#rcts — Public Fediverse posts

Another #PeerReview done.

Manuscript c4,000 words
Review c2,700 words
5hrs

Paper in a key area of my methodological work, so it was really interesting. But I really needed to get stuck in.

Two collaboration projects on the design and reporting of #RCTs that might be useful for others:

https://pubmed.ncbi.nlm.nih.gov/37982521/
presents 19 factors to aid trial design, and the DELTA2 Guidance specifying a target difference and reporting the #SampleSize calculation for RCTs
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2884-0

#StudyDesign

Great day at our Postgraduate Research Symposium at the School of #HealthSciences #DundeeUni !

21 presentations across such diverse topics as breastfeeding, the Dysphoric Milk Ejection Reflex, #MentalHealth literacy, stigma of mental illness, the nursing curriculum, #PPIE in #RCTs, skin to skin care, traumatic birth and... and... 👏

Great opportunity to welcome new students, and to see projects develop over the years.

#PGR #PhD

Touching on trials, reporting guidelines, and journal publishing/ editing - this
@EASE science webinar on 30.09. sounds very promising:
https://ease.org.uk/event/ease-germany-webinar-clinical-trial-transparency-from-registration-to-results-reporting/

#NightshiftEditor #AcademicPublishing #RCTs

Folk have been making overblown medical claims for cold water for a long-time.

Turns out one of the first proposals for a controlled trial (on #scabies fwiw) was a C19th Irish Dr trolling a cold-water proponent.

Our new #OpenAccess #HistoryofMedicine paper: https://link.springer.com/article/10.1007/s11845-025-04027-x

#ColdWaterTherapy #RCTs #MedicalHistory #scabies #IrishMedicine

Photo: Man swims in cold water. Credit: Oleg Dubyna from Poltava, Ukraine. From Wikimedia, Creative Commons Attribution-Share Alike 2.0 Generic license, see https://commons.wikimedia.org/wiki/File:Man_swims_in_cold_water_(34807325734).jpg

I really enjoyed participating in and presenting at the Summer Course 2025 of the Brain and Behavioral Sciences doctoral program at @unibern

I have written two brief summaries, one about the overall programme
https://www.linkedin.com/feed/update/urn:li:activity:7345468437407694850/

and one about my inputs:
https://www.linkedin.com/feed/update/urn:li:activity:7345830294224093184/

If interested, you can find a picture, a description of the course, and future plans of the local team here:
https://www.bbs.unibe.ch/training/summer_course/past_summer_courses/index_eng.html

#ResearchDesign #ECRs #Training #PhD #RCTs

I really enjoyed participating in and presenting at the Summer Course 2025 of the Brain and Behavioral Sciences doctoral program at @unibern

I have written two brief summaries, one about the overall programme
https://www.linkedin.com/feed/update/urn:li:activity:7345468437407694850/

and one about my inputs:
https://www.linkedin.com/feed/update/urn:li:activity:7345830294224093184/

If interested, you can find a picture, a description of the course, and future plans of the local team here:
https://www.bbs.unibe.ch/training/summer_course/past_summer_courses/index_eng.html

#ResearchDesign #ECRs #Training #PhD #RCTs

I really enjoyed participating in and presenting at the Summer Course 2025 of the Brain and Behavioral Sciences doctoral program at @unibern

I have written two brief summaries, one about the overall programme
https://www.linkedin.com/feed/update/urn:li:activity:7345468437407694850/

and one about my inputs:
https://www.linkedin.com/feed/update/urn:li:activity:7345830294224093184/

If interested, you can find a picture, a description of the course, and future plans of the local team here:
https://www.bbs.unibe.ch/training/summer_course/past_summer_courses/index_eng.html

#ResearchDesign #ECRs #Training #PhD #RCTs

I really enjoyed participating in and presenting at the Summer Course 2025 of the Brain and Behavioral Sciences doctoral program at @unibern

I have written two brief summaries, one about the overall programme
https://www.linkedin.com/feed/update/urn:li:activity:7345468437407694850/

and one about my inputs:
https://www.linkedin.com/feed/update/urn:li:activity:7345830294224093184/

If interested, you can find a picture, a description of the course, and future plans of the local team here:
https://www.bbs.unibe.ch/training/summer_course/past_summer_courses/index_eng.html

#ResearchDesign #ECRs #Training #PhD #RCTs

I really enjoyed participating in and presenting at the Summer Course 2025 of the Brain and Behavioral Sciences doctoral program at @unibern

