Changes

May 2026 — minor update. Minor changes to wording around the use of antiplatelets for the secondary prevention of CVD. 

Update

Goals

To support primary healthcare professionals to:

• Be aware when to suspect and make a diagnosis of chronic kidney disease.
• Understand how to classify chronic kidney disease.
• Offer appropriate initial management in primary care.
• Monitor people with confirmed chronic kidney disease in primary care to identify disease progression.
• Arrange referral to a nephrologist, urologist, or other specialist if appropriate, depending on clinical judgement.

Outcome measures

Audit criteria

QOF indicators

Table 1. Indicators related to chronic kidney disease (CKD) in the Quality and Outcomes Framework (QOF) guidance for 2025–2026.

QIPP - Options for local implementation

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

NICE Quality standards

• Adults with, or at risk of, chronic kidney disease (CKD) have eGFR creatinine and albumin:creatinine ratio (ACR) testing at the frequency agreed with their healthcare professional.
• Adults with CKD have their blood pressure maintained within the recommended range. 
• Adults with CKD are offered atorvastatin 20 mg.

[NICE, 2017]

What is it?

• Chronic kidney disease (CKD) is defined as abnormalities in kidney function or structure (or both) present for more than 3 months with associated health implications.
  • Kidney damage may cause fluid and electrolyte imbalance and leakage of protein and/or blood into the urine, resulting in proteinuria and haematuria [Fraser, 2016].
• CKD should be diagnosed in people with either of the following present for a minimum of 3 months:
  • A glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m² on at least two occasions separated by a period of at least 90 days (with or without markers of kidney damage). 
    • The estimated GFR (eGFR) is a measure of the total amount of fluid filtered through all the functioning kidney nephrons per unit of time, and is derived from serum creatinine using standard estimating equations [Fraser, 2016; Webster, 2017].
  • Markers of kidney damage such as urinary albumin:creatinine ratio (ACR) greater than 3 mg/mmol, urine sediment abnormalities, electrolyte and other abnormalities (for example, acidosis) due to tubular disorders, abnormalities detected by histology, structural abnormalities detected by imaging (for example, polycystic kidneys, reflux nephropathy), and a history of kidney transplantation.
    • Urine sediment abnormalities include red blood cells; white blood cells; cellular, fatty, or granular casts; or renal tubular epithelial cells [Fraser, 2016].
• CKD is classified based on the underlying cause, GFR category, and proteinuria category.
  • Accelerated progression of CKD is a sustained decrease in GFR of 25% or more and a change in GFR category within 12 months; or a sustained decrease in GFR of 15 mL/min/1.73 m² within 12 months.

[NICE, 2021; KDIGO, 2024]

What are the causes and risk factors?

There are multiple possible causes and risk factors for chronic kidney disease (CKD) and its progression, including:

• Conditions associated with intrinsic kidney damage, such as:
  • Hypertension — see the CKS topic on Hypertension for more information.
  • Diabetes mellitus — this is the most common cause in adults. See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for more information.
  • Glomerular disease, such as acute glomerulonephritis (this may follow upper respiratory tract infection, hepatitis B, hepatitis C, or HIV infection) — see the CKS topics on Sore throat - acute, Hepatitis B, Hepatitis C, and HIV infection and AIDS for more information.
• Current or previous history of acute kidney injury (AKI).
  • This may be triggered by severe intercurrent illness or dehydration — see the CKS topic on Acute kidney injury for more information.
• Potentially nephrotoxic procedures (such as radiotherapy) or drugs, such as: 
  • Aminoglycosides, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), bisphosphonates, calcineurin inhibitors (such as ciclosporin or tacrolimus), diuretics, lithium, methotrexate, proton pump inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs).
• Conditions associated with obstructive uropathy, such as:
  • Structural renal tract disease. 
  • Bladder voiding problems such as neurogenic bladder, benign prostatic hypertrophy — see the CKS topic on LUTS in men for more information.
  • Recurrent urinary tract calculi — see the CKS topic on Renal or ureteric colic - acute for more information.
• Multisystem diseases with potential renal involvement, such as: 
  • Systemic lupus erythematosus (SLE) which may cause lupus nephritis. 
  • Vasculitis. 
  • HIV  — see the CKS topic on HIV infection and AIDS for more information. 
  • Myeloma — see the CKS topic on Multiple myeloma for more information.
• A family history of CKD stage 5, or hereditary kidney disease such as autosomal dominant polycystic kidney disease, or Alport's syndrome.
• Cardiovascular disease — see the CKS topics on Angina, CVD risk assessment and management, Heart failure - chronic, Peripheral arterial disease, and Stroke and TIA for more information.
• Gout — see the CKS topic on Gout for more information. 
• People with an incidental finding of haematuria or proteinuria. 

