Pipeline Partners: Developing Training and Recruitment Programs for the Oncology Workforce

The Gastroenterology Core Curriculum, Third Edition

In 2006, the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community.1-5 Much of the funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research.”4 Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific key functions to advance the consortium goals. These required key functions are (1) expertise in Biomedical Informatics, (2) a program in Research Education, Training, and Career Development, (3) a program in Community Engagement and Research, (4) an Evaluation component, (5) Pilot Projects in Translational and Clinical Studies, and (6) a Regulatory Knowledge and Support component. Optional CTSA key functions include (1) support of the Development of Novel Clinical and Translational Methodologies, (2) components or cores to support Research Design, Epidemiology, Biostatistics, and Clinical Research Ethics, (3) Clinical Research Resources and Facilities, and (4) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these key functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution. After receiving a CTSA award in 2007, the University of Michigan (U-M) conducted a strategic assessment of the translational research enterprise through over 100 extensive interviews of faculty and staff providing the infrastructure for translational research, as well as the investigators conducting that research. The institution then conducted a survey of research team members involved in human subject research to identify and describe the current challenges facing translational research—specifically, the administrative processes associated with its planning and execution. In addition to identifying the issues, the team rated the technical and cultural/political levels of difficulty in implementing the solutions, as well as the corresponding impact each solution would potentially bring. These were then graphically mapped on a three-dimensional bubble chart (Figure 1). This stratification assisted in the planning, design, and prioritization of solutions, offering insights that guide the refinement efforts of a clinical research enterprise’s organization, business, and information technology (IT) processes. Bubble chart of implementation complexity. The chart orders tasks by level of execution difficulty—both technical and fiscal execution difficulty—as well as organizational and cultural complexity. The bubble size represents impact such that the bigger the bubble, the bigger the impact the change will have on improving translational research. For instance, enhancing study coordinator programs is relatively easy both technically and from an institutional buy-in perspective and was judged to provide a relatively large impact. Creating integrated informational technology systems involves significant investment, is more technically complex, requiring buy-in from multiple parties within the institution but is pivotal for achieving the goal of doing more effective translational research. The visual mapping provides context and definition to the challenge of enhancing the efficiency and effectiveness of translational research not only at the University of Michigan but all of the CTSAs. IT = Information Technology, CTSU = Clinical Trials Support Unit. Eight areas were identified as solution categories. The topics include organizational, procedural, financial, structural, educational, technological, and cultural elements. Transform and expedite study and contract approval process. The contract approval process, especially in regard to industry protocols, was recognized by the faculty as their number one area of discontent. The approval process was not clear to research team members and varied widely by unit and department as well as by type of sponsor. Educational and process improvement opportunities were identified. To address these issues, U-M has set a goal to expedite study approval process so that the contract and regulatory processes are executed within 60 days from submission for all studies and 45 days for industry-sponsored studies. The primary strategy to accomplish this aggressive goal was to create a team consisting of members of the units involved and to reengineer processes and conduct a demonstration project for feasibility within 1 year. Secondary strategies included increasing the transparency of contracting within the system to allow better tracking of proposals by the faculty and study teams, publishing desirable contract terms on a website for faculty and staff to use as protocols are developed, and to create an interactive, web-based research road map to guide faculty and staff through the necessary administrative steps to conduct translational research.6 Establish a clinical research support unit with best practice tools. The current translational research enterprise consists of multiple units with redundant functions of varying quality. The primary strategy was to create a leveraging of the resources of the CTSA to develop a franchisable model built on best practice modules that could then be easily adopted by other units throughout the university. Develop a customer friendly, transparent financial system that spans clinical trial budget creation to account reconciliation and study close out. The lack of transparent and integrated financial systems to track costs and other financial aspects of clinical research including budgeting and billing remains a challenge for study team members. The University of Michigan Office of Research has created the Calendar Review and Analysis Office (CRAO) to assist researchers with this process and is currently implementing a clinical study budget tool, eThority, to create standard billing calenders and processes across the organization. CRAO will also champion the evaluation of financial