Consent Discussions Research Articles

Opting out: confidentiality and availability of an ‘alibi’ for potential living kidney donors in the USA

Ethicists and guidelines have suggested that potential living kidney donors who withdraw from evaluation be offered an ‘alibi.’ We sought to determine what potential living kidney donors are told about...

Abstract A66: Recommendations to address common barriers to diversity in oncology clinical trials: An industry perspective

Abstract Introduction: Racial and ethnic minority enrollment in clinical trials is still a challenge and current recruitment planning has failed to improve diverse representation in clinical trials. The following literature review identified common barriers to diverse trial enrollment resulting in suggested tactics to address these barriers for breast cancer clinical trials. Methods: A literature review was conducted to identify barriers to oncology clinical trial enrollment for African American, Hispanic, Asian American, and Native American populations. A targeted review of barriers for patients in the lower socioeconomic status (SES) bracket was also performed. An advisory board of study coordinators was consulted to assess site–level awareness, barriers, and resources needed from the pharmaceutical industry. Additionally, ongoing initiatives were assessed including use of a Latino toolkit, patient navigators, and community outreach strategies. Results: The number of evidence based recruitment strategies targeting ethnic minorities was found to be lacking. There are four key aspects that influence diverse patients' decisions to participate in trials: family/friends, finances, faith, and physicians/staff. Barriers identified affected a majority of the analyzed patient populations. These included: protocol inclusion/exclusion criteria; logistical concerns; few incentives for participating; and cultural factors. The informed consent form and process were cumbersome and not patient-centric; costs related to travel and co-pays, and mistrust of medical research and the pharmaceutical industry were also identified as common barriers. The primary barriers were lack of invitations and lack of awareness at multiple levels within medical institutions, health care professionals, communities, and the pharmaceutical industry. Suggestions to address enrollment barriers include education to increase awareness, a patient-centric approach to consent and trial discussions, and tailoring site selection strategies. Other suggestions are immersion into communities, patient reimbursement, cultural competency training, pro-active translations, early recruitment planning, and identifying processes for approaching non-English speaking patients. Epidemiology data should also be incorporated in planning to establish baseline and enrollment goals. Conclusion: Although each of the analyzed populations is unique, common themes emerged. A patient-centric approach to increasing diversity in clinical trials should include considering a patient's key influences, addressing common concerns, conducting a properly informed consent process, and empowering a patient's decision making process. Gaps in current recruitment practices do still exist and further research on evidence based diverse recruitment strategies is also needed. Citation Format: Kelly R. Kirsch, Gebra C. Carter, Jacqueline M. Cole, Allicia C. Girvan, Coleman K. Obasaju. Recommendations to address common barriers to diversity in oncology clinical trials: An industry perspective. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A66. doi:10.1158/1538-7755.DISP13-A66

Equity of access: Consent interpretation program at Princess Margaret Cancer Centre (PM) in Canada.

189 Background: Toronto is a multicultural city with over 160 languages spoken by patients. Since 2010, institutional policy requires that professional medical interpreters are used when obtaining informed consent from patients with limited English proficiency (LEP). The availability and cost of these interpreters can be a deterrent for clinical trial participation, particularly when funding is limited. In order to ensure that patients facing language barriers have equitable access to trials, to protect the rights and safety of LEP patients involved in trials, and to improve patient outcomes, adherence to this policy needs to be ensured. Methods: Through a collaboration with the PM Cancer Clinical Research Unit (CCRU) and Interpretation and Translation Services (ITS) supported by the Princess Margaret Cancer Foundation, a 6-month pilot was initiated with full access to interpretation services for all trial patients in November 2012. The CCRU provided training to interpreters on clinical trials and GCP and interpreters reviewed template consent forms provided by ethics boards to cut back on preparation time and costs when delivering a sight translation of study specific consent forms. Trials staff were trained on the process and given badge tags with instructions. Metrics were collected to monitor the use of professional interpreters. Results: Utilization of professional interpreters in trials increased by 16% during the 6-month pilot and 286 requests have been logged to date. Staff were surveyed and indicate this has streamlined the consent process with 83% of respondents saying the new process is easy/very easy. Care providers feel this has allowed them to approach more patients than before this project. Conclusions: This project ensures that accurate information is provided to all patients contemplating participating in or already enrolled in trials, that all patients have the same level of access to treatment, and that there is equity of access for all patients irrespective of their English proficiency. The increased use of professional interpreters in consent discussions indicates better adherence to policy which has allowed the pilot to continue for another year.

