Pressure ulcers (PrUs) have tremendous medical, psychosocial, and financial impact. Estimates suggest that hospitalized patients in the United States receive treatment for more than 2.5 million PrUs each year. 1 In acute and critical care settings, PrU incidence rates can be as high as 40%. 2 Pressure ulcers and their associated complications can prolong length of stay in health care facilities, and treating PrUs can interfere with the progress of rehabilitation. 3,4 The average cost of treating a patient with a PrU is higher than treating a patient without a PrU, even after adjusting costs related to admission characteristics and complications not related to the PrU. 3 The total annual cost of hospital-acquired PrUs is estimated to be $2.2 to $3.6 billion. 1
In recent years, the medical and financial impacts of PrUs have been recognized on a federal level. The Agency for Healthcare Research and Quality (AHRQ; then called the Agency for Health Care Policy and Research [AHCPR]) assembled 2 interdisciplinary panels to develop clinical guidelines for PrU prevention (released in 1992) 5 and for treatment (released in 1994). 6 One of the primary goals adopted by Healthy People 2010 is to reduce the prevalence of PrUs among long-term-care residents from 16 cases per 1000 patients to 8 cases per 1000 patients. 7
In its monograph, “Pressure Ulcers in America,” the National Pressure Ulcer Advisory Panel (NPUAP) stated several goals for PrU research. 2 These goals included “[broadening] financial support for the performance of quality PrU research over the next decade… [and establishing] an agenda for PrU research that focuses on major areas of uncertainty.”2 As part of a strategy to achieve these goals, the NPUAP committed funds in the year 2001 to support the creation and analysis of an on-line database. The NPUAP Database of Current Pressure Ulcer Research Funding was created to characterize PrU research funding in the United States and to identify potential targets for future research and funding initiatives. This article describes how the database was assembled and presents a systematic analysis of the grants identified in the database.
Grant inclusion criteria
To define the focus and scope of the database, several inclusion criteria were established. Grants awarded by federal agencies, corporations, or private organizations based in the United States with project end dates on or after November 15, 2001, were included in the database. The database focused on clinically relevant grants in 3 major categories: (1) studies of PrU assessment, prevention, and treatment; (2) quality of care studies that included PrUs in their outcome measures; and (3) studies of foot pressure management in patients with diabetes mellitus. Many of the concepts behind plantar pressure modeling and pressure-relieving orthotic design are also applicable to body-seat interface modeling and support surface development. For these reasons, the subset of diabetic foot ulcer research concerned with pressure management was included in the database, despite the differences in pathophysiology between diabetic ulcers and PrUs.
Wound healing studies that did not include subjects with PrUs were excluded from the database. Basic science research was generally excluded, with the exception of biochemical studies of PrUs in humans and support surface development research.
Information was sought on grant titles, topics, investigators, funding, participating institutions, project durations, abstracts, and related publications. These details were acquired through searches of on-line databases of federal grant awards and through communications submitted directly to the research team via an on-line questionnaire.
* Federal database search. A group of 6 researchers and clinicians involved in PrU research suggested 66 search terms to identify eligible grants (see Search Terms on-line at http://www.woundcarejournal.com). These terms were used in various combinations to search 4 federal grant databases.The National Institutes of Health (NIH) Computer Retrieval of Information on Scientific Projects (CRISP) database (http://crisp.cit.nih.gov) was searched. This database includes awards made by agencies within the Department of Health and Human Services, including the NIH, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the AHRQ. Information on NIH grant amounts was acquired through the NIH’s Office of Extramural Research Web site (http://www.grants1.nih.gov/grants/award/state/state.htm), which lists awards by fiscal year and state. Information on grants funded through the National Institute on Disability and Rehabilitation Research (NIDRR) was obtained through the National Rehabilitation Information Center (NARIC) database (http://www.naric.com). The National Science Foundation (NSF) FastLane award database (http://www.fastlane.nsf.gov/a6/A6AwardSearch.htm) and the Department of Veterans Affairs Rehabilitation Research and Development Service (VARD) database (http://www.vard.org/query.htm) were also searched. Whenever possible, the investigators verified the grant information and acquired missing data by contacting each grant’s principal investigator via E-mail or telephone.
