Changes

July 2026 — reviewed. A literature search was conducted in June 2026 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. Information on prescribing in pregnancy and breastfeeding has been updated and incorporated into the prescribing information section, the section on Factors affecting choice of laxatives has been incorporated into the Choice of laxatives section, and details on dietary recommendations have been updated and aligned with the British Dietetic Association Guidelines for the dietary management of chronic constipation in adults.

Update

Goals

To support primary healthcare professionals to:

• Identify and manage any secondary causes of constipation.
• Diagnose faecal loading and impaction when appropriate.
• Manage constipation in primary care appropriately.
• Advise on self-management strategies and options for drug treatment of constipation.
• Arrange referral to a specialist if needed.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

QOF indicators

QIPP - Options for local implementation

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

NICE quality standards

What is it?

• Constipation is a heterogeneous, symptom-based disorder. Patients describe defecation that is problematic because of infrequent and/or hard stools, difficulty passing stools (often involving straining), or the sensation of incomplete emptying or anorectal blockage.
  • The Rome IV diagnostic criteria for constipation include spontaneous bowel movements occurring fewer than three times a week. 
  • Stools are often dry, hard, or lumpy, and may be abnormally large or small.
  • In practice constipation is often defined as passage of stools less frequently than the person's normal pattern.
• Chronic constipation usually describes symptoms which are present for at least 3 months. 
• Faecal loading/impaction describes retention of faeces to the extent that spontaneous evacuation is unlikely.
  • Overflow faecal incontinence (previously known as 'encopresis' or 'bypass soiling') is leakage of liquid stool from the proximal colon around impacted faeces, where small quantities of stool may be passed frequently and without sensation. 
• Functional (primary or idiopathic) constipation is chronic constipation without a known cause. Using symptom-based criteria, an international panel of experts classified this group into:
  • Dyssynergistic defecation: paradoxical contraction or inadequate relaxation of pelvic floor muscles during defecation. 
  • Slow transit — prolonged delay in passage of stool through the colon and/or poor propulsion during defecation. 
  • Irritable bowel syndrome-constipation (IBS-C). 
• Secondary (organic) constipation is constipation caused by medication or an underlying medical condition, including endocrine, metabolic, neurological or primary diseases of the colon, for example, stricture, malignancy, or proctitis.

    [Lacy, 2016; Serra, 2017; Corsetti, 2020; Serra, 2020]

How common is it?

Constipation is a common problem which can occur at any age. The reported prevalence rates vary due to differences in study populations and the definition used for constipation.

• Constipation has a global prevalence of 10–15% [Alavi, 2024; Dimidi, 2025]. 
• A UK primary care cohort study found the prevalence of GP-diagnosed constipation was 12.8 per 1000 people [Shafe, 2011].
• A systematic review and meta-analysis of pooled, population-based cross-sectional studies found the global prevalence of constipation to vary according to which Rome criteria were used [Barberio, 2021].
  • Prevalence was 15.3% with Rome I criteria, 11.2% with Rome II, 10.4% with Rome III and 10.1% with Rome IV criteria.
  • The incidence of constipation is around two times higher in women than in men, irrespective of the criteria used.
• There may be a higher prevalence in older age groups; however, data are conflicting [Werth, 2021].
• Constipation is more common during pregnancy than in the general population, affecting about 30% of women — it is thought to be multifactorial, with progesterone-induced intestinal smooth muscle relaxation playing a major role [UKTIS, 2026].

Note: the prevalence of constipation may be underestimated in studies due to the high proportion of people self-treating rather than consulting healthcare professionals [Tack, 2011].

What are the risk factors?

• Potential risk factors for developing constipation include:
  • Female sex. 
  • A family history of constipation. 
  • Low levels of physical activity.
  • Health-related factors.
    • Self-rated health — fair or poor self-rated health was significantly associated with an increased prevalence of chronic constipation in two European studies.
    • Recent surgery — this may be associated with medications including general anaesthetics and opioid analgesics as well as being sedentary following surgery. 
    • Certain medical conditions — for example, gastrointestinal disorders, depression and anxiety, neurological diseases, and diabetes. 
    • Certain medications — constipation is an adverse effect of many drug classes.
• The available evidence for most other factors is either conflicting or insufficient, including:
  • Low levels of fibre or fluid intake.
  • Older age — there is no clear association with older age and constipation. 
  • Lower socioeconomic status. 

 [Serra, 2017; Serra, 2020; Werth, 2021; Alavi, 2024]

What are the secondary causes?

