The Intuitive Foundation funds high quality research that advances the field of robotic-assisted surgery. Thus, the highest priority research proposals address novel, important questions in a methodologically sound, feasible manner. Successful proposals also address problems with broad relevance to the scientific community, or make significant advances to patient care.
A successful application will include a compelling argument for the proposed study’s importance and novelty. This thesis is built on a summary of the current literature, successful identification of a gap in that literature, and explanation of how the proposed research would fill that gap. It should also establish the feasibility of the research, including its scope, a detailed description of the study design and data analysis methods, the team’s expertise, and proposed institutional support around the project. Successful proposals will address one of the Intuitive Foundation’s priority areas described on the grant program website.
Foundation grant reviewers offer that successful applications:
- Thoroughly address reviewer questions and comments sent in response to the applicant’s Letter of Intent.
- Demonstrate how they are building on existing literature in their study background, hypothesis, and experimental design.
- Have the relevant expertise, including project management and statistical support, on the project team to perform the proposed research.
- Provide enough detail in the proposal for reviewers to adequately assess the proposal’s strengths and weaknesses.
- Do not assign project oversight to team members who lack sufficient research experience, such as surgical residents.
- Have adequate experience with data collection tools (e.g., EMG recorders, surveys, etc.) that they intend to use.
- Show awareness of statistical power considerations, and use this knowledge to address the adequacy or limitations of the study design.
- Are realistic about how many participants they can likely recruit and, importantly, retain for the duration of the study.
- Demonstrate clarity and specificity in describing study outcome measures.
- Propose a project scope that is appropriate for the term (12 months) and funding ($60,000) available for the grant. For example, it is inadvisable to propose a study that both 1) intends to answer a novel clinical question and 2) intends to create a novel measurement instrument. Either aim could be a study itself.
- Propose a project that will produce generalizable results that are relevant to many institutions, not just the host institution.
To improve the quality of your research proposal, consider the tips below for each section of the proposal.
Title: It is more important to be clear and concrete, relating to the topic of your research, than it is to be creative.
Summary: Provide an overview of why your research is compelling and how it contributes to the broader surgical community. If your project were to be successful, what new insights would it provide beyond your local institution? This should be broader than your specific research question and will situate your research question within that broader context.
Response to Review Committee Feedback: We appreciate thoughtful, thorough responses that address the concerns raised by reviewers. Responses that minimize reviewers’ concerns will not be looked upon favorably. We understand there are limitations to what can feasibly be done, and those limitations, where they exist, should be explained in a clear, concise manner.
Background and Relevance: Demonstrate your understanding of recent relevant literature, including citations, and explain what gap you will be filling with your proposed research. Note that such citations may be needed to support your research methodology in addition to motivating the study purpose. High priority proposals will build upon previous work rather than repeating work that has already been done. This section should clearly provide the rationale for your proposed study and why it is important to the practice of surgery.
For example, if you were going to study how gender is associated with communication in the operating room during robotic-assisted procedures, you would want to cite literature that describes how to classify types of communication, what gendered differences might occur in team communications, why it is an important question to try to answer, and how the results might change practice. How does your proposed research build on and extend previous relevant research?
Preliminary Work: This section demonstrates your team’s enthusiasm and experience with the proposed topic. If you have performed any pilot studies or completed other related studies, please share what you have done and what the outcomes were. For example, perhaps you have already completed a small pilot study with observations of communication in the operating room at your institution. That would be relevant preliminary work that the review committee would appreciate knowing about.
Objectives, Hypothesis, and Specific Aims: It is important to identify clear, measurable objectives that address the knowledge gap identified in the Background section. Typically, you will identify one overarching research question or hypothesis, for example: “How do communications in the operating room differ by gender during robotic-assisted procedures?” Then, identify two or three specific aims that will generate the data needed to answer this question. For example, one question might be, “Are there more disruptive communications in ORs led by men or women surgeons?” or “Is the proportion of women on the OR team associated with constructive or disruptive communications in the OR?” For each specific aim, briefly explain how you will accomplish that aim.