* On-line form development. A 17-item, on-line questionnaire was developed to allow members of the research community to submit grant information directly to the database via the Internet (http://www.rst.pitt.edu/npuap). The questionnaire was modeled after an on-line form used by the European Pressure Ulcer Advisory Panel (http://www.epuap.org) in its efforts to acquire information on ongoing PrU research. A preliminary version of the form was critiqued by a group of 6 PrU researchers and clinicians to acquire input on the form’s design, content, and ease of use. The revised form was created in Adobe GoLive (version 5.0 for Macintosh; Adobe Systems, Inc, San Jose, CA) and linked to a FileMaker Pro database using Lasso Web Data Engine (version 3.6.5 for Macintosh; Blue World Communications, Inc, Bellevue, WA). The on-line form and accompanying Web site were tested on IBM and Macintosh platforms, as well as America Online, Netscape, and Internet Explorer browser interfaces.
A number of individuals and organizations were encouraged to visit the Web site and complete the on-line form. The NPUAP’s Board of Directors, Corporate Advisory Council, Alumni Council, and collaborating organizations were informed of the database’s Web site and questionnaire through E-mail, newsletter, and meeting announcements. Publicity materials were distributed at the annual conference of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) in June 2001 and to RESNA’s list of E-mail recipients (listserve). The investigators also contacted several rehabilitation engineering research centers and rehabilitation research and training centers, as well as researchers identified by CRISP, NARIC, FastLane, and VARD database searches. In total, more than 150 individuals or organizations were contacted to acquire information on funded grants. The investigators screened incoming grant submissions using the inclusion and exclusion criteria. Grants that did not meet the inclusion criteria were excluded from the database.
Descriptive data concerning funding types, agencies, amounts, and durations were analyzed using a standard spreadsheet program (Excel 2001; Microsoft Corporation, Redmond, WA). Grants were sorted by topic area (Table 1), which were identified by reviewing the title and abstract of each project. Each grant was assigned to a maximum of 3 subtopic areas, depending on which areas best matched the project’s stated objectives. Once sorted, the percentage of grants in each topic and subtopic area was calculated. Grant abstracts were also reviewed to identify patterns in subject population, project design, clinical setting, or other study parameters that could be used to characterize the nature of funded PrU research.
The investigators collected information from 34 grants. Of these, 21 grants were identified through existing databases (20 from CRISP, 1 from NARIC) and 13 were submitted through the on-line questionnaire. Thirty-two of 34 grants were included in the data analysis. Two grants submitted through the on-line questionnaire were not included in the analysis because they did not meet the content criteria. Both of these grants related to wound treatment but did not include subjects with PrUs.
Number of grants by funding source
The majority of the grants (28 of 32) were funded by federal agencies, principally the NIH (Table 2). Seven institutes within the NIH provided PrU research funding, with the largest number of grants funded by the National Institute on Aging. Other federal sources of PrU research funding included the Department of Veterans Affairs (VA), the AHRQ, and the NIDRR.
The investigators identified 1 privately funded grant, sponsored by the New York Physical Therapy Association Research Designated Fund, and 3 corporate grants, all housed within academic centers. No grant information was submitted on-line by corporate entities. Two corporations that were members of the NPUAP’s Corporate Advisory Panel were contacted by the investigators, but they declined to participate, expressing concerns that doing so would require them to disclose proprietary information (personal communication). No other comments were received from corporations.
The 32 grants in the database represent $16,444,117 in research funding. Grant amounts were not available for 4 of the projects in the database: Grant amounts were not found for the 3 proj-ects funded by the National Center for Research Resources, and the principal investigator of 1 corporately funded project declined to release the amount of the grant. Only partial funding amounts were available for 5 projects, 1 each from the National Institute of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of General Medical Sciences, the National Institute of Nursing Research, and the National Institute on Aging (Table 2). These amounts included funding in fiscal years up through, but not beyond, fiscal year 2001. The amounts and percentages were based on the total amount of funding identified for these projects, acknowledging that additional funding for these projects will be given in future fiscal years.
More than 99% of PrU research funding in the database came from federal sources (Table 2). The NIH provided the majority of federal funding (approximately 90%). Within the NIH, the top 3 funders of PrU research were the National Institute on Aging, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute of Child Health and Human Development. The National Institute of Arthritis and Musculoskeletal and Skin Diseases awarded the largest single federal grant in the amount of $3,262,048.
To account for grant duration, the average amount of funding per year for each grant was calculated (see Duration of Grants Awarded by Federal Agencies on-line at http://www.woundcarejournal.com). In cases where the entire grant amount was not available, the amounts were averaged during the number of years of known funding. On average, the NIH awarded the largest amount of funds per year, followed by the VA, AHRQ, and NIDRR. Within the NIH, the highest average grant amounts per year were provided by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, followed by the National Institute of Child Health and Human Development and the National Institute of General Medical Sciences.
