Changes

September 2024 — reviewed. A literature search was conducted in August - September 2024 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The diagnostic criteria for premenstrual dysphoric disorder have been added. There have been no major changes to the recommendations; minor changes and detail have been added in line with recent Cochrane reviews and the 2023 American College of Obstetricians and Gynecologists guideline. The management section structure has been moved away from tiers of severity and towards individual tailored management focusing on individual symptoms and goals based on shared decision making.

Update

Goals

To support primary healthcare professionals to:

• Make an accurate diagnosis of premenstrual syndrome (PMS).
• Provide appropriate advice to women with PMS.
• Offer treatment options that are appropriate for initiation in primary care.
• Refer the woman to secondary care when primary care treatment is not adequate.

Outcome measures

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?

• Premenstrual syndrome (PMS) is a condition characterized by cyclical and repetitive psychological, physical, and behavioural symptoms occurring in the luteal phase of the normal menstrual cycle (that is, the time between ovulation and onset of menstruation) [Hofmeister, 2016; Ismaili, 2016; RCOG, 2016; BMJ Best Practice, 2024].
  • There are over 150 different psychological, physical, and behavioural symptoms that may be associated with PMS [Ismaili, 2016]:
    • Psychological symptoms include depression, anxiety, irritability, loss of confidence, and mood swings.
    • Physical symptoms include bloating and breast pain.
    • Behavioural symptoms include reduced cognitive ability and aggression.
  • A diagnosis of PMS is supported by the timing (rather than the types) of symptoms and the degree of impact on daily activity. 
• Women who experience minor, transient premenstrual symptoms that do not cause impairment of activities of daily living or affect quality of life are said to be experiencing physiological premenstrual symptoms rather than premenstrual syndrome (PMS) [RCOG, 2016; BMJ Best Practice, 2024].
  • Premenstrual symptoms (such as abdominal bloating [most common], breast tenderness, headache, or minor mood changes) are experienced by up to 90% of women of reproductive age, with around 20–30% experiencing symptoms impactful enough to meet the criteria for PMS [ACOG, 2023; BMJ Best Practice, 2024].
  • To differentiate PMS from physiological premenstrual symptoms, it must be demonstrated that symptoms cause significant personal, interpersonal, and/or functional impairment to the woman during the luteal phase of the menstrual cycle [RCOG, 2016; WHO, 2024]. 
• PMS can be classified into core premenstrual disorders (PMDs) and variant PMDs [Ismaili, 2016; RCOG, 2016]:
  • Core PMDs are the most commonly encountered and widely recognized type of PMS. 
    • As with all PMDs, the symptoms experienced must be severe enough to affect daily functioning or interfere with the woman's work, school, performance, or interpersonal relationships.
    • Symptoms are nonspecific and recur in ovulatory cycles. They must be present during the luteal phase and abate as menstruation begins or soon after, which is then followed by a symptom-free week.
    • There is no limit on the type or number of symptoms experienced, but some women will have predominantly psychological, predominantly somatic (physical), or a mixture of symptoms.
  • Variant PMDs are PMDs that do not meet the criteria for core PMDs. They fall into four subtypes:
    • Premenstrual exacerbation of an underlying disorder — symptoms of an underlying disorder (such as diabetes, depression, epilepsy, asthma, and migraine) significantly worsen premenstrually.
    • Non-ovulatory PMDs — symptoms result (rarely) from ovarian activity other than ovulation. This condition is poorly understood due to lack of evidence, but it is thought that follicular activity of the ovary can cause symptoms.
    • Progestogen-induced PMD — symptoms result from exogenous progesterone administration, for example, hormone replacement therapy (HRT) or the combined oral contraceptive (COC) pill. Progestogen-only contraceptives may also cause symptoms but because they are noncyclical, these symptoms are not included within variant PMDs and are considered adverse effects (probably with similar mechanisms) of continuous progestogen therapy.
    • PMDs with absent menstruation — symptoms arise from continued ovarian activity even though menstruation has been suppressed, for example, after a hysterectomy or endometrial ablation, or in women using the levonorgestrel-releasing intrauterine system (LNG-IUS). 
• Premenstrual dysphoric disorder (PMDD) is a severe form of PMS [APA, 2022; BMJ Best Practice, 2024; WHO, 2024]. For more information, see the section on Diagnostic criteria for premenstrual dysphoric disorder.