feasibility prior to proposal initiation; provide more assistance to PIs and research team members with study budgets, through increased training on best practices, budget negotiators, and standardized internal budget; and generate a new reconciliation report that will make study account statements more easily understood by research teams. Improve regulatory approval process and reduce Institutional Review Board (IRB) turn-around time. Significant gains have been made, resulting in a 40% improvement in IRB cycle time. Study teams will be advantaged by continuous improvements to the process. Embedded within the goal to expedite study approval is the goal to reduce IRB turnaround time (TAT) to 21 days for full convened board approval, including ancillary committees, and reduce no more than minimal risk studies to 5 days TAT. U-M is investigating strategies for greater IRB board participation of faculty, instituting another IRB board specifically for industry-based studies, as well as dedicating a board to minimal risk studies. The CTSA is also identifying various research teams to extract best practices. The CTSA has created an IND/IDE consultation and support team for researchers that have already helped over 100 investigators with IND/IDE applications. Create a home for study coordinators to promote education and sharing of best practices. A strong research team, anchored by a solid study coordinator, is critical to clinical research success. Study coordinator turnover was noted to be 18% a year. Of all study coordinators, 75% have been at U-M less than 3 years, compared to 44% of the rest of U-M staff and 56% of study coordinators nationally. Study coordinators noted that there was no coherent program or “home” for them within the system. Several strategies have been developed and are being enacted to address this problem. The CTSA created a virtual, web-based site for study coordinator support that will eventually include standardized resources such as workflow steps, templates, forms, and answers to common questions. A monthly study coordinator forum has been enacted to share challenges and best practices. Human resources has been engaged to develop uniform study coordinator job descriptions and to mentor the coordinators to develop a meaningful career path. Increase patient participation (enrollment) in research. The institution has set an ambitious goal to double patient participation in research in 5 years, while decreasing the number of studies that do not enroll a subject to 5%. A primary strategy to accomplish this was the creation of a web-based participant registry (UMclinicalstudies.org) to help match interested patients and volunteers with open studies. Currently, over 7,000 participants are registered. U-M is also investing in an electronic medical record system that better enables queries and “flags” potentially eligible patients. Further investigation by a study team is necessary to determine the underlying reasons for poor accrual to studies, whether due to missed competitive enrollment periods, rare disease studies that inherently will be challenged to accrue, registry studies with open enrollment, lack of ability to find enough patients within the patient population, or unwillingness to ask patients to participate. Understanding and addressing the underlying issues provides an opportunity for the CTSA to improve the quality, and potentially reduce “waste,” in the proposal and regulatory systems. Achieve efficiencies through integration of multiple, fragmented IT systems. More than 30 IT systems, as well as paper records, were identified that are currently utilized by investigators to perform clinical and translational research. Moreover, multiple IT service providers exist across the institution with poorly defined roles, responsibilities, and accountability. Alignment of key IT systems and personnel that support clinical and translational research is imperative. The CTSA is playing a central role in developing and leading a cohesive strategy that integrates IT for researchers’ benefits. For example, the institution is investing in a system-wide approach to develop an overall architecture that will create a clinical data repository. Evolve the culture of U-M to be more supportive and enthusiastic of clinical research. Like many academic institutions, the University of Michigan has struggled to value clinical research to the same extent as the basic sciences. In interviews and surveys, many faculty noted that choosing a career in clinical research can be seen as “falling between the cracks” or not as respected as a career in basic research. While improving infrastructure demonstrates value to these researchers, it is not enough. The CTSA has advocated to create a working group to make recommendations to University leadership to increase recognition for excellence in clinical research, to refine promotion and incentive criteria to value scholarly clinical activity and emphasize collaboration and innovation across all disciplines (team science). Furthermore, a plan is being developed to expand training programs to support training of those who want to become clinical and translational researchers, beyond the few slots that the CTSA (K and T programs) can currently support. The mission of the CTSA to enhance an investigator’s ability to conduct translational research at the University of Michigan has resulted in concrete organizational plans and investments to improve infrastructure of translational research and increase the satisfaction of participants, faculty, and staff who are engaged in these activities.7 Similar changes are occurring at CTSA institutions all over the country, validating the vision of Dr. Zerhouni and the investment in these vehicles of change by the NIH. Supported by UL 1RR024986 NIH/NCRR—Clinical and Translation Science Award.

