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Subcutaneous fat necrosis in newborns: a systematic literature review of case reports and model of pathophysiology.
Frank, L, Brandt, S, Wabitsch, M
Molecular and cellular pediatrics. 2022;(1):18
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Abstract
BACKGROUND Subcutaneous fat necrosis of the newborn (SCFN) is a rare disease occurring in the first days of life. Characteristically, the infants show hard nodules in subcutaneous tissue, purple or erythematous in color and appear on the upper back, cheeks, buttocks and limbs. In most cases, SCFN is a self-limiting disease, as the nodules disappear in up to 6 months. A severe complication associated with SCFN is hypercalcaemia. Pathophysiological mechanisms causing SCFN or associated hypercalcaemia are not fully understood yet. METHODS A systematic literature research including the six biggest databases for medical research has been used to identify all published case reports of SCFN. N = 206 publications has been identified containing n = 320 case reports. All cases have been classified into four subgroups (depending on reported serum-calcium-level): hypercalcaemia, normocalcaemia, hypocalcaemia or no information given. Reported maternal factors, birth characteristics, details about SCFN, diagnostics, therapy and long-term observations have been extracted from publications. RESULTS This is the first systematic literature research that summed up all published cases of SCFN from 1948 up to 2018. Information about serum calcium level was given in 64.3% of the cases. From those, the majority showed hypercalcaemia (70.5%) (normocalcaemia 25.1%, hypocalcemia 4.3%). 89.3% of newborns with hypercalcaemia showed suppressed levels of the parathormone. Maternal gestational diabetes, maternal hypertensive diseases during pregnancy, macrosomia (> 4000g), asphyxia and therapeutic hypothermia are risk factors for SCFN. Histological findings showed a granulomatous inflammation in 98% of cases. CONCLUSION We identified that maternal, birth characteristics and therapeutic measures are probably risk factors for SCFN. These risk factors should be taken into account within the care of neonates.
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Systematic review with meta-analysis: dietary intake in adults with inflammatory bowel disease.
Lambert, K, Pappas, D, Miglioretto, C, Javadpour, A, Reveley, H, Frank, L, Grimm, MC, Samocha-Bonet, D, Hold, GL
Alimentary pharmacology & therapeutics. 2021;(6):742-754
Abstract
BACKGROUND Poor dietary intake is associated with the development of malnutrition, micronutrient deficiencies, anaemia and osteoporosis in individuals with inflammatory bowel disease. While trials are underway to manipulate the diet of people with IBD, there has been no comprehensive systematic review of the dietary intake of adults with IBD. AIMS To conduct a systematic evaluation and meta-analysis of the dietary intake of adults with IBD, including macronutrients, micronutrients and food group data. METHODS CINAHL, Embase, Medline and Scopus were searched from 1 January 2000 to 25 September 2020 for cohort, case-control or cross-sectional studies that reported usual dietary intake in adults. Data were pooled and reported as weighted mean intake for: all adults with IBD; Crohn's disease; ulcerative colitis; active disease; remission; males; females. A random-effects meta-analysis model compared intake with healthy individuals. RESULTS Forty studies were identified and 19 were included in the meta-analysis. All subgroups of adults with IBD consumed inadequate energy (mean intake in adults with IBD 1980 ± 130 kcal), fibre (14 ± 4 g), folate (246 ± 33 mg) and calcium (529 ± 114 mg) per day. Intake of breads and cereals, legumes, fruit, vegetables and dairy were inadequate. Compared to healthy individuals, adults with IBD consume significantly less dietary fibre (SMD -0.59; 95% CI: -0.73, -0.46). CONCLUSIONS This review provides improved clarity about the dietary intake of adults with IBD. Future attention is required to improve diet quality and increase understanding of factors influencing dietary intake in IBD.
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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.
Calvert, M, Kyte, D, Mercieca-Bebber, R, Slade, A, Chan, AW, King, MT, Hunn, A, Bottomley, A, Regnault, A, Chan, AW, et al
JAMA. 2018;319(5):483-494
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Plain language summary
Clinical trial protocols are essential documents that describe the study design and conduct. The importance of patient-reported outcomes (PRO) has been recognized by major international health policy and regulatory authorities and patients. The aim of this study was to develop an evidence-based extension of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement, identifying additional PRO items recommended for inclusion in clinical trial protocols (extensions), and to elaborate on the existing SPIRIT 2013 statement specifically as applied to PROs (elaborations). The study is a systematic review of existing PRO-specific protocol guidance. It also included a stake holder survey of a group of international experts, and a Delphi exercise and consensus meeting, followed by consultation on the final SPIRIT-PRO Extension. The final SPIRIT-PRO Extension recommends that, in conjunction with existing SPIRIT 2013 items, 16 items (11 extensions and 5 elaborations) should be routinely addressed in all clinical trial protocols in which PROs are a primary or key secondary outcome. Authors conclude that improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centred care.
