Lara Hilton

Meta-analysis: surgical treatment of obesity.

Context The effectiveness of surgical therapy in the treatment of obesity is unclear. Contribution Many published studies of obesity surgery have significant limitations, and case series make up much of the evidence. Evidence is complicated by the heterogeneity of procedures studied. However, surgery can result in substantial amounts of weight loss (20 to 30 kg) for markedly obese individuals. One cohort study documented weight loss for 8 years with associated improvements in comorbid conditions, such as diabetes. Complications of surgery appear to occur in about 20% of patients. Implications Those considering surgical treatment for obesity should understand that, although patients who have surgery can lose substantial amounts of weight, the evidence base for these treatments is limited. The Editors The prevalence of obesity in the United States is reaching epidemic proportions. An estimated 30% of individuals met the criteria for obesity in 19992002 (1, 2), and many industrialized countries have seen similar increases. The health consequences of obesity include heart disease, diabetes, hypertension, hyperlipidemia, osteoarthritis, and sleep apnea (3-7). Weight loss of 5% to 10% has been associated with marked reductions in the risk for these chronic diseases and with reducing the incidence of diabetes (8-14). The increasing numbers of obese individuals have led to intensified interest in surgical treatments to achieve weight loss, and a variety of surgical procedures have been used (Figure 1). Bariatric surgery was first performed in 1954 with the introduction of the jejunoileal bypass, which bypasses a large segment of small intestine by connecting proximal small intestine to distal small intestine. With this procedure, weight loss occurs secondary to malabsorption from reduction of upstream pancreatic and biliary contents. However, diarrhea and nutritional deficiencies were common, and this procedure was discontinued because of the complication of irreversible hepatic cirrhosis. With the development of surgical staplers came the introduction of gastroplasty procedures by Gomez in 1981 (15) and Mason in 1982 (16). In these early procedures, the upper portion of the stomach was stapled into a small gastric pouch with an outlet (that is, a stoma) to the remaining distal stomach, which limited the size of the meal and induced early satiety. These procedures were prone to staple-line breakdown or stoma enlargement and were modified in turn by the placement of a band around the stoma (vertical banded gastroplasty). Figure 1. Surgical procedures. The first gastric bypass was reported in 1967 by Mason and Ito (17). It combined the creation of a small gastric pouch with bypassing a portion of the upper small intestine. Additional modifications resulted in the Roux-en-Y gastric bypass (RYGB), a now common operation that involves stapling the upper stomach into a 30-mL pouch and creating an outlet to the downstream small intestine. The new food limb joins with the biliopancreatic intestine after a short distance. This procedure, performed laparoscopically or by using an open approach, generates weight loss by limiting gastric capacity, causing mild malabsorption, and inducing hormonal changes. A second common technique, particularly outside of the United States, is the laparoscopic adjustable gastric band. This device is positioned around the uppermost portion of the stomach and can be adjusted to allow tailoring of the stoma outlet, which controls the rate of emptying of the pouch and meal capacity. Another procedure, preferred by a number of surgeons, is the biliopancreatic bypass, which combines a limited gastrectomy with a long Roux limb intestinal bypass that creates a small common channel (that is, an intestine where food and biliopancreatic contents mix). This procedure can be combined with a duodenal switch, which maintains continuity of the proximal duodenum with the stomach and uses a long limb Roux-en-Y bypass to create a short common distal channel. These latter 2 procedures generate weight loss primarily through malabsorption. Recent worldwide survey data from 2002 and 2003 show that gastric bypass is the most commonly performed weight loss procedure (65.1%) (18). Slightly more than half of gastric bypasses are done laparoscopically. Overall, 24% of cases are laparoscopic adjustable band procedures; 5.4% are vertical banded gastroplasties; and 4.9% are biliopancreatic diversion, with or without the duodenal switch. In California, the number of bariatric cases increased 6-fold between 1996 and 2000 (19), from 1131 cases to 6304; an estimated 140000 procedures were performed in the United States in 2004. With this escalation in the number of procedures, there have been reports of high postoperative complication rates (20-24). Because of these reports and the increasing use of obesity surgery, we were asked to review the literature to estimate the effectiveness of bariatric