This is a guest post by SPM member, heart patient and author Elizabeth Rankin, BScN. Some background: one of the most-discussed topics on our blog is shared decision-making (SDM), with pages and pages of posts (75 in the category), dating back to 2010’s Salzburg Global Seminar on the subject. It’s of course an essential aspect of participatory medicine.

The idea of SDM first arose around 1990. It’s well documented for its benefits, but there’s still a remarkable amount of change needed. A new paper released February 15 makes clear that merely talking about SDM, or even giving patients a decision aid, doesn’t in any way ensure that the patient’s preference will be heeded. Two of the key findings:

• Patients didn’t get much benefit from the DAs without explanation / coaching. (Duh??)
• Regardless, their doctors largely ignored what the patient decided, and did what they were going to do anyway.(!!)

The article is about whether a patient who needs a stent (tiny tube) in a blood vessel should get one with anti-clotting drugs “baked in” – so-called “drug eluting” – or without. As with all SDM, each has pros and cons, which the patient should be allowed to evaluate. Here’s her story.

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It can be puzzling for patients who are asked to sign a consent-to-treatment document. It shouldn’t be. The information in the document should be structured in the interest of patients, to their level of understanding for the procedure they’ve been recommended. It should define what it is they are agreeing to and requires information that outlines risks and benefits and provide patients other options prior to their signature.

To me this is personal: years ago I got a stent, and if I’d gotten a drug-eluting one it would have been detrimental to my health. I discovered I was unable to tolerate the drug (Clopidrogrel (Plavix). I developed huge bruises over my body which meant I was at risk from any source that could cause bleeding such as injury or a surgical intervention.

The study in this article raises concerns about a lack of consistency in the information process provided patients when attempting to help them make an informed decision.  It becomes clear, not all physicians considered their patient’s preference for a bare metal stent if that choice wasn’t acceptable to their physician. Where bias existed among physicians in favor of a drug-eluting stent, their preference over a patient’s choice calls into question whether the shared-decision-making process is understood and respected by all physicians.

Overall, the study highlighted the need for patients to get information they need to make an informed decision and for physicians to understand and respect the value of the shared-decision-making process. We hope our physicians have a vested interest in protecting a patient’s right to making decisions they feel are right for them.

Personally, I’ve never seen a consent to treatment document that outlined a patient’s risks nor one that refers to “declaring no financial incentive or interest,” something that could persuade a doctor’s or hospital’s interest to promote a particular product such as a drug-eluting stent.

My experience with the consent to treatment process has been limited to hearing either a doctor or nurse outline the pre-op protocol – not a word about the pros and cons of other choices. Providing a handbook to the patient outlining the risks and the surgical process would be helpful. Patients would have the opportunity to use this as a reference prior to and during their hospital stay and upon discharge home. Typical questions patients have asked and had answered could be included.

The results from this study indicate more information related to the process of shared-decision-making is needed for both patients and physicians. Patients need to understand their personal preferences count and know: it is okay to not agree to what a physician is recommending, especially if they believe the recommendation could cause harm. Patients often have experience that points them toward thinking differently, under certain circumstances. When patients feel empowered by their own knowledge and experience they feel more comfortable with their decision to not accept what the physician may recommend.

Patients should be taught to be empowered which is often a contradiction considering medical or hospital policy. The take away from this article for me was: patients and doctors need to acknowledge their respective decisions may differ and, for physicians, a patient’s preference should be recognized and respected.  Patients however must at least be given this opportunity. The study also raised concerns about pharmaceutical influence over physicians. Medical schools and professional organizations should acknowledge big pharma’s undue influence and how this influence is affecting their decision which can influence their patient’s consent. We know there is undue influence and financial rewards to support many functions within the realm of medical teaching and practice.

A patient’s right to know

How might informed patients make choices differently based on their own experience?

This study illustrates the power imbalance professionals have over patients and may even suggest the influence the pharmaceutical industry has over medical professionals. This awareness is something patients need to understand, but they also have to be informed. I believe this can be remedied by creating a better designed document.

An informed consent to treatment document is a way to educate a patient about their options.  Current documents are designed to get a patient to agree vs. a patient’s right to know.

Patients should be given balanced data & evidence to help them understand their options and risks. They need to understand what underlies the consent to treatment agreement so they can ask the “right” questions before they sign the document. From my experience, current documents lack sufficient information.

It might be better to rethink the consent process and also redesign the form patients sign. It might be worthwhile if the document was set out as an educational content-related document they’d sign. Decision aids are recognized as helpful but they are limited in scope. Approached from a different perspective, those drafting any Consent to Treatment document should recognize the value patients have; bringing forth their past healthcare experience. Rather than limit input to only using staff for document redesign we should tap the wisdom of informed patients whose shared experience could stimulate ideas for a re-designed document.

We should expect nothing less if we want transparency & full disclosure.

Summary: The research study calls into question that the lack of information given some patients affects their ability to make an informed decision. Overlooking a patient’s preference for having a bare metal stent sends readers & patients the signal: too often it is a doctor’s preference rather than a patient’s right to know and their right to say no. This study offers readers an opportunity to reassess how we can improve the consent to treatment process and revise the consent to treatment document. This effort will require a different approach toward developing better designed documents.

[1] https://www.ahajournals.org/doi/abs/10.1161/CIRCOUTCOMES.118.005139

[2]  SIDE-EFFECTS:CONNECT™ a professional-patient education tool. www.ElizabethRankin.com

3.Salzburg Global Statement on Shared-Decision-Making: https://www.bmj.com/content/342/bmj.d1745

4. “Clash in the name of Care.” Boston Globe Spotlight Team Jenn Abelson, Jonathan Saltzman, Liz Kowalczyk and editor Scott Allen.