scholarly journals Combining economic modelling and randomised controlled trials: An unexploited synergyCombining economic modelling and randomised controlled trials: An unexploited synergy

10.51744/cmb3 ◽  
2021 ◽  
Author(s):  
Edoardo Masset ◽  
Keyword(s):  
Randomised Controlled Trials ◽  
Policy Implications ◽  
Controlled Trials ◽  
Economic Modelling ◽  
Randomised Trials ◽  
Development Interventions ◽  
Combined Use ◽  
Alternative Approaches ◽  
Randomised Controlled ◽  
Research Director

Over the last decade, many researchers have conducted randomised trials alongside economic models. The work of these researchers has shown that both approaches are strengthened by their combined use and the conclusions they lead to are full of policy implications. In the latest CEDIL Methods Brief, Edoardo Masset, Research Director, CEDIL Programme, uses three examples to offer tips on the application of modelling to evaluate development interventions and explore various policy questions. The brief shows that models and experiments should be seen as complementary, rather than as alternative approaches. This brief is based on the CEDIL Inception Paper No. 9, Structural Modelling in Policy Making, by Orazio Attanasio and Debbie Blair. This paper is available on the CEDIL website.

scholarly journals Preserving equipoise and performing randomised trials for COVID-19 social distancing interventions

2020 ◽  
Vol 29 ◽  
Author(s):  
Ioana Alina Cristea ◽  
Florian Naudet ◽  
John P. A. Ioannidis
Keyword(s):  
Observational Data ◽  
Study Design ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Randomised Trials ◽  
Social Distancing ◽  
Design Choice ◽  
Travel Restrictions ◽  
Randomised Controlled ◽  
Selection Of

Abstract In the coronavirus disease 2019 (COVID-19) pandemic, a large number of non-pharmaceutical measures that pertain to the wider group of social distancing interventions (e.g. public gathering bans, closures of schools, workplaces and all but essential business, mandatory stay-at-home policies, travel restrictions, border closures and others) have been deployed. Their urgent deployment was defended with modelling and observational data of spurious credibility. There is major debate on whether these measures are effective and there is also uncertainty about the magnitude of the harms that these measures might induce. Given that there is equipoise for how, when and if specific social distancing interventions for COVID-19 should be applied and removed/modified during reopening, we argue that informative randomised-controlled trials are needed. Only a few such randomised trials have already been conducted, but the ones done to-date demonstrate that a randomised trials agenda is feasible. We discuss here issues of study design choice, selection of comparators (intervention and controls), choice of outcomes and additional considerations for the conduct of such trials. We also discuss and refute common counter-arguments against the conduct of such trials.

Integrative Medicine and Prospective Research on CAM

2017 ◽  
pp. 272-301
Author(s):  
Mayuree Tangkiatkumjai ◽  
Annalisa Casarin
Keyword(s):  
Clinical Trials ◽  
Integrative Medicine ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Pragmatic Clinical Trials ◽  
Alternative Approaches ◽  
Research Study Design ◽  
Prospective Research ◽  
Future Direction ◽  
Randomised Controlled

There is a link between integrative medicine (IM) and prospective research on complementary and alternative medicine (CAM). IM is the future direction of CAM and research is needed to support clinical practice. Meaning of IM, proposed models of IM, and existing research on IM will be presented. Prospective research on CAM will cover methodologies presenting randomised controlled trials, harms studies of CAM in kidney disease, and a gap of CAM research. Study design and outcome measures are current challenges in CAM/IM research. Several networks of CAM research worldwide are still working on them and have proposed possible alternative approaches, such as pragmatic clinical trials and cohort multiple randomised controlled trials. These approaches would solve some limitations of randomised controlled trials in CAM research.

scholarly journals Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e038765
Author(s):  
Polly Scutt ◽  
Lisa J Woodhouse ◽  
Alan A Montgomery ◽  
Philip M Bath
Keyword(s):  
Outcome Measures ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Randomised Trials ◽  
Vascular Events ◽  
Randomised Controlled

ObjectivesMeta-analysis based on individual patient data (IPD) from randomised trials is superior to using published summary data since it facilitates subgroup and multiple variable analyses. Guidelines and funders expect that researchers share IPD for bona fide analyses, but in practice, this is done variably. Here, we report the experience of obtaining IPD for two collaborative analysis studies.SettingTwo linked studies required IPD from published randomised trials. The leading researchers for eligible trials were approached and asked to share IPD including trial characteristics, patient demographics, baseline clinical data and outcome measures.ParticipantsParticipants in eligible randomised controlled trials included patients with or at risk of cognitive decline/vascular events.Primary and secondary outcome measuresNumbers (%) of trials where the leading researcher responded favourably/negatively or did not respond. If negative, reasons behind the response were collected. If positive, methods used to share IPD were recorded.ResultsAcross the two studies, 391 completed trials were identified. Email addresses for researchers were found for 313 (80%) of the trials. One hundred and forty-eight (47%) researchers did not respond despite being sent multiple emails. Following contact, positive initial responses were received from 92 researchers, resulting in IPD being shared for 78 trials. Eighty-seven (28%) researchers declined to share data; justifications were recorded. The median time from first request to accessing data in one study was 241 (IQR 383.3) days. IPD sources included: direct from researcher, via academic trial funders repository and a website requiring remote analysis of commercial data. Where data were shared, a variety of methods were used to transfer data.ConclusionSharing of IPD from trials is desirable and a requirement of many funding bodies. However, accessing IPD faces multiple challenges including refusals to share, delays in access to data and having to perform analyses on a remote website.Trial registrationNot applicable.

