Powerful new tools to investigate human biology offer hope for rapid advances in the treatment of a wide array of illnesses with vast public health implications. Unfortunately, these tremendous advances have far outpaced the training and retention of new physician–investigators capable of translating these resources into tangible benefits for patients. Indeed, while there has never been a greater demand to expand the pool of physician–investigators, particularly in patient-oriented research, substantial obstacles impede this effort. Young physicians contemplating research careers weigh growing financial pressures against the uncertainty engendered by the tightening of federal research budgets and limited options for mentorship.1–3 Not surprisingly, morale among potential investigators is eroding, with many opting to pursue full-time clinical practice.4,5
Important strategies have been devised to counter the decline in interest in clinical research among young physicians. At the forefront of these efforts are the National Institutes of Health (NIH), which offer career development (K23) and midcareer (K24) awards in patient research, a loan repayment program, and Clinical Research Curriculum Awards (K30), given to institutions for the development, support, or expansion of research training curricula, primarily for fellowship trainees. Additional programs have been developed to promote interest in human research among premedical and medical students, such as summer predoctoral clinical research programs funded by National Research Service Awards (T35). A network of institutions, working under the umbrella of the Clinical and Translational Science Awards, have taken initiatives to formally integrate training and mentoring opportunities into their local research infrastructures.
While significant strides have been made to increase medical students’ and fellows’ exposure to formal research training, few if any formal programs have specifically targeted physicians in residency training. It is likely that residency was considered too busy, given its strenuous schedule that focuses on clinical training and subspecialty selection. The tremendous expansion of data and technology to be mastered during residency in the current clinical environment, along with shorter hospitalizations, higher acuity, and ever-increasing patient turnover, has only increased the challenge. The steady pressure to decrease “length of stay” may also have the insidious effect of steering certain residents away from research careers by undermining scientific inquiry into their patients’ clinical problems in favor of an emphasis on patient “disposition.” Compounding this trend are teaching institutions’ increased reliance on hospitalists as attending physicians on inpatient services,6 which may improve clinical care but almost certainly decreases residents’ exposure to investigators who could serve as mentors. In terms of research manpower, the stakes are high in this era of fast-paced health care delivery; failing to expose residents to research careers exactly when many are finalizing their career plans may be a critical mistake, the impact of which is yet to be fully realized.
In contrast, other trends in residency training make this situation ripe for change. Duty hours rules instituted in 2003 to reduce fatigue mandate that residents perform no more than 80 hours of clinical activities in a week, have one day off per week, and have at least 10 hours between shifts.7 Under these restrictions, residents are better rested, are more capable of being inquisitive about their patients’ problems and their own career development, and have more free time to pursue scholarly activities, which are required by the Accreditation Council for Graduate Medical Education.8
In 2003, recognizing an educational opportunity in the current environment, we designed a course at Massachusetts General Hospital, entitled Tools of Human Investigation, to specifically increase residents’ exposure to human research and to promote early, informed career planning.
Tools of Human Investigation
Tools of Human Investigation (THI) is a two-week rotation required for all second-year residents. It is scheduled four times per year to accommodate all residents and to ensure a small-group interactive environment; approximately 12 to 15 residents participate each quarter. Residents’ only clinical responsibility is one half-day per week for their continuity clinic. They are assigned no overnight call or sick-call responsibilities during the block. Funding for the course is provided by the Department of Medicine and the hospital administration. THI has the following specific aims.
1. To provide an overview of hypothesis generation and testing using a variety of study designs and research methodologies.
THI includes a combination of interactive, small-group, didactic sessions and a formal presentation of a real or mock research proposal. The didactic component is organized into several modules and includes topics in the areas of study design, biostatistics, genetics, and career development, among others (Table 1). We acknowledge that providing an in-depth curriculum in these areas in only two weeks is not feasible. Thus, specific concepts are presented within the framework of an important example from the published literature. This promotes discussion of a core concept with a direct link to its application in practice. Importantly, the course syllabus is dynamic, restructured annually on the basis of residents’ evaluations of the speakers and topics, the need for new topics based on scientific advances, and availability of new faculty eager to participate.
2. To provide housestaff with the skills necessary to critically appraise the scientific literature.
Our training program values and embraces a diversity of career pathways, and we acknowledge that not all residents will pursue research careers. Nevertheless, we believe strongly that, regardless of an individual’s future career choice, whether academic, private practice, health policy, industry, or otherwise, a competency essential for all trainees’ success is an ability to critically appraise the biomedical literature throughout the individual’s career. THI provides the ideal setting to provide mentored critique of research articles and techniques in a concentrated, protected block of time.
