scholarly journals Functional outcome of routine versus on-demand removal of the syndesmotic screw: a multicentre randomized controlled trial

2021 ◽  
Vol 103-B (11) ◽  
pp. 1709-1716
Author(s):  
Fay R. K. Sanders ◽  
Merel F. Birnie ◽  
Siem A. Dingemans ◽  
Michel P. J. van den Bekerom ◽  
Markus Parkkinen ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Controlled Trial ◽  
Final Analysis ◽  
Strong Argument ◽  
Intention To Treat ◽  
On Demand ◽  
Randomized Controlled ◽  
Syndesmotic Screw ◽  
Group 12 ◽  
Routine Removal

Aims The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome. Methods Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS). Results There were 152 patients included in final analysis (RR = 73; ODR = 79). Of these, 59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6). Median OMAS at 12 months after syndesmotic fixation was 85 (interquartile range (IQR) 60 to 95) for RR and 80 (IQR 65 to 100) for ODR. The noninferiority test indicated that the observed effect size was significantly within the equivalent bounds of -10 and 10 scale points (p < 0.001) for both the intention-to-treat and per-protocol, meaning that ODR was not inferior to RR. There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007). Conclusion ODR of the syndesmotic screw is not inferior to routine removal when it comes to functional outcome. Combined with the high complication rate of screw removal, this offers a strong argument to adopt on demand removal as standard practice of care after syndesmotic screw fixation. Cite this article: Bone Joint J 2021;103-B(11):1709–1716.

Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer

2020 ◽  
Author(s):  
Sasan Naraghi ◽  
Niels Ganzer ◽  
Lars Bondemark ◽  
Mikael Sonesson
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Contact Point ◽  
Three Dimensional ◽  
Final Analysis ◽  
Single Centre ◽  
Retention Capacity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Anterior Teeth

Summary Background Retention of the maxillary anterior teeth is commonly recommended to maintain the teeth in their corrected positions. Both fixed and removable retention methods are used, but the certainty of evidence is low. Objective To evaluate post-treatment changes in irregularity of the maxillary six anterior teeth and single tooth contact point discrepancy (CPD) of three different retention methods. Trial design Three-arm parallel group single-centre randomized controlled trial. Materials and methods Ninety patients, 54 girls and 36 boys, were recruited to the study. The inclusion criteria were adolescent patients treated with fixed appliances at least in the maxilla. After gaining informed consent from the patient and their custodians, the patients were randomized to one of three groups: bonded retainer 13–23, bonded retainer 12–22, and removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization, prepared by an independent person, used blocks of 30. The primary outcomes were changes in single CPD and Little’s irregularity index (LII) measured on digitalized three-dimensional study casts before and after 2-year retention. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. Results The LII and CPDs increased slightly in all three groups without any statistically significant differences between the groups. The VFR group showed a small intercanine width increase and some more changes of canine rotations than in the other groups. Harms No harm was observed in any subjects and none of the patients needed retreatment. Limitations The trial was a single-centre study and short-term changes were evaluated. Conclusions All three retention methods showed equally effective retention capacity and all the changes found in the three groups were small and considered clinically insignificant. Thus, the null hypothesis was confirmed. All three methods can be recommended. Trial registration NCT04616755

scholarly journals A Comparative Assessment of Orthodontic Treatment Outcomes of Mild Skeletal Class III Malocclusion Between Facemask and Facemask in Combination with a Miniscrew For Anchorage in Growing Patients: A Single-center, Prospective Randomized Controlled trial

2019 ◽  
Vol 90 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Masahiro Seiryu ◽  
Hiroto Ida ◽  
Atsushi Mayama ◽  
Satoshi Sasaki ◽  
Shutaro Sasaki ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Controlled Trial ◽  
Class Iii ◽  
Class Iii Malocclusion ◽  
Skeletal Class ◽  
Randomized Controlled ◽  
Group 12 ◽  
Prospective Randomized Controlled Trial ◽  
Group A ◽  
Negative Side Effects

ABSTRACT Objectives To investigate the hypothesis that there is difference in the treatment outcomes of milder skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew in growing patients. Materials and Methods Patients were randomly divided into two groups. In one group, the patients were treated with facemask therapy (FM group: 12 males, eight females, average age: 10 years, 5 months ± 1 year, 8 months). In the other group, patients were treated with facemask therapy along with a miniscrew (FM+MS group: 12 males, seven females, average age: 11 years, 1 month ± 1 year, 3 months). A lingual arch with hooks was fixed to the maxillary arch in both groups and a protractive force of 500 g was applied from the facemask to the hooks. The patients were instructed to use the facemask for 12 hours per day. In the FM+MS group, a miniscrew was inserted into the palate and fixed to the lingual arch. Results Mobility and loosening of the miniscrew were not observed during treatment. Lateral cephalometric analysis showed that SNA, SN-ANS, and ANB values were significantly increased in the FM+MS group compared with those for the FM group (SNA, 1.1° SN-ANS, 1.3° ANB, 0.8°). Increase in proclination of maxillary incisors was significantly greater in the FM group than in the FM+MS group (U1-SN, 5.0°). Conclusions During treatment of milder skeletal Class III malocclusion, facemask therapy along with a miniscrew exhibits fewer negative side effects and delivers orthopedic forces more efficiently to the maxillary complex than facemask therapy alone.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

