Healthcare research is expensive and requires a sophisticated approach that is not for the faint of heart. Once beyond the start-up grants, generously offered by the WOCN Center for Clinical Investigation for example, the next step to obtaining larger amounts of funding is wide and major. The 2005 Spotlight on Research series spearheaded by Dr Donna Bliss has identified the key features of a competitive grant application, but a strong proposal does not equate with guaranteed funding. Indeed, only 20% of submissions to the large granting agencies are funded on the first round. The challenges to obtaining funding for all nursing research studies are many, but incontinence research seems to be particularly vulnerable. Are there barriers to conducting research in urinary continence? Are they real or perceived? Are these simply the absolute challenges of many people applying for the same pot of money? The question was recently informally posed to several experts in the field. Their responses are the basis for this editorial and suggest that there are indeed barriers to receiving funding to conduct large studies on the treatment and management of urinary incontinence. The comments fall into several categories: a lack of conceptual framework, imprecise outcome measures, a lack of knowledge of the significance of incontinence by reviewers, staff recruitment and retention, funding, time, and professional pressures.
Lack of conceptual framework
The continence milieu seems misunderstood by granting agencies and may not be considered a high priority. This is in part because continence research is not guided by a cogent and prevailing theory or conceptual model. A conceptual framework is a structure on which to hang related ideas and concepts. Pain is a good example. There is an understood physiologic basis for pain, an accepted tool for assessing pain (visual analog scale), a specific set of questions for inquiring about it, and a defined theory of pain. Incontinence, on the other hand, crosses several conceptual models, fitting under quality of life, psychosocial issues, chronic illness, geriatrics, and rehabilitation. Moreover, the physiologic understanding of bladder function is basic, at best. Classic theories of bladder function, for example, do not account for the sophisticated structure of the urothelium. 1 As a result, the proposal may not "grab" reviewers with new and innovative ideas and it may not easily slot into a distinct category-most large funding bodies list several subsets (quality of life, psychosocial, and randomized trial), and studies must be placed in one of the subsets. An intervention study, for example, of two different methods of pelvic muscle exercises with a control group may have a significant quality-of-life component, but the researcher must register the study into a clinical trials/randomized controlled trials (RCTs) group, competing with bench research with clearly articulated outcomes and effect sizes. The grant is disadvantaged not only because of the reviewers' poor appreciation of the challenges in clinical research, but also because it will be reviewed by statisticians whose background is theory rather than practice. Thus, any researcher with enough temerity to submit to an RCT group must somehow include a statistician on the team who understands the granting agency.
Outcome measures/successful treatment
Outcome measures are particularly challenging (one may even say "vexing") to the continence researcher. In an area of research where placebo benefit is reported more than 40% (at least in the short-term follow-up of many studies) and the diagnoses of urgency or stress incontinence are imprecise and difficult to quantify, one is challenged to determine a minimally effective clinical difference that is meaningful to patients as well as to reviewers. 2,3 Furthermore, there is little agreement on what constitutes successful treatment. Effect sizes are difficult to define because many continence studies suffer from major design limitations: small heterogeneous samples, wide standard deviations, imprecise outcome measures, short-term follow-up, low power (few studies report sample size calculation), and lack of rigor in reporting. 4 This lack of precision negatively influences the proposal review unless the investigators include a detailed justification of how effect size and sample size were determined. Establishing what constitutes a clinically meaningful difference to all parties would be a starting point for power calculation.
Urinary incontinence just isn't a "sexy" topic.
Staff recruitment and retention/infrastructure funding
Even when the grant is obtained, the researcher is faced with the task of finding qualified staff who will be committed to the project over an extended period and willing to endure unpredictable hours and peaks and valleys of work. To maintain staff, researchers may share research assistants to give them full-time work, but even with added benefits, nurses who work as research assistants do not stay for extended periods. They can earn more as a staff nurse and have pension, dental, and medical benefits, something that a researcher simply cannot afford. It is disheartening to train a registered nurse into the research role and have him or her leave (albeit understandably) for a better paying position.