surgery relative to nonsurgical therapy for weight loss and reduction in preoperative obesity-related comorbid conditions. We were also asked to compare outcomes of surgical techniques. This paper is part of a larger evidence report titled Pharmacological and Surgical Treatment of Obesity, which was prepared for the Agency for Healthcare Research and Quality and is available at www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.19289. Methods Literature Search and Selection We began with an electronic search of MEDLINE on 16 October 2002, followed by a search of EMBASE and subsequent periodic search updates (on 22 May, 2 June, 12 June, and 3 July 2003). We also assessed existing reviews of surgical therapy for obesity (10, 25, 26). Three reviewers independently reviewed the studies, abstracted data, and resolved disagreements by consensus (2 reviewers per study). The principal investigator settled any unresolved disagreements. We focused on studies that assessed surgery and used a concurrent comparison group. This category includes randomized, controlled trials (RCTs); controlled clinical trials; and cohort studies. A brief scan of the literature showed that these types of studies were rare. Therefore, we also elected to include case series with 10 or more patients, since these studies can be used to assess adverse events and could potentially augment the efficacy data from comparative studies. Publication bias is one potential limitation of analyzing the available literature because poor or negative results are not as likely to be reported as are successes or positive results. Extraction of Study-Level Variables We abstracted data from the articles, including number of patients and comorbid conditions, adverse events, types of outcome measures, and time from intervention until outcome. Detailed data were also collected on characteristics of the study samples, including median age, percentage of women, median baseline weight (in kilograms or body mass index [BMI]), percentage of patients with comorbid conditions at baseline (diabetes, hypertension, dyslipidemia, and sleep apnea), percentage of improvement or resolution of preexisting comorbid conditions, and median follow-up time. We also recorded whether the case series studies reported on consecutive patients. Choice of Outcomes The main outcomes of interest were weight loss, mortality, complication rates, and control of obesity-related comorbid conditions. We used the most commonly reported measurement of weight loss, that is, kilograms, which allowed us to include the greatest number of studies. Among 111 surgical studies reporting weight loss, 43 reported weight loss in kilograms or pounds, 17 reported excess weight loss or some variant, 46 reported both of these outcomes, and 5 reported neither. A total of 89 studies had sufficient data to be included in the weight loss analysis. Because weight loss achieves health benefits primarily by reducing the incidence or severity of weight-related comorbid conditions, we also compared the effects on these outcomes. Quality of life, an important outcome in assessing tradeoffs between benefits and risks, was reported infrequently. Statistical Analyses Because we included both comparative studies and case series, we conducted several types of analyses. The vast number of types of surgical procedures and technical variations required that we aggregate those that were clinically similar and identify the comparisons that were of most interest to the clinical audience. On the basis of discussions with bariatric surgeons, we categorized obesity surgery procedures by procedure type (for example, gastric bypass, vertical banded gastroplasty), laparoscopic or open approach, and specific surgical details such as length of Roux limb (see the larger evidence report for details). Analysis of the Efficacy of Surgical Weight Loss We extracted the mean weight loss and standard deviation at 12 postoperative months and at the maximum follow-up time (36 months). These times were chosen because they are clinically relevant and are most commonly reported. Of the 89 weight loss studies, 71 reported baseline BMI (average, 47.1 kg/m2), 16 reported baseline weight in kilograms or pounds (average, 123.3 kg), and 2 did not report either. The average age of patients was 38 years, and more than three quarters were women. For comparative studies that reported a within-study comparison of 2 procedures, a mean difference was calculated. Mean differences were pooled by using a random-effects model, and 95% CIs were estimated; the same method was used to determine a pooled mean weight loss for each group considering all studies combined. However, mean difference in weight loss was not calculated. Analysis of Surgery Mortality We recorded the number of deaths observed and the total number of patients in each procedure group. If the study self-identified the deaths as early or postoperative or as occurring within 30 days of the surgery, we termed these early deaths. If the

