Changes

July 2026 — minor update. Prescribing gabapentinoids made consistent with latest Mayo algorithm (May 2026).

Update

Goals

To support primary healthcare professionals to:

• Make a diagnosis of restless legs syndrome (RLS).
• Identify and address any underlying causes of RLS.
• Assess the severity of RLS.
• Control the symptoms of RLS using self-help measures, and drug treatment, if appropriate.
• Arrange appropriate referral where necessary.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

What is it?

• Restless legs syndrome (RLS), also known as Willis-Ekbom disease, is a neurological disorder characterized by an irresistible urge to move the limbs (usually the legs) accompanied by paraesthesia-like sensations that may be described as creeping, crawling, tingling, cramping, or aching.
• Symptoms are typically worse in the evenings, are often associated with sleep disturbance, and are temporarily relieved by movement.
• The underlying pathophysiology of RLS is not fully understood, although it is likely that there is dysfunction of the dopaminergic system within the central nervous system.

[Gossard, 2021; Khachatryan, 2022; Mansur, 2023]

What causes it?

• In most people with restless legs syndrome (RLS) there is no apparent underlying cause, but dopamine and iron regulation are implicated [BMJ Best Practice, 2024].
  • Dysfunction of the dopaminergic system is likely to play a part, but the cause of this dysfunction is not clear. Dopamine activity in the brain has a circadian rhythm that may explain the diurnal variation of the symptoms [Nagandla, 2013; Earley et al, 2014].
  • Dysfunction of iron metabolism may be implicated, even in people who are not iron deficient [Silber, 2021]. Iron is known to have a crucial role in dopamine metabolism. A widely held theory is that insufficient iron levels in the brain lead to a decrease in dopaminergic function, which in turn leads to spinal hyperexcitability, causing the symptoms of RLS [Nagandla, 2013; Earley et al, 2014; Garcia-Borreguero, 2014].
  • RLS can be familial and is thought to be most commonly inherited in an autosomal dominant pattern. Up to 50% of affected people have a family history of RLS [BMJ Best Practice, 2024]. However, several susceptibility loci have been identified, so inheritance patterns can also be more complex [Garcia-Borreguero, 2017].
• RLS is also associated with a number of comorbid conditions, most commonly:
  
  • Pregnancy — RLS occurs in around 21% of pregnant women, most commonly in the third trimester [Chen, 2018; Darvishi, 2020]. Women who have transient RLS during pregnancy have a four-fold increased risk of developing idiopathic RLS later in life [Cesnik et al, 2010].
  • Iron deficiency — present in about 24% of people with RLS [Allen, 2013]. Most people with iron deficiency do not have RLS, but iron deficiency is thought to precipitate or exacerbate RLS in some people [Leschziner, 2012].
  • Stage 5 chronic kidney disease — RLS occurs in about 20% of people undergoing renal dialysis [Gigli, 2004].
• A number of psychological and behavioural disorders have been associated with RLS in cross-sectional epidemiological studies, although there is no robust evidence of causality.
  • Associations with anxiety, depression and ADHD have been found [Sierra Montoya, 2018; Yılbaş. 2022].
  • This is separate to any possible effect of the medications.
• Other conditions that have been associated with RLS (generally based on limited evidence) include [BMJ Best Practice, 2024]:
  
  • A range of neurological conditions, including Parkinsonism, multiple sclerosis, polyneuropathies, acute spinal cord lesions, spinal stenosis, Charcot-Marie-Tooth disease, and lumbosacral radiculopathy.
  • Rheumatoid arthritis.
  • Diabetes.
  • Hypothyroidism.
  • Obesity.
• Certain drugs/substances can precipitate or exacerbate RLS, including [Khachatryan, 2022]:
  • Antidepressants (including tricyclic antidepressants, selective serotonin re-uptake inhibitors, and serotonin noradrenaline re-uptake inhibitors).
  • Some antipsychotics and lithium.
  • Some antiepileptic drugs.
  • Antihistamines.
  • Dopamine receptor blocking agents, such as metoclopramide and prochlorperazine.
  • Beta-blockers.
  • Excessive intake of alcohol, caffeine, or chocolate.

