Presentation of risk

Within the epilepsy clinic, risk information was presented as estimations of the potential risk of an adverse pregnancy outcome. Data from the UK Epilepsy and

Pregnancy Register was quoted to support numeric comparison of the risks between established AEDs and the associated drug-specific MCM risks. These strategies are exemplified by the clinician’s presentation of risks to a 22 year old participant who attended clinic with her fiancé:

273. C: […] right now, just say you wanted to start 274. trying for a child and you kept your dose, you stayed on Epilim. 275. On a dose of 1500mgs a day […] your

276. risk would be higher than 9% chance of having a child with a major 277. malformation, OK […] in comparison with for instance

278. lamotrigine on a lower dose under 200 mg a day, the risk would be 279. around about 3% so there is quite a difference really […] the 280. other thing about Epilim is, we are talking about major

281. malformations such as spina bifida, you might of heard of that, 282. problems with the growth of bones, cleft palate, heart defects these 283. are what we call major malformations …

(OI02; 22 year old, future pregnancy intentions)

The clinician utilized percentage estimations of the size of risk and the naming of specific malformations as strategies to reinforce or frame the objective nature of risks to the unborn baby, positioning Epilim (sodium valproate) as more risky than the proposed alternative, lamotrigine. The quantification of drug risk supports the opportunity to reduce risk by lowering drug dose (discussed further in Section 7.3 Risk Management).

328. C: […] If you’re on a lower dose of Epilim then that risk falls.

329. And if you were on less than 1000mgs your risk would in the region 330. of, just over 5% chance. So being on a reduced dose does

331 reduce the risk… (OI02)

When proposing AED changes, the clinician included warnings against accidental pregnancy resulting in additional fetal drug exposure (two AEDs during the switch- over compared to one AED before and after the switch-over). In the case of OI02, the importance of preventing pregnancy while making changes was highlighted through provision of the evidence of increased risk:

337. C: […] What we do know is the combination of 338. Epilim if it is with other treatments the risks then become really 339. very high indeed. It would be past 10% upwards if you fell 340. pregnant on Epilim and lamotrigine together.

From the perspective of the clinician, the purpose of presenting risk information was to support consideration of what was involved in the proposed treatment changes, such as

the risk of developing a hypersensitivity reaction to the proposed new drug, lamotrigine.

598. C: […] there is also a risk of a rash, a risk 599. of an allergic reaction. It can happen in something between 3 to 5% 600. of people. (OI02; 22 year old, future pregnancy intentions)

The presentation of patient-specific risk information concerning adverse reactions to AEDs was variable, and extended to include the drug-specific risks such as liver failure and death (OI07). The risks of seizures were common examples of patient- specific risk information, utilized to communicate seizure relapse risk for patients having entered remission while taking AEDs, and to communicate the potential risks of seizures during pregnancy and delivery. Epidemiological data from the Medical Research Council (MRC) Antiepileptic Drug Withdrawal Study (Chadwick et al., 1996; Anonymous, 1993b) was quoted to support numeric comparison of the seizure relapse risks between alternative treatment strategies, remaining on AEDs, or gradual AED withdrawal. Seizure relapse risk information assisted OI23 consider the opportunity to withdraw her treatment following an 8 year remission from seizures:

404. C: […] a big study has shown that the risk of seizure 405. recurrence is very high like between 20 and 40% or something 406. like that

407. P: Yes […]

410. C: […] But there is, there was a fairly high 411. risk and because of that, people say maybe we should give

412. people a five year course, but there are no rules written in tablets of 413. stone.

