Nutrition and Physical Activity Clinical Practice Guidelines for Older Adults Living with Frailty.

BACKGROUND: We developed clinical practice guidelines to provide health care providers with evidence-based recommendations for decisions related to the effective management of frailty and pre-frailty using nutrition and physical activity interventions. METHODS: We based the recommendations on two systematic reviews with meta-analyses. Nutrition, physical activity, and combined nutrition and physical activity interventions for adults ≥65y were considered if study populations were identified as frail using a frailty tool or assessment. Risk of bias and certainty of evidence were evaluated. We included physical outcomes, mobility, frailty, cognitive function, activities of daily living, falls, quality of life, diet quality, energy/fatigue levels, health services use, and caregiver outcomes. RESULTS: Overall, mobility improvements were moderate with nutritional strategies that optimize dietary intake, various types of physical activity interventions, and interventions that combine nutrition and physical activity. Physical outcomes, such as body mass and muscle strength, improved moderately with nutritional strategies and interventions that combined nutrition with physical activity. Frailty status improved with multi-component physical activity interventions. Strong recommendations include optimizing dietary intake, performing physical activity, and adopting interventions that combine nutrition and physical activity. We strongly recommend various types of physical activity including muscle strengthening activities, mobilization or rehabilitation exercises, and multi-component physical activity interventions. INTERPRETATION: Tailored nutrition and physical activity interventions based on individual goals and health status are associated with improved clinical and physical outcomes. While the recommendations facilitate shared decision-making, we identified sparse application of validated frailty assessments and lack of standardized research outcomes as critical gaps in knowledge.

Malnutrition modifies the response to multimodal prehabilitation: a pooled analysis of prehabilitation trials.

Patients with colorectal cancer are at risk of malnutrition before surgery. Multimodal prehabilitation (nutrition, exercise, stress reduction) readies patients physically and mentally for their operation. However, it is unclear whether extent of malnutrition influences prehabilitation outcomes. We conducted a pooled analysis from five 4-week multimodal prehabilitation trials in colorectal cancer surgery (prehabilitation: n = 195; control: n = 71). Each patient's nutritional status was evaluated at baseline using the Patient-Generated Subjective Global Assessment (PG-SGA; higher score, greater need for treatment of malnutrition). Functional walking capacity was measured with the 6-minute walk test distance (6MWD) at baseline and before surgery. A multivariable mixed effects logistic regression model evaluated the potential modifying effect of PG-SGA on a clinically meaningful change of ≥19 m in 6MWD before surgery. Multimodal prehabilitation increased the odds by 3.4 times that colorectal cancer patients improved their 6MWD before surgery as compared with control (95% confidence interval (CI): 1.6 to 7.3; P = 0.001, n = 220). Nutritional status significantly modified this outcome (P = 0.007): Neither those patients with PG-SGA ≥9 (adjusted odds ratio: 1.3; 95% CI: 0.23 to 7.2, P = 0.771, n = 39) nor PG-SGA <4 (adjusted odds ratio: 1.3; 95% CI: 0.5 to 3.8, P = 0.574, n = 87) improved in 6MWD with prehabilitation. In conclusion, baseline nutritional status modifies prehabilitation effectiveness before colorectal cancer surgery. Patients with a PG-SGA score 4-8 appear to benefit most (physically) from 4 weeks of multimodal prehabilitation. Novelty: Nutritional status is an effect modifier of prehabilitation physical function outcomes. Patients with a PG-SGA score 4-8 benefited physically from 4 weeks of multimodal prehabilitation.

GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community.

