scholarly journals Randomized Controlled Trials

2021 ◽  
Vol 2 (2) ◽  
Author(s):  
Nidhi Bhatia ◽  
Anju Grewal
Keyword(s):  
Controlled Trial ◽  
Research Question ◽  
Sample Size Calculation ◽  
Allocation Concealment ◽  
Randomised Control Trial ◽  
Sample Population ◽  
Random Allocation ◽  
Randomized Controlled ◽  
Comparison Groups ◽  
Study Designs

A randomized controlled trial (RCT) is a prospective, comparative, quantitative experiment/study that is performed under controlled conditions with random allocation of interventions to comparison groups. Among all the clinical study designs, evidence generated from RCTs is considered to be at top of the evidence pyramid. There are many different RCT designs and they can be classified on the basis of interventions evaluated, participants’ exposure and level of blinding. All RCTs should be planned prospectively, a research question should be formulated, sample population approached and informed consent obtained from participants of the trial. These consented subjects are randomly assigned to any of the study arms and the changes are then measured over time. The basic principles to designing an RCT include formulating a research question, developing a protocol, randomization, allocation concealment, blinding, sample size calculation and registering of RCTs. Appropriate guidelines for reporting RCTs should be followed and RCTs should only be conducted if they are ethically viable, economical and clinically worthwhile. Keywords: Randomised Control Trial (RCT)

scholarly journals Deficiencies in the reporting quality of RCTs in neurosurgery: How can we do better?

2015 ◽  
Vol 42 (S1) ◽  
pp. S12-S12
Author(s):  
A Mansouri ◽  
B Cooper ◽  
S Shin ◽  
D Kondziolka
Keyword(s):  
Sample Size Calculation ◽  
Reporting Quality ◽  
Allocation Concealment ◽  
High Yield ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Study Designs ◽  
Design Factors

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neurosurgery was analyzed to assess adequacy of design and reporting. Methods: A high-yield search of the MEDLINE and EMBASE databases (2000-present) was conducted. The CONSORT and Jadad scales were used to assess the quality of design/reporting. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations. Results: Sixty-one articles were identified. Vascular was the most common sub-specialty (37%). The median CONSORT and Jadad scores were 36 (IQR 27.5-39) and 3 (IQR 2-3). Blinding, sample size calculation and allocation concealment were most deficiently reported. The quality of reporting did not correlate with the study impact. The majority of studies (83%) had pragmatic objectives; while pragmatic studies had compatible design factors, trials with explanatory objectives were less successful. Conclusions: The prevalence and quality of neurosurgical RCTs is low. Many study designs are not compatible with stated objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting. Alternative methodologies merit discussion.

scholarly journals How should a clinician interpret results of randomized controlled trials?

2010 ◽  
Vol 17 (1-2) ◽  
pp. 30-34
Author(s):  
Virginijus ŠAPOKA ◽  
Vytautas KASIULEVIČIUS ◽  
Janina DIDŽIAPETRIENĖ
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Study Groups ◽  
Controlled Trials ◽  
Random Allocation ◽  
Equivalence Testing ◽  
Randomized Controlled ◽  
Selection Of

Randomized controlled trials (RCTs) and systematic reviews are the most reliable methods of determining the effects of treatment. The randomization procedure gives a randomized controlled trial its strength. Random allocation means that all participants have the same chance of being assigned to each of the study groups. The choice of which end point(s) to select is critical to any study design. Intention-to-treat is the preferred approach to the analysis of clinical trials. Sample size calculations and data analyses have an important impact on the planning, interpretation, and conclusions of randomized trials. In this article, we discuss the problematic areas that can affect the outcome of a trial, such as blinding, sample size calculation, randomization; concealment allocation; intention of treating the analysis; selection of end points; selection of traditional versus equivalence testing, early stopped trials, selective publications. Keywords: randomized controlled trials, sample size, outcomes, type of analyses

scholarly journals Study methodology in trauma care: towards question-based study designs

2019 ◽  
Author(s):  
Roderick M. Houwert ◽  
Reinier B. Beks ◽  
Marcel G. W. Dijkgraaf ◽  
Kit C. B. Roes ◽  
F. Cumhur Öner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Observational Studies ◽  
Surgical Intervention ◽  
Controlled Trial ◽  
Research Question ◽  
Observational Research ◽  
Surgical Interventions ◽  
Randomized Controlled ◽  
Study Methodology ◽  
Study Designs

Abstract The randomized controlled trial (RCT) in surgery may not always be ethical, feasible, or necessary to address a particular research question about the effect of a surgical intervention. If so, properly designed and conducted observational (non-randomized) studies may be valuable alternatives for an RCT and produce credible results. In this paper, we discus differences between RCTs and observational studies and differentiate between three types of comparisons of surgical interventions. We assert that results of different designs should be regarded as complementary to each other when evaluating surgical interventions. Criteria for credible observational research are presented to provide guidance for future observational research of surgical interventions. We argue that the research question that is being asked should guide the discussion about the value of a particular study design.