The number of grants relating to each topic area is shown in Table 1. Nearly half (47%) of the grants in the database fell into the category of “other topics,” including grants about quality improvement, economic evaluation, pain, and foot pressure management in patients with diabetes mellitus, among others. Thirty-one percent of the grants were in the category of assessment, followed by preventive interventions (25%) and treatment (22%). The most commonly studied subtopics were quality improvement, risk factors and risk assessment tools, adjunctive therapy and physical agents, and mobilization. Smaller numbers of grants studied foot pressure management in patients with diabetes mellitus, incidence, assessing tissue damage or healing, support surfaces, nutrition, topical agents, and pain. The “topics not described previously” category included 2 grants: 1 studying pressure monitoring and 1 assessing tissue responses to pressure. No project in the database fell into the subcategories “prevalence,” “other assessment topic,” “positioning,” “patient education,” “operative procedures,” or “support surfaces for treatment.”
Complete abstracts were not available for all of the grants in the database. Nonetheless, some patterns in design, subject population, setting, and other variables emerged from the available information. Of 32 projects, 25 involved an analysis of prospectively collected information. Five projects appeared to be retrospective studies, although this could not be confirmed from the information available in the abstract. Not enough information was available for 2 projects to determine whether data collection was prospective or retrospective. Five projects were randomized, controlled trials. Ten projects appeared to be primarily descriptive in nature, observing subjects under a single experimental condition or treatment, with no comparison group. Two projects were case-control studies and 3 were cohort studies. Crossover design, cross-sectional design, repeated measures design, and within-subjects design were used in 1 project each. Insufficient information was available to characterize the design of the remaining 8 projects.
Many of the research studies took place in long-term-care facilities and hospitals, often studying elderly subjects or individuals with spinal cord injuries. Subjects for 7 of 32 studies came from long-term-care facilities. Six studies involved hospitalized patients and 1 studied community dwellers. Not enough information was available on 18 of the studies to determine their settings. Elderly adults were studied in 8 of 32 projects. One project studied adults, but not necessarily elderly subjects, and another studied children. Twenty-two projects did not specify their subject population; 4 of these projects took place in long-term-care facilities, suggesting an older subject pool. Patients with spinal cord injury (4 studies) or diabetes (4 studies) were most commonly studied. Other study populations included subjects with hip fracture, stroke, and dementia. Three studies examined PrU development in white versus African American subjects.
A variety of data sources and types were used in the funded projects. Six studies examined data acquired from health care facility, federal, or academic databases. Fourteen studies examined clinical and functional outcomes other than PrUs, such as falls, medical complications, or mortality. Interface pressure measurements were included in 6 studies, and measurements of blood flow and tissue oxygenation (transcutaneous oximetry, laser Doppler flowmetry, and skin temperature) were used in 3 projects. Biochemical and immunologic outcomes (eg, leukocyte proliferation, protein composition of wound fluid, and interleukin expression) were used in 5 studies. Cost outcomes were included in 2 studies.
The NPUAP Database of Current Pressure Ulcer Research Funding is unique in several aspects. The NPUAP is unaware of any other published PrU research surveys that focus specifically on funded grants rather than published literature. This perspective provides an opportunity for the research and clinical communities to have a sense of what is being studied in real time. In most cases, the research community is informed of projects only after initial results have been obtained and presented, either orally or through written communication. Collecting information about grants as they are awarded enables the research community to learn about projects in their earliest stages. This information may allow researchers with complementary interests to assist each other early in project development. Collecting information about grants also allows the research community to evaluate the content of today’s research and the resources used to generate this research. This information allows advocates within the research community and elsewhere to work for new funding initiatives with agencies that have a history of sponsoring PrU research and with leaders of alternate funding sources.
Another important aspect of the NPUAP database is its use of data collection and dissemination via the World Wide Web. The on-line questionnaire enables data to be collected on a continuous basis. Researchers may update and submit information on new grants at any time from any location. Information on current research grants is readily available on-line for researchers, clinicians, consumers, and other individuals with an interest in PrU research. One goal of the NPUAP is to support the ongoing maintenance of this database and its Web site, http://www.rst.pitt.edu/npuap, and to actively update the database on a regular basis.