What causes it?

• The ovarian hormone cycle appears to be a prerequisite for premenstrual syndrome (PMS), supported by the absence of PMS prior to puberty, during pregnancy, and after menopause. However, the exact cause is uncertain.
• It seems that some women are more sensitive to the normal cyclical changes in oestrogen and progesterones, since the serum concentrations of oestrogen or progesterone are the same in women with or without PMS. It is unknown why this is, but it is likely to be multifactorial. Theories include possible mechanisms such as:
  • Interaction of changing hormone levels with central neurotransmitters.
    • The changing hormone levels may impact the serotonin system - supported by the efficacy of selective serotonin reupdate inhibitors (SSRIs), the role of serotonin in other mood disorders, and the exacerbation of premenstrual symptoms caused by depletion of tryptophan, the main precursor of serotonin.
    • The effects of progesterone and its metabolite, allopregnanolone, on the GABAergic system. In people with PMS, there may be an increased sensitivity to changes in allopregnanolone, which acts as an agonist of the GABA-A receptor to enhance the neurotransmitter's calming effect on mood. SSRIs may also alter allopregnanolone levels. 
  • Genetic susceptibility - certain genetic variations may predispose to the more severe syndrome of premenstrual dysphoric disorder (PMMD), and some studies show a higher likelihood of developing PMS for women whose mother or twin has the condition.
  • There may be an exaggerated immune-inflammatory response.
  • Stress seems to have a role through amplifying sympathetic activity.

[Hofmeister, 2016; Tiranini, 2022; ACOG, 2023; Gudipally, 2023; Modzelewski, 2024]

How common is it?

• Prevalence estimates of premenstrual syndrome (PMS) vary widely depending on the diagnostic criteria and methods used to identify and classify cases [Tiranini, 2022; BMJ Best Practice, 2024]:
  • Up to 90% of women of reproductive age report experiencing at least one premenstrual symptom, but a lower percentage fit the criteria for PMS, which is variable in different studies [ACOG, 2023].
  • A meta-analysis published in 2014 found that globally, the pooled prevalence of PMS was 47.8% [Direkvand-Moghadam, 2014].
  • A study of PMS diagnoses in UK primary care between 1995 and 2013 published in 2016 found there was a significant decrease over this period of time, although rates were unlikely to reflect true incidence or true decline as it depended on GPs recording a specific PMS diagnosis. Incidence rates dropped from 8.3 per 1000 person-years to 1.72 per 1000 person-years over this time period [Sammon, 2016].
  • Although premenstrual symptoms and PMS are believed to be very common, studies suggest around 29–53% of women with clinically significant symptoms seek medical help [Sammon, 2016].
  • A meta-analysis published in 2024 found the point prevalence of the more severe disorder premenstrual dysphoric disorder (PMDD) globally to be 1.6% [Reilly, 2024]. This figure represented a confirmed diagnosis using DSM-5 criteria. 3.2% had a provisional diagnosis.
• The complexity of the condition, with its widespread spectrum of symptoms, and being in both gynaecological and psychiatric groups of disorders in ICD-11, hampers accurate diagnostic recording and prevalence estimates [Modzelewski, 2024].

What are the risk factors?