RATIONALE: This initiative is focused on building a global consensus around core diagnostic criteria for malnutrition in adults in clinical settings. METHODS: In January 2016, the Global Leadership Initiative on Malnutrition (GLIM) was convened by several of the major global clinical nutrition societies. GLIM appointed a core leadership committee and a supporting working group with representatives bringing additional global diversity and expertise. Empirical consensus was reached through a series of face-to-face meetings, telephone conferences, and e-mail communications. RESULTS: A two-step approach for the malnutrition diagnosis was selected, i.e., first screening to identify "at risk" status by the use of any validated screening tool, and second, assessment for diagnosis and grading the severity of malnutrition. The malnutrition criteria for consideration were retrieved from existing approaches for screening and assessment. Potential criteria were subjected to a ballot among the GLIM core and supporting working group members. The top five ranked criteria included three phenotypic criteria (weight loss, low body mass index, and reduced muscle mass) and two etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). To diagnose malnutrition at least one phenotypic criterion and one etiologic criterion should be present. Phenotypic metrics for grading severity as Stage 1 (moderate) and Stage 2 (severe) malnutrition are proposed. It is recommended that the etiologic criteria be used to guide intervention and anticipated outcomes. The recommended approach supports classification of malnutrition into four etiology-related diagnosis categories. CONCLUSION: A consensus scheme for diagnosing malnutrition in adults in clinical settings on a global scale is proposed. Next steps are to secure further collaboration and endorsements from leading nutrition professional societies, to identify overlaps with syndromes like cachexia and sarcopenia, and to promote dissemination, validation studies, and feedback. The diagnostic construct should be re-considered every 3-5 years.

GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community.

RATIONALE: This initiative is focused on building a global consensus around core diagnostic criteria for malnutrition in adults in clinical settings. METHODS: In January 2016, the Global Leadership Initiative on Malnutrition (GLIM) was convened by several of the major global clinical nutrition societies. GLIM appointed a core leadership committee and a supporting working group with representatives bringing additional global diversity and expertise. Empirical consensus was reached through a series of face-to-face meetings, telephone conferences, and e-mail communications. RESULTS: A two-step approach for the malnutrition diagnosis was selected, i.e., first screening to identify "at risk" status by the use of any validated screening tool, and second, assessment for diagnosis and grading the severity of malnutrition. The malnutrition criteria for consideration were retrieved from existing approaches for screening and assessment. Potential criteria were subjected to a ballot among the GLIM core and supporting working group members. The top five ranked criteria included three phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and two etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). To diagnose malnutrition at least one phenotypic criterion and one etiologic criterion should be present. Phenotypic metrics for grading severity as Stage 1 (moderate) and Stage 2 (severe) malnutrition are proposed. It is recommended that the etiologic criteria be used to guide intervention and anticipated outcomes. The recommended approach supports classification of malnutrition into four etiology-related diagnosis categories. CONCLUSION: A consensus scheme for diagnosing malnutrition in adults in clinical settings on a global scale is proposed. Next steps are to secure further collaboration and endorsements from leading nutrition professional societies, to identify overlaps with syndromes like cachexia and sarcopenia, and to promote dissemination, validation studies, and feedback. The diagnostic construct should be re-considered every 3-5 years.

Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: System-wide implementation and audit leads to improved value and patient outcomes.

OBJECTIVE: Enhanced recovery pathways have been shown to reduce length of stay without increasing readmission or complications in numerous areas of surgery. Uptake of gynecologic oncology ERAS guidelines has been limited. We describe the effect of ERAS guideline implementation in gynecologic oncology on length of stay, patient outcomes, and economic impact for a province-wide single-payer system. METHODS: We compared pre- and post-guideline implementation outcomes in consecutive staging and debulking patients at two centers that provide the majority of surgical gynecologic oncology care in Alberta, Canada between March 2016 and April 2017. Clinical outcomes and compliance were obtained using the ERAS Interactive Audit System. Patients were followed until 30 days after discharge. Negative binomial regression was employed to adjust for patient characteristics. RESULTS: We assessed 152 pre-ERAS and 367 post-ERAS implementation patients. Mean compliance with ERAS care elements increased from 56% to 77.0% after implementation (p < 0.0001). Median length of stay for all surgeries decreased from 4.0 days to 3.0 days post-ERAS (p < 0.0001), which translated to an adjusted LOS decrease of 31.4% (95% CI = [21.7% - 39.9%], p < 0.0001). In medium/high complexity surgery median LOS was reduced by 2.0 days (p = 0.0005). Complications prior to discharge decreased from 53.3% to 36.2% post-ERAS (p = 0.0003). There was no significant difference in readmission (p = 0.6159), complications up to 30 days (p = 0.6274), or mortality (p = 0.3618) between the cohorts. The net cost savings per patient was $956 (95%CI: $162 to $1636). CONCLUSIONS: Systematic implementation of ERAS gynecologic oncology guidelines across a healthcare system improves patient outcomes and saves resources.

