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Evaluation of the 'Sip Til Send' regimen before elective caesarean delivery using bedside gastric ultrasound: A paired cohort pragmatic study.
Harnett, C, Connors, J, Kelly, S, Tan, T, Howle, R
European journal of anaesthesiology. 2024;(2):129-135
Abstract
BACKGROUND Pre-operative fasting is routinely advocated to avoid pulmonary aspiration. The European Society of Anaesthesiology and Intensive Care (ESAIC) recommends a fasting period of 2 h for liquids before surgery. Liberal drinking policies such as the 'Sip Til Send' are a suggested alternative to maintain hydration before surgery. OBJECTIVES To compare residual gastric volumes in fully fasted nonlabouring parturients before elective caesarean delivery with the 'Sip Til Send' with water liberal drinking protocol. Our hypothesis was the 'Sip Til Send' would be noninferior to standard fasting at minimising the residual gastric volume immediately before surgery. DESIGN A paired cohort prospective observational pragmatic study using gastric ultrasound, analysed by an operator blinded to the fasting status of each scan. SETTING A tertiary maternity hospital in Dublin, Ireland. The study was conducted between January and June 2023. PARTICIPANTS Pregnant women about to undergo elective caesarean delivery who had followed ESAIC fasting guidelines before admission. INTERVENTIONS Each participant underwent two pairs (semi-recumbent and the semi-recumbent right lateral positions) of standardised ultrasound examinations of the gastric antrum: the order of these scans was randomised. The first pair of scans occurred on admission before the 'Sip Til Send' protocol commenced, the other pair just before spinal anaesthesia for caesarean delivery, after a variable time following the 'Sip Til Send' protocol. MAIN OUTCOME MEASURE The primary outcome was the difference in antral cross-sectional area (CSA) between the fully fasted women on admission and the same women after following the 'Sip Til Send' protocol until just before spinal anaesthesia. RESULTS Fifty-eight women were randomised for the study: 55 and 54 scans in the semi-recumbent position on admission, and 55 and 54 scans in the right lateral position just before spinal anaesthesia. The mean differences (95% CI) in CSA in the semi-recumbent and RL positions were 0.07 (-0.39 to 0.53) cm 2 and 0.04 (-0.60 to 0.68) cm 2 , respectively. Since the of 95% CIs did not cross the predefined noninferiority margin of 0.88 cm 2 , 'Sip Til Send' was noninferior to fully fasting in in terms of the antral CSA. CONCLUSION The 'Sip Til Send' protocol of liberal hydration with water was noninferior to standard fasting prior to elective caesarean delivery. TRIAL REGISTRY NUMBER NCT05783427 ClinicalTrials.gov.
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The British Columbia Farmers' Market Nutrition Coupon Program Reduces Short-Term Household Food Insecurity Among Adults With Low Incomes: A Pragmatic Randomized Controlled Trial.