Task Force 8: Pediatric Cardiology Fellowship Training in Research and Scholarly Activity. SPCTPD/ACC/AAP/AHA.

Clinical Therapy Physics is the real “practice” of Medical Physics. Therapy Medical Physics is reimbursed explicitly and implicitly as having direct contribution to specific patient care — the only Medical Physics sub‐field with this advantage. Whether it is in establishing External Beam, IMRT,SRS or SBRT programs with IGRT or providing Brachytherapy (HDR & LDR) programs for cancer therapy, the Clinical Therapy Medical Physicist works in partnership with the Radiation Oncologist to provide quality services in cancer care. Supervision of dosimetrists and therapists, the other members of the radiation oncology team is an important part played by us. Dr. Hevezi was Director of Medical Physics at the Cancer Therapy & Research Center for 15 years and built an important clinical therapy physics program there. A broad range of clinical services there included not only the above mentioned procedures, but procedures like Total Body Photon Therapy, COMS Eye Plaque therapy, and others. He currently serves as Lead CyberKnife Physicist with the South Texas RadioSurgery Associantion in San Antonio and directs Medical Physics graduate students in the University of Texas Health Science Center at San Antonio. Dr. Hevezi has been recently elected to the Board of Chancellors of the American College of Radiology where he serves as Chair of the Medical Physics Commission. He is former Chair of AAPM's Professional Economics Committee and most recent clinical interest is in developing the CyberKnife SBRT treatment modality for cancer therapy. He holds a basic patent in this technology. On completing the session on Meet the Experts, The Practice of Clinical Therapy Medical Physics, the attendee will: 1. Be able to identify the procedures in Clinical Therapy Medical Physics that are germane to the Practice 2. Be able to describe the interactions between the Medical Physicist and the Radiation Oncology team members 3. Be versed in the method of reimbursement currently available for the Medical Physicist in Clinical Therapy Medical Physics 4. Be able to identify the specific quality assurance procedures that the Medical Physicist must know in the Practice of Clinical Therapy Medical Physics 5. Be able to identify the spectrum of activities the Clinical Therapy Medical Physicist may be called on to perform in the Radiation Oncology Department

WE-AB-213-03: Challenges and Opportunities

This study has confirmed a continuing decrease in the quality and quantity of young physicians entering academic careers in clinical oncology research, defined as cancer research requiring a clinician-patient interaction. Two major contributing factors were identified: the training programs and the research environment. The primary problems for the trainees were the financial insecurity of embarking on an academic career and the poor academic status of their role models in clinical cancer research. The problems regarding the environment of academic oncology and oncology research relate primarily to the strong and widespread perception that grant proposals for clinical oncology research are at a competitive disadvantage with proposals for cancer research in the laboratory. The study results yielded two basic recommendations. The first recommendation is to improve training for clinical cancer research and to implement unique funding mechanisms for trainees. Because physicians devote 3-10 years to clinical training, a minimum of 10 years of clinical research is needed for a clinician to compete effectively as a principal investigator in the R01 and P01 grant areas. The second recommendation is to develop peer review mechanisms that allow clinical research proposals to compete within a pool restricted to proposals in this category. The consensus in the study was that when programs in clinical research and laboratory research are in competition, the clinical proposals have a lower success rate. The problem appears to rest with the fact that the reviewers are frequently from disciplines other than clinical research and, more importantly, that clinical research proposals fare badly in competition against laboratory research proposals even when they are reviewed by appropriate peers. Implementation of this recommendation will require development of a clinical oncology research study section in the Division of Research Grants at the National Institutes of Health to review R01 grant proposals for innovative clinical cancer research, providing an academic environment that would enable the clinical investigator, through increased success in obtaining grants, to be a positive role model for the young physician/scientist.

