13 Research methods, statistics, critical review and evidence-based practice13.1 Introductory concepts

13.1.7 Supporting an informed patient decision

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Written by Resident Doctor Committee · Published

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Relative and absolute measures of effect

Interactive

Risk ratio
0.500treated risk over control risk
Relative risk reduction
50%
Absolute risk reduction
20.0%percentage points
Number needed to treat
5
Odds ratio
0.375

Control arm

Of 100 patients in the control arm, 40 have the event.
Event: 40No event: 60

Treated arm

Of 100 patients in the treated arm, 20 have the event.
Event: 20No event: 80

Treat 5 patients and you would expect one of them to avoid the event who would otherwise have had it. In 100 patients per arm, that is about 20 events avoided.

A risk ratio of 0.50 and an NNT of 5. Keep the risk ratio and change the baseline: at 0.16 and 0.08 the NNT rises to about 13, and at 0.60 and 0.30 it falls to about 4.

Making the choice explicit

Shared decision-making combines evidence and clinical judgement with the person's goals, concerns, previous experiences and circumstances.

The three talk approach has three steps:

  1. Introduce the choice.

  2. Discuss the options, including no treatment or no change, and any legal or urgent clinical constraints.

  3. Support a decision.

  • For less severe depression, NICE (National Institute for Health and Care Excellence) advises against routinely offering antidepressants first line unless they are the person's informed preference.

  • Active monitoring, for someone who declines treatment or is improving, means information, access to help, reassessment normally within 2 to 4 weeks and follow-up after non-attendance.

Absolute numbers over a stated time

  • Give absolute frequencies with the same denominator and time period for every option.

  • Halving a risk from 60 in 100 to 30 in 100 matters far more than halving it from 2 in 1,000 to 1 in 1,000.

  • Present both outcomes, relapse and no relapse, rather than framing only the one that favours your preferred option.

The treated group (holding pills) and the untreated group each have 16 people, and the dark figures had the adverse outcome: 4 treated against 8 untreated, so a shared denominator shows the absolute difference as well as the halving of risk. Psarka. CC BY-SA 4.0, via Wikimedia Commons

Worked example: antipsychotic maintenance

A 2012 review pooled 65 trials with 6,493 participants. The outcomes come from different trial subsets and follow-up periods, so they illustrate the method rather than forecast one person's year.

Outcome per 100 participants

Continuing antipsychotic

Placebo withdrawal

Relapse at 7 to 12 months

about 27

about 64

No relapse at 7 to 12 months

about 73

about 36

Hospital admission

about 10

about 26

Weight gain

about 10

about 6

Movement adverse effects

about 16

about 9

  • Relapse falls by 37 percentage points, so the number needed to treat (NNT) is about 3.

  • The pooled relative risk (RR) was 0.40, slightly different from 27 / 64 because pooling uses weighted study estimates.

  • Do not compare benefits and harms as though their follow-up and definitions matched when they did not.

Baseline risk

  • Absolute benefit depends on baseline risk: if the RR of 0.40 held constant, higher baseline risk would give greater absolute benefit, but constancy is an assumption.

  • Stabilised participants in withdrawal trials, and the withdrawal methods used, may differ from planned gradual reduction in routine care.

Communicating uncertainty

  • The pooled RR had a 95% confidence interval of 0.33 to 0.49, and the NNT was 3 with a confidence interval of 2 to 3.

  • When an interval includes no effect, describe the range of benefits and harms compatible with it.

  • A confidence interval does not capture bias, long-term uncertainty or individual variability.

  • Say plainly when the evidence covers weeks or months but the person is asking about years.

Making the options usable

  • Discuss each option to comparable depth: benefits, harms, practical demands, time to benefit and review.

  • Quality-assured decision aids support the discussion but do not replace it.

  • Give information in manageable chunks and use teach-back to check understanding.

  • Explain terms such as "response", which may mean a fall in a score rather than recovery.

  • Provide suitable interpreters and communication support.

  • Equality Act reasonable adjustment duties include accessible information where relevant.

  • England's Accessible Information Standard (DAPB1605) requires services to identify, record, flag, share, meet and review disability-related communication needs; it does not cover every language need.

Eliciting what the person is weighing

  • Ask about desired outcomes, adverse effects to avoid, tablets versus injections, monitoring, work, family, travel, costs and tolerance of uncertainty.

  • "What would a good six months look like?" can reveal priorities a diagnosis does not.

  • Order of presentation, detail and enthusiasm all steer choices, so explain the basis of any recommendation and do not hide alternatives.

Legal standard for disclosure

Case

Principle

Montgomery v Lanarkshire Health Board (2015)

Take reasonable care to explain material risks of recommended treatment and reasonable alternatives

McCulloch v Forth Valley Health Board (2023)

Which alternatives are reasonable is professional judgement backed by responsible medical opinion; Montgomery's patient-centred risk discussion still applies

A risk is material if a reasonable person in the patient's position would likely attach significance to it, or the clinician should recognise that this particular person would (tremor or sexual effects matter differently to different people).

Capacity and supported decision-making

Jurisdiction

Statute

Starting position

England and Wales

Mental Capacity Act 2005

Presume capacity; take practicable steps to support; an unwise decision alone is not incapacity

Scotland

Adults with Incapacity (Scotland) Act 2000

Benefit, least restriction, relevant wishes, consultation, support for retained skills

Northern Ireland

Mental Capacity Act (Northern Ireland) 2016, partly commenced

Mental Health (Northern Ireland) Order 1986 remains relevant

  • Support includes hearing aids, interpreters, clearer information, a better time of day, or delaying a non-urgent decision until acute disturbance settles.

  • Disagreeing with advice does not by itself show incapacity.

  • Family and supporters are involved according to the person's wishes and confidentiality; they gain no decision-making authority automatically.

Detention in England and Wales

  • Detention does not remove capacity or the duty to involve the person.

  • Section 63 authorises specified treatment for mental disorder, subject to Part IV safeguards; unrelated physical treatment follows ordinary consent law.

  • Under section 58, medication beyond three months needs consent certification or a second opinion appointed doctor (SOAD) certificate; the three months count medication given under the Act, not time since admission.

Recording the decision

  • Record the options, material information, what mattered to the person, the decision and review, and offer an accessible copy.

  • A person with capacity may choose differently from the clinician, subject to statutory powers.

  • If they stop medication, plan the withdrawal rather than implying abrupt cessation is harmless.

  • Record agreed warning signs and follow-up rather than relying on "against medical advice".