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ORIGINAL ARTICLES Developing Quality Indicators for Elderly Surgical Patients Marcia L. McGory, MD,* Kenneth K. Kao, MD,* Paul G. Shekelle, MD, PhD,† Laurence Z. Rubenstein, MD, MPH,‡ Michael J. Leonardi, MD,* Janak A. Parikh, MD,* Arlene Fink, PhD,§ and Clifford Y. Ko, MD, MS, MSHS, FACS* Objective: To develop process-based quality indicators to improve perioperative care for elderly surgical patients. Background: The population is aging and expanding, and physicians must continue to optimize elderly surgical care to meet the anticipated increase in surgical services. We sought to develop process-based quality indicators applicable to virtually all disciplines of surgery to identify necessary and meaningful ways to improve surgical care and outcomes in the elderly. Methods: We identified candidate perioperative quality indicators for elderly patients undergoing ambulatory, or major elective or nonelective inpatient surgery through structured interviews with thought leaders and systematic reviews of the literature. An expert panel of physicians in surgery, geriatrics, anesthesia, critical care, internal, and rehabilitation medicine formally rated the indicators using a modification of the RAND/UCLA Appropriateness Methodology. Results: Ninety-one of 96 candidate indicators were rated as valid. They were categorized into 8 domains: comorbidity assessment, elderly issues, medication use, patient-provider discussions, intraoperative care, postoperative management, discharge planning, and ambulatory surgery. Of note, 71 (78%) of the indicators rated as valid address processes of care not routinely performed in younger surgical populations. Conclusions: Attention to the quality of care in elderly patients is of great importance due to the increasing numbers of elderly undergoing surgery. This project used a validated methodology to identify and rate process measures to achieve high quality perioperative care for elderly surgical patients. (Ann Surg 2009;250: 338 –347) A n important area of concern in our current healthcare system is the topic of improving the quality of care. Improvements in the quality of health care will likely make the largest impact in populations at the greatest risk; the elderly patient population undergoing surgical intervention is likely one such high-risk group. The US population is aging, and according to the US Census Bureau, it is one of the fastest growing segments of the population. The number of individuals over the age of 65 expected to increase 13% by 2010 and more than 50% by 2020.1,2 These population changes will affect From the *Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, CA; †Department of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, CA; ‡Department of Medicine, David Geffen School of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, CA; and §Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, CA. Supported by the National Institute on Aging (NIA), a part of the National Institute of Health grant (number 5R21AG028121-02). Reprints: Marcia L. McGory, MD, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, 72-215 Center for Health Sciences, Box 956904, 10833 Le Conte Ave, Los Angeles, CA 90095-6904. E-mail: [email protected]. Copyright © 2009 by Lippincott Williams & Wilkins ISSN: 0003-4932/09/25002-0338 DOI: 10.1097/SLA.0b013e3181ae575a 338 | www.annalsofsurgery.com not only healthcare delivery, but also utilization of healthcare resources. According to the National Hospital Discharge Survey in 1999, patients age 65 years and older constituted 12% of the population, yet used 48% of inpatient care days and contributed to 40% of hospital discharges. In addition, the aging of the US population will result in a 31% increase in the general surgery workload.1 As an increasing number of elderly patients undergo surgery, the effects of poor quality surgical care will become magnified. Therefore, development of metrics and processes to improve the quality of care for elderly patients undergoing surgery is important. Numerous avenues for quality improvement have been explored including evaluation of risk-adjusted outcomes, as well as regionalization of care to “centers of excellence.” A third method of improvement includes the identification of important process measures that will improve quality. Process measures include interpersonal, diagnostic, and therapeutic aspects of care that occur between patient and provider such as the history, physical examination, and ordering of diagnostic tests.3 Within surgery, examples of process measures include the Surgical Care Improvement Program quality measures. For example, 3 infection-related Surgical Care Improvement Program measures address the use of prophylactic antibiotics (ie, appropriate selection of prophylactic antibiotics, starting within 1 hour of surgery, and discontinuation within 24 hours after surgery).4 There are benefits to the use of process measures. First, process measures identify a priori steps to make improvements. Second, process measures are less likely to require risk adjustment since the criteria for patient eligibility are defined in advance with inclusion and exclusion criteria. On the basis of these advantages, increasing amounts of work are being performed to identify important processes of care for different aspects of healthcare, including surgery. The aging population will significantly increase demand for surgical services, and there is evidence suggesting perioperative care for the elderly may be different than for the nonelderly.5,6 In this regard, there may be a need to develop strategies and identify processes of care to optimize the quality of care in this vulnerable population. Previous work developed process-based quality indicators specifically for patients undergoing colorectal cancer surgery7 and elderly patients undergoing elective major abdominal surgery.8 The current project builds on this work by developing process-based quality indicators applicable to virtually all disciplines of ambulatory or inpatient surgery (elective or nonelective) in the elderly (eg, cardiothoracic, colorectal, general, gynecology, orthopedic, urology, and vascular surgery) to identify both necessary and meaningful ways to improve care in this rapidly growing segment of the population. METHODS A process-based quality indicator is defined as a process measure that if performed results in or signifies higher quality. Conceptually, quality indicators represent the basic level of care, and set a standard that if not met identifies poor quality of care.9 The modified RAND-UCLA Appropriateness Methodology, a modified Annals of Surgery • Volume 250, Number 2, August 2009 Annals of Surgery • Volume 250, Number 2, August 