Reporting randomized trials of psychological and psychosocial interventions: consort-spi 2018

2020 ◽  
pp. 41-49
Author(s):  
A. V. Trusova ◽  
S. G. Klimanova
Keyword(s):  
Psychosocial Intervention ◽  
Randomized Trials ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Evidence Based ◽  
Randomized Controlled ◽  
The World ◽  
Block Scheme ◽  
History Of ◽  
Methodological Principles

Randomized controlled trial (RCT) is a “gold standard” evidence-based approach to the assessment of psychological and psychosocial interventions; the results of RCT provide an opportunity to give a scientifically grounded decision about the effectiveness and the applicability of intervention. The current biopsychosocial approach requires the necessity of having precise, comprehensive, and transparent reports about conducting RCT in medicine, as well as psychological and psychosocial interventions, including psychotherapy. The unified standards for reporting RCT’s results were developed by the CONSORT group (CONsolidated Standards Of Reporting Trials, the latest edition in 2010). They are currently considered a guide for presenting results in leading medical journals in the world. The expansion of CONSORT, which described the standards for presenting the results of psychological and psychosocial intervention CONSORTSPI was developed in 2018. The article presents the history of developing the standards, their scientific and methodological principles, the brief content, and the main instruments used (check-list and block-scheme). It is important to consider the guidelines of CONSORT-SPI 2018 and follow them in order for the scientific community to assess the quality, the applicability of different contexts, as well as replicability of psychological and psychosocial interventions studies.

The history of evidence-based medicine

2016 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Evidence Based Medicine ◽  
Controlled Trial ◽  
Scientific Data ◽  
Therapeutic Interventions ◽  
Evidence Based ◽  
Randomized Controlled ◽  
History Of ◽  
Historical Accounts ◽  
Based Medicine

The pursuit of tests for therapeutic interventions has been a characteristic of Western medicine since ancient times. Historical accounts of the clinical trial are usually expressed through the lens of presentism: how the various components of the first modern randomized controlled trial-the comparison, blinding, and randomization-culminated in Austin Bradford Hill’s 1946 trial of streptomycin for tuberculosis. The factual context of the development of the randomized controlled trial is important if only to emphasize the historicity of contemporary research methodology. However, the adoption of the various components of the trial at any one time has as much to do with changing the socio-political and ethical contexts as the ‘objective’ scientific standards of evidence. Evidence is not just scientific data floating in some ethereal medium, but is also linked to facts and beliefs of the various members of diverse medical communities who interpret evidence and deploy it to legitimize various strategies. This introductory chapter aims to present the background and context through which evidence-based medicine has emerged.

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 717-773
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Randomized Trials ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Hierarchy Of Evidence ◽  
Based Medicine

Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo-controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes. Key words: Randomized controlled trial (RCT), placebo-controlled trial, pragmatic controlled trial, randomization, allocation concealment, sample size, blinding, consolidated standards of reporting trials (CONSORT) statement, minimal clinically important change (MCIC), minimal clinical important difference (MCID)

The History of the Early Controlled Trial: Lessons for Contemporary Clinical Psychologists and Students

2020 ◽  
Author(s):  
Candice Basterfield ◽  
Scott Owen Lilienfeld
Keyword(s):  
Clinical Trial ◽  
Clinical Psychology ◽  
Controlled Trial ◽  
Psychology Students ◽  
Clinical Psychologists ◽  
Evidence Based ◽  
Clinical Psychology Students ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
History Of

In this review, we traverse the long and fascinating journey of the clinical trial, which started with a variety of attempts to examine the effectiveness of psychological and medical interventions, and only later incorporated randomization, blinding, and use of placebos. We also briefly explore why many of these early discoveries were resisted or outright ignored, and how the counterintuitive nature of the clinical trial may help to explain the ongoing criticism and resistance to randomized controlled trials in contemporary clinical psychology. We hope that today’s clinical psychologists, clinical psychology students, and clinical psychology instructors will find much of this material not merely interesting in its own right but informative in affording a broader historical perspective on modern views of evidence-based practice and resistances to it.

scholarly journals Protocol of a Multi-centric Randomized Controlled Trial to Evaluate Efficacy of Telephone-Based Psychosocial Interventions on Future Suicide Risk in Suicide Attempters

2020 ◽  
Vol 42 (6_suppl) ◽  
pp. S39-S45
Author(s):  
Ram Pratap Beniwal ◽  
Priya Sreedaran ◽  
Uttara Chari ◽  
Ashok MV ◽  
Triptish Bhatia
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Treatment ◽  
Suicide Attempts ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Health Treatment ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Telephone Reminders

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck’s Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck’s Hopelessness Scale, Beck’s Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors.

Sign in / Sign up

Export Citation Format

Share Document