“Aim 1. Identify whether communication patterns in operating rooms vary by the gender of the surgeon. By observing communications in operating rooms during robotic-assisted procedures, we will classify each communication into one of three categories: constructive, disruptive, or neutral. We will then compare the pattern of communications in operating rooms with men vs women surgeons.
“Aim 2. Identify whether the gender composition of the team in the operating room during robotic-assisted procedures is associated with communication patterns. Based on observations of operating rooms during robotic-assisted procedures, we will classify communications into one of the three categories described in Aim 1. We will then assess whether the gender composition of the staff in the OR is associated with more or fewer constructive communications.
“We will use these data to test our hypothesis. The results of this study will advance knowledge of differences in communication patterns based on the gender of the team and can help focus future efforts at improving team-based communication which is key for patient safety.”
While it is tempting to ask very ambitious questions, such as, “Are women surgeons better communicators than men?”, these types of questions are often not feasible for a research study that is meant to be completed in one year.
Regardless of your topic, clearly describe the overarching question or hypothesis, followed by two or three specific, measurable objectives. Your research strategy and methods will then describe how you will measure the data needed to address your objectives.
Research Strategy and Methods: Your research strategy and methods should closely align to your specific aims and research questions. Choose your outcomes measures deliberately and make sure they clearly address your stated aims and research objectives. The collective results from the aims should answer the overarching research question of the study.
In the above example of studying communication in the operating room, if the proposal examines the gender composition of teams but only involve surgeons or only record data for surgeons rather than all team members, the research question and outcome measures would not be aligned.
Your proposed methods should describe how you will generate your outcome measures. Include adequate detail so reviewers understand how you intend to execute the study, and do not rely on reviewers to make inferences about your intended plan. Consider applying the PICOTS (population, intervention, comparator, outcome, time span, study type or setting) model to ensure that you address important study design considerations.
As highlighted in the PICOTS model, you should include a comparator arm in your study design whenever possible. For a prospective study, this could be a concurrent control group, or it could be a set of historic, pre-intervention data. Depending on the complexity of your research questions, you may need more than two arms to account for different variables.
Provide a rationale for the specific choices you make in your study design, including affordances and limitations of these choices. For example, describe the inclusion and exclusion criteria for study participants, the justification for using a particular database (if applicable), or why you desire a specific number of study participants.
One way to expand the pool of potential study participants is to include multiple sites in your study design. Inclusion of multiple sites also demonstrates extensibility and reproducibility of your methods. For these reasons, the Foundation encourages inclusion of multiple sites if possible. However, be sure that you allocate sufficient budget to support operations at each site.
If you plan to study costs of care, make sure you understand differences between costs and charges and have access to hospital costs. Determine whether you will have access to actual costs or relative costs. Consider the cost of the entire episode of care, for example the entire hospitalization, rather than just the costs of the specific procedure being investigated.
Statistical Analysis: We strongly urge applicants to consult a statistician to identify appropriate statistical methods prior to submitting their proposals. Your statistical analysis should align with your research strategy and methodology. Be sure to address what is the exposure of interest, what are the outcomes, what are the confounders, what kind of statistical modeling will you be using, and what are the limitations? It is important to identify your analytical strategy prior to study commencement and align it with your methodology.
In this hypothetical study of communication in the operating room, qualitative analysis and correlations would be appropriate. However, if you are assessing attitudes during a survey or based on interviews, your analytical approach would differ.
Ensuring a sufficient number of participants helps minimize variability in your results and maximizes the likelihood that your results will be generalizable to the target population. A statistical power analysis provides a strong rationale for the minimum number of participants needed for your study goals. For this reason, please include the results from a power analysis in your methods. Even if you do not have preliminary data to conduct a power analysis, please consult similar studies that have been done to find a comparable effect size that you can use to estimate your optimal sample size. For the hypothetical operating room communication study, you would need to estimate the effect size of the expected difference based on previously published studies in order to do a power analysis. Your outcome measures could be the number and type of disruptive and constructive communications by surgeon gender. If the results of your power analysis suggest that you cannot adequately power the study due to budget or time constraints of the grant, please state so.
