TY - JOUR
T1 - Lessons Learned While Conducting Research on Prevention of Pressure Ulcers in Veterans With Spinal Cord Injury
AU - Guihan, Marylou
AU - Garber, Susan L.
AU - Bombardier, Charles H.
AU - Durazo-Arizu, Ramon
AU - Goldstein, Barry
AU - Holmes, Sally Ann
N1 - Funding Information:
Supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (grant no. IIR 01-153).
PY - 2007/7
Y1 - 2007/7
N2 - Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Objective: To describe the challenges of conducting a large randomized controlled trial (RCT) to assess the effectiveness of an intervention to prevent recurrent pressure ulcers among a high-risk population of subjects with spinal cord injury (SCI). Design: Prospective multisite, randomized design comparing outcomes of patients who received individualized education and structured telephone counseling follow-up with those of patients receiving customary care. This study was stopped early because of unanticipated recruitment problems. Setting: Six Veterans Affairs SCI specialty centers. Participants: Veterans (N=150) treated for stage III or IV pelvic pressure ulcers. Interventions: Not applicable. Main Outcome Measure: Recurrence (defined as new skin breakdown in the pelvic area) and time to recurrence. The study was stopped early because of slow recruitment, so the focus of this study is lessons learned, not the main planned outcome measures. Results: Subject recruitment did not meet original expectations because almost 50% of those enrolled left the hospital with the study ulcer unhealed (having a healed ulcer was a requirement for participation). No significant differences were observed between groups on rate of or time to recurrence at the time the study was stopped. Among the 6 sites, variability in ulcer management (eg, length of stay, receipt of medical vs surgical treatment, sitting tolerance before discharge) and time to recurrence (median, 4mo) were observed. Conclusions: RCTs in real-world settings are the most robust method of assessing the effectiveness of prevention strategies. However, in complex, rapidly changing health care organizations, blinding is infeasible, it may be impractical to control for every variable that influences a study's outcome, and any assumptions that usual care is static are probably mistaken. Investigators must be prepared to use innovative approaches to maintain the integrity of the study design, including flexibility in inclusion and exclusion criteria to support accrual, obtaining a better understanding of the important aspects of usual care that may need to be standardized, continuous improvement within the intervention arm, and anticipation and minimization of risks from organizational changes. With attention to these delivery system issues and the usual design features of randomized trials, we believe real-world care settings can serve as important laboratories to test pressure ulcer prevention strategies in this population.
AB - Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Objective: To describe the challenges of conducting a large randomized controlled trial (RCT) to assess the effectiveness of an intervention to prevent recurrent pressure ulcers among a high-risk population of subjects with spinal cord injury (SCI). Design: Prospective multisite, randomized design comparing outcomes of patients who received individualized education and structured telephone counseling follow-up with those of patients receiving customary care. This study was stopped early because of unanticipated recruitment problems. Setting: Six Veterans Affairs SCI specialty centers. Participants: Veterans (N=150) treated for stage III or IV pelvic pressure ulcers. Interventions: Not applicable. Main Outcome Measure: Recurrence (defined as new skin breakdown in the pelvic area) and time to recurrence. The study was stopped early because of slow recruitment, so the focus of this study is lessons learned, not the main planned outcome measures. Results: Subject recruitment did not meet original expectations because almost 50% of those enrolled left the hospital with the study ulcer unhealed (having a healed ulcer was a requirement for participation). No significant differences were observed between groups on rate of or time to recurrence at the time the study was stopped. Among the 6 sites, variability in ulcer management (eg, length of stay, receipt of medical vs surgical treatment, sitting tolerance before discharge) and time to recurrence (median, 4mo) were observed. Conclusions: RCTs in real-world settings are the most robust method of assessing the effectiveness of prevention strategies. However, in complex, rapidly changing health care organizations, blinding is infeasible, it may be impractical to control for every variable that influences a study's outcome, and any assumptions that usual care is static are probably mistaken. Investigators must be prepared to use innovative approaches to maintain the integrity of the study design, including flexibility in inclusion and exclusion criteria to support accrual, obtaining a better understanding of the important aspects of usual care that may need to be standardized, continuous improvement within the intervention arm, and anticipation and minimization of risks from organizational changes. With attention to these delivery system issues and the usual design features of randomized trials, we believe real-world care settings can serve as important laboratories to test pressure ulcer prevention strategies in this population.
KW - Pressure ulcers
KW - Rehabilitation
KW - Spinal cord injuries
KW - Veterans
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U2 - 10.1016/j.apmr.2007.03.014
DO - 10.1016/j.apmr.2007.03.014
M3 - Article
C2 - 17601465
AN - SCOPUS:34250755565
SN - 0003-9993
VL - 88
SP - 858
EP - 861
JO - Archives of Physical Medicine and Rehabilitation
JF - Archives of Physical Medicine and Rehabilitation
IS - 7
ER -