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Longer-term outcomes after kidney transplantation from seronegative deceased donors at increased risk for blood-borne viral infection

Reese, Peter P; Halpern, Scott D; Asch, David A; Bloom, Roy; Nathan, Howard; Hasz, Richard; Roth, Joseph; Reitsma, William; Krefski, Louis; Goerlitz, Fred; DeLauro, Gina; Blumberg, Emily; Weng, Francis L; Caplan, Arthur; Thomasson, Arwin; Shults, Justine; Feldman, Harold I
BACKGROUND: Transmission of human immunodeficiency virus and hepatitis C to transplant recipients has drawn attention of the use of allografts from seronegative donors at increased risk for blood-borne viral infection (DIRVI). METHODS: We performed a cohort study of 7803 kidney transplant recipients whose kidneys were recovered through one of two organ procurement organizations from 1996 to 2007. Detailed organ procurement organization data on donor risk factors were linked to recipient data from the Organ Procurement and Transplantation Network. RESULTS: Median recipient follow-up was 3.9 years. Three hundred sixty-eight (5%) patients received DIRVI kidneys, a third of which were procured from donors with a history of injection drug use or commercial sex work. Compared with standard criteria kidney recipients, DIRVI kidney recipients were more likely to be human immunodeficiency virus positive or black. In multivariable Cox regression, using DIRVI recipients as the reference, recipients of standard criteria donor kidneys had lower mortality (hazard ratio [HR] 0.71, P<0.01) and no difference in death-censored allograft failure (HR 1.09, P=0.62), whereas recipients of expanded criteria donor kidneys had no significant difference in mortality (HR 0.98, P=0.83) but a higher allograft failure rate (HR 1.93, P<0.01). High-quality data on posttransplant recipient viral testing were not available. CONCLUSIONS: DIRVI kidney recipients experienced higher mortality than standard criteria kidney recipients. This finding could be explained if sicker patients received DIRVI kidneys (i.e., residual confounding) or the less likely possibility of undetected transmission of viral infections. Given the limitations of registry data used in this analysis, prospective studies are needed to further elucidate these findings.
PMCID:3462444
PMID: 21527872
ISSN: 0041-1337
CID: 163930

Expanding applications of deep brain stimulation: a potential therapeutic role in obesity and addiction management

Halpern, Casey H; Torres, Napoleon; Hurtig, Howard I; Wolf, John A; Stephen, James; Oh, Michael Y; Williams, Noel N; Dichter, Marc A; Jaggi, Jurg L; Caplan, Arthur L; Kampman, Kyle M; Wadden, Thomas A; Whiting, Donald M; Baltuch, Gordon H
BACKGROUND: The indications for deep brain stimulation (DBS) are expanding, and the feasibility and efficacy of this surgical procedure in various neurologic and neuropsychiatric disorders continue to be tested. This review attempts to provide background and rationale for applying this therapeutic option to obesity and addiction. We review neural targets currently under clinical investigation for DBS-the hypothalamus and nucleus accumbens-in conditions such as cluster headache and obsessive-compulsive disorder. These brain regions have also been strongly implicated in obesity and addiction. These disorders are frequently refractory, with very high rates of weight regain or relapse, respectively, despite the best available treatments. METHODS: We performed a structured literature review of the animal studies of DBS, which revealed attenuation of food intake, increased metabolism, or decreased drug seeking. We also review the available radiologic evidence in humans, implicating the hypothalamus and nucleus in obesity and addiction. RESULTS: The available evidence of the promise of DBS in these conditions combined with significant medical need, support pursuing pilot studies and clinical trials of DBS in order to decrease the risk of dietary and drug relapse. CONCLUSIONS: Well-designed pilot studies and clinical trials enrolling carefully selected patients with obesity or addiction should be initiated.
PMID: 21976235
ISSN: 0001-6268
CID: 163924

Genome-sequencing anniversary. What will drive genomics over the next 10 years?

Caplan, Arthur
PMID: 21311001
ISSN: 0036-8075
CID: 163934

Ethics of vaccination programs

Schwartz, Jason L; Caplan, Arthur L
Ethical issues are present at each stage in the vaccine product life cycle, the period extending from the earliest stages of research through the eventual design and implementation of global vaccination programs. Recent developments highlight fundamental principles of vaccine ethics and raise unique issues for ongoing vaccination activities worldwide. These include the 2009-10 H1N1 pandemic influenza vaccination campaign, renewed attention to the potential global eradication of polio, and the ongoing evaluation of vaccine risk controversies, most notably the alleged link between childhood vaccines and autism. These cases present ethical challenges for public health policy-makers, scientists, physicians, and other stakeholders in their efforts to improve the health of individuals, communities, and nations through vaccination.
PMID: 22440783
ISSN: 1879-6265
CID: 163916

Time to mandate influenza vaccination in health-care workers

Caplan, Arthur
PMID: 21789789
ISSN: 0140-6736
CID: 163928

Informed consent in research to improve the number and quality of deceased donor organs

Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D
Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.
PMCID:3717371
PMID: 20975549
ISSN: 0090-3493
CID: 163940

Employee designation and health care worker support of an influenza vaccine mandate at a large pediatric tertiary care hospital

Feemster, Kristen A; Prasad, Priya; Smith, Michael J; Feudtner, Chris; Caplan, Arthur; Offit, Paul; Coffin, Susan E
AIM: Determine predictors of support of a mandatory seasonal influenza vaccine program among health care workers (HCWs). SCOPE: Cross-sectional anonymous survey of 2443 (out of 8093) randomly selected clinical and non-clinical HCWs at a large pediatric network after implementation of a mandatory vaccination program in 2009-10. RESULTS: 1388 HCWs (58.2%) completed the survey and 75.2% of respondents reported agreeing with the new mandatory policy. Most respondents (72%) believed that the policy was coercive but >90% agreed that the policy was important for protecting patients and staff and was part of professional ethical responsibility. When we adjusted for attitudes and beliefs regarding influenza and the mandate, there was no significant difference between clinical and nonclinical staff in their support of the mandate (OR 1.08, 95% C.I. 0.94, 1.26). CONCLUSIONS: Attitudes and beliefs regarding influenza and the mandate may transcend professional role. Targeted outreach activities can capitalize on beliefs regarding patient protection and ethical responsibility.
PMID: 21216318
ISSN: 0264-410x
CID: 163935

Vaccination refusal: ethics, individual rights, and the common good

Schwartz, Jason L; Caplan, Arthur L
Among the obstacles to the success of vaccination programs is the apparent recent increase in hesitancy and outright resistance to the recommended vaccination schedule by some parents and patients. This article reviews the spectrum of patient or parental attitudes that may be described as vaccine refusal, explores related ethical considerations in the context of the doctor-patient relationship and public health, and evaluates the possible responses of physicians when encountering resistance to vaccination recommendations. Health care providers should view individuals hesitant about or opposed to vaccines not as frustrations or threats to public health, but as opportunities to educate and inform.
PMID: 22094142
ISSN: 0095-4543
CID: 163922

Will evidence ever be sufficient to resolve the challenge of cost containment? [Editorial]

Caplan, Arthur L
PMID: 21502551
ISSN: 0732-183x
CID: 163931

The use of human tissues in research: what do we owe the research subjects?

Gronowski, Ann M; Moye, Jack Jr; Wendler, David S; Caplan, Arthur L; Christman, Michael
PMID: 21205881
ISSN: 0009-9147
CID: 163936