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Supplementary Online Content

Layton JB, Kim Y, Alexander GC, Emery SL. Association between direct-to-consumer advertising and testosterone testing and initiation in the United States, 2009-2013. JAMA. doi:10.1001/jama.2016.21041

eTable 1. Yearly Characteristics of the 75 Largest US Designated Market Areas (DMA) eFigure 1. Geographic Distribution of Cumulative Testosterone Advertisement Exposures From Nielsen Television Ratings by Year in the 75 Largest US Designated Market Areas (DMAs) eTable 2. QIC Goodness of Fit Estimates for Models Assessing Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas eFigure 2. Mean Testosterone Testing and Initiation Rates and Interquartile Ranges Compared to Mean Model-Predicted Rates Among Adult Men in the 75 Largest Designated Market Areas in the US, January 2009 – December 2013 eTable 3. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation by Year Among US Men Living in the 75 Largest Designated Market Areas eTable 4. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation With Non-Linear Trends Among US Men Living in the 75 Largest Designated Market Areas, 2009-2013 eTable 5. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas by Varying Lag Times eTable 6. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas, Restricted to Years 2009-2012 and Compared to the Full Study Period

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eTable 1. Yearly Characteristics of the 75 Largest US Designated Market Areas (DMA)

DMA Characteristic Mean (Standard Deviation)

2009 2010 2011 2012 2013 Adult male insurance plan enrollees 73,587 (84,251) 70,618 (86,170) 85,183 (104,158) 96,970 (116,598) 80,826 (98,414) Proportion age 35-39, (SD) 6.30 (0.51) 6.30 (0.51) 6.30 (0.51) 6.30 (0.51) 6.30 (0.51) Proportion age 40-44, (SD) 6.71 (0.41) 6.71 (0.41) 6.71 (0.41) 6.71 (0.41) 6.71 (0.41) Proportion age 45-49, (SD) 7.13 (0.39) 7.13 (0.39) 7.13 (0.39) 7.13 (0.39) 7.13 (0.39) Proportion age 50-54, (SD) 7.26 (0.44) 7.27 (0.44) 7.27 (0.44) 7.27 (0.44) 7.27 (0.44) Proportion age 55-59, (SD) 6.46 (0.48) 6.58 (0.49) 6.58 (0.49) 6.58 (0.49) 6.58 (0.49) Proportion age 60-64, (SD) 5.58 (0.53) 5.72 (0.52) 5.72 (0.52) 5.72 (0.52) 5.72 (0.52) Proportion age 65-69, (SD) 4.14 (0.55) 4.32 (0.56) 4.32 (0.56) 4.32 (0.56) 4.32 (0.56) Proportion age 70-74, (SD) 3.11 (0.51) 3.19 (0.51) 3.19 (0.51) 3.19 (0.51) 3.19 (0.51) Proportion age ≥75, (SD) 2.45 (0.46) 6.21 (1.30) 6.21 (1.30) 6.21 (1.30) 6.21 (1.30) Proportion White, (SD) 77.2 (11.6) 77.1 (11.4) 76.5 (11.5) 76.0 (11.6) 75.5 (11.7) Proportion Black, (SD) 12.2 (8.7) 12.2 (8.8) 12.1 (8.7) 12.0 (8.6) 11.9 (8.5) Mean of median household income, dollars, (SD)

45,757 (8,401) 45,679 (7,929) 46,212 (8,119) 47,050 (8,315) 48,060 (8,407)

Mean physician density / 10,000 population, (SD)

22.7 (5.1) 22.9 (5.16) 23.2 (5.32) 23.5 (5.45) 23.5 (5.4)

Mean testosterone testing rate, (SD) 18.6 (6.2) 18.3 (6.4) 22.7 (8.5) 29.4 (9.4) 30.0 (8.8) Mean testosterone initiation rate, (SD) 6.4 (3.4) 5.6 (2.6) 7.4 (3.20) 8.8 (4.4) 9.0 (4.2) Mean initiation without recent test, (SD)

3.0 (2.7) 2.1 (1.3) 2.5 (1.4) 2.5 (1.5) 2.7 (1.5)

Data represents information derived for 75 included DMAs assessed in January of each year; Age and race distributions from the US Census American Communities Survey; Income and physician density from the Health Resources and Services Administration’s Area Resource File; Enrollees, testosterone testing and initiation data from MarketScan Commercial Insurance Databases. Adult enrollees defined as adult men enrolled in the MarketScan database residing in the DMA on the 15th of the month with 6 months previous enrollment Rates calculated as number of testosterone tests or initiators per 10,000 men with at least 6 months baseline enrollment in the MarketScan database on the 15th of the month



eFigure 1. Geographic Distribution of Cumulative Testosterone Advertisement Exposures From Nielsen Television Ratings by Year in the 75 Largest US Designated Market Areas (DMAs)