[Chawla, 2014; Webster, 2017; KDIGO, 2021a; NICE, 2015; BMJ Best Practice, 2022; KDIGO, 2024]

How common is it?

• Chronic kidney disease (CKD) is a common condition — the incidence and prevalence vary depending on the population studied, including ethnic group and socio-economic class [Fraser, 2016; Webster, 2017].
• There is an estimated global prevalence of 9.1%, with diabetes mellitus accounting for 30-50% of cases [Webster, 2017; KDIGO, 2024].
• Black people, Hispanic people, and those with a family member who has a diagnosis of kidney disease have a higher prevalence than the general population [BMJ Best Practice, 2022].
• In the UK, over 1.9 million adults have been diagnosed with CKD, although there are many more who remain undiagnosed [Molokhia, 2020]. 
  • The estimated prevalence of categories G3-5 is 6%.  
• The prevalence is expected to continue to increase due to an ageing population and a higher incidence of diseases such as type 2 diabetes and hypertension [Hirst, 2020; BMJ Best Practice, 2022].

What are the complications?

The risk of complications from chronic kidney disease (CKD) increases with disease progression. These may include:

• Acute kidney injury.
  • This may initiate or accelerate CKD progression [Vassalotti, 2016] — see the CKS topic on Acute kidney injury for more information.
• Hypertension 
  • Hypertension may contribute to the risk of accelerated CKD progression [Bello, 2017] — see the CKS topic on Hypertension for more information.
• Dyslipidaemia 
  • Secondary causes of dyslipidaemia may include renal causes such as nephrotic syndrome (defined as proteinuria over 3.5 g per day plus hypoalbuminaemia less than 30 g/L) — see the CKS topic on Lipid modification - CVD prevention for more information.
•  Cardiovascular disease — such as myocardial infarction, peripheral arterial disease, and heart failure.
  • People with CKD are 5–10 times more likely to die prematurely than they are to progress to end-stage renal disease (ESRD). The risk of death rises exponentially as renal function worsens, and is largely secondary to cardiovascular disease [Webster, 2017].
  • Economic modelling estimated that in England in 2009–2010, an extra 7,000 strokes and 12,000 myocardial infarctions occurred in people with CKD, compared with age- and gender-matched controls.
• End-stage renal disease (ESRD).
  • People with CKD stage 5 may need renal replacement therapy (RRT) in the form of dialysis or kidney transplantation.
• Hyperkalaemia — this is common in people with CKD due to the kidney's inability to excrete potassium from the diet as the estimated glomerular filtration rate declines. 
• Metabolic acidosis — this is common in patients with CKD, due to the inability of the kidney to excrete acid once the estimated glomerular filtration rate is less than 50 mL/minute.
• Pulmonary oedema — fluid overload may need to be managed with loop diuretics.
• Anaemia 
  • This may present with symptoms such as tiredness, shortness of breath, lethargy, and palpitations. 
  • It may be due to reduced production of erythropoietin by the kidney, reduced red blood cell survival, and iron deficiency [Webster, 2017] — see the CKS topic on Anaemia - iron deficiency for more information.
• Mineral and bone disorder 
  • This may present with bone pain, increased bone fragility, or extra-skeletal calcification, such as in the skin or blood vessels [Webster, 2017].
  • It is caused by disturbed vitamin D, calcium, parathyroid hormone (PTH), and phosphate metabolism due to impaired regulation of intestinal absorption and renal tubular excretion. This subsequently causes abnormalities in bone turnover and mineralisation. Serum calcium may be low or high initially, with vitamin D deficiency, raised serum phosphate, low serum calcium, and secondary or tertiary hyperparathyroidism seen in progressive CKD [Webster, 2017].
• Peripheral neuropathy and myopathy. 
  • This may present with paraesthesia, sleep disturbance, and restless legs syndrome — see the CKS topic on Restless legs syndrome for more information.
• Malnutrition 
  • One of the causes of malnutrition is loss of appetite, secondary to uraemia.
  • This may be seen in ESRD due to poor dietary intake.
• Malignancy
  • People with ESRD may have an excess cancer risk, particularly affecting the renal tract and thyroid gland. The exact cause is not known, but risk factors may include exposure to immunosuppressive agents and immune dysregulation caused by chronic uraemia [Webster, 2017].
• Stroke 
  • A large meta-analysis of 83 studies (n = 2,253,741) that studied the association between glomerular filtration rate (GFR) and albuminuria on stroke risk found an inverse linear relationship between GFR and stroke risk, with an average 7% increase in the relative risk of stroke associated with every 10 mL/min/1.73m² decrease in GFR, and an average 10% increase in the relative risk of stroke associated with every 25 mg/mmol increase in urinary ACR [Masson, 2015].
• All-cause mortality.
  • The risk of all-cause mortality increases with progressive CKD.

