What is informed choice in health care?

The consulting room: what informed choice means in health care, the standard the UK Supreme Court set, what material risk and reasonable alternative mean, and why the decision belongs to the patient

What is informed choice in health care is a question with a precise answer in UK law, and the answer is the standard against which the same two words on a supplement shelf can be measured. In health care, informed choice is the principle that a decision about a person's own body is theirs to make, and that it can only be theirs if they have been given the information a decision needs. The UK Supreme Court set the modern standard in a case about a mother who was not told of a risk in her delivery that she would have wanted to weigh, and the judgment replaced the older test, in which a doctor disclosed what a reasonable doctor would disclose, with a patient-centred one: a person must be told of any material risk of a proposed treatment and of any reasonable alternative, including doing nothing, and a risk is material if a reasonable person in that patient's position would be likely to attach significance to it, or if the doctor should reasonably be aware that this particular patient would. The information must be given in terms the person can understand and weigh, not as a form to sign, and the decision that follows is the patient's, even if the clinician would have decided otherwise.

Three features of that standard matter for everything that follows. First, the information is owed; it is not the patient's job to find it, it is the clinician's job to give it, and a decision made without it is not an informed choice however willingly it was made. Second, the test of what to disclose is the patient's perspective, not the professional's: a risk a surgeon considers trivial is material if the patient would want to know it, which is why a conversation about a person's circumstances comes before a list of risks. Third, alternatives are part of the information, including the alternative of doing nothing, because a choice between one option and silence is not a choice. The professional regulators' consent guidance says the same in practical terms: a dialogue, tailored, with the risks and the options, and a decision the person makes.

That is the consulting room, and the phrase was built there. The next room is the shelf, where the same two words appear on a tub, and the question is what they mean there and what a buyer can do with the principle once they know where it came from.

The standard set out with its three features, and the shelf's borrowing of the phrase, the five things an informed choice about a supplement requires, who owes each, the worked example laid out as the five and the verdict in the next section.

The shelf: the certification programme that borrowed the phrase and what it actually certifies; the principle taken back and applied to a tub as five things; who owes each; the worked example as the five things; and the verdict

On a supplement shelf, informed choice is the name of a certification programme, and it is a real programme doing a specific thing: it screens products for substances on the anti-doping prohibited list, by a blind-sampling regime of product bought from the market, and publishes the products it has certified in a database. The name borrows the health-care principle, and the borrowing is apt in one respect, because a tested athlete choosing a product without knowing whether it has been screened is choosing without a material piece of information, and the programme supplies it. But the programme's attestation is narrow, banned substances and nothing else, and the phrase on the tub does not mean that the buyer has been given the information an informed choice about that supplement requires; it means one risk, relevant to one kind of buyer, has been screened for. A buyer who reads the two words on a tub as the consulting-room standard has been given a logo and taken it for a conversation.

The principle can be taken back from the brand and applied to the tub, and when it is, an informed choice about a supplement needs five things, each with someone who owes it. The first is what the thing does, which is the authorised claim on the GB register and nothing beyond it; the label owes it, and a claim that is not on the register is a claim the person was not entitled to rely on. The second is the dose against the upper level, so that the person knows whether the amount is a correction or an excess; the label and the UK upper levels owe it. The third is the evidence for the person's own situation, because a supplement with strong evidence in the deficient and none in the replete is a different proposition for the two, and a test or a plate reading tells the person which they are; a doctor owes the test and the person owes the reading. The fourth is the material risks, the interactions with medicines, the conditions in which the supplement is a doctor's question, the spacing from other things taken, and the harm record of the ingredient; a pharmacist owes it for anyone on a medicine, and the label owes the warnings. The fifth is the reasonable alternative, including doing nothing, which for most supplements is the plate, and which the shelf never mentions because it does not sell it. A person who has the five has made an informed choice in the health-care sense, whatever logo the tub carries, and a person who has a logo and none of the five has not.

The worked example is laid out as the five things rather than as a pitch, which is what the principle demands of it: {FL}, 1500mg magnesium bisglycinate stated as 300mg elemental, does what its authorised claims say, normal muscle function, normal psychological function and the reduction of tiredness and fatigue, and nothing beyond them; its dose is 80% of the reference value and below the supplemental upper level; its evidence is for a shortfall, which the survey finds in a share of adults, and not for the replete; its material risks are the mineral's spacing from certain antibiotics and thyroid medicines, a pharmacist's question for anyone on one, loose stools above the upper level, and a doctor's question with a kidney condition; and its reasonable alternative is a plate with nuts, seeds, pulses, whole grains and greens, which a person who eats it does not need to supplement. It is batch tested for four metals, UK made under GMP and BRC, 180 capsules for £19.99 at 22p a day, and it is not enrolled in the programme that bears the phrase. The full label breakdown is here.

