Changes

February 2025 — minor update. Added detail relating to the NICE guidance Gambling-related harms: identification, assessment and management [NICE, 2025]. 

Update

Goals

To support primary healthcare professionals to:

• Help a person with opioid dependence remain healthy.
• Reduce the harm associated with illicit drug misuse including the dangers associated with injecting and sharing equipment.
• Refer appropriately to specialist drug services for treatment if abstinence is not possible.
• Help a person with opioid dependence reduce and stop illicit drug misuse, overcome their dependence, make positive lifestyle changes and achieve a stable life.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

 Drug use disorders in adults

• who inject drugs have access to needle and syringe programmes in accordance with NICE guidance. 
• People in drug treatment are offered a comprehensive assessment. 
• Families and carers of people with drug use disorders are offered an assessment of their needs. 
• People accessing drug treatment services are offered testing and referral for treatment for hepatitis B, hepatitis C and HIV and vaccination for hepatitis B. 
• People in drug treatment are given information and advice about the following treatment options: harm-reduction, maintenance, detoxification and abstinence. 
• People in drug treatment are offered appropriate psychosocial interventions by their keyworker. 
• People in drug treatment are offered support to access services that promote recovery and reintegration including housing, education, employment, personal finance, healthcare and mutual aid. 
• People in drug treatment are offered appropriate formal psychosocial interventions and/or psychological treatments. 
• People who have achieved abstinence are offered continued treatment or support for at least 6 months. 
• People in drug treatment are given information and advice on the NICE eligibility criteria for residential rehabilitative treatment.

[NICE, 2012]

What is it?

• The term opioid refers to a group of natural, semi-synthetic and synthetic compounds that act on opioid receptors in the brain (for example, morphine or methadone).
• The term opiate refers to substances derived from the poppy plant and to the semi-synthetic drug diamorphine (heroin), which is produced from poppy compounds. The terms 'opioid' and 'opiate' can be considered largely synonymous, and for this CKS topic, the term 'opioid' is used.
• Opioid dependence develops after a period of regular use of opioids, with the time required varying according to the quantity, frequency and route of administration; factors of individual vulnerability; and the context in which drug use occurs.
  • Physical and psychological dependence can develop within a relatively short period of continuous use (2–10 days).
  • The World Health Organization states that features of opioid dependence are usually evident over a period of at least 12 months, but diagnosis may be made if opioid use is continuous (daily or almost daily) for at least 3 months.
• The key elements of opioid dependence are:
  • A strong internal drive or sense of compulsion to use opioids.
  • Difficulty in controlling use.
  • Increasing priority given to use over other activities and interests.
  • Evidence of tolerance.
  • Persistence with opioid use despite clear evidence of overtly harmful consequences.
  • Withdrawal symptoms when opioid use has ceased or been reduced.
• Opioid dependence should be viewed as a chronic relapsing-remitting disorder that has physical, social, and psychological dimensions.

[NICE, 2014; Mitchell, 2020; WHO, 2022; BMJ Best Practice, 2023a; WHO, 2023]

What are the risk factors for opioid dependence?

The aetiology of opioid dependence is not fully understood — many biological, psychological, and social factors are thought to be involved, including:

• Availability of drugs.
• Peer substance use.
• Adverse childhood experiences such as homelessness, disrupted family dynamics, neglect, and abuse.
• History of mental illness (such as bipolar disorder, depression, and psychosis) or substance misuse.
• Social disadvantage.
• Genetic predisposition.
• Younger age and male gender.

[Degenhardt, 2019; NICE, 2019; BMJ Best Practice, 2023a]

How common is it?

Due to the illegal nature of drug misuse accuracy of prevalence data on opioid dependence is limited.

