Obstetrics & Gynecology:
Pelvic Floor Surgery in the Older Woman: Enhanced Compared With Usual Preoperative Assessment
Richter, Holly E. PhD, MD*; Redden, David T. PhD†§; Duxbury, Andrew S. MD‡; Granieri, Evelyn C. MD, MPH¶; Halli, Anne D.‡; Goode, Patricia S. MD‡§
*Division of Medical Surgical Gynecology, Department of Obstetrics and Gynecology, †Department of Biostatistics, and ‡Division of Gerontology and Geriatric Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; §Birmingham/Atlanta Geriatric Research, Education and Clinical Center (GRECC), Department of Veterans Affairs Medical Center, Birmingham, Alabama; and ¶Department of Geriatric Medicine, Department of Veterans Affairs Medical Center and Mount Sinai School of Medicine, Bronx, New York.
Funded by the American Geriatric Society/Hartford Foundation.
Presented at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, Philadelphia, Pennsylvania, May 1-4, 2004.
Address reprint requests to: Holly E. Richter, PhD, MD, Medical Surgical Gynecology, University of Alabama at Birmingham, 620 20th Street South, NHB 219, Birmingham, Alabama 35249–7333; e-mail: email@example.com.
Received April 28, 2004. Received in revised form November 23, 2004. Accepted December 16, 2004.
OBJECTIVE: To examine whether knowledge of deficits obtained in a preoperative geriatric assessment may benefit postoperative health outcomes in older women undergoing pelvic surgery.
METHODS: This study employed a pre–post intervention cohort design. Primary outcome was difference in scores of the Physical Component Summary and Mental Component Summary of the Medical Outcomes Study Short Form 36 Health Survey in 62 older women who had undergone “usual” compared with an “enhanced” preoperative assessment consisting of Activities of Daily Living, Instrumental Activities of Daily Living, Get Up and Go Test, Draw a Clock Test, Mini Nutritional Assessment, Geriatric Depression Scale, and Social Support Scale. The assessment results were placed on the participant's hospital chart. Repeated measures analysis was used.
RESULTS: There were no significant differences in Mental Component Summary scores between the usual and enhanced assessment cohorts preoperatively (mean ± standard deviation; 49.14 ± 10.61 compared with 53.2 ± 9.33), at 6 weeks (53.69 ± 8.61 compared with 55.47 ± 9.46), or at 6 months postoperatively (53.85 ± 10.77 compared with 56.25 ± 7.25); P = .120 for group effect and P = .798 for group by time interaction. Significant time effect was noted (P = .036). There was no significant difference in Physical Component Summary scores between the usual and enhanced assessment cohorts with respect to group effect (P = .986); there was a significant time effect (P = < .001) and a significant group by time interaction (P = .026). Satisfaction with treatment was high in both cohorts at 6 weeks and 6 months.
CONCLUSION: A preoperative geriatric assessment did not seem to have differential benefit in healthy older women undergoing elective pelvic floor surgery.
LEVEL OF EVIDENCE: II-2
It is estimated that during the next 50 years the population 65 years and older will grow from 35 to 78 million.1 The majority of this population is now and will be women.2 Demand for prolapse and incontinence surgery is projected to increase by 45% in the next 30 years,3,4 commensurate with this increase in the population of older women. It is our responsibility to ensure that older women are optimally prepared to undergo and recover from gynecologic surgery.5,6
Studies assessing the morbidity and mortality of gynecologic surgery in older women reveal minimal7 or no increase in mortality attributable to age alone,8–12 but related more to underlying disease and comorbidities.5 Studies discussing the safety of performing pelvic surgery for benign disease in the older woman with chronic medical conditions8,13–18 concentrate on the intraoperative and postoperative morbidity and mortality and efficacy of the repair rather than the functional and general health outcomes. Evidence from other disciplines19–21 suggests that older surgical patients may be at risk for functional impairment. However, little is known about the functional and general health outcomes in this patient population or whether preoperative, intraoperative, or postoperative intervention enhances functional recovery.
