Child health Endocrine and metabolic Skin and nail
Jaundice in the newborn
Last revised in May 2025
Jaundice is a yellow colouration of the skin and sclerae (whites of the eyes) caused by the accumulation of bilirubin, a bile pigment
Jaundice in the newborn: Summary
- Jaundice is a yellow colouration of the skin and sclerae caused by the accumulation of bilirubin, a bile pigment mainly produced from the breakdown of red blood cells. A raised level of bilirubin in the circulation is known as hyperbilirubinaemia.
- Bilirubin levels are higher in neonates than in adults, partly because newborn babies have a higher concentration of red blood cells, which also have a shorter lifespan.
- For most babies, jaundice is harmless ('physiological jaundice') and is not an indication of an underlying disease. Physiological jaundice can occur in breastfed and formula-fed babies. Prolonged jaundice is a persisting jaundice beyond 14 days in a term baby, or 21 days in a preterm baby. It is more common in breastfed babies and is usually harmless.
- Pathological neonatal jaundice can be caused by a number of factors, including: blood group incompatibility; sepsis; bruising; metabolic disorders; Gilbert's syndrome and Crigler-Najjar syndrome; glucose-6-phosphate-dehydrogenase deficiency; and congenital obstruction and malformations of the biliary system, such as biliary atresia.
- Jaundice that appears in the first 24 hours of life is usually pathological.
- Neurological complications in neonates with jaundice are rare.
- Acute bilirubin encephalopathy is a clinical syndrome that occurs when there is severe hyperbilirubinaemia. Features include lethargy, irritability, poor suck, abnormal muscle tone and posture (opisthotonus), high-pitched cry, apnoea, and eventually seizures and coma.
- Chronic bilirubin encephalopathy describes the permanent clinical consequences that may result from bilirubin toxicity. These include athetoid cerebral palsy, seizures, developmental delay, learning difficulties, vision and hearing problems, and dental dysplasia.
- The prognosis for babies with jaundice due to an underlying condition depends on the cause. Physiological jaundice is generally harmless and resolves by 2 weeks of age, and prolonged jaundice usually resolves by 3 months of age. Where treatment is required, it usually prevents bilirubin toxicity and neurological complications.
- To diagnose neonatal jaundice, the baby should be examined in bright, preferably natural light. If there is doubt about the diagnosis, referral to a neonatologist or paediatrician (depending on local availability) for further assessment should be considered.
- An assessment should be undertaken to determine the extent of jaundice and identify an underlying cause, if possible. However, visual assessment should not be used to assess the severity of hyperbilirubinaemia.
- All neonates with suspected or obvious jaundice should have their bilirubin measured to confirm the diagnosis and guide the need for further investigation and treatment. Usually, in practice, this will involve a same day referral to secondary care, with the urgency depending on the clinical situation, and the logistics depending on local arrangements.
- Neonates with features of bilirubin encephalopathy should be admitted to hospital as an emergency.
- Neonates who are jaundiced at less than 24 hours of age should be urgently admitted to a neonatal or paediatric unit within 2 hours.
- Urgency of referral of other jaundiced neonates will depend on a number of factors, but all neonates for whom jaundice appeared after 24 hours of age should have their bilirubin level measured within 6 hours.
- Secondary care investigations and management will vary depending on the suspected cause and level of bilirubinaemia, but options for treatment include observation, treatment of underlying illness, phototherapy, exchange transfusion, or surgical treatment.
Have I got the right topic?
From birth to 1 months.
This CKS topic covers the diagnosis, assessment, and management of a neonate with jaundice in primary care.
This CKS topic does not cover in detail secondary care treatments such as phototherapy and exchange transfusions, and the bilirubin level thresholds for initiation of these.
There are separate CKS topics on Gilbert's syndrome and Jaundice in adults.
The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. This CKS topic is therefore largely based on the recommendations in the UK-based National Institute for Health and Care Excellence (NICE) guideline Jaundice in newborn babies under 28 days [NICE, 2023a].
How up-to-date is this topic?
Changes
May 2025 — reviewed. A literature search was conducted in April to May 2025 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The topic has undergone minor restructuring. No major changes to the recommendations have been made.
Previous changes
November 2020 — reviewed. A literature search was conducted in November 2020 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The topic has undergone restructuring. No major changes to the recommendations have been made.
September to November 2015 — new topic. The evidence base has been reviewed in detail and recommendations are clearly justified and transparently linked to the supporting evidence.
Update
New evidence
Evidence-based guidelines
No new evidence-based guidelines since 1 May 2025.
HTAs (Health Technology Assessments)
No new HTAs since 1 May 2025.
Economic appraisals
No new economic appraisals relevant to England since 1 May 2025.
Systematic reviews and meta-analyses
No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 May 2025.
Primary evidence
No new primary evidence which reaches the CKS threshold for inclusion published since 1 May 2025.
New policies
No new national policies or guidelines since 1 May 2025.
New safety alerts
No new safety alerts since 1 May 2025.
Changes in product availability
No changes in product availability since 1 May 2025.
Goals and outcome measures
Goals
To support primary healthcare professionals to:
- Make a diagnosis of neonatal jaundice.
- Offer appropriate management.
- Refer neonates with jaundice, when appropriate, for specialist assessment.
Outcome measures
No outcome measures were found during the review of this topic.Audit criteria
No audit criteria were found during the review of this topic.
QOF indicators
No QOF indicators were found during the review of this topic.QIPP - Options for local implementation
No QIPP indicators were found during the review of this topic.
NICE quality standards
Jaundice in newborn babies under 28 days
- Parents or carers of newborn babies have a discussion with healthcare professionals and are given written information about neonatal jaundice within 24 hours of the birth, including what to look for and who to contact if they are concerned.
- Babies with suspected jaundice who are more than 24 hours old have their bilirubin level measured within 6 hours of a healthcare professional suspecting jaundice or a parent or carer reporting possible jaundice.
- Babies with hyperbilirubinaemia are started on treatment in accordance with standardized threshold tables or charts.
Background information
What is it?
- Jaundice is a yellow colouration of the skin and sclerae caused by the accumulation of bilirubin [NICE, 2023a]. Jaundice is associated with a raised level of bilirubin in the circulation, which is known as hyperbilirubinaemia.
- Jaundice in newborn babies is common and is harmless in most cases, and the cause is usually physiological.
- In a minority of cases, where jaundice results from very high or rapidly rising levels of bilirubin, or serious underlying conditions, neurotoxicity may result if this is not identified and treated early [Mitra, 2017].
- Prolonged jaundice is the term for jaundice which persists beyond 14 days in a baby with a gestational age of 37 weeks or more, or beyond 21 days in babies with a gestational age of less than 37 weeks [NICE, 2023a].
What causes it?
- Jaundice is caused by the accumulation of bilirubin [NICE, 2023a].
- Bilirubin is a bile pigment mainly produced from the breakdown of red blood cells.
- Bilirubin levels are higher in neonates than in adults because newborn babies have a higher concentration of red blood cells, which also have a shorter lifespan.
- Red cell breakdown produces unconjugated bilirubin, which is mostly bound to albumin. Unconjugated bilirubin is then metabolised in the liver to produce conjugated bilirubin, which is water soluble and eliminated in the urine and stool. Unbound unconjugated bilirubin is lipid soluble and can cross the blood-brain barrier and cause neurological damage.
- Although most cases are physiological and need no treatment or respond to a short period of phototherapy, it is crucial to identify the rare cases of significant jaundice that might lead to neurological damage, so this can be prevented [Mitra, 2017].
- Jaundice that develops in the first 24 hours of life is usually pathological in nature, as is jaundice associated with conjugated hyperbilirubinaemia [Mitra, 2017; Queensland Health, 2022; Ansong-Assoku, 2024].
- For most babies, jaundice is harmless ('physiological jaundice') and is not an indication of an underlying disease [Queensland Health, 2022; NICE, 2023a].
- In the first week of life, most infants have a bilirubin level that exceeds the upper level of normal for an adult.
- Physiological jaundice can occur in breastfed or formula-fed babies, and results from the increase in volume and decreased lifespan of red blood cells, and immature liver metabolism.
