Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: Rationale, trial design, and methods

2007 ◽  
Vol 28 (6) ◽  
pp. 748-762 ◽  
Author(s):  
Mary E. Charlson ◽  
Carla Boutin-Foster ◽  
Carol A. Mancuso ◽  
Janey C. Peterson ◽  
Gbenga Ogedegbe ◽  
...  
Keyword(s):  
Positive Affect ◽  
Randomized Controlled Trials ◽  
Trial Design ◽  
Controlled Trials ◽  
Healthy Behaviors ◽  
Randomized Controlled ◽  
Design And Methods

scholarly journals An index of the quality of evidence in meta-analysis of randomized controlled trials

2017 ◽  
Author(s):  
Devon D. Brewer
Keyword(s):  
Randomized Controlled Trials ◽  
Trial Design ◽  
Meta Analysis ◽  
Data Availability ◽  
Controlled Trials ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Independent Replication ◽  
Design And Methods

The quality of evidence in meta-analysis of randomized controlled trials is the degree to which the estimated effect represents the "truth." Current approaches to assessing the quality of evidence focus on trial design and methods. I describe a new quality of evidence index composed of four sub-indexes that measure pre-registration, independent replication, data availability, and trial design and methods, respectively. This index is systematic, objective, and quantitative. I illustrate the index with an empirical example and provide a spreadsheet for easy calculation.

Pharmacogenetics in randomized controlled trials: considerations for trial design

2011 ◽  
Vol 12 (10) ◽  
pp. 1485-1492 ◽  
Author(s):  
Frederieke H van der Baan ◽  
Olaf H Klungel ◽  
Antoine CG Egberts ◽  
Hubert G Leufkens ◽  
Diederick E Grobbee ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Trial Design ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Randomized controlled trials in schizophrenia: opportunities, limitations, and trial design alternatives

2011 ◽  
Vol 13 (2) ◽  
pp. 155-172 ◽  
Keyword(s):  
Randomized Controlled Trials ◽  
Trial Design ◽  
Controlled Trial ◽  
Mood Stabilizers ◽  
Controlled Trials ◽  
Trial Methodology ◽  
Double Blind ◽  
Randomized Controlled ◽  
Design Alternatives ◽  
Novel Design

State-of-the art clinical trial design and methodology are enormously important for the advancement of the field. In contrast, the critical relevance of trial conduct and implementation have only more recently been the focus of discussion and research. Although randomized controlled trials are generally considered the gold standard for the assessment of pharmacologic and nonpharmacologic interventions in medicine, trials are vulnerable to complications and influences that can seriously compromise their success. Like interventions, trial design and conduct are also contextual. They need to be individualized and adapted to a number of relevant variables, such as setting, population, illness phase, interventions, patient and rater expectations and biases, and the overall aims of the investigation. While this means that there is no unified approach possible, certain general principles and guidelines require careful consideration. Knowledge of basic solutions and alternatives, and the recognition of the complex challenges that need to be addressed proactively can help to minimize unwanted outcomes, including trial failure and uninformative or falsely negative outcomes. Moreover, novel design alternatives need to be explored that target sample enrichment according to the study question and enhancement of precision in the measurement of relevant outcomes. We propose two novel design strategies that take advantage of the recently validated early antipsychotic response paradigm (that has also been observed with antidepressants and mood stabilizers). In the "early responder randomized discontinuation design" all patients are assigned to the active drug, and only those who had at least a minimal response at 2 weeks are enrolled in a double-blind, placebo-controlled discontinuation trial, enriching the placebo controlled trial portion with true drug responders. In the mirror image "early nonresponder randomized dose increase or augmentation design," early nonresponders at 2 weeks are assigned to staying on the medication or going either to a higher dose or an augmentation agent. It is hoped that through increased attention to the issues raised in this article and further refinement of trial methodology and conduct, the field will make much needed additional progress in the prevention and treatment of schizophrenia.

scholarly journals How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials

2018 ◽  
Author(s):  
Emily K Lindsay ◽  
Brian Chin ◽  
Carol M. Greco ◽  
Shinzen Young ◽  
Kirk Warren Brown ◽  
...  
Keyword(s):  
Negative Affect ◽  
Positive Affect ◽  
Randomized Controlled Trials ◽  
Positive Emotions ◽  
Daily Life ◽  
Skills Training ◽  
Controlled Trials ◽  
Present Moment ◽  
Randomized Controlled ◽  
Mindfulness Interventions

