L E T T E R S :
P U B L I S H E D
A R T I C L E S
editor in response, this author wrote, “Finally, the authors use argumentum ignorantiam (arguing from ignorance) stating that there is no level 1 evidence supporting the use of MERs. This logic is analogous to ‘because I don’t know you are an honest person, you must not be an honest person.’ There are many therapies lacking level 1 evidence and failure to use those therapies risks malpractice.”3 The statement “failure to use those therapies [that] risks malpractice” clearly refers to the “many [italics added] therapies lacking level 1 evidence” and clearly not to MER. How can Mirzadeh and Ponce suggest that this author equates the failure to use MERs with malpractice, as they did when they wrote “Whether Dr. Montgomery means to suggest in his final point that ‘failure to use’ MER ‘risks malpractice’ is unclear, but if he does, we strongly disagree”4? This false attribution of threats of malpractice accusations is counterproductive, and such innuendo has no place in scientific discussion. Mirzadeh and Ponce also wrote that this author disparaged the work of others not using MERs,4 but this simply is not true, unless simply raising questions regarding definitions of terms and statistical analyses is disparaging, which it is not. Mirzadeh and Ponce raise the issue of equipoise without clear or critical discussion.4 Equipoise is a state in which alternatives are equally valid, and thus one can, with clear conscience, choose among them. In its positive sense, all of the alternative are known to be equivalent. However, evidence of equivalence of methods with and without MERs does not exist. Past evidence typically has been based on insufficient sample size, poor statistical design, and historical controls. The latter are greatly confounded by variability in surgeon and physician competence. Randomization to MER or no MER within an individual surgeon’s practice is difficult to achieve,5 and then there is the problem of blinding. In the negative sense of equipoise, all alternatives are equally uncertain. However, this is not the case here. Suggesting that only level 1 evidence-based medicine evidence is legitimate would be solipsistic, and principle evidence and experience support the utility of MERs. Space limitations prevent a sufficient review or point-by-point rebuttal here. Mirzadeh and Ponce insinuate a lack of respect for the good intentions of those attempting to improve surgical practice. Not only is this untrue, it is irrelevant. The Belmont report6 and attendant discussions document that good intentions often fail to protect patients; hence the requirement for institutional review boards in human research. Investigators working to improve surgical care under IRB supervision should be applauded and supported. However, research without reasonable expectations of valid conclusions, regardless of whether because of statistical or experi-
------------------------------------------------------------
*Correspondence to: Dr. Erwin B. Montgomery Jr., MD, Medical Director, Greenville Neuromodulation Center, 179 Main St., Greenville, PA 16125, USA, E-mail: [email protected]
Relevant conflicts of interest/financial disclosures: Dr. Montgomery is author of Intraoperative Neurophysiological Monitoring for Deep Brain Stimulation from Oxford University Press, for which he receives royalties. Full financial disclosures may be found in the online version of this article. Received: 4 March 2015; Revised: 17 March 2015; Accepted: 26 March 2015 Published online 23 May 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/mds.26275
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mental design flaws that should have been known previously, is unethical. This caveat applies to all investigators conducting any human research. That Mirzadeh and Ponce have resorted to argument ad hominem by misrepresentations of the professional opinions and intentions of others who may differ is unfortunate. Hopefully, in the future, having a needed, fair, and reasoned discussion based on ethical principles and critical and clear epistemic analyses of the evidence will be possible. Erwin B. Montgomery Jr., MD* Greenville Neuromodulation Center, Greenville, PA, USA
References 1.
Montgomery EB Jr. Chapter 19—Ethical issues of deep brain stimulation, in Twenty Things to Know About Deep Brain Stimulation. New York: Oxford University Press; 2015:226-246.
2.
Mirzadeh Z, Chapple K, Lambert M, Dhall R, Ponce FA. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
3.
Montgomery EB Jr. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
4.
Mirzadeh Z, Ponce FA. DBS with versus without MER: Clinical equipoise or malpractice? Mov Disord 2015;30:439-441.
5.
Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med 2008;75(Suppl 6):S7-S12.
6.
Belmont Report, Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979. [cited 20xx Month xx]. Available from: http://www.hhs.gov/ohrp/humansub jects/guidance/belmont.html.
