Patrick S. Duggan

Psychiatric and neuropsychiatric adverse events associated with deep brain stimulation: A meta-analysis of ten years' experience

Deep brain stimulation (DBS) has been approved by the FDA for use in the treatment of Parkinsons disease, essential tremor, and dystonia. Case reports and case series have reported significant psychiatric side effects in some individuals. The goal of this meta‐analysis is to characterize the risks and benefits of DBS and to assess its possible use within the psychiatric setting. A search was conducted on PubMed, EBSCO, and PsycInfo in January 2006 that covered the time period 1 Jan 1996–30 Dec 2005. All identified articles were reviewed and those describing adverse events were further examined with a structured instrument. The initial searches yielded 2667 citations; 808 articles met inclusion criteria for the meta‐analysis; 98.2% of studies that specifically assessed motor function reported some level of improvement. Most reported side effects were device or procedure related (e.g., infection and lead fracture). The prevalence of depression was 2–4%, mania 0.9–1.7%, emotional changes 0.1–0.2%, and the prevalence of suicidal ideation/suicide attempt was 0.3–0.7%. The completed suicide rate was 0.16–0.32%. In conclusion, DBS is an effective treatment for Parkinsons disease, dystonia, and essential tremor, and case reports suggest that major depression and OCD may also respond to DBS. Reported rates of depression, cognitive impairment, mania, and behavior change are low, but there is a high rate of suicide in patients treated with DBS, particularly with thalamic and GPi stimulation. Because of the high suicide rate, patients should be prescreened for suicide risk prior to DBS surgery. Additionally, patients should be monitored closely for suicidal behavior post‐operatively.

Do Patients Treated With Dignity Report Higher Satisfaction, Adherence, and Receipt of Preventive Care?

PURPOSE Although involving patients in their own health care is known to be associated with improved outcomes, this study was conducted to determine whether respecting persons more broadly, such as treating them with dignity, has additional positive effects. METHODS Using data from the Commonwealth Fund 2001 Health Care Quality Survey of 6,722 adults living in the United States, we performed survey-weighted logistic regression analysis to evaluate independent associations between 2 measures of respect (involvement in decisions and treatment with dignity) and patient outcomes (satisfaction, adherence, and receipt of optimal preventive care). Then we calculated adjusted probabilities of these outcomes and performed stratified analyses to examine results across racial/ethnic groups. RESULTS After adjustment for respondents’ demographic characteristics, the probability of reporting a high level of satisfaction was higher for those treated with dignity vs not treated with dignity (0.70 vs 0.38, P <.001) and for those involved in, versus not involved in, decisions (0.70 vs 0.39, P <.001). These associations were consistent across all racial/ethnic groups. Being involved in decisions was significantly associated with adherence for whites, whereas being treated with dignity was significantly associated with adherence for racial/ethnic minorities. The probability of receiving optimal preventive care was marginally greater for those treated with dignity (0.68 vs 0.63, P = .054), but did not differ with respect to involvement in decisions (0.67 vs 0.67, P = .95). CONCLUSIONS Being treated with dignity and being involved in decisions are independently associated with positive outcomes. Although involving patients in decisions is an important part of respecting patient autonomy, it is also important to respect patients more broadly by treating them with dignity.

What Does ‘Respect’ Mean? Exploring the Moral Obligation of Health Professionals to Respect Patients

Respect is frequently invoked as an integral aspect of ethics and professionalism in medicine, yet it is often unclear what respect means in this setting. While we recognize that there are many reasonable ways to think about and use the term ‘respect’, in this paper, we develop a conception of respect that imposes a distinct moral duty on physicians. We are concerned mainly with the idea of respect for persons, or more specifically, respect for patients as persons. We develop an account of respect as recognition of the unconditional value of patients as persons. Such respect involves respecting the autonomy of patients, but we challenge the idea that respect for autonomy is a complete or self-sufficient expression of respect for persons. Furthermore, we suggest that the type of respect that physicians owe to patients is independent of a patient’s personal characteristics, and therefore, ought to be accorded equally to all. Finally, the respect that we promote has both a cognitive dimension (believing that patients have value) and a behavioral dimension (acting in accordance with this belief).

CELL-BASED INTERVENTIONS FOR NEUROLOGIC CONDITIONS: ETHICAL CHALLENGES FOR EARLY HUMAN TRIALS

Background: Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. Methods: An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. Results: While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Conclusions: Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

Is Patients’ Preferred Involvement in Health Decisions Related to Outcomes for Patients with HIV?

