Mitchell, K.

Pratt, K.J.

Song, K.M.

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 VA L U E  I N  H E A LT H  1 7  ( 2 0 1 4 )  A 1 - A 2 9 5  A29
Objectives: The objective of this study was to compare the promotional strate-
gies of life style drugs (LSD) with non-lifestyle drugs (NLSD) by content analyzing 
print advertisements. MethOds: 142 print advertisements were analyzed to see 
how LSD and NLSD ad messages differed with respect to rational appeals, emo-
tional appeals and readability. Mann-Whitney U test was performed to compare 
the two groups of drug advertisements with respect to the type of promotional 
claims. Descriptive statistics were computed to summarize data pertaining to 
different ad features. The dataset was composed of 64 LSD advertisements and 
78 NLSD advertisements. Inter- rater reliability was measured by Cohen’s Kappa 
for two raters and was found to be adequate for all the variables used in the 
instrument. Results: Significant differences were observed between LSD and 
NLSD ads with respect to both emotional appeals (p= 0.000) and rational appeals 
(p= 0.000) based on Mann-Whitney U test. LSD ads focused more on emotional 
appeals while NLSD ads were heavy on rational content. A logistic regression 
analysis revealed likelihood estimates for ad claims appearing in the two groups. 
Readability calculated by Gunning-Fog Index for LSD’s was 8.84 and for NLSD’s 
was 11.56. Flesch-Kincaid grade level for LSD and NLSD was found to be 7.65 
and 10.73, respectively, indicating increased complexity of language in NLSD 
ads, which was mostly reflecting of the greater use of technical scientific lan-
guage. cOnclusiOns: The two groups of ads clearly differed with respect to 
type of content, presentation, structure and complexity as well as promotional 
strategies adopted. Rational appeals were more predictive of NLSD ad type while 
emotional appeals were predominant in LSD ads.
PHP115
OPPOrtunities FOr tHe Future OF united states Medical device 
surveillance: an analysis OF tHe JOint rePlaceMent registry (Jrr) 
landscaPe in tHe united states
Pratt K.J., Song K.M., Mitchell K.
Avalere Health LLC, Washington, DC, USA
Objectives: Annually, over 1 million people in the U.S. undergo hip or knee replace-
ments. Registries provide one mechanism to understand the benefits and risks 
of joint replacement in specific populations or care settings. Although countries 
such as Australia and Sweden have successfully established centralized JRRs, the 
U.S. has not. Avalere analyzed the diverse landscape of U.S. JRRs to determine 
the feasibility of creating one coordinated, national JRR for post-market surveil-
lance. MethOds: Avalere identified JRRs in the U.S. through the International 
Consortium of Orthopaedic Registries participants’ list, PubMed searches, abstract 
reviews, and web searches. Using publicly available sources, characteristics of each 
registry were recorded in a table. Avalere assessed this data to better understand 
the feasibility of harmonizing these registry efforts. Results: In total, 25 JRRs were 
identified: 3 national, 4 state, and 18 local. Established between 1967 and 2011, the 
registries spanned 14 states with objectives including post-market surveillance, 
outcome improvement, research, provider feedback, and value-based purchasing. Of 
the 20 registries with enrollment information, 15 enrolled 1-10 hospitals, 4 enrolled 
11-50 hospitals, and 1 enrolled more than 200 hospitals. One registry collected only 
Level I data; 2 collect Levels I-II; 9 collect Levels I-III; and 2 collect Levels I-IV; 11 
registries did not have data level collection information. Registry funding sources 
were self-funded (n= 7), publicly funded (n= 1), private payer (n= 1), and a combina-
tion (n= 2). cOnclusiOns: U.S. registries typically are established to serve the needs 
of their operating organization, which influences factors such as the registry’s mis-
sion, recruitment efforts, and data level collected. While the number of JRRs reflects 
stakeholders’ recognition of their value, the disparate (and sometimes competing) 
nature of efforts may pose challenges to the creation of a national JRR that can 
coordinate existing registries, ensure high quality data collection, and facilitate 
early surveillance to support federal regulatory needs.
