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Coordination Between Primary Care and Women, Infants, and Children to Prevent Obesity for Infants from Low-Income Families: A Pragmatic Randomized Clinical Trial.
Savage, JS, Moore, AM, Kling, SMR, Marini, M, Hernandez, E, Franceschelli Hosterman, J, Hassink, S, Paul, IM, Bailey-Davis, L
Childhood obesity (Print). 2023;(8):515-524
Abstract
Background: Rapid weight gain during infancy is associated with risk for later obesity, yet little research to date has examined the effect of a responsive parenting (RP) intervention with care coordination between pediatric primary care providers and Women, Infants, and Children nutritionists on infant weight. Methods: The Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care study is a pragmatic, randomized clinical trial for mothers and infants (n = 288) designed to examine the effect of a patient-centered RP intervention that used advanced health information technology strategies to coordinate care to reduce rapid infant weight gain compared with standard care. General linear models examined intervention effects on infant conditional weight gain scores, weight-for-age z scores, BMI, and overweight status (BMI-for-age ≥85th percentile) from birth to age 6 months, and mothers' use of food to soothe from age 2 to 6 months. Results: There were no intervention effects on infant conditional weight gain scores or overweight status at 6 months. Infants in the RP intervention had lower mean weight-for-age z scores [M = -0.04, standard error (SE) = 0.04 vs. M = 0.05, SE = 0.04; p = 0.008] and lower mean BMI (M = 16.05, SE = 0.09 vs. M = 16.24, SE = 0.09; p = 0.03) compared with standard care. Mothers' use of emotion-based food to soothe was lower in the RP intervention compared with standard care from age 2 to 6 months [M difference = -0.32, standard deviation (SD) = 0.81 vs. 0.00, SD = 0.90; p = 0.01]. Conclusions: This pragmatic, patient-centered RP intervention did not reduce rapid infant weight gain or overweight but was associated with modestly lower infant BMI and reduced mothers' use of emotion-based food to soothe. Trial Registration: clinicaltrials.gov identifier: NCT03482908.
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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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Combination of aspirin and rosuvastatin for reduction of venous thromboembolism in severely injured patients: a double-blind, placebo-controlled, pragmatic randomized phase II clinical trial (The STAT Trial).
Barrett, CD, Moore, HB, Moore, EE, Chandler, J, Sauaia, A
Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2023;(8):499-507
Abstract
INTRODUCTION Venous thromboembolism (VTE) remains a significant source of postinjury morbidity and mortality. Beta-hydroxy beta-methylglutaryl-CoA (HMG-CoA) reductase inhibitors (rosuvastatin) significantly reduced pathologic clotting events in healthy populations in a prior trial. Furthermore, acetylsalicylic acid (ASA) has been shown to be noninferior to prophylactic heparinoids for VTE prevention following orthopedic surgery. We hypothesized that a combination of rosuvastatin/ASA, in addition to standard VTE chemoprophylaxis, would reduce VTE in critically ill trauma patients. METHODS This was a double-blind, placebo-controlled, randomized trial, evaluating VTE rates in two groups: ASA + statin (Experimental) and identical placebos (Control). Injured adults, 18-65 years old, admitted to the surgical intensive care unit without contraindications for VTE prophylaxis were eligible. Upon initiation of routine VTE chemoprophylaxis (i.e. heparin/heparin-derivatives), they were randomized to the Experimental or Control group. VTE was the primary outcome. RESULTS Of 112 potentially eligible patients, 33% (n = 37, median new injury severity scale = 27) were successfully randomized, of whom 11% had VTEs. The Experimental group had no VTEs, while the Control group had 6 VTEs (4 PEs and 2 DVTs) in 4 (22%) patients (P = 0.046). The Experimental treatment was not associated with any serious adverse events. Due to the COVID-19 pandemic, the study was interrupted at the second interim analysis at <10% of the planned enrollment, with significance declared at P < 0.012 at that stage. DISCUSSION The combination of ASA and rosuvastatin with standard VTE prophylaxis showed a favorable trend toward reducing VTEs with no serious adverse events. An appropriately powered phase III multicenter trial is needed to further investigate this therapeutic approach. LEVEL OF EVIDENCE Level II, Therapeutic.
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Associations between grip strength, cardiorespiratory fitness, cardiovascular risk and mental health in forcibly displaced people from a Greek refugee camp.
