Jeffrey P. Baker

What is subjective global assessment of nutritional status

Presented and described in detail is a clinical technique called subjective global assessment (SGA), which assesses nutritional status based on features of the history and physical examination. Illustrative cases are presented. To clarify further the nature of the SGA, the method was applied before gastrointestinal surgery to 202 hospitalized patients. The primary aim of the study was to determine the extent to which our clinicians SGA ratings were influenced by the individual clinical variables on which the clinicians were taught to base their assessments. Virtually all of these variables were significantly related to SGA class. Multivariate analysis showed that ratings were most affected by loss of subcutaneous tissue, muscle wasting, and weight loss. A high degree of interobserver agreement was found (kappa = 0.78, 95% confidence interval 0.624 to 0.944, p less than 0.001). We conclude that SGA can easily be taught to a variety of clinicians (residents, nurses), and that this technique is reproducible.

Evaluating the Accuracy of Nutritional Assessment Techniques Applied To Hospitalized Patients: Methodology and Comparisons

Herein we describe a methodology which can be used to evaluate the predictive accuracy of nutritional assessment techniques. We use this methodology to compare seven techniques of nutritional assessment in terms of their ability to predict one nutrition associated hospital complication (infection) by dividing a sample of 59 surgical patients into high risk and low risk groups. One technique was subjective global assessment (SGA) of the patients nutritional status on admission to hospital. Five techniques were single objective measurements (albumin, transferrin, delayed cutaneous hypersensitivity, anthropometry, and creatinine-height index). The 7th technique was the prognostic nutritional index. The best combination of sensitivity (0.82) and specificity (0.72) was found with SGA. The second best combination (0.88 and 0.45) was found by using either the prognostic nutritional index or creatinine-height index. We also found that combining the five objective measurements with SGA into a single index did not increase the discriminatory (or predictive) power over that of SGA alone in a clinically significant way. We conclude that a larger study comparing these approaches should be undertaken to confirm these findings and to develop methods which improve the predictive properties of SGA.

Treatment of Active Crohn's Disease With MLN0002, a Humanized Antibody to the α4β7 Integrin

BACKGROUND & AIMS Selective blockade of lymphocyte-vascular endothelium interactions in the gastrointestinal tract is a promising therapeutic strategy for inflammatory bowel disease. This randomized, double-blind, controlled trial assessed the efficacy and safety of MLN0002, a monoclonal antibody targeting the alpha4beta7 integrin, in patients with active Crohns disease. METHODS Patients were randomized to receive MLN0002 2.0 mg/kg (n = 65), MLN0002 0.5 mg/kg (n = 62), or placebo (n = 58) by intravenous infusion on days 1 and 29. The primary efficacy end point was clinical response (>or=70-point decrement in the Crohns Disease Activity Index [CDAI] score) on day 57. Secondary end points were the proportions of patients with clinical remission (CDAI score <or=150) and with an enhanced clinical response (>or=100-point decrement in CDAI). Human anti-human antibody levels were measured. RESULTS Clinical response rates at day 57 were 53%, 49%, and 41% in the MLN0002 2.0 mg/kg, MLN0002 0.5 mg/kg, and placebo groups. Clinical remission rates at day 57 were 37%, 30%, and 21%, respectively (P = .04 for the 2.0 mg/kg vs placebo comparison). At day 57, 12% and 34% of patients in the 2.0- and 0.5-mg/kg groups had clinically significant human anti-human antibody levels (titers > 1:125). There was one infusion-related hypersensitivity reaction. The most common serious adverse event was worsening of Crohns disease. CONCLUSIONS This phase 2 study was suggestive of a dose-dependent beneficial effect of MLN0002 therapy on clinical remission. MLN0002 was well tolerated in patients with active Crohns disease.

Treatment of left-sided ulcerative colitis with butyrate enemas: a controlled trial

Background: The colonic mucosa is highly dependent upon the presence of luminal nutrients. This dependence is most marked in the distal colon. The major luminal nutrients are short chain fatty acids that are produced as a by‐product of colonic fermentation of carbohydrates. Butyrate appears to be the short chain fatty acid most avidly metabolized by the colonic mucosa. It has been suggested that ulcerative colitis is, at least in part, related to an energy deficiency state of the colonic mucosa which may be secondary to impaired short chain fatty acid production, uptake or utilization. The objective of this study was to determine if butyrate given as enema therapy is effective in the treatment of active distal ulcerative colitis.

Given capsule endoscopy in celiac disease: evaluation of diagnostic accuracy and interobserver agreement.

BACKGROUND AND AIMS:Capsule endoscopy (CE) has been increasingly used for diagnosing diseases of the small bowel. It is an attractive technique for assessing celiac disease (CD) because it is noninvasive and provides a close and magnified view of the mucosa of the entire small bowel. In this study, we evaluated the accuracy of CE and interobserver agreement in recognizing villous atrophy (VA) using histopathology as the reference. We also explored the extent of small bowel involvement with CD and the relationship between the length of the affected bowel and the clinical presentation.METHODS:Ten CD patients with histologically proven VA and the same number of controls were subjected to CE. Four, blinded to histology findings, investigators (two with and two without prestudy CE experience) were asked to diagnose VA on CE images.RESULTS:Based on assessment of all four investigators, the overall sensitivity, specificity, PPV, and NPV of CE in diagnosing VA were 70%, 100%, 100%, and 77%, respectively. The sensitivity and the specificity of the test was 100% when the reports of experienced capsule endoscopists only were analyzed. The interobserver agreement was perfect (κ= 1.0) between investigators with prestudy CE experience and poor (κ= 0.2) between the investigators who had limited prestudy exposure to CE. Celiac patients with extensive small bowel involvement had typical symptoms of malabsorption (diarrhea, weight loss) as opposed to mild and nonspecific symptoms in patients whose disease was limited to the proximal small bowel. CE was tolerated well by all study participants with 95% reporting absence of any discomfort.CONCLUSIONS:Although based on a small sample size, the study suggests that CE may be useful in assessing patients with CD. Familiarity with CE technology appears to be a critical factor affecting the accuracy of the test. Larger studies are warranted to more precisely define the advantages and limitations of CE in CD.

