A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation

A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation
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  A Pilot Study of the Vulnerable Elders Survey-13Compared With the Comprehensive GeriatricAssessment for Identifying Disability in Older PatientsWith Prostate Cancer Who Receive Androgen Ablation Supriya G. Mohile,  MD, MS 1,2 Kathryn Bylow,  MD 3,4 William Dale,  MD, PhD 3 James Dignam,  PhD 5 Kandis Martin,  BA 3 Daniel P. Petrylak,  MD 1 Walter M. Stadler,  MD 4 Miriam Rodin,  MD, PhD 3 1 Department of Medicine (Oncology), ColumbiaPresbyterian Medical Center, New York, New York. 2 Department of Epidemiology, Columbia Presby-terian Medical Center, New York, New York. 3 Department of Medicine, Section of Geriatrics,The University of Chicago, Chicago, Illinois. 4 Department of Medicine, Section of Hematology/ Oncology, The University of Chicago, Chicago, Illinois. 5 Department of Health Studies, The University ofChicago, Chicago, Illinois. BACKGROUND.  Impairments in geriatric domains adversely affect health outcomesof the elderly. The Comprehensive Geriatric Assessment (CGA) is a key componentof the treatment approach for older cancer patients, but it is time consuming. In thispilot study, the authors evaluated the validity of a brief, functionally based screening tool, the Vulnerable Elders Survey-13 (VES-13), for identifying older patients withprostate cancer (PCa) with impairment in the oncology clinic setting. METHODS.  Patients with PCa aged   70 years who actively were receiving androgenablation treatment and who were followed within the clinics at the University of Chicago were eligible. Patients self-completed the VES-13 and CGA instrumentsand repeated the VES-13 1 month later. Physical performance and cognitive assess-ments were administered by a research assistant. RESULTS.  Of 50 participating patients, 50% were identified as impaired by the VES-13(score  3). Sixty percent of patients scored as impaired on  2 tests within the CGA,exhibiting deficits in multiple domains. The reliability of the VES-13 (Pearson corre-lation coefficient) was 0.92. The cut-off score of 3 on the VES-13 had 72.7% sensitiv-ity and 85.7% specificity for CGA deficits and was highly predictive for identifying impairment (area under the receiver operating characteristic curve, 0.90). Patients who had mean VES-13 scores   3 performed significantly worse on evaluations of activities of daily living ( P   ¼ .001), physical performance ( P   ¼ .002), comorbidity ( P   ¼ .004), and cognitive impairment ( P   ¼ .003). CONCLUSIONS.  Functional and cognitive impairments are highly prevalent among older patients with PCa who receive androgen ablation in oncology clinics. Thecurrent results indicated that the brief VES-13 performed nearly as well as a con-ventional CGA in detecting geriatric impairment in this population.  Cancer   2007;109:802–10.   2007 American Cancer Society. KEYWORDS: disability, geriatric assessment, prostate cancer, vulnerable elders,functional impairment. P rostate cancer is an age-associated disease. Greater than 70% of allpatients with prostate cancer are diagnosed in men aged > 65 yearsin the United States. 1 The incidence of prostate cancer increases expo-nentially with age; the probability of developing prostate cancerincreases from 2.2% (1 in 45 men) for those aged 40 years to 59 yearsto 13.7% (1 in 7 men) for those aged  60 years. 2 Because of more sen-sitive diagnostic techniques, prostate cancer is being diagnosed morefrequently and at earlier stages. 3 These statistics portend a substantialincrease in the number of men who will be diagnosed with prostatecancer and who will require evaluation for treatment. Presented in part as a poster at the Annual Meet-ing of the American Society of Clinical Oncology, Atlanta, Georgia, June 2–6, 2006.Supported in part by American Society of ClinicalOncology Young Investigator Award (to S.G.M.) Address for reprints: Miriam Rodin, MD, PhD,Department of Medicine, Section of Geriatrics, TheUniversity of Chicago, 5841 South Maryland Avenue,MC 6098, Chicago, IL 60637; Fax: (773) 834-3538;E-mail: mrodin@medicine.bsd.uchicago.eduReceived August 15, 2006; revision receivedNovember 16, 2006; accepted November 20,2006. ª 2007 American Cancer SocietyDOI 10.1002/cncr.22495Published online 11 January 2007 in Wiley InterScience ( 802  The most widely used therapeutic modality in sys-temic hormone-sensitive prostate cancer (ie, biochem-ical prostate-specific antigen [PSA]-only recurrence afterlocal therapy or overt metastatic disease) is androgensuppression by orchiectomy or gonadotropin-releasing hormone agonists. Although the timing of treatmentinitiation for patients with asymptomatic disease is con-troversial, 4 androgen ablation increasingly is employedearlier in the disease course. 