Evidence-informed recommendations on managing breast screening atypia: perspectives from an expert panel consensus meeting reviewing results from the Sloane atypia project.

Evidence-based clinical guidelines are essential to maximize patient benefit and to reduce clinical uncertainty and inconsistency in clinical practice. Gaps in the evidence base can be addressed by data acquired in routine practice. At present, there is no international consensus on management of women diagnosed with atypical lesions in breast screening programmes. Here, we describe how routine NHS breast screening data collected by the Sloane atypia project was used to inform a management pathway that maximizes early detection of cancer and minimizes over-investigation of lesions with uncertain malignant potential. A half-day consensus meeting with 11 clinical experts, 1 representative from Independent Cancer Patients' Voice, 6 representatives from NHS England (NHSE) including from Commissioning, and 2 researchers was held to facilitate discussions of findings from an analysis of the Sloane atypia project. Key considerations of the expert group in terms of the management of women with screen detected atypia were: (1) frequency and purpose of follow-up; (2) communication to patients; (3) generalizability of study results; and (4) workforce challenges. The group concurred that the new evidence does not support annual surveillance mammography for women with atypia, irrespective of type of lesion, or woman's age. Continued data collection is paramount to monitor and audit the change in recommendations.

Colorectal cancer and advanced adenoma incidence during post-polypectomy surveillance: a national cohort study in the English Bowel Cancer Screening Programme.

BACKGROUND: Improved colonoscopy quality has led to debate about whether all post-polypectomy surveillance is justified. We evaluated surveillance within the English Bowel Cancer Screening Programme (BCSP) to determine the yield of surveillance and identify predictive factors for surveillance outcome. METHODS: We performed a retrospective cohort study of individuals undergoing post-polypectomy surveillance between July 2006 and January 2017. BCSP records were linked to the National Cancer Registration Database to identify interval-type post-colonoscopy colorectal cancers (CRCs). Advanced adenoma and CRC at surveillance were documented. CRC incidence was compared with the general population using standardized incidence ratios (SIRs). Predictors of advanced adenomas at first surveillance (S1), and CRC during follow-up, were identified. RESULTS: 44 151 individuals (23 078 intermediate risk; 21 073 high risk) underwent 64 544 surveillance episodes. Advanced adenoma and CRC yields were, respectively, 10.0 % and 0.5 % at S1, 8.5 % and 0.4 % at S2, and 10.8 % and 0.4 % at S3. S1 yield was lowest in those with one index adenoma ≥ 10 mm (advanced adenoma 6.1 %; CRC 0.3 %). The SIR was 0.76 (95 %CI 0.66-0.88), accounted for by the intermediate risk group (intermediate risk SIR 0.61, 95 %CI 0.49-0.75; high risk SIR 0.95, 95 %CI 0.79-1.15). Adenoma multiplicity, presence of a large nonpedunculated adenoma, and greater villous component were associated with advanced adenoma at S1. Older age and multiplicity were significantly associated with CRC risk. CONCLUSION: This large, national analysis found low levels of CRC in those undergoing surveillance and low advanced adenoma yield in most subgroups. Less intensive surveillance in some subgroups is warranted, and surveillance may be avoided in those with a single large adenoma.

Temporary Intraoperative Handoff Report Among Nurse Anesthetists: Utilization of Standardized Handoff Tools and Barriers to Implementation.

The demanding nature of the intraoperative period presents several distractions to anesthesia providers that can hinder effective communication. Implementation of intraoperative and postoperative standardized handoff protocols have improved provider communication; however, these protocols remain underutilized. While temporary anesthesia handoffs arise more frequently than permanent handoffs, limited data exist on how the specific transfer of care processes transpire. The purpose of this study was to explore the usage of standardized handoff tools among certified registered nurse anesthetists, as well as the barriers to implementation during temporary intraoperative handoff. Data from this exploratory mixed-methods study were collected using a 16-question voluntary electronic survey. Most participants (81.2%) reported that they do not use a standardized handoff tool during temporary handoff, but over half (57.1%) believed such tools should be used. Study participants who used a standardized handoff tool were significantly less likely to rank "increases the time spent giving a handoff" as an important barrier (48.6%) compared with those who did not use a tool (71.9%), ( X2(1) = 7.39, P = .007, V = .19). Failure to make standardized handoffs a facility standard of care and lack of reception by receiving anesthesia providers were also ranked as major barriers to implementation.

A case study approach to understanding the pathway to individualised funded supports under the National Disability Insurance Scheme for community-dwelling individuals with acquired brain injury.