[Vassalotti, 2016; Bello, 2017; Gaitonde, 2017; Webster, 2017; NICE, 2021; BMJ Best Practice, 2022; KDIGO, 2021a; KDIGO, 2024]

What is the prognosis?

• The prognosis and progression of chronic kidney disease (CKD) is influenced by the cause — for example, autosomal dominant polycystic kidney disease is the most common genetic cause of CKD and is typically associated with faster progression than other disease entities [Chen, 2023]. 
• Generally, CKD is progressive and leads to end-stage renal disease (ESRD), although as it is a major risk factor for cardiovascular disease, the majority of people with CKD will die before reaching that stage [BMJ Best Practice, 2022].
  • As kidney function declines, complications develop. However, optimization of blood pressure control and reduction in proteinuria may slow the progression to ESRD [BMJ Best Practice, 2022].  
• In a UK retrospective longitudinal cohort study that assessed people with prevalent or incident CKD in 400 primary care practices in the General Practice Research Database (GPRD) in 2010, and at the date of their first classification of CKD, found that in people with CKD stages 3-5 at first classification, by 2010 the condition had [Jameson, 2014]:
  • Remained stable in approximately 50% of people. 
  • Progressed in 10-15% of people. 
  • Improved in 25-30% of people.
• A smaller UK 5-year prospective cohort study of 32 primary care practices of people with CKD stage 3 (n = 1741) found that at the end of the study period, disease outcomes were heterogenous [Shardlow, 2016]:
  • 14.2% of people had died from all causes, and 5.4% specifically from cardiovascular causes.
  • 0.2% of people had developed ESRD.
  • 17.7% of people had progressive disease.
  • 34.1% of people had stable disease.
  • 19.3% of people were in remission with no evidence of CKD.
  • Note: the study population was predominantly elderly (mean age 72.9 years) and Caucasian, so the results may not be directly applicable to the general population.
• ESRD.
  • People are at increased risk if they have accelerated progression of CKD.
  • Over a 5-year period, less than 2% of people with CKD will progress to need renal replacement therapy (dialysis or kidney transplantation) [Webster, 2017].
  • An Italian cohort study (n = 27,642) found the five-year relative survival of people with ESRD on long-term dialysis was 55% compared with age-matched controls in the general population. Older age, comorbid systemic disease and diabetes mellitus showed the strongest association with excess mortality [Nordio, 2012].
• All-cause mortality.
  • A US systematic review of 39 cohort studies or cohort analyses of non-dialysis patients with CKD (n = 1, 371, 990) found the unadjusted relative risk for mortality in people with CKD compared with those without ranged from 0.94 to 5.0 and was significantly more than 1.0 in 93% of cohorts. The absolute risk for death increased exponentially with declining renal function [Tonelli, 2006].
  • In a Swedish population-based cohort study of people with CKD stages 4–5 (n = 3040), the mortality hazard ratio was 3.6 compared with age- and sex-matched controls in the general population [Neovius, 2014].
  • People with CKD are 5–10 times more likely to die than to progress to ESRD. The mortality risk rises with CKD disease progression and is largely due to cardiovascular disease [Webster, 2017].
• Features associated with a poorer prognosis include [KDIGO, 2024]:
  • Decreasing eGFR.
  • Increasing proteinuria.