5,6  Although older men withprostate cancer have a higher incidence of low-risk dis-ease characteristics, they are more likely to be treated with androgen ablation than other modalities, including  watchful waiting. 3,7 Because androgen ablation is con-tinued life-long, many men live with the side effectsfrom androgen ablation for many years. 8 These adverseeffects include complications of osteoporosis, sarcope-nia, declining physical performance, and potential cog-nitive effects. The prevalence of functional, cognitive,and physical impairments in an at-risk population of older men with prostate cancer undergoing treatmentof androgen ablation is not well documented.Older patients are a heterogeneous group, and thespectrum of impairment can range from those who areindependent, to those who are at moderate risk of health deterioration (vulnerable), and those who are ata high risk of functional decline or mortality (frail). 9–11 Disability and comorbidity have distinct and possibly synergistic influences on underlying vulnerability andfrailty in the elderly. Disability, or functional impair-ment, is defined as dependency in performing tasksthat allow for self care and living in the community and also may include difficulties with physical mobility.Comorbidity, the concurrent presence of    2 medicalillnesses, usually chronic in nature, is highly prevalentin older individuals. Frailty, which Fried et al defined asa state in which patients are highly vulnerable to ad-verse health outcomes, is a physiologic state in whichthere is increased vulnerability to stressors that resultsfrom decreased physiologic reserves. 12 Clinical criteria proposed by Balducci and Extermann to identify frailelders include age   85 years, dependence in   1 activ-ities of daily living (ADLs), the presence of   3 comorbidconditions, and the presence of   1 geriatric syndromes(eg, dementia, incontinence, falls). 13  Although defini-tions still are evolving, vulnerable elders have a greaterlikelihood of having modifiable risk factors for healthdeterioration than elders who are frail. Therefore, vul-nerable elders may be targeted for interventions to im-prove cancer-related and overall outcomes. According to the National Cancer ComprehensiveNetwork guidelines, a multidimensional comprehensivegeriatric assessment (CGA) should be a key part of thetreatment approach for vulnerable older cancer pa-tients. 14 The CGA includes evaluation of comorbidity,functional status, physical performance, cognitive abil-ity, psychological status, medication review, and socialsupport. The benefits of geriatric assessment in olderpatients may include prolongation of life and preventionof hospitalizations and admissions to long-term carefacilities, 15–17 prevention of geriatric syndromes, 18–20 rec-ognition of cognitive deficit, 21 improvement of healthstatus, 22 and detection of unsuspected conditions thatmay affect cancer treatment in  > 50% of patients aged  70 years. 23,24 Despite recent studies that demonstratedthe feasibility of CGA in oncology, its adoption as thestandard of care has been slow because of a lack of resources, difficulties with interpreting results, and diffi-culties with implementing targeted interventions in spe-cialty clinic settings, such as urology or oncology. 25–27  A short, simple, validated screening procedure that couldbe adapted to the specialty clinic setting to quickly iden-tify those patients who are at risk for geriatric disability  would be valuable. With such screening, impaired pa-tients could be offered referral to specific geriatric pro-grams for interventions, whereas older patients who arenot at risk would be spared the more cumbersome CGA.Currently, little is known about the usefulness of brief screening tools in selecting those older cancer patients who would benefit most from the full CGA with targetedinterventions.The Vulnerable Elders Survey-13 (VES-13) is a self-administered survey that consists of 1 item for age andan additional 12 items that assess self-related health,functional capacity, and physical performance. 10,11 Inthe national sample of elders from the Medicare Cur-rent Beneficiary Survey that was used to validate the VES-13, a score  3 identified 32% of individuals as vul-nerable. 10,11 This identified group had > 4 times the risk of death or functional decline over 2 years compared with elders who scored  < 3. Higher scores predict in-creasing risk for functional decline and/or death. 28 Theaverage time elders took to complete the VES-13 was < 5 minutes. 