Geriatric assessment, with its additional evaluations of social support and functional, nutritional, and mental status, is considered the cornerstone of elder health care and a major point of differentiation between geriatric and usual adult medicine.22 Much work has been done using various forms of assessment in both inpatient and outpatient arenas over the last few decades, showing such benefits as decreased rates of nursing home admission, decreased mortality, increased independent function, and decreased medical care costs among patients who receive such assessment.23,24
Delirium has been shown to be a serious consequence for the older surgical patient, prolonging hospital stays and reducing function in the postoperative period. Patients with mild to moderate impairment in cognitive function who are particularly likely to develop delirium25 can be quite skilled in hiding their impairments from family and physicians. Geriatric assessment tools can uncover problems such as delirium that may not be obvious in the usual preoperative evaluation but could be important with the stress of surgery and a stay in an unfamiliar environment. Other masked disease processes that can have profound effects on healing and should be diagnosed preoperatively include malnutrition and depression. Knowledge of the support system that is in place to assist the patient throughout the perioperative period is particularly important in cases of mental or physical frailty and needs to be ascertained.26
The aim of this study was to evaluate the impact of adding geriatric assessment tools to the usual preoperative evaluation on the mental and physical health outcomes in older women undergoing elective pelvic floor surgery. The primary hypothesis was that a geriatric assessment would result in improved outcomes in the Physical Component Summary and Mental Component Summary27 of the Short Form 36 health survey as compared with “usual” preoperative assessment alone. A pre–post intervention cohort design was selected to examine this hypothesis due to the lack of any prior studies of preoperative geriatric assessment for women undergoing elective pelvic surgery.
MATERIALS AND METHODS
Institutional review board approval was obtained. A convenience sample of 62 patients, greater than 60 years of age, scheduled to undergo pelvic floor surgery (February 2002 through March 2003) was approached for participation except if participating in another research study. During the first 6 months of the study the only addition to usual preoperative care was that the research nurse administered the Short Form 3627 and a Utility Item Score to consenting patients, preoperatively and at 6 weeks and 6 months postoperatively. The Utility Item Score was based on the answer to the following question: “On a scale of 0 to 100, where 0 represents death and 100 represents perfect health, please indicate how you would rate your current state of health.” These patients underwent the physicians’ usual course of evaluation, including consideration of needed clearance for any significant medical comorbidities. The Health Utility Score and the results of the Short Form 36 were not placed on the patients’ hospital charts. During the second 6 months, patients underwent all of the above assessments as well as undergoing an “enhanced” preoperative geriatric assessment consisting of a baseline functional and cognitive assessment using the Basic Activities of Daily Living (ADL),28 Instrumental Activities of Daily Living,29 Get Up and Go Test,30 “Draw a Clock” Test,31 Mini Nutritional Assessment,32 Geriatric Depression Scale,33 and Social Support Scale.34 The instruments for the enhanced assessment were administered by research nurses, and the results were placed in the patients’ hospital charts. The primary surgeons and resident physician team were aware of the results of the geriatric assessment.
It was thought that knowledge by physicians of patients’ potential deficits in areas of cognitive and functional ability would affect the postoperative care and subsequent physical and mental health outcomes, as measured by the Medical Outcome Study (MOS) derived Short Form 36 Health Survey.27 The Short Form 36 is a 36-item self-report questionnaire designed to survey health status across 8 health concepts: 1) limitations in physical activities due to health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. This questionnaire has been extensively used in studies of women's health issues35 and has been shown to be sensitive to changes in women with incontinence-related surgery or estrogen or behavioral therapy.36 The Short Form 36 has 2 summary indexes, the Mental Component Summary and the Physical Component Summary, which are derived using weighted averages of the individual domain scores.
All patients completed the above assessments after their outpatient preoperative visit with the surgeon and before evaluation and blood work as obtained by the anesthesia preoperative evaluation clinic. Postoperative Short Form 36 and satisfaction with care questionnaires were performed by the research nurse in a telephone interview. Medical comorbidities were classified according to the method of Charlson et al37 by medical record review.