BACKGROUND: The National Disability Insurance Scheme (NDIS) offers opportunity against a historical background of underfunded and fragmented services for people with disability. For people with acquired brain injury (ABI), concerns have been raised about how they access NDIS individualised funded supports. The aim of this research was to explore how community-dwelling individuals with ABI in Queensland navigate the NDIS participant pathway to individualised funded supports. METHODS: This study used a multiple case study design within a policy implementation framework. Twelve people with ABI, nine family members and eight NDIS funded and mainstream service providers participated. Data was collected from relevant NDIS documentation, health records and semi-structured interviews with individuals with ABI, family members, and service providers. RESULTS: The current study highlighted the complexity of navigating the NDIS participant pathway of access, planning, implementation and review for people with ABI, their family and service providers. The NDIS pathway was impacted by the insurance and market based NDIS model itself, time, communication, and the requirement for external supports. Equally, the process was affected by environmental factors, individual person and injury factors as well as service providers, with a range of outcomes evident at the individual, family and system level. CONCLUSIONS: Findings suggest that the NDIS has struggled to make specific allowance for people with ABI and the complexity of their disabilities. Providing people with ABI access to the NDIS Complex Support Needs Pathway may redress many of the difficulties people with ABI experience accessing and using NDIS funded supports.

Heterogeneity in colorectal cancer incidence among people recommended 3-yearly surveillance post-polypectomy: a validation study.

BACKGROUND: Colonoscopy surveillance is recommended for patients at increased risk of colorectal cancer (CRC) following adenoma removal. Low-, intermediate-, and high-risk groups are defined by baseline adenoma characteristics. We previously examined intermediate-risk patients from hospital data and identified a higher-risk subgroup who benefited from surveillance and a lower-risk subgroup who may not require surveillance. This study explored whether these findings apply in individuals undergoing CRC screening. METHODS: This retrospective study used data from the UK Flexible Sigmoidoscopy Screening Trial (UKFSST), English CRC screening pilot (ECP), and US Kaiser Permanente CRC prevention program (KPCP). Screening participants (50 - 74 years) classified as intermediate-risk at baseline colonoscopy were included. CRC data were available through 2006 (KPCP) or 2014 (UKFSST, ECP). Lower- and higher-risk subgroups were defined using our previously identified baseline risk factors: higher-risk participants had incomplete colonoscopies, poor bowel preparation, adenomas ≥ 20 mm or with high-grade dysplasia, or proximal polyps. We compared CRC incidence in these subgroups and in the presence vs. absence of surveillance using Cox regression. RESULTS: Of 2291 intermediate-risk participants, 45 % were classified as higher risk. Median follow-up was 11.8 years. CRC incidence was higher in the higher-risk than lower-risk subgroup (hazard ratio [HR] 2.08, 95 % confidence interval [CI] 1.07 - 4.06). Surveillance reduced CRC incidence in higher-risk participants (HR 0.35, 95 %CI 0.14 - 0.86) but not statistically significantly so in lower-risk participants (HR 0.41, 95 %CI 0.12 - 1.38). CONCLUSION: As previously demonstrated for hospital patients, screening participants classified as intermediate risk comprised two risk subgroups. Surveillance clearly benefited the higher-risk subgroup.

Adverse Outcomes Associated With Intraoperative Anesthesia Handovers: A Systematic Review and Meta-analysis.

PURPOSE: Whether intraoperative handover of anesthesia care increases the risk of adverse outcomes in patients undergoing surgery remains unclear. This systematic review aimed to synthesize the evidence on the association of intraoperative anesthesia handover with delivery of patient care and patient outcomes. DESIGN: This is a systematic review and meta-analysis. METHODS: A comprehensive search was conducted to identify the eligible studies examining the association between intraoperative anesthesia handover and adverse outcomes in patients receiving surgery. The cohort studies and case-control studies were included. The methodological quality of each included study was assessed using the Newcastle-Ottawa Scale. The meta-analysis across the studies was performed using Review Manager. Adjusted odds ratio (aOR) with 95% confidence intervals were used for dichotomous variables. Sensitivity analysis was conducted by removing one study each time and re-estimating the overall effect size. FINDINGS: Seven retrospective cohort studies with 680,155 patients were finally included. Among these participants, 139,362 patients (20.49%) had anesthesia handovers during their surgeries. In pooled analysis, the statistically significant relationship between intraoperative anesthesia handover and composite morbidity was observed (aOR 1.20 and 95% CI 1.12-1.28). However, the number of handovers was not significantly associated with composite of mortality and morbidity (aOR 1.12, 95% CI 1.00-1.25) and in-hospital mortality (aOR 1.26, 95% CI 0.96-1.67). CONCLUSIONS: The findings suggested that each additional intraoperative anesthesia handover increased the odds of composite morbidity. It is important to improve the handover quality and avoid handovers when anesthesia providers have high-risk care events, patients having unstable status, or inadequate handover time.