NO EFFECTS OF SWEET TASTE EXPOSURE AT BREAKFAST FOR 3 WEEKS ON PLEASANTNESS, DESIRE FOR, SWEETNESS OR INTAKE OF OTHER SWEET FOODS: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
pp. 1-33
Author(s):  
Katherine M Appleton ◽  
Jessica Rajska ◽  
Sarah M Warwick ◽  
Peter J Rogers
Keyword(s):  
Controlled Trial ◽  
Sweet Taste ◽  
Breakfast Cereal ◽  
Bayesian Analyses ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Sweet Foods ◽  
Taste Exposure ◽  
Randomised Controlled ◽  
Desire To Eat

Abstract This work investigated the effects of repeated sweet taste exposure at breakfast on perceptions and intakes of other sweet foods, while also examining effects due to duration of exposure (1/3 weeks), test context (breakfast/lunch), and associations between taste perceptions and intakes. Using a randomised controlled parallel-groups design, participants (N=54, 18 male, mean age: 23.9±5.8yrs, mean BMI: 23.6±3.5kg/m2) were randomized to consume either a sweet breakfast (cereal with sucralose) (N=27) or an equicaloric non-sweet breakfast (plain cereal) (N=27) for 3 weeks. On days 0 (baseline), 7, and 21, pleasantness, desire to eat and sweetness were rated for other sweet and non-sweet foods, and sweet food consumption was assessed in an ad-libitum meal at breakfast and lunch. Using intention-to-treat analyses, no statistically significant effects of exposure were found at breakfast (largest F(2,104)=1.84, p=0.17, ηp2=0.03), or lunch (largest F(1,52)=1.22, p=0.27, ηp2=0.02), and using Bayesian analyses, the evidence for an absence of effect in all rating measures was strong to very strong (smallest BF01=297.97 (BF01error=2.68%)). Associations between ratings of pleasantness, desire to eat and intake were found (smallest r=0.137, p<0.01). Effects over time regardless of exposure were also found: sugars and percent energy consumed from sweet foods increased throughout the study smallest (F(2,104)=4.54, p=0.01, ηp2=0.08). These findings demonstrate no effects of sweet taste exposure at breakfast for 1 or 3 weeks on pleasantness, desire for, sweetness or intakes of other sweet foods in either the same (breakfast) or in a different (lunch) meal context.

scholarly journals The Diabetes Transition of Hospital Care (DiaTOHC) Pilot Study: A Randomized Controlled Trial of an Intervention Designed to Reduce Readmission Risk of Adults with Diabetes

2022 ◽  
Author(s):  
Daniel J Rubin ◽  
Preethi Gogineni ◽  
Andrew Deak ◽  
Cherie L Vaz ◽  
Samantha Watts ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Care ◽  
Controlled Trial ◽  
Safety Net ◽  
Cost Ratio ◽  
Readmission Rates ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Safety Net Hospital ◽  
Readmission Risk

Hospital readmission within 30 days of discharge (30-day readmission) is a high-priority quality measure and cost target. The purpose of this study was to explore the feasibility and efficacy of the Diabetes Transition of Hospital Care (DiaTOHC) Program on readmission risk in high-risk adults with diabetes. This was a non-blinded pilot randomized controlled trial (RCT) that compared usual care (UC) to DiaTOHC at a safety-net hospital. The primary outcome was all-cause 30-day readmission. Between 10/16/2017 and 05/30/2019, 115 patients were randomized. In the intention-to-treat (ITT) population, 14 (31.1%) of 45 DiaTOHC subjects and 15 (32.6%) of 46 UC subjects had a 30-day readmission (p=0.88) while 35.6% DiaTOHC and 39.1% UC subjects had a 30-day readmission or ED visit (p=0.72). The Intervention:UC cost ratio was 0.33 (0.13-0.79)95%CI (p&lt;0.01). Among the 69 subjects with baseline HbA1c &gt;7.0% (53 mmol/mol), 30-day readmission rates were 23.5% (DiaTOHC) and 31.4% (UC, p=0.46) and composite 30-day readmission or ED visit rates were 26.5% (DiaTOHC) and 40.0% (UC, p=0.23). In this subgroup, the Intervention:UC cost ratio was 0.21 (0.08-0.58)95%CI (p=0.002). The DiaTOHC Program is feasible and may decrease combined 30-day readmission/ED visit risk as well as healthcare costs among patients with higher HbA1c levels.

scholarly journals StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ann-Marie Küchler ◽  
Dana Schultchen ◽  
Olga Pollatos ◽  
Morten Moshagen ◽  
David D. Ebert ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Population Level ◽  
Control Group ◽  
Cognitive Fusion ◽  
On Demand ◽  
Randomized Controlled ◽  
Increased Risk

Abstract Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.

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