• Worldwide
  • In 2019, the global prevalence of opioid use in people aged 15–64 years was estimated to be 1.2% — almost double the prevalence in 2010 [UNODC, 2021].
  • The Global Burden of Diseases, Injuries, and Risk Factors Study estimated that globally in 2017 [GBD, 2017; Degenhardt, 2019]:
    • 40.5 million people were dependent on opioids (95% uncertainty interval 34.3–47.9 million).
    • 109,500 people (95% uncertainty interval 105,800–113,600) died from opioid overdose.
• Europe
  • The prevalence of opioid use in people aged 15-64 in Europe is estimated to be 0.7% (3.6 million people) [UNODC, 2021].
  • Heroin is the most commonly used opioid in Europe and is responsible for most drug overdose deaths [UNODC, 2021]. The use of high potency synthetic opioids (such as fentanyl) is increasing [Mitchell, 2020].
  • Between 2010 and 2018 Italy, Austria, and France had the highest levels of high-risk opioid use. In 2018, overdose deaths were highest in Germany and the UK [UNODC, 2021].
• UK - Drug use
  • 1 in 11 people aged 16–59 years in England and Wales and 1–14 in Scotland report having used an illicit drug in the last year [UKHSA, 2023].
  • Over 300,000 people aged 15–64 are estimated to use opioids or crack cocaine with around 87,000 injecting drugs [UKHSA, 2023].
  • Heroin is the most commonly injected drug in the UK (data from 2021) [UKHSA, 2023].
• UK - Treatment for opioid use
  • 290,635 adults were in contact with drug and alcohol services in England between April 2022 and March 2023. Of these, nearly half (138,604) were in treatment for opioid use and 20,158 were in treatment for crack cocaine with opioids [OHID, 2023].
  • The proportion of estimated opioid users who are not in treatment between 2014/2015 and 2019/2020 rose from 40.8% to 46.7% [OHID, 2023].
• UK - Drug-related deaths
  • In England and Wales in 2022 [ONS, 2023]:
    • 4907 deaths related to drug poisoning were registered (84.4 deaths per million people). The age-standardised mortality rate for deaths related to drug poisoning has increased every year since 2012.
    • 3240 deaths were in males and 1667 in females.
    • Rates of drug misuse deaths continue to be highest in those born in the 1970s.
    • 2261 deaths involved an opioid, heroin and morphine continue to be the most frequently mentioned opiates (1256 drug-poisoning deaths).
  • In Scotland in 2022 [NRScotland, 2023]:
    • 1051 deaths related to drug misuse were recorded, the highest rates were in people aged 35-54 years.
    • Males were twice as likely as females to have a drug misuse death.
    • Opioids were implicated in 82% of all drug related deaths.
    • People living in the most deprived areas of Scotland were almost 16 times more likely to die from drug misuse than in the least deprived areas.
  • In Northern Ireland in 2022 [NISRA, 2024]:
    • 154 drug related deaths were registered, a 40% increase on number of deaths registered a decade ago.
    • 118 drug-related deaths involved an opioid, heroin and morphine were the most frequently mentioned.
    • 69.5% of drug-related deaths were in males.

What is the prognosis?

• Opioid dependence is a chronic disease characterised by periods of active use, abstinence, and relapse. Relapse rates are over 90% in untreated people. 
• The premature mortality rate of people who use illicit opioids is 10–20 times that of the general population. Causes of excess mortality include overdose, suicide, unintentional injury, and infectious and non-communicable diseases.
• Opioid substitution treatment can reduce illicit opioid use, improve physical and mental wellbeing, and reduce all-cause and overdose mortality.
  • Of 127,385 people who exited the drug and alcohol treatment system in England in 2022-2023, 46% successfully completed treatment and were free from dependence. People treated for opioid use had the lowest rate of successful exits at 23% compared to others taking non-opioids or alcohol. The average time in treatment for people with opiate dependence to complete treatment successfully was 3.3 years. Of 4166 recorded deaths in treatment, 64% were being treated for opiate use [OHID, 2023].
  • A systematic review and meta-analysis of 19 cohort studies found that time spent in opioid substitution treatment with methadone was associated with a reduction in 25 deaths/1000 person-years (95% CI 14 to 36). The rate of death in treatment was less than a third of that out of treatment — the greatest reduction in deaths was in those due to overdose [Sordo, 2017].
• Poorer treatment outcomes and increased risk of adverse outcomes (such as overdose) are associated with concurrent use of opioids and other substances (for example alcohol, cocaine, benzodiazepines, and gabapentinoids).
• People with coexisting mental health conditions have a poorer prognosis, higher rates of relapse, and are more likely to experience multiple disadvantages (including homelessness and criminal justice involvement).

