Pregnancy Sexual health Women's health
Contraception - natural family planning
Last revised in June 2021
Natural family planning is a method of birth control where a woman monitors and records different fertility indicators during her menstrual cycle
Contraception - natural family planning: Summary
- Natural family planning is a term used to describe methods of preventing or planning pregnancy based on observation of different fertility indicators during a woman's menstrual cycle.
- Natural family planning methods can be used to avoid pregnancy by prompting a change in sexual behaviour during the woman's fertile time, such as abstaining from vaginal intercourse or the use of barrier methods of contraception (where appropriate).
- The withdrawal method (coitus interruptus) is used by many couples and is considered a natural method of contraception. However, it is not advised as a method of contraception on its own or as an alternative to abstinence or condom use in women using fertility indicators to avoid pregnancy.
- There are two different types of natural family planning methods:
- Fertility awareness methods (FAM).
- Lactational amenorrhoea methods (LAM).
- FAM involve identifying when a woman is least (or most) fertile by monitoring and recording fertility indicators, such as:
- Basal body (waking) temperature — a slight rise in temperature that persists for 3 days indicates that the fertile time has ended.
- Cervical secretions — an increase in the volume of wet, slippery, and clear cervical secretions indicates that ovulation is approaching.
- Changes in the cervix — the fertile window starts at the first sign of the cervix changing from being low and firm, and the cervical os closed, to the cervix being high and soft and the cervical os open.
- Length of menstrual cycle — involves calculating the length of the menstrual cycle and using this to estimate the time of ovulation and the fertile days of the menstrual cycle.
- LAM involves breastfeeding after childbirth to prevent pregnancy (breastfeeding delays the return of ovulation by disrupting gonadotrophin release). The following conditions must all be met before LAM can be used:
- Complete amenorrhoea.
- Fully or nearly fully breastfeeding (that is, the baby is getting 85% or more of its feeds as breast milk).
- Less than 6 months postpartum.
- If a woman is considering a natural family planning method of contraception:
- An assessment should be done to confirm the suitability of the method. As part of the assessment, the World Health Organization Medical Eligibility Criteria for Contraceptive Use should be applied to assess her eligibility for use of the method.
- Verbal and written information should be provided on how the method works, as well as the efficacy, advantages, and disadvantages of the methods. Women wishing to use fertility indicators for contraceptive purposes should receive support and instruction on the method from a trained practitioner.
- Advice should be offered on other methods of contraception, such as long-acting reversible contraception (LARC), and their comparative efficacy.
- In women for whom pregnancy poses a significant health risk, the reliance on fertility indicators for the prevention of pregnancy is not recommended. Contraceptive options should be discussed with the woman and, where necessary, specialists involved in the management of her condition.
- Women taking drugs that are known to have a teratogenic effect should not rely solely on fertility indicators for the prevention of pregnancy.
Have I got the right topic?
From age 13 years to 60 years (Female).
This CKS topic covers the principles of using fertility awareness methods (FAM) of contraception and the lactational amenorrhoea method (LAM) of contraception.
This CKS topic does not include detailed information on the use of FAM. UK health professionals with an interest in accessing specialist training or wishing to signpost women to a locally trained practitioner can find further details on the Fertility UK website (www.fertilityuk.org).
This CKS topic does not cover the use of other methods of contraception or the management of women requesting emergency contraception. It also does not cover factors affecting the choice of contraception, such as comorbidities, reproductive history, drug treatments, and age; ethical and legal issues around contraception; safe sex advice; or assessment for sexually transmitted infections.
There are separate CKS topics on Amenorrhoea, Chlamydia - uncomplicated genital, Contraception - assessment, Contraception - barrier methods and spermicides, Contraception - combined hormonal methods, Contraception - emergency, Contraception - IUS/IUD, Contraception - progestogen-only methods, Contraception - sterilization, Endometriosis, Infertility, Menorrhagia, and Pre-conception - advice and management.
The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.
How up-to-date is this topic?
Changes
June 2021 — reviewed. A literature search was conducted in May 2021 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic.
No changes to clinical recommendations have been made, but the topic structure has been changed.
The Quality and Outcomes Framework (QOF) indicators listed below have been removed as they were retired in April 2019 [BMS and NHS England, 2019]:
CON001: The contractor establishes and maintains a register of women aged 54 or under who have been prescribed any method of contraception at least once in the last year, or other clinically appropriate interval, for example, the last 5 years for an IUS.
