#studydesign — Public Fediverse posts
Live and recent posts from across the Fediverse tagged #studydesign, aggregated by home.social.
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Another #PeerReview done.
Manuscript c4,000 words
Review c2,700 words
5hrsPaper 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 -
A summary of strengths and limitations of randomized controlled trials and other types of study designs.
https://www.acsh.org/news/2025/12/02/rcts-not-end-all-be-all-49847
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A summary of strengths and limitations of randomized controlled trials and other types of study designs.
https://www.acsh.org/news/2025/12/02/rcts-not-end-all-be-all-49847
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This article offers a good discussion of covariate adjustment in cluster randomised trials:
https://pmc.ncbi.nlm.nih.gov/articles/PMC12550654/There are some good other resources out there, but this one is especially handy due to the breadth of topics covered:
statistical precision, bias from differential recruitment or missing data, how to select covariates, model-based approaches, missing data techniques, and illustration in a case study. -
A review of UK MHRA protocols (k=122) of the use of #Estimand -s offers insights for improvement of protocols due to incomplete or incorrect specifications:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08991-8#RCT #StudyDesign #Registration #Causality
Further resources:
How estimands support stating the exact research question of a study and the interpretation of results:
https://www.bmj.com/content/384/bmj-2023-076316Application of the estimand framework to for studies with Patient-Reported Outcomes:
https://jpro.springeropen.com/articles/10.1186/s41687-020-00218-5
#HRQOL -
Which #SampleSize to use in your pilot or feasibility trial?
Well, you won't find the answer in this review of studies in #ISRCTN (2013 to 2020)
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01416-wBut it is a good intro into the topic, and with 57% not reaching their target sample size, they may interestingly not provide the information they were designed to offer!
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The first rule of #PostDoclife is:
Try not to go crazy #worklifebalance #mentalhealthThe second rule of #Postdoclife is:
Do something useful for science #studydesign #deepwork #methodology #scientificsoftwaredevelopment
#hardworkisrare #focusispreciousThe third rule of #Postdoclife is:
Tell others the cool thing you did #writepapers #outreach #presentationsGo to rule 1.
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Thank you to #HealthPsychology and Behavioral Medicine @unibern for writing a post about the recent Summer Course 2025, “Contemporary Evaluation of Interventions: Mobile, Digital, and Pragmatic”
https://www.linkedin.com/posts/gesundheitspsychologie-und-verhaltensmedizin-gpv-unibe_gpv-unibe-mhealth-activity-7340302148112408577-4_JW/ -
A well-justified epistemological foundation is a key requirement for a #DelphiStudy:
https://www.sciencedirect.com/science/article/pii/S1865921722000769The team argues that #ReportingGuidelines encourage researchers to reflect on and disclose key assumptions and methodological choices in such studies.
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Co-developed at #DundeeUni and #SFU
"A Toolkit for Building a Collective of Older Adult Researchers"
https://www.sfu.ca/starinstitute/about/institute-activities/research-project--coar.html
(COAR)"A practical resource for engaging older adults as active partners in community-based research"
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Research participants being fully informed about the research and to provide their voluntary consent to participate is a cornerstone of ethical research practice.
Secondary school pupils in Cameroon explored how to engage with consent principles, main focus were benefits and risks of participation, #VoluntaryParticipation, and confidentiality
https://journals.sagepub.com/doi/full/10.1177/17470161251335709 -
Mirjam Stieger (Lucerne Uni) and I are invited to present
"Contemporary #Evaluation of Interventions: Mobile, Digital, and Pragmatic"
at @unibern
https://www.bbs.unibe.ch/training/summer_course/index_eng.htmlThis is the annual Summer Course of the Doctoral Program Brain and Behavioral Sciences, and comprises a mixture of keynotes, masterclasses, hidden curriculum etc.
I am very much looking forward to it, and also very honoured to be invited once again to Bern to train #ECRs!
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Tutorial paper illustrating how to develop planned contrasts (as an alternative to #PostHoc comparisons) in #Rstats, including empirical examples with reproducible data:
https://journals.sagepub.com/doi/full/10.1177/25152459241293110 -
🎄Day 9🎄Master #fNIRS Research with Proven #BestPractices 📘
Stay informed and enhance the quality of your studies by following these best practices for fNIRS research. From study design to data reporting, this guide provides valuable insights to help you publish impactful research.
