Surgical Research Involving Persons with Parkinson S Disease

Online Supplemental Data

Studying Neurosurgical Implants for Parkinson Disease: A Question of Design

A.W. Prehn1, D.E. Vawter1, K.G. Gervais1, R.G. DeVries2, J.E. Garrett1, T.B. Freeman3, T.Q. McIndoo1

1Minnesota Center for Health Care Ethics, Minneapolis 2St. Olaf College, Northfield, Minnesota 3University of South Florida, Tampa

Expert Focus Group Questions for Clinical Researchers

Please tell us your name and say just a few words about the type(s) of surgical research for Parkinson’s disease that you have been involved in – for instance, have you conducted lesioning, cellular implant and/or medical device research?

(Costs/Funding) One of our interests, and I’m sure one of yours, is the funding of surgical research involving FDA-regulated products, such as the deep brain stimulator. We know that it is not always easy to get this research funded. How have you dealt with this problem?

Prompts: Tell us, who pays for the costs of surgical device research at your institution? What are the benefits and the problems with this funding arrangement?

(Surgical Research) We now would like to talk about issues around surgical research itself. We know there is quite a range of opinion about the value of surgical trials. Some say surgical trials are important for advancing knowledge about the safety and efficacy of procedures; others feel surgical trials are unnecessary, unfeasible, unethical, and so forth. What do you think?

Prompts: Value of surgical trials compared to surgical judgment Surgical trials obsolete before completion Research results non-transferable Impossible to blind surgeons and patients Unethical to conduct well-controlled surgical trials

Now think about surgical studies for Parkinson’s disease that you are aware of. I’m sure some were well done and some were not done so well. What is it that separates the good from the not-so-good?

[Prompts: I haven’t heard you mention much about:  blinding  controls  use of placebos

 degree of risk  prospect of benefit  randomization  regulatory requirements  adequacy of available funding

Give me some examples of well-done and poorly done surgical studies involving persons with PD.

(Good Decision-making/Vulnerability/Protections) As you all know, there are questions around having persons with advanced PD participate in surgical research. Some people believe they are vulnerable and unable to make good decisions

How do you respond to this? [Prompt: For example, they may be:  coerced by their disease  unable to fully appreciate the risks involved  prone to confusing research with therapy  too sick to be asked to accept risks in the absence of clear therapeutic intent. ]

What evidence supports your concerns/opinions?

Now think about people in the early stages of Parkinson’s disease, under what circumstances might you involve this group of patients in surgical research?

There is a lot of talk in the literature about informed consent – about its problems and promises. Designing a good consent process for complex surgical research can be challenging. Can you give me a few examples where you thought the informed consent process for surgical research either worked, or could have been improved? What happened?

A good consent process is only one of several steps researchers take to protect participants in their research studies. What other steps do you think are especially important to protect participants in surgical research for PD?

[prompts:  inclusion/exclusion criteria  DSMBs  Consent monitors/advocates  Cover financial costs of participation or for research-related injuries  Minimize risks and enhance benefits  Formally assess decisionmaking capacity and appreciation  recruitment performed by someone other than the person’s physician]

(FDA) Another dimension of research with surgically implanted significant risk medical devices is the role played by the FDA. Will you explain how FDA involvement affects surgical research for PD. What are some ways FDA involvement can be helpful? How might the FDA’s role in surgical research be improved?

Now regarding Investigational Device Exemptions, or IDEs: How many of you have conducted research under an IDE? What are the positive and negative features of the IDE process?

[Prompts: Which do you prefer: to engage in research when the manufacturer holds the IDE or when you or a colleague holds it? What’s good about having your own IDE as opposed to working under a manufacturer’s IDE?]

(Incentives/Disincentives) My last set of questions concerns the incentives and disincentives for neurologists and neurosurgeons to become involved in the design and conduct of surgical research. Clearly many neurosurgeons and neurologists never get involved. What are the things that encourage or discourage people from getting involved in surgical research?

Conclusion

Is there anything you would like to mention that we failed to discuss today?

Thank you very much for your time and input.

Studying Neurosurgical Implants for Parkinson’s Disease: A Question of Design

A.W. Prehn1, D.E. Vawter1, K.G. Gervais1, R.G. DeVries2, J.E. Garrett1, T.B. Freeman3, T.Q. McIndoo1

1Minnesota Center for Health Care Ethics, Minneapolis 2St. Olaf College, Northfield, Minnesota 3University of South Florida, Tampa

Interview Questions for Clinical Researchers

Please say just a few words about the type(s) of surgical research for Parkinson’s disease that you have been involved in – for instance, have you conducted lesioning, cellular implant and/or medical device research?

Prompt: Tell us, who pays for the costs of surgical device research at your institution? What are the benefits and the problems with this funding arrangement?