Changes

March 2025 — minor update. Updated link to information from the First Steps Nutrition Trust. 

Update

Goals

To support primary healthcare professionals to:

• Recognize possible clinical features of cow's milk allergy in children.
• Assess a child with suspected cow's milk allergy.
• Diagnose and manage suspected non-IgE mediated cow's milk allergy in primary care, if appropriate.
• Arrange referral of suspected IgE-mediated cow's milk allergy, or severe non-IgE-mediated cow's milk allergy, to a specialist local allergy clinic for confirmation of the diagnosis and ongoing management. 

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

Food allergy

• Children and young people with suspected food allergy have an allergy-focused clinical history taken.
• Children and young people whose allergy‑focused clinical history suggests an IgE-mediated food allergy are offered skin prick or blood tests for IgE antibodies to the suspected food allergens and likely co-allergens.
• Children and young people whose allergy‑focused clinical history suggests a non-IgE-mediated food allergy, and who have not had a severe delayed reaction, are offered a trial elimination of the suspected allergen and subsequent reintroduction.
• Children and young people are referred to secondary or specialist allergy care when indicated by their allergy-focused clinical history or diagnostic testing.

[NICE, 2018a]

What is it?

• Food allergy describes an adverse immune-mediated response that occurs when a person is exposed to specific food allergen(s), usually by ingestion and more rarely by inhalation or skin contact [Burks, 2012; Turnbull, 2015; NICE, 2018b; Vandenplas, 2024].
• Cow's milk allergy is a reproducible immune-mediated allergic response to one or more proteins in cow's milk [Luyt, 2014].
  • Milk contains casein and whey fractions made up of about 20 potentially sensitizing proteins [Fiocchi, 2010].
• Cow's milk allergy can be classified according to the underlying immune mechanism and timing of symptoms [Burks, 2012; Luyt, 2014; NICE, 2018b; Fox, 2019; Vandenplas, 2024]:
  • Immunoglobulin (Ig)E-mediated food allergy follows exposure and sensitization to trigger food allergen(s) with the development of serum-specific IgE antibodies. It produces immediate and consistently reproducible symptoms, which may affect multiple organ systems. Reactions mostly occur within minutes but can occur up to 2 hours after ingestion of cow's milk protein.
  • Non-IgE-mediated food allergy involves a cell-mediated mechanism and reactions are typically delayed. They usually manifest between 2 and 72 hours after cow's milk ingestion.
  • Mixed IgE and non-IgE allergic reactions involve a mixture of both IgE and non-IgE responses. 
• Food sensitization describes the production of serum-specific IgE to food allergens without the clinical symptoms of an allergic reaction to food exposure [Burks, 2012].
• Food intolerances are non-immune adverse reactions to foods and/or food additives, which are distinct from food allergies [Boyce, 2010; Turnbull, 2015; NICE, 2018b].
  • They often present non-specifically with gastrointestinal symptoms, headache, fatigue, and musculoskeletal symptoms. Typically, there is a delay in symptom onset and a prolonged symptomatic phase.
  • The exact cause is unknown, but they may be due to enzyme deficiencies or pharmacological reactions to chemicals.

What causes it?

• Cow's milk allergy is an immune-mediated response to proteins found in cow's milk. The exact underlying mechanism is unknown, but it is thought that various genetic, epigenetic, and environmental factors play an important role [Flom, 2019].
  • Immunoglobulin (Ig) E-mediated cow's milk allergy is caused when there is sensitization to cow's milk proteins, expressed by the production of specific IgE antibodies against cow's milk proteins that bind to the surface of mast cells and basophils. Following exposure to cow's milk proteins, the release of cell mediators, such as histamine, is triggered, causing the clinical features of an allergic reaction [Burks, 2012]. 
  • Non-IgE-mediated cow's milk allergy is thought to be T cell-mediated [Luyt, 2014; Turnbull, 2015].

How common is it?