414. P: Right

415. C: The risks are probably lower now, than at five years (OI23; 30 year old, immediate pregnancy plans)

The risks of seizures in pregnancy were discussed in 20 out of the 23 observed consultations. Clinician’s presented warnings against stopping AEDs as a cause of status epilepticus or death and the likelihood of worsening seizures in approximately a third of women. This approach is illustrated by the following two participant cases: 1. 390. C: don’t make any changes, don’t suddenly stop taking your

391. medication, because if you suddenly did that, you could go on and 392. go into status epilepticus which is continual tonic-clonic seizures 393. and that is extremely dangerous. You know people have been 394. known to die through status

2. 173. C: we particularly don’t want you having convulsions … […]

176. tonic-clonic seizures it can increase the risk of having a miscarriage (OI18, 21 year old, immediate pregnancy intentions)

The value of presenting risk information was to highlight alternative and unexpected future outcomes. For example, the unpredictable course of pregnancy where things could go wrong for both mother and baby was a perspective several women preferred - knowing the ‘worst case’ scenario. From the perspective of the clinician, the purpose of presenting risk information was to advise and support informed patient decision- making to fulfil their ethical duty of care. The presentations of risk information supported women to consider the differing outcomes from decisions made, and the potential for seizure relapse was an unwanted outcome for many women, and required alternative treatment options to be consider. The utility of risk information to clarify the choices available was exemplified by participant OI20 as she considered her options which include: remaining on the current AED with proven effectiveness (7-8 year seizure remission), weighted against a “5% chance of any physical malformations”; or, switching to an alternative AED:

386. C: … if you are switching over from one treatment to another, 387. you know it can destabilize your condition, and

388. you could go on to having seizures. […]

390. C: […] you might start a different medication, and you feel 391. well on it, and have the same control, and it have a slightly, 392. say have the 2%, risk of the physical abnormalities

393. but, you might still have, you might go on to have 394. seizures, we don’t know.

(OI22; 32 year old, immediate plans for pregnancy) 7.1.2 Response to risk information

Women interpreted risk information mainly as helpful and informative, in line with perceptions of the clinician’s duty of care. There were exceptions, and for one participant (OI06) the purpose was interpreted to scare and deter her pregnancy plans:

229. P: They said because like with the tablets the baby could become 230. disabled so I was a bit scared about that,

[…]

239. P: […] that’s what my doctor [GP] said I 240. don’t know if she was trying to scare me…

[…]

247. C: […] you are taking these tablets, which would put the unborn 248. child at risk of having problems. But the risk is about 4%, that we

249. say, in terms of pregnancies. And some women would then 250. say oh then would I need to take the tablets. But in

251. someone like yourself you are having lots of fits. We, there is 252. a risk to the unborn child if you’re having fits that its not /controlled

253. P: /But if I

254. had a baby like about me, could I die or something?

255. C: Usually when patients have epilepsy and if it is controlled, a 256. lot of women with epilepsy have children with no problems and 257. they go through their pregnancy and the delivery with no problems.

(OI06; 20 year old, immediate pregnancy intentions)

The above quote highlights the important relationship between using risk information to inform and its use to direct the patient’s attention to their role in adhering to treatment recommendations (lines 249-51). By challenging the patient’s fears about the risk information provided by her GP, the clinician focuses attention on the opportunity for the patient to reduce the risks to herself and her future baby. The importance of seizure control and the role of AEDs in achieving it are highlighted, rather than simply focusing on the drug-related risk. This supports warnings to the patient considering stopping her tablets, and allows the patient to re-consider her own prior judgements of pregnancy risk. The clinician adopts the role of advisor, focusing the patient’s attention on her continued need for treatment, the inevitable risk she faces from frequent seizures and, at the same time, offering the outcome of healthy children when seizure control has been achieved. OI06 reflected upon the receipt of risk information comparing the ‘high risk’ she understood from her GP’s message and the optimistic ‘lower’ risk as reassuring:

OI06: With the 4% it made me feel a little bit better because it’s not really, to me that's not a high risk, that’s like, kind of a low risk…but the way the (GP) was speaking, it to me, she just said oh it’s a high risk and like it made me feel like she was putting me off…

Preconception risk information was judged by some women as focusing their attention upon future pregnancy, projecting worry concerning the outcome of pregnancy, illustrated by the following extracts:

OI22: I don’t think I will enjoy being pregnant […] I really don’t think I will, I think I’ll just, be wanting it to end…

(32 year old, immediate pregnancy intentions)

