Best Practice Updates for Informed Consent and Patient Education in Weight Loss Surgery

To update evidence‐based best practice guidelines for obtaining informed consent from weight loss surgery (WLS) patients, with an emphasis on appropriate content and communications approaches that might enhance patient understanding of the information, we performed a systematic search of English‐language literature published between April 2004 and May 2007 in MEDLINE and the Cochrane database. Keywords included WLS and informed consent, comprehension, health literacy, and patient education; and WLS and outcomes, risk, patient safety management, and effectiveness. Recommendations are based on the most current literature and the consensus of the expert panel; they were graded according to systems used in established evidence‐based models. We identified over 120 titles, 38 of which were reviewed in detail. Evidence suggests that WLS outcomes, including long‐term rates of relapse, vary by procedure. For some weight loss surgeries, long‐term outcomes may not be known. Risks also vary by patient and provider characteristics. Informed consent should incorporate realistic projections of the short‐ and long‐term risks, benefits, and consequences of surgery, as well as alternatives to WLS. For consent to be informed, the education process should continue until the patient demonstrates comprehension of all relevant material and concepts. Confirmation of comprehension can protect patients engaged in the process of consent for WLS. Future research should focus on the outcomes and consequences of WLS, and different approaches that facilitate patient understanding of, and decision making about, WLS.     

Medical Ghostwriting and Informed Consent

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author‐institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.     

Best Practice Guidelines in Pediatric/Adolescent Weight Loss Surgery

Objective: To establish evidence‐based guidelines for best practices in pediatric/adolescent weight loss surgery (WLS). Research Methods and Procedures: We carried out a systematic search of English‐language literature in MEDLINE on WLS performed on children and adolescents. Key words were used to narrow the field for a selective review of abstracts. Data were extracted, and evidence categories were assigned according to a grading system based on established evidence‐based models. Eight pertinent case series, published between 1980 and 2004, were identified and reviewed. These data were supplemented with expert opinions and literature on WLS in adults. Results: Recommendations focused on patient safety, reduction of medical errors, systems improvements, credentialing, and future research. We developed evidence‐based criteria for eligibility, assessment, treatment, and follow‐up; recommended surgical procedures based on the best available evidence; and established minimum guideline requirements for data collection. Discussion: Lack of adequate data and gaps in knowledge were cited as important reasons for caution. Physiological status, comprehensive screening of patients and their families, and required education and counseling were identified as key factors in assessing eligibility for surgery. Data collection and peer review were also identified as important issues in the delivery of best practice care.     

A Proposed Approach to Informed Consent for Biobanks in China

Biobanks are potential goldmines for genomics research. They have become increasingly common as a means to determine the relationship between lifestyle, environmental exposures and predisposition to genetic disease. More and more countries are developing massive national scale biobanks, including Iceland, the UK and Estonia. Now several large‐scale regional and national biobanks are planned in China, such as Shanghai Biobank, which is defined as a key‐element in Shanghai's twelfth five‐year Development Plan of Science and Technology. It is imperative that the authors who are in charge of the ethical aspect of Shanghai Biobank discuss the ethical aspects of these biobanks up front. Currently there is a great deal of heterogeneity in the approaches to informed consent taken by different countries. In the article, after briefly introducing the biobanks in China, we focus on the three most common approaches: classical informed consent, tiered consent, and one‐time general (or blanket) consent, and propose a version of the latter for China, based on compelling arguments.     

Rethinking Informed Consent in Research on Heroin‐Assisted Treatment

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way.     

医疗紧急情况下知情同意的代理相关法律问题

传统的知情同意原假设是,如果病人没有充分的自主,医疗干预便不能实施,医师在知情同意中的重心是建议者而非治疗者的角色。但是在医疗紧急情况下,为着生命优先、救死扶伤的原则,知情同意严格程序形式需要作出让步,病人的昏迷状态或者濒危状态使得其无法具有自主的能力,就需要通过代理实现同意功能的延伸。紧急情况下将会遇到的非本人的其他主体能否代理、有无能力代理、会否滥用代理权等一系列相关的法律问题。     

Best Practice Updates for Weight Loss Surgery Data Collection

To update evidence‐based best practice guidelines for collection of data on weight loss surgery (WLS). Systematic search of English‐language literature in MEDLINE and the Cochrane Library on WLS and data collection, registries, risk adjustment, accreditation, benchmarks, and administrative and outcomes databases published between April 2004 and May 2007. Use of key words to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence‐based models. During our search, we identified 212 papers; the 63 most relevant were reviewed in detail. Most data collection on WLS has relied on administrative data sets, single‐institution studies, and other sources that are not WLS specific. A six‐center, nationwide study involving data collection has been started by the longitudinal assessment of bariatric surgery, but results are not yet available. Two WLS‐specific, longitudinal, national data collection systems are about to be implemented. Key factors in patient safety include data collection for all weight loss procedures; prospective, risk‐adjusted, universal, benchmarked, longitudinal data collection systems; and use of WLS‐specific data points that track clinical effectiveness and complications following WLS. Data collection will need to include assessments of novel therapies and specific subgroups (e.g., adolescents, the elderly, and individuals who are at the greatest risk or have the most to gain from WLS). Quality indicators, including metrics on processes of care and determination of outliers, need to be established and monitored to advance patient safety and quality improvement.     

The Nocebo Effect of Informed Consent

The nocebo effect, the mirror‐phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent (NEIC). This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis.     

Voluntary Informed Consent in Paediatric Oncology Research

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research‐care context.     

Best Practice Updates for Surgical Care in Weight Loss Surgery

To update evidence‐based best practice guidelines for surgical care in weight loss surgery (WLS). Systematic search of English‐language literature on WLS in MEDLINE, EMBASE, and the Cochrane Library between April 2004 and May 2007. Use of key words to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence‐based models. Evidence‐based best practice recommendations from the most recent literature on surgical methods and technologies, risks and benefits, outcomes, and surgeon qualifications and credentialing. We identified >135 articles; the 65 most relevant were reviewed in detail. Regular updates of evidence‐based recommendations for best practices in WLS are required to address rapid changes in surgical techniques and patient demographics. Key factors in patient safety include surgical risk factors, type of procedure, surgeon training, and facility certification.     

Best Practice Recommendations for Surgical Care in Weight Loss Surgery

Objective: To establish evidence‐based guidelines for best practices for surgical care in weight loss surgery (WLS). Research Methods and Procedures: We carried out a systematic search of English‐language literature on WLS in MEDLINE and the Cochrane Library. Key words were used to narrow the field for a selective review of abstracts. Data extraction was performed, and evidence categories were assigned according to a grading system based on established evidence‐based models. Results: We assessed types of WLS, recommended guidelines for appropriateness, developed strategies for medical error reduction, established criteria for credentialing of systems and practitioners, and specified research needed for the future. Discussion: Surgeon training, credentialing, and type of surgery performed were identified as key factors in patient safety. Other important issues in the delivery of best practice care included appropriate patient selection; use of a multidisciplinary treatment team; facility staffing, equipment, and administrative support; and early recognition and proper management of complications.     

Best Practice Updates for Multidisciplinary Care in Weight Loss Surgery

The objective of this study is to update evidence‐based best practice guidelines for multidisciplinary care of weight loss surgery (WLS) patients. We performed systematic search of English‐language literature on WLS, patient selection, and medical, multidisciplinary, and nutritional care published between April 2004 and May 2007 in MEDLINE and the Cochrane Library. Key words were used to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence‐based models. A total of 150 papers were retrieved from the literature search and 112 were reviewed in detail. We made evidence‐based best practice recommendations from the most recent literature on multidisciplinary care of WLS patients. New recommendations were developed in the areas of patient selection, medical evaluation, and treatment. Regular updates of evidence‐based recommendations for best practices in multidisciplinary care are required to address changes in patient demographics and levels of obesity. Key factors in patient safety include comprehensive preoperative medical evaluation, patient education, appropriate perioperative care, and long‐term follow‐up.     

Best Practice Updates for Pediatric/Adolescent Weight Loss Surgery

The objective of this study is to update evidence‐based best practice guidelines for pediatric/adolescent weight loss surgery (WLS). We performed a systematic search of English‐language literature on WLS and pediatric, adolescent, gastric bypass, laparoscopic gastric banding, and extreme obesity published between April 2004 and May 2007 in PubMed, MEDLINE, and the Cochrane Library. Keywords were used to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence‐based models. In light of evidence on the natural history of obesity and on outcomes of WLS in adolescents, guidelines for surgical treatment of obesity in this age group need to be updated. We recommend modification of selection criteria to include adolescents with BMI ≥ 35 and specific obesity‐related comorbidities for which there is clear evidence of important short‐term morbidity (i.e., type 2 diabetes, severe steatohepatitis, pseudotumor cerebri, and moderate‐to‐severe obstructive sleep apnea). In addition, WLS should be considered for adolescents with extreme obesity (BMI ≥ 40) and other comorbidities associated with long‐term risks. We identified >1,085 papers; 186 of the most relevant were reviewed in detail. Regular updates of evidence‐based recommendations for best practices in pediatric/adolescent WLS are required to address advances in technology and the growing evidence base in pediatric WLS. Key considerations in patient safety include carefully designed criteria for patient selection, multidisciplinary evaluation, choice of appropriate procedure, thorough screening and management of comorbidities, optimization of long‐term compliance, and age‐appropriate fully informed consent.     