Building an International Partnership to Develop Advanced Practice Nurses in Anesthesia Settings: Using a Theory-Driven Approach.

The International Federation of Nurse Anesthetists is calling for international collaboration to develop advanced nursing practice in anesthesia settings globally. However, international collaboration is challenging. Limited information is available about what process and factors specifically lead to a successful international collaboration partnership. This article aimed to describe a theoretical and empirical base that can be used to build and maintain long-term international partnerships. The Theoretical Framework of Developing International Partnerships was developed, which comprises seven interrelated concepts including partnerships, collaborations, environment, structure, process for collaborating, outcomes, and sustainability. It was used to guide an equitable horizontal collaboration partnership to develop anesthesia nursing care in local culture and context. Five major challenges were identified during the collaboration process. Sixty-six strategies were developed to facilitate collaboration using the theoretical framework. This work can inform others in establishing an international collaboration and partnership in advancing nursing knowledge and culturally congruent health care delivery.

Effect of once-only flexible sigmoidoscopy screening on the outcomes of subsequent faecal occult blood test screening.

OBJECTIVE: To investigate the outcomes of biennial guaiac faecal occult blood test (gFOBT) screening after once-only flexible sigmoidoscopy (FS) screening. METHODS: Between 1994 and 1999, as part of the UK FS Screening Trial (UKFSST), adults aged 55-64 were randomly allocated to an intervention group (offered FS screening) or a control group (not contacted). From 2006, a subset of UKFSST participants (20,895/44,041 intervention group; 41,497/87,149 control group) were invited to biennial gFOBT screening by the English Bowel Cancer Screening Programme. We analysed gFOBT uptake, test positivity, yield of colorectal cancer (CRC), and positive predictive value (PPV) for CRC, advanced adenomas (AAs), and advanced colorectal neoplasia (ACN: AA/CRC). RESULTS: Uptake of gFOBT at first invitation was 1.9% lower (65.7% vs. 67.6%, p < 0.01) among intervention versus control group participants. Positivity was 0.4% lower (2.0% vs. 2.4%, p < 0.01) and CRC yield was 0.08% lower (0.19% vs. 0.27%, p = 0.14). PPVs were also lower in the intervention versus control group, at 10.3% vs. 12.3% ( p = 0.44) for CRC, 22.7% vs. 31.4% ( p < 0.01) for AA, and 33.0% vs. 43.7% ( p < 0.01) for ACN. Among those who refused FS ( n = 5532), gFOBT uptake at first invitation was 47.7%, CRC yield was 0.25%, and PPV for ACN was 46.2%. Among FS attenders ( n = 15,363), uptake was 72.2%, CRC yield was 0.18%, and PPV for ACN was 27.9%. CONCLUSIONS: Uptake, positivity and PPV of gFOBT screening were reduced following prior offer of FS screening. However, a quarter of FS screened participants receiving a diagnostic examination after positive gFOBT were diagnosed with ACN.

High test positivity and low positive predictive value for colorectal cancer of continued faecal occult blood test screening after negative colonoscopy.

Objectives The English Bowel Cancer Screening Programme offers biennial guaiac faecal occult blood test (gFOBT) screening to 60-74-year-olds. Participants with positive results are referred for follow-up, but many do not have significant findings. If they remain age eligible, these individuals are reinvited for gFOBT screening. We evaluated the performance of repeat screening in this group. Methods We analysed data on programme participants reinvited to gFOBT screening after either previous negative gFOBT ( n = 327,542), or positive gFOBT followed by a diagnostic investigation negative for colorectal cancer (CRC) or adenomas requiring surveillance ( n = 42,280). Outcomes calculated were uptake, test positivity, yield of CRC, and positive predictive value (PPV) of gFOBT for CRC. Results For participants with a previous negative gFOBT, uptake in the subsequent screening round was 87.5%, positivity was 1.3%, yield of CRC was 0.112% of those adequately screened, and the PPV of gFOBT for CRC was 9.1%. After a positive gFOBT and a negative diagnostic investigation, uptake in the repeat screening round was 82.6%, positivity was 11.3%, CRC yield was 0.172% of participants adequately screened, and the PPV of gFOBT for CRC was 1.7%. Conclusion With high positivity and low PPV for CRC, the suitability of routine repeat gFOBT screening in two years among individuals with a previous positive test and a negative diagnostic examination needs to be carefully considered.

