PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial

Background Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. Methods A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. Discussion The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. Trial registration ClinicalTrials.govNCT04678752. Registered on December 21, 2020.

P-P17 Casting a Wider NET: Defining PEI in patients with Neuroendocrine Tumours using the 13C-MTG breath test

Background Somatostatin-analogues (SSAs) are the first-line treatment of unresectable, symptomatic neuroendocrine tumours (NETs). However, SSAs inhibit pancreatic secretions which could lead to pancreatic exocrine insufficiency (PEI). There is, however, very limited data regarding the physiologic link between SSAs and PEI. PEI negatively impacts patient quality of life (QoL), nutritional status, and clinical outcomes. This is a prospective, observational, cohort study to establish the impact of SSAs on pancreatic exocrine function in patients with NETs, using the 13C-Mixed-Triglyceride (13C-MTG) breath test. Methods Adult patients commencing SSA therapy for NETs, were recruited from December 2020. Patients were excluded if they had a diagnosis of other pancreatic disease, history of upper-gastrointestinal surgery that may alter pancreatic function, or already on SSA therapy. The impact of SSAs on exocrine function was assessed using the 13C-MTG breath test. A quotient of 13CO2/12CO2 was measured by mass spectrometry and the cumulative percent dose recovered at 6 hours (cPDR) is reported. Secondary endpoints investigated were changes in patient weight and Vitamin D levels. Results Exocrine function reduced in all patients (n = 7) following SSA therapy (median reduction from baseline: -22.2%, range: -5.6- -42.1%; p = 0.018) (Figure 1). Vitamin D levels decreased in all but one patient (median decrease from baseline: -11.7%, range: -29.3-10%; p = 0.126). Change in patient weight did not show any significant change (median decrease from baseline: -0.69%, range: -4.26 – 3.6%, p = 0.933). Conclusions SSA therapy appears to have a consistent impact on exocrine function from early in the treatment course. This suggests that there is a widespread underestimation of PEI in this setting. Whether such decrease in exocrine function leads to weight loss remains to be seen. Further studies are required to confirm this work, determine the clinical relevance of this observation, and optimise medical therapy of PEI in this cohort. The 13C-MTG breath test is a feasible and acceptable measure of pancreatic exocrine function in patients treated with SSA therapy for NETs.

Size Matters: The Influence of Patient Size on Antibiotics Exposure Profiles in Critically Ill Patients on Continuous Renal Replacement Therapy

(1) Purpose of this study: To determine whether patient weight influences the probability of target attainment (PTA) over 72 h of initial therapy with beta-lactam (cefepime, ceftazidime, piperacillin/tazobactam) and carbapenem (imipenem, ertapenem, meropenem) antibiotics in the critical care setting. This is the first paper to address the question of whether patient size affects antibiotic PTA in the ICU. (2) Methods: We performed a post hoc analysis of Monte Carlo simulations conducted in virtual critically ill patients receiving antibiotics and continuous renal replacement therapy. The PTA was calculated for each antibiotic on the following pharmacodynamic (PD) targets: (a) were above the target organism’s minimum inhibitory concentration (≥%fT≥1×MIC), (b) were above four times the MIC (≥%fT≥4×MIC), and (c) were always above the MIC (≥100%fT≥MIC) for the first 72 h of antibiotic therapy. The PTA was analyzed in patient weight quartiles [Q1 (lightest)-Q4 (heaviest)]. Optimal doses were defined as the lowest dose achieving ≥90% PTA. (3) Results: The PTA for fT≥1×MIC led to similarly high rates regardless of weight quartiles. Yet, patient weight influenced the PTA for higher PD targets (100%fT≥MIC and fT≥4×MIC) with commonly used beta-lactams and carbapenems. Reaching the optimal PTA was more difficult with a PD target of 100%fT≥MIC compared to fT≥4×MIC. (4) Conclusions: The Monte Carlo simulations showed patients in lower weight quartiles tended to achieve higher antibiotic pharmacodynamic target attainment compared to heavier patients.