Possible secondary causes of constipation include:

• Medications 
  • Aluminium-containing antacids and iron or calcium supplements. 
  • Analgesics, such as opiates and nonsteroidal anti-inflammatory drugs (NSAIDs). 
  • Anticholinergics, such as procyclidine and oxybutynin. 
  • Antidepressants, such as tricyclic antidepressants. 
  • Antipsychotics, such as amisulpride, clozapine, or quetiapine. 
  • Antiepileptic drugs, such as carbamazepine, gabapentin, oxcarbazepine, pregabalin, or phenytoin. 
  • Antihistamines, such as hydroxyzine. 
  • Antispasmodics, such as dicycloverine or hyoscine. 
  • Calcium-channel blockers, such as verapamil. 
  • Diuretics, such as furosemide. 
• Endocrine and metabolic diseases:
  • Diabetes mellitus (with autonomic neuropathy). See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for more information.
  • Hypercalcaemia and hyperparathyroidism. See the CKS topic on Hypercalcaemia for more information.
  • Hypermagnesaemia.
  • Hypokalaemia.
  • Hypothyroidism. See the CKS topic on Hypothyroidism for more information.
  • Uraemia.
• Myopathic conditions 
  • Amyloidosis.
  • Myotonic dystrophy.
  • Scleroderma.
• Neurological conditions 
  • Autonomic neuropathy.
  • Cerebrovascular disease. See the CKS topic on Stroke and TIA for more information.
  • Hirschsprung's disease. See the CKS topic on Constipation in children for more information.
  • Multiple sclerosis. See the CKS topic on Multiple sclerosis for more information.
  • Parkinson's disease. See the CKS topic on Parkinson's disease for more information.
  • Spinal cord injury, disease.
• Structural abnormalities
  • Anal fissures, strictures, haemorrhoids. See the CKS topics on Anal fissure and Haemorrhoids for more information.
  • Colonic strictures (for example following diverticulitis, ischaemia, or surgery). See the CKS topic on Diverticular disease for more information.
  • Inflammatory bowel disease. See the CKS topics on Crohn's disease and Ulcerative colitis for more information.
  • Obstructive colonic mass lesions (for example due to colorectal cancer). See the CKS topic on Gastrointestinal tract (lower) cancers - recognition and referral for more information.
  • Rectal prolapse or rectocele.
  • Postnatal damage to pelvic floor or third degree tear.
• Other causes 
  • Irritable bowel syndrome. See the CKS topic on Irritable bowel syndrome for more information.
  • Slow transit constipation. 
  • Pelvic or anal dyssynergia. 

[Roque, 2015; Wald, 2016; Serra, 2017; Serra, 2020; Alavi, 2024]

What are the complications?

• Complications of chronic constipation include:
  • Faecal loading and impaction. 
  • Progressive faecal retention, distension of the rectum, and loss of sensory and motor function.
  • Haemorrhoids or anal fissure.
• Complications of chronic faecal loading and impaction include:
  • Faecal incontinence, which can be embarrassing and distressing. 
  • Chronic dilatation of the colon may cause megacolon. 
  • Bowel obstruction, perforation, or ulceration.
  • Recurrent urinary tract infections, enuresis and urinary incontinence. 
  • Rectal bleeding.
  • Rectal prolapse. 

[Serra, 2017]

What is the prognosis?

• The prognosis of chronic constipation is variable and depends on the underlying cause. 
• Patients often require weeks or years of lifestyle changes and laxative treatment.
  • A 2017 prospective cohort study (n = 878 patients attending clinic) found 48.5% of people had chronic constipation for more than 10 years [Bellini, 2017]. 
  • In the same study, people with IBS-C reported more severe symptoms than other constipation types. 
• Constipation is not normally life-threatening but does affect quality of life.
  • Older people are at risk of psychological and social distress. 
• Faecal impaction may require emergency admission. There is an associated social and economic burden; in England between April 2013 and 2014 there were 63,427 patients admitted with constipation, and this accounted for 159,997 bed days [Emmanuel, 2017].

[Emmanuel, 2017; Nelson, 2017; Serra, 2020; Dimidi, 2025]

When should I suspect constipation?

• Suspect a diagnosis of constipation if an adult presents with defecation which is problematic because of infrequent stools, difficulty passing stools, or a sensation of incomplete emptying or anorectal blockage. 
  • Typically, bowel movements occurring less than three times a week may be regarded as constipation. 
  • There may be daily bowel movements but associated symptoms such as excessive straining. 
  • Additional symptoms may include lower abdominal pain or discomfort, distension, or bloating. 
  • In practice, constipation is often defined as passage of stools less frequently than the person's normal pattern. 
• Consider a diagnosis of constipation in the elderly if there are non-specific symptoms, such as:
  • Confusion or delirium, functional decline.
  • Anorexia. 
  • Overflow diarrhoea. 
  • Urinary retention. 
• Suspect a diagnosis of faecal loading or impaction if there is a history of:
  • Hard, lumpy stools, which may be large and infrequent, or small and relatively frequent. 
  • Having to use manual methods to extract faeces. 
  • Overflow faecal incontinence, or loose stool. 