Prevalence estimates of cow's milk allergy vary in the literature due to differences in diagnostic classifications, study design and outcomes, methodology, and study populations. There is also a discrepancy between self-reported food allergy and confirmed true food allergy prevalence, with over-estimates in the literature for self-reported symptoms [Burks, 2012; Luyt, 2014; Flom, 2019; Vandenplas, 2024]. 

• Cow's milk allergy is one of the most common presentations of food allergy seen in early childhood, but it is less frequent than egg (9%) and peanut allergy (3%), with a prevalence below 1% in double-blind placebo-controlled food challenge studies [Vandenplas, 2024]. The most common presentation is mild-to-moderate non-IgE-mediated allergy [Venter, 2017].
  • Almost all cases present before one year of age, with a prevalence of between 1.8–7.5% of infants during the first year of life [Luyt, 2014].
• The large EuroPrevall prospective birth cohort study (n = 12,049 children from nine European countries) observed an overall incidence of double-blind placebo-controlled food challenge-confirmed cow's milk allergy of 0.54% in Europe [Schoemaker, 2015].
  • The adjusted incidence in children aged up to 2 years in the UK was 1.28%, with 56% of cases due to non-IgE-mediated allergy (the highest incidence in Europe).
• A meta-analysis of 42 European studies estimated the overall pooled prevalence of cow's milk allergy for all age groups [Nwaru, 2014].
  • The self-reported overall lifetime prevalence was 6%. 
  • The self-reported overall point prevalence was 2.3%. 
  • The point prevalence with positive skin prick testing was 0.3%. 
  • The point prevalence with positive serum-specific IgE testing was 4.7%. 
  • The point prevalence with positive food challenge was 0.6%. 
  • The point prevalence with positive food challenge or clinical history of cow's milk allergy was 1.6%. 
  • The authors noted significant heterogeneity and variable participation rates between studies.
• A recent systematic review of studies on the incidence, prevalence, and time trends of common food allergies in Europe found that the point prevalence was [Spolidoro, 2023]:
  • 5.5% (95% CI 3.8–7.2) for IgE positivity to cow's milk.  
  • 0.7% (95% CI 0.4–1.2) for skin prick positivity.
  • 0.1% (95% CI 0.05–0.2) for IgE positivity plus symptoms.
  • 0.3% (95% CI 0.1–0.5) for food challenge positivity. 
  • 1.8% (95% CI 0.6–3.1) for food challenge positivity or clinical history.

What are the risk factors?

• Risk factors associated with developing cow's milk allergy include [NICE, 2018b]:
  • Comorbid atopic conditions, such as asthma, allergic rhinitis, and atopic eczema [Flom, 2019]. See the CKS topics on Asthma and Eczema - atopic for more information.
    • The development of early-onset atopic eczema before 6 months of age, and severe eczema below the age of 1 year, are associated with the development of egg, milk, and peanut allergy [Turnbull, 2015].
    • The risk of severe allergic reactions is higher in children with asthma, especially those with poorly controlled asthma [Resuscitation Council UK, 2021]. 
  • Existing food allergy — multiple food allergies are relatively common and have been identified in over 90% of people with cow's milk allergy in a high-risk population [Turnbull, 2015; Flom, 2019]. See the CKS topic on Food allergy for more information.
  • Family history of atopy [Luyt, 2014; Santos, 2023; Vandenplas, 2024].
  • Family history of food allergy — confirmed food allergy in a parent or sibling increases the risk of food allergy [Longo, 2013].
  • Male sex — boys have a two-fold higher risk of developing cow's milk allergy than girls in childhood [Flom, 2019].

What are the complications?

