The association of the Braden scale score and postoperative morbidity following urogynecologic surgery.
Key Words: Braden scale, postoperative morbidity, urogynecology.
As the population of the United States (U.S.) ages, the number of women with symptomatic pelvic floor disorders will increase (Wu, Vaughan et al., 2014). The estimated lifetime risk of surgery for stress urinary incontinence and/or pelvic organ prolapse is approximately 20% (Wu, Matthews, Conover, Pate, & Jonsson Funk, 2014). Many of these women will eventually seek surgical management of their symptoms.
Because urogynecologic procedures are elective, physicians do not routinely offer surgery to patients for whom surgery would pose an unnecessarily high risk. Therefore, perioperative complications following urogynecologic procedures are uncommon (Friedman, Gallup, Burke, Meister, & Hoskins, 2006). For women who are considered appropriate surgical candidates, common postoperative complications include urinary tract infections (UTIs). Other infrequent complications include blood transfusions, treatment with intravenous antibiotics for infection, and treatment with diuretics for pulmonary edema. Complications that are even more rare include reoperation and death (Bretschneider, Robinson, Geller, & Wu, 2015).
With an increasing number of women, including aging women (Jonsson Funk et ah, 2013) undergoing elective urogynecologic procedures, identifying reliable predictors of postoperative morbidity has become an important component of preoperative planning and counseling.
The Braden scale (Braden & Bergstrom, 1988) is a widely used tool to assess pressure ulcer risk, and Braden scores have been associated with postoperative morbidity in general surgery patients; however, this scale has not been evaluated in the urogynecologic setting. The aim was to assess whether the Braden scale is associated with postoperative morbidity in women undergoing urogynecologic procedures for stress incontinence and pelvic organ prolapse.
Is the Braden scale score associated with postoperative morbidity in women undergoing urogynecologic procedures for stress incontinence and pelvic organ prolapse?
Pressure ulcer development is merely one example of a clinically measurable marker of frailty. As part of the patient safety movement for all hospitalized patients (Mancuso et al., 2007), the Braden scale has been employed across the U.S. and abroad to assess patient pressure ulcer risk (Agency for Healthcare Research & Quality, 2014; Bergstrom, Braden, Kemp, Champagne, & Ruby, 1998). As interest in frailty as a predictive indicator of morbidity increases, studies evaluating baseline motor and cognitive function as surrogates of frailty have emerged (Bagshaw & McDermid, 2013).
Pressure ulcer risk is correlated with a decline in physical function; therefore, the Braden scale can, in turn, be interpreted as a surrogate measure of frailty. A number of studies in the greater surgical literature have shown that frailty is associated with a higher risk of postoperative morbidity. Frailty, defined by de Vries et al. (2011) as a "physiologic loss of reserve capacity and resistance to stressors" (p. 104), increases patients' susceptibility to perioperative complications. While the development of frailty is a complex process, it can be recognized by a number of discrete clinical manifestations (Bandeen-Roche et al., 2006).
The association between Braden scores and postoperative outcomes in surgical patients was first discussed in a study by Cohen and colleagues (2012). This study found that postoperative Braden scores were an independent risk factor for adverse outcomes in patients aged 65 years and older following abdominal surgery. This research has shown a correlation of Braden scores and postoperative complications in older adult patients undergoing general surgery; however, its clinical applicability in the elective gynecologic setting has yet to be explored.
This was a retrospective cohort study of women who underwent pelvic floor reconstructive surgery between March 2011 and June 2013 at the University of North Carolina (UNC) Hospitals at Chapel Hill. This study was approved by the UNC Biomedical Institutional Review Board. Women aged 18 years and older were included if they underwent stress urinary incontinence and/ or pelvic organ prolapse surgery during the study period. Women with a concurrent gynecologic malignancy and women who were not assigned a preoperative Braden score were excluded.
Given that published literature does not exist regarding the study question, there was inadequate information to estimate an a priori power analysis for sample size. However, several prominent authorities (Hosmer & Lemeshow, 2000; Peduzzi, Concato, Kemper, Holford, & Feinstein, 1996) have determined that for logistic regression, at least 10 cases per variable analyzed were desirable to maintain the validity of the model. Using this guide, it was concluded that a sample size of approximately 450 subjects was a more than adequate sample size to evaluate the study question.