RE: Letter to the Editor Regarding Microelectrode Recordings and Deep Brain Stimulation Surgery—Reasoned Discussion? To the Editor: The purpose of our study was to evaluate the reliability of using intraoperative computed tomography images to determine the stereotactic location of deep brain stimulation (DBS) leads.1 It was not an outcome study evaluating the clinical efficacy of magnetic resonance imaging–based DBS targeting; to address the relationship between stereotactic accuracy and clinical outcome goes beyond the intended scope of that study. We agree with Dr. Montgomery that “the debate regarding microelectrode recordings (MERs) supplementing neuroimaging for identifying [established] targets for Deep Brain Stimulation (DBS) is yet to be settled”. In our previous response to Dr. Montgomery, we outlined the lines of inquiry that we are exploring to clarify the value of MER, given that we now have the opportunity to combine MER and intraoperative imaging. However (apropos of the “rules of evidence”), we believe discussing these results further would be premature until our data have been submitted for
L E T T E R S :
peer review and published or presented. To this end, a manuscript reporting our initial results prospectively evaluating outcomes following bilateral globus pallidus interna DBS using the “asleep” technique is now in press.2 We continue to encourage all of our DBS patients to enroll in our prospective study (ClinicalTrials.gov identifier: NCT01997398), and, in particular, to follow up at 6 months after DBS surgery for Unified Parkinson’s Disease Rating Scale testing. This allows us to prospectively compare the “awake” and “asleep” techniques. Furthermore, we recently obtained institutional review board approval to recruit patients for randomization between the two techniques, and this study has been registered with the ClinicalTrials.gov database (ClinicalTrials.gov identifier: NCT02401308).
P U B L I S H E D
A R T I C L E S
Zaman Mirzadeh, MD, PhD, and Francisco A. Ponce, MD* Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, Phoenix, Arizona, USA
References 1.
Mirzadeh Z, Chapple K, Lambert M, Dhall R, Ponce FA. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
2.
Mirzadeh Z, Chapple K, Lambert M, Evidente VG, et al. Parkinson’s disease patient outcomes after intraoperative CT-guided “asleep” deep brain stimulation in globus pallidus interna. J Neurosurg (in press).
------------------------------------------------------------
*Correspondence to: Dr. Francisco A. Ponce, MD, Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, Phoenix, AZ USA, E-mail: [email protected] Relevant conflicts of interest/financial disclosures: Nothing to report. Full financial disclosures and author roles may be found in the online version of this article. Received: 14 April 2015; Accepted: 17 April 2015 Published online 12 June 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/mds.26274
Movement Disorders, Vol. 30, No. 9, 2015
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P U B L I S H E D
A R T I C L E S
editor in response, this author wrote, “Finally, the authors use argumentum ignorantiam (arguing from ignorance) stating that there is no level 1 evidence supporting the use of MERs. This logic is analogous to ‘because I don’t know you are an honest person, you must not be an honest person.’ There are many therapies lacking level 1 evidence and failure to use those therapies risks malpractice.”3 The statement “failure to use those therapies [that] risks malpractice” clearly refers to the “many [italics added] therapies lacking level 1 evidence” and clearly not to MER. How can Mirzadeh and Ponce suggest that this author equates the failure to use MERs with malpractice, as they did when they wrote “Whether Dr. Montgomery means to suggest in his final point that ‘failure to use’ MER ‘risks malpractice’ is unclear, but if he does, we strongly disagree”4? This false attribution of threats of malpractice accusations is counterproductive, and such innuendo has no place in scientific discussion. Mirzadeh and Ponce also wrote that this author disparaged the work of others not using MERs,4 but this simply is not true, unless simply raising questions regarding definitions of terms and statistical analyses is disparaging, which it is not. Mirzadeh and Ponce raise the issue of equipoise without clear or critical discussion.4 Equipoise is a state in which alternatives are equally valid, and thus one can, with clear conscience, choose among them. In its positive sense, all of the alternative are known to be equivalent. However, evidence of equivalence of methods with and without MERs does not exist. Past evidence typically has been based on insufficient sample size, poor statistical design, and historical controls. The latter are greatly confounded by variability in surgeon and physician competence. Randomization to MER or no MER within an individual surgeon’s practice is difficult to achieve,5 and then there is the problem of blinding. In the negative sense of equipoise, all alternatives are equally uncertain. However, this is not the case here. Suggesting that only level 1 evidence-based medicine evidence is legitimate would be solipsistic, and principle evidence and experience support the utility of MERs. Space limitations prevent a sufficient review or point-by-point rebuttal here. Mirzadeh and Ponce insinuate a lack of respect for the good intentions of those attempting to improve surgical practice. Not only is this untrue, it is irrelevant. The Belmont report6 and attendant discussions document that good intentions often fail to protect patients; hence the requirement for institutional review boards in human research. Investigators working to improve surgical care under IRB supervision should be applauded and supported. However, research without reasonable expectations of valid conclusions, regardless of whether because of statistical or experi-
------------------------------------------------------------
*Correspondence to: Dr. Erwin B. Montgomery Jr., MD, Medical Director, Greenville Neuromodulation Center, 179 Main St., Greenville, PA 16125, USA, E-mail: [email protected]
Relevant conflicts of interest/financial disclosures: Dr. Montgomery is author of Intraoperative Neurophysiological Monitoring for Deep Brain Stimulation from Oxford University Press, for which he receives royalties. Full financial disclosures may be found in the online version of this article. Received: 4 March 2015; Revised: 17 March 2015; Accepted: 26 March 2015 Published online 23 May 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/mds.26275
1294
Movement Disorders, Vol. 30, No. 9, 2015
mental design flaws that should have been known previously, is unethical. This caveat applies to all investigators conducting any human research. That Mirzadeh and Ponce have resorted to argument ad hominem by misrepresentations of the professional opinions and intentions of others who may differ is unfortunate. Hopefully, in the future, having a needed, fair, and reasoned discussion based on ethical principles and critical and clear epistemic analyses of the evidence will be possible. Erwin B. Montgomery Jr., MD* Greenville Neuromodulation Center, Greenville, PA, USA
References 1.
