scholarly journals Cardiovascular Risk Comparison between Expanded Hemodialysis Using Theranova and Online Hemodiafiltration (CARTOON): A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yeonhee Lee ◽  
Myoung-jin Jang ◽  
Junseok Jeon ◽  
Jung Eun Lee ◽  
Wooseong Huh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Rank Test ◽  
Cardiovascular Parameters ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported ◽  
Echocardiographic Parameters

AbstractExpanded hemodialysis (HDx) with medium cutoff (MCO) membranes, which remove middle-to-large molecules well, may be a good option to replace online hemodiafiltration (online-HDF). To provide more evidence, this randomized controlled trial compared several cardiovascular parameters between patients undergoing HDx and online-HDF. Eighty patients undergoing thrice-weekly hemodialysis were randomly assigned to receive either HDx with a Theranova membrane (n = 43) or online-HDF (n = 37). The primary endpoints were changes in brachial-ankle pulse wave velocity (baPWV), echocardiographic parameters, and coronary artery calcium (CAC) scores over 1 year, and the secondary endpoints included blood cardiovascular biomarkers, mortality, and patient-reported outcomes. A linear mixed model and log-rank test were used to estimate the group differences. 65 patients had completed the trial. The changes in baPWV and echocardiographic parameters did not differ between the two groups. The CAC scores remained stable in the online-HDF group, whereas an increasing trend was shown in the HDx group (P = 0.012). Other endpoints, including cardiovascular and all-cause mortalities, were similar between the two groups. The changes in cardiovascular parameters did not differ between HDx with an MCO membrane and online-HDF. However, attention may be needed in patients with high CAC scores or scores with an increasing tendency when online-HDF is replaced with HDx with an MCO membrane.

scholarly journals A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Saline Control ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.

The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

2020 ◽  
Author(s):  
Sabine Kofler ◽  
Andrea Kobleder ◽  
Stefan Ott ◽  
Beate Senn
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Practice Nurse ◽  
Controlled Trial ◽  
Advanced Practice ◽  
Advanced Practice Nurse ◽  
Randomized Controlled ◽  
Written Information

Abstract Background: Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated. Methods: The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) six months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model. Results: Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = −.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses. Conclusion: The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia six months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

Prospective Multicenter Randomized Controlled Trial Comparing Early Protected Movement and Splinting for Fifth Metacarpal Neck Fracture

2021 ◽  
pp. 229255032110119
Author(s):  
Helene Retrouvey ◽  
Josephine Jakubowski ◽  
Mona Al-Taha ◽  
Anna Steve ◽  
Haley Augustine ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Reference Values ◽  
Functional Outcomes ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported ◽  
Elastic Bandage

Background: Fifth metacarpal neck fractures account for 20% of all hand fractures, yet there remains debate with respect to management, particularly when conservative treatment is initiated. The objective of this study is to compare functional and patient-reported outcomes (PROs) in patients treated with early protected movement or splint immobilization. Methods: This national multicenter prospective randomized controlled trial compared 2 groups; elastic bandage with early protected movement versus immobilization with splinting. Demographic characteristics were collected at baseline. Functional outcomes (grip strength testing) and PROs (Brief Michigan Hand Questionnaire [bMHQ]) were collected at 4, 8, and 12 weeks post-intervention. Grip strength values of the injured hand were normalized to both the non-injured hand (at baseline), and the Canadian reference values. Results: Thirty-seven participants from 5 Canadian centers were randomized into the splint (n = 21) or elastic bandage group (n = 16). There were no significant differences in the bMHQ score between the splint (52.1 ± 27.2) or the elastic bandage (46.6 ± 20.4) groups ( P = .51). There were no differences in baseline grip strength between the splint (15.3 ± 8.9 kg) and elastic bandage (19.9 ± 7.5 kg) groups. At 8 weeks, the elastic bandage group had a significantly higher grip strength than the splint group (93% vs 64%, respectively: P < .05), when standardized as a percentage of the Canadian reference values. Conclusion: Patients with Boxer’s fractures treated with early protected movement had better functional outcomes by 8 weeks post-treatment as compared to the Canadian reference values of those treated with immobilization and splinting. Providers should manage Boxer’s fractures with early protected movement.

scholarly journals Nudging customers towards healthier food and beverage purchases in a real-life online supermarket: a multi-arm randomized controlled trial

