Best Practice Guidelines on Informed Consent for Weight Loss Surgery Patients

Objective: To provide evidence‐based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. Research Methods and Procedures: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence‐based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. Results: This Task Group found that the informed consent process contributes to long‐term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Discussion: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.     

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 Practice Updates for Nursing Care in Weight Loss Surger

The objective of this study is to update evidence‐based best practice guidelines for nursing in weight loss surgery (WLS). We performed a systematic search of English‐language literature on WLS and perioperative nursing, postoperative, anesthesia, and discharge published between April 2004 and May 2007 in MEDLINE, CINHAL 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. From these, we developed evidence‐based best practice recommendations from the most recent literature on nursing in WLS. We identified >54 papers; the most relevant were reviewed in detail. Regular updates of evidence‐based recommendations for best practices in WLS nursing are required to address advances in surgery and anesthesiology, as well as changes in the demographics and levels of obesity in WLS patients. Key factors in patient safety include staff education, comprehensive admission assessment, patient education, careful preoperative surveillance and postoperative care, and long‐term discharge follow‐up.     

Behavioral and Psychological Care in Weight Loss Surgery: Best Practice Update

The objective of this study is to update evidence‐based best practice guidelines for psychological evaluation and treatment of weight loss surgery (WLS) patients. We performed a systematic search of English‐language literature on WLS and mental health, quality of life, and behavior modification 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. Our literature search identified 17 articles of interest; 13 of the most relevant were reviewed in detail. From these, we developed evidence‐based best practice recommendations on the psychological assessment and treatment of WLS patients. Regular updates of evidence‐based recommendations for best practices in psychological care are required to address the impact of mental health on short‐ and long‐term outcomes after WLS. Key factors in patient safety include comprehensive preoperative evaluation, use of appropriate and reliable evaluation instruments, and the development of short‐ and long‐term treatment plans.     

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.     

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.     

Endoscopic Interventions for Weight Loss Surgery

In this paper we review the state‐of‐the‐art in endoscopic interventions for obesity treatment and make best practice recommendations for weight loss surgery (WLS). We performed a systematic search of English‐language literature published between April 2004 and June 2008 in MEDLINE and the Cochrane Library on WLS and endoscopic interventions, endoscopically placed devices, minimally invasive surgery, image‐guided surgery, endoluminal surgery, endoscopic instrumentation, interventional gastroenterology, transluminal surgery, and natural orifice transluminal surgery. We also searched the literature on endoscopic interventions and WLS and patient safety. We identified 36 pertinent articles, all of which were reviewed in detail; assessed the current science in endoscopic interventions for WLS; and made best practice recommendations based on the latest available evidence. Our findings indicate that endoscopic interventions and endoscopically placed devices may provide valuable approaches to the management of WLS complications and the primary management of obesity. Given the rapid changes in endoscopic technologies and techniques, systematic literature review is required to address issues related to the emerging role of endoluminal surgery in the treatment of obesity. These interventions should be a high priority for development and investigation.     

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 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.     

Expert Panel on Weight Loss Surgery: Executive Report Update

Rapid shifts in the demographics and techniques of weight loss surgery (WLS) have led to new issues, new data, new concerns, and new challenges. In 2004, this journal published comprehensive evidence‐based guidelines on WLS. In this issue, we've updated those guidelines to assure patient safety in this fast‐changing field. WLS involves a uniquely vulnerable population in need of specialized resources and ongoing multidisciplinary care. Timely best‐practice updates are required to identify new risks, develop strategies to address them, and optimize treatment. Findings in these reports are based on a comprehensive review of the most current literature on WLS; they directly link patient safety to methods for setting evidence‐based guidelines developed from peer‐reviewed scientific publications. Among other outcomes, these reports show that WLS reduces chronic disease risk factors, improves health, and confers a survival benefit on those who undergo it. The literature also shows that laparoscopy has displaced open surgery as the predominant approach; that government agencies and insurers only reimburse procedures performed at accredited WLS centers; that best practice care requires close collaboration between members of a multidisciplinary team; and that new and existing facilities require wide‐ranging changes to accommodate growing numbers of severely obese patients. More than 100 specialists from across the state of Massachusetts and across the many disciplines involved in WLS came together to develop these new standards. We expect them to have far‐reaching effects of the development of health care policy and the practice of WLS.     