3. To encourage discussion of career development through exposure to key research faculty.
Residents’ exposure to faculty on the clinical services is weighted toward those who are primarily involved in clinical practice. While this allows exposure to a broad sample of clinical mentors, residents may or may not gain adequate exposure to clinician–scientists who can serve as role models for early research career development. THI ensures that residents are exposed to an array of senior and junior research faculty in a small-group setting devoid of the stress of clinical care. The THI faculty not only lead a discussion of a core topic related to human research, they also present a snapshot of their own career development. The casual career “show and tell” encourages candid discussions of the realities, challenges, and rewards of research careers. Senior and junior faculty provide complementary perspectives on various critical aspects of career planning—choosing a mentor, weighing fellowship options, nuts and bolts of grants, percent effort and ways to mix clinical medicine and research, negotiating faculty positions, balancing personal and professional life, etc.—that often are not systematically discussed in other settings in residency.
A checklist of key implementation items is presented in List 1 and discussed in further detail in the sections below.
THI is one component of an integrated program of mentored scholarly activity and academic career development that requires ongoing faculty oversight and administrative support throughout the academic year. To support these efforts, the position of associate program director (APD) for clinical and translational research was created. The APD, with the support of 50% of an administrative coordinator for academic career development, is responsible for the design and supervision of the THI program and for managing a number of other ongoing initiatives that support residents’ research and career development. These include organizing the bimonthly research roundtables when residents on research electives informally present their progress to their peers and program leadership; maintaining the research “Wall of Fame” that celebrates residents’ publications, abstracts, posters, and awards; organizing and leading the annual resident Poster Day Competition and Career Retreat; developing a catalog of faculty research projects that are open to residents; organizing the “Science in Medicine” series, during which residents are exposed to leading investigators from both within and outside the institution; and overseeing the budget dedicated to supporting travel stipends for residents presenting at national medical and scientific conferences.
The total annual direct budget of THI is approximately $32,000, allowing approximately $8,000 per quarterly session. The majority of the budget is used to support honoraria for the faculty ($250 per quarter) and the group project mentors ($500 per quarter to compensate for the greater time requirements of meeting with the resident group several times throughout the course). Other direct expenses for THI include printing, supplies, and food. Indirect expenses that do not fall under the THI budget but are vital to its success are salary support for the APD and the administrative coordinator for academic development. Other hospital resources, such as biostatisticians, donate their time, reducing the overall budget. In addition, the faculty observers who are recruited to attend the final presentations and provide objective feedback to the residents about their projects are generally core residency program faculty—program director, APDs, firm chiefs, clinician educators—who do not require additional support. In recent years, all course work and reading materials have been posted on the program’s intranet site, which allows residents to access the material at any time and eliminates the costs related to a printed syllabus.
To secure the initial funding for THI, we designed and presented a detailed proposal to key stakeholders at the departmental and hospital levels. After vetting the proposal with the residents, the chair of medicine, and the Department of Medicine Teaching and Training Council, the Department of Medicine submitted the initial proposal to the hospital for funding. The hospital was supportive of both the concept and design and, six months later, made funding available to implement the inaugural course.
After careful review of the residents’ schedules and overall program goals, we determined that THI would be best implemented during the junior (PGY-2) year of residency training. The senior year (PGY-3) offered the most scheduling flexibility, but we felt that it would to be too late to meet many of the career development goals of THI. In contrast, although interns (PGY-1) could also benefit from exposure to THI, their schedules provided limited flexibility, and it was determined that elective time would be best used for clinical rotations. One exception is made for the preliminary interns, who are offered the option of enrolling in THI during their electives.
The most difficult challenge is scheduling all junior residents in groups of 12 to 15 per block while maintaining adequate housestaff coverage on the main clinical services. Further complications arise because the shifts of junior residents, who are relieved of emergency clinical coverage during the THI blocks, must be covered by senior residents. To avoid conflicts, the quarterly THI blocks are evenly distributed throughout the year while avoiding holidays, major program events, and the late winter and early spring blocks when many junior residents are interviewing for fellowships. When developing the annual schedule, the priority of locking in individual residents to specific THI blocks is superseded only by setting their vacation schedules.
