Innovation is an essential aspect of the advancement of surgery. Procedures and techniques are constantly being refined and improved with the goal of shortening recovery times, reducing complications, and improving health.
Innovation often carries potential risks. If a surgical device or procedure is completely new and has never been used before, there is no way to know for sure whether it will help the patient. For this reason, such a procedure or device is usually classified as research, tested using a strict protocol, and subjected to rigorous oversight by a research ethics board (REB) — a process that can take years.
What happens, though, if a technique is only “sort of” new? Suppose a surgeon wants to use a new technique that is already used in another hospital, or has read about a new and better way of performing a procedure he or she has often used in the past? The surgeon is not performing research, but wants to apply the technique to a patient or a small group of patients. A research protocol is not required for surgical innovations of this kind. In fact, using a research protocol for innovations that do not need it may delay patients from getting timely access to innovative care. On the other hand, it is still important to make sure that innovations do not harm the patients they are meant to benefit. How do you ensure that patients are protected while promoting innovation?
A new policy for surgical innovation
The Department of Surgery at The Hospital for Sick Children (SickKids) has tried to address this question with a simple policy for surgeons to follow when introducing innovations to the hospital. The policy, developed in consultation with the Departments of Bioethics and Quality & Risk Management, represents an attempt to standardize the important issues that a surgeon should consider before performing surgical procedures that are new to SickKids.
Surgeons are asked to submit a request to the Surgeon-in-Chief that includes the following 10 points:
a description of the innovative procedure or device
a rationale for the request and evidence of the procedure or device’s effectiveness: has it been discussed in the surgical literature or used in other hospitals?
evidence that the surgeon’s peers at SickKids, or elsewhere, agree that the procedure or device is appropriate
a description of the potential risks and benefits to the patient: is the procedure more effective than the standard procedure? Will it make recovery time faster or reduce the risks of surgery? Are there other risks that might increase?
special consent considerations: as with any surgical procedure, patients and their parents should understand why the procedure is being proposed and the risks and benefits of the procedure
the initial number of patients to be treated
the expected impact on the hospital’s resources: will it be more or less expensive? Will it take more or less time? How long will it take the patient to recover compared with the standard technique or procedure? Can the hospital afford it?
assurance that the device to be used, if any, is safe and has been approved for use in Canada
evidence that the surgeon and the interdisciplinary team have the necessary skills or training to perform the procedure: has the surgeon taken a course, or has he used the same techniques in other contexts? If the surgeon is trained, how about the rest of the team, including the nurses and anaesthetists who will be looking after the patient? Do they know what to do and what problems to look out for?
plans for collecting and reporting quality assurance and outcome data, so that we can follow up and see whether the innovation was successful and if it should be used again
The Surgeon-in-Chief then reviews the proposal. This review may include calling on independent advisors to help him evaluate it. If the Surgeon-in-Chief decides that the procedure is so innovative that it should be the subject of research, the surgeon can submit a proposal to the REB. If it does not require a submission to the REB, a proposal for innovative surgery generally takes less than two weeks to be accepted or rejected, and sometimes in urgent circumstances less than 24 hours.
Of course, nothing is ever quite as simple as it sounds, and this policy is no exception. Innovation lies along a spectrum, from minor changes in techniques or materials to entirely new procedures. Where do you draw the line? How do you decide whether an innovation is significant enough to require approval? And is your choice always going to be the same as someone else’s? However, our hope is that the policy will facilitate innovation in a way that minimizes risks to patients, increases accountability, helps surgeons think about important issues, and formalizes good practice.
Is the surgical innovation policy working?
The policy was launched in November 2003. Like all policies, not all aspects are followed to the letter. SickKids routinely reviews policy implementation. Over the first year the policy was in effect, 14 applications were submitted and 23 procedures were performed. A review of these procedures showed that in 78% of cases the patient seems to have benefited, and in 56% of cases the procedure cost less than the standard approach.
However, the audit revealed those aspects of the policy that were lacking. The consent documentation was poor in many cases: the patients’ charts showed that the risks and benefits had been documented in only 55% of cases, and the consent for surgery documented that the procedure or device was innovative in only 10% of cases. These figures may be misleading; it is possible that these points were explained, but not written in the chart. Our plan is to revise the policy to include better guidelines for discussing and documenting these issues.
What does the surgical innovation policy mean for patients and families?
Different families have different takes on surgical innovation. Some parents do not want their child to be the first to receive a surgical innovation; others learn of a new procedure and are the first to suggest it to their child’s surgeon. Some prefer to read all the existing literature on a new surgery, while others are happier to let their child’s surgeon make the decision.
Regardless of where you stand along this spectrum, if your child is having surgery, these issues may affect your family. Parents are sometimes hesitant to ask questions for fear of insulting the doctor, but they should not be. If you have questions about any aspect of your child’s surgery, you should feel free to ask the doctor, starting with “Have you done this surgery before?” “How many times have you performed the surgery?” and “How will this surgery benefit my child?”