Meta-analysis : Pharmacologic treatment of obesity

Context The effectiveness of pharmacologic therapy in the treatment of obesity is unclear. Contribution This review of 79 clinical trials involving diet plus the obesity drugs sibutramine, orlistat, fluoxetine, sertraline, bupropion, topiramate, or zonisamide shows that these medications can lead to modest weight reductions of approximately 5 kg or less at 1 year. Available evidence is lacking on the effect of these drugs on long-term weight loss, health outcomes such as cardiovascular events and diabetes, and adverse effects. Implications Those considering pharmacologic treatment for obesity should understand that these drugs can lead to modest weight loss at 1 year, but data on long-term effectiveness and safety are lacking. The Editors Obesity has been defined as excess body fat relative to lean body mass (1) and, in humans, is the result of interactions of the environment with multiple genes. The age-adjusted prevalence of obesity was 30.5% in 19992000 (2). Although it is difficult to precisely estimate the change in prevalence of obesity over time because of changing definitions, nearly all clinical authorities agree that obesity is reaching epidemic proportions (2-13). Obesity is currently defined as a body mass index (BMI) of 30 kg/m2 or greater. Individuals whose BMI falls between 25 kg/m2 and 29.9 kg/m2 are considered overweight. Attempts to meet the body weight goal of the Healthy People 2000 initiative (7)to reduce the prevalence of overweight among adults to less than 20% of the populationdid not succeed. Still, many Americans are trying. According to a national survey (14), about 40% of women and 25% of men reported that they were currently trying to lose weight. However, most weight loss attempts consist of 6 months of loss followed by gradual regain to baseline (15). The health consequences of obesity include some of the most common chronic diseases in our society. Obesity is an independent risk factor for heart disease (16). Type 2 diabetes mellitus, hypertension and stroke, hyperlipidemia, osteoarthritis, and sleep apnea are all more common in obese individuals (17-19). A recent prospective study involving 900000 U.S. adults reported that increased body weight was associated with increased death rates for all cancer combined and for cancer at multiple specific sites (20). Adult weight gain is associated with increased risk for breast cancer in postmenopausal women (21). Weight loss of 5% to 10% can be associated with marked reductions in the risk for these chronic diseases (22). In the Diabetes Prevention Program, weight loss of about 5% to 6% among persons with a BMI of 34 kg/m2, along with increased physical activity, resulted in a 58% reduction in the incidence of diabetes (23). In response to the increase in obesity, pharmaceutical treatments for obesity have become both more numerous and more commonly used. Drugs prescribed for weight loss can be divided into 2 categoriesappetite suppressants and lipase inhibitorson the basis of their putative mechanisms of action. Appetite suppressants can be further subdivided on the basis of the neurotransmitters they are believed to affect. This article, which reviews the available evidence on medications used as obesity treatment in adults (Table 1), is part of a larger evidence report prepared for the Agency for Healthcare Research and Quality titled Pharmacological and Surgical Treatment of Obesity. The larger report is available at www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.19289. Table 1. Prescription Medications Used for Weight Loss Methods Literature Search and Selection Our search for controlled human studies of pharmacologic treatments of obesity began with an electronic search of MEDLINE on 16 October 2002. Subsequently, our librarian conducted current awareness search updates on 22 May, 2 June, 12 June, and 3 July 2003. We also searched the Cochrane Controlled Clinical Trials Register Database and existing systematic reviews. Full details of the search strategy are available in the larger evidence report. To be accepted for analysis, a study of drug therapy had to be a controlled clinical trial that assessed the effect of one of the pharmaceutical agents in humans and reported at least 6-month weight loss outcomes in pounds or kilograms. We made an exception for topiramate, for which most trials reported only percentage of weight loss. Patients in included studies needed to have a BMI of 27 kg/m2 or greater (Appendix Table). The technical expert panel for our evidence report determined which pharmaceutical agents would be included. The panel chose sibutramine, orlistat, phentermine, and diethylpropion, all of which have been approved by the U.S. Food and Drug Administration, as well as other medications being used for weight loss, including fluoxetine, bupropion, sertraline, topiramate, and zonisamide. Extraction of Study-Level Variables and Results Three reviewers, working in groups of 2, extracted