The enhanced assessment instruments used in the study were chosen for their ability to be rapidly administered to older patients and for their ability to cover various domains of functional status, including physical function, cognitive function, emotional function, social function, and general health status. All of the tools are standard instruments of geriatric assessment widely used in research and clinical practice.
One measure of physical function is an individual's ability to complete ADL.28 The set of basic ADLs, those activities necessary to maintain the body, first formulated by Katz et al28 have become standard throughout the realms of geriatric medicine and gerontology. The more advanced instrumental activities of daily living examine the skills needed by adults in modern society necessary to maintain independence.29 Both ADL and Instrumental Activities of Daily Living consist of a checklist of activities and depend upon self-reporting. To obtain a realistic assessment of physical function, a performance-based test was selected to allow the examiner quickly to observe the patient physically move. The Get up and Go test30 is a quick basic direct demonstration of control of body movement, function, and ambulatory ability and is often used in clinical practice and studies of aging, because it requires little time and no specialized equipment.
To measure cognitive function, we chose a tool that has been shown to be a good predictor of inpatient complications and which requires no specialized training or equipment to administer, the Draw a Clock test.31 The Draw a Clock test has been shown to be more sensitive than some longer, more complicated assessments of cognitive function such as the Mini Mental Status Examination and less affected by lower educational levels.38,39
The Mini Nutritional Assessment,32 Geriatric Depression Scale,33 and Social Support Scale34 were chosen because they are all easily completed within minutes and give valuable insights into conditions that could lead to poor surgical outcomes, as well as knowledge of the support system that is in place to assist the patient throughout the perioperative period.
Descriptive statistics were used to characterize the patient population. Analyses began with calculation of means and variances of all outcomes at each observational period of the study and χ2 analyses were used to compare baseline characteristics between groups. The Short Form 36 was administered preoperatively and at 6 weeks and 6 months postoperatively. To account for the longitudinal nature of the design (62 patients providing 3 observations during a 6-month period), repeated measures analysis of variance methods were used. Models were developed for the Short Form 36 composite domains of physical and mental functioning. Tests for the effects of enhanced assessment, time, and the interaction between time and assessment were conducted. Outcomes were also compared across 2 age groups in an exploratory analysis (aged less than 75 years compared with older than or equal to 75 years) to examine whether age significantly predicted longitudinal differences. All analyses were conducted using SPSS 9.0 (SPSS Inc., Chicago, IL) and SAS 9.0 (SAS Institute Inc., Cary, NC).
To estimate statistical power to detect group differences longitudinally, we assumed that group means were equal at baseline, group means differed by 10 points at 6 weeks, and group means still differed by 10 points at 6 months. Using a type I error rate of 0.05, autocorrelation of 0.7, and assuming residual standard deviation of 10, 30 individuals per group yielded 83% power to detect the group differences using the repeated measures analysis of variance described above.
Sixty-two patients presenting to the University of Alabama at Birmingham Continence Center from February 2002 to March 2003 for their preoperative visit were enrolled in the study. Thirty-two subjects were in the enhanced preoperative assessment cohort, 30 in the usual preoperative care cohort, 23 patients were aged 75 years or older (37.1%) and 39 patients were aged less than 75 years (62.9%). Baseline characteristics of the sample are presented in Table 1. There were no differences with respect to age, race, parity, body mass index (BMI), number of medications, or Charlson Comorbidity Score between the usual preoperative evaluation cohort as compared with the enhanced preoperative evaluation cohort. There were also no significant differences in baseline characteristics comparing subjects aged 75 years or older to those aged less than 75 years.
Specific surgical procedures were as noted in Table 2. There were no significant differences in surgery type between the usual care and enhanced assessment cohorts, as well as between subjects aged 75 years or older with those aged less than 75 years (all P > .05). Three percent of patients were American Society of Anesthesiologists physical status Class 1, 58% Class 2, and 39% Class 3.
