Grid-Based Preconception Counseling Can Facilitate Shared Decision Making for Women with Epilepsy
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.304110
Source of Support: None, Conflict of Interest: None
Women with epilepsy (WWE) and their care providers are equally concerned about the risk of seizures and adverse effects of using antiepileptic drugs (AED) during pregnancy to the mother and the baby. The risk of death or other complications during the pregnancy period is high when WWE continue to have seizures. Antenatal exposure to valproate and several other AEDs as monotherapy and polytherapy is associated with a higher risk of Major Congenital Malformations (MCM). The risk of MCM is dose dependent for valproate and several other AEDs. Children who were exposed to AEDs in the antenatal period demonstrate impaired intelligence and language functions when examined in early childhood, and this effect endures into the second decade of life also. There is considerable difficulty in communicating the complexities of the benefits and risks of using AEDs during the preconception period and pregnancy to the women and their relatives. In this technical note, we are presenting the grid-based preconception counseling of the risk and benefits of different treatment options to facilitate shared decision making. The clinician elicits the preferences and concerns of WWE in the first column of the grid. The potential outcomes of different treatment options concerning these preferences and concerns are presented in the remaining columns of the grid so that a shared decision can be reached. This option grid provides an opportunity to the WWE to review the options holistically and make appropriate decisions.
Keywords: Informed consent, option grid, preconception counseling malformation risk, shared decision making, women with epilepsy
Epilepsy is one of the most common serious neurological disorders anywhere in the world. Around 50 million people have epilepsy, and half of them are women. About 12–13 million women with epilepsy (WWE) are in the reproductive age group (15–50 years). Most women with active epilepsy require continued use of antiepileptic drugs (AED) during pregnancy to remain seizure free. A large meta-analysis had shown that adverse outcomes of pregnancy such as spontaneous miscarriage, antepartum hemorrhage, postpartum hemorrhage, hypertensive disorders cesarean section, and preterm birth are increased in WWE. The risk of mortality in pregnancy is increased by tenfold WWE and SUDEP accounted for most of the mortality during pregnancy These observations point towards the need to control seizures by appropriate treatment during pregnancy in WWE. On the other hand, it is widely recognized that the use of AEDs may increase the risk of major congenital malformations in the fetus,, or lead to neurocognitive developmental delay.,
Most WWE who are planning pregnancy have a considerable dilemma about using AEDs. They are worried about the potential risk that the seizures may worsen if medications are reduced or stopped even as they are anxious that the use of AEDs during pregnancy may lead to birth defects in their babies. In many busy practices in low- and middle-income countries, detailed counseling on the nuances of medical management is not delivered properly. The availability of medicines, access to health care, and expertise of the care providers to manage epilepsy and pregnancy vary considerably between low- and middle-income countries and higher-income countries. Many a time, the medical professionals are unable to communicate the risk from different sources (AED usage, seizures during pregnancy, other factors) directly and tangibly. Many of the professional guidelines on managing epilepsy and pregnancy are prepared from the care provider's perspective and are not updated regularly. They may not be of much assistance to the patients or their families to understand the complexity. Several professional organizations and statutory bodies have released guidelines for selecting the appropriate treatment for WWE who are planning a pregnancy., Most women find it difficult to assimilate the evidence base in a balanced manner and make an intelligent decision regarding their treatment. In recent years, several regulatory authorities have issued severe restrictions or ban on the use of valproate in women.
In this special context, the traditional approach of obtaining informed consent for a treatment protocol has certain limitations as its emphasis is in documenting the subject's approval of a given treatment. It does not capture the values, priorities, and concerns of the subject vis a vis. the available literature on the subject. The process of informed consent provides a set of standard information on the treatment options and potential outcomes (favorable and unfavorable) to the subjects before they express their consent to a specific treatment option.
Shared decision making (SDM) is preferable in such situations where there are multiple treatment options and potential outcomes. It goes one step further in that the care provider assists the patient to understand the evidence base. SDM is becoming popular in the care of epilepsy, cardiovascular disorders, elective surgery, mental disorders, and cancer.,
The first step in the process is the elicitation of the patient's values, concerns, goals, preferences, and objections to any line of management. The next step would be to provide evidence-based information on the specific issues and concerns in a balanced way so that the patients can understand options and possible consequences. The last step is to reach a mutual agreement on the preferred line of management.
