Changes

April 2026 — reviewed. A literature search was conducted in March 2026 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The Prescribing information section has been deleted and the text amended to emphasize that antipsychotic medication is not routinely recommended, and should only be initiated following specialist assessment or advice. The recommendations have been updated in line with current evidence in the literature.

Update

Goals

To support primary healthcare professionals to:

• Make a diagnosis of delirium and assess the possible underlying cause(s). 
• Arrange hospital admission or specialist referral for a person person with delirium, if clinically appropriate.
• Investigate and manage delirium in primary care if clinically appropriate.
• Advise on sources of information and support for the person's relatives and/or carers.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE Quality standards

Delirium in adults

• People newly admitted to hospital or long-term care who are at risk of delirium should be assessed for recent changes in behaviour, including cognition, perception, physical function, and social behaviour.
• People newly admitted to hospital or long-term care who are at risk of delirium should receive a range of tailored interventions to prevent delirium.
• People with delirium in hospital or long-term care who are distressed or are a risk to themselves or others should not be prescribed antipsychotic medication unless de-escalation techniques are ineffective or inappropriate.
• People with delirium in hospital or long-term care, and their family members and carers, should be given information that explains the condition and describes other people's experiences of delirium.
• People with current or resolved delirium who are discharged from hospital should have their diagnosis of delirium communicated to their GP.

[NICE, 2023a]

What is it?

• Delirium is a common clinical syndrome characterized by disturbances of cognition, attention, consciousness, or perception that develop over a short time period (hours to days) with a fluctuating course [BGS, 2019; Alexander, 2023; NICE, 2023b]. It cannot be better accounted for by a pre-existing or evolving dementia [BGS, 2021].
• The pathophysiology of delirium is complex and not fully understood, but involves the interaction of underlying predisposing risk factors and a superimposed acute stressor or precipitating factor(s) [Wilson, 2020; Jaqua, 2023]. Pathophysiological mechanisms such as global brain 'atrophy, white matter changes, and disruptions in cerebral blood flow, oxygenation, metabolism, and connectivity have been suggested in the literature [Smith, 2024].
• Delirium may be classified into three different subtypes based on the person's clinical presentation and psychomotor features [BGS, 2021] [Alexander, 2023] [Jaqua, 2023] [NICE, 2023b]:
  • Hypoactive (most common) — the person may become withdrawn, quiet, lethargic, and sleepy.
  • Hyperactive — the person may present with heightened arousal, restlessness, agitation, and aggression.
  • Mixed — signs and symptoms of both hyperactive and hypoactive subtypes are present.

What are the risk factors?

The risk of developing delirium is increased by a number of factors, which include [Inouye, 2014] [Raju, 2015] [BGS, 2019] [Wilson, 2020] [Alexander, 2023] [Jaqua, 2023] [NICE, 2023b]:

• Age over 65 years.
• Pre-existing cognitive impairment, including dementia (may increase the risk of delirium by 2–5 fold on hospital admission) or learning disability. See the CKS topics on Dementia and Learning disabilities for more information.
• Severe illness and clinically deteriorating or at risk of deteriorating.
• Frailty and/or multiple comorbidities (such as stroke or heart failure). See the CKS topic on Multimorbidity for more information.
• Significant trauma such as a current hip fracture.
• Functional impairment (such as immobility or the use of physical restraints such as cot sides).
• Iatrogenic events (such as urinary catheterization, polypharmacy, or surgery).
• History of, or current, alcohol and/or substance misuse. See the CKS topic on Alcohol - problem drinking for more information.
• Vision or hearing impairment, for example, due to impacted earwax. See the CKS topics on Earwax and Hearing loss in adults for more information.
• Poor nutritional status or malnutrition. See the CKS topic on Adult malnutrition for more information.
• End of life phase of illness. See the CKS topic on Palliative care - general issues for more information.

What are the precipitating factors?

The cause of delirium is usually multifactorial in older people and is likely to involve the interplay of pre-existing brain vulnerability and any acute precipitating factor(s) [Inouye, 2014] [Raju, 2015] [Stephens, 2015] [Hosker, 2016] [BGS, 2019] [Wilson, 2020] [Alexander, 2023] [Jaqua, 2023] [NICE, 2023b].