Exposure Range Number of DMAs Median Mean (SD) 3.5-4.3 9 3.9 3.9 (0.3) 4.5-4.9 12 4.7 4.7 (0.2) 5.0-5.4 11 5.2 5.2 (0.2) 5.5-5.7 10 5.6 5.6 (0.1) 5.8-6.1 10 6.0 5.9 (0.1) 6.3-6.6 10 6.4 6.4 (0.1) 6.7-8.3 13 7.2 7.3 (0.5)



Exposure Range Number of DMAs Median Mean (SD) 28.6-29.2 10 29.1 29.0 (0.2) 29.3-29.5 7 29.4 29.4 (0.1) 29.6-29.7 12 29.6 29.6 (0.1) 29.8-29.8 9 29.8 29.8 (0.0) 29.9-30.0 12 30 30.0 (0.0) 30.1-30.3 12 30.2 30.2 (0.7) 30.4-31.2 13 30.5 30.6 (0.2)



Monthly advertisement exposures were summed across the entire year within DMAs, and DMAs were stratified into 7 strata of cumulative advertising exposures containing approximately equal number of DMAs. The borders between exposure strata were defined empirically, thus there are gaps between strata where no DMA had measures in that range. DMAs in white were not included in our analysis.

Source: Nielsen television ratings, 2008-2013

Note: no advertisements were aired in 2008




eTable 2. QIC Goodness of Fit Estimates for Models Assessing Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas Outcome No independent

variables Covariates alone Covariates

and DTCA New testosterone tests -186,796.4889 -970,644.4297 -980,898.8325 New initiation -100,190.8113 -443,412.6609 -446,615.8535 New initiation without recent tests -80,296.2809 -140,416.0290 -140,831.5391 Poisson regression models with Generalized Estimating Equations adjusted for income, race/ethnicity, age, physician density, overall time trend, and seasonality. Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013

Interpretation of QIC Goodness of Fit Statistics

The decreasing QIC with the addition of covariates and the primary testosterone variable does show better predictive ability of the model with the addition of our independent variables. Particularly, the decrease in QIC upon addition of DTCA to the covariates suggests improved model fit due to the DTCA variable.



eFigure 2. Mean Testosterone Testing and Initiation Rates and Interquartile Ranges Compared to Mean Model-Predicted Rates Among Adult Men in the 75 largest Designated Market Areas in the US, January 2009 – December 2013

New A) total testosterone testing and B) initiation and C) initiation without recent serum testosterone testing

A.

B.



C. Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013



eTable 3. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation by Year Among US Men Living in the 75 Largest Designated Market Areas

Outcome Year Association of one-unit increase in advertising

exposures with testosterone

Tests for comparison of yearly associations to 2013

RR (95% CI) RRR (95% CI) p-value New testing 2009 0.996 (0.976, 1.016) 1.005 (0.985, 1.026) 0.63 2010 1.010 (0.995, 1.024) 1.019 (1.004, 1.034) 0.01 2011 1.017 (1.014, 1.020) 1.026 (1.021, 1.031) <0.001 2012 1.008 (1.002, 1.015) 1.017 (1.009, 1.025) <0.001 2013 0.991 (0.987, 0.995) -- -- -- New initiation 2009 0.997 (0.967, 1.027) 1.003 (0.973, 1.034) 0.85 2010 1.025 (1.010, 1.041) 1.031 (1.015, 1.048) <0.001 2011 1.016 (1.011, 1.022) 1.022 (1.014, 1.030) <0.001 2012 1.004 (0.995, 1.013) 1.010 (0.999, 1.021) 0.06 2013 0.994 (0.989, 1.000) -- -- -- Initiation without recent tests 2009 0.955 (0.909, 1.003) 1.006 (0.957, 1.058) 0.81 2010 1.022 (0.992, 1.053) 1.033 (1.001, 1.066) 0.04 2011 1.016 (1.007, 1.026) 1.027 (1.014, 1.041) <0.001 2012 1.005 (0.992, 1.017) 1.016 (1.000, 1.032) 0.05 2013 0.989 (0.979, 0.998) -- -- -- The Rate Ratio (RR) and 95% Confidence Intervals (CI) were derived from Poisson GEE regression models adjusted for income, race/ethnicity, age, physician density, overall time trend, and seasonality. Testosterone advertising was included as a continuous variable, and the RRs estimate the association between a one-unit increase in ad exposure and the testosterone rate; for example, in 2010, one exposure to a testosterone advertisement was associated with a 2.5% higher subsequent initiation rate (RR=1.025, 95% CI: 1.010-1.041), corresponding to a mean absolute increase of 0.18 initiations (95% CI: 0.07-0.29) per 10,000 men per ad. 5 ad exposure to 5 ads in a month was associated with a 13.1% higher subsequent initiation rate (RR=1.131, 95% CI: 1.049-1.220), and a mean absolute increase of 0.94 initiations (95% CI: 0.35-0.1.57) per 10,000 men. The Ratio of Rate Ratios (RRR) compares the RR in the year of interest to the 2013 RR estimate, testing for any difference between the two year estimates Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013