CON003: The percentage of women, on the register, prescribed emergency hormonal contraception one or more times in the preceding 12 months by the contractor who have received information from the contractor about long-acting reversible contraception at the time or within one month of the prescription.
Previous changes
March to April 2016 — reviewed. A literature search was conducted in March 2016 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of the topic. Minor structural changes have been made.
June 2013 — minor update. The 2013 Quality and Outcomes Framework (QOF) options for local implementation have been added to this topic.
March 2013 — minor update. The telephone number for NHS Direct has been updated.
February to June 2012 — reviewed. A literature search was conducted in December 2011 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. No changes to clinical recommendations have been made. However, recommendations have been rewritten for clarity, and superseded guidelines and manufacturers' Summaries of Product Characteristics (SPCs) have been updated accordingly.
March 2011 — the topic structure has been revised to ensure consistency across CKS topics. No changes to clinical recommendations have been made.
February 2010 — updated to include the revised UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) published by the College of Sexual and Reproductive Healthcare (CoSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC). Issued in January 2010.
March 2009 — minor update. The QOF indicators for sexual health have been updated in the section on Goals and outcome measures. Issued in April 2009.
April to September 2007 — converted from CKS guidance to CKS topic structure. The evidence base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence.
July 2006 — minor update. Information regarding orlistat and reduced efficacy of oral contraceptives has been included in the section on Drug interactions. Issued in July 2006.
January 2006 — minor update. Gynol II Jelly, Microval tablets, and Duragel have been discontinued, and the prescriptions have been removed. The Black triangle status has been removed from Cerazette®. Issued in February 2006.
October 2005 — updated to include the new recommendations on missed pills from the FFPRHC Clinical Effectiveness Unit, published in April 2005. Issued in November 2005.
April 2005 — minor update. Neogest® tablets have been discontinued, and the prescriptions have been removed. Issued in April 2005.
February 2005 — updated to include prescribing advice from the Committee on Safety of Medicines (CSM) on the effect of depot medroxyprogesterone acetate contraception on bones. Issued in February 2005.
September 2004 — updated to include the WHO Medical Eligibility Criteria relating to contraception for 2004 and recent licence changes to Cerazette®. Delfen® Contraceptive Foam is being discontinued at the end of October 2004, and the prescriptions have been removed. Issued in September 2004.
January 2004 — reviewed. Validated in March 2004 and issued in June 2004.
January 2001 — rewritten. Validated in March 2001 and issued in June 2001. Guidance on emergency contraception is no longer included in the Contraception guidance but can be found as a separate CKS topic.
December 1997 — written.
Update
New evidence
Evidence-based guidelines
No new evidence-based guidelines since 1 June 2021.
HTAs (Health Technology Assessments)
No new HTAs since 1 June 2021.
Economic appraisals
No new economic appraisals relevant to England since 1 June 2021.
Systematic reviews and meta-analyses
No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 June 2021.
Primary evidence
No new primary evidence which reaches the CKS threshold for inclusion published since 1 June 2021.
New policies
No new national policies or guidelines since 1 June 2021.
New safety alerts
No new safety alerts since 1 June 2021.
Changes in product availability
No changes in product availability since 1 June 2021.
Goals and outcome measures
Goals
- Provide information on the principles of using fertility awareness methods of contraception and the lactational amenorrhoea method of contraception.
- Provide information on the efficacy, advantages, and disadvantages of these methods of contraception.
Outcome measures
No outcome measures were found during the review of this topic.Audit criteria
No audit criteria were found during the review of this topic.QOF indicators
No QOF indicators were found during the review of this topic.
QIPP - options for local implementation
No QIPP criteria were found during the review of this topic.
NICE quality standards
- Women asking for contraception from contraceptive services are given information about, and offered a choice of, all methods including long-acting reversible contraception.
- Women asking for emergency contraception are told that an intrauterine device is more effective than an oral method.
- Women who request an abortion discuss contraception with a healthcare practitioner and are offered a choice of all methods when they are assessed for abortion and before discharge.
- Women who give birth are given information about, and offered a choice of, all contraceptive methods by their midwife within 7 days of delivery.
Background information
What is natural family planning?
- Natural family planning is a term used to describe methods of preventing or planning pregnancy based on observation of different fertility indicators during a woman's menstrual cycle.
- Natural family planning methods can be used to avoid pregnancy by prompting a change in sexual behaviour during the woman's fertile time, such as abstaining from vaginal intercourse. Barrier methods of contraception (such as condoms) can be considered as an alternative to abstinence provided couples have been properly instructed in their use and accept a potentially higher failure rate if using barrier contraception around the time of ovulation (peak fertile time).