Patient-reported dietetic care post hospital for free-living patients: a Canadian Malnutrition Task Force Study.

BACKGROUND: Transitions out of hospital can influence recovery. Ideally, malnourished patients should be followed by someone with nutrition expertise, specifically a dietitian, post discharge from hospital. Predictors of dietetic care post discharge are currently unknown. The present study aimed to determine the patient factors independently associated with 30-days post hospital discharge dietetic care for free-living patients who transitioned to the community. METHODOLOGY: Nine hundred and twenty-two medical or surgical adult patients were recruited in 16 acute care hospitals in eight Canadian provinces on admission. Eligible patients could speak English or French, provide their written consent, were anticipated to have a hospital stay of ≥2 days and were not considered palliative. Telephone interviews were completed with 747 (81%) participants using a standardised questionnaire to determine whether dietetic care occurred post discharge; 544 patients discharged to the community were included in the multivariate analyses, excluding those who were admitted to nursing homes or rehabilitation facilities. Covariates during and post hospitalisation were collected prospectively and used in logistic regression analyses to determine independent patient-level predictors. RESULTS: Dietetic care post discharge was reported by 61/544 (11%) of participants and was associated with severe malnutrition [Subjective Global Assessment category C: odd's ratio (OR) 2.43 (1.23-4.83)], weight loss post discharge [(OR 2.86 (1.45-5.62)], comorbidity [(OR 1.09 (1.02-1.17)] and a dietitian consultation on admission [(OR 3.41 (1.95-5.97)]. CONCLUSIONS: Dietetic care post discharge occurs in few patients, despite the known high prevalence of malnutrition on admission and discharge. Dietetic care in hospital was the most influential predictor of post-hospital care.

Prevalence and predictors of weight change post discharge from hospital: a study of the Canadian Malnutrition Task Force.

BACKGROUND/OBJECTIVES: Little is known about factors associated with weight change post discharge from hospital; yet poor nutritional status in the transition from hospital to community can result in readmission. This exploratory study aimed to determine the factors associated with weight change 30 days post discharge defined as weight gain (WG; 5+ pounds), weight loss (WL; 5+pounds) or weight stable (WS). SUBJECTS/METHODS: A total of 922 medical or surgical patients were recruited from 16 acute care hospitals in 8 Canadian provinces. Telephone interviews were completed with 747 (81%) participants 30 days post discharge using a standardized questionnaire that included: self-reported weight change, assessment of appetite, usage of healthcare services and supports for food-related activities of daily living. Covariates collected during hospitalization, including nutritional status at discharge evaluated by subjective global assessment (SGA), were used in logistic regressions. RESULTS: Among the 747 patients, 26% reported WL, 16.7% had WG and 57.2% were WS. Those with WG were: younger (odds ratio (OR) 0.77 (0.69, 0.85)), male (OR 1.71 (1.12, 2.61)), malnourished at discharge (SGA B OR 2.13 (1.36, 3.33), SGA C OR 2.76 (1.19, 6.62)), and had a good appetite based on the low OR for fair/poor appetite (OR 0.28 (0.11, 0.66)). WL was associated with being on a special diet (OR 1.45 (1.07,1.96)) and reporting fair/poor appetite (OR 2.67 (1.76, 4.07)). CONCLUSIONS: Weight change was relatively common with WL predominating. Several variables were identified to be predictors of WL or weight gain, with appetite being common to both. Future work to further define and confirm these associations is warranted.

Cost impact analysis of Enhanced Recovery After Surgery program implementation in Alberta colon cancer patients.