St. Louis, Missouri, sits astride the confluence of the Mississippi and Missouri Rivers, a position that made the city the “Gateway to the West.” Its most famous monument, the Gateway Arch, memorializes the millions of pioneers who traveled to the city seeking transportation to the frontier lands of the West, and who were outfitted with the tools and knowledge they needed on the journey to these new lands of opportunity. The Clinical & Translational Science Awards (CTSA) program has enabled Washington University (WU) and its regional partners to create a gateway of another sort, aimed at helping researchers toward new opportunities and discoveries in clinical and translational research. The Washington University Institute of Clinical and Translational Sciences (ICTS) was founded in September 2007 to serve as the intellectual and physical home for clinical and translational research and clinical research training at WU and its partner institutions. ICTS was founded on WU's 4 prior clinical research and training grants—GCRC, K12, K30, and T32—and on an existing university-wide strategic initiative in multidisciplinary collaborative research emphasizing genome sciences, biological imaging, and clinical investigation. The formation of the ICTS resulted in a new level of regional partnership with other academic, health care, and industrial and community partners. In its second year of existence, the ICTS is increasingly able to integrate the different strengths of its partners to reach its goals of reinventing and reinvigorating CTS research and training. In designing the ICTS, we used a conceptual model that identified important phases in the progress of a clinical or translational research project (Figure 1). For each phase, we identifed needed resources and potential barriers to completion, and have structured the ICTS in a way that attempts to provide needed resources and expertise for each phase of research from development and refinement of research ideas through translation of results to clinical practice and community implementation. Education, training, and career development are at the heart of our ICTS, and are linked to all research phases and programmatic activities. Our ICTS has 15 key Program Functions, each linked to 1 or more research phases, and each with specific goals, milestones, and evaluation criteria for various services, cores, and programs. We will highlight 2 new and important program functions below: our community-based research efforts and our programs in biomedical informatics. Phases in the evolution of clinical research projects. The 3 CCBR arms serve as a model for community participation to improve research relevant to public health. A central transformative element offour ICTS was the establishment of the Center for Community-Based Research (CCBR), which has initiated community engagement ef orts in 3 important groups: community organizations, community-based health care providers, and individuals from medically underserved populations. Each of the 3 arms is designed to solicit community input to increase the relevance of research to community needs, and to encourage partnerships between academic researchers and community groups. Our Community Advisory Board, established by the 3 arms, meets quarterly, to ensure relevance of the CCBR programs and the ICTS programs as a whole. The Community Organizations program has focused on cultivating partnerships with community organizations and conducting community needs assessments. This new model has spearheaded a series of conferences with our Regional Health Commission to address how our academic medical center can better serve the needs of our local community and improve the public health. In the fall of 2009, we will begin a series of shared conferences with community organizations highlighting successful community-based participatory research projects. These conferences will include joint presentations by academics and community partners and will strive to facilitate the formation of new partnerships. To further stimulate new community-based participatory research projects, we will soon initiate a research grants program, supported by a regional coalition of universities and health care institutions, to fund research projects that include a high degree of cooperation between community organizations and academic researchers. The program has also initiated a traveling poster presentation forum that translates data in a community relevant fashion. The Community Health Care Practitioners program seeks to expand community networks of practitioners to increase opportunities for clinical and translational (T2 and T3) research. One such effort is the Washington University Pediatric and Adolescent Ambulatory Research Consortium (WU PAARC). Currently comprised of approximately 60 community pediatricians and 5 pediatric nurse practitioners, the network provides a formal structure to develop research ef orts that identify best practices and translate research findings into practice. Community pediatricians participate in the consortium in different ways, from contributing ideas and receiving study updates to helping develop study protocols and recruit patients from their practices. Some studies are initiated by WU PAARC physicians, such as a recent study on a Telephone Asthma Program that resulted from physicians’ frustration with patients not using their asthma maintenance medications. For this randomized controlled trial, 362 families with asthmatic children were recruited from 95 community pediatric offices over 13 months. The 12-month telephone asthma coaching intervention helped parents better manage their child's asthma care and improved