Carol M. Mangione

Derivation and Prospective Validation of a Simple Index for Prediction of Cardiac Risk of Major Noncardiac Surgery

BACKGROUND Cardiac complications are important causes of morbidity after noncardiac surgery. The purpose of this prospective cohort study was to develop and validate an index for risk of cardiac complications. METHODS AND RESULTS We studied 4315 patients aged > or = 50 years undergoing elective major noncardiac procedures in a tertiary-care teaching hospital. The main outcome measures were major cardiac complications. Major cardiac complications occurred in 56 (2%) of 2893 patients assigned to the derivation cohort. Six independent predictors of complications were identified and included in a Revised Cardiac Risk Index: high-risk type of surgery, history of ischemic heart disease, history of congestive heart failure, history of cerebrovascular disease, preoperative treatment with insulin, and preoperative serum creatinine >2.0 mg/dL. Rates of major cardiac complication with 0, 1, 2, or > or = 3 of these factors were 0.5%, 1.3%, 4%, and 9%, respectively, in the derivation cohort and 0.4%, 0.9%, 7%, and 11%, respectively, among 1422 patients in the validation cohort. Receiver operating characteristic curve analysis in the validation cohort indicated that the diagnostic performance of the Revised Cardiac Risk Index was superior to other published risk-prediction indexes. CONCLUSIONS In stable patients undergoing nonurgent major noncardiac surgery, this index can identify patients at higher risk for complications. This index may be useful for identification of candidates for further risk stratification with noninvasive technologies or other management strategies, as well as low-risk patients in whom additional evaluation is unlikely to be helpful.

Guidelines abstracted from the American Geriatrics Society Guidelines for Improving the Care of Older Adults with Diabetes Mellitus: 2013 update.

● Incorporate high-quality new evidence with significant effect on diabetes mellitus (DM) care that has become available since the 2003 “Guidelines for Improving the Care of the Older Person with Diabetes Mellitus” into a new 2013 Guideline update. ● Improve the care of older people with DM by providing an updated set of evidence-based recommendations individualized to adults with DM aged 65 and older.

Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement

IMPORTANCE Colorectal cancer is the second leading cause of cancer death in the United States. In 2016, an estimated 134,000 persons will be diagnosed with the disease, and about 49,000 will die from it. Colorectal cancer is most frequently diagnosed among adults aged 65 to 74 years; the median age at death from colorectal cancer is 68 years. OBJECTIVE To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for colorectal cancer. EVIDENCE REVIEW The USPSTF reviewed the evidence on the effectiveness of screening with colonoscopy, flexible sigmoidoscopy, computed tomography colonography, the guaiac-based fecal occult blood test, the fecal immunochemical test, the multitargeted stool DNA test, and the methylated SEPT9 DNA test in reducing the incidence of and mortality from colorectal cancer or all-cause mortality; the harms of these screening tests; and the test performance characteristics of these tests for detecting adenomatous polyps, advanced adenomas based on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative modeling study to provide information on optimal starting and stopping ages and screening intervals across the different available screening methods. FINDINGS The USPSTF concludes with high certainty that screening for colorectal cancer in average-risk, asymptomatic adults aged 50 to 75 years is of substantial net benefit. Multiple screening strategies are available to choose from, with different levels of evidence to support their effectiveness, as well as unique advantages and limitations, although there are no empirical data to demonstrate that any of the reviewed strategies provide a greater net benefit. Screening for colorectal cancer is a substantially underused preventive health strategy in the United States. CONCLUSIONS AND RECOMMENDATIONS The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A recommendation). The decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patients overall health and prior screening history (C recommendation).

Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing

BACKGROUND: Standard clinical practice permits the use of either single-chamber ventricular pacemakers or dual-chamber pacemakers for most patients who require cardiac pacing. Ventricular pacemakers are less expensive, but dual-chamber pacemakers are believed to be more physiologic. However, it is not known whether either type of pacemaker results in superior clinical outcomes. METHODS: The Pacemaker Selection in the Elderly study was a 30-month, single-blind, randomized, controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers. Patients received a dual-chamber pacemaker that had been randomly programmed to either ventricular pacing or dual-chamber pacing. The primary end point was health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey. RESULT: The average age of the patients was 76 years (range, 65 to 96), and 60 percent were men. Quality of life improved significantly after pacemaker implantation (P<0.001), but there were no differences between the two pacing modes in either the quality of life or prespecified clinical outcomes (including cardiovascular events or death). However, 53 patients assigned to ventricular pacing (26 percent) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome. Patients with sinus-node dysfunction, but not those with atrioventricular block, had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing. Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction, but not in those with atrioventricular block. CONCLUSION: The implantation of a permanent pacemaker improves health-related quality of life. However, the quality-of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction.

Guidelines for improving the care of the older person with diabetes mellitus.

BACKGROUND AND SIGNIFICANCE iabetes mellitus (DM) is highly prevalent and increasing in persons aged 65 and older, particularly among racial and ethnic minorities. Estimates have placed the proportion of adults aged 65 to 74 with physician-diagnosed DM at nearly 25% in some ethnic groups. 1 Estimates from the Centers for Disease Control and Prevention indicate that, in 1998, 12.7% of persons aged 70 and older had a diagnosis of DM, up from 11.6% in 1990. 2 There are also large numbers of older adults, almost 11% of the U.S. population aged 60 to 74, with undiagnosed DM. 1 Older persons with DM have higher rates of premature death, functional disability, and coexisting illnesses such as hypertension, coronary heart disease (CHD), and stroke 3,4 than do those without DM. Older adults with DM are also at greater risk than other older persons for several common geriatric syndromes, such as depression, 5,6 cognitive impairment, 7 urinary incontinence, 8 injurious falls, 9–11 and persistent pain. 12,13 Although there are numerous evidence-based guidelines for DM, few guidelines are specifically targeted toward the needs of older persons 14 and help clinicians prioritize care for the heterogeneous population of older adults they may see in their practices. Moreover, the main emphasis of most DM guidelines is on intensive blood glucose control and prevention of microvascular complications. Although control of hyperglycemia is important, in older persons with DM, greater reduction in morbidity and mortality may result from control of cardiovascular risk factors than from tight glycemic control. Additionally, little is known about how well providers of health care for older persons with DM adhere to recommendations for the screening and treatment of common geriatric syndromes, such as depression, injurious falls, urinary incontinence, cognitive impairment, chronic pain, and polypharmacy, which are more prevalent with DM and may significantly influence quality of life. Although interventions to reduce the incidence of geriatric syndromes and to ameliorate their symptoms have been studied in general populations of older adults, few studies have focused on the identification and treatment of these common syndromes in older adults with DM. Moreover, because conditions such as cognitive impairment, polypharmacy, and injurious falls may interfere with the provision of appropriate DM care, the identification and management of these syndromes may enhance the effectiveness of DM management for the busy primary care provider. The purpose of this guideline is to improve the care of older persons with DM by providing a set of evidencebased recommendations that include DM-specific recommendations individualized to persons with DM who are aged 65 and older and recommendations for the screening and detection of geriatric syndromes. Table 1 summarizes the components of care included in the guidelines and the number of randomized controlled trials (RCTs) and systematic evidence reviews that were evaluated for the care recommendations.

Development of the 'Activities of Daily Vision Scale'. A measure of visual functional status.

To develop a method for the evaluation of visual function in subjects with cataracts, the authors identified 20 visual activities and categorized them into five subscales (distance vision, near vision, glare disability, night driving, and daytime driving) that comprised the Activities of Daily Vision Scale (ADVS). Each subscale in the ADVS was scored between 100 (no visual difficulty) and 0 (inability to perform the activity because of visual difficulty). In 334 subjects scheduled for cataract extraction (mean age 75 ± 9 years, 67% women), ADVS scores (mean ± standard deviation) for each subscale ranged from 44 ± 31 for night driving to 72 ± 24 for near vision activities. When administered by telephone, inter-rater reliability coefficients (r) were 0.82 to 0.97 (P < 0.001) for each of the subscales, and test-retest reliability was 0.87 for the scale overall. Cronbachs coefficient a was very high for both the in-person (α=0.94) and telephone (α = 0.91) formats. Criterion validity, the correlation between visual loss and ADVS score, was –0.37 (P < 0.001) when the ADVS was administered in person and –0.39 (P < 0.001) when it was administered by telephone. Content validity as assessed with factor analysis showed that 88% of the variance of the principal components weighted on one factor. The authors conclude that substantial visual disability is not captured by routine visual testing and that the ADVS is a reliable and valid measure of patients perception of visual functional impairment.

