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Data monitoring committees and randomized clinical trials [Letter]

Trachtman, Howard; Caplan, Arthur L
PMID: 30904070
ISSN: 1523-1755
CID: 3776422

Physician Attitudes Toward Living Kidney Donation

Trachtman, Howard; Parent, Brendan; Kirshenbaum, Ari; Caplan, Arthur
Background: Compared to dialysis, living kidney donation has a greater chance of restoring health and is associated with better outcomes than deceased kidney donation. Although physicians advocate for this treatment, it is uncertain how they would act as potential living kidney donors or recipients. Methods: We surveyed 104 physicians, pediatric, and internal medicine nephrologists, to ascertain their attitudes toward living donation. Results: Among surveyed nephrologists, there was nearly universal support for living kidney donation as a viable medical option, and nearly all of them would support a healthy and medically cleared patient who wishes to participate. Although support was still strong, nephrologists were significantly less likely to support their friends and relatives participating in living kidney donation, and their support declined further for friends and relatives donating to nonrelatives. Conclusion: Our findings suggest the need to more deeply examine physician-perceived risks involved in serving as a living kidney donor. Based on differences in surveyed nephrologist attitudes regarding donation to and from loved ones versus nonrelatives, we suggest that physicians should give careful consideration to how they describe the risks of living donation to potential donors.
ISI:000458788300013
ISSN: 1526-9248
CID: 3693712

Comparative effectiveness of neuroablation and deep brain stimulation for treatment-resistant obsessive-compulsive disorder: a meta-analytic study

Kumar, Kevin K; Appelboom, Geoffrey; Lamsam, Layton; Caplan, Arthur L; Williams, Nolan R; Bhati, Mahendra T; Stein, Sherman C; Halpern, Casey H
BACKGROUND:The safety and efficacy of neuroablation (ABL) and deep brain stimulation (DBS) for treatment refractory obsessive-compulsive disorder (OCD) has not been examined. This study sought to generate a definitive comparative effectiveness model of these therapies. METHODS:A EMBASE/PubMed search of English-language, peer-reviewed articles reporting ABL and DBS for OCD was performed in January 2018. Change in quality of life (QOL) was quantified based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the impact of complications on QOL was assessed. Mean response of Y-BOCS was determined using random-effects, inverse-variance weighted meta-analysis of observational data. FINDINGS/RESULTS:Across 56 studies, totalling 681 cases (367 ABL; 314 DBS), ABL exhibited greater overall utility than DBS. Pooled ability to reduce Y-BOCS scores was 50.4% (±22.7%) for ABL and was 40.9% (±13.7%) for DBS. Meta-regression revealed no significant change in per cent improvement in Y-BOCS scores over the length of follow-up for either ABL or DBS. Adverse events occurred in 43.6% (±4.2%) of ABL cases and 64.6% (±4.1%) of DBS cases (p<0.001). Complications reduced ABL utility by 72.6% (±4.0%) and DBS utility by 71.7% (±4.3%). ABL utility (0.189±0.03) was superior to DBS (0.167±0.04) (p<0.001). INTERPRETATION/CONCLUSIONS:Overall, ABL utility was greater than DBS, with ABL showing a greater per cent improvement in Y-BOCS than DBS. These findings help guide success thresholds in future clinical trials for treatment refractory OCD.
PMID: 30679237
ISSN: 1468-330x
CID: 3683132

The Orphan Drug Act Revisited

Thomas, Shailin; Caplan, Arthur
PMID: 30768155
ISSN: 1538-3598
CID: 3656462

Vaccine Trials in Schools: We Must Not Ignore Progress

Hinman, Alan R; Addiss, David; Caplan, Arthur; Carlson, Lisa M; Lavery, James V; Orenstein, Walter A
PMID: 30649954
ISSN: 1541-0048
CID: 3594902

Introduction: The Ethical Frontiers of Gene Editing [Editorial]

Caplan, Arthur; Rakic, Vojin
ISI:000454206100001
ISSN: 0963-1801
CID: 3574762

Maintaining Research and Publication Integrity

Rifai, Nader; Annesley, Thomas M; Moore, Scott; Caplan, Arthur L; Sweet, Deborah J; Hornung, Peter; Rosendaal, Frits R
PMID: 30559173
ISSN: 1530-8561
CID: 3556962

Ethical Issues in Aesthetic and Reconstructive Surgical Innovation: Perspectives of Plastic Surgeons

Lee, Z-Hye; Reavey, Patrick L; Rodriguez, Eduardo D; Chiu, Ernest S; Caplan, Arthur L
Innovative surgery is defined as a novel procedure, a significant modification of a standard technique, or a new application of an established technique. Although innovation is a crucial part of improving patient care in plastic surgery, there are various ethical considerations and dilemmas in performing unvalidated techniques and procedures, especially for non-life-threatening indications. The aim of this study was to gain a better understanding regarding the motivations and ethical considerations of plastic surgeons in their decision to perform innovative operations. An anonymous, institutional review board-approved, online survey was sent to members of the American Society of Plastic Surgeons and other international plastic surgeons worldwide. The survey asked respondents to rank various factors that influence their decisions to perform innovative plastic surgery, both reconstructive and aesthetic, on a five-point Likert scale. Seven hundred thirty-three of 26,028 plastic surgeons (response rate, 2.9 percent) responded to the survey. Although similar factors were considered to be important for both reconstructive and aesthetic operations, only approximately 50 percent of respondents considered institutional review board approval to be an important factor when considering innovation in both reconstructive (50 percent) and aesthetic surgery (51 percent), suggesting that respondents do not consider innovation a form of research that ought be subject to standard research protections. Overall, the authors' survey suggests that more effort must be extended to ethical training in plastic surgery to create a stronger professional atmosphere regarding innovation and, possibly, to the creation of a more formal group charged with oversight of innovation.
PMID: 30589815
ISSN: 1529-4242
CID: 3560162

Consulting evil [Editorial]

Caplan, Arthur
PMID: 30573192
ISSN: 1532-7361
CID: 3557182

Emerging Ethical Challenges Raised by the Evolution of Vascularized Composite Allotransplantation

Caplan, Arthur L; Parent, Brendan; Kahn, Jeffrey; Dean, Wendy; Kimberly, Laura L; Andrew Lee, W P; Rodriguez, Eduardo D
BACKGROUND:Despite early skepticism, the field of vascularized composite allotransplantation (VCA) has demonstrated feasibility. The ethics of VCA have moved past doubts about the morality of attempting such transplant to how to conduct them ethically. METHODS:Leaders of each program performing and/or evaluating VCA in the United States were invited to participate in a working group to assess the state and future of VCA ethics and policy. Four meetings were held over the course of 1 year to describe key challenges and potential solutions. RESULTS:Working group participants concluded that VCA holds great promise as treatment for patients with particular injuries or deficits, but the field faces unique challenges to adoption as standard of care, which can only be overcome by data sharing and standardization of evaluation and outcome metrics. CONCLUSIONS:Adequate attention must be given to concerns including managing the uniquely intense physician-patient relationship, ethical patient selection, ensuring patients have adequate representation, informing and earning the trust of the public for donation, standardizing metrics for success, and fostering an environment of data sharing. These steps are critical to transitioning VCA from research to standard of care, and to its insurance coverage inclusion.
PMID: 30300280
ISSN: 1534-6080
CID: 3334912