Several tools and instruments have been developed to facilitate this process. These are broadly termed decision aids. The decision aids can be visual analog scales, graphs, computer-assisted tools, or option grids. A meta-analysis of 23 studies had shown that SDM interventions could have a variable effect on risk estimation and involvement in clinical decision making.
The complexities of adverse effects of different AED therapies during pregnancy on the mother and fetus, the impact of seizures during pregnancy on the health of the fetus, mother and its social repercussions constitute an ideal setting to adopt SDM for epilepsy care during pregnancy.
The Kerala Registry of epilepsy and pregnancy had been offering preconception care for WWE on a routine basis. Since 1998, 30% of all registrations in this registry were in the preconception stage. A recent analysis of the data from this registry had shown that women who had preconception counseling and care had significantly higher compliance with AED usage, folic acid prophylaxis, and better seizure control during pregnancy. The registry has the approval of the Institutional Ethics committee and informed consent is obtained from all registrants. We had customized a grid-based presentation of treatment options and outcome analysis for counseling patients during preconception clinical encounter. This decision aid is a grid that the care provider generates by actively interacting with the subjects on a one to one face-to-face meeting. The preferences, values, priorities, and concerns of the woman are recorded in the first column of the grid. The care provider would populate the remaining cells in the grid with the potential outcomes under different treatment options. The quantitative details of the outcomes are based on the data from the KREP and other published sets of evidence and information.
The clinician sits with the patient and partner with a pen and paper and draws a grid with several rows and columns. We encourage the patients to state their requirements say; I should not have any seizures, I should not have trouble in conceiving, I should not have any seizures during pregnancy, My baby should not have any birth defects, My baby should not have any neurocognitive defects when he or she grows up. I should not have any complications of pregnancy. I should be able to breastfeed my baby. My medical expenditure should not go up. We enter these requirements cited by the patients in the first column. Afterwards, the clinician sets down the various management options, say not using any AEDs, continuing on current treatment, continuing low dose of the same medicine, switching over to drug A, or B or adding another drug to present treatment. The clinician populates the cells under each column, one at a time, with possible outcomes based on current evidence [see [Table 1] and [Table 2]. The client has the opportunity to see how the various outcomes get modified under different scenarios. A given AED usage may improve seizure control but may carry a higher risk of malformation, while another therapy with lesser malformation risk may predispose to dose escalation during pregnancy or possible breakthrough seizures. The client can weigh the impact of a breakthrough seizure in her social and family life versus less teratogenic effects. This grid is only an illustration and the contents of the grid would vary according to the individual's clinical profile. We often use a visual aid to explain the proportions and percentages [see [Figure 1]]. We use a grid of 100 cells to depict the pregnancy outcome of 100 WWE. The malformation risk when the mother takes no AED is shown as the baseline. The increase in this risk with different AED usage is shown for sets of 100 WWE. A holistic view of the situation is provided by including the green cells to indicate that over 90% of the pregnancies result in no malformations.
This grid-based presentation of the possible outcomes with different treatment options provides the patient and partner with the opportunity to compare the risk-benefit dynamics in an efficient and real-life-like situation and make appropriate decisions. We have customized the grid to the specific needs of individuals. Nevertheless, some recurrent themes emerge over time. This type of counseling takes about 10–15 min for the discussion and SDM.
In our registry, about 30% of the registrations are carried out in the preconception stage, that offered much opportunity to discuss the diverse issues related to pregnancy and the strategies to make pregnancy safer for the mother and baby alike. One of the advantages of this grid-based presentation of the data is that the clients can weigh the merits and demerits of the different treatment options. They can visualize themselves under different scenarios and compare the differences in the outcome. Earlier, when these data are presented to women in verbal form many women were perplexed and confused and would request the doctor to take an appropriate decision. The presentation of the same data in this grid format along with the visual scale improved the situation considerably and most women were able to express their choice or preferences in the treatment options. The data from this registry had shown that who had preconception care had better compliance with treatment and improved seizure outcome during pregnancy. We have put up the protocol of our grid-based preconception counseling for a wider consideration of the professionals and further refinement.
Financial support and sponsorship
Indian Council of Medical Research.
Conflicts of interest
There are no conflicts of interest.
[Table 1], [Table 2]