2009 Developing Quality Indicators for Elderly Surgical Patients TABLE 1. Quality Indicators Rated as Valid for Comorbidity Assessment in Elderly Patients Undergoing Surgery 1. If an elderly patient is undergoing elective or nonelective inpatient surgery, then a panel of preoperative studies should be performed within 30 days before surgery and the results documented in the chart. The panel should include: Hemoglobin or Hematocrit Electrolytes (Na, K, Cl, CO2, glucose) Renal function (BUN, Cr) Albumin Urinalysis Electrocardiogram (within 6 mo) Height Weight 2. If an elderly patient is undergoing elective inpatient surgery, then the initial cardiovascular evaluation should follow the ACC/AHA guidelines including documentation of the following: Placement into appropriate category of perioperative cardiovascular risk (major, intermediate, or minor) based on clinical predictors Assessment of functional capacity as per ACC/AHA guidelines 3. If an elderly patient is undergoing nonelective inpatient surgery, then cardiopulmonary function should be assessed based on physical examination 4. If an elderly patient is undergoing elective inpatient surgery, then there should be documentation of further cardiac evaluation performed, if necessary, according to the ACC/AHA guidelines or documentation why not performed 5. If an elderly patient is undergoing elective or nonelective inpatient surgery, then a screen for pulmonary disease should be performed including the following: Past medical history of pulmonary disease Pulmonary review of systems Pulmonary physical exam 6. If an elderly patient is undergoing elective inpatient surgery and the screen for pulmonary disease reveals dyspnea or exercise intolerance that remains unexplained after physical exam, then there should be documentation of further pulmonary evaluation 7. If an elderly patient is undergoing elective or nonelective inpatient surgery, then creatinine clearance (mL/min) should be estimated 8. If an elderly patient is undergoing elective inpatient surgery and has creatinine clearance less than 30 mL/min, then the patient should receive further medical evaluation (unless previously evaluated) 9. If an elderly patient is undergoing elective or nonelective inpatient surgery, then the presence or absence of diabetes mellitus should be determined by history or random glucose ⬎200 mg/dL within 30 days before surgery 10. If an elderly patient is undergoing elective or nonelective inpatient surgery and has diabetes mellitus, then the following should be assessed: Mechanism of diabetes control Adequacy of diabetes control based on hemoglobin A1c for elective surgery 11. If an elderly patient is undergoing elective inpatient surgery and is taking thyroid hormone replacement, then a thyroid-stimulating hormone level should be checked within 1 year before surgery 12. If an elderly patient is undergoing elective or nonelective inpatient surgery, then the following history should be determined: Tobacco use (current or previous smoker, and number of pack-years) Alcohol use (number and type of drinks per day) 13. If an elderly patient who smokes is undergoing elective inpatient surgery, then the patient should be encouraged to stop smoking when the decision is made to perform surgery or 8 week before the operation (whichever is longer) and the discussion documented in the chart Delphi technique, was employed to develop and rate the quality indicators. In brief, we initially identified candidate quality indicators for elderly surgical patients through published reviews and semi-structured interviews with nationally recognized thought leaders in the fields of anesthesia, cardiac surgery, critical care, general surgery, geriatrics, gynecologic surgery, internal medicine, orthopedic surgery, urology, and rehabilitation medicine. During the semistructured interviews candidate process indicators were identified that were aligned with performing high-quality care to the elderly undergoing major inpatient surgery. Once the 96 candidate indicators were identified, they were categorized into 8 domains spanning the perioperative period. The numbers of candidate indicators in each domain were as follow: comorbidity assessment, (15) evaluation of elderly issues, (28) medication use, (15) patient-provider discussions, (5) intraoperative care, (5) postoperative management, (17) discharge planning, (5) and ambulatory surgery (6). Overall, we assessed the validity of the candidate indicators. This assessment included an explicit synthesis of published data as well as iterative panel ratings, and has been shown in other settings © 2009 Lippincott Williams & Wilkins to produce appropriateness and quality indicators that have face, construct, and predictive validity.10 –15 For each of the 96 identified candidate indicators a systematic published review was performed and the highest level of evidence identified. For candidate indicators concerning effectiveness of treatment (eg, perioperative beta blockade) the highest level of evidence is the randomized controlled trial (RCT), while for candidate indicators concerning risk or prognosis (eg, risk of postoperative delirium), the highest level of evidence is generally considered the prospective cohort study. In situations where the highest level of evidence was limited or absent, lower levels of evidence were evaluated. For example, if RCT data were not available, then controlled clinical trial, cohort or case-control studies, case series, and expert opinion or clinical guidelines were summarized. A 13 member expert panel was assembled that included 3 geriatricians, 1 cardiac surgeon, 1 urologist, 1 gynecologist, 1 orthopedic surgeon, 2 general surgeons, 1 internal medicine/hospitalist, 1 anesthesiologist, 1 critical care physician, and 1 geriatrics/ rehabilitation expert. The expert panelists rated the validity of the www.annalsofsurgery.com | 339 McGory et al Annals of Surgery • Volume 250, Number 2, August 2009 TABLE 2. Quality Indicators Rated as Valid for the Evaluation of Elderly Issues 1. If an elderly patient is undergoing elective inpatient surgery, then a screening nutritional assessment (should include at least history of unintentional weight loss within the past 3 month) should be performed within 8 week prior to surgery 2. If an elderly patient is undergoing elective inpatient surgery and a nutritional assessment shows a risk for malnutrition or presence of protein calorie malnutrition, then a nutrition treatment plan for the preoperative and postoperative periods should be outlined prior to surgery 3. If an elderly patient is undergoing elective inpatient surgery, then an objective cognitive assessment should be performed (such as the 3-Item Recall) within 8 week prior to surgery 4. If an elderly patient is