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#rct

3 posts2 participants0 posts today
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Public
Jan R. Boehnke

@statsepi Maybe of interest:
#Ireland has established the National Clinical Trials Oversight Group to examine Ireland's clinical trials landscape to support better clinical outcomes through increasing the number of trials taking place and improving access to trials for participants:
gov.ie/en/department-of-health

gov.ieNational Clinical Trials Oversight Group
#ClinicalTrials#RCT
Public
Jan R. Boehnke

Talk by @statsepi for those interested in #PublicPolicy #HealthPolicy and the role of clinical trials:
youtube.com/watch?v=kISmPxhUEc

A key point is the importance of investigator-led trials, i.e. those that do not have immediate commercial payoffs, e.g., trials investigating head to head comparisons of 2 medicines on the market; de-escalation of treatment; or those investigating #healthservice practices.

YouTubeInvestigator led clinical trials in Ireland: Finding statistical supports and building capacityBy Darren Dahly
#ResearchPolicy#RCT
Public
Jan R. Boehnke

Very interesting keynote by Mirjam Stieger
If we have this as a goal, "Can Digital Interventions Change Our Personality?"

Explanation of conceptual framework
link.springer.com/article/10.1

Self-selecting increasing conscientious or #Openness to experience
journals.sagepub.com/doi/full/
#SingleGroup

#RCT on self-selected #Big5 change
pnas.org/doi/full/10.1073/pnas
with 12month follow up:
onlinelibrary.wiley.com/doi/fu

SpringerLinkPEACH, a smartphone- and conversational agent-based coaching intervention for intentional personality change: study protocol of a randomized, wait-list controlled trial - BMC PsychologyBackground This protocol describes a study that will test the effectiveness of a 10-week non-clinical psychological coaching intervention for intentional personality change using a smartphone application. The goal of the intervention is to coach individuals who are willing and motivated to change some aspects of their personality, i.e., the Big Five personality traits. The intervention is based on empirically derived general change mechanisms from psychotherapy process-outcome research. It uses the smartphone application PEACH (PErsonality coACH) to allow for a scalable assessment and tailored interventions in the everyday life of participants. A conversational agent will be used as a digital coach to support participants to achieve their personality change goals. The goal of the study is to examine the effectiveness of the intervention at post-test assessment and three-month follow-up. Methods/Design A 2x2 factorial between-subject randomized, wait-list controlled trial with intensive longitudinal methods will be conducted to examine the effectiveness of the intervention. Participants will be randomized to one of four conditions. One experimental condition includes a conversational agent with high self-awareness to deliver the coaching program. The other experimental condition includes a conversational agent with low self-awareness. Two wait-list conditions refer to the same two experimental conditions, albeit with four weeks without intervention at the beginning of the study. The 10-week intervention includes different types of micro-interventions: (a) individualized implementation intentions, (b) psychoeducation, (c) behavioral activation tasks, (d) self-reflection, (e) resource activation, and (f) individualized progress feedback. Study participants will be at least 900 German-speaking adults (18 years and older) who install the PEACH application on their smartphones, give their informed consent, pass the screening assessment, take part in the pre-test assessment and are motivated to change or modify some aspects of their personality. Discussion This is the first study testing the effectiveness of a smartphone- and conversational agent-based coaching intervention for intended personality change. Given that this novel intervention approach proves effective, it could be implemented in various non-clinical settings and could reach large numbers of people due to its low-threshold character and technical scalability.
#hslu_luzern#UniBern
Public
Jan R. Boehnke

Trigg et al discussed conceptualisations of meaningful between-group differences:
rdcu.be/ehHdD

A comment by Kevin Weinfurt advances the discussion w 4 points
rdcu.be/ehHfS

#RCT #Estimand #HRQL

From the abstract:

(1) rather than “between-group difference,” specify the level at which you wish to infer a treatment effect: population or individual;

(2) points of reference may be different for interpreting individual- and population-level treatment effect estimates;
...

rdcu.beConceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints
Public
Jan R. Boehnke

Mirjam Stieger (Lucerne Uni) and I are invited to present
"Contemporary #Evaluation of Interventions: Mobile, Digital, and Pragmatic"
at @unibern
bbs.unibe.ch/training/summer_c

This 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!

Doctoral Program Brain and Behavioral SciencesSummer Course 2025
#RCT#EvaluationResearch#ResearchDesign
Public
Jan R. Boehnke

56th International Meeting of the Society for Psychotherapy Research in Krakow, Poland, 25-28th June.

Conference theme:
"Psychotherapy Research-Practice Integration: Who Are the Voices We Need to Hear?"

Continuing training events around #RCT methods started with the SPR #Dundee Methods Workshop (2021), I'll offer a primer for planning randomised studies of psychotherapeutic interventions.

Other #conference workshops & registration here:
psychotherapyresearch.org/page

Screenshots from the conference registration page, at the top noting the conference topic and dates; at the bottom presenting an abstract for a workshop. Jan Boehnke A primer for planning randomised studies of psychotherapeutic interventions Studies involving randomisation are an integral part of strategies for the evaluation of (causal) effects of therapeutic strategies and interventions. This workshop will present the key elements and practical steps for planning, developing, conducting, and reporting randomised studies of psychological interventions. The core logic and statistical arguments for an experimental study of a psychological intervention will be briefly revisited to clarify when an experimental study (and which type of such a study) is indicated. The main part of the workshop will focus on how to plan, design, and report such a study, including formal requirements to conduct a high quality study (e.g., trial registrations, ethical requirements). We will discuss the use of international guidelines as well as how and when to prepare protocols, statistical analysis plans, and/or registered reports. The workshop is built around the experience from multiple published trials by the presenter and is planned for Q&A phases to tailor the content to the audience. The aim of the workshop is to provide participants with the tools to assess published randomised studies of psycho-social interventions and the steps and resources needed to develop their own study.
#PsychotherapyResearch#Hybrid
Public
Jan R. Boehnke

After collaborating with Jess Deighton, Neil Humphrey and many others since early 2017, the results of the "Education for Wellbeing" programme are out.