Central Nervous System–Active Medications and Risk for Falls in Older Women

OBJECTIVES: To determine whether current use of central nervous system (CNS)‐active medications, including benzodiazepines, antidepressants, anticonvulsants, and narcotics, increases the risk for subsequent falls.

Impact of Age on Perioperative Complications and Length of Stay in Patients Undergoing Noncardiac Surgery

As the U.S. population ages, major surgical procedures are being performed in elderly patients with increasing frequency (1), but few data are available to guide preoperative risk stratification. Several studies have described correlates of cardiac morbidity and mortality in patients undergoing noncardiac surgery (2-8), but the number of elderly patients in most series has been small. Furthermore, few data are available on noncardiac complications, the overall complication rate, and length of stay. We describe the influence of age on perioperative complication and mortality rates in a large cohort of patients undergoing noncardiac surgery. As discussed elsewhere, age was not an independent correlate of major cardiac complications in this cohort (7). This analysis tests the hypothesis that advanced age is a correlate of the overall rate of complications, after adjustment for functional status. Methods Patients All patients 50 years of age or older who underwent major nonemergent noncardiac procedures at Brigham and Womens Hospital, Boston, Massachusetts, from 18 July 1989 to 28 February 1994 were eligible for the study. Major noncardiac procedures were defined as those with an expected length of stay of 2 or more days. Procedures were electively scheduled or were performed nonemergently during inpatient admissions. Eligibility criteria included the ability to speak English and adequate cognitive function to give informed consent. The enrollment and clinical data collection protocols were approved by the institutional review board of Brigham and Womens Hospital. The full study protocol included preoperative interviews by clinical study personnel (physicians or research nurses). Of the 4315 patients who provided informed consent to participate, 621 (14.4%) did not provide consent before surgery for the serial interview portion of the study, which included interviews 1 and 6 months after surgery. Patients who were not interviewed before surgery were not excluded on the basis of age or clinical status, but solely according to the availability of study personnel. Data Collection The data collection protocol is described elsewhere (7, 9, 10). In brief, patients who provided informed consent to the full study protocol underwent preoperative evaluation by clinical investigators (physicians or research nurses) using a structured data form. These evaluations included detailed medical histories, physical examinations, and laboratory tests. For patients who did not undergo this evaluation because they could not be approached or because they declined participation in the interview portion of the study, we obtained clinical data from the structured evaluation by the anesthesiologist found in the medical record. This data source was also used to obtain American Society of Anesthesiologists classification for all patients. Hence, prospectively recorded clinical data were available for all patients. Consenting patients agreed to postoperative sampling of creatine kinase and, if total creatine kinase levels were elevated, measurement of creatine kinaseMB immediately after surgery, at 8 p.m. on the evening of surgery, and on the next two mornings. In all other enrolled patients, creatine kinaseMB was measured according to the physicians orders. Among all participants, the mean (SD) number of cardiac enzyme samples obtained was 4.0 2.2. Electrocardiography was performed in the recovery room and on the first, third, and fifth postoperative days if the patient remained hospitalized. The Charlson Comorbidity Index, a weighted comorbidity score based on the number and the severity of 16 selected medical diseases, was used to quantify the burden of medical comorbid conditions (11). The mean number of other common comorbid conditions in this population was calculated for all patients. Preoperative functional status was assessed in 3890 patients by performing structured interviews using the Specific Activity Scale, an ordinally scaled, four-class instrument based on metabolic expenditure in various personal care, housework, occupational, and recreational activities (12, 13). This group included 196 patients who consented to preoperative interviews but did not consent to the full study protocol, including long-term follow-up. Classification of Outcomes The occurrence of major cardiac events postoperatively was classified by a single reviewer who was blinded to preoperative clinical data and who evaluated only postoperative clinical information, including cardiac enzyme measurements, electrocardiograms, and clinical events. Myocardial infarction was diagnosed on the basis of creatine kinaseMB levels and electrocardiographic findings (10). Major cardiac complications were unstable angina (postoperative typical chest pain associated with