[Degenhardt, 2011; NICE, 2014; DH, 2017; Sordo, 2017; Degenhardt, 2019; Larney, 2019; Mitchell, 2020; BMJ Best Practice, 2023a; NHS Digital, 2023; UKHSA, 2023]

What are the complications?

Complications of opioid dependency include:

• Death  
  • People who misuse or are dependent on drugs (in particular heroin and other opioids) have mortality rates of around 1–2% per year — excess mortality is 10–20 times greater than expected [DH, 2017]. 
  • The main causes of drug-related deaths are overdose, suicide, violence, accidents, and physical health complications of drug misuse. 
• Overdose
  • Risk factors for fatal and non-fatal overdose include injecting drug use, resumption of opioid use after a period of abstinence (for example during or after detoxification or release from prison), polydrug misuse, and comorbid physical or mental health conditions.
• Infection — people who are dependent on opioids are at greater risk of infection including:
  • Staphylococcus aureus and group A Streptococcus — often related to poor general hygiene and unsterile injection practices. Invasive infections can lead to sepsis, bacteraemia, and necrotizing fasciitis, and may be fatal.
  • Blood-borne viruses such as HIV, hepatitis B, and hepatitis C [UKHSA, 2023].
    • In England, Wales, and Northern Ireland in 2021, 1.5% of people who inject drugs were living with HIV. In Scotland, in 2019/2020 HIV prevalence among people attending needles and syringe programmes was found to be 3.8%.
    • In 2021, the prevalence of Hepatitis B in unlinked anonymous monitoring survey participants was 5.9% — the lowest level in the last decade.
    • Hepatitis C remains the most common bloodborne infection among people who inject drugs in the UK. Around half of injecting drug users in the UK are infected with hepatitis C.
  • Tetanus, anthrax, and botulism — these rare but life-threatening infections can be associated with contaminated drugs and poor injecting technique.
  • Tuberculosis — there is a greater prevalence of tuberculosis among people who use drugs compared with the general population.
  • Infective endocarditis — people who inject drugs are at increased risk of infective endocarditis.
• Sexual, reproductive and obstetric problems
  • Drug dependence is associated with sub-fertility, sexually transmitted infections, unplanned pregnancy, intrauterine growth retardation, premature delivery, and fetal addiction syndromes.
• Vascular problems
  • Deep vein thrombosis and pulmonary emboli are more prevalent amongst people who use drugs.
  • Superficial thrombophlebitis — dependent users are susceptible to superficial thrombophlebitis because of repetitive trauma, unsterile techniques, and irritation caused by the drug mixtures. Street drugs are often cut with substances that promote thrombosis (for example, lactose, sucrose, and dextrose). Cocaine, in particular, is associated with the development of thrombosis.
  • Venous and arterial thrombosis can result from poor injecting technique, especially in people injecting into the groin.
• Poor nutrition and dental disease
  • People who have a history of substance misuse are more likely to have poorer oral and dental health and may suffer from poor nutrition.
• Social problems 
  • Criminality such as drug-related theft, imprisonment, violence, and homicide.
  • Child and adult safeguarding issues including observation of drug taking behaviours, neglect, exploitation, involvement in sex work, and human trafficking.
  • Poverty, deprivation, homelessness, and social exclusion.
• Mental health problems 
  • Depression and anxiety.
  • Self-harm or suicide.
  • Comorbid or substance induced psychosis.
  • Loss of memory or impairment of cognitive skills.

[NICE, 2014; DH, 2017; Mitchell, 2020; OHID, 2022; SIGN, 2020; BMJ Best Practice, 2023a; UKHSA, 2023; WHO, 2023]

When should I suspect opioid dependency?

