Time to get clinical over much-needed guidelines

By European Alliance for Personalised Medicine Executive Director Denis Horgan 

Treating patients is often not an easy task - difficult decisions need to be made, often in the face of uncertainty.

But clinical guidelines exist to help, including recommendations aimed at optimising patient care. They are based on existing evidence, systematically reviewed, but because there are so many, it can even then often be difficult to assess which are the best.

Doctors need to quickly identify high quality, trustworthy clinical practice guidelines, in order to improve decision making for the benefit of their patients.

In the US, the Institute of Medicine developed eight standards “for developing rigorous, trustworthy clinical practice guidelines”. While these have yet to be fully pilot-tested, it’s a good start and, crucially, it was the US Congress that called for them in the first place.

Perhaps the European Commission could do something similar?

In both Europe and the US (especially with the rapid emergence of personalised/precision medicine) emphasis is now firmly on improving systems and methods for delivering patient care.

But the patient must trust his or her doctor, and that’s often an issue, on both sides of the Atlantic.

In the US, for example, surveys strongly suggest that public trust in the leaders of its medical profession has declined sharply over the past half century, from 73% in 1966 saying they had ‘great confidence’ in the leaders of the medical profession, but only 34% saying the same in 2012.

Today, according to a recent Gallup poll, only 23% say that they have a great deal or quite a lot of confidence in the US health system as a whole.

Having said that, trust in the integrity of doctors remains buoyant. Almost 70% of the public rate the honesty and ethical standards of physicians as a group as “very high” or “high”.

Generally speaking, clinical guidelines could help in many situations, not merely in keeping trust levels high, and the Brussels-based European Alliance for Personalised Medicine (EAPM) believes it is incumbent upon EU Member States’ governments to call for, and coordinate in a pan-European manner, such guidelines, hopefully with substantial encouragement from the European Commission.

Some examples of effective guidelines include the American Cancer Society’s recommendations for early breast cancer detection in women without breast symptoms.

The society emphasises the importance of finding breast cancer early, stating that: ‘The goal of screening tests for breast cancer is to find it before it causes symptoms (like a lump that can be felt). Screening refers to tests and exams used to find a disease in people who don’t have any symptoms. Early detection means finding and diagnosing a disease earlier than might have happened if you’d waited for symptoms to start.”

It goes on to state that: “Most doctors feel that early detection tests for breast cancer help save thousands of lives each year, and that many more lives could be saved if even more women and their health care providers took advantage of these tests.”

We know that women with a personal history of breast cancer, a family history, a genetic mutation known to increase the risk, and those who had radiation therapy to the chest before the age of 30 are at higher risk. For them, the guidelines are rightly different.

And, the society says: “Women aged 40-44 should have the choice to start annual breast cancer screening with mammograms if they wish to do so. The risks of screening as well as the potential benefits should be considered. Women age 45 to 54 should get mammograms every year.”

It continues: “Women aged 55 and older should switch to mammograms every two years, or have the choice to continue yearly screening.”

These are very clear suggestions, coupled with a recommendation against MRI screening for women whose lifetime risk of breast cancer is less than 15%. All of the above is evidence based.

And when it comes to another great killer, lung cancer, the American Cancer Society states that it has “thoroughly reviewed the subject of lung cancer screening” and issued guidelines that are aimed at doctors and other health care providers.

Some of these are blindingly obvious, given that we all know the risks that tobacco smoking poses. For example, the society says that patients “should be asked about their smoking history”. It adds that patients who meet all of the following criteria “may be candidates for lung cancer screening”.

Those criteria mentioned above are that the patient is between 55-74 years old, is in fairly good health, has at least a ’30 pack-year’ smoking history and is either still smoking or has given up within the last 15 years.

On top of this, doctors should discuss the benefits, limitations, and potential harms of lung cancer screening with their patients.

The main benefit, of course, is a lower chance of dying of lung cancer. It is the biggest global killer of all cancers. Fewer than half of newly diagnosed sufferers live beyond a year, with only 16% surviving for five years.

It is such a huge killer partly because it is harder to detect in its early stages. By the time a person begins to notice symptoms, it has often spread to other parts of the body and is, therefore, difficult to treat.

The majority of lung cancers in both sexes are caused by smoking, but about 15% are not, and the majority of those non-smokers are women, mostly young women.

Lung cancer in women has increased by a staggering 600% over the past 30 years. Today, more are killed each year by lung cancer than they are by breast, ovarian and uterine cancer combined. Nobody is 100% sure why and, certainly, more research is desperately needed.

EAPM says that all lung cancer patients urgently need action at the highest level, adding that improvements will “depend primarily on greater collaboration between member states and across the healthcare sector. The collaboration should include patients, caregivers and patient organisations, who have an indispensable contribution to make”.

The Alliance adds that: “More effort is needed in prevention. Public awareness of the disease and the risk factors should be developed, particularly among younger people, women and front-line healthcare professionals.”

Clinical guidelines play a crucial part in making sure that the right patient receives the right treatment at the right time and, where we don’t have tried-and-tested guidelines, on a pan-European scale, it’s about time that we did.

Share this article: