Data collection systems for weight loss surgery: an evidence-based assessment

OBJECTIVE: To evaluate the existence and efficacy of data collection systems for weight loss surgery (WLS) and establish evidence-based guidelines for the development of a statewide WLS registry in Massachusetts. RESEARCH METHODS AND PROCEDURES: We conducted two systematic searches of English language literature in MEDLINE. The first was on data collection registries related to WLS; the second was an expanded search encompassing other surgical fields (e.g., cardiac and thoracic surgery) and registries (i.e., cancer). Fourteen articles were found to be pertinent. Data were extracted, and evidence categories were assigned according to a grading system based on established evidence-based models. Recommendations were derived from these literature reviews and expert opinion. RESULTS: This task group found that there are no standardized data collection systems for WLS in Massachusetts (or any other states) and no mandated reporting of WLS-specific outcomes. We described existing WLS databases and systems in other surgical fields. Recommendations focused on the importance and feasibility of data collection for WLS and the need to conduct a pilot study and explore options for creating a statewide WLS database. DISCUSSION: A statewide WLS data collection system would optimize patient care by enabling the collection, analysis, and dissemination of best practice data. A broad-based effort is needed to meet challenges involved in defining and implementing such a system.     

Best practice recommendations for anesthetic perioperative care and pain management in weight loss surgery

OBJECTIVE: To develop evidence-based recommendations that optimize the safety and efficacy of perioperative anesthetic care and pain management in weight loss surgery (WLS) patients. RESEARCH METHODS AND PROCEDURES: This Task Group examined the scientific literature on anesthetic perioperative care and pain management published in MEDLINE from January 1994 to March 2004. We also reviewed additional data from other sources (e.g., book chapters). The search yielded 195 abstracts, of which 35 references were reviewed in detail. Task Group consensus was used to provide recommendations when evidence in the literature was insufficient. RESULTS: We developed anesthesia practice and patient safety advisory recommendations for preoperative evaluation, intraoperative management, and postoperative care and pain management of WLS patients. We also provided suggestions related to medical error reduction and systems improvements, credentialing, and future research. DISCUSSION: Obesity-related comorbidities including obstructive sleep apnea place WLS patients at increased risk for complications perioperatively. Regarding perioperative safety and outcomes, conclusive evidence beyond the accepted standard of care in the reviewed literature is limited. Few reports specifically address the perioperative needs of severely obese patients. In this advisory, we synthesize current knowledge and make best practice recommendations for perioperative care and pain management in WLS patients. These recommendations require periodic review as further medical knowledge and evidence evolve.     

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.     

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.     

Behavioral and psychological factors in the assessment and treatment of obesity surgery patients

OBJECTIVE: To provide evidence-based guidelines on the psychological and behavioral screening of weight loss surgery (WLS) candidates and the impact of psychosocial factors on behavior change after gastric bypass surgery. RESEARCH METHODS AND PROCEDURES: The members of the Behavioral and Psychological subgroup of the Multidisciplinary Care Task Group conducted searches of MEDLINE and PubMed for articles related to WLS, behavior changes, and mental health, including quality of life (QOL) and behavior modification. Pertinent abstracts and literature were reviewed for references. A total of 198 abstracts were identified; 17 papers were reviewed in detail. Search periods were from 1980 to 2004. RESULTS: We found a high incidence of depression, negative body image, eating disorders, and low QOL in severely obese patients. Our task subgroup recommended that all WLS candidates be evaluated by a licensed mental health care provider (i.e., psychiatrist, psychologist, or social worker), experienced in the treatment of severely obese patients and working within the context of a multidisciplinary care team. We also recommended development of pre- and postsurgical treatment plans that address psychosocial contraindications for WLS and potential barriers to postoperative success. DISCUSSION: The psychological consequences of obesity can range from lowered self-esteem to clinical depression. Rates of anxiety and depression are three to four times higher among obese individuals than among their leaner peers. A comprehensive multidisciplinary program that incorporates psychological and behavior change services can be of critical benefit in enhancing compliance, outcome, and QOL in WLS patients.     

Criteria for patient selection and multidisciplinary evaluation and treatment of the weight loss surgery patient