How should I assess an adult with constipation?

• If a diagnosis of constipation is suspected, take a history and ask about:
  • Any red flag symptoms or signs that may suggest a serious underlying cause, such as colorectal cancer. These include a sudden change in bowel habit, rectal bleeding or bloody stools, weight loss, abdominal pain or iron deficiency anaemia. See the CKS topic on Gastrointestinal tract (lower) cancers - recognition and referral for more information. 
  • What the person means by 'constipation' and their normal pattern of defecation. 
    • The person's perception of a normal bowel habit may influence the diagnosis of constipation.
  • The onset and duration of constipation, and the frequency and consistency of stools, such as hard/small (pebble-like) or large stools (for example, do they block the toilet); any nocturnal symptoms.
    • Consider the use of the Bristol Stool Chart to provide an objective record of the person's stool form. 
  • Associated symptoms such as rectal discomfort, excessive straining, feeling of incomplete evacuation or blockage, or rectal bleeding; abdominal pain or distension, or anal pain during defecation. 
    • Note: pelvic floor dyssynergia may be suggested by straining and a feeling of incomplete evacuation.
  • Associated nausea, vomiting, loss of appetite and/or weight. 
  • Associated urinary symptoms, urinary incontinence or retention, dyspareunia. 
  • Any family history of colorectal cancer or inflammatory bowel disease. 
  • How symptoms affect the person and impact on quality of life and daily functioning. 
  • Any self-help measures or drug treatments tried, including over-the-counter medication, and symptom response. 
• To assess for any risk factors, ask about:
  • The person's diet, including fibre and fluid intake; normal routine or lifestyle; level of activity and mobility. 
  • The person's toileting habits, for example feeling hurried or being disturbed when trying to defecate; withholding or ignoring the urge to defecate; access to the toilet at home or work, and level of privacy.
  • Any associated psychological or mental health conditions, such as anxiety, depression, cognitive impairment, or an eating disorder. 
  • Any drug treatment or clinical features of an underlying organic cause of secondary constipation, and manage appropriately.
• To assess for faecal loading and/or impaction, ask about:
  • A history of faecal incontinence, for example, is underwear regularly soiled, excessive wiping, or loose stools.
  • Whether the person has needed to use manual measures to relieve constipation.
• Examine the person:
  • Assess for signs of weight loss and general nutritional status.
  • Perform an abdominal examination to check for abdominal pain, distension, masses, or a palpable colon (suggesting retained faecal masses).
  • Perform a digital rectal examination, checking for:
    • Anal fissures, haemorrhoids, skin tags, rectal prolapse, rectocele, skin erythema or excoriation (this may be a sign of faecal leakage).
    • Resting anal sphincter tone; rectal mass lesions and retained faecal masses.
    • Pelvic floor dysfunction (if appropriate) — while asking the person to 'bear down', there may be paradoxical contraction of the anal sphincter on straining. 
    • Leakage of stool; rectal or anal pain. 

Be aware that no investigations are usually required in an adult with functional constipation where there is no suspected underlying cause.

Scenario: Constipation in adults

From age 18 years onwards.

Choice of laxatives

The aim of laxatives is to increase stool frequency or ease of stool passage by increasing stool water content (directly by osmotic or intestinal secretory mechanisms) or by accelerating bowel transit.

• Bulk-forming laxatives (containing soluble fibre) act by retaining fluid within the stool and increasing faecal mass, stimulating peristalsis and also have stool-softening properties. 
  • Examples include:  
    • Ispaghula husk. 
    • Sterculia. 
  • Onset of action up to 72 hours. 
  • They must not be taken immediately before going to sleep, as impaired or reduced gastric motility may impair the intestinal passage and then cause sub-obstruction. Adequate fluid intake is important to prevent intestinal obstruction. Ispaghula and sterculia are not recommended for people taking medicines that reduce peristaltic movement (for example, opioids).
• Osmotic laxatives act by increasing the amount of fluid in the large bowel, increasing stool volume, which leads to stimulation of peristalsis. Lactulose and macrogols also have stool-softening properties. 
  • Examples include:
    • Lactulose. 
    • Macrogols (polyethylene glycols). 
    • Magnesium hydroxide.
    • Phosphate and sodium citrate enemas.
  • Onset of action for lactulose and macrogols is 2–3 days.
  • Adequate fluid intake recommended.
  • Lactulose is very sweet and some people may find it unpalatable.
• Stimulant laxatives cause peristalsis by stimulating colonic nerves (senna) or colonic and rectal nerves (bisacodyl, sodium picosulfate). 
  • Examples include:
    • Senna — hydrolyzed to the active metabolite by bacterial enzymes in the large bowel. Onset of action 8–12 hours. 
    • Bisacodyl and sodium picosulfate — hydrolyzed to the same active metabolite. Bisacodyl is hydrolyzed by intestinal enzymes; sodium picosulfate relies on colonic bacteria. Onset of action 10–12 hours. 
    • Docusate — a surface-wetting agent which reduces the surface tension of the stool, allowing water to penetrate and soften it. It also has a stimulant effect. Onset of action 1–2 days.
  • Stimulants are usually taken in the evening to produce a bowel movement the following morning. Licensed only for short-term use. 
• Prokinetic laxatives 
  • Prucalopride — a selective serotonin (5-HT4) receptor agonist, which stimulates intestinal motility. 
  • May be considered for people in whom treatment with other laxatives has failed to produce an adequate response. Should only be prescribed by clinicians experienced in treating chronic constipation. Licensed for use in women and men.
• Peripheral opioid-receptor antagonists (such as naldemedine) — antagonize opioid actions at specific gastrointestinal opioid receptors without impairing central analgesic effects. 
• Guanylate cyclase-C receptor agonists (such as linaclotide) — this causes secretion of chloride and bicarbonate into the intestinal lumen, which results in increased intestinal fluid and accelerated transit.  
  • This is an option for people with IBS only if optimal or maximum tolerated doses of previous laxatives from different classes have not helped and the person has had constipation for at least 12 months. 
• Rectal laxatives
  • Glycerol suppositories (lubricating and weak stimulant) — onset of action is at least 15 minutes. Suppositories should be moistened before use to aid insertion. 
  • Bisacodyl suppositories (stimulant) — onset of action 10–30 minutes. 
  • Sodium phosphate and sodium bicarbonate suppositories — onset of action 15–30 minutes. 
  • Docusate sodium enema (softener and weak stimulant) — onset of action 20 minutes. 
  • Sodium citrate enema (osmotic) — onset of action 5–15 minutes.  
  • Phosphate enema (osmotic) — onset of action 2–5 minutes. 
  • Arachis oil enema (softener) — Retention enema. Should be warmed before use. 

[NICE, 2014; EMC, 2015; EMC, 2021; EMC, 2022b; EMC, 2022a; EMC, 2024; EMC, 2025b; EMC, 2025c; NICE, 2025; BNF, 2026; EMC, 2025d; EMC, 2026b; EMC, 2026c; EMC, 2026d; EMC, 2026a]

Contraindications and cautions

Do not prescribe laxatives to people with:

• Intestinal obstruction or perforation.
• Paralytic ileus.
• Colonic atony or faecal impaction (bulk-forming laxatives).
• Crohn's disease or ulcerative colitis. 
• Toxic megacolon.
• Severe dehydration (bisacodyl, phosphate enemas).
• Renal impairment (phosphate enemas).
• Galactosaemia (lactulose).
• A history of hypersensitivity to peanuts (arachis oil enema).
• Undiagnosed abdominal pain. 
• Undiagnosed rectal bleeding.
• A sudden change in bowel habit that has persisted more than 2 weeks.

Prescribe laxatives with caution to people with:

• A history of prolonged use — due to the risk of electrolyte imbalance, such as hypokalaemia. There is a risk of overuse or misuse (for example, in eating disorders). In addition, elderly people may inappropriately overuse them due to misconceptions about constipation. Long-term overuse could mask more serious underlying conditions [MHRA, 2020].
• Cardiovascular disease (macrogols) — for treatment of faecal impaction, the dose should be divided so that no more than two sachets of full-strength macrogol compound oral powder are taken in any one hour.
• Lactose intolerance (lactulose).
• Ischaemic heart disease or arrhythmias (prucalopride). 

Note: sodium citrate enemas should be used with caution in the elderly or people at risk of sodium and water retention.

Note: macrogol products are considered high in sodium, this should be taken into account for those people on a low salt diet. The absorption of other medicines could be transiently reduced in people taking macrogol products — other medicines should not be taken orally for one hour before, during and for one hour after taking macrogol.  