data from the same articles and resolved disagreements by consensus. A senior physician resolved any remaining disagreements. We used the Jadad score to evaluate the quality of the studies, using information on study design, method of random assignment, blinding, and withdrawal (34). Jadad scores range from 0 (lowest quality) to 5 (highest quality). We also collected information on withdrawal and dropout rates and calculated the percentage of attrition by dividing the number of patients providing follow-up data by the number of patients initially enrolled. Of the medications we assessed, 3 had up-to-date existing meta-analyses (sibutramine, phentermine, and diethylpropion) and 4 others had a sufficient number of new studies to justify a new meta-analysis (orlistat, fluoxetine, bupropion, and topiramate). However, because heterogeneity was too great for the fluoxetine studies, they are summarized narratively. Selection of Trials for Meta-Analysis The outcome of interest was weight loss between baseline and follow-up. To make our analyses comparable, we stratified them in the same manner as did the recent meta-analysis on sibutramine (35). We defined data collected at 6 months to be data collected at any point between 16 and 24 weeks; likewise, 1-year follow-up data were those collected at any point between 44 and 54 weeks. If a study presented data for 2 or more time points in an interval, for example, 16 and 18 weeks, we chose the longest follow-up measurement for our analysis. Mean Difference For each trial, we extracted the follow-up mean weight loss for the control group, the follow-up mean weight loss for the medication group, and the standard deviation for each group. We then calculated a mean difference for each study, which was the difference between follow-up mean weight loss in the control group versus the medication group. Sensitivity Analyses We conducted sensitivity analyses on 4 study dimensions: Jadad quality score (2 vs. 3), year of publication (1998 or earlier vs. 1999 or later), completion rate (<80% vs. 80% and <70% vs. 70%), and dosage. We tested for differences between subgroups (for example, high-quality vs. lower-quality studies) by conducting a meta-regression analysis using a single dichotomous variable to indicate subgroup membership. We conducted sensitivity analyses to determine the possible impact of dropouts. In these analyses, we assumed that all patients who dropped out had a weight loss of zero. The mean weight loss for a particular study was then recalculated on the basis of the complete sample of both responders and dropouts. We assumed that the standard deviation of weight loss for a study did not change and recalculated the standard error on the basis of the complete sample size. We then conducted a pooled analysis for each medication and follow-up time as performed in the original approach. Meta-Analysis of Weight Loss For the 6-month and 12-month analyses, we estimated a pooled DerSimonianLaird random-effects estimate (36) of the overall mean difference. The mean differences in the individual trials are weighted by both within-study variation and between-study variation in this synthesis. We also report P values derived from the chi-square test of heterogeneity based on the Cochran Q-test (37), and the I2 statistic (38). This latter statistic represents the percentage of study variability that is due to heterogeneity rather than chance and is independent of the number of studies and the effect size metric. Publication Bias We assessed the possibility of publication bias by evaluating a funnel plot. We also conducted an adjusted rank correlation test (39) as a formal statistical test for publication bias. Extraction of Data on Adverse Events We assessed evidence of adverse events from randomized, controlled trials (RCTs) only. We did not include observational studies or case series data. Each trial included in the weight loss analysis was examined to determine whether it reported data on adverse events. Adverse events were recorded as the number of events or the number of people, depending on how the trial chose to report events. Most trials recorded the number of events rather than the number of unique people who experienced the event. Each event was counted as if it represented a unique individual. Because a single individual might have experienced more than 1 event, this assumption may have overestimated the number of people who had an adverse event. Meta-Analysis of Adverse Events For subgroups of events that occurred in 2 or more trials, at least once in the medication group and at least once in the control group, we performed a meta-analysis to estimate the pooled odds ratio and its associated 95% CI. Given that many of the events were rare, we used exact conditional inference to perform the pooling rather than applying the usual asymptotic methods that assume normality. For interpretability, for any significant pooled odds ratio greater than 1 (which indicates that the odds of the adverse