29  Although the utility of the VES-13 com-pared with a more complete geriatric assessment hasnot been tested previously, the VES-13 has been usedin oncology to help with patient selection, risk-stratifi-cation, and toxicity evaluation. 30 In the current pilotstudy, we examined the prevalence of geriatric impair-ment in older patients with prostate cancer who werereceiving androgen ablation and evaluated the utility of the VES-13 in identifying impairment compared withthe CGA. MATERIALS AND METHODS Patient Population and Research Design The study population included a convenience sampleof patients aged  70 years who were receiving androgenablation for histologically confirmed prostate cancer. Geriatric Disability and Prostate CA/Mohile et al. 803  Patients were required to have systemic prostate cancer, which was defined as having started androgen ablationfor a rising PSA level after local therapy (ie, an increasedPSA level on   2 successive measurements   2 weeksapart), 31 or asymptomatic, metastatic disease. Otherinclusion criteria included adequate command of theEnglish language, ability to give informed consent, nohistory of prior cytotoxic chemotherapy use, and noother active cancer diagnosis. All patients had to bereceiving their primary oncology care at the University of Chicago Genitourinary Oncology clinics. Patients who exhibited severe cognitive impairment, as meas-ured by the Short Portable Mental Status Questionnaire(SPMSQ) ( > 5 errors), 32 and/or who had less than an8th-grade education, and who did not have a medicalproxy for medical decision-making were excluded fromstudy participation.In this cross-sectional, observational study design,eligible patients were screened with the VES-13 andcompleted a standardized CGA. The CGA consisted of a compilation of reliable and validated tools that as-sessed major geriatric domains, including functionalstatus, physical performance, comorbidity, number of medications, cognition, and social support. 32–41 It hasbeen demonstrated that impairments in these geriatricdomains have a negative impact on health outcomesin the elderly. 17,24,35,38,42–44 Cut-off scores for impair-ment on the individual assessment tools are associatedprospectively with increased risk for subsequent dis-ability or mortality in the community-dwelling elderly population (Table 1).The reliability of the VES-13 in this population wasdetermined by collecting survey results at a first visitand then 1 month later. The validity of the VES-13 inthis population was assessed by comparing the VES-13results with results from a simultaneous CGA. Patientsself-administered surveys, and a trained member of the research team administered physical and cognitiveperformance measures. Any missing responses fromthe self-administered portion of the research interviews were completed in follow-up interviews over thetelephone.The total score for the VES-13 and scores for eachtest within the CGA were recorded. In addition, eachtest was scored dichotomously, indicating impairmentor no impairment according to published values. Basedon previous research, meeting the cut-off scores forimpairment in   2 tests within the CGA signifies vul-nerability (eg, increased risk for future disability ormortality). 20,21,27,28,35 Impairment on the CGA wasdefined as meeting the cut-off scores for impairmenton  2 of 7 individual tests within the CGA. This defini- TABLE 1Summary of the Vulnerable Elders Survey and Components of the Comprehensive Geriatric Assessment Test (Study) Geriatric domainNo. of questions Administration [Minutes] Score rangeCut-off pointassociated withadverse outcomes*  VES-13 (Saliba et al, 2001 10,11 ) Functionally basedscreening measure13 Self-administered [5] 0–10   3 ADL (Reuben et al, 1992 15 ; Stuck et al,1993 21 ; Katz et al, 1963 33 )Function 8 Self-administered [5–10] 0–16   14IADL (Fried et al, 2004 12 ; Stuck et al,1993 21 ; Lawton, 1988 34 )Function 7 Self-administered [5–10] 0–14   12SPPB (Guralnik et al, 1994, 40 1995 35 ) Objective evaluation of function/physicalperformance3 Separatephysicalperformancetests Administered by memberof research team [10–15]0–12  < 9CALGB (Charlson et al, 1987 36 ) y Comorbidity 18 Self-administered [15] 0–54  > 10No. of medications (Juurlink et al, 2003 38 ) Comorbidity/toxicity potential from druginteractions1 Self-administered [1–5] 0– ?   5RAND MOS Social Support Scale(Ware and Sherbourne, 1992 37 )Social support/access tomedical care and support5 Self-administered [1–5] 0–5  < 4Short Portable Mental Status Questionnaire(Wenger et al, 2003 29 ; Pfeiffer, 1975 32 ;Stump et al, 2001 42 )Cognition/risk for dementia 10 Administered by memberof research team [10–15]0–10  > 3  VES indicates Vulnerable Elders Survey; ADL, Activities of Daily Living; IADL, Instrumental Activities of Daily Living; SPPB, Short Physical Performance Battery; CALGB, Cancer and Leukemia Group B; MOS, Medi-cal Outcomes Study.