- Physiological jaundice usually appears at 2 days of age, peaks on days 3–5, and then decreases, usually by around day 10 in a term baby or within 3 weeks in a preterm baby.
- Physiological jaundice may co-exist with pathological jaundice.
- Prolonged jaundice is a persisting jaundice beyond the first 14 days in a term baby or 21 days in a preterm baby [Mitra, 2017; Queensland Health, 2022; NICE, 2023a].
- This is more common in term, breastfed babies. It is usually harmless; however, it may be caused by a serious underlying disease.
- The mechanism is not fully understood, but it is likely to be multifactorial and involve components of breast milk and aspects of both maternal and infant physiology [ABM, 2017; Gao, 2023].
- Pathological neonatal jaundice has a number of possible causes, including [Queensland Health, 2022; NICE, 2023a]:
- Blood group incompatibility (most commonly Rhesus or ABO incompatibility).
- Other causes of haemolysis.
- Sepsis.
- Bruising, birth trauma, or haemorrhage.
- Metabolic disorders (for example galactosaemia, hereditary fructose intolerance, alpha-1 antitrypsin deficiency, and hypothyroidism).
- Gilbert's syndrome and Crigler-Najjar syndrome — rare causes of neonatal jaundice that are caused by liver enzyme problems. For more information, see the CKS topic on Gilbert's syndrome.
- Glucose-6-phosphate-dehydrogenase deficiency — a familial enzyme deficiency more common in Mediterranean, Middle Eastern, South East Asian, and African populations.
- Congenital obstruction and malformations of the biliary system, such as biliary atresia — cause obstructive jaundice with conjugated hyperbilirubinaemia.
- Congenital infections such as cytomegalovirus, herpes simplex virus, toxoplasmosis, rubella, syphilis, varicella zoster, or parvovirus B19.
- Some cases of neonatal jaundice are prevented by routine aspects of antenatal and postnatal care, for example [Kemper, 2022; NICE, 2023c; CPS, 2025; NICE, 2025]:
- Routine antenatal testing of blood group and antibodies, and the use of anti-D prophylaxis where appropriate, preventing haemolytic disease of the newborn.
- Breastfeeding support or support for parents who use formula milk to establish feeding and help prevent cases associated with suboptimal intake.
How common is it?
- Jaundice is one of the most common conditions requiring medical attention in newborn babies.
- Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life, and about 10% of breastfed babies are still jaundiced at 1 month.
What are the risk factors?
- Factors associated with significant neonatal hyperbilirubinaemia include:
- Decreased gestational age/preterm delivery.
- Low infant birth weight.
- Development of jaundice within the first 24 hours of life.
- Sibling or parent born with jaundice requiring phototherapy/other treatment.
- Breastfeeding, particularly exclusive breastfeeding, with suboptimal intake.
- Visible bruising.
- Scalp haematoma.
- Maternal age older than 25 years.
- East Asian or Mediterranean ethnicity.
- Dehydration.
- Down syndrome.
- Macrosomic infant of a diabetic mother.
- Family history of inherited red blood cell disorders, including glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
[Kemper, 2022; Queensland Health, 2022; NICE, 2023a; CPS, 2025]
What are the complications?
- In young babies, unconjugated bilirubin is able to penetrate the blood–brain barrier. This can be toxic to the tissue of the brain and spinal cord, causing a condition known as bilirubin encephalopathy [NICE, 2023a].
- The level at which bilirubin is likely to cause neurotoxicity is variable and may be affected by a number of factors, such as prematurity, postnatal age, the rate of serum bilirubin increase, serum albumin concentration and co-existing illnesses (particularly if associated with sepsis, acidosis, and hypoxia) [NICE, 2023a].
- A number of terms are used to describe the neurological consequences of hyperbilirubinaemia [Queensland Health, 2022; NICE, 2023a]:
- Acute bilirubin encephalopathy — the clinical syndrome that occurs when there is severe hyperbilirubinaemia and unconjugated bilirubin enters the brain . Features include lethargy, irritability, poor suck, abnormal muscle tone and posture (opisthotonus), high-pitched cry, apnoea, and eventually seizures and coma.