BACKGROUND: The Enhanced Recovery After Surgery (eras) colorectal guideline has been implemented widely across Alberta. Our study examined the clinical and cost impacts of eras on colon cancer patients across the province. METHODS: We first used both summary statistics and multivariate regression methods to compare, before and after guideline implementation, clinical outcomes (length of stay, complications, readmissions) in consecutive elective colorectal patients 18 or more years of age and in colon cancer and non-cancer patients treated at the Peter Lougheed Centre and the Grey Nuns Hospital between February 2013 and December 2014. We then used the differences in clinical outcomes for colon cancer patients, together with the average cost per hospital day, to estimate cost impacts. RESULTS: The analysis considered 790 patients (398 cancer and 392 non-cancer patients). Mean guideline compliance increased to 60% in cancer patients and 57% in non-cancer patients after eras implementation from 37% overall before eras implementation. From pre- to post-eras, mean length of stay declined to 8.4 ± 5 days from 9.5 ± 7 days in cancer patients, and to 6.4 ± 4 days from 8.8 ± 5.5 days in non-cancer patients (p = 0.0012 and p = 0.0041 respectively). Complications declined significantly in the renal, hepatic, pancreatic, and gastrointestinal groups (difference in proportions: 13% in cancer patients; p < 0.05). No significant change in the risk of readmission was observed. The net cost savings attributable to eras implementation ranged from $1,096 to $2,771 per cancer patient and from $3,388 to $7,103 per non-cancer patient. CONCLUSIONS: Implementation of eras not only resulted in clinical outcome improvements, but also had a significant beneficial impact on scarce health system resources. The effect for cancer patients was different from that for non-cancer patients, representing an opportunity for further refinement and study.

Barriers to food intake in acute care hospitals: a report of the Canadian Malnutrition Task Force.

BACKGROUND: Poor food intake is common in acute care patients and can exacerbate or develop into malnutrition, influencing both recovery and outcome. Yet, research on barriers and how they can be alleviated is lacking. The present study aimed to (i) describe the prevalence of food intake barriers in diverse hospitals and (ii) determine whether patient, care or hospital characteristics are associated with the experience of these barriers. METHODS: Patients (n = 890; 87%) completed a validated questionnaire on barriers to food intake, including perceptions of food quality, just before their discharge from a medical or surgical unit in each of 18 hospitals across Canada. Scores were created for barrier domains. Associations between these barriers and selected patient characteristics collected at admission or throughout the hospital stay and site characteristics were determined using bivariate analyses. RESULTS: Common barriers were being interrupted at meals (41.8%), not being given food when a meal was missed (69.2%), not wanting ordered food (58%), loss of appetite (63.9%) and feeling too sick (42.7%) or tired (41.1%) to eat. Younger patients were more likely (P < 0.0001) to report being disturbed at meals (44.6%) than older patients (33.9%) and missing a meal for tests (39.0% versus 31.0%, P < 0.05). Patients who were malnourished, women, those with more comorbidity, and those who ate <50% of the meal reported several barriers across domains. CONCLUSIONS: The present study confirms that barriers to food intake are common in acute care hospitals. This analysis also identifies that specific patient subgroups are more likely to experience food intake barriers. Because self-reported low food intake in hospital was associated with several barriers, it is relevant to consider assessing, intervening and monitoring barriers to food intake during the hospital stay.

Validity and reliability of the new Canadian Nutrition Screening Tool in the 'real-world' hospital setting.

BACKGROUND/OBJECTIVES: Nutrition screening should be initiated on hospital admission by non-dietitians. This research aimed to validate and assess the reliability of the Canadian Nutrition Screening Tool (CNST) in the 'real-world' hospital setting. SUBJECTS/METHODS: Adult patients were admitted to surgical and medical wards only (no palliative patients). Study 1--Nutrition Care in Canadian Hospitals (n=1014): development of the CNST (3 items: weight loss, decrease food intake, body mass index (BMI)) and exploratory assessment of its criterion and predictive validity. Study 2--Inter-rater reliability and criterion validity assessment of the tool completed by untrained nursing personnel or diet technician (DT) (n=150). Subjective Global Assessment performed by site coordinators was used as a gold standard for comparison. RESULTS: Study 1: The CNST completed by site coordinators showed good sensitivity (91.7%) and specificity (74.8%). Study 2: In the subsample of untrained personnel (160 nurses; one DT), tool's reliability was excellent (Kappa=0.88), sensitivity was good (>90%) but specificity was low (47.8%). However, using a two-item ('yes' on both weight change and food intake) version of the tool improved the specificity (85.9%). BMI was thus removed to promote feasibility. The final two-item tool (study 1 sample) has a good predictive validity: length of stay (P<0.001), 30-day readmission (P=0.02; X(2) 5.92) and mortality (P<0.001). CONCLUSIONS: The simple and reliable CNST shows good sensitivity and specificity and significantly predicts adverse outcomes. Completion by several untrained nursing personnel confirms its utility in the nursing admission assessment.