- The withdrawal method (coitus interruptus) is used by many couples and is considered a natural method of contraception. However, it is not advised as a method of contraception on its own (as it is one of the least effective contraceptive methods available) or as an alternative to abstinence or condom use in women using fertility indicators to avoid pregnancy (due to a lack of comparative studies).
- There are two types of natural family planning methods:
What do fertility awareness methods of contraception involve?
- Fertility awareness methods involve identifying when a woman is least (or most) fertile by monitoring and recording fertility indicators, such as:
- Basal body temperature (BBT) — the woman can monitor her BBT (the temperature before rising from bed after resting for at least 3 hours) every day.
- After ovulation, progesterone increases BBT and remains elevated until the beginning of menstruation. This can help to identify ovulation retrospectively and the end of the fertile window.
- A slight rise in temperature that persists for 3 days indicates that the fertile time has ended.
- Cervical secretions — the woman can look and feel for cervical secretions.
- Hormonal changes during the menstrual cycle result in changes in the quantity and appearance of cervical secretions.
- An increase in the volume of wet, slippery, and clear cervical secretions indicates that ovulation is approaching.
- Sexual intercourse on days when cervical secretions are present increases the likelihood of pregnancy.
- When cervical secretions are present, women wishing to avoid pregnancy should not have sexual intercourse, or they should use an additional contraceptive method until 3 consecutive dry days are noted.
- Changes in the cervix — the woman can palpate the cervix.
- The fertile window starts at the first sign of the cervix changing from being low and firm, and the cervical os closed, to the cervix being high and soft and the cervical os open. It ends when the cervix becomes low and firm and the cervical os has been closed again for 3 days.
- Women wishing to avoid pregnancy should use alternative contraception or avoid sex when the cervix feels high and soft and the cervical os open.
- The effectiveness of changes to the cervix as a sole indicator for contraceptive purposes is unknown and therefore is not recommended.
- Length of menstrual cycle (calendar method) — this involves calculating the length of the menstrual cycle (over a minimum of 12 cycles) and using this to estimate the time of ovulation and the fertile days of the menstrual cycle.
- The length of the menstrual cycle can be highly variable, with ovulation usually occurring between 12 and 16 days before menstruation.
- The fertile time lasts for around 8–9 days of each menstrual cycle. The most fertile time is from about 7 days before ovulation until about 2 days after ovulation. This is because sperm in a woman's reproductive tract can remain viable for up to 7 days. The unfertilized egg is viable for about 24 hours, but occasionally more than one egg is released at ovulation (within 24 hours of the first egg being released).
- By plotting menstrual cycles over a period of time, women can establish the earliest and latest time they are at risk of conception.
- During the fertile time, the chances of becoming pregnant are about 10–33% [Wilcox, 1995]. However, the fertile period can be unpredictable, and although the risk of pregnancy in the first 3 days of the cycle is negligible, there is no time in the menstrual cycle when the risk of pregnancy is zero. Estimates of 'safe' days are particularly imprecise when the menstrual cycle is irregular or there is uncertainty about the date of the last menstrual period [CoSRH, 2015].
- Basal body temperature (BBT) — the woman can monitor her BBT (the temperature before rising from bed after resting for at least 3 hours) every day.
- Fertility monitoring devices are available to help monitor hormonal changes in the body.
- Computerized monitoring devices are available that identify the fertile and infertile times by combining temperature with cycle length. The devices may be available to buy commercially but are not widely used or recommended in the UK because of the lack of efficacy data.
- Dipstick tests for luteinizing hormone and ovulation predictor kits are also available and are intended to help women conceive.
- The fertile time is more accurately estimated by a combination of methods than by any single method.
What does the lactational amenorrhoea method of contraception involve?
- The lactational amenorrhoea method (LAM) involves breastfeeding after childbirth to prevent pregnancy.
- Breastfeeding delays the return of ovulation by disrupting gonadotrophin release, but the mechanism is uncertain.
- The following conditions must all be met before LAM can be used:
- Complete amenorrhoea.
- Fully or nearly fully breastfeeding day and night.
- The baby should be getting 85% or more of its feeds as breast milk.
- Water, juice, or vitamins can be given infrequently in addition to breastfeeds. No other liquids should be given.
- There should be no long intervals between day or night feeds (for example, no more than 4 hours during the day or 6 hours at night).
- Less than 6 months postpartum.