undergoing elective inpatient surgery and the patient has an abnormal objective cognitive assessment, then a more detailed cognitive assessment (such as Mini Mental State Exam) should be performed if not previously assessed 5. If an elderly patient is undergoing elective inpatient surgery, then a screen for the following risk factors for development of postoperative delirium should be performed within 8 week prior to surgery: Screening for visual impairment Screening for cognitive impairment Screening for severe illness Screening for BUN/Creatinine ratio ⬎18:1 6. If an elderly patient undergoes elective or nonelective inpatient surgery, then a daily screening exam for postoperative delirium should be performed for the first 5 inpatient days after surgery 7. If an elderly patient undergoes elective or nonelective inpatient surgery and has a new definite or suspected diagnosis of delirium in the postoperative period, then an evaluation for the following core group of precipitating factors for delirium should be undertaken within 4 h from time of identification of delirium episode: Presence of infection including sepsis, pneumonia, urinary tract infection, wound infection, central line infection, intra-abdominal infection Electrolyte abnormalities (Na, K, BUN, Cr, glucose) Hypoxia Uncontrolled pain Urinary retention or fecal impaction Use of sedative-hypnotic drugs 8. If an elderly patient undergoes elective or nonelective inpatient surgery and requires physical restraints in the hospital, then the target behavioral disturbance or safety issue justifying use of the restraints must be identified to the consenting person (patient or legal guardian) and documented in the chart 9. If an elderly patient undergoes elective or nonelective inpatient surgery and is physically restrained and the target behavioral disturbance requiring restraint is identified, then the health care team should include methods other than physical restraints in the care plan 10. If an elderly patient undergoes elective or nonelective inpatient surgery and is placed in physical restraints, then each of the following measures should be enacted: Consistent release from the restraints repositioning at least every 2 h Face to face reassessment by a physician or nurse at least every 4 h and before renewal of the restraint order Observation at least every 15 min, and more frequently if indicated by the patient’s condition, while the patient is in restraints Interventions every 2 h (or as indicated by patient’s condition or needs) related to nutrition, hydration, personal hygiene, toileting, and range of motion exercises 11. If an elderly patient is undergoing elective inpatient surgery, then a preoperative assessment of ambulation ability should be performed with the “Timed Up and Go” Test or documentation of functional mobility status within 8 week prior to surgery 12. If an elderly patient is undergoing nonelective inpatient surgery, then the patient’s baseline ability to ambulate should be documented 13. If an elderly patient undergoes elective or nonelective inpatient surgery and has an abnormal Timed Up and Go Test of ambulation or abnormal preoperative assessment of mobility, then a written plan to deal with this should be made: Preoperatively for elective inpatient surgery Postoperatively for elective inpatient surgery Postoperatively for nonelective inpatient surgery Both of the above for elective inpatient surgery 14. If an elderly patient undergoes elective or nonelective inpatient surgery, then ambulation should be performed by postoperative day 2, or documented why the patient cannot ambulate 15. If an elderly patient undergoes elective or nonelective inpatient surgery and cannot ambulate, then mobilization should be performed by postoperative day 2, or documented why the patient cannot be mobilized 16. If an elderly patient is undergoing elective inpatient surgery, then the presence or absence of the following functional status issues should be documented in the chart, within 8 week prior to surgery: Hearing impairment, including need for hearing aid Visual impairment, including need for glasses Dependence in activities of daily living (ADLs) Dependence in instrumental activities of daily living (IADLs) 17. If an elderly patient is undergoing nonelective inpatient surgery, then whether or not the patient can care for self (independent with ADLs) should be documented in the chart preoperatively (Continued) 340 | www.annalsofsurgery.com © 2009 Lippincott Williams & Wilkins Annals of Surgery • Volume 250, Number 2, August 2009 Developing Quality Indicators for Elderly Surgical Patients TABLE 2. (Continued) 18. If an elderly patient is undergoing elective or nonelective inpatient surgery, then there should be documentation that the patient or caretaker was asked within 8 week prior to surgery, about occurrence of falls within the past year Preoperatively for elective inpatient surgery Postoperatively for elective inpatient surgery Either of the above for elective inpatient surgery Postoperatively for nonelective inpatient surgery Either of the above for nonelective inpatient surgery 19. If an elderly patient is undergoing elective inpatient surgery and has reported 2 or more falls in the past year or a single fall with injury requiring treatment, then the following should be performed: Referral for preoperative fall evaluation that resulted in specific diagnostic and therapeutic recommendations Referral for inpatient postoperative physical therapy (unless the preoperative fall evaluation does not indicate the need for inpatient physical therapy) 20. If an elderly patient is undergoing elective or nonelective inpatient surgery, then a screen for pressure ulcer risk should be performed on admission to the hospital with the Braden or Norton Scale 21. If an elderly patient undergoes elective or nonelective inpatient surgery and is at risk for pressure ulcer development, then a preventive intervention addressing repositioning needs and pressure reduction (or management of tissue loads) must be performed postoperatively until the patient is able to ambulate 22. If an elderly patient undergoes elective or nonelective inpatient surgery, then documentation of skin integrity should be performed daily at least until the patient is able to ambulate 23. If an elderly patient undergoes elective or nonelective inpatient surgery and has a Stage 2, Stage 3, or Stage 4 pressure ulcer, then a treatment plan for postoperative care (including period of inpatient hospitalization and after discharge) must be outlined 24. If an elderly patient is undergoing elective inpatient surgery and has a positive screen in any of the following areas, then the patient should be evaluated or referred for further evaluation within 8 week prior to