How common is it?

• In the UK, US, and Europe, the total prevalence of restless legs syndrome (RLS) is between 5–10%. The prevalence of idiopathic RLS is between 1.9–4.6% of adults in northern Europe.
• RLS can develop at any age, but the mean age of onset is in the third or fourth decade, and prevalence increases with increasing age.
• Over the age of 35 years, the prevalence in women is about double that of men. However, in younger adults, both sexes are equally affected.
• It is thought that the increased prevalence in women over 35 years old may be secondary to pregnancy, as nulliparous women have a similar prevalence of RLS as males.
• RLS occurs in up to one-third of pregnant women (21–31%) and is more frequent in the third trimester of pregnancy. In many cases, it disappears after delivery. The primary occurrence of RLS during pregnancy represents a risk factor for developing RLS later in life (4-fold increase).
• A meta-analysis of 27 studies that included 51,717 pregnant women found the overall prevalence of RLS during pregnancy to be 21%, with rates of 8%, 16%, and 22%, in the first, second, and third trimesters, respectively.

[Chen, 2018; Garcia-Borreguero, 2017; Khachatryan, 2022]

What is the prognosis?

• The natural history of idiopathic restless legs syndrome (RLS) is variable:
  • The typical pattern is of an insidious onset that worsens over time to a clinically significant disease, especially in those with an onset before 45 years of age.
  • In about 70% of patients, the symptoms progress and become moderate to severe [Mansur, 2023]. In addition to the legs, some patients may experience the same symptoms in the arms.
  • Periods of remission can occur. One study that followed up 671 familial cases (people with a strong family history of RLS) over 15 years found that [Xiong, 2010]:
    • In 36% the symptoms became worse.
    • In 41% the symptoms remained stable.
    • In 15% the symptoms diminished.
    • In 8% the symptoms remitted.
• For people with certain comorbid conditions (particularly iron deficiency), treatment of the underlying disease may reduce or eliminate symptoms of RLS [Garcia-Borreguero, 2017; Trenkwalder, 2018].
• RLS associated with pregnancy usually resolves spontaneously after delivery [BMJ Best Practice, 2024].

What are the complications?

• Possible complications of restless legs syndrome (RLS) include:
  • Sleep disturbance — although not an essential diagnostic feature of RLS, sleep disturbance (including problems getting to, and maintaining, sleep) is often prominent. While this may disrupt daily functioning [Allen, 2010] it has also been noted that people with RLS tend to not report a level of daytime sleepiness that corresponds to their degree of sleep loss. It has been hypothesized that this may be because hyperarousal is part of the pathophysiology of RLS [Garcia-Borreguero, 2017].
  • Anxiety and depression — people with RLS have higher rates of anxiety and depression than the general population [Garcia-Borreguero, 2017].
  • The quality of life (QoL) impact of idiopathic RLS is significant.
    • A 2024 systematic review (27 studies with 20,121 participants) found [Broström, 2024]: 
      • The corrected pooled estimated mean score of QoL was 47.92 (CI 95 %: 43.11 to 52.72, range 0-100, i.e., low-high QoL) and was slightly affected by publication year (increased 0.89 by each year, p = 0.12). 
      • The corrected pooled estimated mean score of the mental health component was 47.32 (17 studies, 95 % CI: 43.12 to 51.51, range 0-100) and influenced by RLS instrument (decreased with recent versions, p = 0.05). 
      • The corrected pooled estimated mean score of the physical health component was 39.08 (17 studies, 95 % CI: 33.05 to 45.10, range 0-100), with no statistically significant moderator. 
      • The pooled estimated QoL scores were statistically significantly lower in RLS patients compared to control groups with a standardized mean difference (SMD) of -0.78, -0.57 and -0.50 respectively for overall QoL (24 studies), physical and mental health components (14 studies). 
  • Increased mortality risk — a meta-analysis of eight studies that included 644,506 people (mean age 60 years) of whom 3% had RLS found that [Katsanos, 2017]:
    • Previously identified increased risks of cardiovascular and cerebral events in people with RLS became statistically non-significant once confounding risk factors were accounted for.
    • People with RLS had a statistically significant approximately 50% increased risk of all-cause mortality.
  • Limited data suggest possible increased mortality risk in people with chronic kidney failure and RLS [Garcia-Borreguero, 2017].

