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Implementation of NICE guideline- pdf saved

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Whilst NICE guidelines are not at present legally binding, it is well established that Regulation 7 technology recommendations and Regulation 8 specialized technology recommendations, must be complied with. The general guidance and recommendations under Regulation 5 have been considered open to interpretation and implementation. Case law is now turning this proposition on its head as NICE guidelines become legally binding through case law.

Implications of avoiding the guidance

Whilst the word 'guidelines' may conjure the impression of discretionary and optional advice, this is far from the case. Following the landmark case of Montgomery -v- Lanarkshire (2015) the way that practitioners dealt with consenting patients for operations significantly altered. Legal principles established through case law are binding and they cannot be ignored. The case law on NICE guidelines is likely to have the same effect. When making a decision about how to treat a patient, ignoring and failing to adhere to the NICE guidelines is likely to lead to legal consequences.

Case law

An important case of interest is that of R (Elizabeth Rose) -v- Thanet Clinical Commissioning Group (2014). The case concerned a woman who was undergoing chemotherapy due to a severe form of Crohn's disease. The treatment would in all likelihood leave her infertile. The claimant wanted to undergo oocyte cryopreservation (OC) to preserve her eggs in order to allow her to have her own genetic children in the future. NICE guidelines state that OC should be given to women of reproductive age who are preparing to undergo medical treatment for cancer which may make them infertile. The claimant was an appropriate candidate under the guidelines. However, the CCG's policy was to allow the treatment in clinically exceptional circumstances only, for which they did not consider that the claimant qualified. The CCG also refused to fund the OC due to insufficient evidence demonstrating its effectiveness. When the claim came before Justice Jay, it was held that the CCG was not able to choose not to follow NICE guidance because they disagreed with it.

The general rule in respect of following national policy and state guidance, was established in the case of R -v- North Derbyshire Health Authority, ex parte Fisher (1997) a case prior to the introduction of the NICE guidelines. In this case the Defendant was permitted to depart from the national policy by way of guidance from the secretary of state, only if there was a 'special factor' that meant there was an 'exceptionally justified departure'. In the case of R (Elizabeth Rose) the CCG's disagreement with OC treatment was not considered a special factor which would enable them to depart from NICE guidance. Furthermore, Justice Jay found that the CCG had not put forward a significant case which exceptionally justified departure from the guidance in respect of the R -v- North Derbyshire Health Authority criteria. Disagreement with the OC guidance was not sufficient to justify not following the guidance. This further advocates how the NICE guidelines do not just provide guidance but are increasingly becoming mandatory rules which must be followed.

Dr Naylor, barrister at Exchange Chambers and former general practitioner considers that in the context of a legal claim if the practitioner has failed to consider or apply the guidelines they are likely to be found negligent. 'Clinical practice is being increasingly influenced and some would say dictated by the NICE guidelines. The guidelines are becoming increasingly detailed and prescriptive. There is a perceived disconnect between the world seemingly inhabited by the academics who draft the guidelines and the clinicians working at the coal-face, doing their best in a busy and under-resourced health service. It may be argued that the clinicians should be afforded flexibility in deciding which guidelines to follow. In reality, however, where a claim is based upon a failure to follow the guidelines, that failure is likely to prove fatal in any attempt to defend the claim. The guidelines are, by their very nature, evidence-based and increasingly they are drafted in clear, unambiguous and prescriptive terms. Any decision to depart from the guidelines will usually require full discussion with the patient and in some cases, specialist advice. The quality of the consultation and the standard of record keeping are key factors, when determining whether departure from the guidelines can be justified as being reasonable and rational.'

NICE's website does not refer to the guidance as mandatory but rather they advise that organisations and practitioners delivering services should take NICE guidelines into consideration when treating patients. Yet in the case of R (Elizabeth Rose) Thanet CCG did consider the guidelines but chose not to apply them because they disagreed with them. Therefore even if practitioners can show they considered the guidance they are unlikely to escape liability in the civil courts for failing to apply them.

Reasonable practice

In the courtroom it is independent expert evidence which is used to determine what constitutes 'reasonable practice.' Expert witnesses frequently refer to the guidelines when determining if a practitioner's actions have fallen short of the appropriate standard. However, long before the NICE guidelines it was the case of Bolam -v- Friern Hospital Management Committee (1957) which set the appropriate standard for determining reasonable practice. The so-called 'Bolam test' establishes whether a medical professional has breached their duty of care to a patient and confirms that negligence is not established if the doctor has acted in accordance with a practice accepted as proper by a responsible body of opinion.

Likewise in respect of the NICE guidelines, if it can be shown that the practitioner did not follow the guidelines for a justifiable reason, which is supported by a reasonable body of experts, then the practitioner should not be found negligent. Once again the R (Elizabeth Rose) case appears a stark contrast to this. The CCG considered that they had a justifiable reason for departing from the guidelines and presumably considered the impact of the guidelines when choosing to not adopt them. Yet their reasoning and justification for not adopting the guidelines was insufficient to persuade the judge that the NICE guidelines should not apply.

Guidance in practice

The guidance is prescriptive and in some cases, such as the above, it will provide a clear course of action. Miss Rose was a woman of childbearing age who was undergoing medical treatment which may result in her being left infertile. Therefore, she fell within the criteria for the guidelines and their prescriptive instructions had to be applied.

Not all patients will present in the same way or fall neatly into the criteria for a particular guideline. Determining which guideline to apply appears to be a balancing act of identifying symptoms and acting quickly to eliminate possible causes. Ultimately, the aim of the guidance is to provide an evidential basis for treating a patient in a certain matter. A turning point case will no doubt soon come before the courts to establish whether or not following one guideline over the other will result in a practitioner being found negligent.

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NICE guidelines: not just the gold standard practice

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Whilst NICE guidelines are not at present legally binding, it is well established that Regulation 7 technology recommendations and Regulation 8 specialized technology recommendations, must be complied with. The general guidance and recommendations under Regulation 5 have been considered open to interpretation and implementation.

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This follows the case of Elizabeth Rose, a 25 year old woman who has suffered from a severe form of Crohn's disease since she was 14. Her condition had deteriorated and her doctors recommended bone marrow transplantation and chemotherapy to hopefully bring the disease into remission. This treatment can, however, lead to infertility and the early onset of the menopause.

The claimant wished to secure the best chance of having her own genetic children, and sought NHS funding for oocyte cryopreservation before beginning chemotherapy.

In February 2013, NICE updated its clinical guideline on fertility which gave stronger support for the effectiveness of oocyte cryopreservation. NICE recommends that oocyte or embryo cryopreservation is offered as appropriate to women of reproductive age who are preparing for medical treatment for cancer that is likely to make them infertile.

Clinicians at King's College Hospital Foundation Trust applied for funding for Ms Rose's treatment but Thanet CCG denied the treatment in May 2013 on the grounds that there was not enough evidence to demonstrate its effectiveness. The cost of the Procedure is £4,050.

The CCG's policy was not to grant funding for the procedure unless the applicant has any exceptional clinical circumstances. The CCG considered that the claimant's circumstances were broadly in line with the group of similar patients addressed by the policy and that no exceptionality had been established. Consequently, the CCG refused funding in June 2013.

The NICE fertility guidance was not in the form of a technology appraisal or specialised technology appraisal which CCGs must legally comply with and provide funding for within three months of publication. Instead, the recommendations were made as part of a clinical guideline, and so CCGs do not have a legal duty to comply with NICE guidelines.

Despite this, the court ruled that the CCG was under an obligation in public law to have regard for the NICE guidance and to provide clear reasons for any general policy that does not follow NICE guidance.

The issue in this case was whether CCGs may legitimately disagree with NICE on matters concerning the current state of medical science. It was NICE's view that the evidence base supported the effectiveness of the procedure, and the CCG's sole basis for not following NICE's recommendation was that it disagreed.

Previous case law from 1997 (R v North Derbyshire Health Authority, ex parte Fisher) had found that a decision not to follow national policy in the form of guidance from the Secretary of State was only lawful if there was some 'special factor' which 'exceptionally justified departure'. Disagreement with the policy was not enough. The court applied this judgment to the present case and found that no basis or reasoning on grounds of exceptionality was put forward by the CCG.

The judge, Justice Jay, pointed out that the CCG could have found other reasons, on the basis of exceptionality, for not following the guidance. It had not done so and mere disagreement was insufficient. The policy was therefore unlawful.

Thanet CCG has said that they will consider the full written judgement carefully and will work closely with NHS England in doing so. If necessary we will review our policy on the freezing of eggs.

Sir Andrew Dillon, Chief Executive of NICE, said: "This court ruling highlights that CCGs cannot simply ignore NICE guidelines without having a clear clinical case for doing so. NICE guidelines are based on the best available evidence. Our fertility guideline was recently updated and provides clear support for the use of oocyte cryopreservation."

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Court warns CCG over disagreeing with NICE guidance

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This follows the case of Elizabeth Rose, a 25 year old woman who has suffered from a severe form of Crohn's disease since she was 14. Her condition had deteriorated and her doctors recommended bone marrow transplantation and chemotherapy to hopefully bring the disease into remission.

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Fertility Network | NHS Funding FAQ | Fertility Network

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We have compiled a list of the most frequently asked questions on NHS funding.

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Fertility Fairness - Formerly the National Infertility Awareness Campaign (NIAC) - Formerly the National Infertility Awareness Campaign (NIAC)

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Fertility Fairness - Formerly the National Infertility Awareness Campaign (NIAC)

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Adoption/fostering alternatives

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CCG's accountable to whom?

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Done How do clinical commissioning groups work?

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Clinical commissioning groups NHS see word doc

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In 2004 NICE produced a clinical guideline entitled Fertility: assessment and treatment for people with fertility problems, which made a number of recommendations for the provision of IVF.

The 2004 guideline recommended that 3 cycles of IVF treatment should be provided to infertile couples who had an identified cause for their fertility problems or who had infertility of 3 years duration. In addition to this the guideline recommended that the age ranges of the woman in receipt of the treatment should be between 23-39.

Recognising the advancements in clinical practice, NICE began updating this guideline in 2012 - the final revised guideline was published in February 2013.

The new guideline included the following key recommendations:

3 full cycles of IVF/ICSI should be provided where the female partner is aged 39 and under. A full cycle of IVF/ICSI has been clearly defined as one in which 1 or 2 embryos are replaced into the womb as fresh embryos (where possible) with any remaining good-quality embryos frozen for use later. When these frozen embryos are used, this is still considered to be part of the same cycle.

IVF treatment should be made available to women who have been unable to conceive after two years of regular vaginal intercourse (or 12 cycles of artificial insemination). This is one year less than was previously recommended.

Women aged 40-42 years who have not conceived after two years of regular unprotected intercourse or 12 cycles of artificial insemination (where six or more are by intrauterine insemination), should now be offered one full cycle of IVF, with or without ICSI, provided the following criteria are fulfilled: they have never previously had IVF treatment; there is no evidence of low ovarian reserve; there has been a discussion of the additional implications of IVF and pregnancy at this age. Previously, NICE did not recommend IVF for women older than 39.

Unstimulated intrauterine insemination should be considered as a treatment option for :

People who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem using partner or donor sperm.

People with conditions that require specific consideration in relation to methods of conception (for example, after sperm washing where the man is HIV positive)

People in same-sex relationships

The importance of providing up to three full cycles

NICE's retention of the three cycle recommendation should send a clear signal to commissioners as to the level of service patients should receive.