[EMC, 2021; EMC, 2022b; EMC, 2022a; EMC, 2024; EMC, 2025b; EMC, 2025c; BNF, 2026; EMC, 2025d; EMC, 2026b; EMC, 2026c; EMC, 2026d; EMC, 2026a] 

Adverse effects of laxatives

Adverse effects of laxatives are generally mild and infrequent, and include:

• Bulk-forming laxatives — abdominal distension, flatulence and bloating, and intestinal obstruction (adequate fluid intake should be maintained to avoid obstruction). 
• Osmotic laxatives — abdominal pain, abdominal distension, flatulence, nausea and vomiting, electrolyte disturbances (particularly hypokalaemia and hypokalaemia), and dehydration. 
  • There is a potential interactive effect if polyethylene glycol laxatives are mixed with starch-based food thickeners. The thickening effect may be counteracted, resulting in a thin watery liquid that, when swallowed, increases the risk of potentially fatal aspiration in people with dysphagia. Avoid directly mixing, especially for people with dysphagia.
  • If symptoms of fluid and electrolyte disturbance occur (for example, oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) in people taking macrogol, advise the person to discontinue treatment.
• Stimulant laxatives — gastrointestinal discomfort, diarrhoea, electrolyte imbalance, and albuminuria. Senna may cause yellowish-brown discolouration of the urine.
• Prucalopride — headache, nausea, vomiting, diarrhoea, abdominal pain, flatulence, fatigue, and dizziness.
• Peripheral opioid-receptor antagonists (for example, naldemedine) — abdominal pain, nausea, diarrhoea, and vomiting. Cases of gastrointestinal perforation have been reported, but the frequency is unknown. 
• Phosphate enemas — risk of rectal gangrene in people who are systemically unwell with a history of haemorrhoids.

Note: excessive doses of laxatives may cause diarrhoea, which if prolonged, may cause electrolyte disturbances such as hypokalaemia. 

[EMC, 2021; EMC, 2022b; EMC, 2022a; EMC, 2024; EMC, 2025b; EMC, 2025c; BNF, 2026; EMC, 2025d; EMC, 2026b; EMC, 2026c; EMC, 2026d; EMC, 2026a]

Pregnancy and breastfeeding

Pregnancy

• The UKTIS monograph notes that there is very little epidemiological information on the potential risks associated with laxative use in pregnancy, however most laxatives have minimal systemic absorption and are commonly used during pregnancy. If needed, they should only be used for short time periods, as they may induce electrolyte imbalance during pregnancy [UKTIS, 2026].
  • Bulk-forming laxatives — no adverse fetal effects have been reported.
  • Lactulose or osmotic laxatives — there are limited data on the use of in pregnancy, but manufacturers advise that may be used if considered necessary.
  • Bisacodyl, sodium picosulfate, linaclotide, prucalopride, glycerine suppositories, or enemas — there are no published data on the use of these in pregnancy.
  • Docusate sodium and senna — the limited available data on use in pregnancy suggest no increase risk of congenital malformations, but are insufficient to conclusively state there is no increase in risk, and there are no studies investigating other pregnancy outcomes. The manufacturer advises that use of senna in pregnancy is contraindicated [EMC, 2026a]. 
• If there is uncertainty about the use or safety of laxatives during pregnancy, contact the UKTIS: 
  • To discuss with a teratology specialist, telephone 0344 892 0909.
  • For information on the safety of specific laxatives, see the website at www.uktis.org.

Breastfeeding

• Any laxative can be used during breastfeeding as most are either not absorbed, or are minimally absorbed, from the gastrointestinal tract leading to low or negligible levels in breast milk [SPS, 2023]. However:
  
  • Senna — the manufacturer advises that this is contraindicated in breastfeeding [EMC, 2026a]. 
  • Prucalopride — this can be used with caution as it is excreted in breast milk in small levels [SPS, 2023], although the manufacturer advises that it should be avoided [BNF, 2026].
• If there is uncertainty about the use or safety of laxatives during breastfeeding, contact the UK Drugs in Lactation Advisory Service (UKDILAS) provided by the UK Medicines Information Network:
  • To discuss with a specialist pharmacist, telephone 0116 258 6491.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of constipation.

Search dates

December 2021 - July 2026

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• exp Constipation/, constipat$.tw., exp Fecal Impaction/, ((fecal or faecal) adj impact$).tw., ((fecal or faecal) adj load$).tw., ((difficult$ or delay$ or irregular$ or infrequent or pain$) adj (defecat$ or stool$ or faec$ or fec$)).tw,ab,ti.,(bowel adj movement).tw.

• exp Opiod-Induced Constipation/ , (overflow faecal incontinence).ti,ab., (encopresis or bypass soiling).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
• 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.