inequities across the biomedical research enterprise” .The Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) community was also shocked by the murder of George Floyd. In direct response to those events, our NCATS-supported TBS training program for predoctoral students and postdoctoral fellows tasked a Program Committee on July 13, 2020, to incorporate a focus on systemic racism in biomedical research throughout the TBS curriculum. Members included the co-directors of the TBS program (DLL and KS), a former TL1 trainee (MDG), the Associate Director (EAB), a biomedical scientist who studies the impact of racism on health (KAB), basic scientists , clinical research investigators , and a bioethicist educator (RCS). This paper describes our experience implementing a pilot program to raise awareness of systemic and structural racism in biomedical research in an early career clinical and translational science (CTS) cohort.The curriculum was integrated into the Translational Biomedical Science (TBS) program between September 2020 and August 2021. The curriculum included movie and Journal Clubs, workshops in the Responsible Conduct of Research (RCR), and Visiting Professor Series throughout the academic year. Additional resources beyond the program’s workshops were provided. The homework included the online Harvard Implicit Association Test, which measures attitudes and beliefs that people may be unwilling or unable to report . TraineeSomething the Lord Made, The Immortal Life of Henrietta Lacks, and Miss Evers’ Boys  presented  and Howard University (HU) TBS participants is as follows: ten predoctoral students which consisted of 8 GU and 2 HU, 5 female and 5 male, 8 White and 2 African American, and 1 Hispanic and 9 Non-Hispanic scholars. Furthermore, the program had two GU postdoctoral fellows, 1 female and 1 male, 1 Withheld and 1 White, respectively, and 2 Non-Hispanic scholars.S1: I know what to say when interacting with people from different cultures. Refer to . Refer to Fig. S8: I am aware of the specific obstacles that many individuals underrepresented in biomedical sciences have encountered in their careers. Refer to Fig. S9: I am confident in my ability to identify individuals from groups underrepresented in the biomedical sciences. Refer to Fig. S10: Scientists from different cultures improve biomedical research. Refer to Fig. S11: Do you seek out the perspectives from people of different cultures in your research? Refer to Fig. Statements 1 and 2 addressed the comfort level trainees have interacting with individuals from different cultures. The majority of the trainees expressed positive responses (agree or strongly agree) with knowing what to say to people from different cultures; none disagreed , especially considering minimal mentorship from Blalock. They voiced frustration regarding Blalock’s refusal to support Mr. Thomas’ pursuit of a medical degree and professional advancement, despite Thomas’ qualification for such. They also expressed anger over Mr. Thomas’ classification as a janitor, versus Surgical Assistant to Dr. Blalock, and the absence of support of Mr. Thomas from the larger medical community. Blalock’s lack of mentorship for Mr. Thomas evoked several reactions from the trainees ranging from resignation to sadness to resentment.Statements 3 through 7 centered on bias recognition. While 80% of the trainees at the beginning of the program answered affirmatively that they could recognize unconscious bias and stereotypes in general Fig. C as wellDiversity, Equity, Inclusion and Implicit Bias  community. Several events have focused on diversity and inclusion Table . It is nIn a recent publication, former NIH director Francis Collins et al.  refer brThe evaluation of our program consisted of a 5.0 Likert scale analysis, which measures perceptions, values, and behavioral changes. However, the scale is not able to capture the richness of our discussions. Another limitation was the small sample size of our TL-1 cohort, which prevented robust statistical analyses and conclusions. Furthermore, our cohort may not be representative of prior and future trainees. We also are not evaluating the lasting impact on future trainee motivation and behavior. Thus, it would be interesting to assess the effectiveness of this educational initiative across diverse training programs in CTS over time and during different social periods. Another limitation is the lack of a “control” group, that is, a similar cohort training in CTS that is not exposed to this educational initiative. This is especially relevant since the TBS program is intentionally diverse in terms of fields of CTS, levels of training, institutions, and departments. Thus, weekly exposure to a diverse cohort of peers and near peers may also have impacted the pre- and post-survey responses.The major aspect of our pilot curriculum addressing systemic and structural racism was threading this theme throughout the year-long TBS program. Pre- and post-surveys of our TL1 cohort suggest this integration is an effective educational strategy for early career trainees in CTS. Although the surveys and participation for this pilot program were optional, we had 100% participation. Unlike a stand-alone workshop, this integration enabled us to cover more material on how racism contributes to the pathophysiology of disease, adversely affecting health care, health policy, health outcomes as well as the biomedical scientist while at the same time, providing training in critical competencies of CTS. Incorporating this theme into the curriculum enabled reiteration of themes, a known strategy for reinforcing educational concepts. Furthermore, our emphasis on establishing a safe environment for sharing thoughts and experiences about racial and ethnic challenges, including those from individuals whose ethnicity is underrepresented in science, facilitated the experience. Empowering the trainees to lead and galvanize group conversations around cultural and racial disparities in human health, access to, and use of healthcare services was also instrumental to increasing trainee awareness of these disparities. This enhanced recognition of the negative impact of systemic and structural racism will likely shape their outlook as they pursue their careers. These workshops not only broadened their awareness of racial biases, it also equipped the trainees to approach, support, and advance the conversation to ultimately combat racial and ethnic inequalities in human health and break down systemic institutional barriers. Our program supports the goal of NCATS and other stakeholders to reduce health disparities in CTS. It will be valuable to assess and compare the effectiveness of our program with similar approaches taken by other training programs across the CTSA consortium.