Steven H. Belle

Perioperative safety in the longitudinal assessment of bariatric surgery.

BACKGROUND To improve decision making in the treatment of extreme obesity, the risks of bariatric surgical procedures require further characterization. METHODS We performed a prospective, multicenter, observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007. A composite end point of 30-day major adverse outcomes (including death; venous thromboembolism; percutaneous, endoscopic, or operative reintervention; and failure to be discharged from the hospital) was evaluated among patients undergoing first-time bariatric surgery. RESULTS There were 4776 patients who had a first-time bariatric procedure (mean age, 44.5 years; 21.1% men; 10.9% nonwhite; median body-mass index [the weight in kilograms divided by the square of the height in meters], 46.5). More than half had at least two coexisting conditions. A Roux-en-Y gastric bypass was performed in 3412 patients (with 87.2% of the procedures performed laparoscopically), and laparoscopic adjustable gastric banding was performed in 1198 patients; 166 patients underwent other procedures and were not included in the analysis. The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding was 0.3%; a total of 4.3% of patients had at least one major adverse outcome. A history of deep-vein thrombosis or pulmonary embolus, a diagnosis of obstructive sleep apnea, and impaired functional status were each independently associated with an increased risk of the composite end point. Extreme values of body-mass index were significantly associated with an increased risk of the composite end point, whereas age, sex, race, ethnic group, and other coexisting conditions were not. CONCLUSIONS The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics. In helping patients make appropriate choices, short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese. (ClinicalTrials.gov number, NCT00433810.)

Enhancing the Quality of Life of Dementia Caregivers from Different Ethnic or Racial Groups: A Randomized, Controlled Trial