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial

10.2196/30339 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e30339
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. Objective Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. Methods We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. Results The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. Conclusions This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID) DERR1-10.2196/30339

scholarly journals Designs of studies published in two Brazilian journals of orthopedics and sports medicine, recently indexed in the ISI Web of Science

2009 ◽  
Vol 127 (6) ◽  
pp. 355-358 ◽  
Author(s):  
Rachel Riera
Keyword(s):  
Sports Medicine ◽  
Web Of Science ◽  
Experimental Studies ◽  
Sample Size Calculation ◽  
Allocation Concealment ◽  
Impact Factors ◽  
Isi Web Of Science ◽  
Manual Search ◽  
Study Designs ◽  
De Medicina

CONTEXT AND OBJECTIVE: The methodology and relevance of articles are among the keystones for promoting their citation and increasing journals' impact factors. Study designs appropriate for answering the questions and adequate sample sizes have the aim of reducing the risk of bias. This study evaluated the articles published in two Brazilian journals of orthopedics and sports medicine that were recently indexed in the ISI Web of Science, regarding study design, sample size calculation, randomization and blinding. DESIGN AND SETTING: Descriptive study at Brazilian Cochrane Center. METHODS: Through a manual search, all original manuscripts published in 2007 in Acta Ortopédica Brasileira and Revista Brasileira de Medicina do Esporte were selected and evaluated. RESULTS: All the 60 articles published in Acta Ortopédica Brasileira and the 87 articles in Revista Brasileira de Medicina do Esporte were included and evaluated. The commonest design in Acta Ortopédica Brasileira was experimental studies (n = 19) and in Revista Brasileira de Medicina do Esporte, update or review articles (n =14). Sample calculations were seen in a minority of the articles. None of the eight clinical trials published presented sample calculations or adequate randomization processes. Three were described as blinded, but none described the measures taken to prevent disclosure of the allocation concealment. CONCLUSIONS: Publication of studies of good methodological quality other than review and experimental studies should be strongly encouraged among Brazilian journals, with the aim of increasing their citation and therefore their impact factor.

scholarly journals Effects of Qigong on Depression: A Systemic Review

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Byeongsang Oh ◽  
Sun Mi Choi ◽  
Aya Inamori ◽  
David Rosenthal ◽  
Albert Yeung
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Systemic Review ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Treatment Of Depression ◽  
Rigorous Study ◽  
Study Designs ◽  
Positive Results

Physical exercises and relaxation have been found to be beneficial for depression. However, there is little evidence on the use of Qigong, a mind-body practice integrating gentle exercise and relaxation, in the management of depression. The aim of this paper is to evaluate the effects of Qigong on depression. The paper examined clinical trials measuring the effect of Qigong on depression within six large-scale medical research databases (PubMed, Medline, ProQuest, Science Direct, EMBASE, and PsycInfo) till October 2011. Key words “Qigong,” “depression,” and “mood” were used. Ten studies were identified as original randomized controlled trial (RCT) studies investigating the effect of Qigong on depression as primary (n=2) or secondary outcome (n=8). Four studies reported positive results of the Qigong treatment on depression; two reported that Qigong effect on depression was as effective as physical exercise. One study reported that Qigong was comparable to a conventional rehabilitation program, but the remaining three studies found no benefits of Qigong on depression. While the evidence suggests the potential effects of Qigong in the treatment of depression, the review of the literature shows inconclusive results. Further research using rigorous study designs is necessary to investigate the effectiveness of Qigong in depression.

scholarly journals The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

2021 ◽  
Vol 15 (5) ◽  
pp. 1604-1615
Author(s):  
Mozhgan Zareyee Salehabadi ◽  
Masoomeh Kheirkhah ◽  
Nazanin Esmaeeli ◽  
Shima Haghani
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Control Group ◽  
Random Allocation ◽  
Decision Conflict ◽  
Randomized Controlled ◽  
Empowerment Model ◽  
The Impact

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

scholarly journals Use of scratchcards for allocation concealment in a prehospital randomised controlled trial

2018 ◽  
pp. emermed-2018-207881 ◽  
Author(s):  
Leigh Keen ◽  
Jenna Katherine Bulger ◽  
Nigel Rees ◽  
Helen Snooks ◽  
Greg Fegan ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Prehospital Care ◽  
Controlled Trial ◽  
Allocation Concealment ◽  
Prehospital Setting ◽  
Random Allocation ◽  
Registration Number ◽  
Randomised Controlled ◽  
Fascia Iliaca Compartment Block

BackgroundRapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting.MethodsScratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area.ResultsNineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found.ConclusionParamedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting.Trial registration numberISRCTN60065373; Post-results.

scholarly journals An analysis of productivity app strengths: An environmental scan

2021 ◽  
Author(s):  
Harshdeep Dhaliwal ◽  
Kundan Ahluwalia ◽  
Dana Kukje Zada ◽  
Daphne Qin ◽  
Rameen Tanveer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Muscle Relaxation ◽  
Research Question ◽  
Grey Literature ◽  
Harvard Business Review ◽  
Screening Tools ◽  
Literature Information ◽  
Randomized Controlled ◽  
Business Source Premier ◽  
Reducing Stress

BACKGROUNDIn recent years, productivity apps have become the most commonly used apps. While some may feel productivity apps work solely as a result of the placebo effect , productivity apps have been shown to have three major benefits: accountability, assessment, and improvement. Stress levels were especially reduced in the two meditation groups as opposed to the muscle relaxation group . Furthermore, there has been reported evidence on the effectiveness of app-based meditation and mindfulness in reducing stress and increasing productivity for users.METHODSIn order to answer the research question, published articles from ProQuest, Business Source Premier and Web of Science were used. Additionally, Harvard Business Review was also used as a source of grey literature. Information was collected in order to determine the strengths of competing productivity apps and how they could limit or be applied to the Felicity App. The research was reviewed based on screening tools that assessed validity and relevance. Included studies were published within Asia, North America, Australia, or Europe, and were either quantitative, qualitative, randomized controlled trial (RCT), surveys, experiments with participants, or academic studies. Study screening and extraction were completed independently among two authors. Disagreements following reconciliation between the two authors were settled by a third author.RESULTSThe selected articles discuss information including methods of improving productivity, mobile-based interventions that are effective at improving either overall health or productivity, and techniques that may be applicable to the Felicity App as a mobile-based intervention.CONCLUSIONThe results show that the Felicity App can improve user outcomes by integrating features from other applications.

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. CLINICALTRIAL ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30339

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