The prognosis of incurable cachectic cancer patients on home parenteral nutrition: a multi-centre observational study with prospective follow-up of 414 patients.

BACKGROUND: The role of home parenteral nutrition (HPN) in incurable cachectic cancer patients unable to eat is extremely controversial. The aim of this study is to analyse which factors can influence the outcome. PATIENTS AND METHODS: We studied prospectively 414 incurable cachectic (sub)obstructed cancer patients receiving HPN and analysed the association between patient or clinical characteristics and surviving status. RESULTS: Median weight loss, versus pre-disease and last 6-month period, was 24% and 16%, respectively. Median body mass index was 19.5, median KPS was 60, median life expectancy was 3 months. Mean/median survival was 4.7/3.0 months; 50.0% and 22.9% of patients survived 3 and 6 months, respectively. At the multivariable analysis, the variables significantly associated with 3- and 6-month survival were Glasgow Prognostic Score (GPS) and KPS, and GPS, KPS and tumour spread, respectively. By the aggregation of the significant variables, it was possible to dissect several classes of patients with different survival probabilities. CONCLUSIONS: The outcome of cachectic incurable cancer patients on HPN is not homogeneous. It is possible to identify groups of patients with a ≥6-month survival (possibly longer than that allowed in starvation). The indications for HPN can be modulated on these clinical/biochemical indices.

Providing quality nutrition care in acute care hospitals: perspectives of nutrition care personnel.

BACKGROUND: Malnutrition is common in acute care hospitals worldwide and nutritional status can deteriorate during hospitalisation. The aim of the present qualitative study was to identify enablers and challenges and, specifically, the activities, processes and resources, from the perspective of nutrition care personnel, required to provide quality nutrition care. METHODS: Eight hospitals participating in the Nutrition Care in Canadian Hospitals study provided focus group data (n = 8 focus groups; 91 participants; dietitians, dietetic interns, diet technicians and menu clerks), which were analysed thematically. RESULTS: Five themes emerged from the data: (i) developing a nutrition culture, where nutrition practice is considered important to recovery of patients and teams work together to achieve nutrition goals; (ii) using effective tools, such as screening, evidence-based protocols, quality, timely and accurate patient information, and appropriate and quality food; (iii) creating effective systems to support delivery of care, such as communications, food production and delivery; (iv) being responsive to care needs, via flexible food systems, appropriate menus and meal supplements, up to date clinical care and including patient and family in the care processes; and (v) uniting the right person with the right task, by delineating roles, training staff, providing sufficient time to undertake these important tasks and holding staff accountable for their care. CONCLUSIONS: The findings of the present study are consistent with other work and provide guidance towards improving the nutrition culture in hospitals. Further empirical work on how to support successful implementation of nutrition care processes is needed.

Meta-analysis: oral or enteral nutritional supplementation in cirrhosis.

BACKGROUND: Malnutrition is a common and clinically significant problem in patients with cirrhosis. The impact of nutritional therapy remains unclear. AIM: To provide an up-to-date systematic review and meta-analysis of RCTs of oral or enteral nutritional supplementation (ONS or ENS) on nutritional and clinical outcomes in adult patients with cirrhosis. METHODS: The primary outcome measure was survival. Included: full-text English language RCTs investigating ONS or ENS vs. a standard nonsupplemented diet in patients with cirrhosis. Excluded: parenteral or branched chain amino acids intervention; treatment duration ≤7 days, exclusive evaluation of posttransplant, postsurgical or quality of life outcomes. RESULTS: Six trials (4 ONS/2 ENS) and 470 patients were included with 71% males and median age 53 years. When all studies were combined, there was no reduction in mortality [Relative risk (RR): 0.75 (0.42, 1.32), P = 0.31]. Subgroup analysis of 3 of the 4 ONS studies did demonstrate a mortality reduction [RR: 0.40 (0.18, 0.90), P = 0.03]. Of the 2 ENS studies, one included the sickest patients in the meta-analysis (82% Child Pugh C) and the other had the shortest mean intervention duration (8.6 days), possibly impacting the potential for benefit. Study quality was suboptimal (median Jadad = 2). CONCLUSIONS: Although there is insufficient evidence to definitively state that oro-enteral nutritional supplementation impacts clinical outcomes, on the basis of this analysis, one can be cautiously optimistic that there is the potential for benefit without an increase in adverse events. Adequately powered, Child Pugh stratified studies of at least 1 month in duration are needed to clarify the impact on relevant clinical outcomes.