Meta-analysis: chronic disease self-management programs for older adults

Context Do self-management programs improve outcomes of adults with chronic conditions? Contribution This meta-analysis summarizes data from 53 randomized, controlled trials of self-management interventions for adults with diabetes mellitus, hypertension, or osteoarthritis. Self-management helped reduce hemoglobin A1c and blood pressure levels in diabetes and hypertension, respectively, but had minimal effect on pain and function in patients with arthritis. The authors could not identify any self-management program characteristics that predicted successful outcomes. Cautions The authors found evidence of possible publication bias. Implications Self-management programs may improve some outcomes in patients with some chronic diseases, but how to design an optimal program is not yet clear. The Editors Chronic diseases are conditions that are usually incurable. Although often not immediately life-threatening, they place substantial burdens on the health, economic status, and quality of life of individuals, families, and communities (1). In 1995, 79% of noninstitutionalized persons who were 70 years of age or older reported having at least 1 of 7 of the most common chronic conditions affecting this age group: arthritis, hypertension, heart disease, diabetes mellitus, respiratory disease, stroke, and cancer (1). Of these 7 conditions, arthritis is most prevalent, affecting more than 47% of individuals 65 years of age and older (2). Hypertension affects 41% of this population, and 31% of this group has some form of heart disease (of which ischemic heart disease and a history of myocardial infarction are major components). Diabetes mellitus affects approximately 10% of persons 65 years of age and older and increases the risk for other chronic conditions, including ischemic heart disease, renal disease, and visual impairment (2). Enthusiasm is growing for the role of self-management programs in controlling and preventing chronic disease complications (3-5). Despite this enthusiasm, experts do not agree on the definition of what constitutes a chronic disease self-management program, which elements of self-management programs are essential regardless of the clinical condition, or which elements are important for specific conditions. Several recent reviews on chronic disease self-management interventions have been published, including 2 Cochrane collaborations (6-13). Almost all have been disease-specific. One Cochrane review (12) concluded that there was insufficient evidence to assess the benefit of dietary treatment for type 2 diabetes mellitus programs, but exercise programs led to improved hemoglobin A1c values. A second Cochrane review of self-management for hypertension (11) used unpooled results to conclude that a reduction in the frequency of medication dosage increased adherence. There was not, however, consistent evidence of decreased blood pressure. Almost all previous reviews have been disease-specific or addressed specific intervention components within specific disease conditions (14-17). Two recent reviews assessed self-management programs across conditions. The first review provided a qualitative evaluation of self-management interventions across 3 conditions: type 2 diabetes mellitus, arthritis, and asthma (18). This review, which presented an overall optimistic assessment of self-management interventions, did not, however, include a quantitative synthesis of the data, nor did it address the issue of publication bias. The second review quantitatively assessed 71 trials (both randomized and nonrandomized) that included a self-management education program for patients with asthma, arthritis, diabetes mellitus, hypertension, and miscellaneous other conditions. Meta-analysis found statistically significant benefits for some outcomes within conditions. The authors could not detect meaningful differences in the effectiveness of the programs because of the varying intervention characteristics, such as the use of a formal syllabus, the type of program facilitator, the number of program sessions in which patients participated, and the duration of the program (19). In our review, we sought to quantitatively assess chronic disease self-management programs for older adults within and across disease conditions. We used empirical data from the literature to address 2 research questions: First, do chronic disease self-management programs result in improved disease-related outcomes for specific chronic diseases of high prevalence in older adults? Second, if self-management interventions are effective, are there specific components that are most responsible for the effect, within or across disease conditions? To address these questions, we focused on evaluating the effect of self-management programs for the 3 chronic conditions that have been most commonly studied in controlled trials of older adults: osteoarthritis, diabetes mellitus, and hypertension. Methods Conceptual Model Because there is no accepted definition