• The possible complications of cow's milk allergy include:
  • Severe and life-threatening reactions. 
    • Food allergy is the most common trigger of anaphylaxis in the community. There have been rare cases of life-threatening anaphylaxis following cow's milk ingestion in sensitized children. See the CKS topic on Angio-oedema and anaphylaxis for more information.
  • Stress and anxiety (affecting the child and parents/carers). 
    • This may be associated with the need for constant vigilance over food choices, and risk of accidental food exposure and severe reactions.
  • Reduced quality of life. 
    • Dietary restrictions affect food shopping and family meal provision, which may be stressful and time-consuming.
    • The impact on social interactions, such as eating out, playing at friends' houses, attending birthday parties, and participating in school meals.
    • The impact of peer pressure, stigma, and embarrassment about food allergy.
    • Potential social exclusion, such as not being invited to friends' houses, trips, and activities.
  • Restricted diet and malnutrition.
    • Compared to healthy children, growth in children with food allergy is often impaired and vitamin and mineral deficiencies are common.
    • Infants and young children on an unsupervised cow’s milk exclusion diet are at increased risk of micronutrient deficiencies, mainly relating to insufficient iron, iodine, calcium, and vitamin D and B12 intake. See the CKS topics on Anaemia - iron deficiency and Faltering growth for more information.
  • Development of atopic comorbidities.
    • Cow's milk allergy may be the first stage of the so-called 'allergic march' and may be associated with the later development of other atopic conditions such as asthma, atopic eczema, and allergic rhinitis. See the CKS topics on Asthma, Eczema - atopic, and Allergic rhinitis for more information.
  • Cross-reactivity of other mammalian milks. 
    • Potentially cross-reactive milk proteins may include those in goat, ewe, horse, camel, and buffalo milk.
  • Enterocolitis, proctocolitis, and enteropathy 
    • Food protein-induced enterocolitis syndrome (FPIES) — a non-IgE-mediated response to cow's milk which affects the entire gastrointestinal tract. It typically presents in infancy with protracted vomiting 1-4 hours after food ingestion often accompanied by lethargy and pallor. Chronic FPIES presents as chronic vomiting, watery diarrhoea and faltering growth and can lead to dehydration and shock.
    • Food protein-induced allergic proctocolitis (FPIAP) — a non Ig-E mediated response to food proteins that mostly occurs in breastfed infants. It affects the distal colon and often presents with haematochezia associated with persistent mucus-streaked diarrhoea in otherwise healthy young infants. 
    • Cow's milk-induced enteropathy — this involves the small bowel and may cause secondary lactose intolerance.
  • Eosinophilic oesophagitis.  
    • This is a severe form of non-IgE-mediated allergy, typically presenting with a combination of vomiting, food aversion, and faltering growth in an infant. 
  • Heiner's syndrome.
    • This is a very rare form of pulmonary haemosiderosis caused by cow's milk allergy. 

[Boyce, 2010; Fiocchi, 2010; Luyt, 2014; Muraro, 2014; Turnbull, 2015; Meyer, 2020; Vandenplas, 2021; Vandenplas, 2024]

What is the prognosis?

• The prognosis of cow's milk allergy depends on the child's age, comorbidities, and the immune mechanism involved. However, most children will outgrow their allergy by adulthood [Luyt, 2014].
• A prospective cohort study of infants with IgE-mediated cow's milk allergy (n = 54) who were followed up for 48–60 months found that 57.4% developed tolerance during the study period [Elizur, 2012].
• The large EuroPrevall prospective birth cohort study (n = 12,049 children from nine European countries) re-evaluated 58% of children with confirmed cow's milk allergy 1 year after diagnosis by double-blind placebo-controlled food challenge [Schoemaker, 2015]. It found that
  • Overall 69% of children had become cow's milk tolerant.
  • 56.5% of children with IgE-mediated allergy became tolerant.
  • 100% of children with non-IgE-mediated allergy became tolerant.
• A US retrospective review of clinical records (n = 807) found that cow's milk tolerance (defined by passing an oral challenge or having no reactions in the previous 12 months, and a low serum-specific IgE level) was reached by [Skripak, 2007]:
  • 19% of children by 4 years of age.
  • 42% of children by 8 years of age.
  • 64% of children by 12 years of age.
  • 79% of children by 16 years of age.
• In general, non-IgE-mediated allergy is associated with a faster rate of resolution than IgE-mediated allergy [Luyt, 2014; Flom, 2019].
• Cow's milk allergy is more likely to persist in children with [Elizur, 2012; Luyt, 2014; Flom, 2019]:
  • IgE-mediated disease — particularly in those with a larger reaction on skin prick test or higher serum-specific IgE antibody levels at diagnosis. 
  • Concomitant atopic conditions of asthma or allergic rhinitis. See the CKS topics on Asthma and Allergic rhinitis for more information.
  • A history of severe symptoms and severe initial reactions.
  • A history of multiple food allergies. See the CKS topic on Food allergy for more information.