The verdict: in health care, informed choice is the standard the UK Supreme Court set, a person told of every material risk and every reasonable alternative in terms they can weigh, with the information owed to them and the decision theirs. On a shelf, the same two words name a certification programme that screens one risk for one kind of buyer, and the logo is not the conversation. The buyer takes the principle back and asks five things of any tub, the claim, the dose, the evidence for their situation, the material risks and the alternative, collects each from the label, the register, a pharmacist and a doctor, and makes the choice the phrase was built to describe.

What to check on the label

Questions people also ask

What does informed choice mean in healthcare?

The principle that a decision about a person's own body is theirs and can only be theirs if they have the information a decision needs, set as a legal standard by the UK Supreme Court: a patient must be told of any material risk of a proposed treatment and of the reasonable alternatives, including doing nothing, with a risk being material if a reasonable person in that patient's position would attach significance to it, and the information given in terms the person can understand and weigh rather than as a form to sign; the information is owed by the clinician, the test of what to disclose is the patient's perspective, and the decision that follows is the patient's.

What is the Montgomery ruling on informed consent?

The UK Supreme Court judgment that replaced the older test, in which a doctor disclosed what a reasonable doctor would disclose, with a patient-centred one: a clinician must take reasonable care to ensure the patient is aware of any material risks of the recommended treatment and of any reasonable alternatives, and a risk is material if a reasonable person in the patient's position would be likely to attach significance to it or if the clinician should reasonably be aware that this patient would; it arose from a mother not told of a risk in her delivery that she would have wanted to weigh, and it is the standard the phrase informed choice now carries in UK health care.

Is Informed Choice the supplement certification the same thing?

No; the certification programme borrowed the phrase for its name and does a specific and narrower thing, screening products for substances on the anti-doping prohibited list by a blind-sampling regime of product bought from the market and publishing the certified products in a database, which supplies a tested athlete with one material piece of information and supplies nothing about what the supplement does, its dose, its evidence for the buyer or its interactions; a buyer who reads the logo as the health-care standard has taken a screened risk for a conversation, and the principle is applied to a tub by collecting the five things the programme does not attest.

How do I make an informed choice about a supplement?

By collecting the five things the health-care standard would require and the shelf does not supply: what the thing does, which is its authorised claim on the GB register and nothing beyond it; the dose read against the UK upper level; the evidence for your own situation, which a doctor's test or an honest plate reading tells you, since most supplements have strong evidence in the deficient and none in the replete; the material risks, which for anyone on a medicine a pharmacist owes and the label's warnings state; and the reasonable alternative, which for most supplements is the plate and which the shelf never mentions; with the five in hand the choice is yours in the sense the phrase was built for.

Does this site's magnesium meet the informed choice standard?

It is laid out as the five things rather than as a pitch, which is what the standard asks of a product: it does what its authorised claims say, normal muscle function, normal psychological function and the reduction of tiredness and fatigue, and nothing beyond them; its dose is 300mg elemental at 80% NRV and below the supplemental upper level; its evidence is for a shortfall the survey finds in a share of adults and not for the replete; its material risks are spacing from certain antibiotics and thyroid medicines, a pharmacist's question, loose stools above the upper level and a doctor's question with a kidney condition; and its alternative is a plate with nuts, seeds, pulses, whole grains and greens; it is batch tested for four metals, UK made, 22p a day, and not enrolled in the programme that carries the phrase.

Sources

1. The UK Supreme Court's judgment in Montgomery v Lanarkshire Health Board, which set the modern standard for informed choice in health care: a patient must be told of any material risk and of reasonable alternatives, material meaning a risk a reasonable person in the patient's position would attach significance to, so that the decision is the patient's and the information is owed to them. https://www.supremecourt.uk/cases/uksc-2013-0136.html
2. The sports supplement certification programmes: Informed Sport, Informed Choice, BSCG and NSF Certified for Sport test products or batches for banned substances, the assurance competing athletes rely on. https://sport.wetestyoutrust.com/
3. Retained Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, and the Great Britain nutrition and health claims register. https://www.gov.uk/government/publications/great-britain-nutrition-and-health-claims-nhc-register
4. The UK Expert Group on Vitamins and Minerals safe upper levels report and EFSA tolerable upper intake levels: the vitamins and minerals that accumulate or cause harm with daily long-term intake are the fat-soluble vitamins A and D, iron, zinc, selenium and vitamin B6, each with a defined upper level, against which a fibre-and-protein food extract has no comparable mechanism of accumulation. https://www.food.gov.uk/research/safe-upper-levels-for-vitamins-and-minerals

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