surgery: Risk of malnutrition Impaired cognition Depression Impaired functional status Abnormal ambulation, unsteady gait, or fall risk High risk for delirium (presence of 3 or more risk factors) Presence of fecal or urinary incontinence 25. If an elderly patient undergoes elective inpatient surgery, then the following indications require inpatient follow-up for further evaluation, unless a preoperative evaluation says inpatient follow-up is not needed: Risk of malnutrition Impaired cognition Depression Impaired functional status Abnormal ambulation, unsteady gait, or fall risk High risk for delirium (presence of 3 or more risk factors) Polypharmacy 26. If an elderly patient is undergoing elective or nonelective surgery, then a preoperative note by the operating surgeon should discuss the patient’s risk based on the results of preoperative assessments for elderly issues (eg, nutrition, cognition, delirium risk, fall risk, etc) candidate indicators twice. First, the list of candidate indicators, summary of the supporting published data from the systematic review, and definitions of terms were sent to all of the expert panelists. The panelists individually rated the indicators on a 1 to 9 validity scale: 1 ⫽ definitely not valid, 5 ⫽ of uncertain or equivocal validity, and 9 ⫽ definitely valid. Conceptually, an indicator was defined as valid if it met both of the following criteria: (1) Adequate scientific evidence or professional consensus exists to support a link between the performance of care specified by the indicator and the accrual of health benefits to the patient. (2) A physician or facility with significantly higher rates of adherence to an indicator would be considered a higher quality provider (and low rates of adherence would be considered poor quality of care).16 The rating sheets were returned by mail before the expert panel meeting. Results of the first round ratings were used to guide a subsequent face-to-face meeting and highlight areas of agreement or disagreement among the panelists. The second round of ratings occurred at the face-to-face expert panel meeting. Each panelist was provided with their first © 2009 Lippincott Williams & Wilkins round rating as well as the median and range of scores from the ratings of the 13-member panel.17 However, no panelist knew how another individual panelist rated a specific candidate indicator. Each candidate indicator was discussed to identify areas of disagreement, highlight evidence not cited in the systematic review, and clarify specific definitions or wording of the indicators. In addition, panelists could revise existing indicators to better fit their clinical judgment as well as propose new indicators. A subsequent rerating of the indicators using the 1 to 9 validity scale was performed during this face-to-face meeting. Following the second round of ratings, we used a measure of the degree of spread among panelists’ ratings to determine whether disagreement existed. To test the presence of disagreement, the hypothesis was that 90% of the ratings were within 2 larger regions (eg, 1– 6 or 4 –9). This definition of disagreement is equivalent to that used in other expert panels using the RAND/UCLA appropriateness methodology.18 –20 A “valid” quality indicator was defined as an indicator with a median score greater than or equal to 7.0 without disagreement using the second round ratings. www.annalsofsurgery.com | 341 Annals of Surgery • Volume 250, Number 2, August 2009 McGory et al TABLE 3. Quality Indicators Rated as Valid for Medication Use in Elderly Patients Undergoing Surgery 1. If an elderly patient is undergoing elective inpatient surgery and is taking one of the following classes of medications, then specific instructions regarding preoperative management of the following classes of medications should be given to the patient: Anticoagulation medications Diabetes medications Cardiovascular medications Hormonal medications Ask about herbal medications Preoperative management if taking herbal medications Ask about over the counter medications Preoperative management if taking over the counter medications 2. If an elderly patient is undergoing elective or nonelective inpatient surgery and takes a beta blocker as an outpatient, then unless contraindicated, beta blocker therapy should be continued postoperatively until discharge from the hospital 3. If an elderly patient is undergoing elective or nonelective inpatient surgery, then intravenous antibiotic prophylaxis should be started within 1 h of skin incision 4. If an elderly patient is undergoing elective or nonelective inpatient surgery, then intravenous antibiotic prophylaxis should be discontinued within 24 h after surgery (48 h for cardiac surgery) 5. If an elderly patient is undergoing elective or nonelective inpatient surgery and complex congenital heart disease, a prosthetic valve, or a previous episode of endocarditis, then endocarditis prophylaxis should be given 6. If an elderly patient undergoes elective or nonelective inpatient surgery and does not have cancer or previous venous thromboembolism, then preoperative and postoperative deep venous thrombosis prophylaxis should be provided with low dose unfractionated heparin or low molecular weight heparin according to the Seventh ACCP Conference on Antithrombotic Therapy or document why not appropriate 7. If an elderly patient undergoes elective or nonelective inpatient surgery and has cancer or previous venous thromboembolism, then preoperative and postoperative deep venous thrombosis prophylaxis should be provided with low dose unfractionated heparin or low molecular weight heparin, in addition to mechanical prophylaxis (intermittent pneumatic compression and/or graduated compression stockings) according to the Seventh ACCP Conference on Antithrombotic Therapy or document why not appropriate 8. If an elderly patient undergoes elective or nonelective inpatient surgery and has cancer, then deep venous thrombosis prophylaxis should be provided with low molecular weight heparin for 2 week after hospital discharge or document why not appropriate 9. If an elderly patient with anemia is undergoing elective inpatient surgery, then a treatment plan to address the anemia with one or more of the following should be outlined prior to surgery: Iron and vitamin C Erythropoietin and iron Blood transfusion if hemoglobin ⬍7 g/dL 10. If an elderly patient undergoes elective or nonelective inpatient surgery, then the inpatient medical record should contain the most recent outpatient medications with dosages or document why not available 11. If an elderly patient undergoes elective or nonelective inpatient surgery, then the patient or caretaker should receive the following: A complete list of all medications and dosages to continue