Patient and physician factors associated with overuse and underuse of cancer screening: A factorial, cluster-randomized trial.

206 Background: Cancer screening, like other interventions, requires close patient-provider collaboration. By patient recall, key elements are often omitted from informed consent discussions. Most screening guideline compliance efforts focus on reducing underuse, but overuse is also harmful and may be influenced by distinct factors. Therefore, we are performing a prospective randomized trial of educational interventions to improve screening compliance for breast, cervical, colorectal, lung and prostate cancer at an urban academic medical center. Our hypothesis is that gender, age, prior screening experience, provider recommendations, anticipated benefit and distress, communication and informational support will affect compliance. Our primary data collection will be complete before the Symposium. Methods: We will enroll an age- and sex-stratified sample of 216 patients aged 40 to 89 years, 18 each treated by 12 primary care physicians at two affiliated hospitals, undergoing an annual physical examination in a cluster-randomized prospective trial of educational supports for screening. Screening guideline format (color-coding) and academic detailing will be randomly assigned independently. Patients and providers are surveyed immediately after the encounter to record their recollections of screening discussions and recommendations and their plans. Follow-up surveys at 3, 6 and 12 months assess concordance between expressed screening intentions and behaviors. Results: Pilot results indicate patient gender, age, anticipated screening-related distress and benefit, and prior screening experience affect screening recommendations and intentions. These factors vary by cancer. Patients recall less discussion than providers. Reasons not to screen are infrequently discussed. Conclusions: Cancer screening decisions are complex and vary by screening modality, patient and provider factors and communication. Improving underuse and overuse compliance may require distinct strategies. Screening overuse may be a “lower-stakes” environment to develop strategies to reduce overuse of cancer interventions of marginal or negative benefit, including treatment.

Naked bodies, naked genomes: the special (but not exceptional) nature of genomic information.

Genetic exceptionalism, the view that genomic information is different from other types of sensitive information and deserves exceptional types of protections, has been roundly criticized. However, the public still expresses special fears about the access others might have to their genomic information. In this article, it is argued that there may be a basis for the public perception that genomic information is special, even if it cannot be said that policies could or should be enacted to protect the privacy and confidentiality of genomic information that would be exceptional relative to the protections one would enact to protect other types of sensitive information. The special nature of genomic information lies in understanding that it is neither personal property nor mere information. A genome is, at one and the same time, a physical aspect of a person and information about that person. Genomic data are embodied information that partially constitutes as well as describes individuals and that connects them in physical ways to their ancestors and their relatives. All forms of privacy need to be protected, but some intimate aspects of our lives command special respect. To see a genome is more analogous to seeing a naked body than to seeing a social security number. This metaphor suggests that clinicians and investigators ought to respect the special concerns of patients regarding genomic information while not claiming that there are any exceptional measures one could take to protect genomic privacy. Suggestions are given for how this view might affect patient interactions, consent discussions, public policy, and public trust in genomic research and clinical genetics.

A Training Program for Improving the Informed Consent Discussion Between Clinical Researchers and Their Subjects

Although there are many training programs on informed consent, they seldom model the contextual factors that support the vital elements of communication, including presentation style, body language, providing a comfortable environment, utilizing clear language, and establishing overall rapport with the subject. A team of clinicians at the National Institute of Mental Health (NIMH) created a pilot program that consists of a video ( http://www.youtube.com/watch?v=l26hdCD9g2I ) and didactic presentation to train investigators to conduct informed consent discussions. Thirty-four physicians and eighty nurses were tested on the training content including these contextual factors. Both groups showed an increase in content knowledge after the training. An informed consent training program such as this is feasible and may improve both the knowledge and communication skills necessary for this important process.