Prescription of trace elements in adults on home parenteral nutrition: current practice based on the Canadian Home Parenteral Nutrition Registry.

BACKGROUND: Since the introduction of long-term parenteral nutrition (PN), morbidity due to inadequate replacement or toxicity of routinely administered trace elements has been well described. After decades of experience, much debate still exists about optimal supplementation. In practice, trace elements (TEs) seem to be frequently provided by prescribing an all-inclusive commercial multi-TE admixture with little dosage flexibility. AIM: Our goal was to review TE supplementation practice among 5 PN support centers across Canada, through a retrospective review of the Canadian Home PN Registry. METHODS: Baseline demographic, clinical, and biochemical parameters along with information regarding the PN prescription of 135 patients with complete records were retrieved from the registry database collected between 2005 and 2007. TE supplementation prescriptions were compared with recent guidelines as well as between groups of patients with different PN indications and dietary intake status. Consent was signed by all participating patients. RESULTS: The average daily PN concentrations of TE were as follows: zinc, 8.6 ± 5.5 mg (130.92 ± 84.23 µmol); manganese, 452 ± 184 µg (8.22 ± 3.34 µmol); selenium, 78 ± 45 µg (0.99 ± 0.57 µmol); chromium, 11 ± 5 µg (0.21 ± 0.10 µmol); copper, 0.64 ± 0.35 mg (10.11 ± 5.58 µmol); and iodine, 77 ± 42 µg (0.61 ± 0.33 µmol). The mean daily supplementation of zinc, manganese, copper, and selenium exceeded published recommendations. Patients' underlying anatomy or indication for PN did not significantly influence decisions regarding replacement standards. CONCLUSION: Parenteral TE supplementation in Canadian PN programs needs to be reviewed and adjusted according to most current guidelines. This may require a reevaluation of the commercial TE preparations currently available in Canada and potential new products worldwide to avoid oversupplementation and potential toxicity.

Canadian home parenteral nutrition (HPN) registry: validation and patient outcomes.

BACKGROUND: In Canada, there are an estimated 400 home parenteral nutrition (HPN) patients. In 2006, a registry was created to gather patient outcome information. The aim of this study was to validate the registry and report on HPN patient outcomes. METHODS: Several demographic, clinical parameters were collected. For the validation, paired t test and intraclass correlation coefficient (ICC) were used to assess agreement between repeat entries. For the outcome report, paired t test was used to assess changes, and survival analysis was performed using the Kaplan-Meier method. Results are expressed as mean ± SEM. RESULTS: On validation, there was high correlation/agreement (P < .05) for most parameters except vascular access/line sepsis, liver disease (ultrasound, biopsy, diagnoses), and hospitalizations. For the outcome report, 96 patients had their data entered at 2.24 ± 0.11 years after baseline. Over the period, there was a significant reduction in PN calories (P = .001) and proteins (P < .001). There were no significant changes in nutrition parameters and laboratory results except for lower platelet counts (P = .028), lower plasma potassium (P = .030), and a trend toward an increase in bilirubin from 19.29 ± 4.65 to 29.06 ± 8.73 µmol/L (P = .071). The QOL decreased significantly over time (P < .001) and the survival on HPN was 17.67 ± 1.89 years. CONCLUSIONS: The registry is a valid tool to assess several clinical parameters. On follow-up, HPN patients maintain good nutrition status while PN is reduced but do have a reduced quality of life.