All patients, regardless of preoperative evaluation group, completed the Short Form 36 at the preoperative visit and at 6 weeks and 6 months postoperatively. The enhanced compared with usual preoperative assessment cohorts (Table 3) as well as the cohorts aged 75 years or older compared with aged less than 75 years (Table 4) had significant improvement in Short Form 36 composite scores over time. A comparison of the enhanced preoperative assessment cohort to the usual preoperative assessment cohort (Table 3) and women aged 75 years or older to those aged less than 75 years (Table 4) revealed no significant differences in outcome between groups. Examination of the interaction effect of time upon enhanced assessment in the Physical Component Summary Scores indicates a P value of .025. Figures 1 and 2 depict changes over time in the Short Form 36 component summary scores for the enhanced compared with usual care cohorts.
The mean (± standard deviation) preoperative Utility Item Score for the entire cohort was 81.4 ± 13.6 (median 80, range 45–100), with 0 representing death and 100 representing perfect health. At 6 weeks the mean score was 80.4 ± 14.3 (median 85) and at 6 months, 80.2 ± 15.7 (median 80), with no significant change over time. There was no difference in the Utility Item score between the enhanced preoperative assessment cohort (81.5 ± 14.40, 81.30 ± 13.84, 83.03 ± 15.65) as compared with the usual preoperative assessment cohort (81.28 ± 19.7, 79.47 ± 14.88, 77.63 ± 15.61), baseline preoperatively, 6 weeks postoperatively, and 6 months postoperatively, respectively (group effect, P = .44; time effect, P = .75; group-by-time interaction, P = .29). Similarly, no difference was seen comparing subjects aged 75 years or older (81.74 ± 14.45, 80.44 ± 14.64, 81.39 ± 16.04) to those subjects aged less than 75 years (80.78 ± 12.21, 80.21 ± 14.01, 78.21 ± 15.35), preoperatively, 6 weeks postoperatively, and 6 months postoperatively, respectively (group effect, P = .66; time effect, P = .81; group-by-time interaction, P = .68).
The majority (31/32, 96.9%) of subjects had no ADL and Instrumental Activities of Daily Living (28/32, 87.5%) deficiencies. Most (28/32, 87.5%) of the patients performed the Get Up and Go test in less than 20 seconds and 30 of 31 (96.8%) completed the Clock Test correctly. The majority (31/32, 96.9%) of patients were not depressed based upon scoring in the Geriatric Depression Scale, and the mean score on the Mini Nutritional Assessment was 11.9 ± 1.5 (median 13.0), suggesting minimal nutritional risk factors. Twenty-nine of 32 (90.6%) patients scored perfectly on the social support scale, reflecting an intact social support network.
The mean length of stay for the entire sample was 1.9 ± 0.9 days. Approximately one third of patients (21/62, 33.9%) went home performing intermittent self-catheterization. Few (3/62, 4.8%) of the patients sustained nausea or vomiting, underwent a blood transfusion (1/62, 1.6%), had febrile morbidity (≥ 38.4°C) (1/62, 1.6%), were readmitted (1/62, 1.6%), or had symptoms consistent with altered mental status change (1/62, 1.6%). The majority of patients (58/62, 93.5%) went to their own homes at discharge. Only 1 of 62 (1.6%) went to a rehabilitation facility, 1.6% (1/62) to a nursing home, and 3.2% (2/62) to a family member's home.
With respect to the entire sample, there was high satisfaction noted (usual care cohort, 96.7% (29/30) 6 weeks postoperatively, 100% (29/29) 6 months postoperatively; enhanced cohort 100% (32/32) 6 weeks postoperatively, 85.7% (24/28) 6 months postoperatively; aged less than 75 years 100% (39/39) 6 weeks postoperatively, 91.4% (32/35) 6 months postoperatively; aged 75 years or older 95.7% (22/23) 6 weeks postoperatively, 95.5% (21/22) 6 months postoperatively). There were no differences in satisfaction between the assessment cohort groups.