Aktary, ML, Dunn, S, Sajobi, T, O'Hara, H, Leblanc, P, McCormack, GR, Caron-Roy, S, Lee, YY, Reimer, RA, Minaker, LM, et al
Journal of the Academy of Nutrition and Dietetics. 2024;(4):466-480.e16
Abstract
BACKGROUND The British Columbia Farmers' Market Nutrition Coupon Program (BC FMNCP) provides households with low incomes with coupons to purchase healthy foods from farmers' markets. OBJECTIVE To examine the impact of the BC FMNCP on the short-term household food insecurity, malnutrition risk, mental well-being, sense of community (secondary outcomes), and subjective social status (exploratory outcome) of adults with low incomes post-intervention and 16 weeks post-intervention. DESIGN Secondary analyses from a pragmatic randomized controlled trial conducted in 2019 that collected data at baseline, post-intervention, and 16 weeks post-intervention. PARTICIPANTS/SETTING Adults ≥18 years with low incomes were randomized to an FMNCP group (n = 143) or a no-intervention control group (n = 142). INTERVENTION Participants in the FMNCP group received 16 coupon sheets valued at $21 Canadian dollars (CAD)/sheet over 10 to 15 weeks to purchase healthy foods from farmers' markets and were eligible to participate in nutrition skill-building activities. MAIN OUTCOME MEASURES Outcomes included short-term household food insecurity (modified version of Health Canada's 18-item Household Food Security Survey Module), malnutrition risk (Malnutrition Universal Screening Tool), mental well-being (Warwick-Edinburgh Mental Well-Being Scale), sense of community (Brief Sense of Community Scale), and subjective social status (MacArthur Scale of Subjective Social Status community scale). STATISTICAL ANALYSIS Mixed-effects linear regression and multinomial logistic regression examined between-group differences in outcomes post-intervention and 16 weeks post-intervention. RESULTS The risk of marginal and severe short-term household food insecurity was lower among those in the FMNCP group compared with those in the control group (relative risk ratio [RRR] 0.15, P = 0.01 and RRR 0.16, P = 0.02) post-intervention, with sustained reductions in severe household food insecurity 16 weeks post-intervention (RRR 0.11, P = 0.01). No statistically significant differences were observed in malnutrition risk, mental well-being, sense of community, or subjective social status post-intervention or 16 weeks post-intervention. CONCLUSIONS The BC FMNCP reduced short-term household food insecurity but was not found to improve malnutrition risk or psychosocial well-being among adults with low incomes compared with a no-intervention control group.
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Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial.
Schmidt, C, Magalhães, S, Gois Basilio, P, Gouveia, M, Teixeira, M, Santos, C, Tavares, AI, Ferreira, JP, Ribeiro, F, Santos, M
Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology. 2024;(3):149-158
Abstract
INTRODUCTION The limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. OBJECTIVES To compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. METHODS This is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups' patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combination of endurance [(at 60%-80% of peak oxygen uptake (VO2peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4-5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO2peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses. RESULTS Patients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in Portugal comparing the traditional CR program with a home-based program in HF patients. Our study results will better inform healthcare professionals who care for HF patients regarding CR.
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Effects of a Comprehensive Dietary Intervention Program, Promoting Nutrition Literacy, Eating Behavior, Dietary Quality, and Gestational Weight Gain in Chinese Urban Women with Normal Body Mass Index during Pregnancy.
Li, Q, Piaseu, N, Phumonsakul, S, Thadakant, S
Nutrients. 2024;(2)
Abstract
In urban Chinese women with normal body weight during pregnancy, we implemented a comprehensive dietary intervention program aimed at enhancing nutrition literacy, dietary quality, and gestational weight gain. The methods included both online and offline health education on prenatal nutrition, weekly weight monitoring, family back education practices, and real-time dietary guidance. The intervention was delivered to randomly assigned control and intervention group participants from gestational week 12 to week 24. The intervention group (n = 44; 100% complete data) showed significant differences (mean (SD)) compared to the control group (n = 42; 95.5% complete data) in nutrition literacy (53.39 ± 6.60 vs. 43.55 ± 9.58, p < 0.001), restrained eating (31.61 ± 7.28 vs. 28.79 ± 7.96, p < 0.001), Diet Quality Distance (29.11 ± 8.52 vs. 40.71 ± 7.39, p < 0.001), and weight gain within the first 12 weeks of intervention (4.97 ± 1.33 vs. 5.98 ± 2.78, p = 0.029). However, there was no significant difference in the incidence of gestational diabetes (2 (4.5%) vs. 4 (9.5%), p = 0.629). Participants in the intervention group reported an overall satisfaction score of 4.70 ± 0.46 for the intervention strategy. These results emphasize the positive role of comprehensive dietary intervention in promoting a healthy diet during pregnancy.
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Subsidized gestational diabetes mellitus screening and management program in rural China: a pragmatic multicenter, randomized controlled trial.