Maintenance of clinical benefit in Crohn's disease patients after discontinuation of infliximab: long-term follow-up of a single centre cohort.

BACKGROUND: Tumour necrosis factor-blockade with infliximab has advanced the treatment of Crohn's disease. While infliximab is efficacious, it remains to be determined whether patients who enter clinical remission with an anti-tumour necrosis factor therapy can have their treatment stopped and retain the state of remission. AIM: To assess in patients with Crohn's disease who obtained infliximab-induced remission, the proportion who relapsed after infliximab discontinuation. METHODS: This longitudinal cohort study examined patients from a University-based IBD referral centre. Forty eight patients with Crohn's disease in full clinical remission and who then discontinued infliximab were followed up for up to 7 years. Crohn's disease relapse was defined as an intervention with Crohn's disease medication or surgery. RESULTS: Kaplan-Meier analysis of the proportion of patients with sustained clinical benefit demonstrated that 50% relapsed within 477 days after infliximab discontinuance. In contrast, 35% of patients remained well, and without clinical relapse, up to the end of the nearly 7-year follow-up. CONCLUSIONS: In patients with Crohn's disease with an infliximab-induced remission, stopping infliximab results in a predictable relapse in a majority of patients. Nevertheless, a small percentage of patients sustain a long-term remission.

Trace element contamination of total parenteral nutrition. 2. Effect of storage duration and temperature.

BACKGROUND: Patients who receive home total parenteral nutrition (TPN) frequently are supplied with solutions up to 30 days in advance of anticipated use. The purpose of this study was to determine the stability of trace elements relative to time and temperature conditions, in a typical adult TPN solution stored in a usual home environment by examining variations in delivery of intended trace elements and inadvertent trace element contamination. METHODS: Trace element concentrations were determined using inductively coupled plasma-mass spectrometry technology. The effect of the delivery apparatus, storage duration (36 hours or 30 days) after compounding, and storage temperature (4 degrees C or 20 degrees C) were examined. RESULTS: The delivery apparatus contaminated the delivered TPN solution with cobalt but did not alter trace elements formulated into the TPN solution. Storage duration and temperature significantly decreased three (Zn, Cu, and Mn) of the six trace elements formulated into the TPN solution. Higher temperatures and longer duration of storage accelerated this decrease. Boron, Al, V, Ti, Ba, Sr, and CO were the trace elements that appeared as contaminants during storage. Boron, Al, V, and Ti contamination decreased with higher temperatures and longer duration of storage. CONCLUSIONS: Longer storage duration and higher storage temperature progressively reduced the deliverable concentrations of trace elements specifically formulated into the TPN solution and also of those trace elements that were not formulated into the TPN solution but that appeared as contaminants.

Trace element contamination of total parenteral nutrition. 1. Contribution of component solutions.

BACKGROUND: Trace elements have been shown to contaminate total parenteral nutrition (TPN) solutions. METHODS: This study used the multi-elemental technology of inductively coupled plasma-mass spectrometry to demonstrate the extent to which trace elements were present in amounts above (ie, as contaminants) or below expected levels in eight TPN component solutions. RESULTS: Of the 66 trace elements scanned, there were 12 trace element contaminants in amounts >1 microg/L (zinc, copper, manganese, chromium, selenium, boron, aluminum, titanium, barium, vanadium, arsenic, and strontium) in the eight component solutions studied. Trace element contaminants were present in all solutions, and different trace elements contaminated the solutions at various concentrations. Component solutions of amino acid, potassium chloride, calcium gluconate, and sodium chloride contained the greatest numbers of trace element contaminants, whereas the lowest numbers were present in sterile water and magnesium sulfate. Interlot and intermanufacturer variations were apparent. Measured concentrations of trace elements in the multi-trace element additive solution also were higher than the labeled values. A comparison of the amounts of contaminated trace elements delivered by a typical TPN mixture relative to the amounts typically absorbed by the gastrointestinal tract indicates that the inadvertent delivery of trace elements from contaminated TPN solutions may be substantial. CONCLUSIONS: All eight components tested were contaminated with trace elements not intended to be present in the product, and similarly, the multi-trace element component contained trace elements either above or below that which the label claimed.