• Precipitating factors may include:
  • Infection such as urinary tract infection, infected pressure sore or ulcer, or pneumonia.
  • Metabolic disturbance such as hypercalcaemia, hypoglycaemia or hyperglycaemia, hyponatraemia or hypernatraemia (for example, due to reduced oral intake and dehydration).
  • Cardiovascular disorders such as acute coronary syndrome or heart failure.
  • Respiratory disorders such as pulmonary embolism or exacerbation of chronic obstructive pulmonary disease.
  • Neurological disorders such as stroke, encephalitis, epilepsy, brain tumour, or subdural haematoma.
  • Endocrine disorders such as thyroid dysfunction or Cushing's syndrome.
  • Urological disorders such as urinary retention.
  • Gastrointestinal disorders such as acute abdomen, liver failure, constipation, including faecal impaction, and malnutrition.
  • Falls, trauma, and/or surgery.
  • Uncontrolled chronic or acute pain (such as hip fracture).
  • Psychosocial factors such as depression, sleep deprivation, visual or hearing impairment, emotional stress, change of environment, including recent hospital discharge.
  • Medication, including polypharmacy, recent medication changes, and drug withdrawal:
    
    • Dopamine agonists, tricyclic antidepressants and selective serotonin reuptake inhibitors, anticholinergics, antihistamines, opioids, benzodiazepines, hypnotics, gabapentin, lithium, antipsychotics, anticonvulsants, antiarrhythmics, calcium-channel blockers such as amlodipine, histamine-2 receptor antagonists, theophylline, antispasmodics such as hyoscine, corticosteroids, nonsteroidal anti-inflammatory drugs.
  • Alcohol or substance use, including intoxication or withdrawal.

How common is it?

The reported incidence and prevalence of delirium varies depending on the diagnostic criteria used, the population studied, and the healthcare setting [Wilson, 2020]. The prevalence of delirium in the UK may be under-estimated due to under-diagnosis and under-reporting [RCEM, 2021] [NICE, 2023b].

• The prevalence of delirium in the community is 1–2%, rising to 14% in people over the age of 85 years. In nursing homes, or post-acute care settings, prevalence may be up to 60% [BGS, 2019].
• An analysis of hospital episode statistics (HES) inpatient data in England from 1998 to 2021 found [Luney, 2023]:
  • There were 375,457 episodes with a primary delirium diagnosis over the study period.
  • The mean patient age increased from 74.8 to 82.3 years, and the mean length of hospital stay decreased from 29.3 to 11.8 days.
  • From 2012 to 2021, the incidence rate increased from 5.6 to 19.4 per 10,000 hospital admissions, and the delirium diagnosis rate increased from 1.5 to 7.7 episodes per 1000 person-years.
  • From 1998 to 2015, in-hospital mortality rates reduced from 10.7% to 8.8%, but the 90-day mortality rate was static at around 14%.
• A systematic review of 33 studies of adult secondary care inpatients on medical wards found the overall prevalence of delirium was 23%, with stable prevalence rates seen over the study period from 1980 to 2019 [Gibb, 2020].
• A Royal College of Emergency Medicine publication states that delirium is present in 10–15% of older patients in the emergency department [RCEM, 2021].
• A systematic review of 8 prospective studies found that delirium is diagnosed in 13–42% of palliative patients on hospital admission, with rates increasing to 88% in the weeks to hours leading up to death [Hosie, 2013].
• Another systematic review of 35 studies found the highest incidence rates of delirium were observed in the intensive care unit, post-operatively, and in palliative care settings. It noted, however, that most of the included studies were likely to under-estimate true incidence rates, as they excluded patients with cognitive impairment or dementia at baseline [Inouye, 2014].
• A further systematic review of 42 studies of delirium in different palliative care settings reported point prevalence estimates of 4–12% in the community, 9–57% in patients undergoing hospital palliative care assessments, and 6–74% in inpatient palliative care units. The pooled point prevalence on admission to inpatient palliative care units was 35%, and the prevalence of delirium before death across all palliative care settings (n = 8 studies) was 42–88% [Watt, 2019].

What are the complications?

Possible complications of delirium include accelerated cognitive and functional decline and increased mortality rates [BGS, 2019] [BGS, 2021] [NICE, 2023b].