Gerber, M, Filippou, K, Knappe, F, Morres, ID, Tzormpatzakis, E, Havas, E, Seelig, H, Colledge, F, Ludyga, S, Meier, M, et al
Scientific reports. 2023;(1):20970
Abstract
Muscular strength represents a specific component of health-related fitness. Hand grip strength is used as a simple and dynamic marker of maximum voluntary force of the hand and to estimate overall strength. Today, little is known about the relationship between grip strength and health in forcibly displaced populations. In the present study, we examined whether grip strength is associated with various health outcomes in a sample of forcibly displaced people living in a Greek refugee camp. The present analyses are part of a larger pragmatic randomized controlled trial. In this paper, cross-sectional baseline data of 143 participants (71 men, 72 women) will be presented. In addition to grip strength, the following physical and mental health outcomes were assessed: body weight and body composition, blood pressure, total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides, blood glucose levels (HbA1c), post-traumatic stress disorder (PTSD) symptoms, depressive and anxiety symptoms, pain, and quality of life. Linear regression analyses were carried out to examine how grip strength is associated with the health outcomes, separately for absolute and normalized grip strength scores. Grip strength was positively and strongly associated with percentage muscle mass (normalized grip strength: Stand. B = 0.58, p < .001), whereas a negative association existed for percentage body fat (normalized grip strength: Stand. B = - 0.58, p < .001). No statistically significant associations occurred between grip strength and the other cardiovascular risk markers. In contrast, we found that participants with higher normalized grip strength reported higher levels of PTSD (normalized grip strength: Stand. B = 0.36, p < .05) and depressive symptoms (normalized grip strength: Stand. B = 0.29, p < .05). No significant association occurred between grip strength, anxiety, pain and quality of life. Measuring grip strength in forcibly displaced people can be a useful way to assess their overall muscle strength. Grip strength tests are easy to implement, and results can be used to assess the effects of specific intervention measures. Nevertheless, our results question the usefulness of grip strength as a marker of cardiovascular health and mental wellbeing in a refugee camp setting.
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Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ: a cost-effectiveness analysis from the DIAMONDS trial.
Mistry, H, Maredza, M, Campbell, C, Lois, N, ,
BMJ open. 2023;(10):e067684
Abstract
OBJECTIVES To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ. DESIGN An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold. SETTING 18 UK Hospital Eye Services. PARTICIPANTS Adults with diabetes and centre involving DMO with CRT<400µ. INTERVENTIONS Participants (n=266) were randomised 1:1 to receive SML or SL. METHODS The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates. RESULTS One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%. CONCLUSIONS There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ. TRIAL REGISTRATION NUMBERS ISRCTN17742985; NCT03690050.
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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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Healthcare Costs and Healthcare Utilization Outcomes of Vitamin D3 Supplementation at 5000 IU Daily during a 10.9 Month Observation Period within a Pragmatic Randomized Clinical Trial.
LaRiccia, PJ, Cafaro, T, John, D, van Helmond, N, Mitrev, LV, Bandomer, B, Brobyn, TL, Hunter, K, Roy, S, Ng, KQ, et al
Nutrients. 2023;(20)
Abstract
Vitamin D insufficiency has been linked to multiple conditions including bone disease, respiratory disease, cardiovascular disease, diabetes, and cancer. Observational studies indicate lower healthcare costs and healthcare utilization with sufficient vitamin D levels. The secondary aims of our previously published pragmatic clinical trial of vitamin D3 supplementation were comparisons of healthcare costs and healthcare utilization. Comparisons were made between the vitamin D3 at 5000 IU supplementation group and a non-supplemented control group. Costs of care between the groups differed but were not statistically significant. Vitamin D3 supplementation reduced healthcare utilization in four major categories: hospitalizations for any reason (rate difference: -0.19 per 1000 person-days, 95%-CI: -0.21 to -0.17 per 1000 person-days, p < 0.0001); ICU admissions for any reason (rate difference: -0.06 per 1000 person-days, 95%-CI: -0.08 to -0.04 per 1000 person-days, p < 0.0001); emergency room visits for any reason (rate difference: -0.26 per 1000 person-days, 95%-CI: -0.46 to -0.05 per 1000 person-days, p = 0.0131; and hospitalizations due to COVID-19 (rate difference: -8.47 × 10-3 per 1000 person-days, 95%-CI: -0.02 to -1.05 × 10-3 per 1000 person-days, p = 0.0253). Appropriately powered studies of longer duration are recommended for replication of these utilization findings and analysis of cost differences.
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Clinical application of 4% sodium citrate and heparin in the locking of central venous catheters (excluding dialysis catheters) in intensive care unit patients: A pragmatic randomized controlled trial.