children's asthma control and parents’ quality-of-life scores. An upcoming study will compare 2 corticosteroid treatments for croup, a disease commonly seen in community practice but never before studied in this setting. In addition to WU PAARC-sponsored studies, community pediatricians have opportunities to participate in other studies developed by ICTS researchers including participating in study development and implementation. An example is a prevalence study for community-acquired methicillin-resistant Staph aureu s for which 1,300 children were recruited from 11 WU PAARC practices over an 8-month period. WU PAARC serves as a model for cooperative research between academic and community physicians, and these examples show how those involved have a real opportunity to improve the health of children and adolescents. As our ICTS matures, we plan to expand our practice-based research network activities to include new patient and provider populations. The CCBR has also started HealthStreet, a project linking populations that have been underrepresented in research to health information, referrals to social, medical, and psychiatric services, as well as opportunities to participate in research studies. HealthStreet utilizes Community Health Workers and a comprehensive outreach approach to establish trust between the lay and medical communities. The hub of CCBR activity is a new storefront facility in an underserved neighborhood near our medical center where community members can receive free health screenings, health referrals, and information about WU clinical studies. Community Health Workers also reach people in sites such as beauty shops, laundromats, bus stops, and community agencies to spread the word about services offered, and opportunities for research. The 3 CCBR arms serve as a model for community participation to improve research relevant to public health. CCBR investigators are actively training and engaging other ICTS investigators to collaborate on community-based projects with the goal of addressing “outcomes that matter.” Major institutional goals for improving CTS research are the creation of efficient communication and coordination across key function activities; the creation of an informatics infrastructure capable of integrating ICTS program components for data sharing; and the development of electronic resources of existing clinical and biospecimen data that may be used to develop new clinical studies, identify potential research participants, and execute novel molecular correlative studies. The ICTS Center for Biomedical Informatics (CBMI) is addressing these complex core issues through industry-standard hardware infrastructure and software tools to store, integrate, query, analyze, and visualize complex clinical and molecular data sets. Among the several activities of CBMI are the integration and implementation of the research management tool ClinPortal, development and management of biospecimen tracking tools, and creation of the Clinical Investigation Data Exploration Repository (CIDER), a research repository of medical records. ClinPortal is a research management tool that allows investigators and study coordinators to integrate the data collection and management needs of a clinical study with critical regulatory compliance requirements. Investigators create case report forms using data elements (or variables) that are defined using controlled vocabularies, and ClinPortal then automatically generates the backend database schema as well as the forms to enter the data and conduct queries. Use of ClinPortal offers a number of advantages to the institution and to the investigator. By default, data stored in ClinPortal is available for sharing while following all HIPAA regulations, although the investigator that owns the data may turn of sharing if so desired. As a result, once an investigator has established his or her study within the ClinPortal system, there is potential for sharing relevant data with and from other studies. Data access is controlled both by investigator permissions and by regulatory requirements. Future phases include automated access to clinical data from our hospital and outpatient systems. Assuming appropriate release by the patient and access rights for the researcher, investigators using ClinPortal will eventually have access to clinical data from hospital and clinic sources for their study participants. Tissue Suite, a Web-based biospecimen inventory, tracking, and annotation tool, may be used for study-based biospecimen collection efforts and by other non-study investigators interested in identifying existing biospecimens throughout the medical campus that may be available for translational research. The ICTS Translational Pathology and Molecular Phenotyping (TPMP) Core supports the physical storage of biospecimens, while Tissue Suite is the application supported by both the CBMI and the TPMP to provide the informatics to manage data about those biospecimens. Investigators who are managing their own biospecimen collection efforts outside of the TPMP Core may still make use of the Tissue Suite application to manage their inventory in compliance with caBIG standards. Web accessibility, the ability to share biospecimens and biospecimen-related data, advanced search functionality, and capture of clinical, pathological, and quality assurance data for collected biospecimens are key features of Tissue Suite. Together, ClinPortal and Tissue Suite facilitate collaboration between investigators and data integration across studies. As clinical data becomes available through the ClinPortal tool, biospecimens referenced in the complementary Tissue Suite tool will gain increasing