upon discharge from the hospital A discussion with the patient or caretaker about the purpose of the drug, how to take it, and the expected side effects or important adverse reactions for all medications prescribed for outpatient use A discussion with the patient or caretaker about the purpose of the drug, how to take it, and the expected side effects or important adverse reactions for new medications prescribed for outpatient use Documentation of medication reconciliation between outpatient and inpatient medications 12. If an elderly patient undergoes elective or nonelective inpatient surgery, then the patient should not be prescribed any potentially inappropriate medications according to the Beers Criteria, unless documented why the medication is appropriate 13. If an elderly patient undergoes elective or nonelective inpatient surgery, then standardized elderly-specific postoperative orders should be used 14. If an elderly patient is undergoing elective inpatient surgery, then use of epidural analgesia should be discussed with the patient if there are no contraindications RESULTS Definitions For the purposes of this project, an elderly patient was defined as an individual 75 years or older, including the healthy, elderly patient as well as the elderly patient with significant medical comorbidities. This age cutoff was selected by the panelists in lieu of the traditional age of 65 years, to better target the vulnerable elderly “at-risk” population. Domains A list of the quality indicators rated as valid in each of the 8 domains of care is presented in Tables 1 to 8. The first domain, comorbidity assessment, addressed identification of the type, and 342 | www.annalsofsurgery.com severity of comorbid disease. Thirteen of 15 proposed indicators were judged as valid (Table 1). Examples of indicators rated as valid include standard preoperative evaluation (eg, laboratory tests, electrocardiogram), assessment of functional capacity per the American College of Cardiology/American Heart Association (ACC/AHA) guidelines,21 and assessment of other comorbid diseases (eg, pulmonary, renal). The second and largest domain in this study addressed the evaluation of elderly issues. Twenty-six of 28 process indicators were rated as valid (Table 2). Examples of indicators rated as valid include preoperative screening assessments (eg, cognition, delirium risk) and protocols to prevent the development of postoperative delirium. © 2009 Lippincott Williams & Wilkins Annals of Surgery • Volume 250, Number 2, August 2009 Developing Quality Indicators for Elderly Surgical Patients TABLE 4. Quality Indicators Rated as Valid for Patient-Provider Discussions With Elderly Patients Undergoing Surgery 1. If an elderly patient is undergoing elective or nonelective inpatient surgery, then the patient’s decision-making capacity should be assessed prior to obtaining surgical consent with an ability to describe the surgery, potential complications, and alternatives documented in the medical record 2. If an elderly patient is undergoing elective or nonelective inpatient surgery and does not have the decision-making capacity to sign the surgical consent, then the consent must be signed by the patient’s health care representative or health care proxy 3. If an elderly patient is undergoing elective or nonelective inpatient surgery, then the following issues should be discussed and documented in the medical record: Patient’s priorities and preferences regarding the treatment options (including operative and nonoperative alternatives) Operative risks, including complications and mortality Functional outcome, including period of disability, time to resume normal function, and likelihood of better or worse function Advance directive or living will indicating life-sustaining preferences including mechanical ventilation, cardiopulmonary resuscitation (CPR), hemodialysis, blood transfusion, and permanent enteral feeding Advance directive or durable power of attorney for health care indicating the patient’s surrogate decision maker, or discussion of who would be surrogate decision maker, how to search for a surrogate, or indicate that there is no identified surrogate 4. If an elderly patient undergoes elective or nonelective inpatient surgery and has specific treatment preferences (for example, a do not-resuscitate order or no tube feeding) documented in the medical record, then these treatment preferences should be followed 5. If an elderly patient is undergoing nonelective inpatient surgery, then the preoperative discussion should include the following options: Nonsurgical treatment Goals/aggressiveness of care TABLE 5. Quality Indicators Rated as Valid for Intraoperative Care of Elderly Patients 1. If an elderly patient is undergoing elective or nonelective inpatient surgery and hair removal is required, then hair removal should not be performed with a razor 2. If an elderly patient is undergoing elective or nonelective inpatient surgery, then measures to maintain normothermia of greater than 36°C during the operation should be instituted 3. If an elderly patient is undergoing elective or nonelective inpatient surgery and develops hypothermia less than 36°C, then additional measures to correct the hypothermia should be instituted 4. If an elderly patient is undergoing elective or nonelective inpatient surgery and the procedure is started laparoscopically, then the procedure should be completed in less than 6 h even if converted to an open approach 5. If an elderly patient is undergoing elective or nonelective inpatient surgery, then measures to ensure proper positioning on the operating room table should be documented to prevent peripheral nerve damage and maintain skin integrity Third, the medication use domain had 14 of 15 indicators rated as valid (Table 3). Examples of indicators rated as valid include preoperative medication management (eg, anticoagulants), appropriateness of medications based on the Beers criteria,22 and identification of a complete list of medications and dosages on both admission and discharge from the hospital. The fourth domain, patient-provider discussions, identified 5 indicators that were all rated as valid (Table 4). Examples of indicators rated as valid include assessment of the patient’s decisionmaking capacity, discussion of patient priorities, and preferences regarding goals of care, and necessity of an advance directive. The fifth domain related to intraoperative care and had 5 indicators that were all rated as valid, Table 5. Examples of indicators rated as valid include measures to prevent hypothermia and time limitations for laparoscopic procedures. The sixth domain, postoperative management, had 17 indicators that were all rated as valid (Table 6). Examples of indicators rated as valid include routine postoperative issues (eg, daily inputs and outputs, aspiration precautions), patient independence and communication (eg, access to hearing aids, glasses), and prevention of infection (eg, early removal of Foley catheter, daily examination of central line site), which is a known cause of postoperative delirium. Seventh, in the discharge planning domain, 5 indicators were all rated as valid (Table 7). Examples of indicators rated as valid include evaluation of the home environment (eg, need for medical equipment), predischarge assessment of issues unique to the elderly (eg, cognition, ambulation ability), physician communication (eg, to patient regarding discharge instructions, to primary care doctor © 2009 Lippincott Williams & Wilkins regarding surgery), and a home health visit within 3 days of discharge. In the eighth domain, 6 indicators in the ambulatory surgery domain were rated as valid (Table 8). Examples of indicators rated as valid in the ambulatory surgery domain included preoperative evaluation, assessment of readiness for discharge using the Postanesthesia discharge scoring system, and a follow-up phone call within 24 hours of surgery. DISCUSSION The goal of this project was to develop process-based quality indicators specific to the elderly undergoing ambulatory, or major elective or nonelective in-patient surgery. This topic is important due to aging of the US population, as well as the unique differences in perioperative care for elderly versus nonelderly patients. A number of notable topics were raised during the identification and rating of the quality indicators. First, there are a number of perioperative care items that are identical for elderly and nonelderly patients undergoing surgery (eg, measurement of inputs/outputs, deep venous thrombosis prophylaxis), however, closer attention to these items may be more important in the elderly population given the degree of comorbid disease burden, and decreased functional reserve which affects their ability to tolerate postoperative complications. The expert panel also identified unique process measures that should be performed when caring for the elderly cohort as highlighted in Table 9. There are a number of areas relating to prevention and thorough preoperative www.annalsofsurgery.com | 343 McGory et al Annals of Surgery • Volume 250, Number 2, August 2009 TABLE 6. Quality Indicators Rated as Valid for Postoperative Management of Elderly Patients 1. If an elderly patient with diabetes mellitus undergoes elective or nonelective inpatient surgery, then all postoperative glucose should be ⬍200 mg/dL on postoperative day 1 and postoperative day 2 2. If an elderly patient undergoes elective or nonelective inpatient surgery, then the patient’s fluid status needs to be monitored for at least the first 5 d after surgery with the following: Daily input and output Daily weights Either of the above 3. If an elderly patient undergoes elective or nonelective inpatient surgery, then the following aspiration precautions should be instituted: Head of bed elevation at all times with repositioning Sitting upright while eating and 1 h after completion of eating 4. If an elderly patient undergoes elective or nonelective inpatient surgery, then the following types of chest physical therapy should be performed: Use of incentive spirometer or deep breathing exercises Either chest physiotherapy or use of incentive spirometer or deep breathing exercises 5. If an elderly patient undergoes elective or nonelective inpatient surgery, unless otherwise contraindicated or refused by the patient, then he/she should receive blood transfusion at the following hemoglobin/hematocrit threshold: 8/24 7/21 6. If an elderly patient undergoes elective or nonelective inpatient surgery and he or she is eligible for vaccination (that is, the patient is not up-to-date with pneumococcal or influenza vaccination), then the patient should be offered vaccination against pneumococcus (year round) and influenza (during flu season) 7. If an elderly patient undergoes elective or nonelective inpatient surgery and is deaf or does not speak English, then an interpreter or translated materials should be employed to facilitate communication between the patient and the providers 8. If an elderly patient undergoes elective or nonelective inpatient surgery and has known hearing impairment, then a sign above the bed stating the hearing impairment should be posted in the patient’s room 9. If an elderly patient undergoes elective or nonelective inpatient surgery and has known hearing loss and uses a hearing aid, then the hearing aid or hearing amplification device should be readily accessible to the patient 10. If an elderly patient undergoes elective or nonelective inpatient surgery and has known visual impairment, then a sign above the bed stating the visual impairment should be posted in the patient’s room 11. If an elderly patient undergoes elective or nonelective inpatient surgery and has known visual impairment and uses corrective lenses for any activity of daily living, then the corrective lenses should be readily accessible to the patient 12. If an elderly patient undergoes elective or nonelective inpatient surgery and uses dentures, then the dentures should be readily accessible to the patient 13. If an elderly patient undergoes elective or nonelective inpatient surgery and requires nontunneled central line, then the following should be performed: Daily examination of line placement site for signs of infection Daily examination for presence of swelling in the extremity on the side of line placement Daily documentation of the continued need for the central line 14. If an elderly patient undergoes elective or nonelective inpatient surgery and has a Foley catheter placed during the operation, then the catheter should be removed (or documented why not removed) by postoperative day 3 15. If an elderly patient undergoes elective or nonelective inpatient surgery and has a new fever greater than 38.0°C after postoperative day 2, then the following should be performed within 4 h (unless fever work-up completed within the past 24 h): Urinalysis and urine culture Examination of wound If a central venous line or peripherally inserted central catheter (PICC) is present, then blood cultures should be drawn from both the central venous line or PICC line and peripheral vein Chest radiograph Blood culture (independent of central line or PICC) 16. If an elderly patient undergoes elective or nonelective inpatient surgery, then pain assessments should be performed with each set of vital signs 17. If an elderly patient undergoes elective or nonelective inpatient surgery and has a pain score ⬎5, then a management plan should be offered assessment, including screens for