• Increased mortality rate.
  • A tertiary care prospective cohort study found that patients who presented to an emergency department with delirium had a 70% increased risk of death within six months of hospital attendance, after adjusting for age, comorbidity burden, severity of illness, dementia, functional dependence, and nursing home residence [Han, 2010].
  • Expert opinion in a review article notes that the inpatient mortality rate of delirium is high, ranging from 25% to 39% after adjusting for age, gender, comorbidities, and dementia. In addition, patients hospitalized with prolonged delirium have a three-fold increased risk of dying in the following year, compared with patients who have a quick resolution or complete absence of delirium symptoms [Jaqua, 2023].
  • Expert opinion in an additional review article cites evidence that patients who develop delirium in the intensive care unit have a 2–4 fold increased risk of death both in and out of hospital, and patients who develop delirium on general medical or elderly care wards have a 1.5-fold increased risk for death in the 12 months following hospitalization [Inouye, 2014].
• Increased length of stay in hospital and/or critical care [Bush, 2017; Jaqua, 2023; NICE, 2023b].
• Increased risk of healthcare-associated infections, falls, and pressure sores [Bush, 2017; Wilson, 2020; NICE, 2023b]. See the CKS topics on Falls - assessment and Pressure ulcers for more information.
• Increased risk of admission to long-term care or re-admission to hospital [Wilson, 2020; Jaqua, 2023; NICE, 2023b].
• Increased risk of developing dementia or worsening existing dementia [Bush, 2017; Wilson, 2020; Alexander, 2023; NICE, 2023b].
  • Expert opinion in a review article cites studies showing a 5- to 11-fold increased risk of developing dementia and accelerated cognitive decline following an episode of delirium [Alexander, 2023]. See the CKS topic on Dementia for more information.
• Continence problems [Inouye, 2014]. See the CKS topics on Faecal incontinence in adults and Incontinence - urinary, in women for more information.
• Malnutrition [Bush, 2017; BGS, 2019]. See the CKS topic on Adult malnutrition for more information.
• Functional impairment [Bush, 2017].
• Anxiety, depression, stress, and distress for the person, relatives, and/or carers, which affects quality of life [Bush, 2017; Wilson, 2020; Alexander, 2023]. See the CKS topics on Depression and Generalized anxiety disorder for more information.

What is the prognosis?

Delirium typically has a fluctuating course and variable prognosis, depending on the person's baseline cognitive and physical functioning, comorbidities, precipitating factor(s), and the delirium subtype [Raju, 2015] [Wilson, 2020].

• Expert opinion in a review article notes that delirium varies in duration, with most episodes lasting a few days. Episodes may persist for weeks or months in some people, and up to 20% of affected people may show some symptoms of delirium at 6 months [Wilson, 2020].
• Risk factors for a worse prognosis include:
  • Older age and frailty [de Lange, 2013; Wilson, 2020]. See the CKS topic on Multimorbidity for more information.
  • Pre-existing dementia or cognitive impairment [Raju, 2015]. See the CKS topic on Dementia for more information.
    • A prospective nested cohort study of hospitalized patients with Alzheimer's dementia (n = 263) found that the rate of cognitive decline doubled over the year following hospitalization in those who had delirium, and that this accelerated decline persisted over a 5 year follow-up period [Gross, 2012].
  • Hypoactive subtype of delirium (often unrecognized by healthcare providers) [Inouye, 2014]  [Hosker, 2016; Wilson, 2020].
  • Irreversible precipitating factors such as severe hypoxia [Raju, 2015; Hosker, 2016].
  • Longer duration and increased severity of delirium [Inouye, 2014; Hosker, 2016; Wilson, 2020].
    • Expert opinion in a review article cites evidence that patients with post-operative delirium lasting longer than two weeks are much less likely to return to baseline function [Mattison, 2020].
  • Previous episode of delirium [Hosker, 2016; Wilson, 2020].
  • Visual impairment [Raju, 2015].

When should I suspect a diagnosis of delirium?

Delirium is often underdiagnosed and underrecognized, and it may present atypically in older people. Suspect a diagnosis of delirium in people with a sudden change in behaviour or cognition, which may affect attention, memory, orientation, language, visuospatial ability, and perception.