It remains the case that in order to optimise cost effectiveness, people should receive three full cycles of IVF. Each full cycle, as defined by NICE should include the initial fresh cycle, followed by frozen cycles - depending on the number of embryos produced. At the end of this, if conception has not occurred, they would start another fresh cycle followed by frozen cycles, and so on.

The importance of providing three full cycles of IVF is underpinned by the fact that not all people yield the same amount of viable embryos for transfer. Some may only yield one. These couples are immediately placed at a disadvantage if the option of a third fresh cycle is not made available to them.

A study conducted in 2009, found that the cumulative effect of providing three full cycles of IVF increased the chances of a successful pregnancy to 45-53%. Given the upward trend in success rates, this percentage is likely to only increase over time.

The risk of multiple pregnancy

Multiple pregnancy is recognised as the most common complication presenting the greatest risk for mothers and babies. In January 2009, following an expert group report and public consultation, the HFEA introduced a policy for elective single embryo transfer (eSET) in order to minimise the risk of multiple pregnancies with the overall aim of reducing the UK IVF multiple birth rate to 10%.

The introduction of elective single embryo transfer (eSET) for women most likely to have a multiple pregnancy has increased the importance of offering three full cycles of IVF. Data has confirmed that success rates are not significantly reduced and multiple pregnancies minimised where this approach is adopted.

The emphasis on eSET in the latest NICE guideline (2013) is a welcome development and should help reduce costs to the NHS (a multiple pregnancy is estimated to cost the NHS an average of £4000 more than a singleton pregnancy).

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In 2004 NICE produced a clinical guideline entitled Fertility: assessment and treatment for people with fertility problems, which made a number of recommendations for the provision of IVF. The 2004 guideline recommended that 3 cycles of IVF treatment should be provided to infertile couples who had an identified cause for their fertility problems or who had infertility of 3 years duration.

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One of the founding principles of our NHS is a commitment to providing fair and equal access to healthcare. It is this principle that ignites such passion in us all when it is threatened or belittled. Yet the recent revelation that 13 areas of England have restricted or completely halted IVF treatment, with a further eight consulting on similar steps, shows that we are failing in this commitment.

The World Health Organisation defines infertility as a disease. And guidelines from the National Institute for Health and Clinical Excellence (NICE) recommend that women under 40 with fertility problems should be offered three full cycles of IVF on the NHS. But more than 80% of patients do not currently receive this.

Those who have been through IVF treatment know that it is often a difficult and emotional process, and requires deep commitment to having a child. Critics claim infertility is not a life-threatening condition. Yet fertility treatment creates life, and in my mind that is just as vital to our society. By denying NHS funding for IVF treatment we are creating inequality, where only those with the resources are able to fight for that choice to become parents. As an NHS consultant, I am all too aware of the funding challenges facing our health service. Equally, as a fertility expert and a founder of private fertility clinics, I am also conscious of the rising rates of infertility in the UK - one in six couples now face trouble conceiving.

I passionately believe that cutting or reducing IVF funding is an unnecessary and short-sighted move. We could make the existing budget go so much further simply by making some key changes to how we spend it. As it currently stands, each clinical commissioning group (CCG) individually procures IVF treatment from fertility providers, with significant variance in cost. The price paid for IVF by individual CCGs ranges from under £3,000 to over £11,000 a cycle.

This regional system was developed in the early 1980s, as IVF treatment became accessible, and the NHS pursued an internal market system in which it was thought that allowing the NHS to buy in treatment from competing providers would drive down price and increase efficiency. Yet this is widely considered to have been a failure, and it no longer works in a world where the standardisation of fertility treatment is possible. The massive range in pricing it produces has a fundamental bearing on the number of IVF cycles CCGs are able to provide within their allotted budget for fertility treatment.

There will always be some variance in the fees fertility clinics choose to charge patients, but it is simply unacceptable that in one part of the country the NHS should be charged double for the same treatment. It is essential that the NHS standardises a national price per IVF cycle that would function as a cap on the costs clinics can charge. This would reduce the price per IVF cycle and ensure patients across the country have equal access to IVF treatments, and end the postcode lottery in which people are losing out on the opportunity to become parents, simply by virtue of where they live. The NHS already sets a national price for a wide range of other treatments, from hip replacements to radiotherapy. Why not for IVF? A cost cap for IVF is also already successfully employed across other European countries such as Belgium and France.

At the moment, the private IVF industry is capitalising too much on the lack of a price cap, at the expense of the NHS, taxpayers, and people struggling to have children. A price cap for NHS-funded IVF could allow us to double the number of IVF treatments that can be offered within the existing budget in many regions.

Almost 40 years ago, Britain became the first-ever nation to conceive and deliver an IVF baby. I find it incredibly sad that instead of clamping down on the overcharging of the NHS by private fertility clinics, we are cutting back provision at a rate that could make us the first country in Europe to remove public funding for IVF altogether.

* Geeta Nargund is the medical director of Create Fertility, which runs fertility clinics

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Place a cap on IVF costs and the NHS could double the number of treatments | Geeta Nargund

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One of the founding principles of our NHS is a commitment to providing fair and equal access to healthcare. It is this principle that ignites such passion in us all when it is threatened or belittled.

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Annually, an estimated £68m (€78m; $92m) is spent on in vitrofertilisation (IVF) by the NHS.1 Since 2013, the NationalInstitute for Health and Care Excellence has stipulated thatwomen who meet the criteria should be offered three cycles.By 2017, however, only 27 of England’s 200 clinicalcommissioning groups complied.2

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Annually, an estimated £68m (€78m; $92m) is spent on in vitrofertilisation (IVF) by the NHS.1 Since 2013, the NationalInstitute for Health and Care Excellence has stipulated thatwomen who meet the criteria should be offered three cycles.By 2017, however, only 27 of England’s 200 clinicalcommissioning groups complied.2

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The hidden costs of infertility treatment - ProQuest

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This is a short preview of the document. Your library or institution may give you access to the complete full text for this document in ProQuest.

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https://www.sheffieldccg.nhs.uk/Downloads/Your%20Health%20docs/specialisedfertilitypolicy.pdf

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Abstract

BACKGROUND: IVF and embryo transfer has become an established and increasingly successful form of treatment for infertility, yet significant numbers of couples discontinue treatment without achieving a live birth. This study aims to identify major factors that influence the decision to discontinue IVF treatment. METHODS: Questionnaires were sent to 1510 couples who had undergone IVF treatment at Ninewells Hospital and Medical School, Dundee, Scotland, between January 1995 and December 2001. The main outcome measure was the number of couples who discontinue treatment and the reasons for discontinuation including live birth, lack of success, lack of funding, psychological stress, medical advice, physical discomfort, personal and other reasons. RESULTS: The response rate was 55% (732/1327) with 183 questionnaires returned as address unknown. A total of 515 couples had discontinued treatment at time of response, with 266 (52%) having achieved a live birth. Achieving a live birth was the reason for discontinuation where a single reason was given. Those who did not conceive gave a combination of reasons. Lack of personal and/or National Health Service funding was cited by 23% of couples as a reason. Lack of success and psychological stress were reported as factors by 23 and 36% of couples respectively. These two factors are very strongly associated ( P < 0.001), both being reported by 18% of couples with a reciprocal increase in those quoting lack of success and psychological stress as reasons for discontinuation with increasing number of attempts ( P < 0.0005). Changes in personal circumstances were reported by 30% and <10% gave general discomfort or advice from medical staff as reasons. CONCLUSIONS: Though funding is an important issue, factors including lack of success and psychological stress play a greater role in influencing the decision to discontinue treatment. Better information and support are needed to improve the continuation rates.

Introduction

IVF and embryo transfer has become an established and increasingly successful form of treatment for infertility. The last two decades have seen major advances in reproductive technologies, which along with improved data collection and documentation have increased public awareness of the availability and efficiency of assisted conception. The Human Fertilisation and Embryology Authority (HFEA) 9th Annual Report (2000) shows an improvement of live birth rate from ∼14% in 1991-1992 to ∼22% in 2000-2001 for IVF treatment in the UK.

Increasing awareness, combined with better knowledge of availability of services, has led to an increased demand for assisted conception treatment over the last decade. In 1998-1999, 35 363 IVF treatment cycles were undertaken in the UK compared to 17 031 treatment cycles in 1992-1993. The American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry has reported a 13.5% increase in the number of treatment cycles from 1999 to 2001. The first cycle of treatment is statistically the most successful attempt, but multiple attempts improve the probability of achieving a pregnancy ( Templeton et al., 1996). The estimated cumulative conception rate after four attempts has ranged from 54% ( Tan et al., 1992) to 75% ( Sharma et al., 2002).

Despite the improvements in assisted reproduction technologies and their increasing availability and success, < 30% of women have more than one attempt at IVF in the UK ( Templeton et al., 1996). Many factors have been proposed to explain why so few couples have only one IVF treatment cycle, and in the UK this has been mainly attributed to the lack of National Health Service (NHS) funding. High drop-out rates in assisted conception treatment are a common feature reported in several studies ( Croucher et al., 1998; Roest et al., 1998; Sharma et al., 2002; Schroder et al., 2004; Smeenk et al., 2004). The high drop-out rate following the first treatment cycle often coincides with the end of funding by health authorities, though it is argued that poor prognosis and psychological reasons also contribute to discontinuation of further treatment. Goldfarb et al. (1997) reported that lack of finance was the major reason for discontinuation of treatment after a failed IVF cycle. On the other hand, Emery et al. (1997) documented that one in five couples withdrew from the programme before completion of the available number of treatment cycles while a further one in three significantly delay their treatment cycles. Olivius et al. (2004) have recently reported a drop-out rate of 54% with 26% of couples discontinuing their treatment for psychological reasons, despite state funding being available. Similarly in Australia, Hammerberg et al. (2001) reported that the mean number of cycles started in their population was 3.0 even though funding was available for up to six cycles, indicating that lack of funding is not the sole reason for discontinuation of IVF treatment.

This study aims to determine the number of couples who discontinue assisted conception treatment over a 6 year period, and to identify major factors that influence this decision. This is based on questionnaire data collected from a large cohort of patients attending a single tertiary centre in the UK.

Materials and methods

A cohort of 1510 couples who underwent their first IVF/ICSI treatment cycle in the Assisted Conception Unit, Ninewells Hospital, Dundee, UK, over a 6 year period between January 1995 and December 2001 were identified. An average of 500 cycles is undertaken in the Unit each year providing both NHS and self-funded assisted conception treatment to five health boards. Up to three attempts are offered on NHS funding, and the waiting time to start the first and any subsequent attempts varies from 6 weeks to 2 years. A 6 year period was therefore selected to give a more complete reflection of discontinuation rates, as couples would have completed between two or three-NHS funded cycles in this time.

Questionnaire

The data for this study were obtained from a questionnaire, which was posted to all couples whose current address was available from the unit database. As the responses were anonymous, couples' medical records could not be examined.

The questionnaire had three parts, the first part was for demographic data, the second for details of their assisted conception treatment to date, and the third to determine if treatment had been discontinued and any reasons for this.

The first mailing of 1510 questionnaires was in January 2003 to couples who had completed at least two full cycles of treatment prior to the survey. Those who had first treatment cycle in 2001 would have completed their second attempt at the time of survey. In total, 183 (183/1510,12.1%) questionnaires were returned as address unknown or moved away, so up to 1327 questionnaires were received by couples. After an initial period of 4 months a total of 532 responses had been received. The questionnaire was therefore sent a second time, to the same couples, 6 months after the first. On this occasion it was again sent to all couples as it was not possible to tell who had responded the first time. Couples were instructed not to reply if they had already done so and it is assumed they complied with this. In all, 732 (732/1327, 55.2%) responses were received, an additional 200 returned from the second mailing.