When should I suspect chronic kidney disease?

Suspect chronic kidney disease (CKD) and arrange investigations in people with:

• Risk factors for CKD.
• An incidental finding of:
  • Raised serum creatinine and/or a serum estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m². 
  • Proteinuria (a urinary albumin:creatinine ratio [ACR] of 3 mg/mmol or more). 
  • Persistent haematuria (two out of three urine dipstick tests show 1+ or more of blood), after exclusion of a urinary tract infection (UTI). See the CKS topics on Urinary tract infection (lower) - men and Urinary tract infection (lower) - women for more information.
  • Urine sediment abnormalities, such as red blood cells (may indicate glomerular disease); white blood cells (may indicate pyelonephritis or interstitial nephritis); or granular casts and renal tubular epithelial cells. 
• Possible clinical features of CKD. Be aware that the disease is often asymptomatic in the early stages.

How should I assess people with suspected chronic kidney disease?

If a diagnosis of chronic kidney disease (CKD) is suspected, assess the person for possible associated clinical features.

• Take a medical history and ask about:
  • Signs and symptoms, such as lethargy, itch, breathlessness, cramps (often worse at night), sleep disturbance, bone pain, poor appetite and weight loss, nausea and vomiting, and taste disturbance (often present with end-stage disease).
  • Urine output, such as polyuria (tubular concentrating ability is impaired), nocturia (due to impaired solute diuresis or oedema), or oliguria (urine output less than 0.5 ml/kg/hour). 
  • Medication history, including any potentially nephrotoxic drugs, and over-the-counter or herbal medicines. 
  • Known risk factors for CKD or previous history of acute kidney injury (AKI) — see the CKS topic on Acute kidney injury for more information. 
  • Associated comorbidities or complications of CKD. 
  • A family history of kidney disease, such as autosomal dominant polycystic kidney disease. 
  • Associated clinical features of anxiety or depression — see the CKS topics on Generalized anxiety disorder and Depression for more information.
• Examine for signs of progressive CKD, such as: 
  • Cachexia and signs of malnutrition. 
  • Cognitive impairment (language, orientation, and attention may be particularly affected). 
  • Dehydration or hypovolaemia (risk of AKI) — see the CKS topic on Acute kidney injury for more information.
  • Dyspnoea (may be due to fluid overload, anaemia, or comorbid ischaemic heart disease) — see the CKS topic on Angina for more information.
  • Frothy urine (may indicate proteinuria). 
  • Hypertension (may be primary or secondary to CKD itself). See the CKS topic on Hypertension for more information. 
  • Pallor (due to renal anaemia). 
  • Presence of a flank mass (suggesting possible renal cysts or malignancy). 
  • Palpable distended bladder (suggests obstructive uropathy). 
  • Peripheral oedema (may be due to renal sodium retention, hypoalbuminaemia, or comorbid heart failure) — see the CKS topic on Heart failure - chronic for more information.
  • Peripheral neuropathy (may present with paraesthesia, sleep disturbance, and restless legs syndrome) or myopathy — see the CKS topic on Restless legs syndrome for more information. 
  • Rashes — for example, ecchymosis and purpura (caused by haematological consequences of CKD), or signs of other systemic causes (for example, lupus erythematosus).   
  • Uraemic odour (ammonia-like smell of the breath, may be present in advanced disease). 
• Arrange investigations, as appropriate — see the section on Initial investigations for more information.
• Note: unexplained chronic renal impairment is an HIV indicator condition — for more information, see the CKS topic on HIV infection and AIDS. 

What initial investigations should I arrange?

If a diagnosis of chronic kidney disease (CKD) is suspected, arrange initial investigations in primary care.