* Prospectively associated with an increase in disability, mortality, or adverse outcomes in previous studies. y CALGB adaptation of the Charlson Comorbidity Score. 804 CANCER February 15, 2007 / Volume 109 / Number 4  tion was chosen to select the cancer patients who wereimpaired on multiple geriatric domains who weremost likely to benefit from specific interventions.Impairment on the VES-13 was not included in thisdefinition.Questions that described patient demographics were included with the first survey. Disease characteris-tics, including Gleason score (histologic grading of tu-mor aggressiveness), previous time on androgenablation in months, and disease status (ie, asymptom-atic, rising PSA without overt metastatic disease vs thepresence of metastatic disease by symptoms or on ima-ging studies), were extracted from the medical record.Data were managed in a specific research file that was stored in an area with access limited to membersof the research team. Participation in the study wasentirely voluntary, and ethical standards for humanparticipation were followed strictly. The University of Chicago Institutional Review Board approved the pro-cedures followed. Analytical Methods  We planned to recruit a sufficient number of partici-pants to provide a suitably precise estimate of the pro-portion that scored as impaired on the VES-13. A sampleof 50 enrolled participants would provide an estimate of this proportion to within  6   14%, depending on theprevalence value. Based on previous research in oldercommunity-dwelling adults, we estimated that  > 30% of our sample would score as impaired on the VES-13. 11 Ina study of the VES-13 administered to elders who hadsimilar socioeconomic and demographic characteris-tics, > 60% scored as impaired. 45 To examine patient and disease characteristics,descriptive statistics and summary statistics were em-ployed. Reliability of the VES-13 score was assessed with the Pearson correlation coefficient. To assess thecontribution of age alone to the total score, we alsoexamined other subcategories within the VES-13 forreliability.To determine the most appropriate cut-off pointfor impairment for this sample, a receiver operating characteristic (ROC) analysis was employed. The ROCevaluated the VES-13 as a screening measure for im-pairment compared with the CGA (using the definitionof impairment on the CGA as deficits on  2 individualtests within the battery). 21,46 The area under the ROCcurve (AUC) was calculated to reflect the predictivevalue of the VES-13 for identifying impairment. An AUC of 0.5 represents predictive ability no better thanchance, whereas an AUC of 1.0 indicates perfect pre-dictive ability.The VES-13 score with the most appropriate sen-sitivity and specificity for identification of impairment was to be used for further analyses. In addition,because a VES-13 score  3 is associated prospectively  with adverse outcomes in the elderly, 11 this score also was to be included in further analyses. Confirmatory sensitivity and specificity analyses and positive andnegative predictive values were computed comparing the screening test, the VES-13, with the gold standardfor diagnosing geriatric risk factors, the CGA. In addi-tion, trade-offs between sensitivity and specificity foridentifying impairment with VES-13 compared witheach test within the CGA were examined. Differencesin results on the CGA battery by group, ie, impairedversus not impaired on the VES-13 measure, wereobtained by using 2-sample  t   tests. STATA software(version 9.0) was used for all statistical analyses. RESULTS Sample Fifty-eight patients consented to participate in thestudy, and 50 patients returned completed surveysand were included in the final data analysis. There were no obvious differences in age, race, and prostatecancer characteristics between the 8 patients who were excluded and the patients who completed study procedures. Patient and Disease Characteristics The patients who participated in this study repre-sented an older age group (ages 70–92 years). Thesample population represented in this study was welleducated and primarily was married. Greater than 33%of the patients in our sample were African Americans(Table 2). Although the majority of patients had intermediateor higher grade tumors (  6) according to Gleason scorecriteria, 80% had systemic disease according to PSA cri-teria only. These patients had no evidence of overt met-astatic disease by imaging criteria and