HealtH care use & POlicy studies – Prescribing Behavior & treatment 
guidelines
PHP116
use OF glasgOw antiMicrOBial audit tOOl (gaat) tO assess 
antiMicrOBial use in tHe icus OF an indian PuBlic teacHing HOsPital
Gudapati BNS1, Tiwari P2, Gombar S3, D’cruz S4, Sachdev A4
1National Institute of Pharmaceutical Education and Research, Mohali, India, 2National Institute 
of Pharmaceutical Education and Research (NIPER), S.A.S Nagar, India, 3Government Medical 
College & Hospital, Chandigarh, India, 4Government Medical College and Hospital, Chandigarh, 
India
Objectives: Continuous, indiscriminate and excessive use of antimicrobial agents 
leads to emergence of antimicrobial-resistant organisms. Antimicrobial resistance 
substantially raises health care costs and influences patient outcomes (morbidity 
& mortality). There is a dearth of data available on appropriateness of parenteral 
antimicrobial therapy in the ICUs, especially in Indian settings. This study involves 
applying the GAAT criteria to assess the antimicrobial use. MethOds: This pro-
spective observational study was carried out in the intensive care units of a public 
teaching hospital over a period of 12 weeks. All the relevant data was recorded in a 
pre-designed standardized performa and analyzed. The patients were followed for 
first 7 days of ICU stay and the changes made in the treatment regimen were care-
fully evaluated. Parenteral antimicrobial therapy was assessed for appropriateness 
using GAAT. Intravenous antimicrobial therapy was considered appropriate if two 
or more of the GAAT criteria were met. Results: 85 ICU patients’ records were 
screened during the study period. Out of total 85 patients, 44 patients were male 
while remaining 41 were females. Of these, 74 patient records were found to have 
complete data for studying GAAT criteria. The parenteral antimicrobial therapy was 
found to be appropriate in 61 patients (82%), as per GAAT criteria. cOnclusiOns: 
Parenteral antimicrobial therapy, as per GAAT, in this study was appropriate in 82% 
of the patients. This is a preliminary study, future large scale studies should be car-
ried out over a longer period of time to draw any logical conclusion.
Canadian Agency for Drugs and Technologies in Health is funding initiatives such 
as the Canadian Platform To increase Usage of Real-world Evidence (CAPTURE) 
project in which physicians collaborate on gathering RWD to inform and improve 
standard health care practices. Finally, some US hospitals are leveraging the RWD 
they generate to optimize clinical and economic outcomes for their populations. 
Additionally, US payers are funding comparative effectiveness studies in crowded 
markets with costly assets and generic competition. cOnclusiOns: There is a 
need to monitor HTA agencies’ use of RWD to optimize access of the right treat-
ments to the right patients. There is also a need to approach evidence generation 
in a systematic manner to differentiate assets beyond approval and initial P&R 
as well as to generate evidence only for those gaps that will impact health care 
decisions.
PHP112
evidence-Based Practice recOMMendatiOns: HealtH Quality 
OntariO’s aPPrOacH
Brener S.S., Nikitovic M., Chambers A., Ghazipura M., Schaink A.K., Lambrinos A.I., Levin L.
Health Quality Ontario, Toronto, ON, Canada
Objectives: As part of the Ontario Government’s health system funding reform ini-
tiative, the Evidence Development and Standards division at Health Quality Ontario 
(HQO) was tasked with developing episodes of care consisting of evidence-based, 
best practice recommendations. The HQO clinical handbooks span both medical 
and surgical conditions, in acute care and community based settings, and include 
between 25 and 100 recommendations each. The objective is to describe HQO’s 
methodology for developing evidence-based recommended best practices for epi-
sodes of care within the rapid timelines of the government mandated funding 
reform. MethOds: Over a 1-year period, the method for deriving evidence-based 
recommended practices was systematically and iteratively developed by HQO clini-
cal epidemiologists in collaboration with methodologists, clinical experts and stake-
holders. Results: The resulting approach for applying evidence to best practice 
recommendations included consideration of various evidence sources and consen-