The effect of patient weight and amiodarone use on the energy of a successful shock in cardioversion of atrial arrhythmias – single-center experience study

Background Electrical cardioversion (DCCV) is an effective method of sinus rhythm restitution. Recently published data suggest higher efficiencies of higher discharge energies. The influence of individual parameters on the success of cardioversion is still studying. Purpose To evaluate the influence of individual patient parameters on the energy of a successful external defibrillator shock during cardioversion of atrial arrhythmias Methods The retrospective analysis cohort of all patients treated by DCCV due to atrial arrhythmias between 10/2015 and 1/2020. To evaluate potential predictors for the choice of a higher initial discharge using one-dimensional logistic regression and to include parameters significant at the 10% level of significance (p<0.1) in the multidimensional logistic regression model. Results 1986 electrical cardioversions of 984 patients (382 repeated procedures of the same patients in a cohort). 1292 (65.1%) men and 694 (34.9%) women aged 67.0 (±10.2) years. Mean energy of the first shock 118.9 (±19.2) J with a success rate of 77.8%, energy of the second shock 154.0 (±26.3) J, which increased the overall success to 80.0%, and mean high of the third shock 173.9 (±25.6) J, when the total efficacy of DCCV in sinus rhytm restitution reached 89.8%. From the univariate binary regression, parameters significant at the 10% level of significance (p<0.1) were selected and included in a multidimensional logistic regression model. Only the patient's weight and the use of amiodarone proved to be statistically significant. Weight with OR 1.21 and use of amiodarone with OR 1.43. Conclusion Patient weight and amiodarone use are predictors of the need to use higher energy electric cardioversion. Discussion Amiodarone medication does not appear to increase the defibrillation threshold, but rather is a feature that represents the group of patients treated with more aggressive antiarrhythmic therapy for advanced atrial arrhythmias with more significant structural impairment, but this attitude requires further study. FUNDunding Acknowledgement Type of funding sources: Private hospital(s). Main funding source(s): VAVIA: IGS202009 - Racionální algoritmus při elektivní elektrické kardioverzi fibrilace síní.

Clinical Uses and Short-Term Safety Profile of Ethiodized Poppy Seed Oil Contrast Agent in the Diagnosis and Treatment of Vascular Anomalies and Tumors

Background: There is a sparsity of data on the use of ethiodized poppy seed oil (EPO) contrast agent (Lipiodol) in patients. We investigated the safety of EPO in children, adolescents, and some adults for diagnostic and therapeutic interventions. Methods: All patients who underwent procedures with EPO between 1995 and 2014 were retrospectively included. Demographic characteristics, diagnosis, dose, route of administration, preparation of EPO in combination with other agents, and complications were recorded. Results: In 1422 procedures, EPO was used for diagnostic or treatment purposes performed in 683 patients. The mean patient age was 13.4 years (range: 2 months–50 years); 58% of patients were female. Venous malformations (n = 402, 58.9%) and arteriovenous malformations (n = 60, 8.8%) were the most common diagnosis. Combined vascular anomalies included capillary–lymphatic–venous malformations, fibroadipose vascular anomalies (n = 54, 7.9%), central conducting lymphatic anomalies (n = 31, 4.5%), lymphatic malformations (n = 24, 3.5%), aneurysmal bone cysts (n = 22, 3.2%), and vascularized tumors (n = 11, 1.6%). In 1384 procedures (96%), EPO was used in various combinations with sclerosing and embolization agents, including sodium tetradecyl sulfate, ethanol, and glue. The mean volume of EPO used in interventions was 3.85 mL (range: 0.1–25 mL) per procedure with a mean patient weight of 45.9 kg (range: 3.7–122.6 kg) and a weight-adjusted dose of 0.12 mL/kg (range: 0.001–1.73 mL/kg). In 56 procedures (4%), EPO was used as a single agent for diagnostic lymphangiography. The mean volume was 4.8 mL (range: 0.3–13 mL) per procedure with a mean patient weight of 27.4 kg (range: 2.4–79.3 kg) and a weight-adjusted dose of 0.2 mL/kg (range: 0.04–0.54 mL/kg). Procedural-related complications occurred in 25 (1.8%) procedures. The 20 minor and 5 major complications were related to the primary treatment agents. None of them were directly related to EPO. No allergic reactions were noted. Conclusion: The use of an ethiodized poppy seed oil contrast agent in children, adolescents, and adults for diagnostic or therapeutic purposes is safe.

