Medical Nutrition Therapy Monitoring within the Context of Ryan White Care Act (RWCA) funded Medical Providers

Los Angeles County

An Analysis of a Cross-Sectional Study

Ricardo A. Contreras, MPH Planning and Research Division Office of AIDS Programs and Policy

August 23, 2008

Purpose A preliminary cross-sectional study was conducted using medical nutrition therapy (MNT) monitoring-related data compiled as a convenience sample (n = 245) using Ryan White Care Act (RWCA) funded patients medical charts abstracted between September 2005 and June 2006 by Office of AIDS Programs and Policy staff. Conducting a preliminary data analysis using a convenience sample of abstracted patients medical charts will help understand current limitations and show the way for future opportunities for improvement of MNT compliance to Standards of Care by that group in Los Angeles County. Methods Abstracted charts were summarized utilizing a nutritional therapy monitoring form approved by the Los Angeles County Commission on HIV. The abstracted information was entered into a MS Access database specifically designed to meet the specifications of program staff that requested assistance with this project. Data elements used in this preliminary study included age, gender, presence of hyperlipidemia, hypertension and diabetes noted on chart, low and high density cholesterol and triglyceride values, and median height and weight. Data were further processed and new variables created including Body Mass Index (BMI). Some variables were split into new categories to conform to the case/non-case dichotomy used on the bivariate analyses performed. For example, White vs. Non-White Race/Ethnicity or BMI < 20.0 (indicates being at risk for HIV wasting syndrome) were generated. High Density Cholesterol (hdl) is another variable split into two separate categories: hdl is abnormally low if <=40 among males or <=50 among females. Demographic variables collected and analyzed were race, age, gender and language. Metabolic syndrome components collected during the medical chart review period (September 2005 to June 2006) included Atherogenic dyslipidemia (blood fat disorders - high triglycerides, low HDL cholesterol and high LDL cholesterol; hypertension (available as a binary Yes/No field) and diabetes (available as a binary Yes/No field). The statistical software STATA 9.2 and MS ACCESS 2002 were used both for data management and analysis. 2

Table 1. Selected Demographic Characteristics of Clients on Protease Inhibitor(s) at time Chart Review was performed (Note: Percentages may not add up down columns to 100 due to rounding). On Protease Inhibitor(s) at time of Medical Chart Review
Yes No

Total n Age1: n (%) 18-24 25-44 45-64 65 and over Gender: n (%) Male Female Transgender (Female to Male) Transgender (Male to Female) Missing Race/Ethnicity: n (%) African American/Black Asian /Pacific Islander Hispanic/Latino(a) White/Caucasian Other Missing Language: n (%) English Spanish Other Unknown/Missing

99 (100%) 4 (4.04) 65 (65.7) 29 (29.3) 1 (1.01)

146 (100%) 6 (4.1) 103 (70.6) 34 (23.3) 3 (2.05)

62 (62.6) 28 (28.3) 0 (0.0) 6 (6.06) 3 (3.03)

88 (60.3) 37 (25.3) 2 (1.4) 15 (10.3) 4 (2.74)

21 (21.2) 6 (6.06) 59 (59.6) 9 (9.09) 1 (1.01) 3 (3.03)

30 (20.6) 5 (3.4) 74 (50.7) 25 (17.1) 2 (1.4) 10 (6.9)

26 (26.3) 31 (31.3) 2 (2.02) 40 (40.4)

46 (31.5) 46 (31.5) 0 (0.0) 54 (37.0)

Sampled female clients mean age was 39.25 years of age (median age was 37), while among male clients mean age was 39.05 years of age and their median age was 39

Table 2. Selected Metabolic Syndrome Components of Clients on Protease Inhibitor(s) at time Chart Review was performed.2 On Protease Inhibitor(s) at time of Medical Chart Review
Yes No

Total n BMI Classification : n (%) Extreme Obesity Moderate Obesity Overweight Normal HIV Wasting ( Borderline) Underweight/HIV Wasting No data available Hyperlipidemia: n (%) Yes No Hypertension: n (%) Yes No Diabetes: n (%) Yes No Low Density Cholesterol: n (%) Abnormally High (>100) Within Normal Limits High Density Cholesterol: n (%) Abnormally Low (<=40 if Male) Within Normal Limits (> 40 if Male) Abnormally Low (<=50 if Female) Within Normal Limits (> 50 if Female) Triglycerides: n (%) Abnormally High (>=150) Within Normal Limits (<150)

99 (100%) 2 (2.0) 14 (14.1) 35 (35.4) 30 (30.3) 3 (3.0) 0 (0.0) 15 (15.2) 29 (29.3) 70 (70.7)

146 (100%) 1 (0.7) 26 (17.8) 34 (23.3) 49 (33.6) 1 (0.7) 1 (0.7) 34 (23.3) 46 (31.5) 100 (68.5) 23 (15.8) 123 (84.3) 12 (8.2) 134 (91.8) 108 (74.0) 38 (26.0) 25 (17.1) 78 (53.4) 11 (7.5) 28 (19.2) 97 (66.4) 49 (33.6)

9 (9.1) 90 (90.9)
9 (9.1) 90 (90.9) 69 (69.7) 30 (30.3) 27 (27.3) 41 (41.4) 11 (11.1) 17 (17.2) 73 (73.7) 26 (26.3)

Metabolic syndrome components collected during medical chart review included Atherogenic dyslipidemia (blood fat disorders - high triglycerides, low HDL cholesterol and high LDL cholesterol; hypertension (available as a binary Yes/No field in data used for this cross-sectional study) and diabetes (available as a binary Yes/No field in data used for this cross-sectional study)

Table 3. Cross-sectional Analyses for Referral to Medical Nutritional Therapy vs. Being on Protease Inhibitors: Looking for Confounders.