OBJECTIVE: To provide evidence-based guidelines for patient selection and to recommend the medical and nutritional aspects of multidisciplinary care required to minimize perioperative and postoperative risks in patients with severe obesity who undergo weight loss surgery (WLS). RESEARCH METHODS AND PROCEDURES: Members of the Multidisciplinary Care Task Group conducted searches of MEDLINE and PubMed for articles related to WLS in general and medical and nutritional care in particular. Pertinent abstracts and literature were reviewed for references. Multiple searches were carried out for various aspects of multidisciplinary care published between 1980 and 2004. A total of 3000 abstracts were identified; 242 were reviewed in detail. RESULTS: We recommended multidisciplinary screening of WLS patients to ensure appropriate selection; preoperative assessment for cardiovascular, pulmonary, gastrointestinal, endocrine, and other obesity-related diseases associated with increased risk for complications or mortality; preoperative weight loss and cessation of smoking; perioperative prophylaxis for deep vein thrombosis and pulmonary embolism (PE); preoperative and postoperative education and counseling by a registered dietitian; and a well-defined postsurgical diet progression. DISCUSSION: Obesity-related diseases are often undiagnosed before WLS, putting patients at increased risk for complications and/or early mortality. Multidisciplinary assessment and care to minimize short- and long-term risks include: comprehensive medical screening; appropriate pre-, peri-, and postoperative preparation; collaboration with multiple patient care disciplines (e.g., anesthesiology, pulmonary medicine, cardiology, and psychology); and long-term nutrition education/counseling.     

A model designed to enhance informed consent: experiences from the HIV prevention trials network

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.     

Consent to Sterilization section of the Medicaid-Title XIX form: is it understandable?

INTRODUCTION: We sought to assess readability and comprehension characteristics of the Consent to Sterilization section of the Medicaid-Title XIX form (Title XIX-SCF) in order to determine if it was likely providing informed consent to the Medicaid population. MATERIALS AND METHODS: The current Title XIX-SCF was evaluated using the Readability and Processability Form (RPF). The RPF, designed to assess the format of informed consent documents, assigns points to each of 20 areas of comprehension analysis according to established scoring criteria. Finally, a modified Title XIX-SCF was developed and evaluated using the RPF. RESULTS: The overall RPF score for the current Title XIX-SCF was in the "poor" range (total=37), while the Fry reading level was at the ninth grade. The modified Title XIX-SCF scored in the "excellent" range (total=92), while the Fry reading level was at the sixth grade. CONCLUSIONS: The readability and comprehension demands of the current Title XIX-SCF exceed recommended guidelines for patient education and informed consent materials. The current Title XIX-SCF should be revised to ensure that women understand, desire and consent to permanent sterilization.     

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.     

Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.     

Transparency and accountability in mass media campaigns about organ donation: a response to Morgan and Feeley

We respond to Morgan and Feeley’s critique on our article “Mass Media in Organ Donation: Managing Conflicting Messages and Interests.” We noted that Morgan and Feeley agree with the position that the primary aims of media campaigns are: “to educate the general public about organ donation process” and “help individuals make informed decisions” about organ donation. For those reasons, the educational messages in media campaigns should not be restricted to “information from pilot work or focus groups” but should include evidence-based facts resulting from a comprehensive literature research. We consider the controversial aspects about organ donation to be relevant, if not necessary, educational materials that must be disclosed in media campaigns to comply with the legal and moral requirements of informed consent. With that perspective in mind, we address the validity of Morgan and Feeley’s claim that media campaigns have no need for informing the public about the controversial nature of death determination in organ donation. Scientific evidence has proven that the criteria for death determination are inconsistent with the Uniform Determination of Death Act and therefore potentially harmful to donors. The decision by campaign designers to use the statutory definition of death without disclosing the current controversies surrounding that definition does not contribute to improved informed decision making. We argue that if Morgan and Feeley accept the important role of media campaigns to enhance informed decision making, then critical controversies should be disclosed. In support of that premise, we will outline: (1) the wide-spread scientific challenges to brain death as a concept of death; (2) the influence of the donor registry and team-huddling on the medical care of potential donors; (3) the use of authorization rather than informed consent for donor registration; (4) the contemporary religious controversy; and (5) the effects of training desk clerks as organ requestors at the Department of Motor Vehicles offices. We conclude that organ donation is a medical procedure subject to all the ethical obligations that the medical profession must uphold including that of transparency and truthfulness.     

药物临床研究中痴呆受试者知情同意过程探析

目的为我国痴呆药物临床研究受试者知情同意的规范化提供参考依据。方法对近年来我院关于痴呆药物的临床研究知情同意过程中所存在的问题及其原因进行分析,探究其解决方法。结果随机双盲安慰剂对照研究或针对中重度痴呆患者的研究中,受试者及其知情者的知情同意过程困难,不良事件发生率高,反之随机双盲阳性药对照或轻度痴呆患者的研究上述情况则较少出现。结论建议通过对受试者、知情者的健康教育及对研究者的法制教育,构造完善的法律法规保障制度,健全伦理委员会监督机制等措施来保护受试者及其知情者的权益。     

Ethical issues in youth surveys: potentials for conducting a national questionnaire study on adolescent schoolchildren's sexual experiences with adults

OBJECTIVES: We evaluated ethical constraints concerning youth surveys on child sexual abuse (CSA). METHODS: We reviewed internationally published studies and Danish regulations concerning school-based surveys conducted without active parental consent. RESULTS: Ethical constraints concerning participants in youth community studies have been scantily assessed. Danish legislation accords minors the right to be heard on issues concerning themselves. The anticipated societal benefits of children's participation in community studies justify conducting anonymous surveys among schoolchildren based upon their own informed consent. CONCLUSIONS: No ethical or legal objections were found to conducting an anonymous survey in Denmark on CSA among 9th-grade pupils without parental consent, provided that the survey was accompanied by an offer of counseling.     