nutrition, cognition, and delirium risk that should be routinely performed in the elderly population when undergoing surgery. For example, one discussion area at the expert panel meeting revolved around preoperative assessment of functional status (eg, activities of daily living 关ADLs兴, ambulation) and the goal of returning the patient to a similar functional state postoperatively— or at least identifying the probable level of function postoperatively. These issues are probably not as critical in the nonelderly population, and thus become an increasingly important topic as the surgical team cares for a growing proportion of elderly patients. An additional 344 | www.annalsofsurgery.com discussion area focused on screening and prevention of adverse events, which was applicable to a number of areas including the development of malnutrition, postoperative delirium, and deconditioning. It was interesting to note, however, that while there was strong support for screening and prevention, there was significantly less agreement regarding which of the specific instruments should be used to perform these assessments. For example, the Mini-Nutritional Assessment was proposed as a nutritional screen or 3-item recall as a cognitive screen. However, in most cases the panelists could not agree on a specific screening instrument. Rather, it was deemed important that the evaluation © 2009 Lippincott Williams & Wilkins Annals of Surgery • Volume 250, Number 2, August 2009 Developing Quality Indicators for Elderly Surgical Patients TABLE 7. Quality Indicators Rated as Valid for Discharge Planning of Elderly Surgical Patients 1. If an elderly patient is undergoing elective or nonelective inpatient surgery, then the following discharge planning issues should be assessed: Home environment and possible needs for medical equipment at home prior to discharge Social support and possible needs for home health services prior to surgery for elective inpatient surgery Social support and possible needs for home health services prior to discharge Patient acceptance of possible nursing home or skilled nursing facility placement prior to discharge 2. If an elderly patient undergoes elective or nonelective inpatient surgery and is being discharged, then assessment prior to discharge in the following areas should be performed to compare to preoperative level of function and determine appropriate discharge plan: Nutrition (Mini Nutritional Assessment) Cognition (3-Item Recall or Mini Mental State Exam) Ambulation ability (Timed Up and Go)23 Functional status (ADLs) Presence of delirium 3. If an elderly patient undergoes elective or nonelective inpatient surgery and is being discharged from a hospital to home or to a nursing home, then written discharge instructions should be given and the following should be performed: Comprehension of verbal discharge instructions should be assessed by checking ability of patient or caretaker to repeat back to the health care provider the discharge instructions Documentation of pending laboratory tests or diagnostic studies, if applicable Documentation of follow-up appointment for nonsurgeon physician visits or medical treatments, if applicable Documentation of follow-up appointment with the surgeon or telephone contact with the surgeon within 6 week of discharge 4. If an elderly patient undergoes elective or nonelective inpatient surgery, then results of the operation and hospitalization should be documented and communicated to the patient’s primary care doctor 5. If an elderly patient undergoes elective or nonelective inpatient surgery and is discharged to home, then a home health visit should be performed within 3 day of discharge TABLE 8. Quality Indicators Rated as Valid for Elderly Patients Undergoing Ambulatory Surgery 1. If an elderly patient is undergoing ambulatory surgery, then preoperative evaluation must be performed prior to surgery or prior to the day of surgery 2. If an elderly patient is undergoing ambulatory surgery, then readiness for discharge should include the following: Assessment by Postanesthesia Discharge Scoring System Ability to tolerate fluids Ability to void Assessment of mental status 3. If an elderly patient undergoes ambulatory surgery, then the discharge instructions should include instructions to make a follow-up appointment with the following: Surgeon Primary care provider 4. If an elderly patient undergoes ambulatory surgery, then there should be documentation that the patient has someone available to stay with them for the first 24 h after surgery 5. If an elderly patient undergoes ambulatory surgery, then a follow-up phone call after surgery should be performed (unless documented why no followup phone call is needed) within 24 h of surgery 6. If an elderly patient undergoes ambulatory surgery, then the follow-up phone call should include an assessment of: Pain Tolerance of food, liquids Ability to ambulate Mental status Understanding of postdischarge instructions Understanding of postdischarge medications of nutrition or cognition, for example, should be performed with any number of validated instruments. A second area addressed by the expert panelists is identifying who will be performing these processes of care. There are numerous models of performing perioperative surgical care ranging from the model where the surgeon independently performs the majority of the care, to the model where a range of providers or a multidisciplinary team helps to care for a patient. Although this expert panel seemed to lean more towards a team approach between geriatricians and surgeons, © 2009 Lippincott Williams & Wilkins there are not enough formally trained geriatricians to manage all of the elderly patients undergoing surgery. Regardless of the approach towards perioperative care, process-based quality indicators may be used by all clinicians to improve the processes of care. Given the number of important processes to be performed in the perioperative period, use of a team approach may be advantageous. By embracing a long-range vision when dealing with elderly patients, we can shift from the short-term goal of discharging the patient to a long-term goal of returning the patient to their preoperwww.annalsofsurgery.com | 345 Annals of Surgery • Volume 250, Number 2, August 2009 McGory et al TABLE 9. Process Measures Unique to the Elderly Undergoing Surgery Domain Comorbidity assessment Evaluation of elderly issues Medication use Patient-provider discussions Postoperative management Discharge planning Process Measures Complete standardized cardiovascular risk evaluation per ACC/AHA guidelines Estimation of creatinine clearance Screen for nutrition, cognition, delirium risk, pressure ulcer risk Assess functional status including ambulation, vision/hearing impairment, and