Volume-outcome disparities and informed consent: what should surgeons disclose?

It has been repeatedly shown that higher procedure volumes, by hospital and by physician, are associated with better outcomes. Buttressed by large-scale selective service purchasing, surgical care for many volume-sensitive operations has been regionalized. However, the implications of outcome disparity data for obtaining valid patient consent remain uncertain. When the first large scale outcome study appeared showing empirically that outcomes are volume-related, two prominent bioethicists promptly insisted that such information was material to a reasonable patient's decision whether and where to have a volume-sensitive operation and that surgeons at low-volume hospitals should disclose it. More recently, two surgical oncologists have reiterated that argument, most especially when patients are making decisions about pancreatic or esophageal resections. This proposal tantalizingly appeals to the concept of patient empowerment, supposedly showing appropriate respect for the patient's interest in self-determination by having his surgeon (or physician), rather than others, outline for him personally the risks and benefits associated with surgical care delivered at different hospitals. But on the contrary, a surgeon's conducting a truthful, non-misleading, non-confusing informed consent discussion of statistical outcome disparities in the relentlessly shrinking time typically allowed for this conversation is unrealistic as a general requirement. The traditional approach to informed consent is simpler, less fraught and preferable. By law, a surgeon who is licensed to practice independently and who evidences willingness to examine and to offer an operation to a patient conveys (1) an implicit standard of care assurance, and (2) a fiduciary assurance. In other words, it goes without saying that the surgeon holds it out to the patient that s/he possesses the training and skill necessary to perform the offered service with reasonable skill and safety as measured by the applicable standard of care; that s/he will act in good faith and use his/her best medical judgment on the patient's behalf. Liability attaches when patient harm results from a surgeon's failure on either count. It also goes without saying that the surgeon extends similar assurances for care provided by trainees who are under his or her direct supervisory authority and control. The traditional theory of informed consent forestalls requiring desultory discussions of volume-outcome disparities and will be defended here.

Honesty, trust, and respect during consent discussions in neonatal clinical trials.

“Participating in the study provided an avenue for a premature baby like mine to receive an outstanding level of care and extra support from the research nurse that may not otherwise be available outside research. It was also fulfilling knowing that from this research may come the help that others with this same condition may need. It played a significant role in our education about improving and maintaining his health. ”—Parents of a neonatal clinical trial participant Participation in neonatal clinical trials is often viewed as risky, ethically challenging, burdensome for parents, and a favor that altruistic families are performing for future generations of babies.1,2 Views such as “valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain” are common.3 However, neonatal research need not be viewed through such a negative lens. Parents who have participated in clinical trials may view their research involvement very differently, as an exciting opportunity rather than a burden.4 Participation can have benefits for the newborn child and the family, even if the infant is not assigned by chance to a therapy that proves to be superior after completion of the trial.5,6 Collectively, as a group of research nurses and clinical investigators, we have discussed research participation with >900 families. We have found that when done well, conversations about consent to research can empower and support families at a time of crisis and reassure them that health care professionals are … Address correspondence to Sara B. DeMauro, MD, MSCE, The Children’s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Division of Neonatology, 2 Main, Philadelphia, PA 19104. E-mail: demauro{at}email.chop.edu

Psychosocial Predictors, Assessment, and Outcomes of Cosmetic Procedures: A Systematic Rapid Evidence Assessment