How do I know if a person has restless legs syndrome?

• The diagnosis of restless legs syndrome (RLS) is clinical, as there are no tests to confirm the diagnosis.
• For a diagnosis of RLS to be made, the following criteria must all be met as defined by the International RLS Study Group (IRLSSG):
  • An urge to move the legs usually, but not always, accompanied by or felt to be caused by uncomfortable and unpleasant sensations in the legs.
    • The unpleasant sensations are often difficult to describe, but may include tingling, burning, itching, throbbing, a "creepy-crawly" sensation (like ants, worms, or spiders moving in the legs), or being "like fizzy water in the veins". The sensations are often worse just below the knee, and are described as painful in up to 30–50% of cases.
  • The urge to move the legs and any accompanying unpleasant sensations:
    • Begin or worsen during periods of rest or inactivity, such as lying down or sitting.
    • Are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
    • During rest or inactivity only occur, or are worse, in the evening or night than during the day.
  • The occurrence of the above features is not solely accounted for as symptoms primary to another medical or behavioural condition (for example, myalgia, venous stasis, leg oedema, leg cramps, positional discomfort, or habitual foot tapping).
• The IRLSSG added the following caveats to their diagnostic criteria:
  • Sometimes the urge to move the legs is present without uncomfortable sensations.
  • Sometimes symptoms are felt in the arms or other parts of the body in addition to the legs, but the legs are usually affected first and more severely than other body parts.
  • When symptoms are very severe, relief by activity may not be noticeable but must have been previously present.
  • When symptoms are very severe, the worsening in the evening or night may not be noticeable but must have been previously present.
  • Features that are not necessary for the diagnosis, but are helpful to support the diagnosis of RLS when there is uncertainty, are:
    • Presence of positive family history of RLS (seen in more than 50% of cases).
    • Positive response to dopaminergic therapy.
    • Sleep disturbance with periodic limb movements in sleep (seen in 85% of cases).
• A physical examination will help to identify underlying causes and to rule out differential diagnoses of RLS, but is usually normal in people with idiopathic RLS.

How do I assess a person with restless legs syndrome?

• Determine whether there is an underlying cause that may have precipitated or exacerbated restless legs syndrome (RLS).
• Make an assessment of the frequency and severity of symptoms as these may help to guide treatment choices.
  • Frequency of symptoms varies considerably from less than once a month to daily. The International RLS Study Group (IRLSSG) have defined:
    • Chronic-persistent RLS is when symptoms, when not treated, would occur on average at least twice weekly for the past year.
    • Intermittent RLS is when symptoms, when not treated, would occur on average less than twice a week for the past year, with at least five lifetime events.
  • Severity of symptoms can vary from mildly annoying to disabling.
    • The IRLSSG therefore state that, for clinical significance, the symptoms of RLS should cause significant distress or impairment in social, occupational, educational, or other important areas of functioning by their impact on sleep, energy, daily activities, behaviour, cognition, or mood.
  • Consider using the validated symptom rating scale of the IRLSSG. This is completed by the person with RLS and then graded by the healthcare professional. The overall score gives an indication of severity: mild 1–10; moderate 11–20; severe 21–30; and very severe 31–40.

Which investigations should I carry out?

• There are no investigations to confirm the diagnosis of restless legs syndrome (RLS).
• Request a full iron assessment including ferritin, total iron-binding capacity, and percentage transferrin saturation. This should be measured in the early morning after an overnight fast, as anaemia is not a sufficiently sensitive marker for iron deficiency, which may precipitate or exacerbate RLS.
• Consider other investigations guided by the history and examination (such as renal function, full blood count, thyroid function, blood glucose, folic acid, vitamin B₁₂) toexclude secondary causes of RLS.
• Consider referring to a sleep clinic (if available) if you suspect a sleep disorder, and there is doubt about the diagnosis of RLS. Tests such as polysomnography can help to differentiate RLS from true sleep disorders.