- The risk of pregnancy is increased:
- When menstruation returns.
- If the frequency of breastfeeding decreases. This could be due to supplementary feeding, long intervals between feeds (more than 4 hours during the day), stopping night feeds, and/or the use of pacifiers/dummies.
- When the woman is more than 6 months postpartum.
- The effect of expressing milk on the efficacy of the LAM is not known, but it may be reduced.
How effective are natural family planning methods at preventing pregnancy?
- Fertility awareness-based methods (FAM)
- When used perfectly (consistently and correctly), 1–9% of women will conceive within the first year of use due to method failure.
- When used typically, 24% of women will conceive within the first year of use due to method failure or user failure.
- See the section on Comparative efficacy in the CKS topic on Contraception - assessment for a comparison of the efficacy of the FAM with other methods of contraception.
- Lactational amenorrhoea method (LAM)
- When used perfectly (consistently and correctly), 0.5% of women will conceive during the first 6 months after childbirth due to method failure.
- When used typically, 2% of women will conceive during the first 6 months after childbirth due to method failure or user failure.
- See the section on Comparative efficacy in the CKS topic on Contraception - assessment for a comparison of the LAM with other methods of contraception.
- The withdrawal method (coitus interruptus)
- When used perfectly (consistently and correctly), 4% of women will conceive within the first year of use due to method failure.
- When used typically, 22% of women will conceive within the first year of use due to method failure or user failure.
- See the section on Comparative efficacy in the CKS topic on Contraception - assessment for a comparison of the withdrawal method with other methods of contraception.
What are the advantages and disadvantages of natural contraception methods?
What are the advantages and disadvantages of fertility awareness methods of contraception?
- Advantages
- They can be used by most couples.
- They do not involve the use of chemicals or physical products.
- There are no physical or hormonal adverse effects.
- They can help the woman recognize normal and abnormal vaginal secretions.
- They involve men in the process and can help the woman to communicate about her fertility and sexuality.
- They are acceptable to all faiths and cultures.
- They are immediately reversible.
- Disadvantages
- They are not as effective as other methods of contraception.
- They require continuing cooperation and commitment of both partners.
- To be optimally effective, they must be taught by someone trained to teach natural family planning.
- It may take 2–3 menstrual cycles to accurately identify the fertile time using cervical secretions and basal body temperature.
- They are not suitable for women with irregular cycles.
- Fertility indicators must be monitored and recorded daily.
- Illness, lifestyle, stress, travel, and the use of hormonal treatments can make fertility indicators hard to interpret.
- During the fertile period, couples need to avoid sexual intercourse (which some people may find difficult) or use other contraceptive methods (such as barrier methods).
- Indicators of fertility are unreliable in women who are breastfeeding.
- Natural methods do not protect against sexually transmitted infections, including HIV.
- Some devices and consumables must be purchased, and they can be expensive.
What are the advantages and disadvantages of using the lactational amenorrhoea method of contraception?
- Advantages
- The lactational amenorrhoea method (LAM) can be effective for up to 6 months postpartum.
- It encourages exclusive breastfeeding for up to 6 months postpartum.
- It can be used immediately after childbirth.
- There is no need to do anything at the time of sexual intercourse.
- There is no direct cost, as it requires no supplies or procedures.
- It has no hormonal adverse effects.
- It does not involve abstinence from sexual intercourse.
- Disadvantages
- It does not protect against sexually transmitted infections (STIs), including HIV.
- It becomes unreliable after 6 months and when other foods (including infant milk formula) are introduced into the baby's diet.
- Frequent breastfeeding is inconvenient or difficult for some women.
Management
Scenario: Fertility awareness methods
From age 13 years to 60 years (Female).
How should I assess a woman who is considering using fertility awareness methods of contraception?
- If a woman is considering using fertility awareness methods (FAM), an assessment should be done to confirm the suitability of the method. As part of the assessment, the World Health Organization Medical Eligibility Criteria for Contraceptive Use should be applied to assess the person's eligibility for use of the method.
- See the CKS topic on Contraception - assessment for information on how to assess a woman who is considering using FAM.
What information and advice should I give to a woman who is considering using fertility awareness methods of contraception?
- Provide verbal and written information on fertility awareness methods (FAM).
- This should include information on:
- What FAM involve.
- The efficacy of FAM, including the failure rate relative to other methods of contraception, such as long-acting reversible contraception (LARC).
- The advantages and disadvantages of FAM.
- Fertility monitoring devices, including where they can be purchased and how to use them.