ischemic electrocardiographic changes), myocardial infarction, cardiogenic pulmonary edema, documented ventricular tachycardia, ventricular fibrillation or primary cardiac arrest, and sustained complete heart block requiring pacemaker. Major noncardiac events were pulmonary embolism documented by autopsy, angiography, or a high-probability ventilationperfusion scan; respiratory failure requiring intubation for more than 2 days or reintubation; noncardiogenic pulmonary edema; lobar pneumonia confirmed by chest radiography and requiring antibiotic therapy; acute renal failure requiring dialysis; or cerebrovascular accident with new neurologic deficit. In-hospital mortality was also recorded, and the combined end point of major cardiac or noncardiac complications or death was used in these analyses. Statistical Analysis To evaluate the impact of age on postoperative complications, we performed analyses in which age was considered as a continuous variable and as four categories (50 to 59 years, 60 to 69 years, 70 to 79 years, and 80 years). Because age was not linearly associated with the risk for outcomes, categorized age variables are used throughout this report. Univariate correlations between clinical characteristics and age category were analyzed by using the chi-square test and the Fisher exact test for categorical variables and a t-test or Wilcoxon test for continuous variables. Because several clinical and laboratory variables are associated with age and because it is difficult to exclude the association of age with the event of interest, we included all relevant clinical variables in the multivariate analysis. Logistic regression analysis was used to determine the independent association of age with postoperative complications while controlling for the presence of comorbid conditions, sex, ethnicity, functional status as measured by Specific Activity Scale class, type of procedure, and preoperative laboratory data. Patients for whom data on selected variables were missing were excluded from the model. Clinically relevant variables from the regression model were analyzed for potential interactions, and potentially significant interaction terms were considered in the regression models. A two-sided P value less than 0.05 was considered statistically significant in all analyses. Linear regression models were used to estimate the independent variation in length of stay attributable to age, controlling for sex, ethnicity, preoperative clinical characteristics, American Society of Anesthesiologists classification, type of procedure, postoperative events, and in-hospital mortality. The logarithmic transformation of length of stay was used because of the non-normal distribution of this variable. The percentage change in the geometric mean of length of stay in the final model was used to estimate the numbers of adjusted hospital days attributable to age groups. All analyses were performed by using SAS statistical software for Windows, version 6.12 (SAS Institute, Inc., Cary, North Carolina). Role of the Funding Source The funding source had no role in data collection and analysis or in subsequent decisions about publication of manuscripts. Results Patients The study sample constituted 4315 patients who had a mean age of 67 9 years; 2096 patients (48%) were male and 3903 (90%) were white. Twenty-four percent (1015 patients) were younger than 59 years, 38% (1646 patients) were 60 to 69 years of age, 31% (1341 patients) were 70 to 79 years of age, and 7% (313 patients) were older than 80 years of age. These patients undergoing elective surgery had a low prevalence of comorbid conditions, and 3187 (74%) patients had Charlson Comorbidity Index scores of 0 through 2. The types of procedures performed were orthopedic (35%), intrathoracic (12%), abdominal (12%), abdominal aortic aneurysm (5%), other vascular (17%), and other general surgical procedures (33%). In the oldest age group, significantly fewer patients were male and nonwhite compared with the younger age groups (Table 1). The number of comorbid conditions and the average Charlson Comorbidity Index scores increased with increasing age. The distribution of Specific Activity Scale class and American Society of Anesthesiology class was also significantly worse in the older age groups; a greater proportion of patients 70 to 79 years of age and 80 years of age was classified as class 3 or 4. As expected, the type of surgical procedure performed varied among age groups. Higher percentages of older patients underwent orthopedic procedures, aortic aneurysm repair, and other vascular surgeries (Table 1). Table 1. Patient Characteristics Perioperative Complications Major or fatal perioperative complications occurred in 44 (4.3%) patients younger than 59 years of age, 93 (5.7%) patients 60 to 69 years of age, 129 (9.6%) patients 70 to 79 years of age, and 39 (12.5%) patients 80 years of age or older (P<0.001) (Figure). Age was significantly associated with a higher risk for cardiogenic pulmonary edema, myocardial infarction, ventricular arrhythmias, bacterial pneumonia, respiratory failure requiring intubation, and in-hospital mortality. All other major complications e