ADLs/IADLs Referral for further evaluation for impaired cognition or functional status, high risk for delirium, or polypharmacy Indications for inpatient bowel preparation Evaluation of medication regimen and polypharmacy Avoid delirium-triggering medications and other potentially inappropriate medications (eg, Beers criteria) Assess patient’s decision-making capacity Specific discussion on expected functional outcome, life-sustaining preferences, and surrogate decision maker Prevent malnutrition, delirium, deconditioning, pressure ulcers Daily screen for postoperative delirium and standardized workup for delirium episode Make staff aware if hearing/vision impairment Patient access to glasses, hearing aid, dentures Consider home health for assistance for ostomy care Infection prevention with daily assessment of central line and indication for use, early Foley catheter removal, and standardized fever work-up A discussion with the patient or caretaker about purpose of drug, how to take it, and expected side effects/adverse effects for all medications prescribed for outpatient use Assess social support and need for home health prior to surgery Assess nutrition, cognition, ambulation, and ADLs prior to discharge ative levels of nutrition, cognition, and functional status. In this regard, the outcomes of functional status and quality of life become increasingly important in the elderly surgical population. To achieve this, it is necessary to identify a team of providers both explicitly to evaluate the patient before surgery, as well as to help return the patient to their earlier level of functioning after discharge. For example, Lawrence et al evaluated functional independence after major abdominal surgery in the elderly and found a significant disability 6 months after surgery with respect to functional status (eg, ADLs, and instrumental ADL 关IADLs兴), ambulation, cognition, and physical strength/conditioning.24 It is likely that some elderly patients will not be able to return to their preoperative level of functioning or may require prolonged postoperative rehabilitation or skilled nursing care. However, a thorough preoperative evaluation process should identify those patients at high-risk of functional decline so the discharge planning process can be appropriately discussed with the patient and their family before the decision to pursue surgery. Another issue is the number of necessary quality indicators. Most of the quality measure programs that are currently being used by the Centers for Medicare and Medicaid Services and other agencies include an upper limit of approximately 7 to 8 quality measures per disease topic. In this project, we identified 96 candidate process indicators and 91 were rated as valid by the expert panel. Are all of these needed, or can this number be pared down to a more minimal set of necessary indicators? Since this is our first attempt to identify the important indicators for elderly patients undergoing major surgery, the current work represents a more complete and comprehensive list than may be feasible for an incentive program. However, the entire set of indicators rated as valid for elderly patients undergoing major surgery may be used for other important tasks, including patient-centered quality improvement, education of surgeons, and other providers caring for elderly surgical patients, and development of a comprehensive hospitalbased program for elderly surgical care. For example, a dedicated geriatric care coordinator could assist with quality indicator com346 | www.annalsofsurgery.com pliance through protocol development and implementation as well as collection of data on relevant outcomes to help validate the routine use of these indicators in elderly surgical care. We envision that development of quality indicators for any topic is an iterative process and this current attempt is only the first of many versions. It is important to note that many of the indicators that were rated as valid are more pertinent to the elderly population (eg, evaluation for risk of postoperative delirium, polypharmacy issues). This finding is important to support the notion that caring for the elderly surgery patient is different, and likely more difficult than caring for a nonelderly surgical patient. This study begins formally to identify the items that may help to improve elderly surgical care and outcomes. Although there is a potential logistical hurdle of applying these process measures, we believe that the measures may be used in a variety of ways. Potentially, the measures with face and content validity may be considered as a metric for quality of care benchmarking. Also, most if not all the measures may be used in a quality improvement initiative, either at the individual surgeon level, the surgical department level, or at a hospital level. Certainly, as increasingly more pathways are developed, a number of these indicators may be incorporated into such pathways. Finally, as our goal was to develop “core” indicators that would be related to most surgical specialties, these indicators are applicable across a variety of the surgical specialties, such as urology, orthopedic surgery, and others. There is a limitation to this study regarding the level of evidence found in the literature. After the candidate indicators were identified, a systematic review of the literature was performed and it was evident that most of the indicators did not have level 1 RCT evidence. However, this predicament occurs commonly for many aspects of healthcare, including surgery. Moreover, this is the reason the expert panel methodology was developed—specifically, to identify as best as possible the correct processes to perform when the highest level of evidence is not available. We foresee that as the literature and investigations improve, additional process measures will be added and/or the current process measures will be redefined © 2009 Lippincott Williams & Wilkins Annals of Surgery • Volume 250, Number 2, August 2009 and revised. As stated earlier, this methodology is an iterative process where the current work is merely the first version of these process indicators for elderly patients undergoing surgery. In summary, this is the first project that has developed a comprehensive set of valid process-based quality indicators for elderly patients undergoing ambulatory or in-patient surgery. This work identifies both meaningful and important first steps for high quality of care in the elderly surgical population. Further work is needed to determine if these quality indicators can be measured in the hospital setting, implemented in the routine care of elderly surgical patients, and validated by showing improvement in patient outcomes. 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