Abstract
Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective: To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants: The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results: The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance: The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
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American Society for Metabolic and Bariatric Surgery Integrated Health Nutritional Guidelines for the Surgical Weight Loss Patient 2016 Update: Micronutrients.
Parrott, J, Frank, L, Rabena, R, Craggs-Dino, L, Isom, KA, Greiman, L
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2017;13(5):727-741
Abstract
BACKGROUND Optimizing postoperative patient outcomes and nutritional status begins preoperatively. Patients should be educated before and after weight loss surgery (WLS) on the expected nutrient deficiencies associated with alterations in physiology. Although surgery can exacerbate preexisting nutrient deficiencies, preoperative screening for vitamin deficiencies has not been the norm in the majority of WLS practices. Screening is important because it is common for patients who present for WLS to have at least 1 vitamin or mineral deficiency preoperatively. OBJECTIVES The focus of this paper is to update the 2008 American Society for Metabolic and Bariatric Surgery Nutrition in Bariatric Surgery Guidelines with key micronutrient research in laparoscopic adjustable gastric banding, Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, biliopancreatic diversion, and biliopancreatic diversion/duodenal switch. METHODS Four questions regarding recommendations for preoperative and postoperative screening of nutrient deficiencies, preventative supplementation, and repletion of nutrient deficiencies in pre-WLS patients have been applied to specific micronutrients (vitamins B1 and B12; folate; iron; vitamins A, E, and K; calcium; vitamin D; copper; and zinc). RESULTS Out of the 554 articles identified as meeting preliminary search criteria, 402 were reviewed in detail. There are 92 recommendations in this update, 79 new recommendations and an additional 13 that have not changed since 2008. Each recommendation has a corresponding graded level of evidence, from grade A through D. CONCLUSIONS Data continue to suggest that the prevalence of micronutrient deficiencies is increasing, while monitoring of patients at follow-up is decreasing. This document should be viewed as a guideline for a reasonable approach to patient nutritional care based on the most recent research, scientific evidence, resources, and information available. It is the responsibility of the registered dietitian nutritionist and WLS program to determine individual variations as they relate to patient nutritional care.
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Carnitine supplementation improves cardiac strain rate in children on chronic hemodialysis.
Sgambat, K, Frank, L, Ellini, A, Sable, C, Moudgil, A
Pediatric nephrology (Berlin, Germany). 2012;(8):1381-7
Abstract
BACKGROUND Carnitine plays a key role in energy production in the myocardium. Carnitine deficiency commonly occurs in patients on chronic hemodialysis (HD) and may contribute to cardiomyopathy. METHODS Carnitine levels and cardiac function of nine children on HD were assessed before and after 6 months of intravenous levocarnitine supplementation. Standard echocardiographic (ECHO) measures of left ventricular (LV) function as well as strain and strain rate analysis using novel speckle-tracking echocardiography were performed and the results compared to those of a control group of children on chronic HD. RESULTS Following carnitine supplementation, total (49.0 ± 1.67 vs. 298.0 ± 31.8 μmol/L) and free carnitine (29.0 ± 1.20 vs. 180.4 ± 19.2 μmol/L) increased (p < 0.0001), and the acyl:free (A:F) carnitine ratio improved (0.73 ± 0.04 vs. 0.65 ± 0.05; p = 0.02). There were no changes in standard ECHO measures of LV function, including end diastolic dimension, mass index, ejection fraction, and fractional shortening. There was significant (p = 0.017) improvement in the longitudinal strain rate (-1.48 ± 0.11 vs -1.91 ± 0.12) after carnitine supplementation in the study group. No improvements in LV function, strain, or strain rate occurred in controls. CONCLUSIONS Levocarnitine supplementation improved carnitine levels, the A:F ratio, and longitudinal strain rate in children on HD.