• The strongest risk factor for premenstrual syndrome (PMS) is the presence of ovulatory menstrual cycles. This is supported by the absence of PMS prior to puberty, during pregnancy, and after menopause [RCOG, 2016; BMJ Best Practice, 2024]. 
• Other possible risk factors include [BMJ Best Practice, 2024]:
  • Family history of PMS — monozygotic twin studies suggest a possible genetic component to PMS; however, no genes have been identified [Hofmeister, 2016].
  • Mood disorders — PMS or premenstrual dysphoric disorder (PMDD) may be a precursor to major depression, or follow a diagnosis of depression.
  • Cigarette smoking.
  • Ethnicity. In the USA, PMS and PMDD are more prevalent in white women than black women but people of colour are under-represented in these studies, so whether this is a true finding is unclear.
  • Alcohol intake. Alcohol consumption is associated with an increased risk, and heavy drinking is associated with a higher risk, although further studies are needed to determine whether there is a threshold of alcohol intake under which the harmful effect on PMS is non-existent [Fernández, 2018]. 
  • Sexual abuse and/or trauma.
  • Weight gain [Hofmeister, 2016].
  • Stress [Hofmeister, 2016].

What is the prognosis?

• There are no reports documenting spontaneous remission of premenstrual syndrome (PMS) symptoms before menopause.
• Women with PMS tend to be affected throughout their reproductive lives, although symptoms remit during pregnancy.
• In most women, PMS symptoms can usually be managed with lifestyle modification with or without pharmacological treatment. In women with severe PMS symptoms, surgery (hysterectomy and bilateral salpingo-oophorectomy) may be considered under certain circumstances in secondary care.
• There is some evidence that women with PMS or premenstrual dysphoric disorder (PMDD) are at an increased risk of postnatal depression and suicidal behaviours.

[RCOG, 2016; BMJ Best Practice, 2024]

How should I diagnose premenstrual syndrome?

• Take a history. Ask about:
  • The types of symptoms experienced, including:
    • Psychological symptoms, such as mood swings, irritability, depressed mood, anxiety, feeling out of control, poor concentration, change in libido, and food cravings.
    • Physical symptoms, such as breast tenderness, bloating, headaches, backache, weight gain, acne, and gastrointestinal disturbance.
    • Behavioural symptoms, such as reduced visio-spatial and cognitive ability, aggression, and an increase in accidents.
  • The timing of symptoms in relation to the menstrual cycle. If appropriate, also ask about the presence of symptoms before, during, and after pregnancy.
  • The severity of the symptoms and the degree of impact on daily activity. In particular, ask about the effect of symptoms on the woman's work, school, family life, and interpersonal relationships, and screen for any suicidal thoughts.
  • The woman's medication history, including:
    • Any previous treatment tried and whether symptoms improved with the treatment.
    • Other current medications, including contraceptives.
  • The woman's medical history. In particular, ask about:
    • Any underlying chronic illness (such as diabetes, depression, epilepsy, asthma, and migraine) and whether symptoms of the illness significantly worsen premenstrually.
    • A history of mood disorders.
    • Any surgical procedures (such as a hysterectomy or endometrial ablation).
  • Other possible risk factors for premenstrual syndrome (PMS), including smoking and alcohol use.
• Perform a physical examination as indicated by the woman's age and routine gynaecological and medical recommendations. 
  • If the woman has pelvic pain or abdominal swelling, perform a full physical examination, including an abdominal and pelvic examination, to rule out any other underlying cause of their symptoms.
• Ask the woman to record a daily symptom diary for two or three cycles, and review the woman with the diary. 
  • The Daily Record of Severity of Problems (DRSP) is a validated questionnaire that is widely used for tracking symptoms related to PMS. Other questionnaires are available, such as the one from the National Association for Premenstrual Syndromes (NAPS).
  • Alternatively, patients can keep a simple diary including the dates of their periods and a daily record of symptoms and severity, assigning a simple 1–5 score.
• Diagnose PMS if the symptom diary shows prominence of symptoms during the luteal phase of the menstrual cycle, which resolve with the onset of menses or soon after, followed by a symptom-free week.
  • Symptoms should be severe enough to affect daily functioning or interfere with the woman's work, school, performance, or interpersonal relationships. 
  • For the diagnosis of core premenstrual disorders (PMDs), the most commonly encountered and widely recognized type of PMS, no other underlying disorder should be present.
  • Consider a diagnosis of premenstrual dysphoric disorder (PMDD) if symptoms are severe, if there are several symptoms involved, and symptoms interfere with the person's ability to function when present. For more information, see the section on diagnostic criteria for premenstrual dysphoric disorder.
• If cyclical symptoms are not found, exclude other conditions that could explain the symptoms, such as depression, hypothyroidism, anaemia, irritable bowel syndrome, and endometriosis.
• If the completed symptom diary alone is inconclusive, refer the woman to secondary care. 
  • Symptom diaries can sometimes be confusing and/or inconclusive, especially in women with variant PMDs.
  • Gonadotrophin-releasing hormone (GnRH) agonists are widely used by gynaecologists to establish a definitive diagnosis of PMS by inhibiting cyclical ovarian function. They are used for 3 months (a month for the agonist to generate a complete hormonal suppressive effect plus 2 months’ worth of symptom diaries). Resolution of symptoms after ovarian suppression is considered diagnostic for PMS.