The results of this study suggest no differences over time in the physical or mental health outcomes in older women undergoing elective gynecologic pelvic floor surgery whether or not they received an enhanced preoperative geriatric assessment. Although the interaction component with time and the enhanced assessment cohort approaches statistical significance for the physical component score (Table 3 and Fig. 1), examination of the means reveal that this significance is attributable to a clinically nonrelevant shift of means from 6 weeks to 6 months. Within time-points, pairwise comparisons did not detect statistically significant differences between enhanced and usual care groups The majority of our subjects were healthy and functional and reported no baseline deficiencies in activities of daily living or instrumental activities of daily living, performed the Get Up and Go test in less than 20 seconds, completed the Clock Test correctly, were not depressed, and had minimal nutritional risk factors and intact social support networks. Our results suggest that there may not be a need to apply geriatric assessment techniques to all members of a surgical female population based solely on age. The standard decision-making process between the surgeon and patient may select those women who do not need special geriatric assessment. It may be that those procedures already in place to determine an older woman's abilities to withstand the rigors of elective gynecologic surgery in an academic medical center may be sufficient to select those women who are likely to have good functional and general health outcomes. It is also possible that the additional training in geriatric medicine received by the gynecology residents as a result of an American Geriatrics Society and John A. Hartford Foundation grant, may have diminished the effect of formal assessment instruments. The attending and resident physicians may have informally assessed functional status of patients in both cohorts. The effect of formal preoperative geriatric assessment needs to be tested in other academic institutions and also in community hospitals.
Four commonly recognized independent risk factors for perioperative complications include age, underlying medical disease, obesity, and malignancy.40 In older women admitted to the hospital for an acute medical illness, risk factors for lack of recovery of ADL independence included a Mini Mental State Examination score less than 24 at discharge, use of an assisted device indoors to ambulate, and a timed Get Up and Go of 40 seconds or more.19 In our enhanced protocol, a Mini Mental State Examination was to be performed to assess cognition only if the Draw a Clock was abnormal, and this occurred in only 1 patient. Our study showed that this small population of patients seeking care for pelvic floor dysfunction was functional, healthy, and active and that the surgery improved their overall quality of life. General health perception scores did not significantly change from baseline to 6 months postoperatively. In this population of women, baseline general health perceptions were high and were stable throughout the 6 months of care and convalescence. The lack of difference between the groups of women who underwent an “enhanced” preoperative geriatric assessment compared with usual preoperative assessment was most likely due to their baseline good health and high functional status. Studies targeting enhanced assessment to frailer patients might help define specific populations that may benefit from preoperative geriatric assessment. A limitation of this study was lack of power to do a subset analysis of the effect of preoperative geriatric assessment in the oldest of the old. An exploratory analysis showed that there were no differences seen in women aged 75 years or older as compared with those aged less than 75 years. However, it would be useful for a future study to be limited to patients aged older than 75 years and powered to determine the effect of preoperative geriatric assessment in this age group.
There are other limitations to this study, including its nonrandomized sequential pre–post intervention cohort design, which may not be sensitive to secular trends. However, through the year of the study there were no changes of surgical technique or postoperative care treatment regimens, which may have confounded the results. All patients were on the same postoperative unit, and the sequential design was chosen to limit potential contamination of the cohort receiving the usual preoperative assessment. This study enrolled a convenience sample of patients. Whenever research nurses were available to help with the study, all patients participated unless involved in another study protocol, however, there was no “targeting” of patients in a selective fashion. The two studies that were “competing” for enrollment were clinical trials of specific procedures that would have tended to select out a group of patients who were of highest functional status, appropriately leaving more frail patients to participate in this study. The surgical trials overlapped this study for its entirely, so that any effect on recruitment would be equal in both cohorts. These analyses should be cautiously interpreted and clinical judgment always exercised with respect to the need for increased preoperative evaluative testing to assess baseline functional and cognitive ability before surgery. Future studies to identify specific characteristics of patients who would benefit from preoperative geriatric assessment are indicated.
In summary, in this study of healthy older women undergoing elective gynecologic pelvic floor surgery, there was significant improvement in overall quality of life based on outcome measures using the Short Form 36 health survey, maintenance of general health perceptions, and high satisfaction with their experience 6 months after pelvic floor surgery regardless of preoperative assessment or age.
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