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#RCTs

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Public
Martin Modrák

I am helping design my first randomized trial and I am reading up on group-sequential designs. At this point I am both pleasantly surprised by the efficiency gains possible, but also appalled by the complete disregard for any pre-asymptotic regime where things are not multivariate normal and Brownian.
#stats #RCTs

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Matt Hodgkinson

"The new study ... will recruit 360 people in England and Wales. Half will continue to get help from frontline charities. The other half will get additional help from Greater Change, whose support workers will discuss their financial problems then pay for items such as rent deposits, outstanding debts, work equipment, white goods, furniture or new clothes. They do not make direct transfers to avoid benefits being stopped due to a cash influx."

theguardian.com/society/2024/n

The Guardian · Homeless people to be given cash in first major UK trial to reduce povertyBy James Tapper
#HomelessnessUK#RCTs
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skua

We've seen what ⁨#EBM⁩ ⁨#EvidenceBasedMedicine⁩ produces;
on #Masking with #TomJefferson⁩ assisted by #Cochrane,
the decades of infectious respiratory disease research that poo-hooed #AirborneTransmission, and,
the RWNJ #CassReport⁩ on care for transgender kids.

Lots of bad stuff resulting from fetishising ⁨#RandomControlledTrials⁩ ⁨#RCTs⁩ as the only research that can be relied on.

Will we hear from Trumpists that there's no RCTs that support action on #ClimateChange?

#BadScience
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Giuseppe Michieli

[Articles] #Antivirals for #treatment of severe #influenza: a systematic #review and network meta-analysis of randomised controlled trials thelancet.com/journals/lancet/

In hospitalised patients with severe flu, #oseltamivir & #peramivir might reduce duration of hospitalisation compared with standard care or placebo, although certainty of evidence is low. Effects of all antivirals on mortality & other important patient outcomes are very uncertain due to scarce data from #RCTs.

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skua

1/2
There are academics / scientists who distinguish between #EBM #EvidenceBasedMedicine and #SBM #ScienceBasedMedicine.

EBM seems to fetishise #RandomControlledTrails #RCTs as the #GoldStandard and has given us at least the #Cochrane review on #Masking by #TomJefferson.

And, I think, also the #CassReport into medical care for young transgender people. Here AIUI over relevant 700 studies were rejected on the basis that they weren't RCTs leaving 2 RTCs considered.

sciencebasedmedicine.org/the-c

Science-Based Medicine · The Cochrane mask fiasco: How the evidence-based medicine paradigm can produce misleading resultsLast week, the Cochrane Collaborative was forced to walk back the conclusions of a review by Tom Jefferson et al that had been spun in the media as proving that "masks don't work." Tom Jefferson himse
Continued thread
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Jan R. Boehnke

I think this is a next/ remaining frontier for pragmatic #RCTs in this area and the concept of #Estimands could potentially help here, as an approach to link several elements for trial and intervention planning
jpro.springeropen.com/articles

While the intervention should not be planned to fit a trial, it is clearly possible to develop an intervention with an outcome in mind and theorise about the direction and size/relevance of expected effects.

SpringerOpenWhat is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials? - Journal of Patient-Reported OutcomesBackground Published in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses, and interpretation of results. The use of the estimand framework for describing clinical trial objectives has yet to be extensively considered in the context of patient-reported outcomes (PROs). We discuss the application of the estimand framework to PRO objectives when designing clinical trials in the future, with a focus on PRO outcomes in oncology trial settings as our example. Main We describe the components of an estimand and take a naïve PRO trial objective to illustrate how to apply attributes described in the estimand framework to inform construction of a detailed clinical trial objective and its related estimand. We discuss identifying potential post-randomization events that alter the interpretation of the endpoint or render its observation impossible (also defined as intercurrent events) in the context of PRO endpoints, and the implications of how to handle intercurrent events in the construction of the PRO objective. Using a simple objective statement, “What is the effect of treatment X on patient’s quality of life?”, we build up an example estimand statement and also use a previously published phase III oncology clinical trial to illustrate how an estimand for a PRO objective could have been written to align to the estimate framework. Conclusion The use of the estimand framework, as described in the new ICH E9 (R1) addendum guideline will become a key common framework for developing clinical trial objectives for evaluating effects of treatment. In the context of considering PROs, the framework provides an opportunity to more precisely specify and build the rationale for patient-focused objectives. This will help to ensure that clinical trials used for registration are designed and analysed appropriately, enabling all stakeholders to accurately interpret conclusions about the treatment effects for patient-focused outcomes.
Public
Jan R. Boehnke

We submitted our #EoI for this project in 01-2016.
Today the report was published🎉

Education Endowment Foundation #EEF
EAL in the mainstream classroom (Challenge Partners)
educationendowmentfoundation.o

Great leadership by Louise Tracey at #UniversityLeeds!
Many thanks to all project partners & the #DundeeUni #OpenResearch team for their #SafePod support! ❤️

As this may be my last project focusing mainly on attainment outcomes in schools, I share one (lengthy) thought🧵

Screenshot of the Executive Summary w/o results of which parts can be reproduced here, even Mastodon allows for too few characters: ‘English as an Additional Language (EAL) in the Mainstream Classroom’ was a continuing professional development (CPD) programme for teachers across different subject specialisms to support EAL pupils who are integrated into mainstream classrooms. The CPD programme was designed to build expertise in teachers’ planning and lesson delivery for EAL pupils in whole-class contexts through the development of teachers’ subject-specific and classroom language use. It is based on an understanding that a better use of grammar, core vocabulary, and spoken language by teachers can help EAL pupils’ comprehension and attainment. This programme was trialled with science and history teachers of Year 10 EAL pupils aged 14–16 years (Key Stage 4) in England who were integrated in mainstream classrooms. A total of 223 teachers in 71 schools took part in this two-armed, cluster randomised controlled efficacy trial, which also involved 5,340 pupils, of which 1,505 were EAL pupils. Schools in the trial were randomly allocated to have their teachers participate in the CPD or continue with teaching as usual. The CPD programme delivery was led by Challenge Partners, alongside Hounslow Language Service, Lampton School, and regional Delivery Centres.
#RCTs
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Jan R. Boehnke

Signed. And featured in my #PeerReview seminar yesterday.

