Developing Metrics to Show the Value of Medical Affairs

OBJECTIVE Establish value metrics for Medical Affairs. CHALLENGE The Medical Affairs community has long since focused on defining metrics, to assess (and ultimately improve) their efficiency and demonstrate their value. However, metrics to demonstrate the value of Medical Affairs remain elusive, and development of standardized metrics applicable to any Medical Affairs organization is complicated by inherent differences in this function across organizations. SOLUTION Rather than a prescriptive “one size fits all” approach to value demonstration by Medical Affairs, we instead describe a framework of key considerations and guiding principles. This framework should enable Medical Affairs groups to develop value metrics tailored to individual organizational needs. OUTCOME The guidance we propose encompasses the following: It may seem obvious, but metrics must measure something meaningful; therefore, they should be aligned with common outcomes shared across functions. These can be complemented with more easily measured surrogate metrics that measure the success of individual steps or goals required to reach each broader outcome MEANINGFUL METRICS Demonstrating value may not be appropriately assessed using quantitative metrics (though they are easily measured). Combining quantitative and qualitative metrics can provide more robust metrics QUALITATIVE METRICS Understanding how Medical Affairs and different functions can collectively contribute to a common set of outcomes, via inter-related but distinctive goals, can demonstrate Medical Affairs value within an organization. It can also identify areas of synergy for improved efficiency CROSS-FUNCTIONAL COLLABORATION Metrics are only useful if they are well tracked; it is important to agree timing of assessments, and a tracking method that is not cumbersom

Model 2—Multivariate regression results showing significant associations of plasma biomarker with HIV clinical parameters, CVD risk age, gender, ethnicity and smoking after adjusting for CXCL10, sCD163 and sCD14.

<p>Model 2—Multivariate regression results showing significant associations of plasma biomarker with HIV clinical parameters, CVD risk age, gender, ethnicity and smoking after adjusting for CXCL10, sCD163 and sCD14.</p

There was a significantly strong correlation between sCD14 and smoking where HIV-1 smokers have higher sCD14 levels than HIV-1 non-smokers while patients on an integrase inhibitor had significantly lower sCD14 levels than patients on an alternative treatment.

<p>There was a significantly strong correlation between sCD14 and smoking where HIV-1 smokers have higher sCD14 levels than HIV-1 non-smokers while patients on an integrase inhibitor had significantly lower sCD14 levels than patients on an alternative treatment.</p

Demographics and patient characteristics from 474 HIV positive patients who underwent CVD risk assessments in 2010.

<p>Demographics and patient characteristics from 474 HIV positive patients who underwent CVD risk assessments in 2010.</p

Differing correlation outcomes between the three plasma biomarkers and HIV-1 RNA levels.

<p>A significant correlation was recognised between HIV-1 RNA levels with CXCL10 (A) and sCD163 (B) while there was no significance with sCD14 (C).</p

Laboratory characterization of an aerosol chemical speciation monitor with PM_2.5 measurement capability

<p>The Aerodyne Aerosol Chemical Speciation Monitor (ACSM) is well suited for measuring non-refractory particulate matter up to approximately 1.0 µm in aerodynamic diameter (NR-sub-PM₁). However, for larger particles the detection efficiency is limited by losses in the sampling inlet system and through the standard aerodynamic focusing lens. In addition, larger particles have reduced collection efficiency due to particle bounce at the vaporizer. These factors have limited the NR-sub-PM₁ ACSM from meeting PM_2.5 (particulate matter with aerodynamic diameter smaller than 2.5 µm) monitoring standards. To overcome these limitations, we have redesigned the sampling inlet, the aerodynamic lens, and particle vaporizer. Both the new lens and vaporizer are tested in the lab using a quadruple aerosol mass spectrometer (QAMS) system equipped with light scattering module. Our results show that the capture vaporizer introduces additional thermal decomposition of both inorganic and organic compounds, requiring modifications to the standard AMS fragmentation table, which is used to partition ion fragments to chemical classes. Experiments with mixed NH₄NO₃ and (NH₄)₂SO₄ particles demonstrated linearity in the NH₄⁺ ion balance, suggesting that there is no apparent matrix effect in the thermal vaporization-electron impact ionization detection scheme for mixed inorganic particles. Considering a typical ambient PM_2.5 size distribution, we found that 89% of the non-refractory mass is detected with the new system, while only 65% with the old system. The NR-PM_2.5 system described here can be adapted to existing Aerodyne Aerosol Mass Spectrometer (AMS) and ACSM systems.</p> <p>Copyright © 2017 American Association for Aerosol Research</p

Laboratory evaluation of species-dependent relative ionization efficiencies in the Aerodyne Aerosol Mass Spectrometer

<p>Mass concentrations calculated from Aerodyne's aerosol mass spectrometers depend on particle collection efficiency (CE) and relative ionization efficiency (RIE, relative to the primary calibrant ammonium nitrate). We present new laboratory RIE measurements for a wide range of organic aerosol species (RIE_OA). An improved laboratory RIE calibration protocol with size and mass selection of calibrant particles and a light scattering-based detection of CE is used. Simpler calibrations of alcohol RIEs using binary mixtures with NH₄NO₃ are demonstrated. Models that account for only thermal velocity and electron ionization of vaporized molecules do not reproduce RIE_OA measurements, confirming that other processes are significant. The relationship between RIE_OA and average carbon oxidation state (), a metric used to describe atmospheric OA, is investigated. An average RIE_OA of 1.6 ± 0.5 (2σ) is found for −1.0 < < 0.5, a range consistent with most ambient OA except hydrocarbon-like organic aerosol (HOA) and cooking organic aerosol (COA). RIE_OA from 2 to 7 are found for below and above this range. The RIE_OA typically used for ambient OA (1.4 ± 0.3) is within the laboratory RIE_OA measurement uncertainty of oxidized organic species, but is a factor of 2 to 5 lower than that of reduced species. Such biases in OA mass concentrations have not been observed in published field analyses. Chemically reduced ambient OA may have composition, phase states, or compensating CE effects that are not mimicked well in the laboratory. This work highlights the need for further ambient OA studies to better constrain the composition dependence of ambient RIE_OA, and the need to always calibrate with the OA under study for laboratory experiments.</p> <p>Copyright © 2018 American Association for Aerosol Research</p