Context Providing care for patients with dementia can pose enormous burdens that may be eased with assistance and support. Needs may differ by race or ethnicity. Contributions The investigators randomly assigned Hispanic, black, and white dementia caregivers to receive written educational materials or an intensive intervention to improve caregiver quality of life. The specific interventions were determined by caregivers, were delivered via trained personnel and telephone support groups, and targeted several dimensions of need. The study found that quality of life improved for Hispanic and white caregivers and for black spousal caregivers in the intervention group but not in the control group. The intervention had no detectable effect on the number of care recipients who were institutionalized. Cautions The study used only a single 6-month follow-up assessment, combined heterogeneous cultures and ethnicities into 3 groups, and excluded some ethnicities. Implications An intensive intervention targeting several dimensions of caregiver need improved caregiver quality of life without an apparent effect on care recipient institutionalization. The effect did not differ by caregiver race or ethnicity. The Editors Caring for a family member with dementia is extremely stressful, contributes to psychiatric and physical illness, and increases the risk for death (1, 2). The accumulating evidence on the personal, social, and health effects of dementia caregiving has generated a broad range of intervention studies, including randomized trials aimed at decreasing the burden and stress of caregiving. Several studies have demonstrated statistically significant effects in reducing caregiver burden, lowering caregiver depression, and delaying institutionalization of care recipients (1, 3, 4) through either targeted interventions that treat a specific caregiver problem, such as depression, or broad-based multicomponent interventions that include counseling, case management, and telephone support. Persistent limitations of caregiver intervention research are the paucity of well-controlled randomized trials, the limited range of outcomes examined, small sample sizes and insufficient power, geographic limitations, inadequate racial or ethnic variation, and a scarcity of comprehensive multicomponent interventions (4). Indeed, none of the 41 randomized clinical trials published in the last 5 years met Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized trials (5), and many have serious methodologic problems that call into question the reported findings (4). To address these limitations, the National Institute on Aging and the National Institute of Nursing Research funded a multisite research program designed to develop and test an effective caregiver intervention: the Resources for Enhancing Alzheimers Caregiver Health (REACH) study. We performed the study in 2 phases. In the first phase (REACH I), we tested several different interventions at 6 U.S. sites to identify the most promising approaches to decreasing caregiver burden and depression (6). Results from the study showed that active treatments were superior to control conditions in reducing caregiver burden and that active engagement in skills training statistically significantly reduced caregiver depression (7, 8). The existing literature and findings from REACH I helped guide the design of the REACH II intervention (7, 8). We based the REACH II study on the premise that caregivers can have problems in several areas at varying levels of intensity, and thus, interventions must be responsive to variations in needs among caregivers. The findings from REACH I also suggest that interventions that use active techniques, such as role-playing and interactive practice, are more effective at improving outcomes, such as depression symptoms, compared with more passive methods, such as providing information (7). We based the REACH II intervention on these assumptions and designed the intervention to maximize outcomes by systematically targeting several problem areas, tailored the intervention to respond to the needs of each individual, and actively engaged the caregiver in the intervention process. We hypothesized that participants assigned to the intervention would do better than those in the control group on several indicators of caregiver quality of life, including depression, burden, self-care, and social support and care recipient problem behaviors, and that these differences would be largest among Hispanic or Latino persons because they have lower access to support services (8). In additional analyses, we assessed the effects of treatment on rates of caregiver clinical depression and care recipient institutional placement, as well as the benefits derived from study participation. Methods Caregivers Eligibility criteria for caregivers included the following: Hispanic or Latino, white or Caucasian, or black or African-American race or ethnicity; age 21 years or older; living with or sharing cooking facilities with the care recipient; providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours per day for at least the past 6 months; and reported distress associated with caregiving (reported at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined). We excluded caregivers who were involved in another caregiver intervention study, who had participated in REACH I, or who had an illness that would prevent 6 months of study participation. Other requirements were logistic, including having a telephone, planning to remain in the geographic area for at least 6 months, and competency in either English or Spanish (see Appendix Table 1 for a detailed list of exclusions). Appendix Table 1. Reasons for Ineligibility Care Recipients To be eligible for the study, caregivers had to confirm that their relative had diagnosed Alzheimer disease or related disorders. In addition, we screened care recipients for a history of severe mental illness, head injury, Parkinson disease, or stroke, and we administered the MiniMental State Examination (MMSE) (9). We excluded patients who were bedbound with MMSE scores of 0 because we felt that our intervention had little to offer caregivers who were caring for such patients. Moreover, being bedbound is a risk factor for institutional placement or death, and we sought to exclude caregivers who were likely to transition out of the caregiving role within the 6-month study. For patients who scored more than 23 on the MMSE or had other conditions, such as head injury, we required a physicians diagnosis of Alzheimer disease or related disorders. Procedures We recruited caregiver and care recipient dyads at 5 sites: Birmingham, Alabama; Memphis, Tennessee; Miami, Florida; Palo Alto, California; and Philadelphia, Pennsylvania. Enrollment began in June 2002, and follow-up ended in August 2004. Recruitment occurred in memory disorder clinics, primary care clinics, social service agencies, physician offices, churches, and community centers and by using professionally designed brochures, public service announcements on radio stations, newspaper articles, television, targeted newsletters, and community presentations. We translated all intervention materials and assessment instruments into Spanish for the Hispanic or Latino participants by using established techniques for forward-and-back translation and allowing for regional variation in language expression. We used bilingual and bicultural staff at the 3 sites that recruited Hispanic or Latino participants: Palo Alto, Philadelphia, and Miami. At all sites, assessors and interventionists received cultural sensitivity training and were certified before entering the field. Certified assessors were blinded to group assignment of study participants. The institutional review boards of all 5 site institutions and the coordinating center in Pittsburgh, Pennsylvania, approved the study. We obtained written informed consent from all caregivers and from care recipients whenever possible. Caregivers provided consent on behalf of care recipients who could not do so on their own. After telephone screening (n= 995) and baseline assessment (n= 670), we randomly assigned participants (n= 642) to the intervention or control group (Figure). We stratified randomization by using a block size of 2 or 4 within strata defined by the 5 intervention sites, 3 racial or ethnic groups (Hispanic or Latino, white or Caucasian, and black or African American), and 2 caregivercare recipient relationships (spouse or nonspouse). We performed randomization at the coordinating center by using a computer-generated algorithm and a standard protocol for transmitting randomization information between the coordinating center and the study sites. We administered 1 of 3 follow-up batteries, on the basis of care recipient status at follow-up (full follow-up, bereavement battery, or placement battery), to study participants 6 months after randomization when the intervention was completed. To maximize the number of individuals who could be included in the outcome analyses, we ensured that the 3 batteries were as similar as possible. We did not ask caregivers about caregiver burden and care recipient functional status if their care recipients had died; thus, we could not include these caregivers in the primary outcome analysis (10). Figure. Study flow diagram. *See Appendix Table 1 for reasons for ineligibility. See Appendix Table 2 (for reasons for unavailable end points and types of 6-month follow-up. Appendix Table 2. Reasons for Unavailable End Points and Types of 6-Month Follow-up Trial Groups Intervention The intervention involved a range of strategies: provision of informat

Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit*

Objective To describe stressful experiences of adult patients who received mechanical ventilation for ≥48 hrs in an intensive care unit. Design Prospective cohort study. Setting Four intensive care units within an East Coast tertiary-care university medical center. Patients Patients were 150 adult intensive care unit patients receiving mechanical ventilation for ≥48 hrs. Intervention None. Measurements and Main Results As part of a study of the long-term outcomes of adult patients requiring prolonged mechanical ventilation, we used a 32-item questionnaire to collect data on patients’ stressful experiences, both psychological (e.g., fearfulness, anxiety) and physical (e.g., pain, difficulty breathing), associated with the mechanical ventilation endotracheal tube and with being in an intensive care unit.Of 554 patients who met study criteria and survived prolonged mechanical ventilation, 150 consented and were oriented to person, place, and situation. Two thirds of these patients remembered the endotracheal tube and/or being in an intensive care unit. The median numbers of endotracheal tube and intensive care unit experiences remembered were 3 (of 7) and 9 (of 22), respectively. If a patient remembered an experience in the questionnaire, it was likely to be moderately to extremely bothersome.Some of the items that many patients found to be moderately to extremely bothersome were pain, fear, anxiety, lack of sleep, feeling tense, inability to speak/communicate, lack of control, nightmares, and loneliness. Stressful experiences associated with the endotracheal tube were strongly associated with subjects’ experiencing spells of terror, feeling nervous when left alone, and poor sleeping patterns. Conclusions Subjects were more likely to remember experiences that were moderately to extremely bothersome. This might be because the more bothersome experiences were easier to recall or because most of these experiences are common and significant stressors to many of these patients. In either case, these data indicate that these patients are subject to numerous stressful experiences, which many find quite bothersome. This suggests the potential for improved symptom management, which could contribute to a less stressful intensive care unit stay and improved patient outcomes.

Weight Change and Health Outcomes at 3 Years After Bariatric Surgery Among Individuals With Severe Obesity

IMPORTANCE Severe obesity (body mass index [BMI] ≥35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations. OBJECTIVE To report 3-year change in weight and select health parameters after common bariatric surgical procedures. DESIGN AND SETTING The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery. MAIN OUTCOMES AND MEASURES Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed. RESULTS At baseline, participants (N = 2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%). CONCLUSIONS AND RELEVANCE Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00465829.

Cognitive tests that best discriminate between presymptomatic AD and those who remain nondemented

