WhitePaper–HealthyMeasures
InternalAnalysisofHealthyMeasureSelectionFor2013
6/1/2012 Confidential – For Internal Use Only SAFEWAY, INC. Practice Guidelines for Workplace Health Screenings The primary causes of mortality in the United States are cancer and cardiovascular disease. While several factors play a role in the development of these diseases, many relate to modifiable health behavior. It is important to identify the factors that individuals may be able to improve, promote risk factor management, and ultimately reduce the overall risk for these preventable diseases. (Chart from Lloyd‐Jones 2010) Based on a review of the literature, five modifiable health factors were selected for inclusion in Safeway’s Healthy Measures Program: body composition, lipid management, blood pressure control, smoking status, and blood sugar management. This white paper outlines the factors, the current research supporting risk assessment of these factors, and practical considerations related to evaluating risk for chronic disease in the workplace. Page | 2 As of June 5, 2012 SAFEWAY, INC. 1. Body Composition The presence and distribution of body fat has been identified by leading health organizations as a major predictor of risk for chronic disease. Additionally, there are multiple options for evaluating body composition that are useful for both identifying at‐risk individuals and raising awareness among those who would benefit from behavior change. As a result, assessment of body composition can be a valuable component of worksite health screenings. Presently, the preferred metrics used to assess body composition are body mass index (BMI) and waist circumference (WC). Both measures are non‐invasive, easy to calculate, reliable, and inexpensive, which are important considerations when selecting biomeasures that will be taken across a large population in a workplace setting. Alternatives approaches to evaluating body composition, including bioimpedance and dual energy x‐ray absorptiometry (DEXA), are very costly and tend not to provide much more accuracy than less time‐consuming approaches based on anthropometrics (NIH 1998). While there is some debate around the accuracy of BMI, specifically among individuals with special metabolic profiles, it is highly correlated to obesity, fat mass, and risk of other diseases (ADA 2009). The table below, from the National Institutes of Health, highlights the increased risk for diabetes, hypertension, heart disease and stroke associated with higher body mass indices. Still, considering the gaps that exist in using BMI to evaluate body composition, we have incorporated weight circumference as a secondary metric to improve risk assessment. WC, as a measure of central adiposity, can capture unique body fat distributions that may not be reflected by BMI. Candidates who should be considered for waist circumference measurement include athletes and individuals of Asian descent. Note that waist‐to‐hip ratio is another option for measuring central adiposity, but it has been shown to be inferior to WC (NIH 1998, Cornier 2011). Page | 3 As of June 5, 2012 SAFEWAY, INC. (Chart from NIH 2004) (Chart from NIH 1998, information aligns with ADA 2009 and USPSTF 2003) As the prevailing method for assessing body composition, body mass index also proves useful from a coordinated care/case management perspective. Individuals being screened will recognize the measure and translate it to weight management goals set with the help of their physician or other health professionals (ADA 2009). Since the ultimate goal is to help at‐risk individuals manage their risk, it is beneficial to align incentives with achievable targets. There is consensus among health experts that weight loss and management has three goals: 1) reduce body weight, 2) maintain a lower body weight over the long term or 3) at minimum, prevent further weight gain. A broad, measurable goal for individuals seeking to achieve a healthy weight is a 10% decrease in body weight (NIH 1998). GUIDELINES: Ideal*: 18.5 ≤ Body Mass Index < 25 AND waist circumference measured at the iliac crest [men ≤102cm (≤40in)/women ≤88cm (≤35in)] Low risk: Body Mass Index between 25‐30 (including 25) High risk: Body mass index ≥ 30 Recommend measuring weight circumference on all participants GOAL FOR INDIVIDUALS AT LOW OR HIGH RISK: Reduce body weight by 10%. *Exceptions should be made for pregnant women. Page | 4 As of June 5, 2012 SAFEWAY, INC. 2. Lipid Management As the most common cause of death in adults in the U.S., coronary heart disease merits focused attention from any groups seeking to reduce the burden of chronic disease. Several risk factors have been identified as targets for therapy, and most refer to ideal health behaviors and factors: Behaviors: abstinence from smoking within the last year, ideal body mass index, physical activity at goal, consumption of a dietary pattern that promotes cardiovascular health Factors: abstinence from smoking within the last year, untreated total cholesterol <200mg/dL, untreated blood pressure <120/<80, absence of diabetes mellitus (Lloyd‐Jones 2010). Workplace screenings should make a concerted effort to measure the behaviors