Demographic data were abstracted from the UNC electronic medical record (EMR), including age, race, insurance status, smoking status, past medical history, past surgical history, current medications, body mass index (BMI), and degree of prolapse based on the pelvic organ prolapse quantification (POP-Q) exam.
Surgical data included preoperative hematocrit, operative time, anesthesia time, estimated blood loss (EBL), intraoperative complications, and intraoperative transfusion. Operative time was defined as time of surgical incision to the time at the end of the procedure when the patient is returned to the dorsal supine position. Postoperative length of hospitalization, readmissions, and reoperations were also abstracted from the UNC EMR.
Measure of Comorbidity
We evaluated pre-operative comorbidities using the Charlson Comorbidity Index (CCI), a validated scale reflective of patients' comorbidity burden. The CCI is a method of predicting mortality by categorizing comorbidity status based on a weighted scale that takes into account the number and seriousness of diseases. Overall burden of comorbid state is quantified on a scale of 1 to 6, with higher scores indicating higher number and more severe comorbid conditions with higher likelihood of mortality (Charlson et al., 1990; Charlson, Pompei, Ales, & MacKenzie, 1987). Baseline scores were divided into two categories, with scores of 0 to 1 indicating lower risk comorbid states and scores of 2 to 6 indicating more severe states.
Measure of Frailty
The Braden scale is a validated tool that assesses six categories of health: sensory perception, moisture, activity, mobility, nutrition, and friction and shear (Bergstrom et al., 1998). Possible scores range from 6 to 23; a lower score is associated with a higher pressure ulcer risk. A Braden score of greater than 18 represents no risk, 15 to 18 mild risk, 13 to 14 moderate risk, 10 to 12 high risk, and 9 or lower severe risk. The Braden scale is administered by a nurse preoperatively, postoperatively, and daily throughout an inpatient stay as part of routine nursing care. Braden scores from both the preoperative and post-operative settings were abstracted from the UNC EMRs.
Measure of Postoperative Morbidity
The primary outcome criterion was postoperative morbidity defined as grade II or greater complication on the Clavien-Dindo scale (Dindo, Demartines, & Clavien, 2004) in the six-week postoperative period. Any complication that occurred during this six-week postoperative period was included in the analysis. All postoperative complications were defined by the Clavien-Dindo scale (see Table 1). Clavien-Dindo grade II or greater represents a deviation from the normal postoperative course that requires pharmacologic treatment other than the standard anti-emetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Interventions, such as blood transfusions, intravenous antibiotics, and total parenteral nutrition, are included in this category.
Clavien-Dindo grade II or greater complications were considered significant because they represent a deviation from the normal postoperative course and require pharmacologic treatment other than the standard anti-emetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Clavien-Dindo grade I complications were not included in the primary outcome because such complications are not considered to be clinically significant. Clavien-Dindo grade I complications are managed with supportive measures and medications used routinely during the postoperative period.
General Statistical Plan
Data were analyzed with IBM SPSS version 18.0. The Pearson-[X.sup.2] statistical test and t-test were used where appropriate. For the -[X.sup.2] test for variables with more than two categories, we used adjusted standardized residuals to determine which categories were related to significant p-value (i.e., adjusted standardized residuals > 1.96). A p-value less than 0.05 was considered statistically significant.
Logistic regression analysis was used to determine whether baseline Braden scores are associated with the occurrence of postoperative complications among the sample. There was concern that this relationship may be affected or hidden by potentially confounding variables, such as patient age, preoperative comorbidities as operationalized using the CCI score, BMI, smoking status, and/or length of surgery; thus, these variables were included as covariates and held constant across the model. This action was expected to increase the accuracy of the results.
Of the 508 women who underwent stress urinary incontinence and/or pelvic organ prolapse surgery during the study period, 460 (90.6%) met inclusion criteria for the study; 48 were excluded due to missing preoperative Braden scores. Among the sample, 12.4% had a CCI score of [greater than or equal to] 2, indicating a moderate comorbidity burden. BMI was reported (M = 29.0, SD = 6.1kg/[m.sup.2]). In terms of pelvic organ prolapse, a majority of women (80.2%) had [greater than or equal to] stage II prolapse. Additional characteristics of the sample are presented in Table 2.