Mindfulness meditation interventions – which train skills in monitoring present-moment experiences with a lens of acceptance – have shown promise for increasing positive emotions. Using a theory-based approach, we hypothesized that learning acceptance skills in mindfulness interventions helps people notice more positive experiences in daily life, and tested whether removing acceptance training from mindfulness interventions would eliminate intervention- related boosts in positive affect. In two randomized controlled trials (RCTs) of stressed community adults, mindfulness skills were dismantled into two structurally equivalent interventions: (1) training in both monitoring and acceptance (Monitor+Accept) and (2) training in monitoring only (Monitor Only) without acceptance training. Study 1 tested 8-week group- based Monitor+Accept and Monitor Only interventions compared to a no treatment control group. Study 2 tested 2-week smartphone-based Monitor+Accept and Monitor Only interventions compared to an active control training. In both studies, end-of-day and momentary positive affect and negative affect were measured in daily life for three days pre- and post- intervention using ambulatory assessments. As predicted, across two RCTs, Monitor+Accept training increased positive affect compared to both Monitor Only and control groups. In Study 1, this effect was observed in end-of-day positive affect. In Study 2, this effect was found in both end-of-day and momentary positive affect outcomes. In contrast, all active interventions in Studies 1 and 2 decreased negative affect. These studies provide the first experimental evidence that developing an orientation of acceptance toward present-moment experiences is a central mechanism of mindfulness interventions for boosting positive emotions in daily life.

scholarly journals Methodological Challenges in Randomized Controlled Trials on Smartphone-Based Treatment in Psychiatry: Systematic Review

10.2196/15362 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e15362 ◽  
Author(s):  
Morten Lindbjerg Tønning ◽  
Lars Vedel Kessing ◽  
Jakob Eivind Bardram ◽  
Maria Faurholt-Jepsen
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Psychiatric Disorders ◽  
Trial Design ◽  
Conflicts Of Interest ◽  
Diagnostic Procedures ◽  
Controlled Trials ◽  
Sufficient Information ◽  
Randomized Controlled ◽  
Methodological Challenges

Background Smartphone-based technology is developing at high speed, and many apps offer potential new ways of monitoring and treating a range of psychiatric disorders and symptoms. However, the effects of most available apps have not been scientifically investigated. Within medicine, randomized controlled trials (RCTs) are the standard method for providing the evidence of effects. However, their rigidity and long time frame may contrast with the field of information technology research. Therefore, a systematic review of methodological challenges in designing and conducting RCTs within mobile health is needed. Objective This systematic review aimed to (1) identify and describe RCTs investigating the effect of smartphone-based treatment in adult patients with a psychiatric diagnosis, (2) discuss methodological challenges in designing and conducting individual trials, and (3) suggest recommendations for future trials. Methods A systematic search in English was conducted in PubMed, PsycINFO, and EMBASE up to August 12, 2019. The search terms were (1) psychiatric disorders in broad term and for specific disorders AND (2) smartphone or app AND (3) RCT. The Consolidated Standards of Reporting Trials electronic health guidelines were used as a template for data extraction. The focus was on trial design, method, and reporting. Only trials having sufficient information on diagnosis and acceptable diagnostic procedures, having a smartphone as a central part of treatment, and using an RCT design were included. Results A total of 27 trials comprising 3312 patients within a range of psychiatric diagnoses were included. Among them, 2 trials were concerning drug or alcohol abuse, 3 psychosis, 10 affective disorders, 9 anxiety and posttraumatic stress disorder, 1 eating disorder, and 1 attention-deficit/hyperactivity disorder. In addition, 1 trial used a cross-diagnostic design, 7 trials included patients with a clinical diagnosis that was subsequently assessed and validated by the researchers, and 11 trials had a sample size above 100. Generally, large between-trial heterogeneity and multiple approaches to patient recruitment, diagnostic procedures, trial design, comparator, outcome measures, and analyses were identified. Only 5 trials published a trial protocol. Furthermore, 1 trial provided information regarding technological updates, and only 18 trials reported on the conflicts of interest. No trial addressed the ethical aspects of using smartphones in treatment. Conclusions This first systematic review of the methodological challenges in designing and conducting RCTs investigating smartphone-based treatment in psychiatric patients suggests an increasing number of trials but with a lower quality compared with classic medical RCTs. Heterogeneity and methodological issues in individual trials limit the evidence. Methodological recommendations are presented.

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