What is this blog about?

-
This is blog is about the PoINT project - Public Involvement in Numerical aspects of trials. 
Involving patients and the public in clinical trials has the potential to improve research and its relevance and reduces research waste by improving recruitment. However, to achieve its maximum impact, we need to better understand how to operationalise patient and public involvement (PPI) across all aspects of a trial process. Patients should have the opportunity to be heard in all aspects of clinical trials, including numerical aspects which play an essential role in how trials are designed, analysed and reported. For example, patients could be directly involved in informing the most important analyses questions; or in discussing interpretation of results. Currently, little is known about how patients are involved in numerical aspects of trials.
Our main aim with this project is to ask: what are the important numerical aspects of trials that patients and the public can and want to contribute to?

Comments

Post a Comment

Popular posts from this blog

Missing data

-
Image
What does it mean? When a participant outcome is unavailable, due to a missing questionnaire or non-attendance to a trial related clinical appointment, their results are unknown. We call this missing data. In the toothpaste trial, this would mean we don’t know a participant's pain score at the end. We have a number of options available to try to account for the missing values. For example, we can use statistical tools that aim to predict what happened to patients that did not provide results, taking into account these predictions are uncertain, ie we do not know for sure what happened to those participants. You can find out more about what missing data is and its impact on interpretation of treatment claims here . How could patients be involved? Patients can help us predict missing values so we can assess treatment effect with more certainty. Example  Some participants in the toothpaste trial will have their pain score missing. For those participants and to ensure we investigate di
Read more

Analysis methods: how the trial data will be analysed

-
 What does it mean? When patients enter a trial, we collect their information. We usually collect their information at baseline (who is taking part in the trial?), and during follow-up (with questionnaires and/or clinical visits). This information is gathered in a database and analysed to answer the ultimate trial question - does the treatment work when compared with a control (usually another treatment)?  Trial analysis is complex and involves statistical models that estimate the treatment effect, ie how well the treatment works when compared with a control.  The statistical models we use to analyse trial data may be "adjusted for" patient's characteristics. This usually happens if we believe those characteristics are important to understand the treatment effect. Statistical models make assumptions about the information collected and it is important to know those assumptions in order to interpret the findings of the trial correctly. An example In the toothpaste trial, we
Read more

Withdraw or lost to follow-up

-
 What does it mean? Trial participants may leave the trial actively (for example, they contact the trial team to say they no longer wish to participate) or passively (they stop answering questionnaires or attending clinical visits, this is usually called "lost to follow-up"). Both options are called "withdrawal from the trial". From a trials analysis point of view, they usually mean we can't include these participants in the final analysis.  An example Emma was happy to join the toothpaste trial and attend clinical visits every year for three years. However, she started a new job in a different city and is no longer available to attend clinical visits. Emma contacts the trial team and says she no longer wishes to take part. Emma has withdrawn from the toothpaste trial. How can patients be involved? Patients can be involved in collecting and interpreting information related to trial participant's withdrawal. They can also help decide the best way to summarise
Read more