What else might it be?

• Various conditions may be confused with restless legs syndrome (RLS) including:
  • Positional discomfort.
  • Nocturnal leg cramps — these always involve a specific muscle group and they usually require stretching of the muscle more than non-specific movement to relieve symptoms, and are usually unilateral. For more information, see the CKS topic on Leg cramps.
  • Arthritis — affects synovial joints, most commonly those of the knees, hips, and the small joints of the hand. For more information, see the CKS topic on Osteoarthritis.
  • Peripheral neuropathy — this is not usually associated with restlessness or helped by movement. It does not worsen in the evening or at night time, and sensations are of numbness, tingling, or pain. Note that peripheral neuropathy and RLS may coexist, and people may have symptoms of both.
  • Deep vein thrombosis — this is usually accompanied by a swollen leg and a change in skin colour. For more information, see the CKS topic on Deep vein thrombosis.
  • Akathisia — this is characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. It occurs most commonly owing to the use of neuroleptic drugs. It lacks a circadian pattern.
  • Intermittent claudication — this usually worsens with exercise and improves with rest. For more information, see the CKS topic on Peripheral arterial disease.
  • Painful legs and moving toes — a rare disorder that does not involve an urge to move the limb.
  • Polyneuropathy — this can be due to various aetiologies including trauma, nerve compression, diabetes mellitus, nutritional disorders, and infections. These mostly cause sensory disturbances and are not typically relieved by activity.

Scenario: Management of restless legs syndrome

From age 18 years onwards.

Pregabalin

• The use of pregabalin for restless legs syndrome (RLS) is off-label.
• Initial dose of 75 mg in people aged under 65 years and 50 mg in people aged over 65 years.
• For RLS the medication is best taken in the evening (or 1-2 hours before maximum symptoms), as symptoms are usually nocturnal.
• The usual effective range is 150-450 mg daily and the maximum recommended daily dose for RLS is 450 mg. CKS did not identify any specific guidance on dose titration and the requirement for divided daily doses. However, for another indication (neuropathic pain), it is recommended that initial pregabalin dose can be doubled after 3–7 days, and then increased incrementally on a weekly basis to the maximum dose if required.
• For detailed prescribing information (other than dosing) on pregabalin, see prescribing information section on Pregabalin in the CKS topic on Neuropathic pain - drug treatment.

[Silber, 2021; EMC, 2024a; BNF, 2025]

Gabapentin

• The use of gabapentin for restless legs syndrome (RLS) is off-label.
• Initial dose of 300 mg if the person is under 65 years old and 100 mg if the person is over 65 years old. 
• Average effective dose is 1200-1800mg and maximum recommended dose for RLS is 2700 mg. CKS did not identify any specific guidance on dose titration for use in RLS, but other indications suggest that the initial pregabalin dose can be doubled after 3–7 days, and then increased incrementally on a weekly basis to the maximum dose if required. 
• For RLS the doses are best taken in the evening, (or 1-2 hours before maximum symptoms), as symptoms are usually nocturnal.
• Absorption is maximised by taking up to 600mg at 2 hourly intervals.
• Magnesium reduces absorption and should be avoided for 3 hours after a dose.
• For detailed prescribing information (other than dosing) on gabapentin, see prescribing information section Gabapentin in the CKS topic on Neuropathic pain - drug treatment.

[Silber, 2021; EMC, 2024b; BNF, 2025] 

Codeine

• For detailed prescribing information on codeine, see the CKS topic on Analgesia - mild-to-moderate pain.

Benzodiazepines and Z-drugs

• For detailed prescribing information on benzodiazepines and Z-drugs, see the CKS topic on Insomnia.