Critical evaluation of the role of clinical assessment and body composition studies in patients with malnutrition and after total parenteral nutrition.

verely malnourished patient, the exact rec-ognition of early and subtle malnutrition isnot as simple. Furthermore, the results ofsuch marginal deficiency are not clearlyknown. Since the recognition and knowledgeof the effects of early malnutrition are bothimportant in defining the need for nutritionalsupport, several investigators have attemptedto study this area. They have related a varietyof parameters of anthropometry and bio-chemistry

The Subjective Global Assessment: a review of its use in clinical practice.

Many methods of evaluating malnutrition have been proposed that combine multiple components such as dietary and medical history, amount of weight loss, biochemical variables, and anthropometry. The Subjective Global Assessment (SGA), first described by Baker et al in 1982, SGA was introduced to assess the patient for malnutrition at the bedside, without the need for precise body composition analysis. Since it was developed, the SGA has been used in various different patient populations, including surgical and oncology patients. It remains the most reliable and efficient method of nutrition assessment. The authors present a review of the SGA and how it has been used in a variety of areas within medicine.

A randomized, double-blind, placebo-controlled trial of CDP571, a humanized monoclonal antibody to tumour necrosis factor-α, in patients with corticosteroid-dependent Crohn's disease

Aim : To evaluate CDP571, a humanized monoclonal antibody to tumour necrosis factor‐α, for the treatment of corticosteroid‐dependent Crohns disease.

The development of a novel intracolonic occlusion balloon for transcolonic natural orifice transluminal endoscopic surgery: description of the technique and early experience in a porcine model (with videos)

BACKGROUND Transgastric and transvaginal approaches in natural orifice transluminal endoscopic surgery (NOTES) are the most commonly used, although the transcolonic approach may have some advantages. OBJECTIVE To develop a workable technique for transcolonic NOTES. DESIGN A nonsurvival study followed by a survival study in a porcine model. Transcolonic peritoneoscopy was performed with the use of a novel intracolonic occlusion balloon. The colotomy was closed with endoclips. A necropsy and histologic evaluation were performed 2 weeks after surgery. SETTING Academic hospital, health science research center. SUBJECTS Fifteen female Yorkshire pigs (5 nonsurvival, 10 survival). INTERVENTIONS A balloon-tipped catheter was placed proximal to the colotomy site. The balloon was inflated to occlude the colonic lumen. An endoscope was inserted through the anus. Colonic incision was created with an endoscopic needle-knife at 15 to 20 cm from the anal verge. Peritoneoscopy was performed. The colotomy was closed with endoclips. MAIN OUTCOME MEASUREMENTS Rates of complications, survival, healing, and adhesions. RESULTS Two initial experiments were complicated by bowel distension and contamination of the incision area by colonic content. In the remaining 13 pigs, the experiments were performed with the use of the intracolonic occlusion balloon. No complications were documented. Necropsies were performed 2 weeks after surgery. Gross and histologic evaluations demonstrated near complete healing. Minimal adhesions were identified in 4 of 10 pigs. LIMITATION Imperfection of the prototype balloon. CONCLUSIONS Excessive bowel distension and fecal contamination because of spillage from the proximal bowel may be barriers to performing transcolonic NOTES. Isolation of the operative area by splitting the bowel and sealing the colonic lumen with the balloon above the colonic incision may overcome these problems and optimize the technique.

Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn’s Disease

BACKGROUND AND AIMS The Crohns Disease Endoscopic Index of Severity [CDEIS] and Simplified Endoscopic Score for Crohns Disease [SES-CD] demonstrate consistent overall intra- and inter-rater reliability. However, the reliability of some index items is relatively poor. We evaluated scoring conventions to improve the reliability of these items. METHODS Five gastroenterologists with no previous experience scoring the CDEIS or SES-CD were trained on their use. A total of 65 video recordings of colonoscopies were scored blindly by each gastroenterologist before and after additional training on index scoring conventions. Intra-class correlation coefficients [ICCs] assessed the effect of application of these conventions on the reliability of the CDEIS, SES-CD, and a Global Evaluation of Lesion Severity [GELS] score. RESULTS Following training on scoring conventions, inter-rater ICCs (95% confidence interval [CI]) for the total SES-CD score increased from 0.78 [0.71, 0.85] to 0.85 [0.79, 0.89]. The ICCs for the total CDEIS and GELS scores were not affected: corresponding inter-rater ICCs were 0.74 [0.65, 0.81] and 0.49, [0.38, 0.61] before and 0.73 [0.65, 0.81] and 0.53 [0.42, 0.64] following application of scoring conventions. Estimations of ulcer depth, surface area, anatomical location, and stenosis were important sources of variability. CONCLUSIONS Use of scoring conventions previously developed by expert central readers enhanced the reliability of the SES-CD but did not similarly affect the CDEIS or GELS. As the SES-CD is more likely to be reliable than the CDEIS and can be optimised with targeted training, it is the preferred instrument for use in clinical trials.