I don't think that this is only about #PreRegistration.

One of our #RCTs received this year a 2.5k word review which did not refer to the #registration, statistical analysis plan, protocol, nor submitted appendices 🤦🤷

Also extrapolating from the style of that review:
How much anger and frustration that person could have avoided.

Edit: Link (Google Doc):
docs.google.com/document/d/1Y9

Screenshot of a presentation slide, main content quoted below, and with a screenshot of a Tweet by Brendan Nylan promoting the initiative for Preregistration Transparency in peer review. Reviewing ALL relevant materials Are there appendices? Are there external resources associated with the manuscript (e.g., OSF files) and have you checked them as far as relevant for the manuscript? (e.g., at least whether they are there) Are the documents that pre-define the conduct of the study? Registration of the study or review? Pre-registration?
#NightshiftEditor#PublicationEthics#ResearchIntegrity
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Jan R. Boehnke

Quality of life as an outcome of psychological treatments in people living w schizophrenia-spectrum disorders:

#MetaAnalysis of 60 independent #RCTs, analysing associations btw treatments (psychoeducation, CBT, cognitive, ...) and QOL (QLS, #WHOQOL, MANSA):
cambridge.org/core/journals/ps

It covers subjective (k=45) and objective (k=15) QOL outcomes
#HRQL #BeyondWilsonCleary

Interestingly, the latter were more frequently considered as #PrimaryOutcome-s in the analysed studies.

Cambridge CoreWhich psychological interventions improve quality of life in patients with schizophrenia-spectrum disorders? A meta-analysis of randomized controlled trials | Psychological Medicine | Cambridge CoreWhich psychological interventions improve quality of life in patients with schizophrenia-spectrum disorders? A meta-analysis of randomized controlled trials
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Jan R. Boehnke

I'll be offering an introduction to #simulation methods to determine #SampleSize-s for clustered / nested studies.

Apparently another popular session at #RMeF23 🙇

One of the classics that got me into this area is Ukoumunne's
onlinelibrary.wiley.com/doi/ab

I was always interested in how to straddle the overlap between observational #TherapistEffect studies* and #RCTs in this area.

#Rstats #StudyDesign

* eg., rdcu.be/dqi20

NCRM advert for the "How to" session on: How to use simulation methods for power analyses and sample size calculations in cluster-randomised designs Wednesday, 08.11.2023, UK-4pm
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Jan R. Boehnke

In #ISOQOL-s #QualityTALK, Carolyn Schwartz provides an insight into her development as a researcher
isoqol.org/the-story-behind-th

Reflecting on research experiences with people living with Multiple Sclerosis, she realised that what was important to patients did not form a consistent hierarchy of domains for each patient over time. This led her into #ResponseShift research and she discusses her most recent #SysReview on the importance of the phenomenon in #RCTs #Trials:
jpro.springeropen.com/articles

www.isoqol.orgThe story behind “The Elephant in the Room”: A long journey begins with a single step* | ISOQOL
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Owen Ozier

Looking to improve your applied #econometrics skills this summer, #EconTwitter ?

Pam Jakiela and I are thrilled to be back in person, teaching our summer school course on #RCTs in #development at the #Barcelona School of Economics (BSE), July 10-14.

Topics: RCT design, power calc's, attrition/bounding, strata/fixed effects, multiple testing, #machinelearning to choose controls and for treatment effect heterogeneity, pre-analysis plans – all w/ hands-on applications.

bit.ly/3YXmvaT

Barcelona School of EconomicsDevelopment Economics Summer SchoolDevelopment Economics Summer School courses at the Barcelona School of Economics
Continued thread
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Matt Hodgkinson

...an RCT in an ecology journal (besjournals.onlinelibrary.wile) gives good evidence of a bias in favour of high-income country authors under single-anonymised #PeerReview, but no benefit for low-income country authors with double-anonymised review. They found no indication of #GenderBias. Only mandatory double anonymisation would make a difference to country-level bias, because those whose chances it hurts are unlikely to opt for it. #RCTs

Implications for double-blind review In our double-blind peer review trial we find compelling evidence that blinding author identities improves fairness during peer review. That authors from low income and/or non-English countries are aware of geographic and language biases is clear from perspectives presented in editorials and commentaries (e.g. Clavero, 2011) and surveys (Ho et al., 2013; Rowley & Sbaffi, 2018; Taylor & Francis, 2015). Authors from lower-income and non-English countries are also more likely to choose to be reviewed double-blind when given the option (McGillivray & De Ranieri, 2018). Unfortunately, our data suggest that choosing to be reviewed with your identity blinded (when blinding is optional) will probably not benefit authors from low-income countries because the primary bias is not that authors from low-income countries are judged more harshly when their identities are known (relative to how they would be judged if their identities were unknown). Instead, authors from higher-income countries appear to be judged more positively when their identities are known, relative to how they would be judged when their identities are unknown. We suggest that offering optional blinding of author identities, as the Nature journals and The American Naturalist allow, is therefore unlikely to solve the actual biases that exist in peer review.
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