For the purpose of sample size calculation, please focus on one endpoint. Interactive resources for computing sample size can be found at the following websites:
https://clincalc.com/stats/samplesize.aspx
Participant Recruitment Plan: In this section, clearly state how many participants you will need to accomplish your aims and how you plan to recruit them. For example, if you plan to recruit through a surgical society’s listerv, please state that here. The review committee will want to know that you can access the participants needed to make your study successful. In the case of the OR communication example, researchers would need to affirm access to operating rooms and those who work in them. Your recruitment plan would describe how you would make OR staff aware of your project and the timeline over which you would recruit participants.
Many studies depend on engaging the same volunteer participants at repeated instances, such as a test-retest protocol. It is common to experience participant attrition in these studies. Please consider your anticipated attrition rate in calculating your target number of participants. Also describe any plans you have to improve participant retention.
Make sure the participants you recruit will enable you to answer the question you are posing. Be realistic about how many participants you can recruit and retain for the duration of your study, particularly if they are unpaid volunteers. If your participants include healthcare professionals – surgeons, nurses, surgical technicians, fellows, residents, etc. – be sure you have agreement from them or their supervisors to participate. If you intend to recruit participants who are not part of your target population, such as recruiting medical students instead of surgeons to study surgical skill acquisition, include a justification for this choice along with consideration of relevant similarities and differences between your study group and your target population.
For example, in the study of how gender is associated with communication in the operating room during robotic-assisted procedures, you would ideally have a way of collecting data directly from operating rooms. You would therefore need access to the OR as well as the cooperation of those who work there. If for some reason you can’t do that, you would need to explain how your alternate plan would still be able to address the proposed research question.
Timeline and Milestones: A thoughtfully planned project timeline will help ensure your proposal is feasible within the 12-month timeline of this funding opportunity. Relevant milestones may be related to specific aims or steps that need to be taken to complete those aims. Be realistic in what your team can accomplish. The expectation is that by the end of the 12-month period, your team will have at the very least completed data analyses and submitted one abstract. Look at recent publications of similar studies to evaluate the level of effort and time they required.
Keep in mind that only 50% of the awarded funds are distributed at the start of the grant – and only after proof of IRB approval or equivalent has been submitted to the Foundation – with the remaining funds being distributed after submission of a mid-year project update report. Consider what processes may be out of your control, such as IRB review. In the OR communication example, potential milestones might include obtaining IRB at every participating institution, finalizing survey or interview design, completing data collection, and completing data analysis.
Institutional Facilities and Support: In the interest of funding proposals that are likely to be successful, those that clearly indicate support from their institution and availability of necessary resources are most likely to be funded. Please be mindful of the type of expertise you need on your team and make sure you have the necessary collaborators to make your research successful. In the OR communication example, evidence of access to the operating room and qualitative researchers would be key to supporting the proposal.
Budget: Indirect costs must be no more than 20% of the total requested budget. These related costs of using the university’s facilities and administrative support cannot be claimed as direct costs. Indirect costs are part of the real costs of conducting the funded research. Please consult with your institution’s office of research for additional information on indirect costs.
Hard equipment (such as computers) must be limited to $5,000. Total budget cannot exceed $60,000, and the project must be completed 12 months after initial funds are received. In creating an appropriate budget, please be as realistic and reasonable as you can. If your study involves multiple sites, allocate sufficient funds to support protocol delivery at those sites. Please note that grant funds may not be used to support salaries of physicians and surgeons.
If you are at an institution within the United States, please upload your institution’s W9. If you are outside the U.S., please upload a letter from your institution indicating that it is a non-profit institution. We will confirm non-profit equivalency prior to release of funds.
Additional documents that you may include, if you wish, are tables, figures, or videos that help explain your study.
If you have any questions or would like to discuss your application with the Foundation, we’d love to hear from you. Please email grants@intuitive-foundation.org.