BMC Medicine ◽  
2022 ◽  
Vol 20 (1) ◽  
Author(s):  
Josine M. Stuber ◽  
Jeroen Lakerveld ◽  
Loes W. Kievitsbosch ◽  
Joreintje D. Mackenbach ◽  
Joline W. J. Beulens
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
Real Life ◽  
Healthy Food ◽  
Lower Percentage ◽  
Randomized Controlled ◽  
Deprived Areas

Abstract Background Nudging is increasingly used to promote healthy food choices in supermarkets. Ordering groceries online is gaining in popularity and nudging seems efficacious there as well, but is never comprehensively tested in real-life. We evaluated the real-life effectiveness of nudging in an online supermarket on healthy food purchases. Methods We conducted a multi-arm, parallel-group, individually randomized controlled trial in an online supermarket. During 1 month, all customers were randomized to (1) control condition, (2) information nudges, (3) position nudges, and (4) information and position nudges combined. Allocation was concealed and customers were not blinded, but unaware of the intervention. Mean differences between the control condition and the intervention arms in the total percentage of healthy purchases were assessed with a linear mixed model. We tested for effect modification by area-level deprivation. Results Based on sales data from 11,775 shoppers, no overall significant effects were detected. Yet, effects were modified by area-level deprivation (pArm 2 < 0.001). Among shoppers from deprived areas, those allocated to information nudges purchased a 2.4% (95%CI 0.8, 4.0) higher percentage of healthy products compared to controls. No significant differences were observed for position (− 1.3%; 95%CI − 2.8, 0.3) and combined nudges (− 0.1%; 95%CI − 1.7, 1.5). Shoppers from non-deprived areas exposed to information nudges (− 1.6%; 95%CI − 3.2, − 0.1) and the combined nudges (− 2.1%; 95%CI − 3.6, − 0.6), but not position nudges (− 0.9%; 95%CI − 2.4, 0.7), purchased a lower percentage of healthy products. Conclusion Information nudges in an online supermarket can increase healthy product purchases, but only for those living in deprived areas. The adverse effects found on purchasing behaviors for those from non-deprived areas call for further research. Further research should also focus on real-life effects of online healthy food nudging as part of a broader nutrition intervention strategy, and on the equitability of the online nudging intervention within populations. Trial registration Retrospectively registered in the ISRCTN registry at May 21, 2021 (ISRCTN10491616).

scholarly journals Slow Cortical Potential Versus Live Z-score Neurofeedback in Children and Adolescents with ADHD: A Multi-arm Pragmatic Randomized Controlled Trial with Active and Passive Comparators

2021 ◽  
Author(s):  
John Hasslinger ◽  
Sven Bölte ◽  
Ulf Jonsson
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Pragmatic Trial ◽  
Cortical Potential ◽  
Future Research ◽  
Z Score ◽  
Slow Cortical Potential ◽  
Randomized Controlled

AbstractNeurofeedback (NF) as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) has been evaluated in several trials, but the specificity and generalizability of effects remain unclear. This four-arm randomized controlled trial evaluated the efficacy of Slow Cortical Potential (SCP; standard NF protocol) and Live Z-score (LZS; non-standard NF protocol) delivered in high-frequency format (five sessions per week during five weeks), compared to Working-memory training (WMT; active comparator) and Treatment-as-usual (TAU; passive comparator). N = 202 children/adolescents aged 9 to 17 years with ADHD participated. The primary outcome measure was multi-report (self-, teacher-, and parent-report) ADHD core symptoms on the Conners-3, assessed at baseline, posttreatment, and 6-months follow-up. Data were analyzed using a linear mixed model. Between-group differences were scarce and did not show a distinct pattern. Superiority of LZS over TAU at endpoint were observed for teacher-rated measures only, while significant differences between SCP and TAU were restricted to posttreatment measurements. Contrary to our expectations, LZS outperformed SCP at endpoint for teacher-rated hyperactivity (-5.37; 95% CI: -10.14 to -0.60; p = .028; d = -.36) and overall ADHD symptoms (-2.20; -4.18 to -0.22; p = .030; d = -.41). There was no indication that either form of NF was superior to WMT. No severe adverse events were reported during the trial, whereas transient stress-related problems were quite frequent. Overall, the results from this pragmatic trial do not provide convincing support for broad implementation of NF in child and adolescent psychiatric services. Future research should try to clarify for whom and under what circumstances NF might be a viable treatment option.

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