To appropriately evaluate the results of this project, it is important to acknowledge its potential weaknesses. First, neither the database nor the analysis should be considered an exhaustive representation of all PrU research being conducted at this time. Because the project relied primarily on voluntary submissions, the completeness of the database depends largely on the extent to which publicity efforts reached those in a position to identify eligible grants and the responsiveness of the research community to requests for information. Although the investigators made every effort to inform the PrU research community of the database and encourage participation, it is likely that additional, unreported grants exist. Second, grants coming from federal sources are disproportionately represented in the database because only federal funding agencies had existing on-line grant databases that could be easily searched for PrU research projects. In particular, NIH’s CRISP database was the most inclusive, easy to search, and informative database identified. As a result, federal projects, particularly NIH-funded projects, are overrepresented in the database. Furthermore, all corporate entities that responded to the request for information declined to release this information due to confidentiality and proprietary concerns. The only corporate funding included in the database was that provided to investigators at academic institutions. This excludes what may be the largest amount of funding for research and development involved with support surface development, wound healing, pharmaceutical development, and other PrU-related products. In addition, sources of private funding for PrU research were difficult to identify. The investigators were unable to find any existing databases of private funds. All these factors may artificially increase the proportion of PrU research funding that comes from federal sources. Efforts will be made in the future to improve the ability to capture greater amounts of private and extramural corporate funding. Finally, some of the information contained in the database is incomplete or may contain errors. Any erroneous information contained in preexisting grant databases persists in the NPUAP Database of Current Pressure Ulcer Research Funding, unless subsequent data supplied by the principal investigator of each grant allowed for correction. In addition, some abstracts contained only minimal information, making judgments about the design and objectives of the study difficult to determine. Despite these issues, the database allows the NPUAP to reach a number of conclusions and make several recommendations.
More funding needed
The $16.4 million of PrU research funding identified by the database is less than 0.5% of the estimated $3.6 billion annual cost of PrU care in the United States. 1 Furthermore, if one considers that many studies in the database examine a range of outcomes, of which PrU development is only one, the amount of PrU research funding is actually less than the total amount of funding in the database. Assuming these numbers meaningfully represent the magnitude of PrU research funding, such funds are insufficient to adequately improve PrU prevention and quality of care. A substantial increase in PrU research funding should be a national goal.
The lack of PrU research funding may be due to 3 factors: (1) lack of agencies committed to supporting PrU research, (2) lack of researchers applying for funding, or (3) lack of well-designed, significant PrU research proposals. This study suggests that 99% of funding for PrU research comes from federal agencies. If this is true, then researchers must remain proactive in lobbying federal agencies to continue and expand their support of PrU research. However, researchers must also increase their lobbying of private and corporate foundations to increase their support of PrU research. In particular, investigators should encourage corporate and private funders to disseminate the availability of funding for PrU research. Any efforts made to facilitate the identification of nonfederal funding sources will help maximize the funds utilized for PrU research.
Key areas understudied
A number of important research areas were underrepresented among the funded projects analyzed, including incidence and prevalence, support surfaces, pain, operative treatment, positioning, economic evaluation, patient and caregiver education, avoidable versus unavoidable PrUs, health care database quality, and PrU care in the home setting (see Understudied Areas on-line at http://www.woundcarejournal.com).
Seeking and securing grant funds
Many opportunities exist for clinicians to support and/or participate in clinical PrU studies to help close gaps in knowledge. It is critical for clinicians to be part of the research team to ensure that the issue being examined has clinical relevance. Clinicians can work with senior researchers in a number of ways, from helping to identify relevant questions to assisting in data collection and analysis. Clinicians with some research experience may also wish to apply for grants.
For clinicians or investigators interested in conducting PrU research, finding agencies willing to fund PrU research may be challenging. However, key search engines are available to provide assistance. The Foundation Center Web site (http://fdncenter.org), for example, contains information on more than 4800 foundations. Another good source for investigating PrU funding is the Community of Science, COS Funding Opportunities (http://fundingopps2.cos.com), which allows visitors to search potential private and federal agencies by typing in key words. In addition, several federal agencies, particularly the NIH, have been identified by the NPUAP Database of Current Pressure Ulcer Research Funding as having a history of funding PrU prevention and management studies. For example, entering the phrase “pressure ulcer” under the search prompt on http://www.nih.gov will identify potential funding opportunities for PrU studies. For tips on securing research funding, see Keys to Successful Applications on-line at http://www.woundcarejournal.com.
The NPUAP Database of Current Pressure Ulcer Research Funding has been established as an ongoing service to clinicians, researchers, and health care policy experts with an interest in PrUs. The NPUAP database intends to facilitate communication among researchers, identify specific gaps in current knowledge, and stimulate the development of important research projects that will be fundable. Individuals with an interest in PrU research are encouraged to review and submit grant information through the database Web site, http://www.rst.pitt.edu/npuap. Contributions to the database are essential to the success of this endeavor.