Previous studies suggest that patients who are more involved in their medical care have better outcomes. We sought to compare health care processes and outcomes for patients with HIV based on their preferred level of involvement in health decisions. Cross-sectional analysis of audio computer-assisted interviews with patients at an urban HIV clinic. One thousand and twenty-seven patients awaiting an appointment with their primary care provider. Patients were asked how they preferred to be involved in decisions (doctor makes most or all decisions, doctor and patient share decisions, patient makes all decisions). We also asked patients to rate the quality of communication with their HIV provider, and their self-reported receipt of and adherence to HAART. Overall, 23% patients preferred that their doctor make all or most decisions, 63% preferred to share decisions with their doctor, and 13% preferred to make all final decisions alone. Compared to patients who prefer to share decisions with their HIV provider, patients who prefer that their provider make all/most decisions were significantly less likely to adhere to HAART (OR [odds ratio] 0.57, 95% CI 0.38–0.86) and patients who preferred to make decisions alone were significantly less likely to receive HAART or to have undetectable HIV RNA in unadjusted analyses (OR 0.52, 95% CI 0.31–0.87 for receipt of HAART; OR 0.64, 95% CI 0.44–0.95 for undetectable HIV RNA). After controlling for potentially confounding patient characteristics and differences in patient ratings of communication quality, patients who preferred that their provider make all/most decisions remained significantly less likely to adhere to HAART (OR 0.58, 95% CI 0.38–0.89); however, the associations with receipt of HAART and undetectable HIV RNA were no longer significant (OR 0.60, 95% CI 0.34–1.05 for receipt of HAART; OR 0.80, 95% C.I 0.53–1.20 for undetectable HIV RNA). Although previous research suggests that more patient involvement in health care decisions is better, this benefit may be reduced when the patient wants to make decisions alone. Future research should explore the extent to which this preference is modifiable so as to improve outcomes.

Can patient-centered attitudes reduce racial and ethnic disparities in care?

Purpose Patient-centeredness has been advocated to reduce racial/ethnic disparities in health care quality, but no empirical data support such a connection. The authors’ purpose was to determine whether students with patient-centered attitudes have better performance and are less likely to demonstrate disparities with African American compared with white standardized patients (SPs). Method Third-year medical students were assessed by SPs at the Clinical Educational Center of the Johns Hopkins University School of Medicine in 2002. One African American and one white actor were trained as SPs for each of four case scenarios; students were randomly assigned to interact with either SP for each case. Before the exam, students were surveyed about their attitudes towards patient-centered medicine. Students with and without patient-centered attitudes were compared with regard to their performance with African American and white SPs. Outcome measures were student exam scores in interpersonal skill, history taking, physical exam, and counseling. Results All 177 of eligible students participated in all four case scenarios. With white SPs, students with patient-centered attitudes performed similarly to students without patient-centered attitudes in all four areas. However, with African American SPs, students with patient-centered attitudes performed significantly better than students without patient-centered attitudes in interpersonal skills (71.4 versus 69.4, P = .010), history taking (63.8 versus 61.1, P = .003), and counseling (92.1 versus 88.7, P = .002) and not significantly different in physical exam performance (73.6 versus 68.6, P = .311). Conclusions Patient-centered attitudes may be more important in improving physician behaviors with African American patients than with white patients and may, therefore, play a role in reducing disparities.

Discourses of disease, discourses of disadvantage: A critical analysis of National Pandemic Influenza Preparedness Plans

Growing recognition of the threat of pandemic influenza to global health has led to increased emphasis on pandemic influenza preparedness planning. Previous analysis of national pandemic preparedness plans has revealed that those plans paid scant attention to the needs and interests of the disadvantaged. This paper investigates those findings via critical discourse analysis of the same plans as well as World Health Organization guidance documents. The analysis reveals that the texts operate within and as parts of an ordered universe of discourse. Among the six discourses which emerge from the analysis the scientific, political, and legal dominate the social, cultural, and ethical. This order of discourse delineates a specific regime of truths within which the lives, needs, and interests of the disadvantaged are masked or neglected. Unless the plans recognize their discursive construction, implementation of the policies and practices they prescribe runs the risk of further disadvantaging those very populations most likely to require protection.

The role of animal models in evaluating reasonable safety and efficacy for human trials of cell-based interventions for neurologic conditions.

Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain.

Planning for an Influenza Pandemic: Social Justice and Disadvantaged Groups

Because an influenza pandemic would create the most serious hardships for those who already face most serious hardships, countries should take special measures to mitigate the effect of a pandemic on existing social inequalities. Unfortunately, there is little evidence that anybody is thinking about that.