Deng, Y, Xing, J, Tan, Z, Ai, X, Li, Y, Zhang, L
PloS one. 2023;(7):e0288117
Abstract
OBJECTIVES The feasibility of utilizing 4% sodium citrate as an alternative locking solution for central venous catheters (CVCs) (excluding dialysis catheters) was assessed. METHODS Using heparin saline and 4% sodium citrate as locking solution, then 152 patients in ICU undergoing infusion with central venous catheters, were randomly assigned to receive either 10 U/mL heparin saline or 4% sodium citrate. The used outcome indicators include: four indexes of blood coagulation at 10 minutes after locking and 7 d after the first locking, bleeding around the puncture site and subcutaneous hematoma rate, gastrointestinal bleeding rate, catheter indwelling time, catheter occlusion rate, catheter-related bloodstream infection (CRBSI) rate, rate of ionized calcium < 1.0 mmol/L. The main outcome indicator was the activated partial thromboplastin time (APTT) at 10 min after tube locking. The trial was approved by relevant authorities (Chinese Clinical Trial Registry, no: ChiCTR2200056615, registered on February 9, 2022, http://www.chictr.org.cn; Ethics Committee of People's Hospital of Zhongjiang County, no: JLS-2021-034, approved at May 10, 2021, and no: JLS-2022-027, approved at May 30, 2022). RESULTS Among the main outcome measures, the heparin group showed a significant increase in APTT compared to the sodium citrate group at 10 min after locking (LSMD = 8.15, 95%Cl 7.1 to 9.2, P < 0.001). Among the secondary outcome measures, the heparin group demonstrated a significant increase in prothrombin time (PT) compared to the sodium citrate group at 10 minutes after locking (LSMD = 0.86, 95%CI 0.12 to 1.61, P = 0.024). It is found that APTT (LSMD = 8.05, 95%CI 6.71 to 9.4, P < 0.001), PT (LSMD = 0.78, 95%CI 0.14 to 1.42, P = 0.017) and fibrinogen (FB) (LSMD = 1.15, 95%CI 0.23 to 2.08, P = 0.014) at 7 d after locking are increased in the heparin group compared to sodium citrate group. There was no significant difference in catheter indwelling time between the two groups (P = 0.456). The incidence of catheter blockage was lower in sodium citrate group (RR = 0.36, 95%CI 0.15 to 0.87, P = 0.024). No CRBSI occurred in the two groups. Among the safety evaluation indexes, the incidence of bleeding around the puncture site and subcutaneous hematoma was lower in sodium citrate group (RR = 0.1, 95%CI 0.01 to 0.77, P = 0.027). There was no significant difference in the incidence of calcium ion < 1.0 mmol/L between the two groups (P = 0.333). CONCLUSIONS In ICU patients using CVCs (excluding dialysis catheters) infusion, employing 4% sodium citrate as a locking liquid can reduce the risk of bleeding and catheter occlusion without any hypocalcemia.
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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 .
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Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial.
Hagman, E, Johansson, L, Kollin, C, Marcus, E, Drangel, A, Marcus, L, Marcus, C, Danielsson, P
International journal of obesity (2005). 2022;(8):1527-1533
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BACKGROUND Pediatric obesity lifestyle treatment is not always successful. Frequent clinical visits are of major importance to certify sufficient effect but are difficult due to the associated costs and the great demands on families. We hypothesized that an interactive digital support may reduce the need for frequent physical visits. The aim of the study was to assess 1-year weight outcome for patients using a digital support system compared with standard care. METHODS An obesity lifestyle treatment with a digital support system was implemented in one clinic in Stockholm, Sweden. Measurements from a custom-made body scale without digits for daily home measurement of weights were transferred via Bluetooth to a mobile application, where BMI Z-score was calculated and presented graphically with an individualized weight loss target curve. An automatic transfer of data to the web-based clinic interface enables a close monitoring of treatment progress, and frequent written communication between the clinical staff and families via the application. One-year outcome was compared with a randomly retrieved, age and sex matched control group from the Swedish childhood obesity treatment register (BORIS), which received standard treatment at other clinics. Main outcome was change in BMI Z-score and missing data was imputed. RESULTS 107 children were consecutively included to digi-physical treatment and 321 children to standard care. Age range 4.1-17.4 years (67% males). The attrition rate was 36% and 46% respectively, p = 0.08. After 1 year, the mean ± SD change in BMI Z-score in the treatment group was -0.30 ± 0.39 BMI Z-score units and in the standard care group -0.15 ± 0.28, p = 0.0002. The outcome was better for both sexes and all age groups in the digi-physical treated group. CONCLUSION A digital support system with a personalized weight-loss target curve and daily weight measurements shared by the family and the clinic is more effective than a standard care childhood obesity treatment. GOV ID NCT04323215.