The Cost of Primary Care Research

Despite its critical role in the development of a research enterprise, the requirement for support for start-up efforts has not been quantified, and no scheme for such quantification has been published. Appropriately, grant budgets do not include the costs of getting to the point of grant submission. However, costs are incurred that must be covered by some source.

We provide a model that lists categories that will allow for the quantification of primary care research costs, including those incurred before the receipt of grant funds (Figure). In this model we assume that a significant portion of primary care research will be practice based, and thus we have included in our model costs related to the practices. One way of developing and using a “laboratory” for practice-based research is through the development and use of a practice-based research network, and thus these costs are also reflected in our model. We acknowledge that many aspects of the model would also apply to research in other settings, including basic science research and traditional clinical research in academic settings.

Methods

To develop our model, a group of University of Wisconsin and Wisconsin Research Network investigators experienced in primary care research explored the activities and associated costs necessary for conducting research projects. This group included an academic family physician (J.W.B.), a community family physician (D.H.), and 3 experienced research staff members (P.W., M.B.P., L.M.). We began with 4 core assumptions and then identified 10 phases of activity in the research process, the first 4 of which occur before the receipt of grant funding.

Four Assumptions

On the basis of our collective experience, our group made 4 assumptions that are important for our analysis of the costs associated with primary care research. These assumptions are:

1. Expensive phases of the research process occur before the receipt of grant funds. It is therefore difficult to initiate major research solely through the grant-funding process. Many activities related to developing hypotheses, determining research methods, doing pilot work, and producing fundable proposals must occur before grant funding. Based on our collective experiences in applying for federal funding, we estimate that an investigator requires approximately a year of full-time equivalent work (eg, 25% time over 4 years) to get his or her first R01 grant funding.^19-21 An unsuccessful application by one skilled individual was estimated to cost 220 hours of effort, exclusive of the time of staff and colleagues.²²
2. We need community practice settings for primary care research, and their research activities should be rewarded at approximately the same rate as other practice activities. Not only are these settings critical when physician practice is the object of the research, but it also seems that patient recruitment may be better (possibly with less selection bias) in community practices,²³ since more patients are served by these than academic practices. Physicians and patients in community practice settings cannot participate without remuneration, especially when many studies and more time-consuming and sophisticated interventional studies are done. This is not only an issue of physician volunteerism. More physicians and staff are members of corporate medical entities that are beginning to insist on reimbursement for every corporate activity. Generally, pharmaceutical research is the only research that has budgeted adequate reimbursement for practices.
3. Patients must not incur costs for participating in research activities. Making patients financially support research will reduce participation and potentially increase selection bias.
4. An exact calculation for the budgeting of research activities across various primary care settings is not possible, since expenses are organization- and project-dependent. However, general estimates could be fit into the model.

The Research Process Before the Receipt of Grant Funding

The costs of research in primary care can be classified into 10 phases of operation by the series of tasks that have to be accomplished and by the organizations that will be required to accomplish them. Although our list may not exhaust the possible range of phases and organizations, it can serve as a framework for discussion of the resources needed to conceptualize a project, apply for funding, and carry out research. Not all phases are applicable to all projects, but in general most research will require activity in most phases.

• Phase 1: Develop and Maintain a Commitment to Research. Regardless of whether a formal research network is used, researchers must convince the practice community to support research efforts, especially since projects that originate within academic departments may be removed from the interests and concerns of physicians in community practice. If a research network is involved as a means to maintain the “laboratory,” an ongoing investment in network operations is required. We note that even ongoing successful research institutions generally cannot rely solely on grant funding.²⁴ These institutions often have some base support from other sources, such as state funding.
• Phase 2: Conceptualize and Design a Project. Time and energy must be invested in literature reviews, conferences, and consultations to design a research project that builds on existing experience and knowledge. The active involvement of clinicians at this stage helps to ensure buy-in and, more important, ensures that the results of the research are likely to be relevant to practice.
• Phase 3: Pilot-Test and Revise the Design. Generally, it is necessary to conduct some preliminary research to demonstrate feasibility and work out methodologic details before writing the grant proposal. Data collection instruments may have to be identified or developed, and some statistical analysis should be done.
• Phase 4: Write and Submit the Grant Proposal. Preparing a grant proposal requires time for writing, obtaining institutional review board approval, realistic budgeting, consultation, and revision. These efforts may not achieve the desired goal of funding, however; only 20% of NIH submissions receive funding on the first submission.