• Drug misuse may be identified when a person:
  • Consults for another medical problem (that may or may not be drug-related).
  • Actively requests help with substance misuse — this may be prompted by motivation to change behaviour or a developing crisis, such as an impending court case, health, or relationship problems. 
• Clinical features of: 
  • Opioid misuse include chronic constipation, weight loss, nausea and/or vomiting, sedation and needle marks, scars, and necrosis or abscesses on skin near veins.
  • Opioid intoxication include disturbances in consciousness, cognition, perception, speech or coordination, mood changes (for example euphoria followed by apathy and dysphoria), impaired judgement, constriction of pupils (may be absent if intoxication is due to synthetic opioids such as fentanyl), itching and scratching, sedation, hypotension, bradycardia, and hypoventilation.
    • Be aware of other conditions that may present similarly to opioid intoxication such as head injury, meningitis and encephalitis, diabetic ketoacidosis or hypoglycaemia, Wernicke’s encephalopathy, electrolyte disturbance, hypoxia or hypercapnia, and systemic infection.
  • Opioid withdrawal include watering eyes, rhinorrhoea, yawning, sneezing, sweats, cool and clammy skin, piloerection, dilated pupils, cough, abdominal cramps, nausea, vomiting, diarrhoea, backache, tremor, insomnia, restlessness, anxiety, irritability or aggression, hypertension, and tachypnoea.
    • The onset and duration of opioid withdrawal symptoms varies according to the half-life of the drug taken. Heroin withdrawal symptoms start within 12 hours of the last dose and can persist for 4–5 days. Methadone withdrawal symptoms start 24–74 hours after the last dose and can persist for 7–14 days.
• Other clinical features may include those associated with complications of opioid dependency such as:
  • Infection and vascular problems.
  • Malnutrition, poor dental health, and neglect.
  • Disorders of mood (particularly anxiety or low mood), delusions or hallucinations, or confusion. The person may have a past medical history of overdose, depression, or psychosis.
  • Forensic history including past custodial sentences, probation, or community service.
  • Evidence of social problems such as family dysfunction, unemployment, homelessness, and financial problems.
• Essential features listed in the World Health Organisation International Classification of Diseases (ICD-11) for diagnosis of opioid dependence include:
  • A pattern of recurrent episodic or continuous use of opioids plus evidence of two or more of the following:
    • Impaired control of opioid use in terms of onset, termination, or levels of use.
    • Increasing precedence of opioid use over other aspects of life, such as maintenance of health, daily activities, and responsibilities, such that opioid use continues or escalates despite harm or negative consequences.
    • Tolerance or a need to use increasing amounts of opioids to achieve the same effect.
    • Withdrawal symptoms following cessation or reduction in use of opioids.
    • Repeated use of opioids or pharmacologically similar substances to prevent or alleviate withdrawal symptoms.
• Features of dependence are usually evident over a period of at least 12 months but the diagnosis may be made if use is continuous (daily or almost daily) for at least 3 months.

How should I assess a person with suspected opioid dependence?