of what constitutes a chronic disease self-management program, we used an intentionally broad definition to avoid prematurely excluding relevant studies. On the basis of a conceptual framework derived from the clinical literature and from discussions with social scientists with expertise in self-management, we defined chronic disease self-management as a systematic intervention that is targeted toward patients with chronic disease. The intervention should help them actively participate in either or both of the following: self-monitoring (of symptoms or of physiologic processes) or decision making (managing the disease or its impact through self-monitoring). We attempted to understand the characteristics particular to chronic disease self-management programs that may be most responsible for their effectiveness. On the basis of the literature and expert opinion, we postulated 5 hypotheses regarding the effectiveness of chronic disease self-management programs that feature the following characteristics: Tailoring. Patients who receive interventions tailored to their specific needs and circumstances are likely to derive more benefit than those receiving interventions that are generic. roup setting. Patients are more likely to benefit from interventions received within a group setting that includes others affected by the same condition than from an intervention provided in some other setting. Feedback. Patients are more likely to derive benefit from a cycle of intervention followed by some form of individual review with the provider of the intervention than from interventions where no such review exists. Psychological emphasis. Patients are more likely to derive benefit from a psychological intervention than from interventions where there is no psychological emphasis. Medical care. Patients who receive interventions directly from their medical providers (physicians or primary care providers) are more likely to derive benefit than those who receive interventions from nonmedical providers. Outcome Measures From the literature, we identified outcomes of interest to include the following: clinical outcomes, such as pain and function for osteoarthritis; measures that have strong links to clinical outcomes, such as hemoglobin A1c levels, fasting blood glucose levels, and patient weight for diabetes and blood pressure for hypertension; and intermediate outcomes, such as knowledge, feeling of self-efficacy, and health behaviors that are postulated to be related to clinical outcomes. Databases for Literature Search We used several databases and published documents to identify existing research and potentially relevant evidence for this report. For our primary source of citation information from 1980 until 1995, we used An Indexed Bibliography on Self-Management for People with Chronic Disease (20), published by the Center for Advancement of Health in association with the Group Health Cooperative of Puget Sound; we obtained any studies not listed in the bibliography (including those published later than 1995) by searching MEDLINE, PsycINFO, and CINAHL. We also used the Cochrane Library (its database of systematic reviews and the central register of controlled trials); the Assessment of Self-Care Manuals, published by the Evidence-based Practice Center at the Oregon Health Sciences University (21); and 77 other previously completed reviews relevant to this project. We retrieved all relevant documents referenced in these publications, and we updated our search in September 2004. Each review discussed at least 1 intervention aimed at chronic disease self-management. We also searched the Health Care Quality Improvement Projects database, maintained by the U.S. Centers for Medicare & Medicaid Services. This database contains reports known as narrative project documents, each of which describes an individual research project conducted by a Medicare Peer Review Organization; most projects in this database are not published elsewhere. Each report includes the projects background, aims, quality indicators, collaborators, sampling methods, interventions, measurement, and results. A complete description of our literature search has been reported elsewhere (22). Article Selection and Data Abstraction Two trained physician reviewers, working independently, conducted the article selection, quality assessment, and data abstraction; disagreements were resolved by consensus or third-party adjudication. Articles were not masked. We included all randomized trials that assessed the effects of an intervention or interventions relative to either a group that received usual care or a control group among the elderly and for our 3 conditions. Most studies compared their intervention with usual care or with a control intervention designed to account for the added attention received in the intervention (such as attending classes on vehicle safety instead of attending classes on self-management). Because our analysis was funded by the Centers for M

Pregnancy and fertility following bariatric surgery: a systematic review.