When should I suspect cows' milk allergy?

Be aware that the clinical features of cow's milk allergy are variable in type and severity and can overlap with other common conditions, so clinical judgement is needed when interpreting symptoms.

• Suspect a diagnosis of cow's milk allergy in children who have:
  • One or more of the symptoms and signs listed in Table 1. 
  • Multiple, persistent, severe, or treatment-resistant symptoms (such as gastro-oesophageal reflux disease [GORD], atopic eczema, or chronic gastrointestinal symptoms, such as constipation). See the CKS topics on GORD in children, Eczema - atopic, and Constipation in children for more information.
• Clinical features are most commonly cutaneous (70-75%), and less frequently gastrointestinal (13-14%), respiratory (1-8%), and very rarely cardiovascular. 
  • Up to 1 in 4 infants presents with a combination of symptoms involving more than one organ system. 
• Note: if there is a suspected severe IgE-mediated allergy, severe systemic reaction, and/or anaphylaxis, see the CKS topic on Angio-oedema and anaphylaxis for information on emergency management.

Table 1. Symptoms and signs of possible IgE- and non-IgE-mediated cow's milk allergy.*

How should I assess a child with suspected cow's milk allergy?

If a diagnosis of cow's milk allergy is suspected on the basis of reported or observed clinical features, assess the child to help distinguish between IgE- and non-IgE-mediated allergy, and manage appropriately.

• Take an allergy-focused history by asking about:
  • The symptoms, severity, frequency of occurrence, speed of onset, duration, route of exposure, and the timing of the reaction in relation to cow's milk exposure. A food and symptom diary may be helpful.
    • Symptoms usually develop within a week of cow's milk introduction, although they may be delayed for several weeks.
    • Reactions may be triggered by food ingestion, inhalation, or skin contact (rare). 
  • The form in which milk has been ingested (fresh, processed, cooked, or baked), and the quantity. 
    • The trigger is usually cow's milk, however, it may be cow's milk protein in maternal breast milk in infants who are exclusively breastfed (rare).  
    • IgE-mediated reactions usually occur following a small amount of milk, whereas non-IgE-mediated reactions usually occur after ingestion of larger volumes of milk. 
  • Any uneventful exposures to cow's milk before or after the reaction. 
  • The setting of reactions (such as school or home).
  • The reproducibility of symptoms on repeated cow's milk exposure.
  • The age when symptoms started, the child's feeding history (age of complementary feeding [weaning], breast- or formula-fed), weight gain, and nutritional status.
    • Most affected children present by 6 months of age; onset is rare after 12 months of age. 
    • If the child is currently being breastfed, ask about the mother’s diet. 
  • Cultural and religious factors that affect the foods they eat.  
  • Any comorbid atopic conditions such as asthma, eczema, or allergic rhinitis; any history of other food allergies. See the CKS topics on Asthma, Eczema - atopic, Allergic rhinitis, and Food allergy for more information.
  • Any family history of food allergy or atopic conditions, particularly in parents and siblings. 
  • Any symptom response to elimination and reintroduction of cow's milk, and/or medications tried, such as oral antihistamines. 
• Examine the child for:
  • Nutritional status and growth, including weight, length/height, and calculation of body mass index (BMI). 
  • Any signs of a clinical reaction. 
  • Any signs of allergy-related comorbidities (such as atopic eczema, asthma, and/or allergic rhinitis). See the CKS topics on Eczema - atopic, Asthma, and Allergic rhinitis for more information.
  • Any signs suggesting an alternative diagnosis. 
• Offer skin prick testing and/or serum-specific IgE allergy testing if there is suspected IgE-mediated cow's milk allergy, depending on local referral pathways and availability.
  • Tests should only be undertaken by healthcare professionals with the appropriate competencies to select, perform and interpret them. 
  • Skin prick tests should only be undertaken where there are facilities to deal with an anaphylactic reaction. 
  • Be aware that there are no reliable allergy tests to confirm the diagnosis of non-IgE-mediated allergy. 
• Do not use the following alternative diagnostic tools to diagnose cow's milk allergy:
  • Serum-specific immunoglobulin (Ig)G testing. 
  • Vega testing (electroacupuncture devices). 
  • Applied kinesiology (muscle strength testing). 
  • Hair analysis (assessing mineral content). 
  • Atopy patch testing. 