Preoperative Braden scores ranged from 16 to 23 (M = 22.4, SD = 1.1); postoperative scores ranged from 11 to 23 (M = 19.5, SD = 2.3). Table 3 provides a summary of the Braden scale scores. The overall rate of postoperative complications was 9.1%. Table 4 presents the Clavien-Dindo grades and associated complications. Although most women were at no or low risk for pressure ulcers, t-test indicated that preoperative Braden scores were significantly lower in the group with postoperative complications (M= 21.6, SD = 1.9 versus M = 22.5, SD = 0.9, p = 0.008).
Table 5 provides a summary of a logistic regression analysis adjusted for age, BMI, smoking status, CCI, and length of surgery. Preoperative Braden scores remained significantly associated with postoperative morbidity; increasing length of surgery (in hours) was also significantly associated with an increased risk of postoperative morbidity. Table 6 demonstrates that there was no association found between postoperative Braden scores and postoperative morbidity (p = 0.83).
In a secondary analysis, we excluded UTI from the outcome data, even though UTIs are categorized as Clavien-Dindo grade II complications. The rationale was that UTIs are frequently encountered in the postoperative setting following urogynecologic procedures and are often not considered to be a significant deviation from a routine postoperative course. With UTIs excluded, the rate of complications decreased from 9.1% to 7.0%. Using the same logistic regression model, preoperative Braden scores remained significantly associated with postoperative morbidity (OR = 0.61, 95% Cl [0.46, 0.82]). Length of surgery also remained significantly associated with postoperative morbidity [OR = 1.62, 95% CI [1.22, 2.14]).
This study found that preoperative Braden scores were associated with clinically significant postoperative morbidity in women undergoing urogynecologic procedures. Lower preoperative Braden scores were significantly associated with a higher risk of complications, even in the sample that was at low risk for pressure ulcer development. Although the study population had relatively normal Braden scores, this study is important because it provides further exploration of ways to identify patients at risk for adverse postoperative outcomes.
The association between Braden scores and postoperative outcomes in surgical patients was first discussed in a study by Cohen and colleagues (2012). This study found that postoperative Braden score was an independent risk factor for adverse outcomes in patients aged 65 years and older following abdominal surgery. Preoperative scores were not evaluated in the Cohen et al. (2012) study. In our study, preoperative, rather than postoperative, Braden scores were predictive of postoperative morbidity in this patient sample. It is unclear why preoperative, and not postoperative, Braden scores were associated with morbidity in this patient sample; however, this may be a reflection of the heterogeneity of surgeries performed because increasing length of surgery was also found to be an independent risk factor for postoperative morbidity.
The Braden scale may prove to be a useful tool in determining a patient's preoperative fitness in a population where functional deficits are less immediately apparent. Overall, this patient sample was at low risk for pressure ulcers, yet lower preoperative Braden scores were significantly associated with postoperative morbidity even when controlling for age, BMI, smoking status, comorbidities, and length of surgery. This finding suggests that the Braden scale may be capturing a unique dimension of preoperative fitness. The usefulness of the Braden scale in predicting morbidity in the population of women who undergo elective urogynecologic surgery is still unclear, and further research is needed to address this question.
Strengths and Limitations
In addition to the novel application of the Braden scale, a strength of this study is the use of the validated Clavien-Dindo scale to classify postoperative complications and discern which complications are clinically significant (Dindo et al., 2004). Secondly, the inter-rater reliability of the Braden scale is high (Hightower et al., 2010). This study is further strengthened by a secondary analysis in that the exclusion of UTIs did not affect the findings. Lastly, the study sample was a large cohort of women who were not only diverse in age, but also in the types of surgeries they underwent.
The study is limited by the original intent of the Braden scale--to serve as a risk assessment tool for nurses, and it has not been validated to assess frailty or postoperative risk directly. Another limitation is the retrospective design and the associated inherent potential for bias. Lastly, urogynecologic surgery is elective, and the patient population may represent a relatively healthy cohort of women; thus, these findings may not be generalizable to patients with a higher comorbidity burden.