CONTEXT Use of bariatric surgery has increased dramatically during the past 10 years, particularly among women of reproductive age. OBJECTIVES To estimate bariatric surgery rates among women aged 18 to 45 years and to assess the published literature on pregnancy outcomes and fertility after surgery. EVIDENCE ACQUISITION Search of the Nationwide Inpatient Sample (1998-2005) and multiple electronic databases (Medline, EMBASE, Controlled Clinical Trials Register Database, and the Cochrane Database of Reviews of Effectiveness) to identify articles published between 1985 and February 2008 on bariatric surgery among women of reproductive age. Search terms included bariatric procedures, fertility, contraception, pregnancy, and nutritional deficiencies. Information was abstracted about study design, fertility, and nutritional, neonatal, and pregnancy outcomes after surgery. EVIDENCE SYNTHESIS Of 260 screened articles, 75 were included. Women aged 18 to 45 years accounted for 49% of all patients undergoing bariatric surgery (>50,000 cases annually for the 3 most recent years). Three matched cohort studies showed lower maternal complication rates after bariatric surgery than in obese women without bariatric surgery, or rates approaching those of nonobese controls. In 1 matched cohort study that compared maternal complication rates in women after laparoscopic adjustable gastric band surgery with obese women without surgery, rates of gestational diabetes (0% vs 22.1%, P < .05) and preeclampsia (0% vs 3.1%, P < .05) were lower in the bariatric surgery group. Findings were supported by 13 other bariatric cohort studies. Neonatal outcomes were similar or better after surgery compared with obese women without laparoscopic adjustable gastric band surgery (7.7% vs 7.1% for premature delivery; 7.7% vs 10.6% for low birth weight, P < .05; 7.7% vs 14.6% for macrosomia, P < .05). No differences in neonatal outcomes were found after gastric bypass compared with nonobese controls (26.3%-26.9% vs 22.4%-20.2% for premature delivery, P = not reported [1 study] and P = .43 [1 study]; 7.7% vs 9.0% for low birth weight, P = not reported [1 study]; and 0% vs 2.6%-4.3% for macrosomia, P = not reported [1 study] and P = .28 [1 study]). Findings were supported by 10 other studies. Studies regarding nutrition, fertility, cesarean delivery, and contraception were limited. CONCLUSION Rates of many adverse maternal and neonatal outcomes may be lower in women who become pregnant after having had bariatric surgery compared with rates in pregnant women who are obese; however, further data are needed from rigorously designed studies.

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis

BackgroundChronic pain patients increasingly seek treatment through mindfulness meditation.PurposeThis study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults.MethodWe conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use.ResultsThirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life.ConclusionsWhile mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.

Comparison of an Interstitial Cystitis/Bladder Pain Syndrome Clinical Cohort With Symptomatic Community Women From the RAND Interstitial Cystitis Epidemiology Study

