Delighted to have had the opportunity to teach #systematicReview and #metaAnalysis of #RCTs to #MSc #students at #THSTI #Faridabad #India, helping train the next generation of #Indian #clinicalTrialists #BritishCouncil

...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

Randomised controlled trial shows existence of ideological bias and of authority #bias among #economists; economic analysis is enhanced when the necessary normative context of #economics is openly admitted: https://doi.org/10.1093/cje/beac071 #RCTs

Next was a good discussion with David Atkin on how to use #RCTs to answer policy questions (and also when they're not appropriate) at #INSEAD https://www.youtube.com/watch?v=sJMzfkjPXJ0 (4/11)

#RCTs in the #VascularAccess field are uncommon

in 2020 we discussed drug coated balloons http://www.nephjc.com/news/drugcoatedballoon on #NephJC

Now there is this large RCT https://www.kidney-international.org/article/S0085-2538(23)00182-5/fulltext

- industry funded
- expensive stents
- effect on AVF patency (left) much less impressive than target lesion patency (right)

First was an interesting talk on improving clinical trials with #MachineLearning by Alihan Hüyük with discussion from Carl-Fredrik Burman, @MiroDudik, Sean Hayes, and Suetonia Palmer at the University of Cambridge. This is an extremely important problem, and the approach presented here could generalize to #RCTs more broadly https://www.youtube.com/watch?v=t3xeMyaPvR4 (2/10)

Amen

https://goodscience.substack.com/p/the-nih-should-launch-a-clinical?publication_id=1010915&isFreemail=true

The NIH funding of clinical trials is a scattershot blundering mess

#EBM #ClinicalTrials #RCTs

(1/4) Why do we need this method?

"Traditional" approach was to pool data within patient subgroups, and then compare. But this breaks up #RCTs. If subgroup distributions vary across trials, so will relative weights -- risking trial-level confounding and hence aggregation bias

No more #PHacking or vague #HealthClaims for products to obscure the fact that they lack solid evidence from #RCTs for such claims. So says the FTC. We say that's definitely a good call.
https://conscienhealth.org/2023/01/ftc-asks-for-rcts-not-vague-health-claims/

Virtual "Open Days" for the #UCL #ICTM MSc Statistics for Clinical Trials now open for booking! Free, various dates Jan-June 2023. I'm excited to be co-leading the #metaAnalysis module for this course. #stats #ClinicalTrials #RCTs

https://www.ucl.ac.uk/population-health-sciences/events/2023/jan/msc-statistics-clinical-trials-open-days

New in the International Journal of Infectious Diseases, co-authored by Assistant in Biostatistics Kimberly W. Hart with colleagues Alexander M. Kaizer at University of Colorado, Wesley H. Self at Vanderbilt University Medical Center (Emergency Medicine), and more. https://doi.org/10.1016/j.ijid.2022.12.028 #COVID19 #lopinavir #ritonavir #RCTs #ClinicalTrials

Indicators of questionable research practices were identified in 163,129 #RCTs #QRPs
https://www.jclinepi.com/article/S0895-4356(22)00307-9/fulltext?rss=yes

(1) risk of #bias assessments
(2) modifications in primary outcomes that were registered in trial registration records (proxy for selective reporting bias);
(3) ratio of the achieved to planned sample sizes; and
(4) statistical discrepancy.

#QuestionableResearchPractices

The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review https://pubmed.ncbi.nlm.nih.gov/36455317/

"use of verbal risk presentation decreased anxiety and increased satisfaction.A lower readability level decreased anxiety and improved comprehension and knowledge"

#consent #RCTs #surgery

My colleagues Brennan Kahan and Andrew Copas are advertising a #UCL #PhD opportunity 'Developing practical guidance for design and analysis of #cluster #RCTs #trials to match the chosen #estimand .'
Closing date 16th Jan 2023 https://www.findaphd.com/phds/project/developing-practical-guidance-for-design-and-analysis-of-cluster-randomised-trials-to-match-the-chosen-estimand/?p149492

Operationalization of #assent for research participation in pre-adolescent children: a scoping review https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-022-00844-2

Pie charts:
a Criteria used to determine ability to provide assent. b Information provided to child during the assent process

#consent #ethics #RCTs #peds #children #paediatrics #pediatrics

Electronic informed #consent criteria for research #ethics review: a scoping review (34 studies).
https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-022-00849-x

#RCTs

To Glyn's point, the other day, this from Victor Montori:
https://onlinelibrary.wiley.com/doi/10.1111/hex.13654?af=R

100 video-recorded encounters, obtained from an RCT of an #SharedDecisionMaking intervention. Researchers noted the occurrence/order of the 4 canonical #SDM steps: fostering choice awareness, providing information, stating preferences, and deciding.

The normative steps of SDM are infrequently observed in their prescribed.

#fidelity #InterventionConvergence #RCTs

When is data too old to inform nursing science and practice?
https://onlinelibrary.wiley.com/doi/10.1111/jan.15411
The Journal of Advanced #Nursing says the period of data collection should be no more than 3 years before submission of the manuscript.

Earlier - on the timely #reporting of #RCTs:
EU clinical trials have to post results within six (paediatric trials) or 12 months (non-paediatric).
https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en

#PublicationLag #FileDrawerEffect

Approaches to the Assessment of Clinical Benefit of Treatments for Conditions that Have Heterogeneous Symptoms and Impacts: Potential Applications in Rare Disease https://www.valueinhealthjournal.com/article/S1098-3015(22)04744-1/fulltext?rss=yes

6 assessment approaches identified:
- composite or other multi-component endpoints;
- multi-domain responder index (MDRI);
- most bothersome symptom (MBS);
- goal attainment scaling (GAS);
-sliding dichotomy; and
- adequate relief.

#Regulation
#RareDiseases
#RCTs
#HealthEconomics
#HTA

The latest from Gordon Guyatt's stable: Instruments assessing risk of #bias of #RCTs frequently included items that are not addressing risk of bias issues.

17 instruments; 61 items clearly not addressing risk of bias; item classification survey - 66 items. Respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items.

#EBM #SysRev

https://www.jclinepi.com/article/S0895-4356(22)00268-2/fulltext