Screening for developmental dysplasia of the hip in a rural health district: An analysis of practice.

OBJECTIVE: To describe hip dysplasia screening practices in a local rural health district. DESIGN: Cross-sectional study of hospital birth records, local physiotherapy records, public community health electronic medical record (Community Health Information Management Enterprise database) and a survey of local clinicians who work with infants and children. SETTING: Three rural public hospitals and community health centres in a New South Wales health district. PARTICIPANTS: Birth records (n = 196) from March 2012 to May 2012; attendance at child and family nurse checks (n = 788) May 2013-April 2014; 13 cases of managed developmental dysplasia of the hip (DDH) 2012 and local clinicians (n = 49). RESULTS: At birth, the majority of infants (91%, 179/196) had documented hip screening. Community health records show this dropped to 75% (587/788) at 1-4 weeks and 29% (227/788) at 6-8 weeks. A survey of local clinicians (54% response rate; 49/91) revealed most (78%) screen for DDH and less than half (43%) use guidelines. Almost all (97%) clinicians reported screening for DDH at 6-8 weeks of age. Only 51% of clinicians reported having specific training for DDH screening and 76% would like further training. The rate of late DDH requiring management in 2012 was 0.87% (7/806) and the rate of late DDH requiring surgery was 0.25% (2/806). CONCLUSION: DDH screening practices are well established at birth in the rural health district. There is variability in DDH screening practices beyond 8 weeks of age. Clinicians report variations in their knowledge and training. Training in DDH screening and hip screening prompts added to the personal health record might improve rates of DDH screening beyond 8 weeks of age.

Patient experience of CT colonography and colonoscopy after fecal occult blood test in a national screening programme.

OBJECTIVE: To investigate patient experience of CT colonography (CTC) and colonoscopy in a national screening programme. METHODS: Retrospective analysis of patient experience postal questionnaires. We included screenees from a fecal occult blood test (FOBt) based screening programme, where CTC was performed when colonoscopy was incomplete or deemed unsuitable. We analyzed questionnaire responses concerning communication of test risks, test-related discomfort and post-test pain, as well as complications. CTC and colonoscopy responses were compared using multilevel logistic regression. RESULTS: Of 67,114 subjects identified, 52,805 (79 %) responded. Understanding of test risks was lower for CTC (1712/1970 = 86.9 %) than colonoscopy (48783/50975 = 95.7 %, p < 0.0001). Overall, a slightly greater proportion of screenees found CTC unexpectedly uncomfortable (506/1970 = 25.7 %) than colonoscopy (10,705/50,975 = 21.0 %, p < 0.0001). CTC was tolerated well as a completion procedure for failed colonoscopy (unexpected discomfort; CTC = 26.3 %: colonoscopy = 57.0 %, p < 0.001). Post-procedural pain was equally common (CTC: 288/1970,14.6 %, colonoscopy: 7544/50,975,14.8 %; p = 0.55). Adverse event rates were similar in both groups (CTC: 20/2947 = 1.2 %; colonoscopy: 683/64,312 = 1.1 %), but generally less serious with CTC. CONCLUSIONS: Even though CTC was reserved for individuals either unsuitable for or unable to complete colonoscopy, we found only small differences in test-related discomfort. CTC was well tolerated as a completion procedure and was extremely safe. CTC can be delivered across a national screening programme with high patient satisfaction. KEY POINTS: • High patient satisfaction at CTC is deliverable across a national screening programme. • Patients who cannot tolerate screening colonoscopy are likely to find CTC acceptable. • CTC is extremely safe; complications are rare and almost never serious. • Patients may require more detailed information regarding the expected discomfort of CTC.

Maternal prepregnancy body mass index and offspring attention-deficit/hyperactivity disorder: a quasi-experimental sibling-comparison, population-based design.