Referral to Medical Nutritional Therapy vs. Being on Protease Inhibitor(s) at time of Medical Chart Review Stratified by Selected Demographic and Metabolic Syndrome Components
Potential Confounder (stratifying variable) p value (0.05 alpha level) Statistically Significant Difference? No n/a

Race (White vs. Non-White) BMI < 20.0 Kg (At risk for HIV Wasting)

0.902 Cell value < 5, unable to calculate this value 0.497 0.016 0.443 0.177 0.006 0.3081 0.9177 0.281

BMI >= 25.0 Kg (Overweight or Obesity) Hyperlipidemia Hypertension Diabetes Low Density Cholesterol High Density Cholesterol (Males) High Density Cholesterol (Females) Triglycerides

No Yes No No Yes No No No

Results The sample consisted of 245 client charts abstracted between September 2005 and June 2006. Descriptive statistics were generated to answer basic questions about the sampled population. Among sampled females, their mean age was 39.25 years of age (median age was 37), while among males their mean age was 39.05 years of age and their median age was 39. Among people who were on protease inhibitors at the time of medical chart review, their mean age was 40.2 and their median age was 40. Among clients who were referred to MNT, their mean age was 39.5 and their median age was 38. The majority of people on protease inhibitors were male (62.6 %) and Hispanic/Latino (59.6%). Bi-variate relationships between Referral to a medical nutrition therapy (the outcome) and being on protease inhibitors at the time of medical chart review (the exposure) were conducted stratified by race, gender, language, BMI<20.0, BMI>=25.0, hyperlipidemia, hypertension, diabetes, low density cholesterol, high density cholesterol (split for both men and women), and triglyceride levels as documented in the sampled charts. No statistically significant association was found between outcome variable (MNT Referral) and exposure variable (Being on Protease Inhibitors at time of medical chart review) when stratified by confounding variables, except for hyperlipidemia (p = 0.0163, alpha = 0.05) and low density cholesterol (p = 0.0057, alpha = 0.05). For the majority of potential confounders, therefore, the Mantel- Haenszel (M-H) test of homogeneity3 was found to be non-statistically significant (see table 3). Almost two thirds of clients (65.6%) who were on protease inhibitors at time of chart review period were in the 25-44 age range, were male (62.6%), Hispanic/Latino (59.6%), but their language was undetermined (40.4%). The majority of sampled clients who were overweight (35.4%) were on protease inhibitors at the time of medical chart abstraction. The opposite is true of clients with normal BMI levels, where the majority of sampled clients were not on protease inhibitors at the time of medical chart abstraction (33.6%). With respect to low density cholesterol, it was found that the majority of clients

A non-statistically significant M-H test of homogeneity indicates no effect modification or interaction due to confounding

included in the sample were suffering from abnormally high (>100) low density cholesterol levels (69.7%). About 29 % of clients in the sample were suffering from hyperlipidemia. The majority of clients who were on protease inhibitors showed abnormally high (>=150) triglyceride levels (about 74%).

Pros and Cons of conducting a cross-sectional study based on a convenience sample (Conclusions) The Medical Nutrition Therapy record sample (n=245) was collected without taking advantage of a randomizing strategy to minimize potential biases due to sampling error. For example, it was determined that chart abstraction was based on randomly selecting 10 charts from a list of available medical chart records from each agency that provided such list to OAPP staff (n = 36). Not all agency medical charts were abstracted: the convenience sample used for this study only included 27 out of 36 possible agencies. Any statistically significant finding cannot be generalized to the population from which these records were abstracted (i.e., the underlying HIV/AIDS population in medical care at the time of medical chart abstraction). This study was conducted at a single point in time and had no follow-up of any clients. By design, the exposure status (being on protease inhibitors) and outcome status (being referred to MNT) were measured at one point in time (during chart review only). This study will help compare the prevalence of MNT referral status among protease inhibitor exposed and non-exposed clients at the time of chart review. An advantage to using this study design is that it usually uses population-based samples (but this is not the case for the MNT study). Therefore, this study lacks generalizability to a larger population (HIV/AIDS population in medical care). Another advantage of using the cross-sectional study design is that it is relatively inexpensive and quick to complete. Cons against using the cross-sectional design are that it is difficult to separate cause from effect, because measurement of exposure and outcome is conducted at the same time. This is a significant weakness when trying to asses if being referred to MNT therapy is influenced by the presence of metabolic syndrome components while being on protease inhibitors. For purposes of the MNT cross-sectional study, it is impossible to determine if a sampled 7

clients abnormal hyperlipidemia and low density cholesterol level is actually the result of being exposed to protease inhibitors at the time of the study (there was no family history or prior medical condition history abstracted). It is recommended to approach any findings derived from this cross-sectional study with caution. Having conducted this study, however, shows the need for more HIV/AIDS nutrition related evaluation studies to help identify areas for improvement in the delivery of services including MNT. It is also recommended that attention be paid to collecting random data samples while thinking about potential research questions and appropriate study designs that will help guide more thorough program evaluation activities for the benefit of people living with HIV/AIDS in Los Angeles County.