and factors above, with the understanding that measurement may sometimes be challenging and imperfect. Currently, the Framingham risk model is the classic approach used to identify risk factors, and prevent or treat coronary heart disease. While suitable for physician settings, the Framingham model is time‐intensive and therefore burdensome for both employees and screeners in a workplace setting. In lieu of the complete Framingham model, employers may focus on lipid management (one of the primary components of the Framingham model) in screening settings. Below is a chart that compares the reliability, accuracy, patient burden and provider burden for five screening strategies (AHRQ 2001). (Chart from AHRQ 2001) As indicated in the chart, there are a variety of lipoprotein‐based metrics that can be used to assess risk. Traditionally, fasting lipoprotein levels have been used to evaluate risk, as LDL cholesterol is the primary target of therapy (NIH 2004). LDL cholesterol measurements were calculated using the Friedewald equation, which is based on total cholesterol, HDL cholesterol and triglycerides. Since triglyceride levels can vary by fat intake, it was necessary to measure lipid levels in the fasting state. However, nonfasting measures are often more ideal for workplace screenings as they afford much more flexibility for both employees and providers. Recent advances in technology have allowed for direct LDL measurement, making nonfasting measurement possible, but there remains uncertainty about the association between nonfasting direct LDL and risk for cardiovascular disease. Considering both accuracy and feasibility, it makes most sense to use the total cholesterol:HDL cholesterol ratio for screenings (Lund 2009, Nordestgaard 2009, Lund 2011, Miller 2002, Mora 2008, Mora 2009, van Dieren 2011, Barrett 2009). Optimal TC:HDL cholesterol ratios fall below 5, with the ideal ratio being 3.5 (AHA 2011). Page | 5 As of June 5, 2012 SAFEWAY, INC. LDL Cholesterol (mg/dL) Total Cholesterol (mg/dL) HDL Cholesterol (mg/dL) <100 Optimal <200 Desirable <40 Low 100‐129 Near Optimal/Above Optimal 200‐
239 Borderline High 60 High 130‐159 Borderline High 240 High 160‐189 High 190 Very high (NIH 2004) Other candidates for risk assessment are non‐HDL cholesterol, triglycerides and other nontraditional factors. Although non‐HDL cholesterol can be measured in the nonfasting state, there is no consensus around ideal levels for general screening of asymptomatic adults. In the absence of parameters that can be used for screening, non‐HDL cholesterol may not be a useful indicator of proper lipid management (NIH 2002). With respect to triglycerides, there is much debate around the correlation between elevated triglycerides and coronary heart disease risk. Since it is not clear whether triglycerides level is independently associated with heart disease, routine screening of triglyceride levels is not widely recommended (AHRQ 2001, Miller 2011). Finally, large scale screenings based on lipids beyond the standard lipid panel, or other nontraditional risk factors (such as C‐reactive protein, homocysteine level, and lipoprotein(a) level) are not recommended (Greenland 2010, USPSTF 2009). GUIDELINES: Fasting: Ideal: Total cholesterol < 200 mg/dL Borderline: Total cholesterol between 200 ‐ 240 mg/dL (including 200) High: Total cholesterol ≥240 mg/dL Nonfasting: Ideal: TC/HDL ratio < 3.5 Low risk: TC/HDL ratio between 3.5 ‐ 5.0 (including 3.5) At risk: TC/HDL ratio ≥ 5.0 Page | 6 As of June 5, 2012 SAFEWAY, INC. Blood Pressure Control The third factor workplace health screenings should monitor is blood pressure control. Hypertension is associated with damage to many organs, including the heart, brain, kidney and eyes (ADA 2008). In fact, risk for cardiovascular disease doubles for each 20/10 mmHg increment in blood pressure over 115/75 mmHg (NIH 2004). The secondary disease burden presented by elevated blood pressure can be mitigated by medication and behavioral interventions in individuals who are at risk. Individuals who are already hypertensive should understand the importance of adhering to a physician‐prescribed medication regimen. The majority of individuals with hypertension will require two medications to reach the treatment goal of <140/90 (or <130/80 mmHg for those with diabetes or chronic kidney disease) (ADA 2008, NIH 2004). Classification for hypertension, along with measurement techniques are specified in the charts below (NIH 2004). (Chart from NIH 2004) GUIDELINES: Ideal*: Systolic < 120mm Hg AND Diastolic < 80mm Hg Low Risk: Systolic between 120 ‐ 140mm Hg (including 120) OR Diastolic between 80 ‐ 90mm Hg (including 80) At risk: Systolic ≥ 140mm Hg OR Diastolic ≥ 90mm Hg *Individuals with diagnosed hypertension may be considered in the ideal range with BP <140/90 mm Hg Page | 7 As of June 5, 2012 SAFEWAY, INC. 4. Smoking Status The negative consequences of smoking on chronic disease have been extensively documented. Cancer, cardiovascular disease and pulmonary disease are all attributable to smoking via DNA damage, inflammation and oxidative stress. Ultimately, cigarettes are responsible for 20% of deaths in the United