🎁✨ Ready to refine your approach? https://doi.org/10.1117/1.NPh.8.1.012101 -
Recommendations for conduct and write-up of observational studies from my #NightshiftEditor threads got some attention on #LinkedIn
https://www.linkedin.com/feed/update/urn:li:activity:7229141904678887424/The five suggested papers in brief:
1) STROBE
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.00402972) Confounder selection
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6447501/3) DAG tutorial
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821727/4) Table 2 Fallacy
https://academic.oup.com/aje/article/177/4/292/147738?login=false5) Prediction vs causation
https://academic.oup.com/ije/article/49/6/2074/5831974?login=false -
https://pubmed.ncbi.nlm.nih.gov/38401800/ Recreational MDMA doses do not elicit hepatotoxicity in HepG2 spheroids under normo- and hyperthermia (de Oliveira, et al, 2024) #mdma #fda #psychedelic #psychedelics #psychedelicresearch #fda #studydesign #litreview #ptsd #psychedelicassistedtherapy #mdmaassistedtherapy #entactogens #neuroscience
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https://pubmed.ncbi.nlm.nih.gov/38982828/ Entactogen Effects of Ketamine: A Reverse-Translational Study (Hess, et al, 2024) #ketamine #psychedelic #psychedelicresearch #entactogens #psychedelics #depression #neuroscience #fda #studydesign #mentalhealth #litreview #antidepressant #ketaminetherapy #psychedelictherapy
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https://pubmed.ncbi.nlm.nih.gov/38979497/ Ketamine in the effective management of chronic pain, depression, and posttraumatic stress disorder for Veterans: A meta-analysis and systematic review (Liu, et al, 2024) #ketamine #pain #depression #ptsd #psychedelic #psychedelics #psychedelicresearch #psychedelicmentalhealth #mentalhealth #veterans #chronicpain #fda #studydesign #litreview #ketamineassistedtherapy #psychedelicassistedtherapy
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https://psychedelicmentalhealth.net/neural-correlates-subjective-experiences-meditation-psychedelics-ketamine-psychotherapy/ Neural correlates and subjective experiences in meditation vs psychedelics, including ketamine (Preliminary Lit Review)
A preliminary, evolving review of the literature. (Ongoing Draft) | Psychedelic Institute of Mental Health & Family Therapy #meditation #psychedelics #ketamine #ayahausca #lsd #psilocybin #dmt #neuroscience #Psychedelic #Litreview #research #studydesign #fda #mdma #psychedelicassistedpsychotherapy #cognitivebehavioraltherapy -
https://psychedelicmentalhealth.net/psychedelic-therapy-cognitive-behavioral-therapy-ketamine-context-competencies/ Psychedelic Cognitive Behavioral Therapy: On Ketamine, Context and Competencies in "Assisted-Psychotherapy” #psychedelic #psychedelics #cognitivebehavioraltherapy #psychedelicresearch #studydesign #fda #mdma #cbt #ketamine #ketamineassistedtherapy #psychedelicassistedtherapy #ketamineassistedpsychotherapy #psychedelicassistedpsychotherapy #lsd #psilocybin #neuroscience #telehealth
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Trying out ghost in anticipation of it joining the Fediverse. https://psychedelic-institute-of-mental-health.ghost.io/ #psychedelic #psychedelics #psychedelicassistedpsychotherapy #ketamineassistedpsychotherapy #cognitivebehavioraltherapy #studydesign #litreview #psychedelicresearch #psychedelictherapist #fediverse #ghostio
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https://psychedelictherapypalmsprings.com/feed/dsm-psychiatric-diagnosis-meaningless-study-says #dsm #psychiatry #dsm5 #trauma #ptsd #depression #anxiety #mentalhealth https://www.sciencedirect.com/science/article/abs/pii/S0165178119309114?via%3Dihub #fda #mdma #studydesign #heterogeneity #litreview
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https://psychedelic-institute-of-mental-health.ghost.io/does-the-psychedelic-experience-matter/ still working on this one, but it’s coming together — #psychedelics #psychedelic #ketamine #fda #mdma #mdmaassistedpsychotherapy #mdmaassistedtherapy #ketamine #Ketamineassistedtherapy #ketamineassistedpsychotherapy #psychedelic #psychedelics #psychedelictherapy #psychedelicassistedpsychotherapy #nde #mysticalexperience #therapycult #phenomenology #consciousness #neuroscience #studydesign #psychedelicresearch #psychotherapy #lsd #dmt #psilocybin #psilocin #ayahausca
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https://www.psychiatrist.com/jcp/ketamine-plus-psychotherapy-for-ptsd/ #ketamine #psychotherapy #ptsd #fda #mdma #studydesign #research #psychedelics #psychedelic #ketamineassistedpsychotherapy #psychedelicassistedtherapy #psychedelicassistedpsychotherapy #ketaminetherapy #metaanalysis #litreview #psychotherapy #mentalhealth
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#Psilocybin Versus #ketamine in Treatment-Resistant #depression (PSIKET_001) #clinicaltrial #studydesign #psychedelics #psychedelic #psychedelicresearch #fda #mdma Now recruiting in #czechrepublic
ClinicalTrials.gov ID NCT05383313