Statistical methods

Most data handling and analysis was performed with the Minitab (v13) package. In general, the questionnaire was designed so that results could be recorded as frequency or percentage in each category of response. Approximate 95% confidence intervals (CI) were used to express the precision of estimates of population percentages.

The complete frequency distribution was obtained for discrete quantitative variables such as number of completed IVF treatment cycles. Some grouping of extreme values was made in cases where there were a large number of low frequency values in a long upper tail. Quartiles and extremes were used to summarize frequency distributions. Pearson's χ ²-statistic, with appropriate degrees of freedom, was used to test for independence between categorical variables. Odds ratios with 95% CI were used to compare probabilities of events in different subgroups of patients. For the results of test procedures and CI to be meaningfully interpreted and applied to a general population of couples who had experienced assisted conception, the sampling procedure used must be assumed to introduce no biases.

Ethics

All aspects of the study were given approval by the Local Medical Research Ethics Committee. All data were stored under the terms of the Data Protection Act 1998.

Results

A comparison was made between the responses received from the two mailings of the questionnaire, in particular for the variables: ages of female and male partner at start of treatment; number of IVF cycles started; number of frozen embryo transfers; and discontinuation of treatment. There was no appreciable difference between the responses of those who replied to the first mailing and of those who replied to the second mailing for any of these variables. The results from the two mailings were therefore pooled and analysed together for all 732 respondents.

As was to be expected, a large percentage (94%) of first treatment cycles was undertaken at Ninewells Hospital with similarly high percentages for the second (94%) and third (93%) attempts, which can be attributed to the stability of the local population. The percentage had dropped by the fourth and fifth and further attempts to 91 and 84% respectively.

Demographics

The mean age of the female partner of couples treated in the Unit during the study period was 36 (range 23-44) years, with the mean number of attempts being 3 (range 1-6) and a clinical pregnancy rate of 20.5%. The indication for IVF treatment included tubal factor (29%), unexplained infertility (36%), endometriosis (14%), anovulation (7%), and male factor (14%).

The median age of the female partner at time of response was 37 years and the age ranged from 24 to 48 years; for the male partners, the corresponding median age was 39 years, with ages ranging from 25 to 65 years. Overall, 9.6% of female partners and 15.3% of male partners already had one or more children, while in 5.6% of couples both partners already had children. A total of 575 (78.6%) couples reported primary subfertility. The median duration of subfertility was 4 years, the lower and upper quartiles were 3 and 6 years respectively, and it was ≥10 years in 8.7% of couples. Ninety-two per cent of female partners were between 26 and 40 years at first treatment. The mean live birth rate per attempt reported by the respondents was 16.8%.

Number of IVF treatment cycles started

Figure 1 gives the distribution of the number of IVF treatment cycles started. Of 732 respondents who made at least one attempt, 486 (67%) made two or more attempts, 303 (42%) made three or more attempts, 119 couples (16%) made four or more attempts and 48 (7%) made five or more attempts. NHS funding was available to 55-60% of couples in their first, second, third and fourth attempt, with the remaining couples funding themselves. Thirty-five per cent of those who had a fourth attempt and were funded by the NHS gave a history of a previous abandoned cycle.

Chances of successful IVF treatment

More than 95% of couples had discussed the chances of successful IVF treatment, i.e. of pregnancy. Their awareness of the success rate with number of attempts was elicited. The majority of couples appeared to have a reasonable awareness of the success rate with one attempt, which was given as 10-30% by 67% of couples. However, 10% of couples were not prepared to predict the success rate with one attempt. Couples' awareness of the success rate after three consecutive attempts appeared much poorer with 52% of couples quoting between 10-30%, and only 26% of couples quoting a more realistic value of ≥30%. The proportion of couples who did not venture a response to success rate with three attempts was somewhat higher than for success with a single attempt at 17%.

Counselling

Sixty-seven per cent of the respondents recalled being offered counselling; however, only 20% of couples saw an independent counsellor at the Assisted Conception Unit. Of those who stated that counselling had not been offered, 153 of the 187 respondents (82%) felt it should have been.

Discontinuation of treatment

Of the 732 responding couples, 513 (70%) had discontinued IVF treatment while the remaining 217 were considering further treatment. Of these, only 71 (71/217, 32.7%) were on an NHS waiting list for further treatment cycles. A total of 247 patients of the 732 respondents (34%) had discontinued treatment without achieving a pregnancy.

Table I shows the number of couples who undertook exactly 1, 2, 3 or ≥4 cycles along with the total number who dropped out, the number who achieved a live birth, and those who did not become pregnant but discontinued treatment in each of these groups. The drop-out rate was 70% overall and per attempt it was lowest at 66% for those who had undergone two treatment cycles to date and highest at 79% for couples who had undergone three cycles.

Reasons for discontinuation of treatment

Fifty-two per cent (266/513) of those discontinuing treatment had achieved a pregnancy, with the remaining 48% couples discontinuing treatment without doing so. Percentages for each of the reasons suggested for discontinuing treatment in the questionnaire are shown in Figure 2. Most couples gave more than one of these reasons.

Lack of personal or NHS funding was cited by 23% of couples as a reason. Lack of success and psychological stress were reported as factors by 23 and 36% of couples respectively. These two factors are very strongly associated ( P < 0.001), both being reported by 18% of couples. Other reasons, which include change in personal circumstances, were reported by 30% of couples. Less than 10% of couples gave general discomfort or advice from medical staff and others as reasons.

Reasons for discontinuation by number of treatment cycles

Table II gives the percentage of couples discontinuing treatment after each started attempt from first to fourth or later attempt for each of the suggested reasons. For each reason, the χ ²-test with 3 degrees of freedom was used to investigate whether it would be reasonable to suppose that the drop-out rate was the same at every treatment cycle. The P-values for these tests are also given in Table II.

There was a reduction in the percentage of couples discontinuing treatment because of pregnancy with increasing number of treatment cycles ( P < 0.0005). This reflects that the success rate decreases with each further attempt. There was a reciprocal increase in the percentage of couples quoting lack of success ( P < 0.0005) and in those reporting psychological stress ( P < 0.0005) as reasons for discontinuing treatment with increasing number of attempts.

Drop-out due to personal financial difficulties showed an increase with number of cycles, particularly after the second attempt ( P < 0.01), whereas drop-out reported from lack of NHS funding appeared roughly constant across all cycles ( P = 0.48) averaging out at 19%. There was a noticeable increase with number of attempts in drop-out in those couples obtaining others' advice ( P = 0.037) but no real change with number of attempts in drop-out from discomfort ( P = 0.60). The percentage of couples who gave 'other' reasons was effectively constant at 30% with increasing number of attempts ( P = 0.17).

Age of female partner at discontinuation of treatment

Age at discontinuation of treatment did not appear to have a great impact on the percentage of those giving any of the listed reasons for discontinuing treatment. However, the female partner was significantly younger on average for those couples who stopped treatment after the first attempt than for those who had more than one treatment cycle ( P < 0.0005). This was still true even when the couples who achieved pregnancy were omitted ( P < 0.001).

Single versus multiple reasons for discontinuation of treatment

Of the 513 respondents who had discontinued treatment, 250 couples gave only one reason (group 1). This was listed as pregnancy achieved in 71% of this group, while other personal reasons were quoted by a further 17% (Figure 3). None of the other listed reasons was cited by >3% of couples in this group.

Where more than one reason was cited (group 2 comprising 263 couples), the percentages of couples indicating each of the listed reasons is shown in Figure 3. Psychological stress was reported by 69% of these couples. Interestingly 25% of this group had also achieved a pregnancy but did not wish to consider further treatment because of other indicated reasons.

The most commonly cited pair of reasons for discontinuing treatment was psychological stress and lack of success.

Discussion

Several studies have reported rates of discontinuation of IVF treatment. In The Netherlands, where state funding is available for up to three attempts, the drop-out rate after three cycles was reported as 62.4% ( Land et al., 1997), while in Sweden, Olivius et al. (2004) reported a drop-out rate of 54% even though funding was still available to these couples. In the UK the drop-out rates are reported to be higher ( Templeton et al., 1996) as very little and disparate NHS funding has been available to most couples. However, even in the UK, Emery et al. (1997) reported a high drop-out rate from a clinic where funding was available to couples. Studies have shown that both female and male partners give evidence of stress while undergoing IVF treatment ( Boivin and Tafekman, 1995) while others have shown that the aspiration and waiting to become pregnant can be more stressful than the treatment itself ( Laffont and Edelmann, 1994b).

This study was carried out in an Assisted Conception Unit in Scotland, where NHS-funded assisted conception treatment has been available for two or three fresh attempts within set eligibility criteria, along with self-funded treatment. The aim of the study was to estimate the actual discontinuation rates in an assisted conception programme over a 6 year period. The response rate to the survey questionnaire was 55%, with 266 (36%) couples discontinuing treatment after achieving a live birth. Thirty-four per cent (247/732 respondents) had discontinued treatment without achieving a pregnancy in the 6 year period.

A couple's decision to discontinue treatment is probably due to a complex interplay of factors. Several potential factors were included in the study, so those which are relevant could be identified and highlighted. In this cohort ∼70% of the respondents had more than one treatment attempt, in contrast to previously published data ( Templeton et al., 1996). NHS funding was available to ∼55-60% of the couples up to the fourth attempt and undoubtedly has contributed to 40% of couples having up to three attempts, unlike previous data suggesting only 30% of couples have more than one attempt. Though NHS funding is usually for up to three attempts, reported funding of a fourth attempt may reflect previous abandoned cycle. Despite funding being available for up to six cycles in a population in Australia, the mean number of cycles started in that study was 3.0 regardless of achieving a live birth ( Hammerberg et al., 2001). This study also confirms that lack of funding is not the sole or main reason for discontinuing treatment. Seventy-two per cent of the respondents in this study had discontinued treatment at the time of the response, with 52% of those discontinuing after achieving a live birth. Of those still considering treatment, only one-third were still on a waiting list, implying that the decision to continue treatment was not based solely on funding issues.

Couples had a good awareness of the estimated chances of a live birth with one attempt of IVF treatment, though their awareness or understanding of the cumulative live birth rates with three or more attempts was poor. Counselling is offered to all couples before, during or after treatment, both in a written information pack, and during consultations. Only 67% of couples recalled that counselling had been offered, while 20% saw an independent counsellor in the unit. This is similar to the experience of previous researchers ( Boivin, 1997; Hammerberg et al., 2001). Although patients may express an interest in taking up counselling, the actual take-up rate is <25%. However, they are reassured to know that counselling is available ( Laffont and Edelmann, 1994a).

An increasing number of attempts was linked to increasing personal financial strain, though lack of NHS funding after the third attempt did not significantly influence the drop-out rate. Physical discomfort or disruption had no apparent impact on the decision to discontinue. The observed increase in the drop-out rate for 'other reasons', including changed personal circumstances after the third attempt had failed, was not significant. Medical advice or advice from family and friends played a minor role. In this study, the age of the female partner was lower in those who discontinued treatment after one attempt, indicating that prognosis was not a major factor influencing their decision to stop treatment despite failing to achieve a pregnancy.