• Arrange blood tests for serum creatinine and estimated glomerular filtration rate (eGFR), and advise the person not to eat meat for at least 12 hours before the test.
  • If the eGFR is less than 60 mL/min/1.73 m², repeat the test within 2 weeks to exclude causes of acute deterioration. 
  • If the eGFR remains less than 60 mL/min/1.73 m² on repeat, with no evidence of sudden deterioration in renal function suggesting acute kidney injury, repeat the eGFR within 3 months.
    • Interpret the eGFR result with caution if the person has extremes of muscle mass, is pregnant, has oedema, is malnourished or uses protein supplements, or is from an ethnic group (for example, black, Asian, or other minority ethnic groups) where its use has not been well validated.
    • Allow for biological and analytical variability of serum creatinine (plus or minus 5%) when interpreting changes in eGFR. 
  • See the CKS topic on Acute kidney injury for details on urgent management if there is a sudden deterioration in renal function at any time.
• Arrange an early morning urine sample to measure the urinary albumin:creatinine ratio (ACR). If the result is:
  • Between 3 and 70 mg/mmol — repeat the test in a subsequent early morning sample to confirm the results within 3 months.
  • 70 mg/mmol or more — a repeat test is not needed. See the section on Management in primary care for information on ongoing management.
    • If the ACR is 70 mg/mmol or more, protein:creatinine ratio (PCR) can be used as an alternative to ACR. 
• Do not use a urine dipstick to test for proteinuria unless it can measure albumin at low levels and expresses the result as an ACR. 
  • If unexplained proteinuria is an incidental finding on a reagent strip, offer testing for CKD using eGFR creatinine and ACR.
  • Note: transient increases in urine ACR may be seen with menstruation, urinary tract infection (UTI), strenuous exercise, and upright posture ('orthostatic proteinuria'). 
• Arrange a urine dipstick test to check for haematuria. 
  • If there is 1+ or more of blood on dipstick, arrange a mid-stream urine sample (MSU) to exclude a UTI, and manage accordingly.
    • See the CKS topics on Urinary tract infection (lower) - men and Urinary tract infection (lower) - women for more information.
  • If there is persistent non-visible haematuria (two out of three urine dipstick tests show 1+ or more of blood after exclusion of a UTI), with or without proteinuria, consider the possibility of urinary tract malignancy in appropriate age groups. For more information, see the CKS topic on Urological cancers - recognition and referral for more information on further management.
• Make a diagnosis of CKD after initial investigations if either of the following are present for a minimum of 3 months: 
  • Markers of kidney damage.
    • ACR is 3 mg/mmol or more.
    • There are urine sediment abnormalities.
    • Persistent haematuria.
    • Electrolyte and other abnormalities due to tubular disorders.
    • Abnormalities detected by histology.
    • Structural abnormalities are detected by imaging.
    • There is a history of kidney transplantation.
  • eGFR is less than 60 mL/min/1.73 m².
• Classify CKD to determine the severity and risk of disease progression — see the section on Classification of CKD for more information.
  • Be aware that a significant increase in serum creatinine, for example, by more than 20%, may indicate significant renal impairment in the presence of normal eGFR readings (eGFR greater than 90 mL min/1.73 m²). 
• Assess for cardiovascular risk factors —  measure body mass index (BMI), blood pressure, serum HbA1c, and lipid profile.  
• Consider checking the person's nutritional status. 
• Consider arranging a renal tract ultrasound if indicated, for example, if the person has symptoms of urinary tract obstruction or a family history of polycystic kidney disease and is aged over 20 years.
• Arrange for serum creatinine, eGFR, urinary ACR, and urine dipstick testing to be checked annually if the person has not been diagnosed with CKD but has ongoing risk factors for CKD.

Scenario: Management of chronic kidney disease

From age 18 years onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on primary care management of chronic kidney disease. 

Search dates

February 2019 - April 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 7th February 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 ( chronic kidney disease OR CKD or chronic renal insufficiency ) OR TI ( chronic kidney disease OR CKD or chronic renal insufficiency ) 
S1    (MH "Renal Insufficiency, Chronic+") 

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.