Keiko Tokunaga

Development of the DESIGN‐R with an observational study: An absolute evaluation tool for monitoring pressure ulcer wound healing

DESIGN is a seven‐item (depth, exudates, size, inflammation/infection, granulation, necrosis, and pocket) monitoring scale for pressure ulcers developed in 2002 by the scientific education committee of the Japanese Society of Pressure Ulcers. DESIGN is a very useful tool for chronological monitoring of each pressure ulcer, but a key limitation of this tool is its inability to compare the wound‐healing process among different pressure ulcers in different patients due to a lack of statistical item weighting. Our aim was to weight DESIGN items by statistical analysis and develop a new validated tool to overcome this limitation. Subjects comprised 3,601 patients with pressure ulcers. Patients were followed every week during the study period. To establish the weighting of each item and grade, we estimated the probabilities of wound healing at 12‐month follow‐up using multivariable Coxs regression analysis. Weighting (−β value) for each item in order of the highest rank was: pocket, 2.289; size, 1.573; inflammation/infection, 0.778; granulation tissue, 0.682; exudate, 0.543; and necrotic tissue, 0.529. Based on these findings, a new, validated “DESIGN‐Rating tool” for monitoring the progression of pressure ulcer healing was developed, implying the development of an absolute evaluation tool and clinical indicator to assess the quality of medical care.

Clinical wound assessment using DESIGN‐R total score can predict pressure ulcer healing: Pooled analysis from two multicenter cohort studies

There are few clinical tools with both predictive validity for pressure ulcer healing and availability in broad populations. We evaluated whether the total scores from DESIGN‐R tool could predict pressure ulcer healing. We followed 3,196 patients with pressure ulcers from two multicenter cohort studies until wound healing, patient death, or discharge. Wound severity was evaluated by DESIGN‐R tool from 0 (healed) to 66 (greatest severity). In the multivariate Cox proportional hazard model, higher DESIGN‐R total scores at baseline were associated with lower healing rates (hazard ratio 0.90, 95% confidence interval 0.89–0.92), independent of the patients characteristics, setting types, and wound depth or location. DESIGN‐R had discriminative value for wound healing up to 90 days; the area under the receiver‐operating characteristics curve from univariate analysis was 0.81 for healing within 30 days and 0.74 for healing within 30–90 days. The cutoff points were 9 for healing within 30 days and 18 within 30–90 days (positive and negative predictive value 78.8 and 74.1%; 63.9 and 81.1%, respectively). These points were validated for both superficial and deep ulcers. DESIGN‐R can be a useful tool to predict pressure ulcer healing for a wide range of patient populations, settings, and wound locations.

Serum albumin level is a limited nutritional marker for predicting wound healing in patients with pressure ulcer: two multicenter prospective cohort studies.

BACKGROUND & AIMS We aimed to investigate the predictive validity of serum albumin for pressure ulcer healing, according to patient condition and wound characteristics. METHODS This study was a secondary analysis of pooled data from two multicentre cohort studies undertaken in 2005 and 2007. All adult patients with pressure ulcer were included and were tracked until wound healing or discharge from care. Baseline serum albumin data were obtained from medical charts. RESULTS A total of 2530 patients were analyzed. By multivariate Cox proportional hazards analysis, higher serum albumin level was associated with wound healing of only superficial pressure ulcers for patients in acute/postoperative conditions (hazard ratio 1.29, 95% confidence interval 1.13-1.46) and the cutoff point was 24/25 g/L. However, the addition of serum albumin level to other factors resulted in little increase in the ability to predict wound healing as measured by the overall C-statistics. For patients in chronic/palliative conditions, serum albumin level as the continuous variable was not significantly associated with ulcer healing. CONCLUSIONS The addition of serum albumin marker may not have much advantage to predict pressure ulcer healing although its level can be associated with ulcer healing, depending on patient condition and wound depth.

Prospective longitudinal evaluation of quality of life in patients with permanent colostomy after curative resection for rectal cancer: a preliminary study.