The three most significant factors influencing the decision to discontinue treatment appear to be decreasing pregnancy rates, the continuing lack of success, and the psychological stress associated with increasing number of attempts. Similar findings of increasing despair after repeated unsuccessful cycles of IVF have been reported in a recent qualitative study by Peddie et al. (2005). In summarizing the relationship between stress and infertility, Domar (2004) reported that the most common reason for termination of treatment was psychological burden. Other studies have shown that psychological stress was the most common reason for discontinuing treatment ( Goldfarb et al., 1997; Olivius et al., 2004) and may have an impact on treatment outcome ( Klonof-Cohen, 2001; Smeenk et al., 2001). Emotional stress is inherent to infertility itself, with this study showing the increasing degree of distress following failure to conceive after consecutive attempts of IVF treatment. A previous study has shown that women find a negative pregnancy test, waiting for the result and the wait between attempts to be the most stressful stages of IVF ( Laffont and Edelman, 1994b). More support should be considered from providers of IVF treatment at these stages, though whether it will ameliorate anxiety needs evaluation.

This study highlights the fact that couples need clear and individualized information about their treatment to make an informed decision, which should be restated between attempts. The information regarding the cumulative live-birth rates following three or four attempts at IVF treatment was not well understood by this group of patients. A better understanding of this information may help in coping with failures after repeated attempts and help to reduce the psychological stress that this unavoidably causes. Whether better uptake of counselling services will reduce the drop-out rate is not clear, though couples need to know that it is available. While the efficiency of IVF treatment is improving, it does not guarantee a successful outcome. Health care providers involved in assisted conception treatment need to be more aware of the psychological stress associated with repeated attempts at IVF and strategies to improve outcome and support to couples need to be considered.

Acknowledgements

We are indebted to our patients who took time to respond to the questionnaire. This study was supported by a grant from Ferring Pharmaceuticals.

References

Author notes

1Assisted Conception Unit, Ninewells Hospital & Medical School, Dundee DD1 9SY and 2Department of Mathematics, Dundee University, Dundee, UK

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Reasons for discontinuation of IVF treatment: a questionnaire study

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BACKGROUND: IVF and embryo transfer has become an established and increasingly successful form of treatment for infertility, yet significant numbers of couples discontinue treatment without achieving a live birth. This study aims to identify major factors that influence the decision to discontinue IVF treatment.

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Capture ideas you wish to save for future projects here.

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Collaborative Commissioning (England)

Fertility Fairness is keen to assist commissioners wherever possible, in order to help them commission fertility services effectively and efficiently. Our 2011 patient survey found that whilst more than half of GPs were perceived to hold the necessary information of infertility and the treatment options available to provide an effective service, a significant number still lacked this vital knowledge.

As the 'gatekeepers' of NHS services, it is essential that GPs are well informed when it comes to the causes of, and treatments available for, infertility. Lack of information in this area of medicine has, at times, contributed towards to a lack of interest at commissioner level. If commissioners do not address this knowledge gap, there is a danger that fertility services could become marginalised.

GPs play a leading role on CCG governing boards and they are expected to commission a number of services of which fertility is just one. They are directly responsible for managing around 60% of the total NHS budget, which they must ensure covers the health needs of their entire local population. Consequently, commissioners are placed under enormous pressure to allocate funding appropriately.

Recognising this challenge we recommend the following - that commissioners:

Always seek to collaborate with neighboring CCGs in order to save on procurement costs and minimise variations in access

Always consult service users in the run up to any change in policy

Always consult with medical staff in the primary, secondary and tertiary care setting before making a change to a policy

Always use the 2013 NICE guideline as the basis for local policies

Challenge the cost per cycle quoted by providers and compare to other regions when procuring tertiary fertility services

Publish all details regarding their assisted conception policy on their CCG website (even if the policy is in the process of being updated)

Communicate proposed changes to GPs working in the community well in advance of the change taking place

And in so far as is possible:

Notify Fertility Fairness and Fertility Network UK of a change in policy or an upcoming consultation via our contact page.

Measuring provision and increasing transparency (England)
Fertility Fairness will be issuing Freedom of Information requests to your CCG on an annual basis. We do this to compare provision across the country.
The reason we have to do this is that many CCGs do not publish their assisted conception policies on their website. Sometimes a policy is published online, but it can be 'lost' amongst a variety of other policies and this is often very confusing for patients who deserve to know what their local level of provision is. Fertility Fairness therefore urges commissioners to publish all information relating to their assisted conception policy even if it is in the process of being updated.

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Collaborative Commissioning (England) Fertility Fairness is keen to assist commissioners wherever possible, in order to help them commission fertility services effectively and efficiently. Our 2011 patient survey found that whilst more than half of GPs were perceived to hold the necessary information of infertility and the treatment options available to provide an effective service, a significant number still lacked this vital knowledge.

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Acronyms are common in the medical world, and it's no different when it comes to fertility treatment. Don't be outfaced by the jargon - read our clear explanations of the different treatment options, who they're suitable for and the risks involved.
Explore fertility treatments
Preserving your fertility involves freezing your eggs, sperm, embryos or reproductive tissue so that you can hopefully have a biological family in the future. Read about why you might want to preserve your fertility and the different treatment options available.
Find out about fertility preservation
If you have a serious inherited disease in your family, embryo testing and treatments can be used to avoid passing the disease onto any children you might have. Find out about your options and the things to consider.
Find out about embryo testing and treatment
You might be thinking about going to another country for treatment because the price is often lower. Find out about the important issues to consider when thinking about this option and where to go for advice on finding a clinic.

Find out more about treatment abroad

Fertility treatments are generally very safe. However, there are some risks to be aware of, which range from mild discomfort to more serious conditions. Understand all the risks and what you need to look out for.

Find out more about risks of fertility treatment

If you can't use your own eggs and/or sperm, you're in a same sex couple, or you're a single woman, you can have fertility treatment using donated eggs, sperm or embryos. Find out more about using sperm, eggs or embryos from a donor.

Find out more about using a donor

Your clinic may offer you optional 'extras' on top of your normal fertility treatment, often at an additional cost, but not all of these have been proven to be effective. Find out more about what these treatments involve and what evidence there is for them so you can make an informed decision.

Complementary and alternative therapies may be suggested to patients undergoing fertility treatment to help with relaxation or general wellbeing. This page explains what these therapies are and the costs of them.
Find out more about complementary and alternative therapies
If you need to have fertility treatment you have two options: you can either pay for it yourself or you can see if you're eligible for treatment on the NHS. Find out more about your options.
Find out more about costs and funding for fertility treatment
If you're travelling to, or have been to, a country or area with a risk for Zika virus transmission, there are some precautions you should take. Read the guidance from Public Health England.

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The most important thing you can do when making decisions about fertility treatment is to ensure you are well informed. Get clear, impartial information on the different types of fertility treatments available and find out about costs and funding, the risks of treatment, using a donor and having treatment abroad.

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https://academic-oup-com.ezproxy.cul.columbia.edu/humrep/article/21/5/1110/987107

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legacy of HEFA 2013

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Implementation of NICE guidelines for ART

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Irresponsibly infertile

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Background

Infertility is common and in vitro fertilization (IVF) is a widely used treatment. In IVF the need increases and the effectiveness and appropriateness decrease by age. The purpose of this study was to describe allocation of resources for IVF by women's age, socioeconomic position, area of residence and treatment sector (public vs. private) and to discuss how fairly the IVF resources are allocated in Finland.

Methods

Women who received IVF between 1996 and 1998 (N = 9175) were identified from the reimbursement records of the Social Insurance Institution (SII). Information on IVF women's background characteristics came from the Central Population Register and the SII, on treatment costs from IVF clinics and the SII, and on births from the Medical Birth Register. The main outcome measures were success of IVF by number of cycles and treated women, expenditures per IVF cycles, per women, per live-birth, and per treatment sector, and private and public expenditures. Expenditures were estimated from health care visits and costs.

Results

During a mean period of 1.5 years, older women (women aged 40 or older) received 1.4 times more IVF treatment cycles than younger women (women aged below 30). The success rate decreased by age: from 22 live births per 100 cycles among younger women to 6 per 100 among older women. The mean cost of a live birth increased by age: compared to younger women, costs per born live birth of older women were 3-fold. Calculated by population, public expenditure was allocated most to young women and women from the highest socioeconomic position. Regional differences were not remarkable.

Conclusion

Children of older infertile women involve more expense due to the lower success rates of IVF. Socioeconomic differences suggest unfair resource allocation in Finland.

Live Birth

Socioeconomic Position

Infertility Treatment

Medical Birth Register

Dydrogesterone

IVF is costly and in countries where IVF is offered only in the private sector its availability depends on a couple's ability to pay [, ]. In France, where IVF costs are fully covered by public resources, the use of IVF did not differ according to women's socioeconomic position []. In countries where IVF services are offered both in the public and in the private sector, wealthy couples can shorten their waiting times by using services in both sectors []. In Finland, the private sector is an important provider of IVF: over 60% of all IVF treatments are provided by private clinics []. However, the use of private services is partly covered by national health insurance: 60% of doctors' fees and a part of the cost of the examinations are reimbursed according to a fixed scale of charges. The part of the fee that exceeds the fixed charge is not reimbursable. In the public sector, patients pay a small user charge for their clinic visits. In both sectors about 50% of the drug costs are reimbursed by the Social Insurance Institution.

The cohort of women having received IVF between 1996 and 1998 in Finland (N = 9175) has already been described [], as well as their background characteristics []. In brief, using a pre-designed algorithm (presented in detail earlier, []), women were identified from the reimbursement files of the Social Insurance Institution (SII), which covers the whole Finnish population. According to the algorithm all women born between 1940 and 1981 having received reimbursements for any of the drugs in the following groups during the 1996-1998 period were picked from the Drug Register: clomifen, gonadotrophin, GnRH-agonist, and a progesterone drug Lugesteron. For the women having bought drugs in the above-mentioned groups, drugs from the following groups were additionally included: human chorionic gonadotrophin, eastradiol and a progestin drug (dydrogesterone). For each woman the treatment cycles were formed by using this drug data. The cycles were linked to the Procedure Register, with codes for ovum pick-up, cultivation of ovum, intracytoplasmic sperm injection, and embryo transfer. By using all the gathered information, the cycles were classified into other ART (assisted reproduction including ovulation induction with or without insemination) and IVF by using the specific inclusion criteria [].

Private expenditures include costs paid by the woman (excluding reimbursements from the SII). Public expenditures include costs paid by the health care system (excluding user charges). All costs and reimbursements have been inflated to correspond to 2005 prices (in euros) using a consumer price index compiled by Statistics Finland.

Data on women were linked to the Finnish Medical Birth Register to identify live births resulting from IVF. Data on identified children were linked to other health care registers until the end of 2004 to follow-up the health of IVF children []. To measure treatment success, live births per initiated cycle (all live births per all cycles) and per treated woman (only one live birth per woman) were calculated. Multiple pregnancies with two or more live infants were calculated as one. The mean price of different types of IVF cycles by care sector were calculated as well as private, public, and total expenditures by women's background characteristics and by live births. To count expenditure by population groups to show distribution of IVF expenditures across all women in the total population, we used the mean population of females aged 20-49 in Finland by socioeconomic position and area of residence according to census information for 1995 and 2000 available from Statistics Finland. Men were not included, because regardless of male or female factor infertility, in most cases the women are treated (drugs, ovum pick-ups, and embryo transfers) and expenditures of treatments (also ICSI) are billed from and reimbursed to the women. The actual distribution of costs within the family was not available.

The study plan was approved by the STAKES research ethics committee (18 th September 1998). For register linkages, the National Data Protection Authority was consulted and permissions from the registry keepers obtained.

During the mean 1.5 year study period, IVF women received on average 2.7 cycles (Table ) resulting in at least one live birth for 40% of women (Table ). The success rate per cycle was on average 15%.

