Real-World Evidence Studies: Checking it Once, Checking it Twice…

By now, either through posts on this tHEORetically Speaking blog, the official blog of HealthEconomics.Com, or through your own personal experience, it is apparent that real world evidence (RWE) is a hefty subject to tackle. Synthesizing evidence into something meaningful that meets the needs of the 5 Ps – Pharma, Payers, Providers, Patients, and Policy-Makers, as well as any other pertinent stakeholder, is no small task. Add to that the fact that this is real world evidence –  and not your run-of-the-mill clinical data where everything is carefully planned and controlled for – and you have a potential recipe for disaster!  So how do you navigate the waters and keep your boat headed in the right direction?

The first place to start is by attending the first ever virtual summit on RWE being held THIS THURSDAY (Dec. 11, 2014 from 8 a.m. – 5 p.m. ET; for more information and to register for this FREE summit, visit http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence/).  The Summit is entirely virtual…meaning you can attend from anywhere on the globe, as long as you have an internet connection. Join us by clicking on the graphic below.

Thanks for downloading your copy of the Final Findings from the Survey 2014 on Real World Evidence_image001

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ship      Amy Smalarz, President of Strategic Market Insight, will discuss the tools you need for successfully navigating the RWE boat. Specifically, Amy will describe how she has helped otherschecklist structure and maximize their RWE. Amy has developed her own RWE Checklist for Success that she will share with the audience (and even allow for audience feedback- after all, we  are all in this together!). This Checklist will visually present how to ensure the correct stakeholders have been incorporated and included. It will also provide a map to use throughout the  RWE process, to make sure the proper stakeholders are engaged at the right time, and detail just how exactly they should be engaged. RWE doesn’t happen overnight, and it shouldn’t  be an afterthought. Amy will highlight the importance of having discussions around RWE before project development.

How do you make this happen? Amy knows, and she will discuss strategies to facilitate conversations among the key players to get things moving and plans in place before moving forward. Recognizing that not all projects are created equal, the Checklist allows the user to customize the tool so that it meets the needs of individual projects.

Like everything else in life (including clinical trials), RWE is an evolving process. Amy will share her stories on how she sees things evolving, and what this may mean for RWE. You won’t want to miss out on this Virtual Summit (virtual = you can participate from the comfort of your office or home!) this Thursday. It’s not too late to register for this meeting (did we mention it is FREE, and more than 300+ of your colleagues have already signed up???  http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence/). Learn how others are successfully navigating the RWE waters, and how to use your Checklist for success to charter your own boat!

Join us on December 11th at this free, day-long Virtual event and find out!   See you Thursday!!!

 

More about the Speakers

amysmalarz Amy Smalarz, PhD, is President of Strategic Market Insight.  Amy has a PhD in Social Policy and Health Services Research from Brandeis University. She also has a Masters in Health Care Administration from Simmons College and BA in Biology and Sociology from Brandeis University.  She has worked for various payer groups and consulting/data analytics companies conducting HEOR and Market Access research for more than 13 years.  Awards and honors include the Tom Crossman Prize for Public Policy (Simmons College, 2002), the best paper based on a dissertation (Academy of Management, Health Care Division, 2006) and being an Agency for Healthcare Research and Quality (AHRQ) Fellow (Brandeis University, 2002 – 2005).

 

This blog posting was written by Meg Franklin, PharmD, PhD, Owner and President Franklin Pharmaceutical Consulting, LLC, on behalf of HealthEconomics.Com. Dr. Franklin may be reached at mfranklin.fpc@gmail.com or www.franklinpharmaceutical.com.

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Real-World Evidence: Why Patients Matter.

Take 2 tablets and call me in the morning

We’ve moved, finally, beyond assuming that an off-the-cuff statement like “take 2 and call me in the morning” is first-quotesufficient.  But maybe we haven’t moved far enough to ask the important questions of “why isn’t it sufficient?”. Health Literacy and Cultural Competency are two buzzwords that health professionals are likely to encounter these days, and their importance in achieving a desired endpoint in patient care cannot be understated.

second-quoteSo what exactly does Health Literacy mean?  How do we implement a Cultural Competency in our healthcare system?  And most importantly, what do we need to know to understand how literacy and culture affect health outcomes and research conducted among a wide and diverse patient population?