- Chronic bilirubin encephalopathy — the permanent consequences of bilirubin toxicity, which become apparent in the first year of life in babies with a history of severe prolonged hyperbilirubinaemia . Clinical features include choreo-athetoid cerebral palsy, seizures, developmental delay, learning difficulties, vision and hearing problems, and dental dysplasia.
- Kernicterus — a term used to describe the clinical features of acute or chronic bilirubin encephalopathy and the pathological findings of deep yellow staining in the brain.
- Neurological complications in neonates with jaundice are rare.
- A prospective surveillance study of infants born in the UK and Republic of Ireland between 2003 and 2005 found the incidence of bilirubin encephalopathy to be 0.9 per 100,000 live births [Manning, 2007].
- In high resource countries, studies suggest that in the absence of risk factors such as sepsis or Rhesus haemolytic disease, chronic bilirubin encephalopathy or kernicterus occur in around 1 in every 200,000 live births [ABM, 2017], and overall, in around 1 in every 100,000 infants [Par, 2023].
What is the prognosis?
- For most babies, jaundice is not an indication of an underlying disease, and physiological jaundice is generally harmless and resolves by 2 weeks of age [NICE, 2023a].
- Prolonged unconjugated jaundice, in a baby who is otherwise well, is also usually benign and self-limiting within 12 weeks of age [Mitra, 2017; Queensland Health, 2022].
- For most babies who require treatment for jaundice, phototherapy prevents bilirubin toxicity [Queensland Health, 2022; Ansong-Assoku, 2024]. If treatment is delayed or inadequate, bilirubin encephalopathy can occur.
- The prognosis for babies with jaundice due to an underlying condition depends on the cause [Ansong-Assoku, 2024]. In many cases, the underlying condition may resolve spontaneously (for example, bruising) or may require treatment (for example, neonatal infection) or surgical correction (for example, biliary atresia), leading to resolution of ongoing jaundice. However, the prognosis may be more variable when jaundice is secondary to specific genetic or metabolic defects.
Diagnosis of jaundice in the newborn
How should I diagnose neonatal jaundice?
- Base the diagnosis of neonatal jaundice on clinical observation at every contact, particularly within the first 72 hours.
- If the baby has one or more risk factors for developing significant hyperbilirubinaemia, ensure they are re-examined during the first 48 hours.
- Record findings in the notes.
- Examine the baby in bright, preferably natural light, for example, in daylight by a window.
- Look at the skin of the whole body, and blanch to assess for jaundice (for example, gently pressing on the nose).
- Also examine the sclerae and gums.
- Be aware that jaundice may be more difficult to see in darker skin.
- If jaundice is suspected, the diagnosis and degree of hyperbilirubinaemia will be confirmed by measurement of serum bilirubin in secondary care. Do not rely on visual inspection alone to estimate bilirubin level in a baby with suspected jaundice.
- If there is doubt about the diagnosis, consider referral to a neonatologist or paediatrician (depending on local availability) for further assessment.
- Do not measure bilirubin levels routinely in babies who are not visibly jaundiced.
- Parents, carers, and health care professionals should all look for jaundice in babies. Offer parents and carers verbal and written information within 24 hours of the birth on:
- How to check the baby for jaundice.
- What to do if they suspect jaundice.
- The importance of seeking urgent medical attention if jaundice is suspected within the first 24 hours.
- The importance of checking the baby's nappies for dark urine or pale chalky stools.
- The fact that neonatal jaundice is common and reassurance that it is usually transient and harmless.
Basis for recommendation
These recommendations are largely based on expert opinion in the National Institute for Health and Care Excellence (NICE) guideline Jaundice in newborn babies under 28 days [NICE, 2023a], as well as the NICE Quality Standard Jaundice in newborn babies under 28 days [NICE, 2023b], and are also consistent with the recommendations within the Queensland Maternity and Neonatal Clinical Guideline Neonatal jaundice [Queensland Health, 2022].
Recording examination findings
- A previous expert reviewer of this CKS topic emphasized the importance of specifically recording the presence or absence of jaundice when a neonate is seen.