Objective: To identify the most accurate cognitive measures in discriminating between individuals with presymptomatic AD and individuals who remained nondemented. Methods: During a 10-year prospective community study, 120 nondemented subjects completed a battery of standard cognitive tests and clinically manifested AD 1.5 years later. Performance on each of 16 cognitive tests was compared between these 120 presymptomatic cases and 483 controls who remained nondemented over the 10-year follow-up period. The area under the receiver operating characteristic (AUC) curve for each test was used to measure its accuracy of discrimination between cases and controls. Results: Among the 16 neuropsychological tests, Word List Delayed Recall discriminated best between cases and controls (AUC = 0.806), followed by the Word List 3rd Learning Trial (0.787), Word List 1st Learning Trial (0.774), and Trail-making Test B (0.773), compared to the Mini-Mental State Examination (MMSE) (0.726). Both Word List Delayed Recall and Word List 3rd Learning Trial were significantly more accurate than the MMSE. The combination of Word List Delayed Recall and Trail-making Test B comprised the optimal set of cognitive measures, with the highest AUC (0.852). Conclusion: Measures of delayed recall and executive functions were the best discriminators between those who would manifest AD 1.5 years later and those who would remain nondemented. These findings are relevant for the early detection of AD and, therefore, for prevention and early intervention trials. Executive dysfunction may be a subtle manifestation of incipient AD, along with memory dysfunction.

Long-term follow-up after bariatric surgery: a systematic review

IMPORTANCE Bariatric surgery is an accepted treatment for obesity. Despite extensive literature, few studies report long-term follow-up in cohorts with adequate retention rates. OBJECTIVE To assess the quality of evidence and treatment effectiveness 2 years after bariatric procedures for weight loss, type 2 diabetes, hypertension, and hyperlipidemia in severely obese adults. EVIDENCE REVIEW MEDLINE and Cochrane databases were searched from 1946 through May 15, 2014. Search terms included bariatric surgery, individual bariatric procedures, and obesity. Studies were included if they described outcomes for gastric bypass, gastric band, or sleeve gastrectomy performed on patients with a body mass index of 35 or greater, had more than 2 years of outcome information, and had follow-up measures for at least 80% of the initial cohort. Two investigators reviewed each study and a third resolved study inclusion disagreements. FINDINGS Of 7371 clinical studies reviewed, 29 studies (0.4%, 7971 patients) met inclusion criteria. All gastric bypass studies (6 prospective cohorts, 5 retrospective cohorts) and sleeve gastrectomy studies (2 retrospective cohorts) had 95% confidence intervals for the reported mean, median, or both exceeding 50% excess weight loss. This amount of excess weight loss occurred in 31% of gastric band studies (9 prospective cohorts, 5 retrospective cohorts). The mean sample-size-weighted percentage of excess weight loss for gastric bypass was 65.7% (n = 3544) vs 45.0% (n = 4109) for gastric band. Nine studies measured comorbidity improvement. For type 2 diabetes (glycated hemoglobin <6.5% without medication), sample-size-weighted remission rates were 66.7% for gastric bypass (n = 428) and 28.6% for gastric band (n = 96). For hypertension (blood pressure <140/90 mm Hg without medication), remission rates were 38.2% for gastric bypass ( n = 808) and 17.4% for gastric band (n = 247). For hyperlipidemia (cholesterol <200 mg/dL, high-density lipoprotein >40 mg/dL, low-density lipoprotein <160 mg/dL, and triglycerides <200 mg/dL), remission rates were 60.4% for gastric bypass (n = 477) and 22.7% for gastric band (n = 97). CONCLUSIONS AND RELEVANCE Very few bariatric surgery studies report long-term results with sufficient patient follow-up to minimize biased results. Gastric bypass has better outcomes than gastric band procedures for long-term weight loss, type 2 diabetes control and remission, hypertension, and hyperlipidemia. Insufficient evidence exists regarding long-term outcomes for gastric sleeve resections.

Effect of Multicomponent Interventions on Caregiver Burden and Depression: The REACH Multisite Initiative at 6-Month Follow-Up

Meta-analysis was used to examine pooled parameter estimates of 9 active compared with 6 control conditions of the Resources for Enhancing Alzheimers Caregiver Health (REACH) project at 6 months on caregiver burden and depressive symptoms. Associations of caregiver characteristics and outcomes were examined. For burden, active interventions were superior to control conditions (p = .022). Also, active interventions were superior to control conditions for women versus men and for caregivers with lower education versus those with higher education. For depressive symptoms, a statistically significant association of group assignment was found for Miamis family therapy and computer technology intervention (p = .034). Also, active interventions were superior to control conditions for Hispanics, nonspouses, and caregivers with lower education. Results suggest interventions should be multicomponent and tailored.