Implications for Urologic Healthcare
This study is unique in that we explored a novel application of a commonly used hospital risk assessment tool. Physicians' familiarity with this scale may be limited even though most patients are routinely assigned a preoperative Braden scale by nursing staff. The goal is to raise awareness of this risk assessment tool among physicians, which could lead to enhanced coordination of patient care between nurses and physicians. For example, once a nurse identifies a patient with a low Braden score, the nurse could then initiate patient-centered communication with the physician, which could ultimately trigger more intense postoperative follow up, specific patient/family counseling, or risk-modifying interventions.
Identifying predictors of postoperative morbidity for women undergoing elective urogynecologic procedures is essential to providing safe and comprehensive care. With increasing attention paid to the relationship between frailty, hospitalization risks, and clinical outcomes, new indices and scales are being developed to improve the identification of at-risk populations. In order to create clinically meaningful tools with particular focus on identifying modifiable preoperative risk factors, further research into the biomarkers and phenotypic traits of frailty should be performed.
Additional investigation is also needed to evaluate preoperative fitness with respect to the criteria evaluated in the Braden scale, with special focus on the Braden scale subcategories significantly associated with morbidity. While the Braden scale has been used primarily to recognize patients at high risk of developing pressure ulcers, this widely utilized scale may also be a clinically meaningful tool that can assist clinicians in identifying patients at risk of postoperative morbidity. Further research is needed to determine whether the Braden scale is applicable to other clinical settings and whether it is predictive of perioperative complications in women undergoing other types of gynecologic surgery.
The Braden scale is a widely used tool to assess pressure ulcer risk, and Braden scores have been associated with postoperative morbidity in general surgery patients. However, this scale has not been evaluated in the urogynecologic setting. Thus, the objective was to assess whether the Braden scale score is associated with postoperative morbidity in women undergoing urogynecologic procedures for stress incontinence and pelvic organ prolapse.
The convenience sample consisted of 460 women who underwent stress urinary incontinence and/or pelvic organ prolapse surgery at the University of North Carolina Hospital between March 2011 and June 2013.
A retrospective approach examined Braden scale scores as a primary predictor of clinically significant postoperative complications, defined as Clavien-Dindo grade II or greater, while controlling for specific possible confounding variables.
Preoperative Braden scores ranged from 16 to 23 (M = 22.4, SO =1.1) and were significantly associated with postoperative complications (M = 22.5, SD = 0.9 versus M = 21.6, SD = 1.9, p = 0.008) in women without and with complications, respectively. The overall postoperative complications rate was 9.1%. In a logistic regression analysis adjusted for age, body mass index (BMI), smoking status, comorbidities, and length of surgery, lower preoperative Braden scores remained significantly associated with postoperative morbidity (OR = 0.62, 95% CI [0.48, 0.80]).
Among this sample of women undergoing urogynecologic surgery, lower preoperative Braden scores were associated with postoperative morbidity.
