Many times when I am writing about a topic or answering a question for Hot Flash readers, you may notice, I reference “the guidelines” in a particular area. At other times, I’ve discussed changes in guidelines. When these changes happen, they are often covered in the media — things like mammography screening or infant sleep — and my patients have lots of questions. You probably do too, especially when they turn into panic headlines.
As much as we talk about medical guidelines, in my experience most people don’t know exactly what they are, who is writing them, or what their real purpose is. I believe that understanding what exactly guidelines are will help you make more-informed medical decisions for you and your family. So today I am going to pull back the curtain for a behind-the-scenes look at medical guidelines. It may change the way you think of them.
What are guidelines and who are they for?
At their simplest, medical guidelines are published recommendations regarding the management of a specific health-related topic from a group of experts on that topic. There are guidelines issued on everything from whether infants should use walkers, to which antibiotics to prescribe for a urinary tract infection, to when to get screened for various types of cancers, to goals for blood pressure readings in different types of patients on blood pressure medications.
Guidelines are not written with the intention that they are interpreted and read by the general public. The intended audience for published guidelines are physicians and public health professionals who then apply the guidelines to individual people or populations. This is not always how it works. The media often cover the publication of new guidelines, and when those are controversial (for example, the 2023 guidelines for managing childhood obesity), that can generate confusion.
What do the guideline documents look like?
What gets discussed in the media (and even among doctors) are top-line summary statements. But published guidelines can be upward of 80 or 100 pages of text that address relatively specific subject matter. The recent guidelines published by the Endocrine Society on vitamin D supplementation are 41 pages long and address 14 different questions. For each of those questions, the authors provide a recommendation and rate the strength of that recommendation.
The rating is intended to tell the reader how convinced the experts are that this is the right recommendation based on the strength of the research. In my experience, this is where we start to lose the nuance of the authors’ message. The ratings are often given in a cryptic code, for example the Endocrine Society uses a number 1 through 4, with 1 being the strongest recommendation and 4 being the weakest, followed by 0 to 4 pluses that indicate what type of data is available to support that recommendation.
For instance, in the guidelines for osteoporosis, the recommendation to treat postmenopausal osteoporosis is 1/++++, meaning it is strongly recommended and is supported by strong evidence from randomized controlled trials. While the recommendations are given up front on pages 1 and 2, the key for understanding what 1/++++ means doesn’t happen until page 20 (of a 28-page publication). Additionally, every publication has its own code and definitions, making it difficult for even a deep reader to understand the subtleties of the authors’ message.
Doctors and patients alike often assume that if the authors are making a recommendation, the evidence for that recommendation must be strong. But that is not always the case. A deep reading of the 2023 update to the breast cancer screening guidelines tells us that the authors changed the age to initiate breast cancer screening due to a lack of evidence regarding how new digital mammography technology performs in younger women, and the fact that previous guidelines were based on data that did not include many women of color.
Some guidelines also cover highly diverse groups of patients. The guidelines regarding cholesterol management have separate recommendations for different groups of people, from those with Type 2 diabetes to those taking or abusing testosterone. All that detail may be useful to me at different times in my practice, but it often gets reduced to clickbait headlines in the media.
Where do guidelines come from?
Guidelines are recommendations of experts. But who chooses the topics, the experts, and publishes the results? Largely, two types of organizations.
There are professional societies, such as the Endocrine Society, the American Academy of Pediatrics (AAP), and the American College of Obstetricians and Gynecologists (ACOG). They are independent of government health agencies and are also involved in publishing research journals and organizing conferences where researchers present their work. There are also public health agencies, such as the U.S. Preventive Services Task Force (USPSTF), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA), which is responsible for creating dietary guidelines, that also publish guidelines.
In some cases, there are guidelines on a single topic from multiple different groups. For example, the USPSTF, ACOG, and the American Cancer Society have all issued guidelines regarding breast cancer screening in normal-risk women. For many years those guidelines differed regarding the age at which breast cancer screening should begin. This left doctors and patients wondering which guidelines they should follow, and, not surprisingly, different people made different choices. Luckily, in 2023 the USPSTF revised its guidelines to bring them into agreement with the others.
The experts who are responsible for making the recommendations and writing the published paper are doctors, public health experts, and scientists who have particular expertise in an area. They get together in a series of meetings to review the evidence, consider the cost-effectiveness of a treatment, debate its importance, and come up with a series of recommendations on the topic at hand.
These experts are humans, who come to these meetings with their own interests, experiences, and biases. Some of them may be the authors of research on the topic. Some may consult with pharmaceutical companies and get funding from those companies to study new medications. Particularly in the case of government agencies, there may be lobbyists looking to sway the guidelines committee in one direction or the other.
Ultimately, the committee has to agree to a set of recommendations that will be published for their job to be done. You can imagine that the authors may not all agree on every point. There is often a need to compromise. This can help balance out biases and limit the influence of an individual committee member. I have been at conferences where an expert will voice their disagreement with certain points in guidelines they themselves co-authored.