Partner: …We’ve spoke about it a hell of a lot really because we want, the first is find out how bad it is, because I’d rather she’d be healthy than have

something happen wrong, you know instead of having two, have nothing… (OI14; 27 year old, immediate pregnancy intentions)

Questions raised during preparation for pregnancy revealed the extent of worry concerning the risk of seizures at the time of delivery as an added source of anxiety. From the patient perspective, there was a need for reassurance regarding the risks of uncontrolled seizures. This was managed by a minority of clinicians playing down the chance of seizures influencing pregnancy outcome, and emphasising the risks as only becoming significant if the woman required admission into an intensive care unit. For many women, this type of reassurance was counter-intuitive, illustrated by the following 39 year old participant reflecting on her experience of seizures in pregnancy and her concern for her unborn baby:

FG123: I started fitting … and then I was coming round and just wanted to curl up and die … I felt so awful yet the fear set in and this little baby inside me is it going survive, am I killing this baby off. I couldn’t control it and I just didn’t know what was going on. I was in and out, in and out and then as I say she arrived and I had this little girl and I couldn’t believe it

For one participant (OI23), the potential for worsening seizures during pregnancy raised additional concerns. The clinician (who had neurology training) played down the risks associated by maternal anxiety upon pregnancy outcome – although obstetric opinion is sometimes in opposition to this view:

596. Partner: … from my perspective, it was if you’re going to have a 597. baby it needs to be worry free, and if you’re going to worry more 598. doing, going one path, that’s probably going to have a greater effect 599. on how the pregnancy goes, I would have, from my point of view,

600. but

601. C: Yes, well if, you would still be fine 602. P: Yes

603. C: Even if you worry a little bit, your baby will still be fine (OI23) OI23: … how I feel now is I’m worried about having the seizures in pregnancy,

but I suppose the reason I am getting upset and crying, is because I’m scared of the actual seizure itself. (30 years, immediate pregnancy plans) Clinicians addressed these concerns by reinforcing the importance of optimising epilepsy management prior to pregnancy, and recommendations for booking early into obstetric care on discovery of pregnancy.

Describing a future child, as ‘being at high risk’ either due to seizures or in utero AED exposure, required women to compare their desires for pregnancy against the needs of the unborn child. Blame was the most commonly expressed emotion identified by

women across the entire study population, while for some this emotion was interpreted as selfishness (see also, Chapter 9, section 9.2 The Selfish Decision), as illustrated by the following participant:

OI08: […] I suppose some people would say that I was selfish, if I knew there was a 10% possibility of a child being disabled. Because I still want to have a baby, then perhaps I shouldn’t do it? But, why shouldn’t I, there’s people taking heroin and they’re still doing it.

(27 year old, future pregnancy intentions)

The presentation of risk information in percentage terms was objected to by a small group of women as failing to support their informed decision-making, which required more detailed narrative description. From this group, one participant who had experience of delivering two children affected by in utero exposure to sodium valproate, expressed her response to being presented with the percentage chance that something could happen if she were to consider further pregnancy:

FG21: […] but the thing is, if you’re that one percent you know it’s hard. If you’re that one person, (41year old)

The perceived risk could be zero if reviewed retrospectively when the outcome of pregnancy is known, whereas if the adverse event occurred you would reflect that your risk had been 100%. Avoiding a focus upon numeric risk was managed by some women by reliance on luck. Illustrated by the following participant as taking the chance that the desired healthy outcome of her pregnancy would occur:

FG121: […] I suppose I was just a bit naive in thinking that everything would be okay… we both decided to just sort of take the chance and see what happens. Luckily you know she is fine now… I’ve not been too bad through the pregnancy, so it is something that we maybe looking to do again some time in the future. So I do think I am fairly lucky as in how, how it affected my pregnancy ... (32 year old)

Reference to luck, in terms of relief that a potential risky outcome did not occur, implied a perceived lack of influence upon the management of risk. It also detracted from the work of the clinician in supporting pregnancy planning and future decision- making, implying the participant’s good outcome was the result of fate.