Infrastructure funding
Although researchers expect equipment such as computers, filing cabinets, and desk space to be available for the conduct of research, so too are heat, light, air conditioning, general cleaning, and central management for grants and financial staff necessary to maintain researchers and their grants. The university, to pay for such services, will often charge up to 40% overhead costs to researchers. These are valid expenses that ensure that the grant is processed and managed properly throughout its timeframe, but if the researcher has not calculated overhead charges into the original grant budget, he or she may find himself or herself in a significant budget short fall.
Reviewers who do not understand the issue of incontinence
It is more common to have a grant rejected than accepted. Reviewers' comments are often helpful and constructive for revising and resubmitting in the next round. It is frustrating, however, when, based on the reviewers' comments, there is an apparent lack of appreciation of the significance of incontinence-its impact on socializing, quality of life, skin health, or economics. Incontinence just doesn't have a "sexy" cache when compared to other conditions, yet it affects millions of Americans and costs more than $19 billion a year in direct and indirect health costs. 5
Funding availability
Research is expensive, and competition for large sums of money is highly competitive. A review of recent National Institutes for Health (NIH) grants shows more than 50,000 studies funded between 2003-2005, but only 91 of which focus on incontinence. The Canadian Institute for Health Research (CIHR) funded more than 5,000 studies in 2003-2004, of which only 12 had incontinence in the title. What we don't know from NIH or CIHR is the number of continence studies submitted compared to the number funded. Topics of these high-quality projects reflect an emerging trend to support team centers that are comprehensive and include basic science as well as intervention studies. With limited resources, agencies wish to see research programs that will provide a foundation for ongoing scholarship and research. It is possible that the days of single-center or single-intervention studies are numbered.
Perhaps one of the most insidious of all the barriers is TIME. Writing proposals takes a zealous commitment in time and energy, and large proposals take approximately 1 year to develop. Proposal writing means setting aside other projects and personal interests to write, revise, and collaborate with coinvestigators. It requires tremendous stamina to complete forms electronically (at grant submission time CIHR routinely and unpredictably closes for several hours because of overload) and to obtain all the necessary signatures, especially if the study is multisite. Not only do the investigators have to sign forms, but also do their department heads, indicating by their signature that if the study is funded, the investigator will receive necessary department support. Any researcher will tell the novice that obtaining signatures is almost the worst part of the whole submission process!!
Faculty/department expectations
Finally, career and promotion pressures present their own set of barriers to quality continence research. Faculty evaluation committees expect annual productivity in terms of publications and money received. Publications must be in journals with an impact factor (an artificial ranking of journals based on the number of articles published in a journal in a given time frame/number of citations of the articles). In Europe, particularly, impact factor plays a huge role in journal selection. Journals such as JWOCN that do not have a listed impact factor will not receive cutting-edge manuscripts. In North America, the trend is beginning in the same way, with academics including in their CV the impact factor each journal in which they have published. Of significance is if the principal investigator has the majority of publications in a journal without a listed impact factor, the grant success will be directly and negatively affected.
In conclusion, the recent International Consensus on Incontinence (ICI meeting) 2004 appealed to the attendees to engage in high-quality trials in continence management to close the gaps in the current knowledge base. If so many gaps are known, why is research not funded? The contributions listed by experienced researchers illustrate a few of the challenges faced when trying to meet research demands. If research is so challenging, one could also ask, "Why choose an academic career and why choose research?" The answer is not simple, but most will say that despite the downfalls, research is a privilege and the thrill of exploration never fades. When a grant is finally funded, the frisson of excitement when opening the envelope provides an almost addictive affirmation that one's work is valued and has the potential to contribute.
My thanks for creative input from the following, all of whom have suffered at least one grant rejection in their careers:
Donna Bliss, University of Minnesota
Sandra Engberg, University of Pittsburgh
Mandy Fader, University College London & University of Southampton
Charis Glazener, University of Aberdeen
Mary Palmer, University of N Carolina
Joanne Robinson, Rutgers University
References