Recent breast implant complications led to a UK government policy review of the evidence concerning cosmetic interventions. We synthesised cosmetic intervention research evidence covering psychosocial factors associated with requesting procedures and psychological outcomes, effects of procedures on psychological outcomes, preintervention assessments for identifying those at risk, alternative therapy effectiveness, and issues in achieving informed consent. Undertaking a systematic rapid evidence assessment, six databases and three journals were searched. Included studies were systematic reviews or primary studies of participants requesting cosmetic procedures; published 2002-2012; containing either psychological or psychosocial measures, a psychological outcome, or evaluation of informed consent. Reviewers independently assessed study eligibility, extracted data, and assessed quality, undertaking narrative synthesis. Methodological quality of the included 13 systematic reviews and 179 primary studies was low, with wide variation in psychosocial measures. Findings suggest several psychosocial factors (e.g., intimate partner violence) may be associated with requesting cosmetic surgery. Multiple factors (e.g., unrealistic expectations) may predict poor psychological outcomes. Current psychological screening tools focus predominantly on body dysmorphic disorder (BDD) symptoms. Psychological and pharmacological interventions are effective alternative BDD treatments. Patients and doctors bring different needs to informed consent discussions, inconsistently matched to those required by professional ethics, litigation risk, and facilitating profit. Systematically reviewing this literature for UK policy has highlighted that some groups may be at risk of poor post-cosmetic procedure outcomes. Practitioners and patients must explore reasons for seeking cosmetic procedures and discuss all potential results and alternative solutions. Future research should employ more robust methodologies to identify effects in those at risk, led by consensus on a core set of psychological outcomes.

The patient perspective of clinical training—An empirical study about patient motives to participate

This study introduces a comprehensive model to explain patients’ prosocial behavioral intentions to participate in clinical training. Using the helping decision model, the authors analyze the combined impact of factors that affect participation intentions. The model includes intrapersonal and interpersonal appraisals triggered by an awareness of the societal need for clinical training as a practical part of medical education.The results of our empirical study (N=317) show that personal costs and anxiety as negative appraisals and a warm glow as a positive appraisal affect participation intentions and fully mediate the effect of the patient's awareness of the societal need. The study results indicate that communication strategies should address patient beliefs about negative personal consequences of participation rather than highlighting the societal need for practical medical education related to clinical training. Based on the results, medical associations could develop guidelines and provide training for physicians on how to motivate patients to participate in clinical training, resulting in more patient-centered standardized consent discussions.

Sellar and parasellar lesions – Clinical outcome in 61 children

ObjectiveTo evaluate clinical outcome in a 10-year consecutive series of children operated for sellar and parasellar tumors with special focus on neuropsychology and endocrinology. Patients and methodsWe analyzed 61 children (30 female) under 18 years of age (mean age 9.9, range 1 month–17 years) operated between 2000 and 2010. Medical records were evaluated retrospectively; postoperative histologic diagnoses included 20 craniopharyngiomas, 17 gliomas, 6 pituitary adenomas and 18 rare tumor entities. ResultsOf 61 patients, 58 (95%) were still alive at last follow-up. Three patients died, all due to progression of malignant rhabdoid tumors. Postoperative clinical morbidity consisted of endocrinological (66%), visual (60.7%) and other neurological deficits (55.9%) after a mean follow-up of 44 months. When compared to all other tumor entities in this series, craniopharyngiomas were associated with high rates of gross-total resection (p=0.008), frequent progression of residual tumor (p=0.005) scotomas (p=0.013), persistent diabetes insipidus (p<0.001), and panhypopituitarism (p<0.001). Surgically treated gliomas showed higher rates of motor weakness (p=0.004), double vision (p<0.001), and milder forms of endocrinopathy (single hormone deficits, p=0.02). In general, deterioration in school performance was associated with multiple surgeries (p=0.018) and radiotherapy (p=0.021). ConclusionExcellent overall survival in these patients is possible, however malignant rhabdoid tumors have a poor prognosis. Aggressive treatment is associated with significant morbidity. Children operated for craniopharyngioma showed an expected high rate of endocrine deterioration, whereas glioma patients had higher incidences of motor weakness and double vision. The treating physicians should be well aware of all these considerable postoperative deficits, especially when facing interdisciplinary management decisions, and for the informed consent discussions with the patient and the parents.