BACKGROUND: High maternal prepregnancy body mass index (BMI) has been associated with increased risk of offspring attention-deficit/hyperactivity disorder (ADHD). However, whether this effect is attributable to maternal or familial level confounds has been little examined. METHODS: The present study sought to examine these associations, utilizing data from the medical records of a health care system which treats 350,000 patients annually and a sibling-comparison design in a sample of 4,682 children born to 3,645 mothers. RESULTS: When examining the overall maternal effect, a linear association was observed between maternal prepregnancy BMI and child ADHD [b = 0.04, 95% confidence interval (95% CI) = 0.02-0.06, p = .0003], such that a one-unit (i.e. 1 kg/m2 ) increase in prepregnancy BMI was associated with a 4% increase in the odds of ADHD (exp b = 1.04). However, when the model was reparameterized to take full advantage of the sibling design to allow for the examination of both maternal and child-specific effects, the child-specific prepregnancy BMI effect was not reliably different from zero (b = -0.08, 95% CI = -0.23 to 0.06, p = .24). In contrast, at the maternal-level, average prepregnancy BMI was a reliably non-zero predictor of child ADHD (b = 0.04, 95% CI = 0.02-0.06, p < .0001) with each one-unit increase in maternal prepregnancy BMI associated with a 4.2% increase in the odds of ADHD (exp b = 1.04, 95% CI = 1.02-1.06). CONCLUSIONS: The association between maternal prepregnancy BMI and offspring ADHD may be better accounted for by familial or maternal confounds rather than a direct causal effect of BMI.

Assistive technology evaluations: Remote-microphone technology for children with Autism Spectrum Disorder.

The goal of this study was to conduct assistive technology evaluations on 12 children diagnosed with Autism Spectrum Disorder (ASD) to evaluate the potential benefits of remote-microphone (RM) technology. A single group, within-subjects design was utilized to explore individual and group data from functional questionnaires and behavioral test measures administered, designed to assess school- and home-based listening abilities, once with and once without RM technology. Because some of the children were unable to complete the behavioral test measures, particular focus was given to the functional questionnaires completed by primary teachers, participants, and parents. Behavioral test measures with and without the RM technology included speech recognition in noise, auditory comprehension, and acceptable noise levels. The individual and group teacher (n=8-9), parent (n=8-9), and participant (n=9) questionnaire ratings revealed substantially less listening difficulty when RM technology was used compared to the no-device ratings. On the behavioral measures, individual data revealed varied findings, which will be discussed in detail in the results section. However, on average, the use of the RM technology resulted in improvements in speech recognition in noise (4.6dB improvement) in eight children, higher auditory working memory and comprehension scores (12-13 point improvement) in seven children, and acceptance of poorer signal-to-noise ratios (8.6dB improvement) in five children. The individual and group data from this study suggest that RM technology may improve auditory function in children with ASD in the classroom, at home, and in social situations. However, variability in the data and the inability of some children to complete the behavioral measures indicates that individualized assistive technology evaluations including functional questionnaires will be necessary to determine if the RM technology will be of benefit to a particular child who has ASD.

Safety and Efficacy of Subcutaneous Immunoglobulin in the Treatment of Neuromuscular Disorders.

Many neuromuscular diseases may be treated with immunoglobulins. In the United States, the major form of immunoglobulin used is intravenous (IV). Recently, there has been an increased interest in research regarding the use of subcutaneous immunoglobulin (SCIg), mainly for improved patient quality of life, convenience, potential for fewer systemic adverse events, and avoiding wear-off. The widespread use of the subcutaneous formulation in neurology has been affected by some limitations, mainly the smaller volume and higher frequency of infusions compared to IV administration. Also, there are different pharmacokinetic properties that should be considered to evaluate whether they change the immunomodulatory effect. There are several formulations available that address some limitations. Several studies have assessed efficacy, safety, and quality of life of SCIg in neurology. This review article summarizes the current evidence for the use of SCIg in neuromuscular diseases. It also addresses the pharmacokinetic differences and the different formulations available. The current available preliminary evidence indicates that SCIg is at least as effective as the IV formulations.

Patient safety in anesthesia: learning from the culture of high-reliability organizations.

There has been an increased awareness of and interest in patient safety and improved outcomes, as well as a growing body of evidence substantiating medical error as a leading cause of death and injury in the United States. According to The Joint Commission, US hospitals demonstrate improvements in health care quality and patient safety. Although this progress is encouraging, much room for improvement remains. High-reliability organizations, industries that deliver reliable performances in the face of complex working environments, can serve as models of safety for our health care system until plausible explanations for patient harm are better understood.

Examining transfer of care processes in nurse anesthesia practice: introducing the PATIENT protocol.