The costs of different types of IVF cycles are given in Table . Of the total IVF costs, 36% came from drugs, 21% from interventions, and 42% from other direct costs (data not shown). During the mean 1.5 year follow-up, total costs per treated woman were EUR 6500, of which 40% were paid by women themselves (from private sources) and 60% from public sources (data not shown). In the private sector, the out-of-pocket payment was 50% and in the public sector 24% of total expenditures. The cost of a live birth was on average EUR 16 000 (Table ). In the population-based calculation showing the distribution of IVF expenditures across the whole population of fertile-age women(aged 20-49), the expenditures during the study period of 1996 to 1998 were EUR 60 per woman (Table ), of which EUR 24 were paid by women themselves and EUR 36 from public sources.

The use, success and expenditures of IVF were age-dependant. Numbers and rates of women having received IVF were highest among women aged 30-34 (Table ), but the treatment was more intense for older women (number of cycles per woman) (Table ). The success rate per cycle and per woman decreased by age (Table ); the number of needed cycles for live birth increased by age (Table ). The higher treatment intensity among older women did not compensate for the lowered success rate, and about 47% of women aged under 30 and only 17% of women aged 40 or older succeeded in achieving a live birth after the treatment period (mean 1.5 years) (Table ).

The use, success and expenditures of IVF also varied somewhat by socioeconomic position. Women from the highest socioeconomic position received more cycles and on a population-based examination used IVF twice as much as the blue-collar women in every age-group (Table ) as well as spent more of their own money for IVF treatment compared to blue-collar women regardless the age of the women (data not shown). About 25% of white-collar women aged under 30 succeeded in achieving a live-birth, but only 19% of blue-collar women after the mean 1.5 year treatment period succeeded (Table ), while the number of needed cycles per live birth among blue-collar women was higher. Except for the oldest women, the total expenditure and the proportion of public expenditure were higher among blue-collar women than among upper-white collar women (Table ). Due to the higher use of IVF, in every age group, the public expenditure was about two-fold for upper white-collar women compared to blue-collar women (Table ).

Among infertile women in the care system, older women with poorer success rates (i.e. increased need) received more treatments, and expenditures per live birth were much higher among them than among younger women. The expenditures per population were lower among older women, since fewer older women were treated. Because no data relating to the desire for a child by age were available, it is not certain whether all younger and older women wishing to have a baby were in the IVF care system. Women from a higher socioeconomic position had more often used IVF care, and total and societal costs per population were higher than among women from the lower socioeconomic position. Regional differences were not remarkable.

Traditionally the discussion on unfairness in health care has focussed on socioeconomic position and gender and less on age. As expected, there were fewer older than younger women in the care system, because childbearing is usually started earlier than 35 years. The mean age of maternity is 30 years in Finland []. However, if older women sought IVF treatment, they received more cycles because of lower success, and the expenditure of a live-birth increased according to age due to the increased number of cycles and amount of expensive drugs in the cycles. Pregnancy and birth complications and poor foetal outcomes in general increase by age [, ] suggesting that expenditures of pregnancy and child birth of older women would also increase by age. Thus, if IVF resources are scarce, it would be wise to concentrate on treating younger women. On the other hand, it can be argued that age should not be a reason to turn women away from IVF, because for older women, IVF may offer the last chance to become pregnant and have a child []. Should older women with greater need receive more resources than younger women? From a public health perspective treating older women with increasing costs and risks and decreasing success of IVF is not wise. Furthermore, if the older women's desire for children increases i.e. care seeking increases, which has already been reported in the United Kingdom [], the problem of resource allocation will grow in the future. Both the scarce health care resources and the increasing need for prioritisation speak for focusing treatments on women in their normal childbearing age.

In Finland, over 60% of IVF treatments are provided in the private sector and women from the highest socioeconomic position are overrepresented in the private sector []. In spite of the reimbursement of private services, the private expenditure remains higher i.e. more of women's own financial resources are needed for treatments in the private sector compared to the public sector. The use of private services is likely to create unfairness also in Finland. However, the unfairness is smaller than in countries where IVF is not covered by health insurance [, ]. In the United Kingdom where 80% of IVF is given in the private sector, authorities have warned that IVF is becoming more commercial and people with insufficient income are in danger of remaining without treatments []. According to the review by Dawson et al.[], the most common reasons for inability to obtain IVF treatment have been financial.

For some infertile couples the adoption of a child is an alternative to infertility treatment. However, adoption is costly for couples, too. In Finland, only foreign adoptions are available. It can be argued that, if a part of the costs of infertility treatments are covered from public funds, the adoption costs should be covered, too. In the late 1990s Finnish couples had to pay all the expenditures of adoption themselves, but since 2003 parents adopting a child from abroad can claim an adoption grant from the Social Insurance Institution to offset some of the adoption cost. The adoption grant is a tax-free, one-time payment. Its amount depends on the child's country and varies between EUR 1900 to EUR 4500. According to present study, the society covers about 60% of IVF expenditures i.e. EUR 9600 per IVF live birth, which is about 2- to 5- fold compared to the coverage of adoption.

It is difficult to determine an optimal and equal age to stop the resource allocation for IVF. Treatment of selected women aged 40-43 has been found to be quite successful [, ] and natural pregnancies also occur for women in their forties. However, a given age-limit could be a signal that encourages women to attempt to give birth during the normal fertile age. Social and family policy should promote circumstances that are suitable for childbearing at a young age. As Chavkin [] and Stillman [] have pointed out that this is a big challenge especially for countries that lack policies supporting parents who both work.

This study shows that the resources used for IVF varied by women's age and socioeconomic position. IVF-children of older women involve more expense due to the lower success rates of IVF. Women from higher socioeconomic positions used more IVF resources than other women. Women and men need information on declining fertility by age as well as the complexity of IVF. Causes of unequal use of IVF services should be studied further, and resource allocation for high technology should be made transparent.

Mika Gissler, Tiina Sevón and Elina Hemminki contributed equally to this work.

Acknowledgements

The study was supported financially by the Academy of Finland (number 73159), the Social Insurance Institution, the Ministry of Education (The School of Doctoral Programs in Public Health), and the National Research and Development Centre for Welfare and Health.

We thank the two IVF clinics for providing their price lists and IVF costs to us.

Electronic supplementary material

Competing interests

The authors declare that they have no competing interest regarding this nationwide register-based cohort study.

Authors' contributions

RK collected and analysed the data and drafted the manuscript. MG contributed to conception and design of the study and interpretation of the data. TS participated in the design and analysis of the study. EH made substantial contributions to conception and design of the data as well as interpretation of the data and helped in drafting the manuscript through critical revision. All authors read and approved the final manuscript,

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Resource allocation of in vitro fertilization: a nationwide register-based cohort study

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Infertility is common and in vitro fertilization (IVF) is a widely used treatment. In IVF the need increases and the effectiveness and appropriateness decrease by age. The purpose of this study was to describe allocation of resources for IVF by women's age, socioeconomic position, area of residence and treatment sector (public vs.

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Ethics and HEFA

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Patient perception of HEFA

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Role of HEFA

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EBSCO

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PUBLIC HEALTH

Public health is the societal approach to protecting and promoting health. Generally through social, rather than individual, actions, public health seeks to improve the well-being of communities. By maintaining a safe water supply, immunizing schoolchildren, or engaging in epidemiologic research, public health seeks to ensure societal conditions under which people can lead healthier lives, 1 minimizing threats to our health "that can be averted or lessened only through collective actions aimed at the community." 1(p20) The providers of public health interventions often are governments, rather than private practitioners. Indeed, the provision of health services, generally the domain of medicine, becomes the responsibility of public health departments when services are provided by public clinics or hospitals.

Public health interventions date back more than 3 centuries. In 1701, Massachusetts passed laws for isolation of smallpox patients and quarantine of ships. 1(p57) In the early 1800s, Edward Chadwick demonstrated in England that differences in social conditions led to a more than 2-fold difference in life expectancy between upper and lower classes. Also in the 1800s, Lemuel Shattuck, in Massachusetts, implemented the first system of vital health statistics. 2 Governments began conducting investigations of housing conditions and garbage heaps and mapping them in relation to outbreaks of disease, 2 and by the end of the 19th century, state and local boards of health were being created to enforce sanitary regulations. 1(pp60-61)

By the early 20th century, public health was seen as cost-effective as well as useful, 2 and more money was directed to public health programs. During World War II, given the need for a healthy population for the military, the US Public Health Service established the Center for Controlling Malaria in the War Areas, later the Centers for Disease Control and Prevention. Epidemiology developed as the science of public health, to study "the distribution and determinants of health-related states or events in defined populations and [to apply this knowledge] to the control of health problems." 3(p4)

Today, public health practitioners use tools in addition to epidemiology to accomplish their work, still focusing primarily on communitywide, typically prospective, approaches to improve health. Some public health functions-surveillance, vital statistics, disease and injury reporting, and disease registries-relate to epidemiology and the collection of data. In addition, practitioners investigate outbreaks, conduct contact tracing, provide health education and other preventive interventions, and conduct research related to public health. Last, public health professionals sometimes create or enforce health-related regulations and legislation, for example, mandating screening, treatment, immunizations, or-rarely-quarantine.

States' authority to pass laws to improve the public's health dates to the 19th century and is referred to as the "police power": "coercive action under state authority to encourage educational efforts . . . seize property, close businesses, destroy animals, or involuntarily treat or even lock away individuals." 4(p42) These various public health tools and functions, while together successful in decreasing morbidity and mortality, nonetheless raise questions of ethics in terms of the means by which these successes are achieved.

BIOETHICS AND PUBLIC HEALTH

Bioethics helps health professionals and public policymakers recognize moral dilemmas in health care and biomedical research and provides principles and moral rules with which to navigate through these dilemmas. (A framework of bioethics based on principles, as put forward by Beauchamp and Childress, 5 will be used here. However, there are many other bioethical frameworks, including, for example, ethics of care, casuistry, and virtue-based ethics.)

Dating to the 1960s and 1970s, bioethics grew out of questions of fairness in resource allocation, moral issues raised by new technologies, and a lack of oversight in human-subjects research. The public was swept up in debate about whether the first artificial kidney center should allocate scarce resources on the basis of social criteria and whether Karen Ann Quinlan should be kept alive artificially when she had no meaningful cognition.

In 1969, the Institute of Society, Ethics, and the Life Sciences (now the Hastings Center) was created to address questions of bioethics and to provide frameworks with which to analyze contemporary moral dilemmas in medicine and science. 6 In 1974, after several reports of US government-sponsored research that compromised the rights and welfare of study subjects, a new national commission issued the Belmont Report, which included ethics principles to guide the conduct of human subjects research-beneficence, respect for persons, and justice. 7 Early framers of bioethics elaborated on these principles and provided examples of how they were useful in analyzing dilemmas from other areas of health care, not just research. 5

These early framers argued that, a priori, no principle ought to have moral superiority over any other. At the same time, the issues that animated bioethics in the early years-the need to tell patients and research subjects the truth, the patient's right to refuse care or research participation-were ones in which the principle of respect for autonomy, perhaps given too little moral attention previously, was now given preeminent moral status. 8-10 Informed consent, a practical application of the autonomy principle, became a hallmark of the new bioethics, and codes of ethics for clinical practice, while still emphasizing the need not to harm the patient, added clauses requiring physicians to "best care for the dignity of man in patients or research subjects." 11(p21)

That contemporary medical ethics or research codes have made the right to noninterference central is understandable, given the context out of which they emerged. That public health practitioners, lacking guidelines of their own, must turn to these same codes for professional moral direction, however, is more problematic. In rare instances, existing medical or research codes do discuss traditional public health functions, such as breaching patient confidentiality to report diseases to the state. 12 In such instances, however, the physician's behavior is presented as an allowable exception to usual ethics rules in the name of public health.