I have written two brief summaries, one about the overall programme
https://www.linkedin.com/feed/update/urn:li:activity:7345468437407694850/

and one about my inputs:
https://www.linkedin.com/feed/update/urn:li:activity:7345830294224093184/

If interested, you can find a picture, a description of the course, and future plans of the local team here:
https://www.bbs.unibe.ch/training/summer_course/past_summer_courses/index_eng.html

#ResearchDesign #ECRs #Training #PhD #RCTs

Plant-based diets are beneficial for #health & #environment. Now a #review & meta-analysis showed that there are no real differences btwn #plantbased & omnivorous #diets in terms of upper body, lower body & overall muscular strength, either: doi.org/10.1186/s407... #metaanalysis #RCTs #muscles

Are Plant-Based Diets Detrimen...

Getting ready for my keynote on "Evidence-Based Professional Practice and Randomised Controlled Trials" where we will look a bit into #PragmaticTrials across #MentalHealth and #Education.

Lots of resources to read up on Pragmatic Trials around, eg. at #NIH
https://rethinkingclinicaltrials.org/

The Peto in the quote below is Richard, e.g.: https://pubmed.ncbi.nlm.nih.gov/795448/

#UniBern #DundeeUni #RCTs

Two articles on the role of #MedicalStatistics in #HealthSciences which are a good #CPD read for both #QuantitativeMethods experts as well as health content experts:

Medical statisticians: Always on tap, but never on top?
https://eprints.whiterose.ac.uk/id/eprint/211342/

And this paper aims to provide guidance on why, when and on what to consult with statisticians when setting up a research project
https://www.cambridge.org/core/journals/bjpsych-advances/article/statistical-consulting-guidelines-for-new-researchers-in-psychiatry-and-mental-health-beyond-chatgpt/22BD35892A1760918B5BFBC0EBE5D7C4

#ECR #ProjectDesign #RCTs #Trials #Epidemiology

Two articles on the role of #MedicalStatistics in #HealthSciences which are a good #CPD read for both #QuantitativeMethods experts as well as health content experts:

Medical statisticians: Always on tap, but never on top?
https://eprints.whiterose.ac.uk/id/eprint/211342/

And this paper aims to provide guidance on why, when and on what to consult with statisticians when setting up a research project
https://www.cambridge.org/core/journals/bjpsych-advances/article/statistical-consulting-guidelines-for-new-researchers-in-psychiatry-and-mental-health-beyond-chatgpt/22BD35892A1760918B5BFBC0EBE5D7C4

#ECR #ProjectDesign #RCTs #Trials #Epidemiology

Two articles on the role of #MedicalStatistics in #HealthSciences which are a good #CPD read for both #QuantitativeMethods experts as well as health content experts:

Medical statisticians: Always on tap, but never on top?
https://eprints.whiterose.ac.uk/id/eprint/211342/

And this paper aims to provide guidance on why, when and on what to consult with statisticians when setting up a research project
https://www.cambridge.org/core/journals/bjpsych-advances/article/statistical-consulting-guidelines-for-new-researchers-in-psychiatry-and-mental-health-beyond-chatgpt/22BD35892A1760918B5BFBC0EBE5D7C4

#ECR #ProjectDesign #RCTs #Trials #Epidemiology

Two articles on the role of #MedicalStatistics in #HealthSciences which are a good #CPD read for both #QuantitativeMethods experts as well as health content experts:

Medical statisticians: Always on tap, but never on top?
https://eprints.whiterose.ac.uk/id/eprint/211342/

And this paper aims to provide guidance on why, when and on what to consult with statisticians when setting up a research project
https://www.cambridge.org/core/journals/bjpsych-advances/article/statistical-consulting-guidelines-for-new-researchers-in-psychiatry-and-mental-health-beyond-chatgpt/22BD35892A1760918B5BFBC0EBE5D7C4

#ECR #ProjectDesign #RCTs #Trials #Epidemiology

Two articles on the role of #MedicalStatistics in #HealthSciences which are a good #CPD read for both #QuantitativeMethods experts as well as health content experts:

Medical statisticians: Always on tap, but never on top?
https://eprints.whiterose.ac.uk/id/eprint/211342/

And this paper aims to provide guidance on why, when and on what to consult with statisticians when setting up a research project
https://www.cambridge.org/core/journals/bjpsych-advances/article/statistical-consulting-guidelines-for-new-researchers-in-psychiatry-and-mental-health-beyond-chatgpt/22BD35892A1760918B5BFBC0EBE5D7C4

#ECR #ProjectDesign #RCTs #Trials #Epidemiology

Can vitamin D help prevent colorectal cancer? The science is promising – but not straightforward
#Health #VitaminD #Cancer #ColorectalCancer #ColonCancer #CancerPrevention #HealthResearch #CancerAwareness #VitaminDStudies #CancerRisk #MedicalResearch #RCTs
https://the-14.com/can-vitamin-d-help-prevent-colorectal-cancer-the-science-is-promising-but-not-straightforward/

This looks great: Andrew Gelman (@statmodeling_bot ) would be joining Nancy Cartwright and Berna Devezer. Short idea talks, lots of panel discussion and Q&A.