Is There an Ethical Obligation to Disclose Controversial Risk? A Question From the ACCORD Trial

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists.

Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship

BackgroundIt is thought that a dependent relationship between patients and physicians who enroll their own patients in research compromises voluntary informed consent. Therefore, several ethical guidelines for human subject research provide approaches to mitigate these compromises. Currently, these approaches have not been critically evaluated. In this article, we analyze the approaches of ethical guidelines to manage the influence of a dependent relationship between patients and physicians on voluntary informed consent and discuss the strengths and weaknesses of these approaches.MethodsWe performed a review of international ethical guidance documents on human subject research, listed in the Oxford Textbook of Clinical Research Ethics and found through cross referencing. We also searched Global Ethics Observatory (GEObs) and the World Health Organization (WHO) website. Guidelines from all years were eligible for inclusion. The date last searched was December 2013.DiscussionWe identified two basic guideline approaches: 1. a process approach, which focuses on the person who obtains informed consent, that is, an independent individual, such as a research nurse or counselor; and 2. a content approach, emphasizing the voluntary nature of participation. Both approaches are valuable, either because the influence of the physician may diminish or because it empowers patients to make voluntary decisions. However, the approaches also face challenges. First, research nurses are not always independent. Second, physician-investigators will be informed about decisions of their patients. Third, involvement of a counselor is sometimes unfeasible. Fourth, the right to withdraw may be difficult to act upon in a dependent relationship.ConclusionsCurrent guideline approaches to protect voluntary informed consent within a dependent relationship are suboptimal. To prevent compromises to voluntary informed consent, consent should not only be obtained by an independent individual, but this person should also emphasize the voluntary nature of participation. At the same time, dependency as such does not imply undue influence. Sometimes the physician may be best qualified to provide information, for example, for a very specialized study. Still, the research nurse should obtain informed consent. In addition, patients should be able to consult a counselor, who attends the informed consent discussions and is concerned with their interests. Finally, both physicians and research nurses should disclose research interests.

Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process

for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions. The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific. The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.

Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations

Background Use of discussion and questioning is an effective supplement to written information provision during trial recruitment. Current evaluations of recruitment consultations monitor information delivered by recruiters, ignoring evidence of patient understanding/misunderstanding. This study a) developed a method of evaluating the quality of information provision and understanding during informed consent consultations for RCT recruitment (QUICC-RCT) that took patient responses into account and b) investigated the feasibility of applying it as a tool to evaluate informed consent (IC) in recruitment consultations.

From genetic counseling to “genomic counseling”

Genetic counseling is “the process of helping people understand and adapt to the medical, psychological, and familial implications of genetic contributions to disease.” Traditionally, this process includes collecting and interpreting the family and medical history, risk assessment, a comprehensive educational process for potential genetic testing, informed consent, and psychosocial assessment and support (National Society of Genetic Counselors' Definition Task Force et al. 2006). While genetic counseling falls within the scope of many health care professionals, clinical geneticists (physicians) and masters level genetic counselors have been working in the United States for more than 40 years, providing genetic counseling primarily for single-gene conditions. Debate about what “genomic counseling” will include and who will practice it has been fueled by the transition from single-gene focused genetic counseling and testing to a full genomic medicine approach. The routine incorporation of genomic medicine will likely induce differences in the scope, approach and process of genetic counseling (Table ​(Table1).1). In this commentary, I will discuss the several areas where practice will likely change as we move toward “genomic” counseling, with a focus on the unique skills and roles that genetic counselors and clinical geneticists provide. Table 1 Changes that will impact the transition to “genomic counseling.”