Referral
- Experts acknowledge that it can be difficult to detect jaundice, particularly in babies with darker skin [NICE, 2023a; Queensland Health, 2022]. CKS has therefore pragmatically recommended referral of babies for whom the diagnosis of jaundice is uncertain. This is based on the limited resources available in primary care to measure bilirubin levels and the potentially serious implications of a missed diagnosis of neonatal jaundice.
Screening
- In the UK, the NICE guideline recommends that newborn babies are not routinely tested for bilirubin level [NICE, 2023a]. CKS is aware that in some other countries, national guidance recommends routine screening of all newborns with bilirubin testing [Kemper, 2022; CPS, 2025].
How should I assess a baby with suspected jaundice?
- Review the baby's Personal Child Health Record (the 'red book') and hospital birth discharge documentation, and talk to the parent or carer to determine if there are features that can influence the development of significant hyperbilirubinaemia. Be aware of:
- Obstetric history (including the mother's Rhesus status and blood group if known, and any maternal red cell antibodies) and the baby's gestational age at birth.
- Age at onset and duration of jaundice.
- Feeding history: type of feeding and whether there have been any problems with adequate intake. Ask about the number of wet and dirty nappies in a day.
- Four or more wet nappies per day by 72 hours of age suggests adequate intake.
- Three to four stools per day by the fourth day of life is usual.
- Colour of urine and stools. Specifically ask about the presence of dark urine and/or pale stools. Dark urine and pale or chalky stools may indicate liver disease.
- Signs of illness (for example, lethargy, fever, vomiting, significant weight loss, or irritability).
- Family history of relevant conditions — for example, significant haemolysis (including glucose-6-phosphate-dehydrogenase deficiency). Ask whether any siblings or close family members have required hospital treatment such as phototherapy or exchange blood transfusion for neonatal jaundice.
- Examine the neonate to assess for:
- Any signs of illness, including fever.
- Appropriate weight gain (compared with previous measurements if available).
- Evidence of bruising (for example, cephalhaematoma following ventouse delivery).
- Evaluate the extent of jaundice.
- Jaundice in the neonate spreads from the head downwards with increasing severity (cephalocaudal progression).
- In some cases, only the head may appear jaundiced.
- However, be aware that a visual assessment alone is not a reliable indicator of bilirubin level and therefore should not be used to estimate the severity of jaundice.
- Refer urgently to secondary care for the further investigations which will be required. See the section on management for information about referral and urgency.
Basis for recommendation
These recommendations are largely based on information from the National Institute for Health and Care Excellence (NICE) guideline Jaundice in newborn babies under 28 days [NICE, 2023a] and the Queensland Maternity and Neonatal Clinical Guideline Neonatal jaundice [Queensland Health, 2022].
Management
Scenario: Management
From birth to 1 months.
Management of neonatal jaundice
- All neonates with visible jaundice need a bilirubin measurement, either with a transcutaneous bilirubinometer or serum bilirubin level. As this is not generally available in primary care, this usually involves immediate or same-day referral.
- Follow local protocols for arranging assessment with the appropriate level of urgency, but broadly:
- Arrange emergency admission (via 999 ambulance) if there is jaundice in a baby who is unwell or with features of bilirubin encephalopathy (for example, atypical sleepiness, poor feeding, irritability, vomiting, or hypotonia followed by hypertonia).
- Arrange urgent admission to a neonatal or paediatric unit (depending on local arrangements) within 2 hours if jaundice first appears at less than 24 hours of age.
- Arrange urgent assessment in a neonatal or paediatric unit (depending on local arrangements) as soon as possible and to be seen within 6 hours (using clinical judgement regarding more urgent referral or admission) in all other babies with suspected or obvious jaundice.
- If transcutaneous bilirubin measurements are available in primary care, record the level within 6 hours and manage according to local protocols.
- In babies who have prolonged jaundice (onset after 24 hours but persisting after 14 days in babies of gestational age of more than 37 weeks or 21 days in those with gestational age less than 37 weeks), refer to the neonatal team on the same day, but the assessment may be booked by them within a few days if the baby is otherwise well, depending on local protocols.