scholarly journals Effect Measures in Meta-Analysis

2015 ◽  
Vol 62 (2) ◽  
pp. 75-80
Author(s):  
Md Belal Hossain
Keyword(s):  
Fixed Effects ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Random Effects Model ◽  
Fixed Effects Model ◽  
Randomised Trials ◽  
Effect Measure ◽  
Randomised Controlled

When conducting a meta-analysis of randomised controlled trials outcomes, appropriate choice of the effect measure is important. This article demonstrates on various types of effect measures in meta-analysis, for example, binary, continuous and ordinal outcomes. A general fixed effects model and a random effects model are employed for combining these outcomes in meta-analysis. Six trials totaling 1876 patients from a meta-analysis of randomised controlled trials evaluating the efficacy and drawbacks of limited (D1) versus extended lymphadenectomy (D2) for proven gastric adenocarcinoma are analysed for binary and continuous outcomes. An individual patient data consisting of five randomised trials of anti-cholinesterase drug tacrine in patients with Alzheimer's disease is also discussed for ordinal outcomes. DOI: http://dx.doi.org/10.3329/dujs.v62i2.21969 Dhaka Univ. J. Sci. 62(2): 75-80, 2014 (July)

scholarly journals Defining the Features of Registry Based Randomised Controlled Trials (rRCT): A Systematic Review

2020 ◽  
Author(s):  
Niamh O Shea ◽  
Joseph Eustace ◽  
Frances Shiely
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Grey Literature ◽  
Controlled Trials ◽  
Free Text ◽  
Cochrane Central Register ◽  
Narrative Synthesis ◽  
Randomised Trials ◽  
Key Features ◽  
Randomised Controlled

Abstract Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures such as case report completion, randomisation and follow up data. While the practice of utilising registries to support the conduct of randomised trials is increasing, the reporting of how a registry is used within a trial can vary, causing difficulty in identifying registry based randomised trials and interpreting their exact definition. Methods: The databases PubMed, Embase, Cinahl Plus, Scopus and the Cochrane Central Register of Controlled Trials will be searched using a combination of subject headings, MeSH and free text terms. Search terms will be adapted accordingly for each database, with English language articles included and no other filters applied. Also, grey literature and reference lists will be searched, contacting trial authors for clarification when necessary. Two independent reviewers will complete study screening, selection and quality assessment. A preliminary synthesis will be conducted tabulating the relevant evidence into separate data extraction tables. A narrative synthesis approach will be adopted based on the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews.Results: The present study will synthesise existing registry based randomised trial literature and define their key features.Conclusions: It is essential that trialists and researchers can review published trials and endeavour to duplicate trial designs. There is a lack of consensus in terms of the reporting of registry based randomised trials, making replication of this emerging trial design difficult. This review will clearly summarise and define the key features of these randomised trials, to allow researchers understand and reproduce the novel registry based randomised controlled trial methodology. Systematic Review Registration: PROPSERO CRD42020192419

Integrative Medicine and Prospective Research on CAM

2019 ◽  
pp. 17-37
Author(s):  
Mayuree Tangkiatkumjai ◽  
Annalisa Casarin
Keyword(s):  
Clinical Trials ◽  
Integrative Medicine ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Pragmatic Clinical Trials ◽  
Alternative Approaches ◽  
Research Study Design ◽  
Prospective Research ◽  
Future Direction ◽  
Randomised Controlled

There is a link between integrative medicine (IM) and prospective research on complementary and alternative medicine (CAM). IM is the future direction of CAM and research is needed to support clinical practice. Meaning of IM, proposed models of IM, and existing research on IM will be presented. Prospective research on CAM will cover methodologies presenting randomised controlled trials, harms studies of CAM in kidney disease, and a gap of CAM research. Study design and outcome measures are current challenges in CAM/IM research. Several networks of CAM research worldwide are still working on them and have proposed possible alternative approaches, such as pragmatic clinical trials and cohort multiple randomised controlled trials. These approaches would solve some limitations of randomised controlled trials in CAM research.

Sign in / Sign up

Export Citation Format

Share Document