Long-term mortality and quality of life after prolonged mechanical ventilation*

ObjectiveTo describe and identify factors associated with mortality rate and quality of life 1 yr after prolonged mechanical ventilation. DesignProspective, observational cohort study with patient recruitment over 26 months and follow-up for 1 yr. SettingIntensive care units at a tertiary care university hospital. PatientsAdult patients receiving prolonged mechanical ventilation. InterventionsNone. Measurements and Main ResultsWe measured mortality rate and functional status, defined as the inability to perform instrumental activities of daily living (IADLs) 1 yr following prolonged mechanical ventilation. The study enrolled 817 patients. Their median age was 65 yrs, 46% were women, and 44% were alive at 1 yr. Median ages at baseline of 1-yr survivors and nonsurvivors were 53 and 71 yrs, respectively. At the time of admission to the hospital, survivors had fewer comorbidities, lower severity of illness score, and less dependence compared with nonsurvivors. Severity of illness on admission to the intensive care unit and prehospitalization functional status had a significant association with short-term mortality rate, whereas age and comorbidities were related to long-term mortality. Fifty-seven percent of the surviving patients needed caregiver assistance at 1 yr of follow-up. The odds of having IADL dependence at 1-yr among survivors was greater in older patients (odds ratio 1.04 for 1-yr increase in age) and those with IADL dependence before hospitalization (odds ratio 2.27). ConclusionsMortality rate after prolonged mechanical ventilation is high. Long-term mortality rate is associated with older age and poor prehospitalization functional status. Many survivors needed assistance after discharge from the hospital, and more than half still required caregiver assistance at 1 yr. Interventions providing support for caregivers and patients may improve the functional status and quality of life of both groups and thus need to be evaluated.

Positive Aspects of Caregiving Contributions of the REACH Project to the Development of New Measures for Alzheimer’s Caregiving

The aim of this study was to assess a newly developed measure for the positive aspects of caregiving using a sample of dementia caregivers. The measure was developed and administered to 1,229 participants in a national collaborative Alzheimer’s disease caregiver study and evaluated for validity and reliability using standard psychometric analyses. Factor analysis identified two components in this nine-item measure: Self-Affirmation and Outlook on Life. Cronbach’s alphas for the components were .86 and .80, respectively. For the entire scale, Cronbach’s alpha was .89. The Positive Aspects of Caregiving measure, tested with a large, diverse, and well-characterized sample shows promise as a valid and reliable instrument. With additional implementation and testing, the measure has the potential to substantially increase our understanding of basic caregiving research and the outcomes of intervention efforts.

Incidence of Alzheimer’s disease in a rural community in India: The Indo–US Study

Objective: To determine overall and age-specific incidence rates of AD in a rural, population-based cohort in Ballabgarh, India, and to compare them with those of a reference US population in the Monongahela Valley of Pennsylvania. Methods: A 2-year, prospective, epidemiologic study of subjects aged ≥55 years utilizing repeated cognitive and functional ability screening, followed by standardized clinical evaluation using the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and the National Institute of Neurological and Communicative Disorders and Stroke–Alzheimer’s Disease and Related Disorders Association criteria for the diagnosis, and the Clinical Dementia Rating scale for the staging, of dementia and AD. Results: Incidence rates per 1000 person–years for AD with CDR ≥0.5 were 3.24 (95% CI: 1.48–6.14) for those aged ≥65 years and 1.74 (95% CI: 0.84–3.20) for those aged ≥55 years. Standardized against the age distribution of the 1990 US Census, the overall incidence rate in those aged ≥65 years was 4.7 per 1000 person–years, substantially lower than the corresponding rate of 17.5 per 1000 person–years in the Monongahela Valley. Conclusion: These are the first AD incidence rates to be reported from the Indian subcontinent, and they appear to be among the lowest ever reported. However, the relatively short duration of follow-up, cultural factors, and other potential confounders suggest caution in interpreting this finding.