clinical annotation, making them even more valuable for translational research studies. Another major focus of the CBMI has been the development of a comprehensive research patient data warehouse. CIDER contains a wealth of data from the electronic medical records of most inpatients and outpatients seen at the WU medical center and affiliated hospitals in the BJC HealthCare system. This system will become available to ICTS investigators in 2009 and will initially contain data on patient encounters, laboratory testing, and medications. We sought community input in designing the patient notification and opt-out procedures and in strictly designating access and use of this information by qualified investigators. We expect that CIDER will become a very useful tool for many clinical and translational researchers to perform a review preparatory to research, identify potential participants to recruit to active clinical studies both by querying CIDER and as they are encountered in the health care system, and implement quality assurance and improvement initiatives. In addition to these highlighted functions, the CBMI is working on other ways to simplify communication and tracking within the ICTS. One new project is the creation of an electronic Research Concierge function to serve as the focal point to help clinical and translational researchers navigate through the study planning, design, review, and execution processes. This Research Concierge function will be added to WU's existing site that currently provides single sign-on access to the resources necessary to propose, manage, and close research projects and satisfy compliance requirements for research. In a nod to St. Louis history, these resources can be found at the WU Research Gateway Web site (http://research.wustl.edu). More information about the WU ICTS can be found at our main site http://icts.wustl.edu.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: 1. How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations 2. How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations 3. How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of all aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: 1.How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations 2.How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations 3.How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.

This toolkit brings together those with first-hand experience of designing, delivering, evaluating and participating in a Longitudinal Integrated Clerkship (LIC) within a UK Higher Education Institution and those working closely on programmes focussing on Health Education England (HEE)'s and NHS England's national priorities. In August 2022, a collaborative workshop was held for students and tutors participating in a London-based LIC in 2021–2022, faculty with prior experience in running LICs, and HEE representatives. The aim of the workshop was to co-produce a toolkit to guide undergraduate institutions, who may wish to introduce an LIC within their medical school curriculum that aligns to these national priorities. Although this toolkit primarily focuses on a UK audience, we anticipate that other health systems facing a need for similar educational reform may also find use for this toolkit. The NHS Long Term Plan,1 the HEE Future Doctor Report2 and The Enhance Programme3 have outlined key national priorities for the future of health and social care (Figure 1), including how we can train our workforce to deliver these aims. These priorities include embedding generalist skills in early career doctors, so they can better provide person-centred care in the context of complex multi-morbidity, while considering the impact of deep-rooted health inequity and social determinants of health. They can better provide person-centred care in the context of complex multi-morbidity, while considering the impact of deep-rooted health inequity and social determinants of health. This toolkit has been written for medical schools but may also be beneficial for other undergraduate and postgraduate health educators, who are considering setting up longitudinal educational programmes to meet their local and national health and workforce priorities. This document may also enable health and social care providers and third sector organisations, who are partnering up to support educational programmes, to better understand how longitudinal courses may benefit their health priorities. Currently, undergraduate and postgraduate training is fragmented in its provision of educational supervision and patient care. The lack of continuity of relationships with patients, supervisors and peers, can make it harder to effectively address the increasing complexity of multi-morbidity at an individual and population level. Because this fragmentation continues in the educational experience of postgraduates, it has a domino effect on undergraduates placed within those fragmented clinical settings—it becomes easy to see how this cyclical lack of continuity could perpetuate workforce burnout and poor retention.4, 5 This cyclical lack of continuity could perpetuate workforce burnout and poor retention. There is also a need for the future workforce to better understand the effects of health inequity, both at an individual and community level. It is well-recognised that certain groups of patients have poorer health outcomes than others.6 However, a deeper understanding of local population health priorities is difficult to achieve within our current, fragmented teaching and training programmes and instead requires being embedded into a community over a period of time. A deeper understanding of local population health priorities