- General advice and information for parents and carers:
- Reassure parents and carers that:
- Neonatal jaundice is common and is usually transient and harmless.
- Breastfeeding can usually continue.
- Encourage breastfeeding mothers to breastfeed frequently and to wake the baby for feeds if necessary. Ensure there is sufficient access to breastfeeding support, and refer for this if necessary. For more information, see the CKS topic on Breastfeeding problems.
- Advise on additional sources of information and support, including:
- National Institute for Health and Care Excellence (NICE) neonatal jaundice public information.
- NHS Health information on Newborn jaundice.
- The Breastfeeding Network.
- La Leche League, a breastfeeding support charity.
- National Childbirth Trust (NCT).
- Bliss, a charity organisation for babies born premature or sick.
- Reassure parents and carers that:
Secondary care investigations and management
- In secondary care, serum bilirubin levels are measured in order to confirm the diagnosis and guide treatment. This may be done by a transcutaneous bilirubinometer or by a blood test to measure serum bilirubin.
- Neonates with significant bilirubinaemia will have additional investigations to determine any underlying causes, which may include:
- Serum bilirubin.
- Full blood count, blood packed cell volume and blood film — to help identify, for example, anaemia, haemolysis, thrombocytopaenia, infection, hereditary red cell membrane disorders or polycythaemia.
- Blood group (mother and baby) — ABO incompatibility is suggested by a mother with blood group O and a baby with group A or B. Rhesus incompatibility is suggested if the mother is Rhesus negative and her baby is Rhesus positive.
- DAT (Coombs' test) — used to diagnose ABO or Rhesus isoimmunization.
- Liver function tests — in congenital infection, liver enzymes may be increased.
- Routine metabolic screening, including screening for congenital hypothyroidism, if not already performed.
- Blood glucose-6-phosphate-dehydrogenase (G6PD) levels, taking into account ethnic origin — to check for G6PD deficiency.
- Microbiological cultures of blood, urine, and/or cerebrospinal fluid (if infection is suspected) — to look for a source of infection.
- The choice of treatment in secondary care will depend on a number of factors, including the underlying cause of the jaundice. Options include:
- No treatment — this may be appropriate for well neonates with physiological or breastmilk jaundice and a bilirubin level below the treatment threshold.
- Treatment of any underlying illness (such as infection).
- Phototherapy — absorption of light through the skin converts unconjugated bilirubin into products that are more easily excretable in the stool and urine.
- Exchange transfusion — indicated if the baby has signs of bilirubin encephalopathy and considered if the risk of kernicterus is high or jaundice is not responding to phototherapy.
- Early surgical treatment — required for conditions such as biliary atresia.
Basis for recommendation
The recommendations on management of neonatal jaundice are based largely on recommendations in the National Institute for Health and Care Excellence (NICE) guideline Jaundice in newborn babies under 28 days [NICE, 2023a], the NICE Quality Standard Jaundice in newborn babies under 28 days [NICE, 2023b], as well as the NICE guideline Postnatal care [NICE, 2023c], and a sample of local NHS referral protocols for GPs, for example, the NHS Cornwall and Isles of Scilly clinical referral guideline Neonatal jaundice [NHS, 2021], the NHS Oxford University Hospitals NHS Foundation Trust referral information, Neonatal unit referrals [NHS, 2024], and the Bristol, North Somerset and South Gloucestershire (BNSSG) REMEDY referral pathways and joint formulary section on Jaundice [NHS, 2023].
Supporting evidence
This CKS topic is largely based on the UK-based recommendations in the National Institute for Health and Care Excellence guideline Jaundice in newborn babies under 28 days [NICE, 2023a].
How this topic was developed
This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.
Search strategy
Scope of search
A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of jaundice in the newborn.
Search dates
November 2020 - May 2025
Key search terms
Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.
- *"Hyperbilirubinemia, Neonatal"/
- *"Jaundice, Neonatal"/
- ("new-born" or newborn or neonate).ti,ab. and (jaundice or hyperbilirubin$).ti,ab.
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
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.
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.
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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.
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Competing interests declared for this topic:
None.
References
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