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.     

An Update on Best Practice Guidelines for Specialized Facilities and Resources Necessary for Weight Loss Surgical Programs

The objective of this study is to update evidence‐based best practice guidelines for specialized facilities and resources for weight loss surgery (WLS). We performed systematic search of English‐language literature on WLS and facilities, equipment, and resources 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. Evidence‐based best practice recommendations from the most recent literature on specialized facilities and resources for WLS were developed. We identified 1,647 papers in our literature search; the 46 most relevant were reviewed in detail. Regular updates of evidence‐based recommendations for best practices in facilities and resources for WLS are required to address technology advances and growing recognition of the need for adequate equipment and specially built nursing units. Key factors in patient safety include availability of trained personnel and specialized equipment for the care of extremely obese WLS patients.     

Best Practices in Policy and Access (Coding and Reimbursement) for Weight Loss Surgery

To update evidence‐based best practice guidelines for coding and reimbursement and establish policy and access standards for weight loss surgery (WLS). Systematic search of English‐language literature on WLS and health‐care policy, access, insurance reimbursement, coding, private payers, public policy, and mandated benefits published between April 2004 and May 2007 in MEDLINE, EMBASE, and the Cochrane Library. 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. We identified 51 publications in our literature search; the 20 most relevant were examined in detail. These included reviews, cost‐benefit analyses, and trend and cost studies from administrative databases. Literature on policy issues surrounding WLS are very sparse and largely focused on economic analyses. Reports on policy initiatives in the public and private arenas are primarily limited to narrative reviews of nonsurgical efforts to fight obesity. A substantial body of work shows that WLS improves or reverses most obesity‐related comorbidities. Mounting evidence also indicates that WLS confers a significant survival advantage for those who undergo it. WLS is a viable and cost‐effective treatment for an increasingly common disease, and policy decisions are more frequently being linked to incentives for national health‐care goals. However, access to WLS often varies by payer and region. Currently, there are no uniform criteria for determining patient appropriateness for surgery.     

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.     

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.     

A multimedia tool for the informed consent of patients prior to gastric banding

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video‐based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding. Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process. Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups. Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.     

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.     

Update on Best Practice Recommendations for Anesthetic Perioperative Care and Pain Management in Weight Loss Surgery, 2004–2007

To reevaluate and update evidence‐based best practice recommendations published in 2004 for anesthetic perioperative care and pain management in weight loss surgery (WLS), we performed a systematic search of English‐language literature on anesthetic perioperative care and pain management in WLS published between April 2004 and May 2007 in MEDLINE and the Cochrane Library. We identified relevant abstracts by using key words, retrieved full text articles, and stratified the resulting evidence according to systems used in established evidence‐based models. We updated prior evidence‐based best practice recommendations based upon interim literature. In instances of controversial or inadequate scientific evidence, the task force reached consensus recommendations following evaluation of the best available information and expert opinion. The search yielded 1,788 abstracts, with 162 potentially relevant titles; 45 were reviewed in detail. Despite more information on perioperative management of patients with obstructive sleep apnea (OSA), evidence to support preoperative testing and treatment or to guide perioperative monitoring is scarce. New evidence on appropriate intraoperative dosing of muscle relaxants allows for greater precision in their use during WLS. A novel application of α?2 agonists for perioperative anesthetic care is emerging. Key elements that may enhance patient safety include integration of the latest evidence on WLS, obesity, and collaborative multidisciplinary care into clinical care. However, large gaps remain in the evidence base.     

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.