Why are guidelines important?
The above makes clear: these guidelines are written by humans, who come with biases and are often working with incomplete data. This means the guidelines can be imperfect. But that is not a reason not to have them. In fact, these guidelines are very important for a number of reasons.
- Guidelines provide doctors with a resource when they are making decisions regarding how to manage a particular patient. They can be especially helpful in summarizing the available data regarding specific patient populations. I treat a number of patients who are trans male and take testosterone. I know that taking testosterone can raise cholesterol levels. I can consult the guidelines for managing high cholesterol in transgender patients taking testosterone to supplement my own experience treating patients.
- They are used to establish standards of care for litigation. If a patient or their family sues a doctor or hospital during the proceedings, there will often be much discussion as to whether the medical team were following the standards of care, which often stem from the clinical guidelines at the time of the incident.
- Guidelines can influence what tests and treatments are covered by insurance. In 2021 the USPSTF revised its guidelines to recommend initiating colon cancer screening with colonoscopy at age 45 instead of age 50. In 2020 most insurance companies would not pay for a patient to have a screening colonoscopy if they were under age 50. Now, screening colonoscopy is routinely covered for people between the ages of 45 and 50.
- Guidelines may also affect medication coverage. For many years, the American Association of Clinical Endocrinology (AACE) guidelines for Type 2 diabetes recommended metformin as the first treatment that should be offered to lower blood sugar in patients with Type 2 diabetes. Over the past 20 years, new medications that not only lower blood sugar but also help patients with diabetes manage their weight and reduce their risk of having a heart attack or stroke were approved by the FDA. However, many insurance companies required that patients try metformin first and have it be ineffective before they would cover the newer medications. Now the AACE guidelines list the newer medications as preferred. As a result, many insurance companies will cover them as a first-line medication — no trial of metformin needed.
- Guidelines are used to develop public policy. Dietary guidelines help determine public policy regarding school lunches. Guidelines regarding breastfeeding support policies that allow women time and accommodations for pumping at work. During the COVID-19 pandemic, CDC guidelines provided a framework for sick-leave policies.
How should guidelines be used?
I often say guidelines are just that, guidelines. They are not intended to be hard-and-fast laws, but rather a starting point to help in our medical decision-making. The balance of benefit and risk described in the guidelines may not apply to the patient in front of me.
The guidelines for treating hypothyroidism are a great example. The main test we use to monitor thyroid function is thyroid-stimulating hormone (TSH). The guidelines recommend that if only the TSH is abnormal, in most cases you should not treat the patient unless that number is more than double the upper end of abnormal.
In many cases, that may be the right answer. However, some of the reasoning in the guidelines is related to the cost of treatment. If the patient sitting in front of me is a very symptomatic young woman who is feeling terrible, and her levels have been abnormal more than once, she and I may not be very concerned with the cost (which anyway in this case is a generic and cheap). It is relatively safe and could help her feel better. In this case, it would be reasonable to try the medication in spite of the guidelines.
This is where the art of medicine comes into play. A skillful physician will not just know the guidelines but will consider how the details of the guidelines and the details of the particular patient intersect. They will apply the guidelines with nuance. Applying guidelines without nuance and context leads to one-size-fits-all medicine that leaves patients feeling frustrated and unheard. It erodes the trust between doctors and patients, who may ultimately not seek the care they need.
Understanding guidelines can also help you frame your conversations with your doctor. You can ask: How do the guidelines apply to me? What is the strength of a guideline being applied? And what evidence supports that guideline? Hopefully this will lead to more meaningful conversations about your care.
The bottom line
- Guidelines are a series of detailed recommendations from a group of experts regarding how to manage a particular clinical situation. They are published by public health agencies and professional organizations.
- Guidelines are not just published to support doctors; they can be used to determine insurance coverage and best practices in cases of litigation.
- Guidelines are not intended to be followed slavishly but to serve as a basis for individual clinical decision-making.
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Oh how I wish the clinical judgment you mention could play a larger role. As you say, it’s critical, but so often it doesn’t or can’t happen.
Plenty of doctors have their pay docked or could get in trouble if they don’t recommend a screening contrary to the guidelines, even if it makes total sense for the individual patient. Or thin patients get weight-shamed in pregnancy, even if the pregnancy is totally healthy, because their initial BMI was “too low”. Or people got shamed, specifically by doctors, for not following finicky covid guidelines, even if a low-risk toddler crossing state lines before vaccination was not exactly at the top of the list of pressing public health issues. It should work the way the article lays out, but so often it doesn’t. Also it can be nigh impossible to get a timely appointment to even discuss anything with a doctor (waits for a simple primary care visit, gyno visit, or dermatologist checkup are more than a year in my area.) Le sigh.
Are these organizations taking enough responsibility for preventing misinterpretation by the media? From my position as a person, patient and communications professional, it appears not. If the media is always going to take a shallow pass at the guidelines for the juiciest headline, what can the organizations that create them do to better prevent the public from becoming misinformed?