At best, this leaves public health professionals needing to muddle through most other situations on their own; at worst, it could lead them, or even the public, to assume that public health is the branch of health care sanctioned by bioethics to make exceptions to existing ethics rules at will, in the name of public health and safety. Indeed, it is in great part because such power is vested in public health by law that a code or framework of ethics designed specifically for public health is so very important. The need for a code of ethics for public health, then, might be viewed as a code of restraint, a code to preserve fairly and appropriately the negative rights of citizens to noninterference.

A code or framework of public health ethics must emphasize positive rights as well, however. Public health has affirmative obligations to improve the public's health and, arguably, to reduce certain social inequities. A code of public health ethics is needed to address such social justice functions of public health. While frameworks have been put forward in medicine to help clinicians think through the ethical issues in a clinical case, 13, 14 no analogous framework is available for public health practitioners.

We live in a morally pluralistic society, and it is inevitable that moral appeals will conflict when attempts are made to determine appropriate public policy. A framework for public health ethics will help public health professionals recognize the multiple and varied moral issues in their work and consider means of responding to them.

AN ETHICS FRAMEWORK FOR PUBLIC HEALTH

A 6-step framework is proposed for consideration. Components of this framework were proposed in an earlier article, 15 and a similar framework was proposed for public health and human rights by Gostin and Lazzarini. 16 This is not a code of professional ethics, which more likely would address general norms and expectations of professional behavior and probably would be the product of a professional society. Rather, this is an analytic tool, designed to help public health professionals consider the ethics implications of proposed interventions, policy proposals, research initiatives, and programs.

1. What are the public health goals of the proposed program?

The first step for any proposed public health program is to identify the program's goals. These goals generally ought to be expressed in terms of public health improvement, that is, in terms of reduction of morbidity or mortality. For example, an HIV screening program should have as its ultimate goal fewer incident cases of HIV, not simply that a certain proportion of individuals will agree to be tested. A health education program in cardiac risk reduction should have as its ultimate goal (or the ultimate goal of a larger program of which it is a part) that individuals will have fewer heart attacks, not simply that individuals will learn new information or even that they will change their behavior. A research study should have as its ultimate goal (or the ultimate goal of a larger trajectory of which it is a part) that findings, if positive, will be implemented with the target population and improve its health status.

While more proximate and process goals (such as whether individuals will learn health information or whether they will agree to be tested) are critical pieces of program planning and evaluation and may be crucial to achieving health improvement, the fundamental goal of decreased morbidity and mortality is the outcome by which the program or series of programs ultimately must be assessed. This is not to say that each individual program or research study must achieve this end. Epidemiologic studies may provide descriptive data that lead scientists years later to develop an intervention that will result in a reduction in morbidity or mortality; a health education program may be one of multiple and varied interventions that together reduce risks and ill health. The argument put forth here, however, is that public health programs, interventions, or studies must be designed with an awareness of the relationship between this program and an ultimate reduction in morbidity or mortality.

Of course, other types of benefits, generally social benefits, can accrue from public health programs as well. Public health programs can result in greater employment, for example, as well as less tangible benefits, such as coalition-building or the strengthening of communities. These benefits are extremely important and should be given strong consideration. They are, however, the incidental or intermediary outcomes of public health programs, rather than the programs' final goal. If a program has as its goal to increase employment as an end in itself (rather than, for example, to increase employment as a means to lower psychological morbidity or as a means to improve socioeconomic status and therefore lead to improved health) or to strengthen communities (rather than to strengthen communities as a means to decrease interpersonal violence or as a means to help watch out for the well-being of the young or old persons in the community), then the program is primarily a social program, not a public health program.

As described further below, a reduction in morbidity and mortality need not and could not be the goal of every individual public health intervention or program; however, individual public health programs should not be undertaken that are not part of a larger package of programs whose combined goal is the reduction of morbidity and mortality.

According to this view, an intervention whose goal is to improve access to care among hard-to-reach populations has an extremely relevant public health goal, assuming, of course, the program is effective in improving access. Other examples of interventions designed to reduce social inequalities will be discussed further in step 5.

Also relevant when we consider public health goals and benefits is to whom the benefit will accrue. Public health interventions often are targeted to one set of individuals to protect other citizens' health. Partner notification programs and directly observed therapy for tuberculosis are designed primarily to protect citizens from the health threats posed by others. In some contexts, public health programs are designed primarily to protect individuals from themselves, revealing that much of public health is inherently and unabashedly paternalistic. Health education campaigns, blood pressure screening, seat belt laws, and 55-mile-per-hour speed limits, while motivated in part by social concerns about costs, are, I suggest, motivated primarily to further individuals' ability to protect their own health. Restricting someone's liberty to protect him- or herself and restricting liberty to protect another person pose different ethical burdens, discussed further in step 3.

2. How effective is the program in achieving its stated goals?

Proposed interventions or programs are based on certain assumptions that lead us to believe the programs will achieve their stated goals. Step 2 asks us to examine what those assumptions are and what data exist to substantiate each of them. A cardiac risk reduction program has as its ultimate goal the reduction of fatal and nonfatal cardiac events. The assumptions of this education program (or the larger effort of which it is a piece) are that the program will reach individuals at risk for cardiac events; those individuals will learn the risk reduction messages; individuals will change their behavior (e.g., stop smoking, change diets, increase exercise) in ways suggested by the program; these changes would not have occurred without the program; and the behavior change in itself will result in fewer cardiac events.

While many health education programs are very effective at transmitting information that recipients learn and understand, programs generally are less successful at inducing behavior change. 17, 18 Thus, while a rather narrow evaluation may demonstrate success (in terms of participants' understanding the message), a program ultimately cannot claim success if behavior is unaffected and morbidity and mortality rates remain unchanged.

This is not to suggest that each program must reduce morbidity by itself. Individual health education or screening programs, for example, might be pieces of larger initiatives to reduce cardiac morbidity and mortality. Data may show that multiple education campaigns in different formats and with different messages are required to induce widespread behavior change. Multidimensional efforts are appropriate and useful, if data show that the combination is likely to evoke the desired result. Again, however, if the multiple approaches are simply hypothesized or assumed to reduce illness events, then further research must be done; a public health program is not yet justified.

This step of examining existing data to challenge our assumptions and implement only data-based policies or programs is often neglected in public health. One can assume that this is not because professionals are indifferent to whether their methods relate to their outcomes, but because we simply assume that they do, and we neglect to find data that prove us right or wrong. Thus, we introduce a program based on the assumption that some number of people who learn that cigarettes cause asthma and lung cancer will quit smoking, or we call for HIV screening because we assume that individuals who learn they are infected will begin to use condoms in sexual relationships. It is when our assumptions seem most intuitively obvious that we are at greatest risk of neglecting to determine to what extent they are supported by real evidence.

While all programs must be based on sound data rather than informed speculation, the quality and volume of existing data will vary. The question for policy and ethics analysis, then, is what quantity of data is enough to justify a program's implementation? As a rule of thumb, the greater the burdens posed by a program-for example, in terms of cost, constraints on liberty, or targeting particular, already vulnerable segments of the population-the stronger the evidence must be to demonstrate that the program will achieve its goals. Indeed, because many public health programs are imposed on people by governments and not sought out by citizens, the burden of proof lies with governments or public health practitioners to prove that the program will achieve its goals. Thus, if at least some data do not exist that demonstrate the validity of a program's assumptions, the analysis can stop right here, and, ethically, the program should not be implemented. Conversely, the presence of good data alone does not justify the program; it allows us to move to the next stage of the analysis.

3. What are the known or potential burdens of the program?

If data suggest that a program is reasonably likely to achieve its stated goals, then the third step of the framework asks us to identify burdens or harms that could occur through our public health work.

Although a variety of burdens or harms might exist in public health programs, the majority will fall into 3 broad categories: risks to privacy and confidentiality, especially in data collection activities; risks to liberty and self-determination, given the power accorded public health to enact almost any measure necessary to contain disease; and risks to justice, if public health practitioners propose targeting public health interventions only to certain groups. Different types of burdens are more or less likely to result from different types of public health activities.

Disease surveillance and vital statistics, designed to monitor health and population trends, raise potential privacy concerns, especially since data collection is mandatory and data often are individually identifiable and, in many cases, publicly available. Although the types of data collected are not considered very personal or sensitive by most persons, everyone has his or her own boundary of privacy. Further, for some individuals, particular elements of vital statistics, such as paternity or cause of death, could be seen as invasions of their privacy. Finally, vital statistics and other publicly collected data can reveal patterns about ethnic groups or neighborhoods that may be stigmatizing or otherwise harmful.

Communicable disease reporting raises privacy concerns as well, but the infringement and risks potentially are greater, since names are reported only of those who have reportable (and often socially stigmatizing) conditions. Given that individuals typically want the ability to control whether and to whom private information is disclosed, disease reporting carries the additional risk of a breach of confidentiality if security measures are not followed or do not work. For some, there is a risk of privacy infringement only to the extent that confidentiality is not maintained and harms such as social stigma or loss of employment ensue from unwarranted disclosure. For others, the privacy infringement is viewed as a wrong in itself, regardless of whether any tangible harm ensues.

Disease reporting is an example of a public health function that, at least on its face, is distributionally unfair, in that the burdens of the program are borne by those with the disease, generally for the benefit of others who do not have the disease. This unevenness of burdens and benefits may be justified in certain instances, when the benefits are important and when there are no less burdensome ways to achieve them. Unevenness in benefits and burdens is never appropriate, however, if groups are burdened in ways that are arbitrary and without public health justification. Further, a program that does not target particular groups explicitly may, in fact, lead to targeting in its implementation. One study, for example, suggested that doctors are more likely to report a patient with HIV to the health department if the patient is Black and male, 19 despite language in the statute requiring the reporting of all persons with HIV. The appropriateness of creating targeted public health programs justified by epidemiologic data is discussed further in step 6.

Contact tracing, which sometimes accompanies communicable disease reporting, poses additional privacy risks. Not only are an individual's name and condition reported, but individuals are asked to provide the names of other (usually sexual) contacts they have had. Obviously a privacy infringement in itself, contact tracing also invades the privacy of individuals whose names are disclosed, who are not able to decide for themselves whether to release their names to officials. As stated above, harms can occur if confidentiality protections fail, and individuals can feel wronged simply by virtue of the violation of their privacy. Justice concerns also arise if contact tracing programs are not implemented fairly.

Health education poses interesting questions in terms of ethics. In certain ways, health education is the ideal public health intervention, since it is completely voluntary and seeks to empower people to make their own decisions regarding their health once they are equipped with accurate information. From an ethics perspective, education clearly is preferable to other preventive strategies, to the extent that they are equally effective, because it poses few, if any, burdens.