Healthcare Providers, Researchers, Policy-Makers, and Patient Advocacy groups must consider what happens – or doesn’t happen – when we provide information or health directives to patients who can’t read – or, who may not be able to read on the level on which the information was written.  Sure, the “box may be checked” that the patient received healthcare information, but was it readable, understood, and acted upon?  Why or why not?

venn diagramBeyond literacy, we must also ask about (and understand) the patients’ culture.  To what extent does a patient’s personal identification, language, thoughts, communications, actions, customs, beliefs, values, and institutions influence beliefs and belief systems surrounding health, healing, wellness, illness, disease, and delivery of health services?

As health outcomes researchers and healthcare providers, we must consider both Health Literacy and Cultural Competency in the deployment of healthcare and the conduct of research, particularly real-world evidence (RWE) trials that are often conducted with diverse patient populations.

If you don’t feel you are doing this to the extent that is needed, then you need to hear Dr. Donney John, Founder & CEO of Urban Medical Solutions and Interim Executive Director of NOVAScripts Central, discuss some of these issues and more at the first ever Real-World Evidence virtual Summit hosted by HealthEconomics.Com (for more information or to register please go to: http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence/).  During his portion of the programming, Don will discuss why RWE should be a focal point for patient care. He’ll also discuss cultural competency and health literacy and what factors to consider in the design, implementation, and communication of results from RWE studies. RWE is important for helping patients feel they are understood and connected with their health. What role do patients play in the development of RWE? What role does RWE play in improving a patient’s management of their care?

So, don’t miss out on the chance to make sure you know what you need to know about Health Literacy and Cultural Competency for Real-World Evidence research.  Oh, and it’s free to attend.  And it’s virtual…meaning you can attend from anywhere on the globe, as long as you have an internet connection.

Thanks for downloading your copy of the Final Findings from the Survey 2014 on Real World Evidence_image001

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Putting it all into PROspective

Any Pain

Patients Reported Outcomes (PROs) are acknowledged as a vital component to the complete healthcare picture, but they haven’t gained the traction they deserve. Join us at the RWE Virtual Summit where Linda Abetz-Webb, CEO of Patient-Centred Outcomes Assessment (P-COA), will discuss the compelling reasons why we should be measuring Patient Reported Outcomes. She’ll take a look at where things are now in the PRO world, and where they should be going. Linda will also delve into the ‘patient-centered outcomes’ terminology  (click here to see PCORI’s approach to a definition) that is flooding the healthcare headlines.  Linda will examine RWE from a patient perspective. Linda’s vast experience in this arena will provide for a lively presentation and help the audience gain some PROspective. To register for the Virtual Summit, please go to: http://www.healtheconomics.com/home/1st-ever-virtual-summit-real-world-evidence

“See” you on the 11th!

More about the Speakers

Donney John is a practicing pharmacist, healthcare consultant and entrepreneur, with considerable expertise in the areas of patient engagement, population health management, transition in care and mobile health technology solutions.  Don is the founder & CEO of Urban Medical Solutions and Interim Executive Director of NovaScripts Central, a non-profit pharmacy that provides free medications to uninsured patients in the northern Virginia area.  He is also the founder and CEO of Urban Medical Solutions, a health consulting company which provides consultative services focusing on clinical workflow and technology integration.  Don holds a Doctor of Pharmacy degree from St. John’s University in Queens, New York, and has completed a pharmacy residency with Massachusetts College of Pharmacy & Health Sciences.

 

Linda Abetz-Webb is the CEO of Patient-Centred Outcomes Assessment (P-COA). She has over 20 years of experience in developing, validating, and implementing clinical outcomes assessments (COA- patient, observer, and clinician reported). Linda has successfully utilized COAs to maximize market access and patient adherence. Her specific expertise is in pediatrics and/or rare diseases.

This blog posting was written by Meg Franklin, PharmD, PhD, Owner and President Franklin Pharmaceutical Consulting, LLC, on behalf of HealthEconomics.Com. Dr. Franklin may be reached at mfranklin.fpc@gmail.com or www.franklinpharmaceutical.com.

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