Pramipexole

Ropinirole

Rotigotine

Augmentation – a complication of long-term drug treatment

• Augmentation is a major complication of dopaminergic treatment for restless legs syndrome (RLS) [Winkelman, 2025; Silber, 2026].
  • It is a long-term consequence of treatment that may develop months or years after treatment is initiated.
  • Augmentation is characterized by worsening symptoms of RLS, in particular their earlier onset in the day, increased intensity, or spread to the arms or trunk.
  • Augmentation should be considered when any:
    • Maintained increase in symptom severity develops despite appropriate treatment.
    • Maintained increase in symptom severity develops following a dose increase, particularly if a dose reduction leads to an improvement in symptoms.
    • Earlier onset of symptoms that develop in the afternoon/evening.
    • Spreading of symptoms to previously unaffected body parts.
    • Shorter latency to symptom onset during the day when at rest.
  • Rates of augmentation appear to be greater the higher the dose of any given drug, and the longer the duration of treatment. Rates of augmentation appear to be less with rotigotine transdermal patches, which have a longer half-life and duration of action.
    
    • Augmentation is more likely with pramipexole and ropinirole, occurring in 40–70% of patients during a 10-year period. It is less likely with the rotigotine patch; 36% of patients will develop augmentation after 5 years while using this [Silber, 2021]  [BMJ Best Practice, 2024].
  • Augmentation should be distinguished from rebound symptoms (where symptoms recur early in the morning as the effect of treatment wears off), loss of efficacy, and natural progression of the disease.
  • If apparent augmentation develops:
    • Measure the person's serum ferritin. If the concentration is less than 50–75 micrograms/mL, investigate potential causes of iron deficiency anaemia and if appropriate offer oral iron supplements.
    • Ask the person about any lifestyle factors (such as sleep deprivation, alcohol use, decreased mobility) or recent medicine use (such as dopamine antagonists, antihistamines, or antidepressants), in addition to any recent opioid discontinuation or blood loss that could cause symptoms mimicking augmentation.
    • If there are no apparent exacerbating factors, and symptoms are severe, wean off the causative drug [Silber, 2026]. Do not stop abruptly as this can cause profound insomnia and a worsening of symptoms. Switch to an alternative (low dose opioids or gabapentinoids depending on patient history and preference), but it is recommended that you seek specialist advice in this situation. Ideally the alternative drug should be started as the dopaminergic drug is reduced.

Loss of efficacy – a potential complication of drug treatment

• Loss of efficacy commonly occurs for all drugs in the long-term treatment of restless legs syndrome (RLS)[Gossard, 2021] .
• Over time the drug dose often needs to be increased in order to maintain the original effect on symptoms. Unlike augmentation, symptoms are not worse than before treatment initiation. If loss of efficacy is suspected:
  • Check for iron deficiency and/or whether serum ferritin is less than 50–75 micrograms/mL. Investigate causes for iron deficiency anaemia and offer oral iron supplements if appropriate.
  • For people taking monotherapy for RLS, rather than increasing the dose, consider adding in a second drug from another class. Alternatively, stop the current drug slowly and switch to a drug in another class.

Impulse control disorders – a potential complication of drug treatment

• Treatment with dopamine-receptor agonists is associated with impulse control disorders (ICDs) [Gossard, 2021].
  • ICDs include pathological gambling, binge eating, compulsive shopping, and hypersexuality.
  • ICDs develop in 6–17% of people with RLS who take dopamine agonists.
  • If a person develops an ICD, the dopamine agonist should be withdrawn or the dose reduced until the symptoms resolve. An option is to switch treatment to a non-dopaminergic drug.
• The British National Formulary (BNF) has also issued a warning about the association between the use of dopamine-receptor agonists and ICDs [BNF, 2025].

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on the primary care management of restless legs syndrome.

Search dates

July 2020 -January 2025

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 9th July 2020). These were combined with filters to identify guidelines, systematic reviews and primary care relevant literature in EBSCOhost MEDLINE. The strategy was adapted for The Cochrane Library databases. 

S4 S1 OR S2 OR S3
S3 AB willis-ekbom OR TI willis-ekbom
S2 AB restless leg* OR TI restless leg*
S1 (MH "Restless Legs Syndrome")

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 that 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.