Central nervous system active medications and risk for fractures in older women.

BACKGROUND Use of central nervous system (CNS) active medications may increase the risk for fractures. Prior studies are limited by incomplete control of confounders. METHODS To determine whether use of CNS active medications, including benzodiazepines, antidepressants, anticonvulsants, and narcotics, increases fracture risk in elderly, community-dwelling women, we examined use of these 4 categories of medications in a cohort of 8127 older women and followed the participants prospectively for incident nonspine fractures, including hip fractures. Current use of CNS active medications was assessed by interview with verification of use from containers between 1992 and 1994 and between 1995 and 1996. Use was coded as a time-dependent variable. Incident nonspine fractures occurring after the initial medication assessment until May 31, 1999, were confirmed by radiographic reports. RESULTS During an average follow-up of 4.8 years, 1256 women (15%) experienced at least one nonspine fracture, including 288 (4%) with first hip fractures. Compared with nonusers, women taking narcotics (multivariate hazard ratio [HR], 1.40; 95% confidence interval [CI], 1.06-1.83) and those taking antidepressants (multivariate HR, 1.25; 95% CI, 0.99-1.58) had increases in the risks for any nonspine fractures. Women taking tricyclic antidepressants and those using selective serotonin reuptake inhibitors (SSRIs) had similar fracture rates. There were no independent associations between benzodiazepine use or anticonvulsant use and risk for nonspine fracture. Women taking antidepressants compared with nonusers had a 1.7-fold increase in the risk for hip fracture (multivariate HR, 1.65; 95% CI, 1.05-2.57). We did not observe independent associations between use of any of the other 3 classes of CNS active medications and risk of hip fracture. CONCLUSIONS Community-dwelling older women taking narcotics have an increased risk for any nonspine fracture, and those taking antidepressants have a greater risk for nonspine fractures, including hip fracture. Rates of fracture were similar in women taking tricyclic antidepressants and those using SSRIs. Benzodiazepine use and anticonvulsant use were not independently associated with an increased risk of nonspine fractures, including hip fracture.

What Is the Concordance Between the Medical Record and Patient Self-Report as Data Sources for Ambulatory Care?

Background:The validity of quality of care assessments relies upon data quality, yet little is known about the relative completeness and validity of data sources for evaluating the quality of care. Objectives:We evaluated concordance between ambulatory medical record and patient survey data. Levels of concordance, variations by type of item, sources of disagreement between data sources, and implications for quality of care assessment efforts are discussed. Design and Subjects:This was an observational study that included 1270 patients sampled from 39 West Coast medical organizations with at least 1 of the following: diabetes, ischemic heart disease, asthma or chronic obstructive pulmonary disease, or low back pain. Measures:Items from both data sources were grouped into 4 conceptual domains: diagnosis, clinical services delivered, counseling and referral, and medication use. We present total agreement, kappa, sensitivity, and specificity at the item and domain-levels and for all items combined. Results:We found good concordance between survey and medical records overall, but there was substantial variation within and across domains. The worst concordance was in the counseling and referrals domain, the best in the medication use domain. Patients were able to report with good sensitivity on memorable items. Conclusions:Quality ratings are likely to vary in differing directions, depending on the data source used. The most appropriate data source for analyses of components of and overall quality of care must be considered in light of study objectives and resources. We recommend data collection from multiple sources to most accurately portray the patient and provider experience of medical care.