scholarly journals The People’s Trial: Supporting the Public’s Understanding of Randomised Trials.

2021 ◽  
Author(s):  
Elaine Finucane ◽  
Ann O’Brien ◽  
Shaun Treweek ◽  
John Newell ◽  
Kishor Das ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Randomised Trial ◽  
Health Claims ◽  
Public Understanding ◽  
Randomised Trials ◽  
Online Surveys ◽  
The Public ◽  
Trial Conduct ◽  
Robust Evidence

Abstract BackgroundRandomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People’s Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims. MethodsUsing a reflexive approach, we describe the processes of development, conduct and dissemination of The People’s Trial. ResultsOver 3000 members of the public, from 72 countries, participated in The People’s Trial. Through a series of online surveys, the public chose the question The People’s Trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e., ‘Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed?’ We called this trial The Reading Trial.We report processes of The People’s Trial in seven phases, paralleling the steps of a randomised trial, i.e., question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned. ConclusionThe People’s trial engaged members of the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims. Trial Registration The Reading Trial was registered 4th December 2019 on ClinicalTrials.gov, ID: NCT04185818.

scholarly journals Does Reading a Book in Bed Make a Difference to Sleep in Comparison to Not Reading a Book in Bed? The People's Trial- an Online, Pragmatic, Randomised Trial

2021 ◽  
Author(s):  
Elaine Finucane ◽  
Ann O’Brien ◽  
Shaun Treweek ◽  
John Newell ◽  
Kishor Das ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Randomised Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomised Trials ◽  
Media Campaigns ◽  
The Public ◽  
Equal Chance ◽  
Group A ◽  
Sleep Control

Abstract BackgroundThe best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found can be put down to the treatment received rather than other things, such as where people live, or health conditions they might have.The People’s Trial aimed to help the public better understand randomised trials by inviting them to design and carry out a trial. The question chosen by the public for The People’s Trial was:‘Does reading a book in bed make a difference to sleep, in comparison to not reading a book in bed?’ This paper describes that trial, called ‘The Reading Trial’.MethodsThe Reading Trial was an online, randomised trial. Members of the public were invited to take part through social media campaigns. People were asked to either read a book in bed before going to sleep (intervention group) or not read a book in bed before going to sleep (control group). We asked everyone to do this for seven days, after which they measured their sleep quality. Results During December 2019, a total of 991 people took part in The Reading Trial, half (496 (50%)) in the intervention group and half (495 (50%)) in the control group. Not everyone finished the trial: 127 (25.6%) people in the intervention group, and 90 (18.18%) people in the control group. Of those providing data, 156/369 (42%) people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. When we consider how certain we are of this finding, we estimate that, in The Reading Trial, sleep improved for between 8% and 22% more people in the intervention group compared to the control group.ConclusionsReading a book in bed before going to sleep improved sleep quality, compared to not reading a book in bed.Trial Registration Registered 4th December 2019, ClinicalTrials.gov ID: NCT04185818.

scholarly journals The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

BMJ ◽  
2020 ◽  
pp. m115 ◽  
Author(s):  
Munyaradzi Dimairo ◽  
Philip Pallmann ◽  
James Wason ◽  
Susan Todd ◽  
Thomas Jaki ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adaptive Design ◽  
Randomised Trial ◽  
Adaptive Designs ◽  
Future Research ◽  
Randomised Trials ◽  
Public And Private ◽  
Key Stakeholders ◽  
Potential Benefits ◽  
Explanatory Text

AbstractAdaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

scholarly journals Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People’s Trial—an online, pragmatic, randomised trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elaine Finucane ◽  
Ann O’Brien ◽  
Shaun Treweek ◽  
John Newell ◽  
Kishor Das ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Randomised Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomised Trials ◽  
Media Campaigns ◽  
The Public ◽  
The People ◽  
Equal Chance ◽  
Group A

Abstract Background The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found can be put down to the treatment received rather than other things, such as where people live, or health conditions they might have. The People’s Trial aimed to help the public better understand randomised trials by inviting them to design and carry out a trial. The question chosen by the public for The People’s Trial was: ‘Does reading a book in bed make a difference to sleep, in comparison to not reading a book in bed?’ This paper describes that trial, called ‘The Reading Trial’. Methods The Reading Trial was an online, randomised trial. Members of the public were invited to take part through social media campaigns. People were asked to either read a book in bed before going to sleep (intervention group) or not read a book in bed before going to sleep (control group). We asked everyone to do this for 7 days, after which they measured their sleep quality. Results During December 2019, a total of 991 people took part in The Reading Trial, half (496 (50%)) in the intervention group and half (495 (50%)) in the control group. Not everyone finished the trial: 127 (25.6%) people in the intervention group and 90 (18.18%) people in the control group. Of those providing data, 156/369 (42%) people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. When we consider how certain we are of this finding, we estimate that, in The Reading Trial, sleep improved for between 8 and 22% more people in the intervention group compared to the control group. Conclusions Reading a book in bed before going to sleep improved sleep quality, compared to not reading a book in bed. Trial registration ClinicalTrials.gov NCT04185818. Registered on 4 December 2019.