When should I suspect premenstrual dysphoric disorder?

Diagnostic criteria for premenstrual dysphoric disorder (PMDD) differ very slightly between the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the International Classification of Diseases 11th Revision (ICD -11). Definitions are broadly the same, differing mainly in the specifics of the number of symptoms required (not specified by ICD-11), the examples of symptoms described, and the categorization of the condition.

• It is defined in DSM-5 as a mental health illness within the depressive disorders category. Specifically, for a DSM-5 diagnosis of PMDD:
  • The woman must have a minimum of five of the eleven listed symptoms, with a minimum of one being related to mood, during most menstrual cycles over the last year. The symptoms must be present in the final week before menstruation and start to improve within a few days of its onset, and be minimal or absent in the week after.
  • At least one of the following symptoms must be present:
    • Marked mood lability/mood swings.
    • Marked depressed mood, feelings of hopelessness or self-deprecating thoughts.
    • Marked irritability or anger or increased interpersonal conflicts.
    • Marked anxiety or tension.
  • Additionally there must be further symptoms, reaching a total of five between the two lists:
    • Reduced interest in usual activities.
    • Difficulty concentrating.
    • Lethargy, easily tired, or lack of energy.
    • Marked changes in appetite.
    • Sleep changes (hypersomnia or insomnia).
    • A sense of feeling overwhelmed or out of control.
    • Physical symptoms, such as breast tenderness or swelling, joint or muscle pain, bloating, or weight gain.
  • These symptoms must cause significant distress or interference with usual activities or relationships.
  • The symptoms do not represent an exacerbation of another mental health disorder, and cannot be attributable to a substance or another medical condition.
  • There should be confirmation by using a symptom diary for at least two cycles.
• In ICD-11, PMDD is included within both genitourinary disorders and depressive disorders categories, and is similarly defined by a pattern of mood, cognitive or somatic symptoms:
  • Symptoms must begin several days before the onset of menstruation, start to improve within a few days of its onset, and then become minimal or absent within around a week of menstruation starting. These symptoms should be present during a majority of menstrual cycles within the past year.
  • Symptoms must include at least one affective symptom, such as depressed mood, labile mood, irritability or anxiety, and additional cognitive or somatic symptoms such as lethargy, joint pain, overeating, hypersomnia, breast tenderness, swelling of extremities, difficulty concentrating or forgetfulness.
  • Symptoms must be severe enough to cause significant distress or functional impairment.
  • Symptoms do not represent the exacerbation of another mental health condition or be better accounted for by another mental health condition.
  • Symptoms are not attributable to another medical condition or the effects of a substance or medication.
  • The cyclical nature of symptoms should be ideally confirmed by a symptom diary over at least two cycles.