PURPOSE The RAND Interstitial Cystitis Epidemiology survey estimated that 2.7% to 6.5% of United States women have urinary symptoms consistent with a diagnosis of interstitial cystitis/bladder pain syndrome. We describe the demographic and clinical characteristics of the symptomatic community based RAND Interstitial Cystitis Epidemiology cohort, and compare them with those of a clinically based interstitial cystitis/bladder pain syndrome cohort. MATERIALS AND METHODS Subjects included 3,397 community women who met the criteria for the RAND Interstitial Cystitis Epidemiology high sensitivity case definition, and 277 women with an interstitial cystitis/bladder pain syndrome diagnosis recruited from specialist practices across the United States (clinical cohort). Questions focused on demographic information, symptom severity, quality of life indicators, concomitant diagnoses and treatment. RESULTS Average symptom duration for both groups was approximately 14 years. Women in the clinical cohort reported worse baseline pain and maximum pain, although the absolute differences were small. Mean Interstitial Cystitis Symptom Index scores were approximately 11 for both groups, but mean Interstitial Cystitis Problem Index scores were 9.9 and 13.2 for the clinical cohort and the RAND Interstitial Cystitis Epidemiology cohort, respectively (p <0.001). The RAND Interstitial Cystitis Epidemiology subjects were more likely to be uninsured. CONCLUSIONS The RAND Interstitial Cystitis Epidemiology community cohort was remarkably similar to an interstitial cystitis/bladder pain syndrome clinical cohort with respect to demographics, symptoms and quality of life measures. In contrast to other chronic pain conditions for which clinical cohorts typically report worse symptoms and functional status than population based samples, our data suggest that many measures of symptom severity and functional impact are similar, and sometimes worse, in the RAND Interstitial Cystitis Epidemiology cohort. These findings suggest that interstitial cystitis/bladder pain syndrome is significantly burdensome, and likely to be underdiagnosed and undertreated in the United States.

Depressive disorders and panic attacks in women with bladder pain syndrome/interstitial cystitis: a population-based sample

OBJECTIVE We report the population prevalence of probable depressive disorders and current panic attacks in women with bladder pain syndrome/interstitial cystitis (BPS/IC) symptoms and describe their characteristics and access care. METHOD We conducted a telephone screening of 146,231 households and telephone interviews with women with BPS/IC symptoms. A weighted probability sample of 1469 women who met the criteria for BPS/IC was identified. Measures of BPS/IC severity, depressive symptoms, panic attacks and treatment utilization were administered. T and χ(2) tests were used to examine differences between groups. RESULTS Over one third of the sample (n=536) had a probable diagnosis of depression, and 52% (n=776) reported recent panic attacks. Women with a probable diagnosis of depression or current panic attacks reported worse functioning and increased pain and were less likely to work because of bladder pain. CONCLUSIONS In this community-based sample, rates of probable current depression and panic attacks are high, and there is considerable unmet need for treatment. These findings suggest that clinicians should be alert to complaints of bladder pain in patients seeking treatment for depressive or anxiety disorders and to complaints of emotional or personal problems in patients seeking treatment for painful bladder symptoms.

Meditation for Posttraumatic Stress: Systematic Review and Meta-analysis.

Objective: We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. Method: Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. Conclusions: Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes.

Trials and tribulations on the road to implementing integrative medicine in a hospital setting

Abstract In this paper, results are reported from a five year qualitative study involving a stakeholder analysis of a hospital-based centre for integrative medicine. The objective of the study was to identify the barriers and the facilitators for creating integrative medicine in this setting. The study documented the timeline of the Centre from its very hopeful beginning to its demise. The paper focuses on the administrative implementation process, examining the original expectations in light of the organisational culture, business model, impact of policies and regulations, and the trade-offs made between the original goals and those attained within this environment. One of the most troubling aspects arising from this case study was that no corrective mechanism was in place for program design flexibility once previously created policies were deemed harmful to the Centre. When the major assumptions on which the Centre was founded, turned out to be false, there was no turning back and the Centre collapsed.

Program Evaluation of Total Force Fitness Programs in the Military

ABSTRACTThe Chairman of the Joint Chiefs of Staff has charged the militarys medical and research communities to join with the line community in rapidly and efficiently building a framework to promote and measure total force fitness (TFF). The need to identify the elements of promising TFF programs, and to evaluate whether and how they work, has taken on a new urgency, as we witness the heavy toll of combat exposure on our military members and families. We propose a rigorous methodology for conducting program evaluation, including the study of structure, process, and outcomes. The proposed model combines both quantitative and qualitative methods, to assess the effectiveness and replicability of holistic, multidimensional programs as they are implemented. We describe an additional model for the assessment of efficacy through group randomization trials. The result is a comprehensive model that can be used to assess and compare TFF programs.