Residents are expected to attend all sessions during THI except those that conflict with their weekly continuity clinics. Most THI sessions are scheduled for the morning to minimize conflicts with afternoon clinics. In addition, a limited number of residents (i.e., 2–3 in a complement of 12) are assigned to clinic on any given afternoon, to prevent a large proportion of the group from being absent at sessions that cannot be scheduled in the morning. Speakers are made aware in advance that some residents will be unavailable for sessions because of their continuity clinic responsibilities. While in THI, the junior residents are scheduled for a maximum of 45 hours per week. The remaining 35 duty hours are free for reading course materials, developing the research project, and preparing the research proposal presentation.
Faculty selection, retention, and content development
The content of THI was designed to broadly represent the types of human research performed in academic centers. Given the telescoped time period of the course, the emphasis is on exposure to the core concepts of different disciplines rather than the in-depth instruction that characterizes masters programs. Faculty members are invited on the basis of their research expertise, ability to effectively communicate that expertise to residents, and willingness to participate in the program. Honoraria are offered as a token of appreciation, but mostly to convey to the faculty the importance of THI to the training program. Ultimately, we retain faculty because they find their participation in the program to be personally rewarding.
Virtually each session is led by a different faculty member. While this exposes residents to diverse career paths, it requires substantial coordination among the faculty to minimize redundancy. A faculty handbook, which provides a general overview of the course goals and outlines the key concepts to be covered in each session, helps the faculty design their presentations while enabling them to determine which concepts are covered elsewhere, thereby limiting repetition.
During the two-week course, residents are required to develop a research proposal as a vehicle to solidify the concepts they have studied. Proposals must include a clear statement of the hypotheses to be tested, methods, ethical considerations, statistical approaches, sample size calculation, limitations, alternate approaches, and future directions. Time blocks are reserved for independent work on projects and for meeting with mentors. In addition to their mentors, the residents have access to a biostatistician for consultation as needed, and the course director is available to answer any additional questions. The residents formally present their research proposals on the final day of the THI course, with critique by other THI participants and senior faculty.
When selecting a research topic, residents have two options: they can work alone on an existing project supervised by their own mentors or in small groups on a new research proposal with a mentor supplied by the program. In contrast to the solo projects, which continue a well-defined project and regularly scheduled meetings between mentor and trainee, the group projects require much greater support and oversight from the THI course. We ask all residents, before they begin the THI block, to tell us whether they will work alone or in groups; if they opt for the group, we ask that they provide a list of their broad interests. We then divide the residents according to their interests and assign each group a faculty mentor. Mentors, who volunteer to participate, are typically junior faculty members who dedicate much of their professional effort to research. Two to four mentors are required for any given round of THI to ensure that each interest group has no more than four housestaff. Mentors are offered a $500 honorarium for their efforts, which include helping their group develop the mock study and participating on the final day of THI when all solo and group projects are formally presented.
Given the extremely short timeline for developing their proposals, we encourage the groups to adhere to the following general schedule to maximize the value of their time with the mentors.
* Meeting 1 (days 1–2): Residents meet alone to develop two to three possible ideas for their proposal.
* Meeting 2 (days 2–5): Residents meet for the first time with the mentor to discuss the potential choices and finalize a single idea to pursue.
* Meeting 3 (days 3–7): Residents develop a working draft of the proposal on their own.
* Meeting 4 (days 6–10): Residents meet for the second time with the mentor to review the draft proposal and discuss complicated issues.
* Meeting 5 (days 6–12): Residents meet with the statistician to review statistical approaches and sample size estimates.
* Meeting 6 (days 10–14): Residents meet to finalize the proposal.
A sampling of recent individual and group projects are presented in List 2.
Measures of THI’s Effect
Among the most challenging aspects of administering THI is how to best measure its impact. By mandating the course for all residents, we have sacrificed the opportunity to rigorously test its effects against an unexposed control group. Thus, our potential evaluation tools are limited to longitudinal assessments of individual trainees—before-and-after analyses—and comparisons of career choices of THI trainees with historical controls before THI’s implementation. However, each approach has inherent limitations. The vast changes in residency training and in the forces that influence career choices make it difficult to discern what effects, if any, are directly attributable to THI.
Acknowledging these limitations, we administer a pretest at the outset of the course to document baseline fund of knowledge, and then a posttest at the end to assess improvement over time. Both pre- and posttests are multiple-choice and test identical concepts with minor modifications to the questions and their sequence. Each faculty member provides three to four questions that address the core concepts they will cover in their sessions. Although a consistent improvement in test scores from pre- to posttest are encouraging, this testing strategy only accounts for short-term changes in knowledge base rather than long-term retention and, furthermore, does not address other key goals of THI, such as exposure to mentors and long-term effects on career choice. In the absence of a formal, validated tool to evaluate these aspects of THI, we require the residents to complete surveys that allow us to refine our content and faculty selections from year to year and that help us understand whether they see value in the program. Indeed, over 82% of the more than 200 residents surveyed to date agree or strongly agree that THI is an important addition to the curriculum of the training program.