1. Beckrich K, Aronovitch SA. Hospital-acquired pressure ulcers: a comparison of costs in medical vs surgical patients. Nurs Econ 1999; 17:263–71.
2. Pressure ulcers in America: prevalence, incidence, and implications for the future. An executive summary of the National Pressure Ulcer Advisory Panel monograph. Adv Skin Wound Care 2001; 14:208–15.
3. Allman RM, Goode P, Burst N, Bartolucci AA, Thomas DR. Pressure ulcers, hospital complications, and disease severity: impact on hospital costs and length of stay. Adv Wound Care 1999; 12:22–30.
4. Indig R, Ronen R, Eldar R, Tamir A, Susak Z. Pressure sores: impact on rehabilitation following surgically treated hip fractures. Int J Rehabil Res 1995; 18:54–5.
5. Panel on the Prediction and Prevention of Pressure Ulcers in Adults. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline, No. 3. AHCPR Publication No. 92-0047. Rockville, MD: Agency for Health Care Policy and Research; May 1992.
6. Bergstrom N, Bennett MA, Carlson CE, et al. Treatment of Pressure Ulcers. Clinical Practice Guideline, No. 15. AHCPR Publication No. 95-0652. Rockville, MD: Agency for Health Care Policy and Research; December 1994.
A DATABASE UPDATE
The National Pressure Ulcer Advisory Panel (NPUAP) Database of Current Pressure Ulcer Research Funding was updated in 2002. New contacts included:
* Department of Veterans Affairs (VA) Centers of Excellence
* National Institute on Disability and Rehabilitation Research (NIDRR) Spinal Cord Injury and Brain Injury Model Centers
* Principal investigators of projects listed on http://www.clinicaltrials.gov and http://www.rehabtrials.org
* More than 25 private organizations identified through The Foundation Center (http://www.fdncenter.org) and Community of Science (http://www.cos.com).
Funding sources and amounts
The updated NPUAP database contains 54 active grants, representing $21,558,464 in funding. Twenty-nine (54%) of these grants were newly identified. Of these, 18 grants were identified through the National Institutes of Health’s (NIH) Computer Retrieval of Information on Scientific Projects (CRISP) database, 8 through the on-line questionnaire, 2 through the NIDRR’s National Rehabilitation Information Center (NARIC) database, and 1 through http://.www.clinicaltrials.gov. Seven of 32 grants in the 2001 database expired before November 15, 2002, and were removed from the database. The 25 remaining grants were combined with the 29 newly identified grants, bringing the total to 54.
As in 2001, federal agencies funded the majority of grants in the database (47 of 54). The NIH (17) and NIDRR (4) funded most of the newly identified grants. Within the NIH, the National Institute of Diabetes and Digestive and Kidney Diseases funded the largest number of newly identified grants (5), followed by the National Institute of Child Health and Human Development (4), and the National Institute of Nursing Research (NINR, 4). One newly identified grant was funded by the Centers for Disease Control and Prevention, adding this agency to the list of federal supporters of pressure ulcer (PrU) research. Two private and 2 corporate grants were newly identified.
The largest amounts of newly identified funding came from the Agency for Healthcare Research and Quality ($1,667,485) and the NIDRR ($1,333,125). Within the NIH, the largest amount of newly identified funding came from the NINR ($1,566,322). The funding in the database from the majority of institutes within NIH decreased, particularly funding from the National Institute of General Medical Sciences ($938,115). The National Institute on Aging (NIA) awarded the highest average amount per grant ($1,552,324). Corporate funding in the database increased by $1,006,855, mostly due to a single grant. Private funding increased by $38,000. Funding amounts were not available for 9 of the newly identified grants.
When updating the database, the subtopic areas of plantar pressure management, dressings and topical agents, and quality improvement gained the largest number of newly identified grants (6, 5, and 5, respectively). Several common themes also emerged. Four newly identified grants examine how psychosocial or behavioral issues impact PrU risk and prognosis. Five newly identified grants study individuals in the community, rather than acute care patients or long-term-care residents. In addition, 6 grants involve the development of clinically useful sensors to assess mechanical factors that contribute to PrU development and 5 grants fund randomized clinical trials.
Although the expansion of the NPUAP database is encouraging, many topics remain understudied. In addition, the number of corporate and privately funded grants identified in 2002 remained small, despite additional efforts to capture grants funded through these sources. Researchers are encouraged to develop fundable proposals that address areas of uncertainty in PrU research and to explore all sources of potential funding.