Marion Campbell

Taken today 😊

Lovely autumn colours on campus 🍂🍁 @uniofaberdeen.bsky.social

I'm doing a webinar in two weeks (15 Oct 1-2pm BST), part of NIHR Research Support Service's Methods Academy series, on the age-old question: should I do a stepped wedge trial?

Free registration, details here: tinyurl.com/z6cjvce3

@nihr-rss.bsky.social @wiphcem.bsky.social @qmul-wiph.bsky.social

Excellent three days in Bristol as part of the #BOASTiC (Bristol Oxford Aberdeen Surgical Trials Course). We've enjoyed the in-depth look at surgical trials with delegates designing their own studies by the end of the 3rd day! @marionkcampbell.bsky.social @situ-oxford.bsky.social

Great #MethodologyMonday post on assessing acceptability in a pilot trial. Highlights the MRC complex intervention framework that AIMS Periop has used in its frailty research.

The measure can help highlight how an intervention may need to be improved ahead of full evaluation 7/7

Constructs include affective attitude (how someone feels about the intervention), burden, ethicality, intervention coherence (understanding of how the intervention works), opportunity costs, perceived effectiveness, & self-efficacy (one’s confidence that they can use it). 6/7

Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions - BMC Health Services Research Background The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of he...

When assessing the acceptability of an intervention, Sekhon et al have developed a useful tool (the Theoretical Framework of Acceptability): a theory-based measure that can be used to assess acceptability of an intervention to its users. 5/7
bmchealthservres.biomedcentral.com/articles/10....

Assessment of acceptability can be explored through multiple approaches eg via qualitative interviews or focus groups, via questionnaires or via proxy measures eg consent rates 4/7

The MRC complex intervention framework gives a useful summary of the range of people whose views should be considered. It also encourages adopting a diverse approach. 3/7
See www.bmj.com/content/374/...

This is particularly the case when planning for the evaluation of complex interventions as they are often multi-faceted and involve/impact many different parties (including at patient, professional and system levels) 2/7

One of the key things to address when undertaking a feasibility study ahead of a trial is the acceptability of different aspects of the proposed trial (intervention, trial processes, proposed outcomes etc) to all relevant parties 1/7
#MethodologyMonday #125

The Bone & Joint Journal. Extract from article titled 'Clinical trials in Trauma and Orthopaedics: time to think Bayesian?'

The use of Bayesian methods in the design of trials and the analysis of the findings provides several potential benefits, which may be particularly applicable in Trauma & Orthopaedic surgery.

#ClinicalTrials #BayesianStatistics #RCTs #OrthoSky
@docfarrow.bsky.social

ow.ly/xeXm50WRwZN

Trials Methodologist/ Senior Trials Methodologist (Statistics) in Sutton | The Institute of Cancer Research View details and apply for this Trials Methodologist/ Senior Trials Methodologist (Statistics) vacancy in Sutton. Salary : Commencement on the salary range is subject to comparable skills an...

We're currently looking for a Trials Methodologist/Senior Trials Methodologist to join our team.

You can find out more about the role and how to apply here:
jobs.icr.ac.uk/vacancies/13...

#ResearchJobs #TrialsMethodology🧪

This👇 …. often unseen but crucial role

Monday wisdom

📣FUNDING ALERT: The NIHR/MRC Better Methods Better Research Programme has three new calls open:
- Researcher-Led
- Methodology for the incorporation of health and environmental impacts in health/social care
- Guidance development

Closing 2nd Dec
See: www.nihr.ac.uk/funding-oppo...

For Monday crowd. INSPECT-SR, a tool to help you identify problematic (inc. fraudulent) RCTs, now available.

A recent paper in the BMJ (by Ying et al) is a good read - with worked examples, tables and code to help calculate an appropriate pilot sample size. It also stresses the importance of aligning sample sizes with the objectives of the pilot study 6/6
www.bmj.com/content/bmj/...

There are a number of papers outlining approaches to pilot study sample size calculations - from rules of thumb (eg Julious) to ones based on estimating precision of standard deviations eg Sim & Lewis 5/6
Julious: onlinelibrary.wiley.com/doi/10.1002/...
Sim & Lewis: www.jclinepi.com/article/S089...

A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020 - Pilot and Feasibility Studies Background Pilot and feasibility studies provide information to be used when planning a full trial. A sufficient sample size within the pilot/feasibility study is required so this information can be e...

Totton et al published an interesting review exploring what sample sizes have been used in pilot and feasibility studies over recent years 4/6
pilotfeasibilitystudies.biomedcentral.com/articles/10....

Uncertainties may include estimating likely recruitment rates, rates of consent, follow up and so on … so the approach to sample size is generally about estimation and precision not significance testing 3/6

It is first important to stress that pilot and feasibility studies are *not* about detecting intervention effects. They are about exploring key uncertainties ahead of the main trial 2/6

I seem to have been discussing pilot and feasibility studies a lot this week. One question often asked is how big should my pilot/feasibility study be? 1/6
#MethodologyMonday #124

We are co-authors on 2 new papers in @bonejointjournal.bsky.social - one on the potential of Bayesian trials in T&O and a Bayesian reanalysis of the WHiTE8 trial.
And … our own Jemma Hudson is the featured author 😊
@docfarrow.bsky.social
@marionkcampbell.bsky.social

Links to papers below 👇

The four UK higher education funding bodies confirm the pause in the criteria setting and publication of final guidance for REF 2029 for a short period, as announced by the UK Science Minister Lord Vallance today at the Universities UK conference. 2029.ref.ac.uk/news/pause-t...

Scottish beach advice for the Summer.
Arrive early to grab a spot 🏴󠁧󠁢󠁳󠁣󠁴󠁿

There has been a lot of debate recently about the promise of real world data - the routine (observational) data collected on patients eg  treatments received, clinical outcomes etc – for estimating treatment effects. But can they deliver? 1/9
#MethodologyMonday #123

I agree - there needs to be much more done to improve the inclusivity of trials! There was a useful recent rapid response in the BMJ from @vickylshepherd.bsky.social outlining the importance of this, and some of the work being done in this space. www.bmj.com/content/390/...

Ahoy! Learn about the importance of randomisation through history in my library at www.jameslindlibrary.org. For example, read how the GISSI trials embedded patient and public health oriented randomised trials into the Italian health service 40 years ago
www.jameslindlibrary.org/articles/emb...