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.     

接受供精辅助生殖技术治疗夫妇知情同意与生育伦理知识调查研究

目的：探讨接受供精辅助生殖技术（ART）治疗夫妇对知情同意和生育伦理的认知、行为和态度。方法：对在广东省计划生育专科医院登记接受供精人工授精技术治疗的92例对象进行自填式问卷调查。内容包括一般信息、生育压力、知情同意和生育伦理的认知、态度和行为。资料处理方法采用描述性统计。结果：对象面临强烈的生育渴求和巨大的生育压力,且主要来源于对象自己、社会和父母。对供精人工授精技术治疗有比较充分的知情,但仅有75%的对象知道ART后代可能发生出生缺陷。在接受供精人工授精技术治疗时,如果可以选择供精者生物学特征时,58%的对象优先选择供精者身高,其次是相貌和学历。对象支持在治疗前签署知情同意书。结论：对接受供精ART治疗的夫妇,在治疗前应做好知情同意的全过程。     

《侵权责任法》医疗知情同意实践问题研究

结合〈侵权责任法〉中关于医疗知情同意的具体医疗实践,明确了肇事司机不可以为受伤者签署知情同意书,＂三无＂患者知情同意应由本人签署,以及患者签署授权委托书等问题,为医疗机构正确行使知情同意提供法律依据.     

接受供精辅助生殖技术治疗夫妇知情同意与生育伦理知识调查研究

目的：探讨接受供精辅助生殖技术（ART）治疗夫妇对知情同意和生育伦理的认知、行为和态度。方法：对在广东省计划生育专科医院登记接受供精人工授精技术治疗的92例对象进行自填式问卷调查。内容包括一般信息、生育压力、知情同意和生育伦理的认知、态度和行为。资料处理方法采用描述性统计。结果：对象面临强烈的生育渴求和巨大的生育压力,且主要来源于对象自己、社会和父母。对供精人工授精技术治疗有比较充分的知情,但仅有75%的对象知道ART后代可能发生出生缺陷。在接受供精人工授精技术治疗时,如果可以选择供精者生物学特征时,58%的对象优先选择供精者身高,其次是相貌和学历。对象支持在治疗前签署知情同意书。结论：对接受供精ART治疗的夫妇,在治疗前应做好知情同意的全过程。     

Effects of USPSTF guidelines on patterns of screening and treatment outcomes for prostate cancer

The updated United States Preventive Services Task Force(USPSTF) for prostate cancer in 2012 recommends against prostate-specific antigen(PSA) based screening for men of all ages. Prostate cancer is the second most common and second most deadly cancer in American men. PSA screening for prostate cancer has been present since 1994 leading to an over diagnosis and over treatment of low volume disease. There is an overall agreement of men towards the guidelines but even with the understanding of the USPSTF, these men tend to follow more personal beliefs that have been influenced by their knowledge of the disease process and physician influence. Physicians also followed the directions of the patients and opted not to change their current practice of PSA screening despite the new guidelines. Time, legal, and ethical issues were some of the barriers that physicians faced in tailoring their practice towards screening. The importance of informed consent is highlighted by both the patients and the physicians and clearly more effective when the patient was pre-informed of the disease processand prompted the physicians to initiate conversation of informed screening. Younger patients were inclined towards aggressive treatment and older patients opted towards watchful waiting both with emphasis on the importance of evidence-based information provided by the physician. Decision aids were useful in making informed decisions and could be used to educate patients on screening purposes and treatment options. However, even with well-created decision aids and physician influence, patients' own belief system played a major part in healthcare decision making in either screening or treatment for prostate cancer.     

Informed consent: the physicians' perspective

Using the current controversy in breast cancer treatment as a model, this paper reports on physicians' attitudes and behavior in the use of informed consent. Findings are based on a survey of 170 oncologists from eight countries and representing three medical specialties. Physician responses indicate that they regarded informed consent as an intrusion into the doctor-patient relationship. Problems identified by the physicians included: decreasingly effective doctor-patient communication; less personalized relationships with patients and curtailed freedom with regard to disclosure procedures. They also viewed the informed consent regulation as having a negative impact on their patient care. The constraints of obtaining informed consent reduced physicians' willingness to participate in scientific experiments. The consent form was seen to highlight their dual role as care-giver and scientific investigator, making them uncomfortable in dealing with patients. These findings demonstrate the ways in which legal restrictions associated with the introduction of new technologies critically affect the practice of medicine.