- Information on FAM is available from several sources, including:
- The NHS website (www.nhs.uk).
- Sexwise, a website produced by the FPA (Family Planning Association) for the National Health Promotion Programme for Sexual Health and Reproductive Health (www.sexwise.org.uk).
- The Fertility UK website (www.fertilityuk.org).
- This should include information on:
- Advise the woman that she would need counselling, training, and ongoing support from a person trained to teach FAM.
- The Fertility UK website has information on how to access locally trained FAM practitioners.
Basis for recommendation
These recommendations are largely based on the College of Sexual and Reproductive Healthcare (CoSRH) clinical guideline Fertility awareness methods [CoSRH, 2015].
Scenario: Lactational amenorrhoea method
From age 13 years to 60 years (Female).
How should I assess a woman who is considering using the lactational amenorrhoea method of contraception?
- If a woman is considering using the lactational amenorrhoea method (LAM), an assessment should be done to confirm the suitability of the method. As part of the assessment, the World Health Organization Medical Eligibility Criteria for Contraceptive Use should be applied to assess the person's eligibility for use of the method.
- See the CKS topic on Contraception - assessment for information on how to assess a woman who is considering using LAM.
What information and advice should I give a woman who is considering using the lactational amenorrhoea method of contraception?
- Provide verbal and written information on the lactational amenorrhoea method (LAM).
- This should include information on:
- What LAM involves.
- The efficacy of the LAM, including the failure rate relative to other methods of contraception, such as long-acting reversible contraception (LARC).
- The advantages and disadvantages of LAM.
- Information on LAM is available from several sources, including:
- The NHS website (www.nhs.uk).
- Sexwise, a website produced by the FPA (Family Planning Association) for the National Health Promotion Programme for Sexual Health and Reproductive Health (www.sexwise.org.uk).
- The Fertility UK website (www.fertilityuk.org).
- This should include information on:
- Advise the woman that when the LAM criteria no longer apply, she should continue to breastfeed but must switch to another method of contraception.
Basis for recommendation
These recommendations are based on what CKS considers to be good clinical practice.
Supporting evidence
This CKS topic is largely based on the College of Sexual and Reproductive Healthcare (CoSRH) clinical guideline Fertility awareness methods [CoSRH, 2015].
How this topic was developed
This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.
Search strategy
Scope of search
A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of contraception - natural family planning.
Search dates
March 2016 - March 2021
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 Natural Family Planning Methods / methods*Which includes the terms below:
- Periodic Abstinence
- Abstinence, Periodic
- Natural Family Planning
- Family Planning, Natural
- Rhythm Method of Family Planning, Temperature
- Rhythm Method of Family Planning, Cervical Mucus
- Rhythm Method of Family Planning
- Symptothermal Method of Family Planning
- Rhythm Method of Family Planning, Calendar
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
Sources of national policy
- Department of Health
- Health Management Information Consortium (HMIC)
Patient experiences
Sources of medicines information
The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.
Stakeholder engagement
Our policy
The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:
- Clinical accuracy.
- Consistency with other providers of clinical knowledge for primary care.
- Accuracy of implementation of national guidance (in particular NICE guidelines).
- Usability.
Principles of the consultation process
- The process is inclusive and any individual may participate.
- To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
- Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
- Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
- External reviewers are not paid for commenting on the draft topics.
- Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
- All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
- All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.
Stakeholders
- Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
- Stakeholders identified from the following groups are invited to review draft topics:
- Experts in the topic area.
- Professional organizations and societies (for example, Royal Colleges).
- Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
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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.
References
- CoSRH (2015) Fertility awareness methods. College of Sexual and Reproductive Healthcare. http://www.cosrh.org [Free Full-text]
- Frank-Herrmann, P., Heil, J., Gnoth, C., et al. (2007) The effectiveness of a fertility awareness based method to avoid pregnancy in relation to a couple's sexual behaviour during the fertile time: a prospective longitudinal study. Human Reproduction 22(5), 1310-1319. [Abstract]
- Hatcher, R.A., Rinehart, W., Blackburn, R., et al. (1997) The essentials of contraceptive technology: a handbook for clinic staff. Chapter 12 - intrauterine devices (IUDs). Population Information Program. https://www.press.jhu.edu
- Hatcher, R., Trussel, J., Nelson, A., et al. (Eds.) (2011) Contraceptive technology. 20th edn. Bridging the Gap Communications.
- NICE (2016) Contraception. QS129. National Institute of Health and Care Excellence. http://www.nice.org.uk [Free Full-text]
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