You can find a top-level summary here:
annafreud.org/research/current

You can find the DFE briefings and technical report here:
gov.uk/government/publications

And you find #PrePrint papers for impact, implementation, qualitative & economics here:
osf.io/kxug7/

Education for Wellbeing Education for Wellbeing, led in partnership by mental health charity Anna Freud and UCL, tested five interventions and involved more than 30,000 primary and secondary school students. Education for Wellbeing was a large-scale research programme, funded by the Department for Education, involving two randomised control trials. Through Education for Wellbeing, we evaluated a range of mental health and wellbeing interventions being delivered in primary and secondary schools. Our aim was to examine the impact of these approaches on children and young people’s mental health. The programme ran between 2018 and 2024. Across England, 32,655 pupils across 513 schools participated in Education for Wellbeing. The Anna Freud Schools Division delivered the interventions within the programme and the Evidence-Based Practice Unit evaluated the approaches, examining their impact on pupils’ mental health and wellbeing. 
#RCT#CACE#AnnaFreud
Continued thread
Public
Jan R. Boehnke

...the analyses highlight the importance of sleep as a potential driver of adolescent wellbeing, and that the developmental cascade may be different across genders.

#CYPMH #MentalHealth

Read Claudia Rutherford's and my thoughts when launching this format in the journal and why we thought #RegisteredReports would fit well into #HRQL #HealthEconomics #RCT research processes:
rdcu.be/d8JXk

rdcu.beRegistered Reports at “Quality of Life Research”
Public
Jan R. Boehnke

Interesting #CaseStudy (New Zealand) investigating feasibility, direct costs, total time required to access administrative datasets for outcome assessments in #RCT follow-ups. Data linkage was feasible, but the evaluation of the costs vs. benefits (e.g., such as optimising the assessment methods if primary data are collected) depended on the cohort size:
bmcmedresmethodol.biomedcentra

BioMed CentralTime and cost of linking administrative datasets for outcomes assessment in a follow-up study of participants from two randomised trials - BMC Medical Research MethodologyBackground For the follow-up of participants in randomised trials, data linkage is thought a more cost-efficient method for assessing outcomes. However, researchers often encounter technical and budgetary challenges. Data requests often require a significant amount of information from researchers, and can take several years to process. This study aimed to determine the feasibility, direct costs and the total time required to access administrative datasets for assessment of outcomes in a follow-up study of two randomised trials. Methods We applied to access administrative datasets from New Zealand government agencies. All actions of study team members, along with their corresponding dates, were recorded prospectively for accessing data from each agency. Team members estimated the average time they spent on each action, and invoices from agencies were recorded. Additionally, we compared the estimated costs and time required for data linkage with those for obtaining self-reported questionnaires and conducting in-person assessments. Results Eight agencies were approached to supply data, of which seven gave approval. The time from first enquiry to receiving an initial dataset ranged from 96 to 854 days. For 859 participants, the estimated time required to obtain outcome data from agencies was 1,530 min; to obtain completed self-reported questionnaires was 11,025 min; and to complete in-person assessments was 77,310 min. The estimated total costs were 20,827 NZD for data linkage, 11,735 NZD for self-reported questionnaires, and 116,085 NZD for in-person assessments. Using this data, we estimate that for a cohort of 100 participants, the costs would be similar for data linkage and in-person assessments. For a cohort of 5,000 participants, we estimate that costs would be similar for data linkage and questionnaires, but ten-fold higher for in-person assessments. Conclusions Obtaining administrative datasets demands a substantial amount of time and effort. However, data linkage is a feasible method for outcome ascertainment in follow-up studies in New Zealand. For large cohorts, data linkage is likely to be less costly, whereas for small cohorts, in-person assessment has similar costs but is likely to be faster and allows direct assessment of outcomes.
Replied in thread
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Sektorenkoppler 🏡🌞👍 :verified:

3/x

➡️ Natürlich benötige ich auch am Abend Strom und wie wir alle wissen, gibt’s im Winter kaum #PV Energie. Daher möchte ich meinen #RCT Speicher zum günstigsten Zeitpunkt laden und im teuersten Moment entladen

➡️ Es gibt wohl die fertige RCT Lösung „Power Manager“. Diese kostet jedoch einmalig X€ und jährlich 72€ und das muss man erst mal wieder rein bekommen

➡️ Daher habe ich mit #HomeAssistant herum gespielt und tatsächlich konnte ich den Speicher manuell ansteuern

Public
Jan R. Boehnke

#1/ First day of #ISOQOL started with an interesting symposium on progress when optimizing the collection of patient-reported outcomes in clinical trials.

Part of the discussion were desirable changes to the publication system when publishing expert consensus and guidance documents:

1) What does #PeerReview for such a document look like?

2) Static journal publications may not be the best format for such documents.

Both seem solvable, no?
#HTD

#NightshiftEditor#RCT#ScientificPublishing
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