What else might it be?

Alternative diagnoses which may present similarly to cow's milk allergy include:

• Food intolerance (a non-immune adverse reaction), for example, lactose intolerance caused by an inability to digest and absorb dietary lactose.
  • Symptoms of lactose intolerance may overlap with those of non-IgE-mediated cow's milk allergy if there is cow's milk-induced enteropathy, and may present with abdominal pain, bloating, flatulence, and explosive diarrhoea following ingestion of lactose-containing foods.
  • Congenital lactase deficiency is very rare, does not usually manifest before 5 years of age, and is seen in small populations in Finland and Russia, for example. 
  • Acquired or secondary lactose intolerance is usually transient and may occur with mucosal damage due to underlying gut conditions, such as following gastroenteritis. See the CKS topic on Gastroenteritis for more information. 
• Other food allergies (such as egg, soya protein, or wheat allergy) or allergies to other substances (such as animal dander, moulds, and dust). See the CKS topic on Food allergy for more information.
• Anatomical abnormalities, such as Meckel's diverticulum, intussusception, malrotation of the gut. 
• Coeliac disease — see the CKS topic on Coeliac disease for more information.
• Colic — see the CKS topic on Colic - infantile for more information.
• Constipation — see the CKS topic on Constipation in children for more information.
• Crohn's disease — see the CKS topic on Crohn's disease for more information.
• Gastrointestinal infection — see the CKS topic on Gastroenteritis for more information. 
• Gastro-oesophageal reflux disease (GORD) — see the CKS topic on GORD in children for more information.
• Irritable bowel syndrome — see the CKS topic on Irritable bowel syndrome for more information. 
• Pancreatic insufficiency (such as in cystic fibrosis). 
• Ulcerative colitis — see the CKS topic on Ulcerative colitis for more information.

Scenario: Suspected cow's milk allergy

From birth to 5 years.

Scenario: Confirmed non-IgE-mediated cow's milk allergy

From birth to 5 years.

Cetirizine

• For prescribing information, see the section on Oral antihistamines in the CKS topic on Allergic rhinitis.

Chlorphenamine

• For prescribing information, see the prescribing information section on Chlorphenamine in the CKS topic on Food allergy.

Loratadine

• For prescribing information, see the section on Oral antihistamines in the CKS topic on Allergic rhinitis.

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on primary care management of cows' milk protein allergy.

Search dates

October 2019 - July 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 24th October 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 ( (milk N3 (hypersensitiv* or allerg*)) ) OR TI ( (milk N3 (hypersensitiv* or allerg*)) ) 
S1    (MH "Milk Hypersensitivity") 

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.