• Be aware that falls and loss of appetite are often warning signs for delirium.
• Behaviour change typically develops acutely over hours to days.
  • Usually, there is clinical evidence of an underlying precipitating factor, such as infection or a drug interaction or change. 
  • Symptoms typically fluctuate (come and go, or increase and decrease in severity). Lucid intervals may occur during the day, and behavioural disturbance may be worse at night.
• Behavioural or cognitive changes may include:
  • Altered cognitive function — the person may be disoriented, have memory and language impairment, worsened concentration, slow responses, and confusion. The person may not be able to recall details of their current illness, instructions, or names.
  • Inattention — the person may be easily distractible and have difficulty focusing and moving attention from one thing to another, for example, they are unable to maintain a conversation or follow reasonable commands.
  • Disorganized thinking — the person may have disorganised, rambling, or irrelevant conversation, unclear or illogical flow of ideas, and difficulty expressing their needs and concerns.
  • Altered perception — the person may experience paranoid delusions, misperceptions, or visual or auditory hallucinations that may be distressing.
  • Altered physical function:
    • Hypoactive delirium (more common, often missed) — the person may be lethargic, have reduced mobility and movement, slow responses, worsened concentration, lack interest in daily activities, reduced appetite, and become quiet and withdrawn.
    • Hyperactive delirium — the person may have increased sensitivity to their immediate surroundings with agitation, restlessness, sleep disturbance, wandering, and hypervigilance.
    • Mixed — the person has a combination of signs and symptoms of hyperactive and hypoactive subtypes.
  • Altered social behaviour — the person may have changes in mood including labile mood, attitude, and/or emotions (such as fear, paranoia, anxiety, depression, irritability, apathy, anger, or euphoria). Their behaviour may be inappropriate, and they may have difficulty engaging with or following requests or become socially withdrawn.
  • Altered level of consciousness — the person may have a clouding of consciousness, reduced awareness of their surroundings, and sleep-cycle disturbances (such as daytime drowsiness, night-time insomnia, disturbed sleep, or complete sleep cycle reversal). Impaired consciousness can be subtle, and may initially only be apparent as lethargy or distractibility.

How should I assess a person with suspected delirium?

Delirium is a clinical diagnosis based on the person's symptoms, signs, and relevant investigation results.

• Ideally, take a history from the person and a collateral history from a relative or carer, if possible. Ask about:
  • The rapidity of onset, nature, and course of any acute change in behaviour, cognition or functioning suggesting delirium.
  • The person's baseline functional and cognitive state, including the ability to manage at home, to take medication, and to interact and communicate with others.
  • Any likely risk factors and precipitating factors.
  • Any comorbidities (for example, chronic obstructive pulmonary disease, depression, urinary catheterization, dementia, Parkinson's disease, or palliative care).
  • Any current medication (including over-the-counter medications and herbal remedies), medications recently started or stopped, possible deliberate or accidental drug overdose, and recent drug withdrawal (such as benzodiazepines).
  • Any alcohol or other substance misuse or dependency.
  • Any sensory impairment (such as vision and hearing), use of ill-fitting or non-functioning hearing aids or glasses, history of impacted earwax.
  • The person's social situation and support, including carer input, other informal support, and any recent change.
• Examine the person:
  • Check temperature, blood pressure (including lying and standing to check for postural changes), heart rate and rhythm, capillary refill time to assess hydration status, finger-prick blood glucose, pulse oximetry to assess for hypoxia, and weight and body mass index (BMI).
  • Perform a detailed general examination to identify any precipitating factors.
    • Assess frailty score and for signs of self-neglect, nutritional status, and chronic disease.
    • Assess for non-verbal signs of pain, for example, due to occult hip fracture, particularly in people with communication difficulties (such as a learning disability or dementia).
    • Be aware that hypoactive and mixed delirium subtypes may be more difficult to recognize clinically.
  • Perform a neurological examination to assess for focal neurological signs which may suggest an alternative or co-existing cause for symptoms.
• Consider using a cognitive screening test to assess attention, orientation, and recall and if available, compare the current score with a previous score to help differentiate acute from chronic cognitive changes. The Comprehensive Geriatric Assessment Toolkit website (www.cgakit.com) provides assessment tools, such as:
  • The 4 A’s test (4AT), which assesses for the 4 items of alertness; abbreviated mental test of orientation; attention test; and acute change or fluctuating course.
  • The brief Confusion Assessment Method (bCAM),  which assesses for acute onset and fluctuating confusion, inattention and easily distractible, disorganized thinking (conversation may be unclear and incoherent), and altered level of consciousness (hyperalert, drowsy, or difficult to rouse).
• Most people with delirium will need urgent hospital admission for same-day investigation and treatment of precipitating factors. See the section on Admission and referral for more information.
• If hospital admission is not felt to be necessary or clinically appropriate, consider arranging targeted investigations in primary care, depending on the clinical presentation and wishes of the person, relatives and/or carers, such as:
  • Full blood count — to assess for signs of infection or anaemia. See the CKS topics on Anaemia - B12 and folate deficiency and Anaemia - iron deficiency for more information.
  • Urea and electrolytes — to assess for signs of dehydration and acute kidney injury, and/or electrolyte disturbance (such as hyponatraemia or hypokalaemia). See the CKS topics on Acute kidney injury, Chronic kidney disease, and Hyponatraemia for more information.
  • HbA1c — to assess for diabetes mellitus. See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for more information.
  • Bone chemistry — to assess for hypercalcaemia or hypocalcaemia. See the CKS topic on Hypercalcaemia for more information.
  • Liver function tests — to assess for liver disease. See the CKS topic on Jaundice in adults for more information.
  • Inflammatory markers such as erythrocyte sedimentation rate and C-reactive protein — may suggest infection or inflammation.
  • Thyroid function tests — to identify hyperthyroidism or hypothyroidism. See the CKS topics on Hyperthyroidism and Hypothyroidism for more information.
  • B12 and folate — to assess for vitamin deficiency. See the CKS topic on Anaemia - B12 and folate deficiency for more information.
  • Urine dipstick testing and/or mid-stream urine (MSU) sample for culture and sensitivity — to assess for urinary tract infection or hyperglycaemia. See the CKS topics on Diabetes - type 1, Diabetes - type 2, Urinary tract infection (lower) - men, and Urinary tract infection (lower) - women for more information.
  • Sputum culture — to assess for lower respiratory tract infection. See the CKS topic on Chest infections - adult for more information.
  • Chest X-ray — to assess for pneumonia or heart failure, for example. See the CKS topics on Chest infections - adult and Heart failure - chronic for more information.
  • Urine or blood toxicology screen — if the person is taking digoxin, lithium, alcohol, or other recreational drugs, for example.
  • Electrocardiogram (ECG) — to identify cardiac conditions, including arrhythmias. See the CKS topic on Palpitations for more information.

