This article describes results of a randomized trial of neurosurgical procedures designed to eliminate seizures in children under 18 years of age whose epilepsy is resistant to drug therapy.
Importantly, the story notes significant side effects attributable to the surgeries, and the struggle to receive insurance coverage. Yet, readers will likely want more information about the study–for example, how old the children were, and what kind of neurosurgery they had.
Editor’s note: After initial publication of this review, we changed the rating under Quantify Benefits from Not Satisfactory to Satisfactory. The star rating was changed from 3 stars to 4 stars. This also affected the headline, which we have since updated. See the related criterion below.
Surgical approaches to intractable seizure disorders — with some children and adults experiencing hundreds of significant seizures a day — have been shown to improve quality of life and maintain cognitive health, particularly in young children for whom brain plasticity is stronger than in adults. Thus, clinical trials to better clarify both the benefits and the harms of such surgeries worldwide are important in improving the evidence base for these procedures.
The article does an outstanding job of noting the cost of surgery, although the article could have been stronger if it had pointed out the estimated costs of drug therapies, hospitalizations and sometimes institutionalization of children and adults who are severely disabled by some forms of seizure disorders.
Although there is some quantification of benefits, the article doesn’t specify the actual number of children who had the primary outcome — a year without seizures. And thus the statement in the lead that brain surgery in the study group can produce a 10-fold increase in the odds of being seizure free after one year will be difficult for readers to put into perspective. And as noted above, the article does not specify how many operations or what types of surgery were performed on what ages of children.
Editor’s note: While the story doesn’t state the absolute amount of children who experienced improvement after surgery compared to the control group, the story does give readers enough information to understand the measured benefits. For this reason, we changed our initial rating from Not Satisfactory to Satisfactory.
Seventy-seven percent of the children were free of seizures at one year after the surgery, compared with seven percent in a control group of youngsters who received medical therapy alone while waiting for surgery.
Harms are explained but again without much quantification.
The article describes the general level of evidence but it would have been a much stronger article had it specified the specific types of cognitive and other tests used to evaluate the outcomes in the children. Other details were needed, too: how old the children were; what kind of neurosurgery they had; and what the major limitations of the study were.
The article does quote a Boston specialist who was not a part of the study, which was conducted in India.
The article does note that drug therapies are standard of care, but does not specify what drugs are used. More significantly, because the article does not specify in any real detail what kinds of surgeries were performed on the study group, it is difficult for readers to compare alternatives.
Beyond noting that costs are a frequent barrier in India to getting the surgery, the article does not say anything about general availability of the operations, or define categories of candidates.
The article notes this is the first trial of its kind in children. This appears to be accurate. There have been very few randomized trials (a recent Cochrane review found only four, and only one compared surgery to medical therapy); there is a recent trial (ERSET) that went down to age 12, but was almost all in adults. One point that’s important to note: There is nothing in the study to support the statement that the earlier surgery is done, the better; only that this shows that it appears to substantially decrease seizure frequency in children, as it has been shown to do in adults.
The article quotes outside sources.