is difficult to achieve within our current, fragmented teaching and training programmes and instead requires being embedded into a community over a period of time. LICs (Figure 2) are an ideal educational model to address the issues of fragmentation of the student experience, and the need for students to have a better grasp of local population health. LICs place a greater emphasis on continuity for students and patients,7 greater responsibility for patient care, with more rewarding outcomes for students/trainees, and their patients and communities.8 Furthermore, many of the LICs in the United Kingdom are based in primary care,9 which provides a fertile ground for students to develop meaningful longitudinal patient relationships, and allows students to be embedded within a local community. The discussions within our workshop were informed by the existing literature on LICs which provides an international lens on how to develop LICs, what benefit they can provide, and their pitfalls.10-12 This toolkit builds on this literature with our lived experience within a UK health care and higher education environment, and aims to re-frame the importance of LICs as an educational model that better aligns to new integrated care priorities in the United Kingdom. For consistency in this toolkit, we use the term 'Longitudinal Integrated Clerkship' as it is most commonly known within the literature. However, there is debate about whether this term is relevant to the UK context and whether a more general term such as 'longitudinal placement' would better capture what currently exists and is achievable within the UK landscape.13 Design & Development of an LIC Evaluation and Research of an LIC To ensure an LIC that is sustainable, it is important to identify and consult with key stakeholders from the outset. Consideration of your institution's culture will also be important to ensure the success of an LIC, particularly with regard to the assessment process and how the LIC will be perceived within the hidden curriculum.14 A co-created mission statement for your LIC can help to ensure that all stakeholders are on the same trajectory. The overarching aim of your LIC is likely to depend on your local context. For example, in your local area, a main driver may be the need to address workforce recruitment and retention. Alternatively, addressing health inequity within underserved communities in the local area may be your main driver. When considering learning outcomes for your LIC, these can be considered under the headings of educational and health outcomes to ensure mutual benefit for those served by health systems and educational institutions. Similarly to a programme's mission statement, LIC outcomes are best defined with input from educational, health and community stakeholders. Investment at this stage from all stakeholders will be important as there may be conflicting priorities that will need to be worked through. Educational outcomes should align with the broader priorities and values of your institution, as well as national priorities, such as the Medical Licencing Assessment and those from HEE. Creation of a curriculum blueprint will be useful at this stage. Health outcomes would consider NHS policy documents (such as the Five Year Forward view), as well as local policies relevant to health context. The success of an LIC will depend on how the principles of the longitudinal model are adapted to fit with existing educational and service delivery models in your institution and local area. While there are existing frameworks of what an LIC might look like, these are based on the international literature, and local context should be considered for the successful delivery of an LIC. For example, from current literature, an LIC should be long enough for students to establish meaningful relationships, and Worley et al. suggest that an appropriate length of time should be from 6 to 12 months.15 We would suggest the length of time should be conducive to students having repeated encounters with the same patients, educators and peers to maximise relationships. There is no formal consensus on how 'repeated encounters' should be defined but the aim is for students to experience patient care over time in different settings with different health care practitioners. Facilitating sustained patient–student partnerships across the course of an LIC lies at the heart of this educational model. It is through these partnerships that mutual benefit can be garnered. The aim is for students to experience patient care over time in different settings with different health care practitioners. Table 1 outlines some important factors to consider during the design of your LIC. Consider the overarching outcomes of your LIC. Use this to decide what stage of medical school it is best delivered in. Early years E.g., Key LIC outcome = deeper understanding of the health inequity and preventative care for your population. You may wish to introduce these foundational concepts via an LIC at an early stage of clinical training, when there may be more curriculum space to dedicate to these concepts, and students are establishing their values around health equity. Later years E.g., Key LIC outcome = enhancing preparation for practice in line with national priorities In this case, the LIC may be better suited for those who are about to graduate New medical schools or those undergoing curriculum review may wish to implement an LIC for an entire cohort Medical schools with an established curriculum could pilot an LIC with a small group of students, with a phased roll-out in future years, allowing for improvements in your model if you fully roll out. Or there are many LICs