Level of Evidence--Level VI
(Polit & Beck, 2012)
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C. Emi Bretschneider, MD, is a Resident Physician, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Maria L. Nieto, MD, is a Fellow Physician, Division of Urogynecology Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Elizabeth J. Geller, MD, is an Associate Professor, Division of Urogynecology Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Mary H. Palmer, PhD, is a Professor, Division of Adult and Geriatric Health, School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Jennifer M. Wu, MD, MPH, is an Associate Professor, Division of Urogynecology Department of Obstetrics and Gynecology and Center for Women's Health Research and Center for Aging and Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Table 1. Clavien-Dindo Classification of Surgical Complications Grade Definition I Any deviation from the normal postoperative course without the need for pharmacological treatment, surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are; drugs as anti-emetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. II Requiring pharmacological treatment with drugs other than such allowed for grade 1 complications, including blood transfusions and total parenteral nutrition. III Requiring surgical, endoscopic or radiological intervention. IV Life-threatening complication including central nervous system complications requiring intensive care management. V Death. Source: Dindo et al., 2004. Table 2. Characteristics of the Sample (N = 460) Characteristic n % Race White 362 78.7 Black 56 12.2 Other 42 9.1 Parous 444 96.5 Insurance None/charity 49 10.7 Private 388 84.3 Medicaid 3 0.7 Medicare 19 4.1 Tobacco use 33 7.2 POP-Q stage Stage 0 11 2.5 Stage 1 77 17.3 Stage 2 171 38.4 Stage 3 154 34.6 Stage 4 32 7.2 Charlson Comorbidity Index 0 284 61.7 1 119 25.9 2 42 9.1 3 11 2.4 4 1 0.2 5 3 0.7 Hysterectomy 128 28.0 Vaginal 84 18.3 Abdominal 14 3.1 Laparoscopic or robotic 30 6.6 Anterior procedure 148 32.2 Posterior procedure 209 45.4 Any anti-incontinence procedure 238 51.7 Apical suspension 223 48.5 Any intraoperative complications 22 4.8 Table 3. Summary of Preoperative and Postoperative Braden Scale Scores (N =460) Preoperative Postoperative (n = 460) (n = 425) Pressure Ulcer Risk Category (Braden Scale Score) n % n % No risk (19 to 23) 454 98.7 298 64.8 Mild risk (15 to 18) 6 1.3 109 23.7 Moderate risk (13 to 14) 0 0.0 12 3.0 High risk (10 to 12) 0 0.0 4 0.9 Severe risk (9 or less) 0 0.0 0 0.0 Table 4. Clavien-Dindo Grade and Associated Complications (n = 46) Clavien-Dindo Grade and Complications n Grade II Blood transfusion 19 Antibiotics (IV unless otherwise indicated) Urinary tract infection (oral antibiotics) 13 Perineal infection (oral antibiotics) 1 Vaginal cuff abscess 1 Pneumonia 1 Cellulitis 2 Pyelonephritis 1 Sepsis 1 Pulmonary edema requiring IV furosemide 3 Pulmonary embolism requiring Coumadin 1 IV anti-hypertensive 3 IV beta-blockers due to tachycardia 1 Hyponatremia requiring salt tabs 2 Total parenteral nutrition 1 Transient ischemic attack 1 Grade III Reoperation for small bowel obstruction 2 Reoperation for arterial bleed 1 Reoperation for placement of ureteral stents 1 Grade IV Non-ST elevation myocardial infarction with initiation 1 of heparin drip Table 5. Summary of Logistic Regression Analysis of Association of Preoperative Braden Scores and Postoperative Morbidity Variable B SE P OR [95% CI] Preoperative Braden score -0.48 0.13 <0.01 0.62 [0.48, 0.80] Age (decades) 0.26 0.14 0.08 1.29 [0.97, 1.71] Lower risk comorbidity score 1.36 0.81 0.09 3.88 [0.80, 18.8] Higher risk comorbidity 1.31 0.83 0.11 3.70 [0.73, 18.6] BMI (kg/[m.sup.2]) -0.05 0.03 0.16 0.96 [0.90, 1.02] Smoker 0.58 0.67 0.39 1.79 [0.48, 6.72] Length of surgery (in hours) 0.37 0.13 <0.01 1.45 [1.13, 1.86] Note: Comorbidity score of 0 is the reference group. Table 6. Summary of Logistic Regression Analysis of Association of Postoperative Braden Scores and Postoperative Morbidity Variable B SE P OR [95% CI] Postoperative Braden score -0.06 0.07 0.42 0.94 [0.82, 1.08] Age (decades) 0.40 0.14 <0.01 1.49 [1.13, 1.97] Lower risk comorbidity 1.11 0.77 0.15 3.02 [0.67, 13.6] Higher risk comorbidity 1.17 0.79 0.14 3.23 [0.68, 15.3] BMI (kg/[m.sup.2]) -0.04 0.03 0.25 0.96 [0.90, 1.03] Smoker 0.69 0.68 0.31 2.00 [0.53, 7.53] Length of surgery (in hours) 0.31 0.13 0.02 1.36 [1.05, 1.75] Note: Comorbidity score of 0 is the reference group.
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|Author:||Bretschneider, C. Emi; Nieto, Maria L.; Geller, Elizabeth J.; Palmer, Mary H.; Wu, Jennifer M.|
|Date:||Jul 1, 2016|
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