Health education, however, although an essential component of most public health campaigns, will not be appropriate for all situations. First, education may not work in all settings, and more burdensome measures may be required. Second, to increase effectiveness, educational programs may introduce ethically questionable practices, such as manipulation or even coercion. A smoking cessation program, for example, may try to manipulate attitudes by suggesting that smokers are unpopular and by providing only partial or even false information to achieve its ends. 20

Third, all health education campaigns are potentially paternalistic, suggesting that certain ways of being (e.g., in greater aerobic health) are universally valued. Additional work is needed to examine when and where paternalism in public health is justified, especially since biomedical ethics generally has steered professionals away from paternalism except when it is specifically requested by patients. (See Bernard Lo for a discussion of paternalism in which he concludes that "when disagreements persist after repeated discussions, the patient's informed choices and definition of best interests should prevail," 21[pp39-43] and a discussion of patients who do not want to make their own decisions. 21[p29])

Fourth, health education programs may target messages to certain audiences. Although such targeting is often justified on public health grounds (e.g., epidemiologic data demonstrate that members of this population are at greatest risk, so their pictures will go on the billboards and messages will be promoted on the radio stations they listen to), the social and even public health ramifications of targeting must be seriously considered. Social stigma can result if, for example, certain subgroups of the population are assumed to be the ones who carry sexually transmitted diseases, and opportunities for public health intervention will be missed entirely if we all come to believe, through well-intentioned media campaigns, that only certain groups are at risk for domestic violence or HIV.

Finally, health education campaigns may be accompanied by incentives. Incentives generally are considered ethically less problematic than coercive measures or threats, but even incentives could be ethically questionable in certain contexts, such as when financial incentives are given for using particular types of birth control or avoiding pregnancy. 22

Public health research carries burdens. Human subjects regulations already describe the types of harms that could occur through research participation. These include medical risks if the research is clinical, and psychological or social risks if the research is epidemiologic or social science. In recent years there has also been increased attention to the personal and social burdens that can result from injustice or exploitation in research when certain populations are disproportionately disadvantaged or privileged through research participation.

In addition to these well-articulated risks, however, is the harm that can occur if public health research findings are never implemented in public health policy or practice. Any study conducted imposes, at the very least, the burden of inconvenience on those who participate, and may, of course, pose more significant risks to the individuals or communities who volunteer. An institutional review board allows research to go forward because of the benefits expected to emerge from study findings. If research findings are never translated into policy, however-a situation that occurs far too often-no benefits accrue from the research. In such instances, participants were wronged through a misleading (albeit not deliberately so) informed consent process, and the risk-to-benefit ratio could rarely be considered favorable.

Regulations and legislation, strictly speaking, are coercive, since they impose penalties for noncompliance. As such, they pose risks to liberty and self-governance. While many of these measures, such as reduced speed limits, childproof bottles, and immunization, have demonstrated efficacy, they nonetheless are the most intrusive approach to public health. Edmund Pellegrino and David C. Thomasma write:

Involuntary and coercive measures must be undertaken with a clear perception of the dangers they pose to a democratic society: loss of personal freedom to choose a lifestyle, dependence upon governments to define values and concepts of the good life, and the imposition of cultural homogeneity. Involuntary measures also assume a benign, wise, and responsive government-something history finds singularly rare. 10(p375)

While threats to autonomy are the most obvious threats posed by public health regulations and legislation, such regulations and legislation can, in some circumstances, be associated with physical risks, or risks to individuals' health, as well. Federally approved and mandated vaccinations carry health risks to individuals; widespread spraying to prevent the spread of mosquito-borne viruses can cause proximate health problems to some individuals who inhale the chemicals. Finally, in this instance as well, the law can impose, by design or inadvertently, threats to justice if regulations impose undue burdens on particular segments of society.

4. Can burdens be minimized? Are there alternative approaches?

This piece of the framework requires us to minimize burdens once they have been identified. If step 3 suggests that a program or policy carries potential or actual burdens, we are ethically required to determine whether the program could be modified in ways that minimize the burdens while not greatly reducing the program's efficacy. Public health professionals, for example, when ready to report a patient's name and disease to the state, should inform patients that their names, by law, must be reported to public health authorities but that the law also requires that they be reported confidentially. Although reporting programs are not optional, the policy is more respectful of patients if patients are adequately informed.

Contact tracing programs, similarly, pose threats to privacy and confidentiality. Yet contact tracing programs, strictly speaking, are voluntary, in that no sanctions are imposed on citizens who refuse to cooperate. It is ethically incumbent on public health practitioners to inform individuals sought for contact tracing of their right to refuse to disclose the names of their partners, as well as of their right to inform partners themselves, have a known health care provider do it, or have partners contacted by an agent of the state.

If 2 options exist to address a public health problem, we are required, ethically, to choose the approach that poses fewer risks to other moral claims, such as liberty, privacy, opportunity, and justice, assuming benefits are not significantly reduced. Making this assessment relies on the existence of sound data. If data show that a voluntary screening program will test essentially the same number of individuals as a mandatory one, because almost no one refuses testing when asked, then it would be ethically improper to implement a mandatory program. 23(chap6) If disease surveillance is equally effective with unique identifiers or with names, a program of unique identifiers is the morally preferable choice.

5. Is the program implemented fairly?

This piece of the framework corresponds to the ethics principle of distributive justice, requiring the fair distribution of benefits and burdens. 5(pp326-394) Public health benefits, such as clean water, cannot be limited to one community, nor can a single population be subjected to disproportionate burdens. HIV screening programs, for example, cannot be implemented only in poor or minority communities without strong justification (see Stoto et al. 23 for a discussion of why universal HIV screening programs are ethically preferable to targeted programs); cardiac risk reduction programs cannot be targeted exclusively to White men when women and minorities are also at substantial risk of heart disease.

That programs be implemented fairly is even more important if restrictive measures are proposed. Injustice is wrong for its own sake, and also for the material harms it can evoke. Social harms result if social stereotypes are created or perpetuated, such as the stereotype that only certain segments of the population are vulnerable to sexually transmitted diseases. In addition, real public health harms result when individuals do not believe that they are at risk for disease because they were never targeted in education campaigns, or because their own doctors never screened them for a condition because they didn't fit the popular risk profile. 24 This does not mean that programs or resources must be allocated equally to all communities-rather, the allocations must be fair. That is, differences cannot be proposed arbitrarily or on the basis of historical assumptions about who might be at risk. Again, unequal distributions of programs must be justified with data. Moreover, the social consequences must be considered if a community is allotted resources unequally, and these consequences must be balanced against the benefits to that community or others.

Discussed less frequently is whether, or the degree to which, public health has any explicit role in righting existing injustices, especially given the strong link between poor living conditions and poor health outcomes. To what extent is there a positive responsibility on the part of public health professionals to advocate better housing, better jobs, and better access to food programs, since such advocacy might be the best route to improving the public's health?

Several notions of justice allow and even require unequal allocation of benefits to right existing inequities. John Rawls posits that justice requires us to allocate our resources unequally to help the least well-off. 25 Norman Daniels discusses the need for all members of society to be brought to a level of "species-typical normal functioning," 26 which also could result in the unequal distribution of certain resources. Admittedly, not all philosophers have adopted this notion of justice; some make a distinction between preexisting societal inequities that are unfair (because they resulted from a person or community having been wronged by an identifiable source), where intervention is owed, and inequities that are merely unfortunate (that is, due to acts of God or circumstance), where no intervention is morally required. 27

Public health, I would argue, does have a positive responsibility to engage in programs and interventions that seek to lessen societal inequalities, at the very least when those inequalities relate (as essentially all do) to health outcomes. Indeed, it is hard to find a more powerful predictor of health than class, 28, 29 and it is thus an appropriate, if not obligatory, function of public health to reduce poverty, substandard housing conditions, and threats to a meaningful education-if for no other reason than to reduce the incidence of disease.

6. How can the benefits and burdens of a program be fairly balanced?

If it is determined that a proposed public health intervention, policy, or program is likely to achieve its stated goals, if its potential burdens are recognized and minimized, and if the program is expected to be implemented in a nondiscriminatory way, a decision must be reached about whether the expected benefits justify the identified burdens. Recognizing, of course, that public policy is based on multiple considerations in addition to ethics, the question must still be asked whether, from an ethics perspective, the program should go forward. Health department officials and other public health professionals may not have the power to implement all programs they think would be beneficial, but they do have a responsibility both to advocate programs that do improve health and to remove from policy debate programs that are unethical, whether because of insufficient data, clearly discriminatory procedures, or unjustified limitations on personal liberties.

And yet while most reasonable people will agree, in the abstract, that burdens and benefits must be balanced, and that the most burdensome programs should be implemented only in the context of extensive and important benefits, disagreements are all but guaranteed over the details. Depending on one's perspective, there will be differing views over how burdensome various programs are, such as having one's name reported to the state or being required to immunize children before they start school. Citizens can be expected to differ over how important it is to protect a water supply for future generations, particularly if it means significantly higher taxes or prohibiting recreational use of a public body of water-which is clearly a benefit, not only in terms of individual pleasure, but also in terms of community cohesiveness.

Solutions to these inevitable disagreements must be reached through a system of fair procedures. Procedural justice requires a society to engage in a democratic process to determine which public health functions it wants its government to maintain, recognizing that some infringements of liberty and other burdens are unavoidable. There should be open discussion of what a society gains from good public health and why such benefits often cannot be obtained through less communal or more liberty-preserving methods. The discussion, of course, should also address why other interests also have moral claim. Such a process, even when procedurally fair by most standards, must not result in decisions based solely on the will of the majority. Indeed, deliberations, particularly around significantly burdensome proposals, must be scrutinized to ensure that the views of the minority are given due consideration. Highly burdensome programs should be preceded by public hearings, not just votes, so that minority views can be heard and considered.

At the same time, it is important to acknowledge that there will always be some number of persons who do not want their water fluoridated, do not want their children immunized, do not want to wear seat belts, and do not want speed limits on public roads. That there is dissent is insufficient justification for blocking a public health program; indeed, dissent is inevitable in all proposals. Dissent must be considered, however, and it deserves special attention if it is raised exclusively by a particular identified subgroup such as an ethnic minority, a particular age group, or residents of a particular neighborhood.

In balancing values and interests, the greater the burden imposed by a program, the greater must be the expected public health benefit, and the more uneven the benefits and burdens (that is, burdens are imposed on one group to protect the health of another), the greater must be the expected benefit. Programs that are coercive should be kept to a minimum, should never be implemented when a less restrictive program would achieve comparable goals, and should be implemented only in the face of clear public health need and good data demonstrating effectiveness. Nonetheless, we are a pluralistic society, including with regard to our notions of ethics. Different states and communities will decide differently which public health activities are appropriate and which are overly burdensome. Ultimately, that different communities will enact different public policies, based on their own balancing of benefits and burdens, may be indicative of a fair process, or at least a pluralistic process, steering local public health policy.

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Public health is the societal approach to protecting and promoting health. Generally through social, rather than individual, actions, public health seeks to improve the well-being of communities.

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Value frameworks

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Capture ideas you wish to save for future projects here.

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Capture items to keep in mind when drafting the outline here or use this space to begin your outline.

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The BMJ found that only 4 of 195 clinical commissioning groups had altered their IVF policy to reflect the NICE 2013 guidelines, which advised that the age limit for women undergoing IVF should be raised from 40 to 42 and that IVF should also be offered to single women and same sex couples

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Capture ideas you wish to explore further during the Workshop here.

perspective of justice- from govt or patients

definition of infertility changing- is it a disease?

influx of people from Eastern Europe

Procuring tertiary fertility services

Definition of justice with regards to NHS- John Stuart Mill- principle of equality

Healthcare rights

Obesity exclusion

Differences between clinical commissioning groups  - funding issues

infertility increases with age- decreasing success of IVF

Postcode lottery

Number of children

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Background

Infertility is common and in vitro fertilization (IVF) is a widely used treatment. In IVF the need increases and the effectiveness and appropriateness decrease by age. The purpose of this study was to describe allocation of resources for IVF by women's age, socioeconomic position, area of residence and treatment sector (public vs. private) and to discuss how fairly the IVF resources are allocated in Finland.

