Intention-to-treat Analysis Controls the Bias When Suffer From Noncompliance and Missing Outcomes in Randomized Controlled Trial Study

Key Points Pathogen-inactivated platelets were noninferior in preventing bleeding only in intention-to-treat analysis. In contrast to animal models, alloimmunization could not be prevented when using pathogen-inactivated platelets.

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Presenting a randomized controlled trial

10.1093/med/9780198779100.003.0012 ◽

2017 ◽

Author(s):

Janet L. Peacock ◽

Sally M. Kerry ◽

Raymond R. Balise

Keyword(s):

Randomized Controlled Trial ◽

Randomized Trials ◽

Controlled Trial ◽

Consort Statement ◽

Cluster Randomized Trials ◽

Intention To Treat ◽

Randomized Controlled ◽

The Consort Statement ◽

Cluster Randomized ◽

Treat Analysis

Chapter 12 covers all aspects of reporting a randomized controlled trial, and illustrates the use of the CONSORT statement and its checklist to report a trial. It discusses what is meant by intention-to-treat analysis. It considers the presentation of trials with other designs, particularly cluster randomized trials.

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

Trials ◽

10.1186/s13063-021-05333-2 ◽

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

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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

10.20944/preprints202201.0078.v1 ◽

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<0.01). Among the 69 subjects with baseline HbA1c >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.

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Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjaa073 ◽

2020 ◽

Author(s):

Jenny Kallunki ◽

Lars Bondemark ◽

Liselotte Paulsson

Keyword(s):

Randomized Controlled Trial ◽

Early Treatment ◽

Untreated Control ◽

Controlled Trial ◽

Class Ii ◽

Control Group ◽

Class Ii Malocclusion ◽

Single Centre ◽

Intention To Treat ◽

Randomized Controlled

Summary Objectives To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes. Trial design Two-arm parallel group single-centre randomized controlled trial. Material and methods A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes. Results Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients. Limitations The trial was a single-centre trial and can thus be less generalizable. Conclusions The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet. Trial registration NCT04508322.

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

European Journal of Orthodontics ◽

10.1093/ejo/cjaa077 ◽

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

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Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

The Scientific World JOURNAL ◽

10.1155/2015/718607 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 3

Author(s):

R. Casañas ◽

R. Catalán ◽

R. Penadés ◽

J. Real ◽

S. Valero ◽

...

Keyword(s):

Primary Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Antidepressant Medication ◽

Psychoeducational Intervention ◽

Control Group ◽

Intention To Treat ◽

Symptoms Of Depression ◽

Randomized Controlled ◽

Treatment Naïve

Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention.Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis.Results. The PE program group showed remission of symptoms of 40% (P=0.001) posttreatment and 42% (P=0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’sd′=0.55).Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

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A Randomized Controlled Trial of Two Different Lengths of Nicotine Replacement Therapy for Smoking Cessation

BioMed Research International ◽

10.1155/2013/961751 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Abu S. Abdullah ◽

Anthony J. Hedley ◽

Sophia S. C. Chan ◽

Tai-Hing Lam

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Replacement Therapy ◽

Nicotine Replacement Therapy ◽

Controlled Trial ◽

Point Prevalence ◽

Nicotine Replacement ◽

Intention To Treat ◽

Randomized Controlled ◽

Quit Rate

This study examined if 2-week free nicotine replacement therapy (NRT) would be more effective than 1-week free NRT to help smokers quit smoking at 6 and 12 months. In a single-blinded randomized controlled trial design, 562 Chinese smokers who attended a smoking cessation clinic in Hong Kong, China, were randomly allocated into two groups (A1 and A2): A1 (n=284) received behavioural counselling with free NRT for 1 week; A2 (n=278) received similar counselling with free NRT for 2 weeks. All subjects received printed self-help materials to support their quitting efforts. A structured questionnaire was used for data collection, including pattern of NRT use and self-reported 7-day point prevalence quit rate at 6 months and 12 months. Among the participants, the mean number of cigarettes smoked per day was 18.8 (SD=10.9). By intention-to-treat analysis, 7-day point prevalence quit rates were not significantly different between A1 and A2 groups at 6-month (27.5% versus 27.3%;P=0.97) and 12-month (21.1% versus 21.2%;P=0.98) followup. The findings suggest that two-week free NRT was not more effective than 1-week free NRT to increase smoking cessation rate among Chinese smokers.

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Cognitive Behaviour Therapy for Bulimia Nervosa and Eating Disorders Not Otherwise Specified: Translation from Randomized Controlled Trial to a Clinical Setting

Behavioural and Cognitive Psychotherapy ◽

10.1017/s1352465814000393 ◽

2014 ◽

Vol 43 (6) ◽

pp. 641-654 ◽

Cited By ~ 24

Author(s):

Sarah Knott ◽

Debbie Woodward ◽

Antonia Hoefkens ◽

Caroline Limbert

Keyword(s):

Eating Disorders ◽

Randomized Controlled Trial ◽

Eating Disorder ◽

Cognitive Behaviour Therapy ◽

Controlled Trial ◽

Behaviour Therapy ◽

Intention To Treat ◽

Randomized Controlled ◽

Eating Disorder Psychopathology ◽

Cognitive Behaviour

Background: Enhanced Cognitive Behaviour Therapy (CBT-E) (Fairburn, Cooper and Shafran, 2003) was developed as a treatment approach for eating disorders focusing on both core psychopathology and additional maintenance mechanisms. Aims: To evaluate treatment outcomes associated with CBT-E in a NHS Eating Disorders Service for adults with bulimia and atypical eating disorders and to make comparisons with a previously published randomized controlled trial (Fairburn et al., 2009) and “real world” evaluation (Byrne, Fursland, Allen and Watson, 2011). Method: Participants were referred to the eating disorder service between 2002 and 2011. They were aged between 18–65 years, registered with a General Practitioner within the catchment area, and had experienced symptoms fulfilling criteria for BN or EDNOS for a minimum of 6 months. Results: CBT-E was commenced by 272 patients, with 135 completing treatment. Overall, treatment was associated with significant improvements in eating disorder and associated psychopathology, for both treatment completers and the intention to treat sample. Conclusions: Findings support dissemination of CBT-E in this context, with significant improvements in eating disorder psychopathology. Improvements to global EDE-Q scores were higher for treatment completers and lower for the intention to treat sample, compared to previous studies (Fairburn et al., 2009; Byrne et al., 2011). Level of attrition was found at 40.8% and non-completion of treatment was associated with higher levels of anxiety. Potential explanations for these findings are discussed.

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