The British Fertility Society along with a number of other professional associations and the Human Fertilisation and Embryology Authority (HFEA) published a joint document on the subject of IVF 'add-ons' last week (see this week's news story). This was a heavily-debated document for a number of reasons, not least the perceived benefits to clinics and/or patients of so-called add-ons.
The HFEA has provided patient information for a list of IVF add-ons which are commonly offered in clinics as a way to try to enhance success. The listed items do not have proven benefit and have been given either amber (limited evidence of benefit) or red (no evidence of benefit) in their traffic-light style grading system. This is not a comprehensive list, and in common with many medical processes, the answer is never clear-cut.
Whilst it is laudable to aim for high-quality evidence to support clinical practice, whether it be a test, a treatment, procedure or use of a piece of equipment, across the field of health care there are very many areas of practice where good evidence is lacking and indeed may be impossible to attain.
Good clinical reasoning based on scientific theory and a pragmatic approach may be appropriate for some individualised decision making – an example in our field would be a decision to remove a sizeable fibroid in a woman with subfertility and early pregnancy losses. Whilst it is almost impossible to undertake a trial of such treatment in a meaningful way, it is possible that for this woman such a reasoned approach may be helpful. Observational data collection over time may provide some weight to the hypothesis that surgical removal may be beneficial nevertheless.
In rare cases there may never be the numbers of patients available to undertake a properly-powered trial, while if the inclusion criteria are widened it may make the trial meaningless in clinical terms and weaken the potential to show benefit even if subgroup analysis is undertaken. On that basis, with a sound understanding of the medication or procedure, and what the practitioner is aiming to achieve, a trial of n=1 may be acceptable.
Indeed, as is often cited, lack of evidence of benefit does not equate to evidence of no benefit. We must be careful not to stifle innovative thinking and genuine medical development by the rigidity of considering the randomised controlled trial to be the only valid research tool.
Why then are we in such difficulties with IVF add-ons? For two major reasons:
Firstly, in a fast-moving specialty, we are quick to introduce new technologies without proper trials even when they could have been undertaken. There are good examples (eg preimplantation genetic screening) where the ultimate reality has been very far from the hoped-for outcomes – we are now on a second round of debating the benefits of this technology which are not yet clear despite its wholesale adoption in some centres. Secondly, the costs of empirical treatments and technologies are mostly passed directly to patients.
It is difficult in this situation to separate the aim to help by the introduction of a new 'treatment' from the perception that early adoption has as much to do with commercial competition and profit-making from a vulnerable population of patients. It is often said that a clinic must offer add-ons not to lose patients to a competitor offering the same.
Our patients are vulnerable in that they are often desperate to start or complete their family for which they may have waited some considerable time and for whom treatment is complex and without guarantee of 'cure'.
Moreover, abandoned by NHS commissioners they are often footing large treatment bills which are rarely, if ever, covered by workplace or private insurance. They may become toughened by the amount of legwork, research and effort they need to put in to get what they want but may be oblivious to the fact that doing something 'different' or paying for something extra, may reap little genuine reward.
They are hence balancing their lay (albeit often very sophisticated) understanding of reproductive physiology, ART technology and clinic blurb and prices against what they most desire – a baby at the earliest opportunity. The role of the expert clinician is to cut through that determination and desperation not simply to accede to patient pressure and certainly not to commercial pressure.
There is no doubt that professionals in our specialty have their patients' interests at heart and many feel the conflict of offering non-proven treatments in the face of the kind of criticisms described. There may indeed be situations where empirical treatment may be offered in the patient's best interests for their psychological wellbeing rather than measurable success rate benefits. Such decision to treat would almost always be on an individual patient basis however.
Even if it is not what they want to hear, we are required to make sure that a treatment programme however complex is entirely in the best interests of the individual patient. It is incumbent upon us to act with integrity in our attempts to achieve that aim: to be realistic about what we can and can't do, honest about our treatments and the evidence behind them and to help to manage- through careful, empathic counsel patients' expectations. If patients can learn to trust that integrity, then the clinic price list need not become a shopping list of apparent cumulative benefit as far as can be afforded.