scholarly journals The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

2019 ◽  
Author(s):  
Munyaradzi Dimairo ◽  
Philip Pallmann ◽  
James Wason ◽  
Susan Todd ◽  
Thomas Jaki ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adaptive Design ◽  
Randomised Trial ◽  
Adaptive Designs ◽  
Future Research ◽  
Randomised Trials ◽  
Public And Private ◽  
Key Stakeholders ◽  
Potential Benefits ◽  
Explanatory Text

Abstract Background Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised. Methods This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 Statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process. Results The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist is comprised of seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text. Conclusions The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

scholarly journals How to prove that your therapy is effective, even when it is not: a guideline

2015 ◽  
Vol 25 (5) ◽  
pp. 428-435 ◽  
Author(s):  
P. Cuijpers ◽  
I. A. Cristea
Keyword(s):  
Gold Standard ◽  
Treatment Guidelines ◽  
Randomised Trial ◽  
Small Sample ◽  
Risk Of Bias ◽  
Randomised Trials ◽  
Control Groups ◽  
Policy Makers ◽  
Small Sample Sizes ◽  
Positive Effect

Aims.Suppose you are the developer of a new therapy for a mental health problem or you have several years of experience working with such a therapy, and you would like to prove that it is effective. Randomised trials have become the gold standard to prove that interventions are effective, and they are used by treatment guidelines and policy makers to decide whether or not to adopt, implement or fund a therapy.Methods.You would want to do such a randomised trial to get your therapy disseminated, but in reality your clinical experience already showed you that the therapy works. How could you do a trial in order to optimise the chance of finding a positive effect?Results.Methods that can help include a strong allegiance towards the therapy, anything that increases expectations and hope in participants, making use of the weak spots of randomised trials (risk of bias), small sample sizes and waiting list control groups (but not comparisons with existing interventions). And if all that fails one can always not publish the outcomes and wait for positive trials.Conclusions.Several methods are available to help you show that your therapy is effective, even when it is not.

A Subtle but Intractable Problem? Public Attitudes to Sectarianism in 2014

2015 ◽  
Vol 24 (3) ◽  
pp. 266-287 ◽  
Author(s):  
Rachel Ormston ◽  
John Curtice ◽  
Stephen Hinchliffe ◽  
Anna Marcinkiewicz
Keyword(s):  
Public Opinion ◽  
Public Attitudes ◽  
Evidence Base ◽  
Social Attitudes ◽  
The Public ◽  
Public Beliefs ◽  
Intractable Problem ◽  
Robust Evidence

Discussion of sectarianism often focuses on evidence purporting to show discriminatory behaviour directed at Catholics or Protestants in Scotland. But attitudes also matter – in sustaining (or preventing) such discriminatory behaviours, and in understanding the nature of the ‘problem of sectarianism’ from the perspective of the Scottish public. This paper uses data from the Scottish Social Attitudes survey 2014. The survey fills a gap in the evidence base by providing robust evidence on what the public actually thinks about sectarianism in modern Scotland. It assesses public beliefs about the extent and nature of sectarianism and its perceived causes. Tensions in public opinion and differences in the attitudes of different sections of Scottish society are explored.

L'importance des outils de planification forestière dans les opérations de relations publiques en Suisse | The importance of forestry planning tools in public relations operation in Switzerland

2004 ◽  
Vol 155 (11) ◽  
pp. 487-491
Author(s):  
Christina Giesch Shakya
Keyword(s):  
Forest Management ◽  
Public Relations ◽  
Management Plan ◽  
Public Understanding ◽  
The Public ◽  
Forest Management Plan ◽  
Forest Enterprises ◽  
Forestry Services ◽  
Regional Forest ◽  
Structured Questionnaire

The current study examines the importance of planning and management documents (notably the forest management plan and the regional forest plan) for public relations purposes. 17 people (15 forest engineers and 2 forest guards) were interviewed using a semi-structured questionnaire. The results of our survey show that some of the information used for public relations is taken from the planning documents. The forest management plan is primarily considered to be an internal document, but it also provides information on the objectives of forest enterprises, justifications of the planned measures, numbers and maps. The regional forest plan contributes to the public relations in three ways: its content provides information about objectives, description of forest functions, projects and measures. In addition, the participation of the public in the process of elaborating this plan is an ideal opportunity to heighten awareness in society and further public understanding of the forest and forestry services. Finally, as the regional forest management plan is in the public domain, it functions as a type of «show case» of the forest service.

scholarly journals Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

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