had minimalor no disease symptoms. There was a wide range of treatment lengths with androgen ablation (range,3–96 months); however, 80% of men in the samplehad been on androgen deprivation for > 12 months. Distribution of VES-13 and CGA Scores There was a wide range of scores on the VES-13 within the sample population (range, 0–9). The medianscore was 2.5, and the an interquartile ratio was 4.5.Using scores  3 to signify impairment, 10,11 50% of thispopulation scored as impaired. VES-13 scores withineach category are depicted in Table 3. Reflecting theolder age of this sample, 72% and 24% of patients wereages   75 years and   85 years, respectively. Forty-twopercent of patients scored the maximum of 2 points within the physical disability section, and 30% of  Geriatric Disability and Prostate CA/Mohile et al. 805  patients had difficulty or did not perform   1 of thetasks that evaluated function.This sample also was impaired using the CGA asthe gold standard (Table 4). Sixty percent of patientsdemonstrated deficits in  2 tests within the CGA. Themedian number of impaired tests was 3 (range, 0–7impaired tests), and 25% of patients were impaired in  4 domains within the CGA. Reliability of the VES-13 Measure The reliability of the total VES-13 measure was 0.92using the Pearson correlation coefficient. After exclud-ing age, which was 1 of the criteria in the VES-13, thereliability of subcategories within the VES-13 remainedacceptably high (self-rated health, 0.52; physical abil-ity, 0.60; functional ability, 0.70). Sensitivity and Specificity Analyses  An ROC was constructed to determine the appropriate VES-13 cut-off point for impairment in this sample and was designed to compare the VES-13 with the CGA asthe gold standard (Fig. 1). Overall, the VES-13 washighly predictive for identifying impairment compared with the CGA, with an AUC of 0.900 (standard error,0.05; 95% confidence interval for detecting asymptom-atic normals, 0.800–0.995). The VES-13 remained pre-dictive for identifying impairment when excluding patients who scored in the impaired range because of age alone (  85 years). Except for social support, the VES-13 also was predictive for impairment in specificgeriatric domains compared with individual tests withinthe CGA (Table 4). Finally, 2-sample  t   tests were used toexamine group differences in scores on individualmeasures within the CGA. Patients who were impairedby the VES-13 screening measure performed signifi-cantly worse on all tests with the exception of socialsupport (Table 5). DISCUSSION  A high proportion of older patients with prostate can-cer who are receiving androgen ablation have geriatricimpairment that may place them at greater risk fordecline or death. Fifty percent of the sample in thisstudy met the definition of vulnerability on the VES-13 (scores   3), and 60% of patients scored in the im-paired range on   2 individual tests within the CGA.High levels of impairment were noted in measuresthat were designed to evaluate the ability of patients TABLE 2Baseline Patient and Disease Characteristics Characteristic Value  Age, y Median 78Range 70–92Education, y Median 14Range 8–20Time on ADT, moMedian 36Range 3–96Race, % White 64Black 36Marital status, %Married 72Unmarried 28Disease status, %Biochemical recurrence 80Overt metastases 20Baseline VES-13 scoresMedian score 2.5Score range (of 10 possible) 0–9Score  3, % 50 *  ADT indicates androgen-deprivation therapy. TABLE 3 Vulnerable Elders Survey Scores by Category  Category Frequency (%),n 5 50Points accumulated perscoring instructions  Age, y  < 75 38 075–84 38 1  85 24 3Self-rated healthFair or poor 34 1Good, very good, or excellent 66 0Physical disability: No. of items marked with a lot of difficulty or unable to do(1 point for each response: maximum, 2 points)*0 48 01 12 12 14 23 14 24 6 25 4 26 2 2Functional disability: No. of items marked as needing help or not performing task because of health (4 points for  1 response) y 0 70 01 10 42 8 43 4 44 4 45 4 4 *  Respondents were asked how much difficulty they had  on average   with the following physical activ-ities: stooping, crouching, or kneeling; lifting or carrying objects as heavy as 10 pounds; reaching orextending arms above shoulder level; writing or handling and grasping small objects; walking a quarterof a mile; or doing heavy housework, such as scrubbing floors. y Respondents were asked whether, because of their health or physical condition, they had any diffi-culty shopping for personal items, managing money, walking across the room, doing light housework,or bathing or showering. 806 CANCER February 15, 2007 / Volume 109 / Number 4
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