What else might it be?

• As there are over 150 different possible symptoms associated with premenstrual syndrome (PMS), the range of differential diagnosis is vast.
• The following conditions may present with similar symptoms to that of PMS:
  • Depression — characterized by persistent low mood and/or loss of pleasure in most activities, and a range of associated emotional, cognitive, physical, and behavioural symptoms. For more information, see the CKS topic on Depression.
  • Anxiety and panic disorders — presents with disproportionate, pervasive, uncontrollable, and widespread worry, and a range of somatic, cognitive, and behavioural symptoms that occur on a continuum of severity. For more information, see the CKS topic on Generalized anxiety disorder.
  • Hypothyroidism — the clinical consequence of deficient secretion by the thyroid gland. Often presents with non-specific symptoms, such as muscle weakness, constipation, and menstrual disturbances. For more information, see the CKS topic on Hypothyroidism.
  • Hyperthyroidism — due to excessive secretion by the thyroid gland. Signs and symptoms include weight loss, poor sleep, heat intolerance, palpitations, atrial fibrillation, and hyperreflexia. For more information, see the CKS topic on Hyperthyroidism.
  • Anaemia — presents with pallor, tachycardia, palpitations, fatigue and lethargy, night cramps, dyspnoea, headache, and faintness. For more information, see the CKS topics on Anaemia - iron deficiency and Anaemia - B12 and folate deficiency.
  • Dysmenorrhoea — presents with painful cramping, usually in the lower abdomen, occurring shortly before or during menstruation, or both. For more information, see the CKS topic on Dysmenorrhoea.
  • Mastalgia — symptoms are limited to breast tenderness and swelling. For more information, see the CKS topic Breast pain - cyclical.
  • Migraine — characterized by attacks of moderate or severe headache with typical associated symptoms such as photophobia, phonophobia, nausea, and vomiting. For more information, see the CKS topic on Migraine.
  • Irritable bowel syndrome — a chronic, relapsing, and often lifelong disorder of gastrointestinal function with no discernible structural or biochemical cause. Characterized by abdominal pain/discomfort associated with, or relieved by, defecation; a change in bowel habit, with constipation, diarrhoea, or both constipation and diarrhoea; and/or abdominal bloating. For more information, see the CKS topic on Irritable bowel syndrome.
  • Interstitial cystitis — presents with pelvic pain, urinary frequency, urgency of micturition, and pressure in the bladder and pelvis. It predominantly affects middle-aged women.
  • Endometriosis — occurs when there is tissue resembling endometrial glands and stroma outside the uterine cavity, which induces a chronic inflammatory reaction. It is often associated with dysmenorrhoea, pelvic pain, and subfertility. For more information, see the CKS topic on Endometriosis.
  • Chronic fatigue syndrome — presents with mental and physical fatigue which is exacerbated by activity. May be associated with muscle and joint pain; depression and anxiety are also common.
  • Fibromyalgia — presents with pain associated with generalized morning stiffness that is worsened by stress, cold, and activity.
  • Systemic lupus erythematosus — commonly presents with constitutional symptoms as well as musculoskeletal problems (for example arthralgia, arthritis, and myalgia), skin problems (for example alopecia and butterfly rash), and cardiopulmonary and neurological features.

Scenario: Management of premenstrual syndrome

From age 12 years onwards (Female).

Search strategy

Scope of search

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

Search dates

April 2019 - August 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 22nd March 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.

S4    S1 OR S2 OR S3 
S3    AB ( PMS or PMT ) OR TI ( PMS or PMT ) 
S2    AB ( premenstrual or pre-menstrual ) OR TI ( premenstrual or pre-menstrual ) 
S1    (MH "Premenstrual Syndrome+") 

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• Institute for Clinical Systems Improvement
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Bandolier
• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• LactMed
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.