PC-FACS

PC-FACS

Informed consent for return of incidental findings in genomic research

Researchers face the dilemma of how to obtain consent for return of incidental findings from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database, abstracts from the 2011 American Society of Human Genetics meeting, and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants. Most researchers and participants endorsed disclosure of a wide range of information about return of incidental findings, including risks, benefits, impact on family members, data security, and procedures, for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 min or less to this process and expressed concerns that disclosed information would overwhelm participants, a concern shared by many participants themselves. There is a disjunction between the views of investigators and participants about the amount of information that should be disclosed and the practical realities of the research setting, including the time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process.

Reply

Sir: In response to questions raised by Dr. Swanson in his letter to the Journal, we submit the following. Although we found several of his points to be only tangentially relevant to the subject matter within the original article and others to be fully explained within the article itself, we have elected to respond to both. It is understood on the basis of communication with Dr. Swanson that he has had a limited and unsuccessful experience with gluteal augmentation with silicone implants.1 The authors do not advocate the performance of this procedure without adequate training and advance study. Resources to assist the surgeon interested in learning this technique are available through both textbooks and teaching courses at national meetings of the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery. Success with this procedure is highly dependent on both technique and perioperative care, as would be the case with nearly all procedures that plastic surgeons perform. As we state in the first paragraph of the original article, leaner patients that desire the addition of greater volume to the gluteal region are not candidates for fat grafting procedures.2 Dr. Swanson’s recommendation that we stop trying to improve on gluteal augmentation techniques using implants and limit ourselves presumably as a specialty to suction lipectomy and fat grafting procedures ignores the obvious. Patients without adequate autologous donor fat to achieve the results desired in gluteal volume are not candidates for fat grafting procedures. With respect to his concerns about the scar location within the intergluteal cleft and that analogous breast scars would not be tolerated, even when wound separation has occurred, these typically heal remarkably well and in most cases so well within the cleft that, to most untrained eyes, they are hardly even identifiable as scars. The need for scar revision after gluteal augmentation is so rare that we did not even identify the occurrence within the study. Scars associated with other aesthetic procedures of the face, breast, and trunk seem to be of much greater significance than those associated with gluteal augmentation. Procedural statistics available through our national societies are heavily reliant on surgeon participation. At this time, based on the relatively small numbers of cases reported by member surgeons of the American Society of Plastic Surgeons for buttock augmentation procedures, it is unlikely that small relative changes can be relied on entirely as indicative of overall popularity. The most recent statistical reporting available by the American Society for Aesthetic Plastic Surgery for 2012 reveals that more than 7000 buttock augmentation procedures (not stratified for implants versus fat grafting) were performed by member surgeons, representing an increase of 40 percent over 3 years.3 It is the impression of the surgeon authors of this study that buttock augmentation with silicone implants has increased significantly in popularity over the past 5 years. The overall complication rate reported by this study of 38.1 percent should be interpreted relative to the complication rate associated with other aesthetic implant procedures. Breast augmentation is widely regarded as a safe procedure with a high patient satisfaction rate despite an even higher 45 percent complication rate studied over a 7-year period.4 To suggest that somehow breast augmentation surgery using implants should be an accepted procedure yet gluteal augmentation with implants should not seems an arbitrary judgment. We believe that Dr. Swanson’s response misses the point of the study. The intent of the study was not to promote the procedure but to address physician preference and broadly identify complication rates. Decisions about whether an individual patient should be a candidate for the procedure should be determined by well-trained surgeons familiar with the body of literature on the subject and in the course of an informed consent discussion with the patient. DISCLOSURE Dr. Gonzalez receives royalties from the sale of his book, Buttocks Reshaping (Rio de Janeiro, Brazil: Indexa Editora Ltda; 2006). Dr. Mendieta receives royalties from the sale of his book, The Art of Gluteal Sculpting (St. Louis, Mo.: Quality Medical; 2011). The remaining authors have no other relevant financial disclosures. M. Mark Mofid, M.D. Constantion G. Mendieta, M.D. Douglas M. Senderoff, M.D. Division of Plastic Surgery University of California San Diego San Diego, Calif.

Das Aufklärungsgespräch als Teil der Patientensicherheit in der Kindertraumatologie

In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.