eTable 4. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation With Non-Linear Trends Among US Men Living in the 75 Largest Designated Market Areas, 2009-2013

DTCA Term

New testing New initiation Initiation without tests

RR (95% CI) RR (95% CI) RR (95% CI) Linear 1.0164 (1.0122, 1.0207) 1.0153 (1.0101, 1.0206) 1.0168 (1.0077, 1.0259) Quadratic 0.9990 (0.9987, 0.9994) 0.9992 (0.9988, 0.9997) 0.9992 (0.9984, 0.9999) The Rate Ratio (RR) and 95% Confidence Intervals (CI) were derived from Poisson GEE regression models adjusted for income, race/ethnicity, age, physician density, overall time trend, and seasonality. Testosterone advertising was included as a continuous variable, and the RRs estimate the association between a one-unit increase in ad exposure and the testosterone rate. Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013

Interpretation of Non-linear Trends

The positive rate ratio resulting from the linear term indicates that every one-unit increase in advertising exposure, (e.g. an increase from 1 to 2 advertisement views per month) is associated with increased measures of testosterone testing and initiation. However, the rate ratio below one resulting from the quadratic term indicates that with each one-unit increase in advertising exposure, the magnitude of the positive association is reduced. For example the association of a monthly increase in advertising views from 5 to 6 (RR=1.012, 95% CI: 1.009-1.014) is not as strong as a monthly increase from 1 to 2 advertisement exposures (RR=1.015, 95% CI: 1.012-1.019).



eTable 5. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas by Varying Lag Times Lag time New testing New initiation Initiation

without tests RR (95% CI) RR (95% CI) RR (95% CI) One month 1.000 (0.997, 1.002) 0.999 (0.996, 1.002) 1.003 (0.999, 1.007) Three months 0.998 (0.995, 1.000) 0.999 (0.996, 1.003) 0.998 (0.992, 1.004) The Rate Ratio (RR) and 95% Confidence Intervals (CI) were derived from Poisson GEE regression models adjusted for income, race/ethnicity, age, physician density, overall time trend, and seasonality. Testosterone advertising was included as a continuous variable, and the RRs estimate the association between a one-unit increase in ad exposure and the testosterone rate; for example, in the one month lag analysis, one exposure to a testosterone advertisement was associated with a 0.0% lower subsequent initiation rate (RR=0.999, 95% CI: 0.996-1.002), corresponding to a mean absolute increase of -0.01 initiations (95% CI: -0.03-0.01) per 10,000 men per ad. Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013



eTable 6. Association of Total Monthly Testosterone Direct-to-Consumer Advertising With Testosterone Testing and Initiation Among US Men Living in the 75 Largest Designated Market Areas, Restricted to Years 2009-2012 and Compared to the Full Study Period

Outcome Association of one-unit exposure to advertising

with testosterone, 2009-2012

Association of one-unit exposure to advertising

with testosterone, 2009-2013

Comparison of the 2009-2012 estimate to the 2009-2013

estimate

RR (95% CI) RR (95% CI) RRR (95% CI) p-value New testing 1.012 (1.009, 1.014) 1.006 (1.004, 1.008) 1.006 (1.003, 1.009) 0.0002 New initiation 1.011 (1.008, 1.015) 1.007 (1.004, 1.010) 1.004 (0.999, 1.009) 0.09 Initiation without recent tests

1.011 (1.004, 1.017) 1.008 (1.002, 1.013) 1.003 (0.995, 1.011) 0.49

The Rate Ratio (RR) and 95% Confidence Intervals (CI) were derived from Poisson GEE regression models adjusted for income, race/ethnicity, age, physician density, overall time trend, and seasonality. Testosterone advertising was included as a continuous variable, and the RRs estimate the association between a one-unit increase in ad exposure and the testosterone rate. The Ratio of Rate Ratios (RRR) compares the RR in the year of interest to the 2013 RR estimate, testing for any difference between the two year estimates Source: Truven Health Analytics MarketScan databases, Nielsen television ratings, 2009-2013



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