Use of laparocentesis in the treatment of ascites in patients with liver cirrhosis

Ascites occurs in about 60 % of patients with cirrhosis within 10 years of diagnosis. Laparocentesis is the preferred first-line therapy in patients with cirrhosis and massive tense ascites, allowing more than 5–6 liters of ascitic fluid to be removed at one time. The search for informative prognostic factors and the development of a method for predicting unfavorable outcomes of repeated laparocenteses in patients with ascites are relevant to timely refer this contingent of patients to perform TIPS.The purpose of the study was to develop and evaluate the diagnostic significance of a model for determining the probability of unfavorable outcomes of laparocentesis in patients with ascites on the background of liver cirrhosis.The results of treatment of 99 patients with the ascitic syndrome associated with intrahepatic portal hypertension were studied. The multiple regression analysis using the binary response logit model was carried out to calculate the prediction models. The analysis of the treatment results of patients with liver cirrhosis and ascites by the laparocentesis method revealed a number of factors that influence the onset of an unfavorable outcome. 2 models with the inclusion of initial variables are the most promising for forecasting. Model A includes: patient weight, serum-ascites total protein gradient, hyponatremia; model B: MELD-Na score, serum-ascitic total protein gradient, patient weight. The developed prediction method is highly informative, effective, easily applicable, and can be widely used in clinical practice.The ability to predict an unfavorable outcome in patients with portal hypertension and ascites after laparocentesis allows for a personalized approach in the process of timely selection of more effective, but also more expensive treatment methods, such as TIPS, which will help us to increase the therapy effectiveness and the survival of this cohort of patients.

Inadequacy of gestational weight gain during high-risk pregnancies is not associated with household food insecurity

Background Inadequate gestational weight gain (GWG) is associated with adverse outcomes in maternal and child health and can be enhanced by social inequalities, such as lower education and household food insecurity (HFI). Women are more vulnerable to HFI, which has been associated with negative health effects for pregnant women during the prenatal and puerperal periods, particularly in regard to the aggravation of pregnancy risks. This study investigated the association between sociodemographic characteristics and HFI with respect to adequacy of total GWG among women with high-risk pregnancies. Methods This was a prospective cohort study that evaluated the total GWG of 169 pregnant women. The women were seen at a public university hospital in the metropolitan region of Rio de Janeiro (Brazil). Their sociodemographic and gestational characteristics and the Brazilian Scale of Domestic Food Insecurity were investigated. To estimate the total GWG, the difference between the patient weight at the last prenatal visit and the initial patient weight was verified, with both collected from the medical records of the pregnant women. The classification of the total GWG considered the recommendations of the Institute of Medicine (IOM) (2009). A multinomial logistic regression model assessed the risk (odds ratio; OR) and confidence intervals (CI 95%)) of insufficient and excessive GWG with exposure to HFI and other covariates (p value <0.05). Results Insufficient and excessive GWG were observed in 27.8% and 47.9% of the pregnant women, respectively. More than half of the women (74.6%) had a high education level. Exposure to mild HFI occurred in 44.2% of the women. After adjustment, the HFI was not associated with insufficient or excessive GWG. The educational level of women was the only variable significantly associated with a lower risk of GWG insufficiency (OR: 0.10; 95% CI: 0.01–0.89). Conclusions In this population, higher maternal education was a protective factor against insufficient GWG. We highlight the importance of additional health support and counseling for women in the most vulnerable social conditions, considering the importance of access to information for reducing health risks.

Transaxillary Approach for Surgical Repair of Simple Congenital Cardiac Lesions: Pitfalls, and Complications

Background: In the treatment of simple congenital cardiac lesions, percutaneous and cosmetic surgical approaches have steadily gained prominence. Surgically, right vertical axillary approach is sparsely used despite superior cosmesis and less pain and blood product usage. Knowledge of potential pitfalls could lead to its more widespread acceptance. Methods: We retrospectively analyzed perioperative outcomes of 104 consecutive patients who underwent surgery by this technique between mid-2016 and December 2019, including ostium secundum (67), sinus venosus (34), coronary sinus (1), and ostium primum (1) atrial septal defects and hemianomalous pulmonary venous connection (1). Perioperative variables, surgical times, complications, and follow-up data were analyzed. Results: Patient weight ranged from 6.8 to 41 kg. Incision length ranged from 4 to 6 cm. There was no mortality. All cannulation was central. Difficulty in cannulation (inferior vena cava) was seen in two patients. Morbidity included pneumothorax in 2 (1.9%) patients and subcutaneous emphysema necessitating prolonged intercostal drain retention in 20 (19.2%) patients. Surgical time increased linearly (r = 0.567; P < .001) with increasing patient weight but cardiopulmonary bypass (CPB) time remained unaffected. No chest deformities or paresthesia were noted on follow-up. Scar size decreased in some patients. Conclusions: Right vertical axillary approach can be safely employed to treat simple congenital cardiac lesions with adequate awareness of potential pitfalls. Increasing patient weight increases the surgical time but does not affect CPB times. Incidence of pneumothorax and subcutaneous emphysema is similar to other thoracotomy approaches. It is cosmetically superior.