States (HHS 2010). Smoking cessation is a modifiable risk factor that should be a priority for workplace health initiatives, and therefore smoking status is an essential component of screenings. There are two primary ways to characterize smoking status: self‐report and biomarker measurement. In a workplace setting, and particularly as part of a health screening, self‐reported tobacco use is highly prone to bias. Therefore, the biomarker approach is a much more reliable way to identify those who could benefit from smoking cessation interventions. Salivary or plasma cotinine levels are the most common measures used to identify individuals at risk. Since nearly all people are exposed to secondhand smoke, it is rare to find cotinine levels of zero; a threshold must be established to distinguish between active smokers and nonsmokers. Long‐term federal studies use plasma cotinine to identify smokers, and have set 10‐20 ng/ml to indicate active smoking status. Other studies indicate that a level of 10ng/ml is a suitable cotinine cutoff level to identify smokers when using salivary cotinine (Etzel 2004, SRTN 2002). GUIDELINES: Ideal: Salivary cotinine level <10ng/ml At risk: Salivary cotinine level ≥10ng/ml Page | 8 As of June 5, 2012 SAFEWAY, INC. 5. Blood Sugar Management Public health statistics indicate that diabetes is, and will continue to be, a significant contributor to disease burden in the United States. As a result, there is potential utility in screening for diabetes among individuals who are overweight or obese with one or more risk factors for diabetes OR individuals over age 45 with no risk factors (ADA 2012, USPSTF 2008). In a workplace setting, it is important to review employee demographics and current health status to determine whether it is truly useful to incorporate diabetes screening into the general health screening protocol. There are three well‐recognized options for diabetes screening, and all are measures of blood sugar management: Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and oral glucose tolerance test (OGTT). All three metrics have defined ranges for normal, prediabetes, and diabetes, which is important, as the prediabetic state is quickly becoming an opportune moment to provide intervention (ADA 2012). ADA 2012 WHO/IDF 2006 Hemoglobin A1c (HbA1c) 5.7‐6.4% (prediabetes); Not recommended ≥6.5% (diabetes) Fasting plasma glucose (FPG) 100‐125mg/dL 110‐125mg/dL (prediabetes); (prediabetes); ≥126mg/dL ≥126mg/dL (diabetes) (diabetes) Oral glucose tolerance test 140‐199mg/dL <140 mg/dL (in addition to FPG (OGTT) (prediabetes); ≥200mg/dL criterion); ≥200mg/dL (diabetes) In terms of ease of administration, HbA1c is the preferred method for screening as it can be conducted in the nonfasting state. HbA1c, a 2‐3 month average of blood glucose, is also a familiar measure to current diabetics. It may therefore be useful in terms of providing consistent information for current diabetics (who are advised to maintain HbA1c <7%), as well as enabling use of a standard process across all individuals. It should be noted that the WHO, after considering cost and availability of the test, does not recommend use of HbA1c (WHO/IDF 2006). Another point to note is that there may be racial and ethnic differences in HbA1c that are independent of glycemia, potentially clouding the accuracy of the measure across a diverse population (Herman 2009, Egede 2001, ADA 2012). GUIDELINES: Ideal*: Hemoglobin A1c < 5.7% Low Risk: Hemoglobin A1c between 5.7%‐6.5% (including 5.7%) High Risk: Hemoglobin A1c ≥6.5% *Exceptions may be made for Type 1 diabetics and Type 2 diabetics who are diagnosed by a physician. Page | 9 As of June 5, 2012 SAFEWAY, INC. 6. Progressing Toward Ideal One of the most important goals of workplace health programs is to help individuals who are at or near the ideal to maintain that health status. As Dee Edington stated in his book Zero Trends, “the natural flow of risks is to high risk. The natural flow of costs is to high costs. Risks and costs increase with age.” A pillar of any worksite health strategy is to help individuals buck the trend toward moving into higher risk. Incentives for attaining these biometric parameters, coupled with yearly testing, is one way of helping individuals stay healthy. More frequent measurements has been considered but come with operational challenges and administrative cost. Instead, the integration of key messaging and an overarching wellness platform as drivers towards a culture of health has been the main method to help individuals stay healthy. However, to encourage further improvement a second layer of goals towards the ideal is beneficial. To that end, we have developed a secondary incentive that focuses on recognizing individuals who meet the ideal standard on each biometric. Page | 10 As of June 5, 2012 SAFEWAY, INC. References: Agency for Healthcare Research and Quality (2001). Systematic evidence review: screening for lipid disorders. Retrieved from: http://www.ahrq.gov/downloads/pub/prevent/pdfser/lipidser.pdf American Diabetes Association. (2012). Standards of medical care in diabetes – 2012. 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