that are small cohort student-selected programmes. If do you choose to run a pilot LIC, consider how you will advertise and recruit prospective students. The format of an LIC can vary internationally. Within the United Kingdom, LIC structure can range from a full time LIC to 1 day a week. Also consider the balance between Consider if your original LIC outcomes can be achieved in your chosen format and whether you can evaluate and assess these outcomes (see below for evaluation and assessment) within the constraints of your given structure. LICs can take place in a variety of settings with one setting usually acting as the main base for student learning Adequate supervision ensures clinical and educational safety for students and the patients they care for. This is an important consideration across all clinical settings. Also consider how undergraduates and postgraduates, and students from different health professions within the same learning environment can be brought together to enhance learning for both groups, e.g., through group supervision, tutorials or patient care. Assessment should be considered from the outset of LIC planning to ensure there is alignment with learning outcomes, as well as medical school and national assessments. Consider How and when these assessments will be reviewed should also be factored into the timetable for students and supervisors. LICs are likely to require a shift in mindset and logistics from the existing culture of learning at your institution, not only from the perspective of students, but also placement supervisors and central faculty. Adequate support for all relevant groups will help to identify early teething problems and ensure smoother transitions during implementation (see Table 2). With any educational intervention, particularly one that is new to an institution, there will be multiple reasons to collect data. For future iterations of the course, it is important to establish what worked well and what could be improved. Broadly, this type of data would be regarded as evaluation. Additionally, different stakeholder groups will have particular outcomes they are interested in, and these data might fall under the category of research. When deciding what data to collect, it is worth looking back at the primary LIC objectives, and planning from the outset how evaluation will be conducted and data collected, alongside the design and development of the overall LIC. This will help make early decisions regarding why the data are being collected, when and from whom, and ensures timely ethics and funding applications. Reviewing the existing literature at this stage will help shape both the LIC and your evaluation and research questions. Kirkpatrick's hierarchy can be a useful heuristic when considering what type of data to collect—for example, collecting qualitative data from different stakeholders on their perceptions and experience of the LIC. You may also choose to collect specific quantitative student or patient outcome data. When deciding who to collect data from, consider the whole range of stakeholders. For example, if a key aim of your LIC is to improve patient access to health care in your local area, it would be important to hear from patients themselves on their experiences. When deciding who to collect data from, consider the whole range of stakeholders. While data are often collected to look at what additional value an intervention provided, it is equally important to ensure no harm has inadvertently been inflicted on stakeholder groups in the process. This is also something to consider when deciding what parameters should be evaluated. The timeframe of data collection is also an important consideration. In keeping with a longitudinal process, some research questions may be better answered by looking at different points across the course, to capture how data change over time. When writing up and presenting data, consider involving all stakeholders in this process. It would be worth looking at presenting and publishing avenues that reach a broad audience—for example, health care arenas, patient and community facing publications, and medical educators. The future health workforce will require new complex skills to manage increasingly complex population needs. Current undergraduate training needs to consider how it is preparing future graduates to develop the skills needed to adapt to the rapidly changing health care landscape. An LIC places continuity and integration at its core and is an ideal educational model to embed these key skills within the curriculum. This, in turn, could help prepare our future workforce in providing person-centred integrated care that meets population need. This toolkit can be used to guide those considering educational reform in line with population need. Finally, it is the collaborative partnerships with students, policy makers, educators, and health and social care providers that will help ensure alignment between population priorities, workforce needs and medical education. Current undergraduate training needs to consider how it is preparing future graduates to develop the skills needed to adapt to the rapidly changing health care landscape. We would like to thank Mohammed-Hareef Asunramu, one of our LIC students, and Monika Gupta from Health Education England's London Enhancing Generalist Skills Team for their contribution to this work. The authors have no conflict of interest to disclose. No data have been used in this submission that would require formal ethical approval. All participants of our workshop have been listed as authors and have contributed and consented to the work.

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