Xu, T, Xia, Q, Lai, X, He, K, Fan, D, Ma, L, Fang, H
BMC medicine. 2024;(1):98
Abstract
BACKGROUND The increasing prevalence of gestational diabetes mellitus (GDM) is a major challenge, particularly in rural areas of China where control rates are suboptimal. This study aimed to evaluate the effectiveness of a GDM subsidy program in promoting GDM screening and management in these underserved regions. METHODS This multicenter, randomized controlled trial (RCT) was conducted in obstetric clinics of six rural hospitals located in three provinces in China. Eligible participants were pregnant women in 24-28 weeks' gestation, without overt diabetes, with a singleton pregnancy, access to a telephone, and provided informed consent. Participants were randomly assigned in a 1:1 ratio to either the intervention or control groups using an internet-based, computer-generated randomization system. The intervention group received subsidized care for GDM, which included screening, blood glucose retesting, and lifestyle management, with financial assistance provided to health care providers. In contrast, the control group received usual care. The primary outcomes of this study were the combined maternal and neonatal complications associated with GDM, as defined by the occurrence of at least one pre-defined complication in either the mother or newborn. The secondary outcomes included the GDM screening rate, rates of glucose retesting for pregnant women diagnosed with GDM, dietary patterns, physical activity levels, gestational weight gain, and antenatal visit frequency for exploratory purposes. Primary and secondary outcomes were obtained for all participants with and without GDM. Binary outcomes were analyzed by the generalized linear model with a link of logistic, and odds ratios (OR) with 95% confidence intervals (CIs) were reported. Count outcomes were analyzed by Poisson regression, and incidence rate ratios with 95% CIs were reported. RESULTS A total of 3294 pregnant women were randomly assigned to either the intervention group (n = 1649) or the control group (n = 1645) between 15 September 2018 and 30 September 2019. The proportion of pregnant women in the intervention group who suffered from combined maternal and/or neonatal complications was lower than in the control group with adjusted OR = 0.86 (0.80 to 0.94, P = 0.001), and a more significant difference was observed in the GDM subgroup (adjusted OR = 0.66, 95% CI 0.47 to 0.95, P = 0.025). No predefined safety or adverse events of ketosis or ketoacidosis associated with GDM management were detected in this study. Both the intervention and control groups had high GDM screening rates (intervention: 97.2% [1602/1649]; control: 94.5% [1555/1645], P < 0.001). Moreover, The intervention group showed a healthier lifestyle, with lower energy intake and more walking minutes (P values < 0.05), and more frequent blood glucose testing (1.5 vs. 0.4 visits; P = 0.001) compared to the control group. CONCLUSION In rural China, a GDM care program that provided incentives for both pregnant women and healthcare providers resulted in improved maternal and neonatal health outcomes. Public health subsidy programs in China should consider incorporating GDM screening and management to further enhance reproductive health. TRIAL REGISTRATION China Clinical Trials Registry ChiCTR1800017488. https://www.chictr.org.cn/.
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Rationale, Design, and Patient Characteristics of a Cluster-Randomized Pragmatic Trial to Improve Mineralocorticoid Antagonist Use.
Clark, KAA, Victoria-Castro, AM, Ghazi, L, Yamamoto, Y, Coronel-Moreno, C, Kadhim, BA, Riello, RJ, O'Connor, K, Ahmad, T, Wilson, FP, et al
JACC. Heart failure. 2024;(2):322-332
Abstract
BACKGROUND Despite robust evidence and strong guideline recommendations supporting use of mineralocorticoid receptor antagonists (MRAs) to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF), these medications remain underused in clinical practice. OBJECTIVES The goal is to determine if providing a tailored best practice alert (BPA) to outpatient providers suggesting guideline-recommended MRAs or information about available hyperkalemia treatment, if present, for patients with HFrEF will increase short-term MRA prescriptions. METHODS PROMPT-MRA (Pragmatic Trial of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists) is a pragmatic, cluster-randomized, controlled study. A total of 119 providers were randomized to receive a BPA or usual care. During an outpatient visit with participating providers, the BPA displayed recent laboratory test values and ejection fraction. The alert suggested guideline-recommended MRAs for eligible patients with a serum potassium of <5.0 mEq/L or novel potassium binders for those with a serum potassium of ≥5.0 mEq/L, each linked to an order set containing the corresponding medication and laboratory monitoring. RESULTS PROMPT-MRA completed enrollment with 1,210 patients. The primary outcome of PROMPT-MRA is to determine if a tailored BPA for outpatients with HFrEF will lead to higher MRA prescriptions 6 months following randomization compared with usual care. Secondary outcomes included incidence of hyperkalemia, use of novel potassium binders, heart failure hospitalizations, and mortality. CONCLUSIONS If effective, the BPA can be scaled to improve population health outcomes with increased MRA prescribing among eligible patients with HFrEF, with or without a history of hyperkalemia. (Pragmatic Trial of Alerts for Use of Mineralocorticoid Receptor Antagonists [PROMPT-MRA]; NCT04903717).