• The purpose of the initial consultation in routine general practice is to:
  • Identify and respond to any emergency or acute problems.
  • Confirm the person is taking psychoactive substances and ascertain the level of dependence and motivation for change.
  • Identify physical and mental health problems.
  • Identify social problems.
  • Assess risk behaviours and advise on harm reduction measures.
  • Refer the person onwards to specialist services for treatment including psychosocial interventions.
• Be aware that the person may be reluctant to talk about drug use for many reasons, including fear of being stigmatized, judged, or attracting unwanted attention from outside services such as the police or social services.
  • Following the initial assessment, further comprehensive assessments may need to be conducted over several sessions. It may be appropriate for concerned friends, relatives, carers, or other professionals already involved to attend.
• Take a history, asking about:
  • Reasons for presenting.
  • Drugs being used (including prescribed and over-the-counter medicines, alcohol, and tobacco).
    • Ask about quantity and frequency of use; pattern of use; routes of administration (including any injecting or inhalation); supply of needles and syringes; sharing habits; knowledge of how to inject safely; and correct disposal of used equipment.
    • Consider asking (sensitively and where relevant) how drugs are obtained and funded. This may uncover criminality, abuse, trafficking, sex work, or diversion of family income.
    • The Alcohol, Smoking and Substance Involvement Screening Tool – Lite (ASSIST-Lite) can be used to identify alcohol, drug, and tobacco smoking-related risk.
  • Medical history including:
    • Current or previous physical complications of drug use such as bloodborne and other infections, liver disease, skin problems, overdose, vascular problems, and sexually transmitted infections.
    • In women, last menstrual period (consider pregnancy and contraceptive needs), and last cervical smear.
    • Other health problems and current medications.
  • Mental health including:
    • Current or previous self-harm, anxiety, depression, other severe mental illness, personality disorders, and history of abuse or trauma — details of contact with mental health services should be recorded.
    • Assess current mood and risk of self-harm.
    • Asking about possible gambling-related harms. 
  • Family history of:
    • Substance use and dependence.
    • Relevant medical, psychiatric, or psychosocial factors.
  • Social history including: 
    • Family, housing, and living arrangements.
    • Problems in personal relationships including risk of violence and abuse.
    • Contact with partners or household members who misuse drugs or alcohol.
    • Education, employment, benefits, and financial problems.
    • Criminal involvement, offending, and other legal issues, including arrests, fines, outstanding charges and warrants, probation, imprisonment, violent offences and criminal activity, and involvement with workers in the criminal justice system.
  • Past contact with treatment services including:
    • Previous efforts to reduce or stop taking drugs including what helped and what did not help or caused relapse.
    • Current motivation for change and available support to achieve treatment and recovery goals.
• For drug-misusing parents or other adults with dependent children:
  • Obtain information on the children (including ages and names) and any drug-related risks to which they may be exposed including:
    • Effect of drug misuse on functioning, for example, intoxication or agitation.
    • Effect of drug-seeking behaviours, for example, leaving children unsupervised or contact with unsuitable characters.
    • Impact of physical and mental health on parenting.
    • Emotional availability to children.
    • Effects on family routines, for example, school attendance and routine medical and dental health checks.
    • Other people supporting the children, for example, family, and their fitness to provide that support.
    • Ability to access professional support.
    • Storage of illicit drugs, prescribed medication, and drug-using paraphernalia.
  • If children are living elsewhere (for example with a relative or in a statutory care setting) ask for contact details to enable information sharing with relevant care providers.
  • For more information, see the CKS topic on Child Maltreatment - recognition and management.
• Examine the person to:
  • Confirm evidence of drug misuse (for example, needle tracks, and signs of drug intoxication or withdrawal) — injecting into the groin or neck are indications of high-risk drug use. 
  • Check for the presence of complications.
  • Assess mental health.
  • Assess respiratory, cardiovascular, and other body systems depending on the specific clinical presentation. 
• Consider the need for investigations in primary care.

What investigations should I consider?

Depending on the specific clinical situation and local arrangements, investigations may be requested by specialist drug services or initiated in primary care.

• Initial investigations vary according to the person’s history, risks, symptoms, and examination findings and may include:
  • Tests to identify complications of drug misuse such as:
    • Full blood count, haematinics, liver, renal, and thyroid function tests.
    • Screening for bloodborne viruses (hepatitis B, hepatitis C, and HIV).
    • BHcG in women of childbearing potential.
    • Tuberculosis testing.
    • Electrocardiogram (ECG).
    • Chest X-ray and/or pulmonary function tests.
  • Drug screening tests:
    • Urine drug screening — different opioids persist in the urine for different lengths of time (for example, up to 48 hours for heroin and up to 7–9 days for methadone metabolites). See Table 1 for information on the duration of detectability of drugs in urine. 
    • Mouth swab tests — oral fluid is easier to collect and harder to switch or adulterate samples. However, drugs are present in lower concentrations and there is a shorter detection window (for example, heroin can be detected only up to 24–48 hours later with mouth swabs), so only very recent drug use can be detected.
    • False-positive and false-negative results can occur with drug screening tests and results should be interpreted in conjunction with clinical signs such as visible injection sites and signs of withdrawal. If necessary tests should be repeated. 

Table 1. Duration of detectability of drugs in urine.

Scenario: Management

From age 16 years onwards.

Scenario: Managing special circumstances

From age 16 years onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on primary care management of opioid dependence.

Search dates

June 2019 - February 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 17th June 2019). 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.

S3     S1 OR S2
S2    AB ( ((opioid* or opiate* or heroin or methadone or buprenorphine or diamorphine or naloxone) N3 (dependen* or addiction* or withdrawal or detoxification or substitution or taper* or overdose* or "use disorder" or "use disorders" or misuse or abuse)) ) OR TI ( ((opioid* or opiate* or heroin or methadone or buprenorphine or diamorphine or naloxone) N3 (dependen* or addiction* or withdrawal or detoxification or substitution or taper* or overdose* or "use disorder" or "use disorders" or misuse or abuse)))
S1    (MH "Opioid-Related Disorders+") 

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
• Institute for Clinical Systems Improvement
• 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

• Bandolier
• 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)
• LactMed
• 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.