Sponsor: National Institute of Mental Health, Czech Republic https://clinicaltrials.gov/study/NCT05383313?intr=Ketamine%20psilocybin&rank=5 — This study does direct comparison with an active placebo midazolam which is not an #antidepressant -
https://clinicaltrials.gov/study/NCT05746572?term=mdma%20ptsd%20and%20emory&rank=1&a=8 Emory University plans #fda Phase 2 study of #mdma plus a type of behavioral #psychotherapy called Exposure Therapy for the treatment of #ptsd — This study is unrelated to the MAPS/Lykos new drug application for #mdmaassistedtherapy and a reminder #psychedelic #research is robust and ongoing. #studydesign should include blinding with #ketamine and comparison to #cognitivebehavioraltherapy #psychedelics
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Top FDA official overrules staff to approve gene therapy that failed trial - https://apple.news/AXkboQ5CsQXCzdmNLXodiMg #fda #mdma #psychedelics #psychedelic #studydesign #research
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https://finance.yahoo.com/news/atai-life-sciences-announces-beckley-110000192.html Phase 1/2a Trial of ELE-101 (IV #psilocin for Major Depressive Disorder, with Initial Results from Phase 1, First Patients Dosed in Phase 2a #depression #psychedelic #psychedelics #psychedelicresearch #fda #esketamine #ketamine #psilocybin #psychedelicresearch #studydesign #fda Will they blind with #ketamine by iv, study with / without #cognitivebehavioraltherapy & compare to existing #antidepressants ?
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"During these trials, the participants were randomly assigned to receive one of three commonly prescribed antidepressant medications (escitalopram, sertraline or venlafaxine extended release (XR) (n = 164)) or an established behavioral intervention that integrated problem-solving with behavioral activation, compared with treatment as usual (n = 86)” #psychedelic #studydesign #fda — That established behavioral intervention was #psychotherapy using ideas that became #cognitivebehavioraltherapy
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"During these trials, the participants were randomly assigned to receive one of three commonly prescribed antidepressant medications (escitalopram, sertraline or venlafaxine extended release (XR) (n = 164)) or an established behavioral intervention that integrated problem-solving with behavioral activation, compared with treatment as usual (n = 86)” #psychedelic #studydesign #fda — That established behavioral intervention was #psychotherapy using ideas that became #cognitivebehavioraltherapy
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https://www.nature.com/articles/s41562-023-01787-3 A systematic review and meta-analysis of transdiagnostic cognitive behavioural therapies for emotional disorders (Schaeuffele, et al, 2024) #cognitivebehavioraltherapy #metaanalysis #psychedelics #psychedelic #fda #mdma #ketamine #psychedelicassistedpsychotherapy #studydesign #depression #anxiety #psychotherapy
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#psychedelic #mdma #cognitivebehavioraltherapy #fda #psychedelics #studydesign #psychedelicassistedtherapy #psychedelicassistedpsychotherapy Note how other pharmaceutical companies aren’t comparing to gold standard #psychotherapy claiming their “molecules don’t require” the assisted-psychotherapy, something that has been part of psychedelics since the late 1800’s. Blind with #ketamine https://www.npr.org/sections/shots-health-news/2024/06/13/nx-s1-4998523/mdma-fda-maps-psychedelic-research
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... #LogicModels and tools like this into #RCT development in educational research, the dependency of effect sizes on control groups seems less discussed (or I still have not found the correct key words to find the underpinning literature).
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While not expressing disagreement or agreement with the #study's #conclusions, the #experiment design included some features that make it difficult to #generalize from.
For example, they eliminated those homeless with a history of #substance #abuse. That by itself makes the #headline claims a bit suspect, or at least not clearly #supported by evidence.
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Two interesting papers on different ways consolidating hypotheses and analyses:
One are different types of Registration (incl. #RegisteredReports), the other is conducting analyses with key data being masked.
Blinding analyses:
https://link.springer.com/article/10.1007/s11229-019-02456-7Blinding vs. #Registration:
https://journals.sagepub.com/doi/10.1177/25152459221128319It seems that combining this to "report writing based on masked data" could be a viable combination.
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Looking for some advice on how to model toxicity scales for an observational study.
#datamethods #statistics #ClinicalResearch #StudyDesign #OrdinalRegression #Regression #rms #radonc #diabetes #toxicity
https://discourse.datamethods.org/t/advice-regarding-analysis-plan-for-a-study/6273