Human factors, such as inadequate situation awareness, have been associated with preventable accidents in anesthesia practice. Integral to developing situation awareness in the operating room environment is the safe and efficient exchange of essential information when the care of a patient is transferred from one anesthesia provider to another for circumstances such as breaks, meals, and the end of a scheduled work shift. An effective transfer involves the communication of critical information in an effort to preserve the quality and continuity of care. HumaThis article describes a 2-phase, nonexperimental exploratory study with a purpose to (1) examine current transfer of care practices of Certified Registered Nurse Anesthetists during the intraoperative period and (2) develop, implement, and evaluate a communication checklist tool designed to improve situation awareness. Findings from this study have the potential to contribute to the understanding of current transfer of care practices, promote situation awareness in a swift and organized manner, and minimize variation in transfer of care processes that exist in practice today.

Childhood agricultural injuries: an update for clinicians.

Every three days a child dies in an agriculture-related incident, and every day 45 children are injured in the United States. These tragedies should not be regarded as "accidents," as they often follow predictable and preventable patterns. Prevention is not only possible, but vital, since many of these injuries are almost immediately fatal. Major sources of fatal injuries are machinery, motor vehicles, and drowning. Tractor injuries alone account for one-third of all deaths. The leading sources of nonfatal injuries are structures and surfaces, animals (primarily horses), and vehicles (primarily all-terrain vehicles [ATVs]). Children living on farms are at a higher risk than hired workers, and are unprotected by child labor laws. Preschool children and older male youth are at the highest risk for fatal injury, while nonfatal injury was most common among boys aged 10-15 years. Multiple prevention strategies have been developed, yet economic and cultural barriers often impede their implementation. Educational campaigns alone are often ineffective, and must be coupled with re-engineering of machines and safety devices to reduce fatalities. Legislation has the potential to improve child safety, yet political and economic pressures often prohibit changes in child labor laws and mandated safety requirements. Clinicians play a pivotal role in injury prevention, and should actively address common rural risk-taking behaviors as part of the routine office visit in order to help prevent these tragedies.

Causes of obesity.

The prevalence of obesity has been rising steadily over the last several decades and is currently at unprecedented levels: more than 68% of US adults are considered overweight, and 35% are obese (Flegal et al., JAMA 303:235-241, 2010). This increase has occurred across every age, sex, race, and smoking status, and data indicate that segments of individuals in the highest weight categories (i.e., BMI > 40 kg/m(2)) have increased proportionately more than those in lower BMI categories (BMI < 35 kg/m(2)). The dramatic rise in obesity has also occurred in many other countries, and the causes of this increase are not fully understood (Hill and Melanson, Med Sci Sports Exerc 31:S515-S521, 1999).

Implantable gastric stimulator does not prevent the increase in plasma ghrelin levels that occurs with weight loss.

UNLABELLED: The SHAPE (Screened Health Assessment and Pacer Evaluation) trial was a 24 month randomized multicenter placebo-controlled study to determine the efficacy of an implantable gastric stimulator (IGS) for weight loss. This report is an investigator-initiated sub-study at one site designed to assess whether IGS affects plasma levels of ghrelin and peptide YY (PYY). The device was implanted in all subjects but was activated in the TREATMENT group (n = 7, BMI = 41.5 ± 2.0 kg/m2) and remained inactive in the CONTROL (n = 6, BMI = 39.5 ± 1.7 kg/m2) during the first 12 months. IGS was activated in both groups during months 12-24. Fasting venous blood was drawn at months 0, 12, and 24 and an oral glucose tolerance test (OGTT) was performed at month 12. Although there was no difference in weight loss at 6 months ( CONTROL: -6.6 ± 1.5% vs. TREATMENT: -6.2 ± 1.4%), at 24 months the CONTROL group exhibited weight gain from baseline (+2.2 ± 1.5%) that was significantly different from the weight loss in the TREATMENT group (-1.9 ± 1.4%; P < 0.05). At 12 months, fasting ghrelin was significantly increased (P < 0.05) in the TREATMENT group (285 ± 35 to 336 ± 35 pg/ml; weight change, -4.9 ± 1.4%), but not in the CONTROL (211 ± 36 to 208 ± 35 pg/ml; weight change, -3.4 ± 1.5%). No significant change was observed in postprandial suppression of plasma ghrelin or in fasting and postprandial PYY levels. In conclusion, IGS does not prevent the increase in fasting plasma ghrelin levels associated with weight loss. Further studies are needed to determine whether changes in technology can improve weight loss and maintenance, perhaps using gut hormones as biomarkers of possible efficacy.