Patient Thoughts on Medical Tests for Research

Here is a guest post I wrote earlier this year for METAvivor called “How Do People Feel about Bone Marrow Exams?” It was based on a study with Bonnie King from Stanford. While this may be one of the more gruesome-sounding medical procedures that some patients go through, it is not necessarily unique.

Too often, researchers think about all of the cool data they can collect during a clinical trial or research study, without thinking about what is would be like to experience all of those test procedures. Well, patients think about it, and often wonder what is wrong with the researchers!

I’m always perplexed when I hear about “adherence” issues in clinical trials. It used to be called “compliance” but that wasn’t as accurate, and brought up more negative connotations for the research community.

The fact is, for patients, endurance is the best term.

– Deborah Collyar

Staying in a clinical trial, or on any prolonged treatment plan, is an endurance test. There are many unpleasant, and sometimes risky, things that you have to do but hopefully you will get something out of it at the end. Patients hope for positive responses to treatment, or even remission, but that is not always possible.

x-ray film of the brain computed tomography

This is one of many reasons why it is important for those of us who represent patients to be involved in research discussions, from conceptual design to trial completion. We ask questions, such as, “Why do you need x number of these tests? Are they absolutely necessary to answer the questions in this study? What else could be done? Have you thought about asking the patient?”

Let’s work together to make the experience of participating in clinical trials as smooth as possible. Trial participants contribute so much already – they deserve to respect and consideration when we ask them to do things for research.

 

Getting Real about Patients & Clinical Trials

I’ve been asked countless times to write about patients and clinical trials. Guess it’s time to share what I’ve learned, along with other patient advocates, as we work beside researchers in the proverbial trenches. Just so happens that this post coincides with April Fool’s Day – hope that’s not an omen!

Why this series?

This is the first in a series on Patients & Clinical Trials (CT). Why? Because clinical trials are really the only tried & true way we get new diagnostics, treatments, and preventive approaches to people. For all diseases and health conditions.

But the research system isn’t very good at it, even after 70+ years. It’s not for lack of trying – BILLIONs have been spent on tweaking existing structures, but perplexing problems persist.

Heads up on CT activities

Other themes will also emerge, based on over 20 years of changing research and medicine culture (or at least trying to). In the meantime, here are some of my activities in the CT world:

Event Inscription on Sign

Other activities:information-orange-circle_fkMzuUIu_L

  • The California Technology Assessment Forum (CTAF), part of ICER, released their recommendations from the February meeting for new drugs in diabetes and asthma.
  • CTTI just released materials from an expert meeting about the issues surrounding FDA streamlined approvals for new antibiotic drug development. A summary will be posted soon. You can also read a past post called Antibiotic Resistance – It’s Complicated!
  • Cures Within Reach focuses on ways that existing drugs can be used for other purposes. More from this group in a guest blog post here soon!
  • Two DCIS studies are being funded by PCORI to help answer treatment questions for this pre-cancer, and learn how women feel about them. You can also read a past post called When is ‘Carcinoma’ Not Cancer?
  • The Center for Medical Technology Policy (CMTP) is working on recommendations to allow patients to switch treatments in a clinical trial if their cancers keep growing.
  • The Metastatic Breast Cancer Alliance (MBCA) is creating a summary of their February meeting from the Research Task Force to Advance Progress.
  • The NC ProCESS project on prostate cancer has convened a patient advisory board to help communicate effectively with prostate survivors in their study.
  • Two groups I’m working with (MRCT and the NCI NCTN Biospecimen Banks) are discussing how to handle the challenges of giving individual research results to patients.

You can also read past CT posts about:

There are many other clinical trial happenings – these are just some of the ones in which I’m involved! Yes, it’s heavy on cancer, but remember that cancers cover the gamut from rare diseases to millions of people.

Updates will be posted regularly. Let me know what you’d like to hear about. TTFN.

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

7 Ways to Keep Your Funders Excited

This was originally posted on December 9, 2014 for nFocus Solutions, which provides great data solutions for non-profits, government agencies, and communities. Check them out (after reading this post, of course)!

Do you know what funders want most?

They want tangible results they can see and understand. They also want to feel like they are part of your vision. After all, they are helping you reach your goals.

To be proactive and help funders feel engaged with your organization’s mission, you don’t need to hand them a crystal ball with an image of your organization. Just give them clear, concise facts that give them a clear picture of your programs. Your future will soon reap rewards.

Try these 7 methods to keep funders engaged, motivated and excited:

1. Remember WIIFM

‘What’s In It For Me?’ is a tried and true adage, and funders definitely wonder about this when they hear your pitch. But your story isn’t about you; it’s about growing your community through creativity, determination and follow through. Show them how it feels to make things happen by drawing them into your success.