sus from expert panels which were formed for each of the clinical topics. Preference 
was given to existing Ontario Health Technology Assessment Committee (OHTAC) 
recommendations as these are developed using a decision-making framework that 
considers the clinical benefit offered by a health intervention, in addition to value 
for money; societal and ethical considerations; and economic and organizational 
feasibility. Where OHTAC recommendations did not exist, international guidelines 
were reviewed and selected based on their contextual relevance and assessment 
of their rigor of development using the AGREE II instrument. Uncertainty or con-
flict between the guidelines, or by the expert panel members, was addressed with 
systematic evaluations of the literature through rapid reviews and evidence-based 
analyses. cOnclusiOns: While continually evolving to balance thoroughness and 
timeliness of evidence, HQO has developed a method of deriving episode of care 
recommended best practices set on an evidentiary base within a time-constrained 
government mandate.
HealtH care use & POlicy studies – Patient registries & Post-Marketing 
studies
PHP113
Perceived BeneFits and Barriers OF Payer-ManuFacturer POst-
Marketing OutcOMes study cOllaBOratiOns
Olvey E.L1, Svoboda K.2, Coraggio R.2, White N.P.1, Yi D.2, del Rosario C.2, Malik S.2
1NucleusX Market Access, Altanta, GA, USA, 2Percipient LLC, Somerville, NJ, USA
Objectives: To assess the currently perceived benefits and barriers of post-
marketing payer-manufacturer outcomes study collaborations by US payers and 
pharmaceutical manufacturers. MethOds: Regional and national US payers and 
pharmaceutical manufacturers with experience in collaborative post-marketing 
outcomes study endeavors were invited to participate in an hour-long telephone 
survey. The survey consisted of questions regarding their perceptions on the benefits 
and barriers of potential post-marketing outcomes study collaborations, as well 
as attributes of potential collaborators, studies, products or diseases that would 
be most highly valued. Descriptive statistics were used to characterize the survey 
responses. Results: A total of 12 payers and four pharmaceutical manufacturer 
representatives participated in the survey. Payers most often mentioned that the 
greatest benefit to partnering with manufacturers was the value manufacturers 
bring in terms of expertise and resources (58%). Benefits manufacturers identified 
included demonstrating consistency in outcomes data relative to randomized clini-
cal trial data and effectiveness in real-world populations. The two most commonly 
cited barriers by payers regarding participation in these post-marketing outcomes 
research collaborations included misaligned incentives (58%) and resource inten-
siveness (58%). The manufacturers felt that payers are generally wary of these types 
of collaborations due to possible perceptions of influence, and noted that payers 
are usually only willing to engage and focus on high-budget impact projects and 
collaborations. Payers’ most important consideration when selecting a pharma-
ceutical partner for outcomes studies was the willingness of the manufacturer to 
compromise and align on objectives (42%). Manufacturers agreed that alignment on 
objectives and expectations is critical for a successful partnership. cOnclusiOns: 
As competition in the pharmaceutical marketplace increases and recent US health 
care reform moves forward, payer-manufacturer post-marketing outcomes research 
collaborations will be increasingly critical as a demonstration of value to all stake-
holders.
PHP114
are PrOMOtiOnal strategies OF liFestyle drugs diFFerent FrOM nOn-
liFestyle drugs? a cOntent analysis OF dtc Print Media
Shanbhag P.1, Kapratwar A.1, Nayak R.2
1St. Johns University, Fresh Meadows, NY, USA, 2St. John’s University, Jamaica, NY, USA


PHP115 Opportunities For The Future Of United States Medical Device Surveillance: An Analysis Of The Joint Replacement Registry (Jrr) Landscape In The United States 

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PHP115 Opportunities For The Future Of United States Medical Device Surveillance: An Analysis Of The Joint Replacement Registry (Jrr) Landscape In The United States

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