Montgomery EB Jr. Chapter 19—Ethical issues of deep brain stimulation, in Twenty Things to Know About Deep Brain Stimulation. New York: Oxford University Press; 2015:226-246.
2.
Mirzadeh Z, Chapple K, Lambert M, Dhall R, Ponce FA. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
3.
Montgomery EB Jr. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
4.
Mirzadeh Z, Ponce FA. DBS with versus without MER: Clinical equipoise or malpractice? Mov Disord 2015;30:439-441.
5.
Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med 2008;75(Suppl 6):S7-S12.
6.
Belmont Report, Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979. [cited 20xx Month xx]. Available from: http://www.hhs.gov/ohrp/humansub jects/guidance/belmont.html.
RE: Letter to the Editor Regarding Microelectrode Recordings and Deep Brain Stimulation Surgery—Reasoned Discussion? To the Editor: The purpose of our study was to evaluate the reliability of using intraoperative computed tomography images to determine the stereotactic location of deep brain stimulation (DBS) leads.1 It was not an outcome study evaluating the clinical efficacy of magnetic resonance imaging–based DBS targeting; to address the relationship between stereotactic accuracy and clinical outcome goes beyond the intended scope of that study. We agree with Dr. Montgomery that “the debate regarding microelectrode recordings (MERs) supplementing neuroimaging for identifying [established] targets for Deep Brain Stimulation (DBS) is yet to be settled”. In our previous response to Dr. Montgomery, we outlined the lines of inquiry that we are exploring to clarify the value of MER, given that we now have the opportunity to combine MER and intraoperative imaging. However (apropos of the “rules of evidence”), we believe discussing these results further would be premature until our data have been submitted for
L E T T E R S :
peer review and published or presented. To this end, a manuscript reporting our initial results prospectively evaluating outcomes following bilateral globus pallidus interna DBS using the “asleep” technique is now in press.2 We continue to encourage all of our DBS patients to enroll in our prospective study (ClinicalTrials.gov identifier: NCT01997398), and, in particular, to follow up at 6 months after DBS surgery for Unified Parkinson’s Disease Rating Scale testing. This allows us to prospectively compare the “awake” and “asleep” techniques. Furthermore, we recently obtained institutional review board approval to recruit patients for randomization between the two techniques, and this study has been registered with the ClinicalTrials.gov database (ClinicalTrials.gov identifier: NCT02401308).
P U B L I S H E D
A R T I C L E S
Zaman Mirzadeh, MD, PhD, and Francisco A. Ponce, MD* Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, Phoenix, Arizona, USA
References 1.
Mirzadeh Z, Chapple K, Lambert M, Dhall R, Ponce FA. Validation of CT-MRI fusion for intraoperative assessment of stereotactic accuracy in DBS surgery. Mov Disord 2014;29:1788-1795.
2.
Mirzadeh Z, Chapple K, Lambert M, Evidente VG, et al. Parkinson’s disease patient outcomes after intraoperative CT-guided “asleep” deep brain stimulation in globus pallidus interna. J Neurosurg (in press).
------------------------------------------------------------
*Correspondence to: Dr. Francisco A. Ponce, MD, Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, Phoenix, AZ USA, E-mail: [email protected] Relevant conflicts of interest/financial disclosures: Nothing to report. Full financial disclosures and author roles may be found in the online version of this article. Received: 14 April 2015; Accepted: 17 April 2015 Published online 12 June 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/mds.26274
Movement Disorders, Vol. 30, No. 9, 2015
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