Best Practices for Perioperative Nursing Care for Weight Loss Surgery Patients

Objective: To describe the unique nursing responsibilities involved in providing nursing care to severely obese weight loss surgery patients and to develop evidence‐based guidelines for safe patient care. Research Methods and Procedures: We performed a systematic review of the scientific literature using MEDLINE and CINAHL. A specific search of nursing journals from 1985 to 2004 identified 134 articles; 16 were found to be pertinent. These were reviewed in detail and used in the context of this report. The quality of the evidence was graded according to a system derived from established evidence‐based models. Recommendations were developed from published evidence and expert opinion. Results: This Task Group found that safe and competent nursing care requires assessment of, and provision for, the complex physical and psychological needs of weight loss surgery patients. We developed evidence‐based guidelines for preoperative, perioperative, and postoperative care that address risk factors unique to severely obese patients. We also addressed issues related to the use of proper body mechanics and positioning to avoid on‐the‐job injury to nursing staff. Discussion: We found that patient safety is best served when nurses are specifically trained to deal with the physical, medical, and psychosocial needs of severely obese patients and when they play an integral role in the multidisciplinary healthcare team. This role should start with a patient's first contact with the system and continue through discharge and follow‐up. Special attention needs to be paid to the widespread bias and discrimination that severely obese individuals often experience.     

Coding and Reimbursement for Weight Loss Surgery: Best Practice Recommendations

Objective: To review the use and usefulness of billing codes for services related to weight loss surgery (WLS) and to examine third party reimbursement policies for these services. Research Methods and Procedures: The Task Group carried out a systematic search of MEDLINE, the Internet, and the trade press for publications on WLS, coding, reimbursement, and coding and reimbursement policy. Twenty‐eight articles were each reviewed and graded using a system based on established evidence‐based models. The Massachusetts Dietetics Association provided reimbursement data for nutrition services. Three suppliers of laparoscopic WLS equipment provided summaries of coding and reimbursement information. WLS program directors were surveyed for information on use of procedure codes related to WLS. Results: Recommendations focused on correcting or improving on the current lack of congruity among coding practices, reimbursement policies, and accepted clinical practice; lack of uniform coding and reimbursement data across institutions; inconsistent and/or inaccurate diagnostic and billing codes; inconsistent insurance reimbursement criteria; and inability to leverage reimbursement and coding data to track outcomes, identify best practices, and perform accurate risk‐benefit analyses. Discussion: Rapid changes in the prevalence of obesity, our understanding of its clinical impact, and the technologies for surgical treatment have yet to be adequately reflected in coding, coverage, and reimbursement policies. Issues identified as key to effective change include improved characterization of the risks, benefits, and costs of WLS; anticipation and monitoring of technological advances; encouragement of consistent patterns of insurance coverage; and promotion of billing codes for WLS procedures that facilitate accurate tracking of clinical use and outcomes.     

The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.     

Informed Consent in Direct‐to‐Consumer Personal Genome Testing: The Outline of A Model between Specific and Generic Consent

Broad genome‐wide testing is increasingly finding its way to the public through the online direct‐to‐consumer marketing of so‐called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision‐making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings.     

Addiction,Voluntary Choice,and Informed Consent: A Reply to Uusitalo and Broers

In an earlier article in this journal I argued that the question of whether heroin addicts can give voluntary consent to take part in research which involves giving them a choice of free heroin does not – in contrast with a common assumption in the bioethics literature – depend exclusively on whether or not they possess the capacity to resist their desire for heroin. In some cases, circumstances and beliefs might undermine the voluntariness of the choices a person makes even if they do possess a capacity for self‐control. Based on what I took to be a plausible definition of voluntariness, I argued that the circumstances and beliefs typical of many vulnerable heroin addicts are such that we have good reasons to suspect they cannot give voluntary consent to take part in such research, even assuming their desire for heroin is not irresistible. In a recent article in this journal, Uusitalo and Broers object to this on the grounds that I misdescribe heroin addicts' options set, that the definition of voluntariness on which I rely is unrealistic and too demanding, and, more generally, that my view of heroin addiction is flawed. I think their arguments derive from a misunderstanding of the view I expressed in my article. In what follows I hope therefore to clarify my position.     

Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.