Join us on April 25th to discuss RCTs, replications, and scientific inference.
https://sites.google.com/view/cepbi/talks-gatherings?authuser=0

#stats #causalInference #RCTs #philsci

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

But if you are chronically infected with a variant that the monoclonal were effective against (something that #sequencing can determine), perhaps we should do the #RCTs and relicense these withdrawn antibodies possibly in combination with antivirals as therapeutics for #longcovid

"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."

https://www.theguardian.com/society/2024/nov/24/homeless-people-to-be-given-cash-in-first-major-uk-trial-to-reduce-poverty

#HomelessnessUK #RCTs

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

[Articles] #Antivirals for #treatment of severe #influenza: a systematic #review and network meta-analysis of randomised controlled trials https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01307-2/fulltext?rss=yes

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.

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.

https://sciencebasedmedicine.org/the-cochrane-mask-fiasco-how-the-evidence-based-medicine-paradigm-can-produce-misleading-results/

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
https://jpro.springeropen.com/articles/10.1186/s41687-020-00218-5

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.

Substantial work has been undertaken on understanding problems of effect size calculation, comparison & aggregation for #RCTs in these settings (https://www.sciencedirect.com/science/article/pii/S0883035515304808) and where consensus work around the #EEF has led to communication and standardisation. 👏

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)
https://educationendowmentfoundation.org.uk/projects-and-evaluation/projects/eal-in-the-mainstream-classroom

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🧵

#RCTs

Quality of Life Research 03-2024
https://link.springer.com/journal/11136/volumes-and-issues/33-3, incl.

A #SysReview of #HRQL in emergency laparotomy #RCTs
https://link.springer.com/article/10.1007/s11136-023-03531-w

comparison of @promisNIH 29/global physical and #MentalHealth scores
https://link.springer.com/article/10.1007/s11136-023-03559-y

and using unsupervised IRT models for assessing sample heterogeneity
https://link.springer.com/article/10.1007/s11136-023-03560-5
#Psychometrics

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):
https://docs.google.com/document/d/1Y9Y4ilH06xvcKKreZnZE7pf_6kd6GHuRI6u6U45f3vs/edit?pli=1

#NightshiftEditor #PublicationEthics #ResearchIntegrity

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):
https://www.cambridge.org/core/journals/psychological-medicine/article/which-psychological-interventions-improve-quality-of-life-in-patients-with-schizophreniaspectrum-disorders-a-metaanalysis-of-randomized-controlled-trials/BC266982A851D9B22CB69782578D59FA

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.

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
https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.1330

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

#Rstats #StudyDesign

* eg., https://rdcu.be/dqi20

In #ISOQOL-s #QualityTALK, Carolyn Schwartz provides an insight into her development as a researcher
https://www.isoqol.org/the-story-behind-the-elephant-in-the-room-a-long-journey-begins-with-a-single-step/

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:
https://jpro.springeropen.com/articles/10.1186/s41687-022-00510-6

Quick #ResearchMethods reminder from the #NightshiftEditor desk:

"In randomised trials, rather than comparing randomised groups directly some researchers carry out a significance test comparing a baseline with a final measurement separately in each group."

"This approach is biased and invalid, producing conclusions which are, potentially, highly misleading."

https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-264

#RCTs #HRQL #CONSORT

Last week "Quality of Life Research" #ISOQOL published 4 papers:
https://link.springer.com/journal/11136/online-first

For example,

#participatory item development & #IRT evaluation of the Vancouver Airways #Health Literacy Tool
https://rdcu.be/dgW5x
#Psychometrics

#HRQL among homeless individuals in Germany during the #COVID19 pandemic
https://link.springer.com/article/10.1007/s11136-023-03455-5

Secondary pooled analysis of the patient-reported outcomes in the ASPIRE I + II #RCTs in people living with #MDE
https://link.springer.com/article/10.1007/s11136-023-03451-9
#NCT03039192 NCT03097133

...an RCT in an ecology journal (https://besjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/1365-2435.14259) 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