What else might it be?

Other conditions which may present similarly to delirium include:

• Dementia — may present with chronic progressive cognitive changes. Sleep-wake cycle disturbance is common in Alzheimer's dementia. Dementia with Lewy bodies may cause fluctuation in cognition and visual hallucinations. Dementia and delirium may coexist. See the CKS topic on Dementia for more information.
• Bipolar disorder — late-onset mania can present with features similar to hyperactive delirium. See the CKS topic on Bipolar disorder for more information.
• Psychosis and schizophrenia — can present with features similar to hyperactive delirium; typically causes auditory rather than visual hallucinations. See the CKS topic on Psychosis and schizophrenia for more information.
• Depression — may present similarly to hypoactive delirium, with mood change, anorexia, fatigue, sleep disturbance, and psychomotor change. See the CKS topic on Depression for more information.
• Anxiety — behavioural changes associated with delirium can include anxiety and hypervigilance. See the CKS topic on Generalized anxiety disorder for more information.
• Thyroid disease — hyperthyroidism and hypothyroidism may present similarly to hyperactive delirium and hypoactive delirium, respectively. See the CKS topics on Hyperthyroidism and Hypothyroidism for more information.
• Intracranial bleed or stroke — may present with acute cognitive changes. See the CKS topic on Stroke and TIA for more information.
• Encephalitis — may be infective or non-infective and may present with aphasia or amnesia.
• Epilepsy — some forms of epilepsy may present with subtle behaviour or mood changes and clouding of consciousness. The post-ictal phase may present with clinical features similar to hypoactive delirium. See the CKS topic on Epilepsy for more information.
• Charles Bonnet syndrome — visual hallucinations may occur in people with significant vision loss, and can range from simple patterns or straight lines to detailed pictures of people, faces, animals, and inanimate objects. The person retains insight that the images are not real.
• Delirium tremens — may present with similar symptoms of confusion, disorientation, agitation, and hallucinations, but is often accompanied by fever and signs of autonomic hyperactivity such as sweating and tachycardia. See the CKS topic on Alcohol - problem drinking for more information.

Management

From age 18 years onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of delirium.

Search dates

February 2021 - March 2026

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• exp delirium/, delirium.tw, exp confusion/, confusion.tw,
• exp diagnosis/, diagnostic criteria.tw, exp risk factors/, incidence/, prevalence/
• Palliative care/
• Terminally ill/
• *Primary Health Care/

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team who develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.