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Mothers' experiences of a lifestyle intervention for weight reduction 12 months after gestational diabetes mellitus: Qualitative findings from the PAIGE2 study.
Kemp, BJ, Creighton, RM, Cupples, G, Kelly, B, McAuley, E, Fleck, O, Wallace, H, Graham, U, McCance, DR
Midwifery. 2024;:103911
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The standardised pooled prevalence of gestational diabetes mellitus (GDM) globally is approximately 14 %, a reflection of increasing rates of obesity in women of childbearing age. Lifestyle interventions to reduce GDM and subsequent type 2 diabetes (T2D) have been deemed a research priority but are challenging to perform and have variable success rates. The PAIGE2 study was a pragmatic lifestyle randomised controlled trial for women with GDM and body mass index ≥25 kg/m2, which began during pregnancy and continued for one year postnatally. The primary outcome was weight loss 12 months postnatally compared with mothers receiving standard maternity care. Qualitative results are presented from end of study focus groups conducted amongst intervention mothers to gather feedback and determine acceptability of the PAIGE2 intervention. In total, 19 mothers participated in five virtual focus groups. Content analysis explored general study experience, longer term changes to lifestyle and suggested improvements of intervention components including monthly phone calls, motivational text messages, Fitbit experience, Slimming World, and study contact timings. Overall, most mothers found the individual PAIGE2 intervention components enjoyable, although opinions differed as to which were the most effective. Several mothers claimed the intervention helped them make long-term changes to their behaviours. A common suggested improvement was the establishment of a local group where mothers could share their experiences. In conclusion, most mothers deemed the intervention acceptable, and felt that with minor enhancements, it could be utilised as an effective tool to support weight loss after pregnancy and reduce future risk of obesity and T2D.
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Lifestyle intervention based on exercise and behavioural counselling and its effect on physical and psychological health in outpatients with schizophrenia spectrum disorders. An exploratory, pragmatic randomized clinical trial.
Fernández-Abascal, B, Suárez-Pinilla, M, Cobo-Corrales, C, Crespo-Facorro, B, Suárez-Pinilla, P
Schizophrenia research. 2023;:256-268
Abstract
Patients with Schizophrenia Spectrum Disorders (SSD) often lead unhealthy lifestyles. This pragmatic trial evaluated the effectiveness of a lifestyle intervention, consisting of a 12-week aerobic exercise program and behavioural counselling, in SSD outpatients with metabolic syndrome (MetS). It also aimed to assess persistence of potential effects in a 24-month long-term follow-up. Effectiveness was measured in terms of a wide range of outcomes involving physical and psychological health, quality of life, physical activity and changes in motivation to exercise within the context of the self-determination theory. Our primary outcome was waist circumference change. Thirty-three out of 48 participants completed the study. No differences between groups were found in terms of BMI change or other metabolic parameters. However, the active group (AG) showed improvement regarding waist circumference, negative symptomatology and identified motivation to exercise during the study and follow-up. The AG exhibited changes toward a more active pattern of activity after intervention. Moreover, belonging to the AG was a significant predictor for achieving any degree of clinical improvement after 24-month follow-up. Combined interventions of exercise and behavioural counselling in SSD patients with MetS should be considered as an essential part of the integral treatment in the context of mental health services.
