Background
Deep brain stimulation (DBS) is an effective and approved therapy for advanced Parkinson’s disease (PD), and a recent study suggests efficacy in mid-stage disease. This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD.
Methods
Thirty subjects with idiopathic PD (Hoehn & Yahr Stage II off medication), age 50–75, on medication ≥ 6 months but < 4 years, and without motor fluctuations or dyskinesias were randomized to optimal drug therapy (ODT) (n=15) or DBS+ODT (n=15). Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months.
Results
As hypothesized, the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months. The DBS+ODT group took less medication at all time points, and this reached maximum difference at 18 months. With a few exceptions, differences in neuropsychological functioning were not significant. Two subjects in the DBS+ODT group suffered serious adverse events; remaining adverse events were mild or transient.
Conclusions
This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD. The results of this trial provide the data necessary to design a large, phase III, double-blind, multicenter trial investigating the safety and efficacy of DBS in early PD.
In an academic medical center clinic, the presence of electronic records was not seen as a dramatic impediment to therapeutic communications. Concerns regarding privacy and data security were significant, and may contribute to reluctances to adopt electronic records in other settings. Further study of clinicians' views and use patterns may be helpful in guiding development and deployment of electronic records systems.
Ongoing work on clinical ethics consultation service quality improvement and engagement with our nursing colleagues about their concerns prompting-and their evaluations of-clinical ethics consultation are necessary.
Against the background assumptions that (a) knowing what clinical ethics consultation represents to those with whom ethics consultants work most closely is a necessary component for being responsible in the practice of ethics consultation, and (b) the complexities of soliciting and understanding colleague evaluations require another inherent responsibility for the methods by which ethics consultations are evaluated, in this article we report our experience soliciting, analyzing, and trying to understand retrospective evaluations of our Clinical Ethics Consultation Service. These evaluations were collected through a quality assessment effort at our institution. Drawing from the qualitative elements of our survey instrument, we describe unexpected variations among the requests for ethics consultation and the retrospective reports from those colleagues making the requests. Focusing on just one aspect - the reason for request - raised several core questions about how we should evaluate those retrospective reports, what could be learned from the differences that we were now encountering, and what we could learn about the process of evaluating our practices. Working through these questions, we suggest several issues to consider in ongoing efforts to describe and evaluate clinical ethics consultation: the role of time and memory in evaluating retrospective evaluations, the importance of attending to the language of moral shift or disruption with which our colleagues describe their experiences, and how to understand the role of ethics consultation in creating 'moral space' (a la Margaret Urban Walker's conception) for colleagues to process their moral experiences.
Deciding who should receive maximal technological treatment options and who should not represents an ethical, moral, psychological and medico-legal challenge for health care providers. Especially in patients with chronic heart failure, the ethical and medico-legal issues associated with providing maximal possible care or withholding the same are coming to the forefront. Procedures, such as cardiac transplantation, have strict criteria for adequate candidacy. These criteria for subsequent listing are based on clinical outcome data but also reflect the reality of organ shortage. Lack of compliance and non-adherence to lifestyle changes represent relative contraindications to heart transplant candidacy. Mechanical circulatory support therapy using ventricular assist devices is becoming a more prominent therapeutic option for patients with end-stage heart failure who are not candidates for transplantation, which also requires strict criteria to enable beneficial outcome for the patient. Physicians need to critically reflect that in many cases, the patient’s best interest might not always mean pursuing maximal technological options available. This article reflects on the multitude of critical issues that health care providers have to face while caring for patients with end-stage heart failure.
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