Strengths, Limitations, and Future Directions
THI aims to bridge the discontinuity between the research exploration encouraged during medical school and the rigorous clinical research expected during fellowship. Numerous medical schools have developed curricula that encourage research innovation among medical students,9,10 and interest in academic medicine is thought to be increasing.11 In parallel, the NIH has directed funding toward the support of young investigators, both with improved institutional research infrastructure and loan repayment programs.12–14 Yet, a lack of support for research during residency can have the unintended effect of suppressing interest that was cultivated during medical school. Indeed, recent data suggest that residents are particularly lacking in the biostatistical knowledge that is essential for success in clinical research.15 Given the ongoing changes in clinical training driven by duty hours requirements and other forces, an opportunity exists for renewed emphasis on research exposure during residency.
The THI course has been highly praised by housestaff in their postcourse surveys, with more than 80% citing it as an outstanding addition to the curriculum. Residents particularly appreciate the opportunity to interact with esteemed faculty and potential mentors who are less visible in the clinical community. Anecdotally, exposure to a diversity of career tracks has allowed many residents to more clearly formulate how they wish to combine their clinical and research interests into a viable career plan and thereby present a stronger sense of purpose at fellowship interviews. Some residents capitalize on the opportunity to remain in contact with their THI instructors, who can discuss research ideas, provide career advice, and point residents toward appropriate mentors in other fields. It is important to emphasize that the success of THI is largely based on the contribution of the faculty and their willingness to present multiple seminars per year, with many returning each year. Critical to the retention of faculty is the gratification they derive from the housestaff and their inquisitiveness. Practically, the new avenue for mentorship and attracting high-quality trainees to their labs are additional tangible rewards for the THI faculty. Though nominal, the provision of honoraria to the faculty emphasizes the department’s commitment to education in general, and THI in particular.
The breadth of the faculty at Massachusetts General Hospital, an important ingredient of the success of THI, may not generalize to all institutions interested in implementing similar programs. Alternative approaches could rely on a smaller core of faculty to deliver multiple presentations. Although this would limit the number of faculty to whom residents are exposed, it would promote greater consistency in teaching styles with less redundancy compared with a course in which each session is led by a different faculty member. Programs may look beyond their own departments and benefit from faculty in other specialties within their academic communities. Alternatively, institutions could choose to implement a similar course as an elective, which could be run once per year for interested residents, or to develop collaborations with nearby academic institutions that could accept outside residents for brief research blocks.
The ultimate goal of THI is training residents to be better prepared for their future with more focused career plans—research or otherwise. Clearly, attracting more residents to academic careers is an additional goal. However, measuring the long-term success of a novel educational program for residents, such as THI, is challenging, will require extended follow-up, and, because of the lack of a control group, must rely on historical controls. Our pre- and post-THI tests and surveys capture short-term changes in knowledge of specific concepts and attitudes toward academic careers. These are useful for year-to-year improvements to the course, but they cannot be used to validate the impact of the course over the long-term. While one possible approach to assess the longer-term impact of THI might be to administer surveys several years after graduates have completed the course and established their careers, novel methods of measuring the effect of curricular innovations such as THI are urgently needed, and we eagerly await reports from other institutions that may have developed and validated such metrics. Other limitations include the significant logistical commitment required to administer THI, including the costs and scheduling requirements. Indeed, removing one fourth of the junior resident class from clinical activity for two weeks can strain the staffing of clinical rotations.
Obstacles to expanding the pool of clinician–scientists are substantial. A number of NIH efforts have successfully targeted fellows, junior faculty, and even medical students, but few if any formal programs specifically designed for residents have been reported. Unexpectedly, new duty hours regulations have created the opportunity to reevaluate formalized exposure to human research among residents in training. A seminar course such as THI, in which residents are extracted from the fast-paced clinical service and provided two weeks of “back to the classroom” time to focus specifically on career development, knowledge of study design, and research training, is one unique approach to fostering academic interest among residents.
The authors thank Dennis A. Ausiello, MD, chairman, Department of Medicine, MGH, and the MGH hospital administration for supporting the development of this novel educational program; the dedicated faculty of THI; and the MGH residents for their inquisitiveness, dedication to education, and willingness to participate in experimental curricula.