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The impact of COVID-19 on a large pragmatic clinical trial embedded in primary care.
Leatherman, SM, Hau, C, Klint, A, Glassman, PA, Taylor, AA, Ferguson, RE, Cushman, WC, Ishani, A
Contemporary clinical trials. 2023;:107179
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INTRODUCTION The COVID-19 pandemic had significant impact on clinical care and clinical trial operations, but the impact on decentralized pragmatic trials is unclear. The Diuretic Comparison Project (DCP) is a Point-of Care (POC) pragmatic trial testing whether chlorthalidone is superior to hydrochlorothiazide in preventing major cardiovascular (CV) events and non-cancer death. DCP utilized telephone consent, data collection from the electronic health record and Medicare, forwent study visits, and limited provider commitment beyond usual care. We assessed the impact of COVID-19 on recruitment, follow-up, data collection, and outcome ascertainment in DCP. METHODS We compared data from two 8-month periods: Pre-Pandemic (July 2019-February 2020) and Mid-Pandemic (July 2020-February 2021). Consent and randomization rates, diuretic adherence, blood pressure (BP) and electrolyte follow-up rates, records of CV events, hospitalization, and death rates were compared. RESULTS Providers participated at a lower rate mid-pandemic (65%) than pre-pandemic (71%), but more patients were contacted (7622 vs. 5363) and consented (3718 vs. 3048) mid-pandemic than pre-pandemic. Patients refilled medications and remained on their randomized diuretic equally (90%) in both periods. Overall, rates of BP, electrolyte measurements, and hospitalizations decreased mid-pandemic while deaths increased. CONCLUSIONS While recruitment, enrollment, and adherence did not suffer during the pandemic, documented blood pressure checks and laboratory evaluations decreased, likely due to fewer in-person visits. VA hospitalizations decreased, despite a considerable number of COVID-related hospitalizations. This suggests changes in clinical care during the pandemic, but the limited impact on DCP's operations during a global pandemic is an important strength of POC trials. CLINICAL TRIAL REGISTRATION NCT02185417.
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Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial.
Ter Maaten, JM, Beldhuis, IE, van der Meer, P, Krikken, JA, Postmus, D, Coster, JE, Nieuwland, W, van Veldhuisen, DJ, Voors, AA, Damman, K
Nature medicine. 2023;(10):2625-2632
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Measurement of natriuresis has been suggested as a reliable, easily obtainable biomarker for assessment of the response to diuretic treatment in patients with acute heart failure (AHF). Here, to assess whether natriuresis-guided diuretic therapy in patients with AHF improves natriuresis and clinical outcomes, we conducted the pragmatic, open-label Pragmatic Urinary Sodium-based algoritHm in Acute Heart Failure trial, in which 310 patients (45% female) with AHF requiring treatment with intravenous loop diuretics were randomly assigned to natriuresis-guided therapy or standard of care (SOC). In the natriuresis-guided arm, natriuresis was determined at set timepoints, prompting treatment intensification if spot urinary sodium levels were <70 mmol l-1. The dual primary endpoints were 24 h urinary sodium excretion and a combined endpoint of time to all-cause mortality or adjudicated heart failure rehospitalization at 180 days. The first primary endpoint was met, as natriuresis in the natriuresis-guided and SOC arms was 409 ± 178 mmol arm versus 345 ± 202 mmol, respectively (P = 0.0061). However, there were no significant differences between the two arms for the combined endpoint of time to all-cause mortality or first heart failure rehospitalization, which occurred in 46 (31%) and 50 (31%) of patients in the natriuresis-guided and SOC arms, respectively (hazard ratio 0.92 [95% confidence interval 0.62-1.38], P = 0.6980). These findings suggest that natriuresis-guided therapy could be a first step towards personalized treatment of AHF. ClinicalTrials.gov registration: NCT04606927 .