PURPOSE: The aim of this study was to evaluate health-related quality of life in patients with a colostomy immediately before and during the first year after surgery. SUBJECTS AND SETTING: Patients (aged ≥20 years) who were diagnosed with rectal cancer and scheduled to undergo curative surgery with a permanent colostomy were recruited for this study. Data were collected at 2 university hospitals in Tokyo. METHODS: Participants were asked to complete a self-administered questionnaire regarding health-related quality of life before surgery and a mailed or hand delivered questionnaire to evaluate quality of life at 2, 6, and 12 months after surgery using the Short Form–36 version 2. For patients who responded at all 4 time points, the scores at each time point were compared using paired t tests to examine longitudinal changes in quality of life after surgery. RESULTS: Mean quality-of-life scores in most domains before surgery and during the first year after surgery were lower than the normal control in the norm-based scoring method. Scores at 2 months after surgery were lower than those before surgery. At 12 months after surgery, however, quality-of-life scores improved almost to the level observed before surgery, with the exception of the score in the social functioning domain. Statistical differences in scores between the time points of the survey were observed in the role-physical, bodily pain, and mental health domains. CONCLUSIONS: These results suggest that patients with permanent colostomy after curative resection for rectal cancer need additional medical support and care before surgery and during the first year after surgery.

Predictive validity of weekly monitoring of wound status using DESIGN-R score change for pressure ulcer healing: a multicenter prospective cohort study.

There are few studies on predictive validity of methods to monitor the healing process of pressure ulcers. We evaluated whether the change of DESIGN‐R (rating) score could predict subsequent healing, and determined the optimal cutoff points. In a multicenter prospective cohort study, patients were followed until wound healing or censoring. Wound severity was evaluated by the DESIGN‐R tool every week, and the score change was calculated over 1–4 weeks (n = 411, 286, 224, and 170, respectively). In the multivariate analyses stratified by depth, a one‐point improvement in DESIGN‐R score over any period was positively associated with healing within the next 30 days independent of initial wound severity (hazard ratios over each 1–4 weeks ranging from 1.16 to 1.33 for superficial ulcers and from 1.21 to 1.27 for deep ulcers; all p < 0.05). The optimal cutoff points over 1–4 weeks were set as negative change for superficial ulcers and as positive change of ≥two points for deep ulcers. Nonhealing rate was higher for ulcers with DESIGN‐R score change below the cutoff points than that aforementioned for both depths. Weekly monitoring by the DESIGN‐R tool will be advantageous for evaluating prognosis of pressure ulcers independent of initial wound severity and depth.

PATIENT RISK FACTORS FOR PRESSURE ULCERS IN THE CRITICAL CARE SETTING: 676

PURPOSE: Various studies have reported on patients who develop pressure ulcers within the first week or fortnight of hospitalization in the critical care setting. The purpose of this study was to identify pressure ulcer risk indicators and when the pressure ulcer occur in the critical care setting. METHODOLOGY: A prospective longitudinal study was designed to collect relevant data on all patients at risk of developing pressure ulcers. The study facility is a 606-bed tertiary care hospital. One-hundred six of the 272 subjects admitted to the ICU/HCU during 3-month period were included in this study. The criteria for selection were being: (1) an adult older than 19 years of age, (2) free from pressure ulcers on admission, and (3) hospitalized more than 24 hours. The data were collected on admission to the ICU/HCU at 48 and 72 hours after admission, and then every 48 hours until discharge, or for a maximum of 15 days. The Pearson, Chi-square, and logistic-regression analyses were used to identify the variables associated independently with pressure ulcers (SPSS ver.11.0). Informed consent was obtained. RESULTS: Subjects’ mean age was 60.0, SD 15.8 years, and mean APACHE2 score was 7.8, SD 4.3. Nineteen (7.5%) of the 272 subjects developed pressure ulcers during the study, and 8 (42.1%) of the 19 subjects developed them during surgery, which was statistically significant. (P < .004) The incidence of pressure ulcers in surgical patients in this study was 7.1%, and multivariate analysis revealed that undergoing lengthy surgical procedures, being an emergency postoperative patients, using lateral and prone position, and body mass index (BMI) were key factors. Receiver-operating characteristic (ROC) curves for BMI show best balance between sensitivity and specificity at 20.37 (75.0%, 78.1%). CONCLUSION: In the critical care setting, it is important to prevent pressure ulcer formation during surgery. Additionally, being emergency postoperative patients, lateral position, prone position, and a BMI below 20.37 were significant risk factors for pressure ulcer formation.