For example, you could share your program in a newsletter that illustrates ‘before’ and ‘after’ reading levels or shows an increase in attendance and time. This can tie your accomplishments back to their funding. Be sure to avoid simply bean counting and demonstrate factual results.

2. Collaborate for long-term gain

3d businessmen inside gear. Teamwork concept. Isolated

Funders appreciate groups that impact entire communities. They realize that no one can do it all, so they often fund partnerships for impact. Take the challenge: develop a plan with organizations that complement your services. According to Stacie Hines, current project manager at nFocus Solutions, “Funders like to see data share agreements—it proves you’re working together.”

3. Be nimble

Flexibility is key, and so are tangible goals. That might mean changing your methods and managing your data. Set short-term goals that help reach your long-term vision. Try tracking your efforts with a logic model that connects inputs, activities and outcomes to prove your impact over time. “Having a defined approach will help you stay focused,” Hines explains.

4. Identify trends as they happen

To stand out, learn where your community needs help. Take the pulse and track real data that walks through your doors. When Hines was employed at Reading and Beyond in Fresno, Calif., she helped them develop their Promise Neighborhood, or federally-supported communities that aim to improve educational opportunities for youth. She reminds us, “In today’s world, measuring outcomes is critical to prove your impact.” The good news: you don’t need a crystal ball. Instead, turn your data into knowledge and lead your community to decisive action.

5. Don’t forget your staff

Attractive female employee pointing at blueprint with her African colleague near by

Your staff can make or break your organization. They also have ideas about how to make your programs shine. Funders sometimes connect to the front line in order to get the real story, so make sure your employees understand your strategy and how their efforts affect the goals and mission.

6. Bring funders with you

Today’s funders are active; they want to follow your progress. Be sure to communicate regularly—not just when it’s time to ask for more money. They may help you avoid potholes that you don’t see at full throttle. Hines adds, “Ask them if they would like to volunteer or attend events where your clients will be.” At the Fresno County Economic Opportunities Commission, Hines invited funders to contribute their time and talents to provide a direct way to connect on a personal level.

7. Be specific

When you ask for money, be specific about programs and share the whole cost. Funders don’t have time to figure out what ‘support’ means. Provide a menu of different projects and break down numbers over time. You can also request funding levels and in-kind donations. And keep asking until they say no, then schedule requests on a yearly basis.

These steps not only keep funders happy and engaged, they can re-energize organizations and ultimately impact communities.

All content © 2016 by Deborah Collyar and nFocus Solutions, Inc.unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

How Do We Get Better Research Results?

We learn about diseases and illnesses from research studies. Some focus on treatment (clinical trials), while others study groups of people (observational studies). Unfortunately, many studies are unclear, wrong, or can’t be easily transferred into everyday medical practice.

Study designs actually matter. They determine whether a research study helps real patients or just asks esoteric questions to further careers or make profits.

There are many ways to improve research studies. Let’s start with observational studies.

Observational Studies

There is one very simple concept to remember about observational studies:

different-paths_M15wj8_dCorrelation does not mean causation!

In other words, just because A and B fit together (are related, associated, or correlated with each other), it doesn’t mean that A caused B to happen.

HealthNewReview.org posted a great article about this, called Observational Studies – Does The Language Fit The Evidence? – Association Versus Causation.

There are several types of observational studies. This chart explains the pros and cons of each type.

F. Perry Wilson suggested a (better?) way to design observational studies in a recent MedPage Today post. A regular problem with these studies is that real life includes many things (factors) that researchers don’t include in studies:

“There are always other confounding factors that we didn’t think about, or we didn’t measure.” – F. Perry Wilson, MD

He suggests a method that helps build in factors that traditional study designs often overlook. Wilson did a great job of explaining both of these concepts in his article:

  • Randomized clinical trials (RCTs), known as the gold standard of clinical research, and
  • Instrumental variable analysis (IVs), which has not been popular, even though it has been around for over 80 years.

Study designs need to answer questions that apply to real people. This is why some of us work with study sponsors to infuse the patient perspective into study design and implementation. In case you are interested, here are some examples in articles and presentations. Just let me know if you’d like to join us.

There are lots of issues in trial design – this is just one. Future post material – aren’t you excited?! Please share your thoughts or add resources on observational studies in the comments. Thanks!

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

Patients want Results. Share Data. Plain & Simple.

It certainly made my week when CT Arena asked me to write a guest post on returning research results to trial participants. It’s the small victories that keep you going, you know?

Creating plain language study result summaries for people is becoming popular these days, thanks to a recent regulation from the European Medicines Agency (EMA). The EMA is similar to the U.S. Food & Drug Administration (FDA). Clinical trial summaries can help patients make better decisions, and show respect to trial participants.

It’s strange to become one of the world’s experts in this field – it’s one of many interests! You can link to the article here. And feel free to contact me for more information – happy to help!

All content © 2015 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.