Methods

Women who received IVF between 1996 and 1998 (N = 9175) were identified from the reimbursement records of the Social Insurance Institution (SII). Information on IVF women's background characteristics came from the Central Population Register and the SII, on treatment costs from IVF clinics and the SII, and on births from the Medical Birth Register. The main outcome measures were success of IVF by number of cycles and treated women, expenditures per IVF cycles, per women, per live-birth, and per treatment sector, and private and public expenditures. Expenditures were estimated from health care visits and costs.

Results

During a mean period of 1.5 years, older women (women aged 40 or older) received 1.4 times more IVF treatment cycles than younger women (women aged below 30). The success rate decreased by age: from 22 live births per 100 cycles among younger women to 6 per 100 among older women. The mean cost of a live birth increased by age: compared to younger women, costs per born live birth of older women were 3-fold. Calculated by population, public expenditure was allocated most to young women and women from the highest socioeconomic position. Regional differences were not remarkable.

Conclusion

Children of older infertile women involve more expense due to the lower success rates of IVF. Socioeconomic differences suggest unfair resource allocation in Finland.

Live Birth

Socioeconomic Position

Infertility Treatment

Medical Birth Register

Dydrogesterone

IVF is costly and in countries where IVF is offered only in the private sector its availability depends on a couple's ability to pay [, ]. In France, where IVF costs are fully covered by public resources, the use of IVF did not differ according to women's socioeconomic position []. In countries where IVF services are offered both in the public and in the private sector, wealthy couples can shorten their waiting times by using services in both sectors []. In Finland, the private sector is an important provider of IVF: over 60% of all IVF treatments are provided by private clinics []. However, the use of private services is partly covered by national health insurance: 60% of doctors' fees and a part of the cost of the examinations are reimbursed according to a fixed scale of charges. The part of the fee that exceeds the fixed charge is not reimbursable. In the public sector, patients pay a small user charge for their clinic visits. In both sectors about 50% of the drug costs are reimbursed by the Social Insurance Institution.

The cohort of women having received IVF between 1996 and 1998 in Finland (N = 9175) has already been described [], as well as their background characteristics []. In brief, using a pre-designed algorithm (presented in detail earlier, []), women were identified from the reimbursement files of the Social Insurance Institution (SII), which covers the whole Finnish population. According to the algorithm all women born between 1940 and 1981 having received reimbursements for any of the drugs in the following groups during the 1996-1998 period were picked from the Drug Register: clomifen, gonadotrophin, GnRH-agonist, and a progesterone drug Lugesteron. For the women having bought drugs in the above-mentioned groups, drugs from the following groups were additionally included: human chorionic gonadotrophin, eastradiol and a progestin drug (dydrogesterone). For each woman the treatment cycles were formed by using this drug data. The cycles were linked to the Procedure Register, with codes for ovum pick-up, cultivation of ovum, intracytoplasmic sperm injection, and embryo transfer. By using all the gathered information, the cycles were classified into other ART (assisted reproduction including ovulation induction with or without insemination) and IVF by using the specific inclusion criteria [].

Private expenditures include costs paid by the woman (excluding reimbursements from the SII). Public expenditures include costs paid by the health care system (excluding user charges). All costs and reimbursements have been inflated to correspond to 2005 prices (in euros) using a consumer price index compiled by Statistics Finland.

Data on women were linked to the Finnish Medical Birth Register to identify live births resulting from IVF. Data on identified children were linked to other health care registers until the end of 2004 to follow-up the health of IVF children []. To measure treatment success, live births per initiated cycle (all live births per all cycles) and per treated woman (only one live birth per woman) were calculated. Multiple pregnancies with two or more live infants were calculated as one. The mean price of different types of IVF cycles by care sector were calculated as well as private, public, and total expenditures by women's background characteristics and by live births. To count expenditure by population groups to show distribution of IVF expenditures across all women in the total population, we used the mean population of females aged 20-49 in Finland by socioeconomic position and area of residence according to census information for 1995 and 2000 available from Statistics Finland. Men were not included, because regardless of male or female factor infertility, in most cases the women are treated (drugs, ovum pick-ups, and embryo transfers) and expenditures of treatments (also ICSI) are billed from and reimbursed to the women. The actual distribution of costs within the family was not available.

The study plan was approved by the STAKES research ethics committee (18 th September 1998). For register linkages, the National Data Protection Authority was consulted and permissions from the registry keepers obtained.

During the mean 1.5 year study period, IVF women received on average 2.7 cycles (Table ) resulting in at least one live birth for 40% of women (Table ). The success rate per cycle was on average 15%.

The costs of different types of IVF cycles are given in Table . Of the total IVF costs, 36% came from drugs, 21% from interventions, and 42% from other direct costs (data not shown). During the mean 1.5 year follow-up, total costs per treated woman were EUR 6500, of which 40% were paid by women themselves (from private sources) and 60% from public sources (data not shown). In the private sector, the out-of-pocket payment was 50% and in the public sector 24% of total expenditures. The cost of a live birth was on average EUR 16 000 (Table ). In the population-based calculation showing the distribution of IVF expenditures across the whole population of fertile-age women(aged 20-49), the expenditures during the study period of 1996 to 1998 were EUR 60 per woman (Table ), of which EUR 24 were paid by women themselves and EUR 36 from public sources.

The use, success and expenditures of IVF were age-dependant. Numbers and rates of women having received IVF were highest among women aged 30-34 (Table ), but the treatment was more intense for older women (number of cycles per woman) (Table ). The success rate per cycle and per woman decreased by age (Table ); the number of needed cycles for live birth increased by age (Table ). The higher treatment intensity among older women did not compensate for the lowered success rate, and about 47% of women aged under 30 and only 17% of women aged 40 or older succeeded in achieving a live birth after the treatment period (mean 1.5 years) (Table ).

The use, success and expenditures of IVF also varied somewhat by socioeconomic position. Women from the highest socioeconomic position received more cycles and on a population-based examination used IVF twice as much as the blue-collar women in every age-group (Table ) as well as spent more of their own money for IVF treatment compared to blue-collar women regardless the age of the women (data not shown). About 25% of white-collar women aged under 30 succeeded in achieving a live-birth, but only 19% of blue-collar women after the mean 1.5 year treatment period succeeded (Table ), while the number of needed cycles per live birth among blue-collar women was higher. Except for the oldest women, the total expenditure and the proportion of public expenditure were higher among blue-collar women than among upper-white collar women (Table ). Due to the higher use of IVF, in every age group, the public expenditure was about two-fold for upper white-collar women compared to blue-collar women (Table ).

Among infertile women in the care system, older women with poorer success rates (i.e. increased need) received more treatments, and expenditures per live birth were much higher among them than among younger women. The expenditures per population were lower among older women, since fewer older women were treated. Because no data relating to the desire for a child by age were available, it is not certain whether all younger and older women wishing to have a baby were in the IVF care system. Women from a higher socioeconomic position had more often used IVF care, and total and societal costs per population were higher than among women from the lower socioeconomic position. Regional differences were not remarkable.

Traditionally the discussion on unfairness in health care has focussed on socioeconomic position and gender and less on age. As expected, there were fewer older than younger women in the care system, because childbearing is usually started earlier than 35 years. The mean age of maternity is 30 years in Finland []. However, if older women sought IVF treatment, they received more cycles because of lower success, and the expenditure of a live-birth increased according to age due to the increased number of cycles and amount of expensive drugs in the cycles. Pregnancy and birth complications and poor foetal outcomes in general increase by age [, ] suggesting that expenditures of pregnancy and child birth of older women would also increase by age. Thus, if IVF resources are scarce, it would be wise to concentrate on treating younger women. On the other hand, it can be argued that age should not be a reason to turn women away from IVF, because for older women, IVF may offer the last chance to become pregnant and have a child []. Should older women with greater need receive more resources than younger women? From a public health perspective treating older women with increasing costs and risks and decreasing success of IVF is not wise. Furthermore, if the older women's desire for children increases i.e. care seeking increases, which has already been reported in the United Kingdom [], the problem of resource allocation will grow in the future. Both the scarce health care resources and the increasing need for prioritisation speak for focusing treatments on women in their normal childbearing age.

In Finland, over 60% of IVF treatments are provided in the private sector and women from the highest socioeconomic position are overrepresented in the private sector []. In spite of the reimbursement of private services, the private expenditure remains higher i.e. more of women's own financial resources are needed for treatments in the private sector compared to the public sector. The use of private services is likely to create unfairness also in Finland. However, the unfairness is smaller than in countries where IVF is not covered by health insurance [, ]. In the United Kingdom where 80% of IVF is given in the private sector, authorities have warned that IVF is becoming more commercial and people with insufficient income are in danger of remaining without treatments []. According to the review by Dawson et al.[], the most common reasons for inability to obtain IVF treatment have been financial.

For some infertile couples the adoption of a child is an alternative to infertility treatment. However, adoption is costly for couples, too. In Finland, only foreign adoptions are available. It can be argued that, if a part of the costs of infertility treatments are covered from public funds, the adoption costs should be covered, too. In the late 1990s Finnish couples had to pay all the expenditures of adoption themselves, but since 2003 parents adopting a child from abroad can claim an adoption grant from the Social Insurance Institution to offset some of the adoption cost. The adoption grant is a tax-free, one-time payment. Its amount depends on the child's country and varies between EUR 1900 to EUR 4500. According to present study, the society covers about 60% of IVF expenditures i.e. EUR 9600 per IVF live birth, which is about 2- to 5- fold compared to the coverage of adoption.

It is difficult to determine an optimal and equal age to stop the resource allocation for IVF. Treatment of selected women aged 40-43 has been found to be quite successful [, ] and natural pregnancies also occur for women in their forties. However, a given age-limit could be a signal that encourages women to attempt to give birth during the normal fertile age. Social and family policy should promote circumstances that are suitable for childbearing at a young age. As Chavkin [] and Stillman [] have pointed out that this is a big challenge especially for countries that lack policies supporting parents who both work.

This study shows that the resources used for IVF varied by women's age and socioeconomic position. IVF-children of older women involve more expense due to the lower success rates of IVF. Women from higher socioeconomic positions used more IVF resources than other women. Women and men need information on declining fertility by age as well as the complexity of IVF. Causes of unequal use of IVF services should be studied further, and resource allocation for high technology should be made transparent.

Mika Gissler, Tiina Sevón and Elina Hemminki contributed equally to this work.

Acknowledgements

The study was supported financially by the Academy of Finland (number 73159), the Social Insurance Institution, the Ministry of Education (The School of Doctoral Programs in Public Health), and the National Research and Development Centre for Welfare and Health.

We thank the two IVF clinics for providing their price lists and IVF costs to us.

Electronic supplementary material

Competing interests

The authors declare that they have no competing interest regarding this nationwide register-based cohort study.

Authors' contributions

RK collected and analysed the data and drafted the manuscript. MG contributed to conception and design of the study and interpretation of the data. TS participated in the design and analysis of the study. EH made substantial contributions to conception and design of the data as well as interpretation of the data and helped in drafting the manuscript through critical revision. All authors read and approved the final manuscript,

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Resource allocation of in vitro fertilization: a nationwide register-based cohort study

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Infertility is common and in vitro fertilization (IVF) is a widely used treatment. In IVF the need increases and the effectiveness and appropriateness decrease by age. The purpose of this study was to describe allocation of resources for IVF by women's age, socioeconomic position, area of residence and treatment sector (public vs.

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Is IVF treatment in the UK available in a just fashion?