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Reposted

Tim Feeney @tfeend.bsky.social · 14d

Every. Single. Time. Although i think the falling off the bike is me *truly* learning the method.

Donald Szlosek @dszlosek.bsky.social · 14d

Anyone else ever feel like this? #StatsSky #Statistics

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Reposted

Margarita Moreno-Betancur @margaritamb.bsky.social · 28d

NEW PAPER! (in press in EPIDEMIOLOGY)

Have you wondered:
- How to specify a target trial: as an ideal trial or something else?
- What biases do target trial emulations and actual RCTs share?
- How does it all relate to potential outcomes?

Read here! 👉 arxiv.org/abs/2405.10026
#EpiSky #CausalSky

The ideal trial: defining causal estimands that balance relevance and feasibility in target trial emulations and actual randomized trials

Causal inference is the goal of randomized trials and many observational studies. The first step in a formal causal inference framework is to define the causal estimand, and in both types of study thi...

arxiv.org

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Reposted

Jack Wilkinson @jdwilko.bsky.social · Sep 8

For Monday crowd. INSPECT-SR, a tool to help you identify problematic (inc. fraudulent) RCTs, now available.

Jack Wilkinson @jdwilko.bsky.social · Sep 5

www.medrxiv.org/content/10.1...

INSPECT-SR: A tool for assessing trustworthiness of randomised controlled trials.

INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials

The integrity of evidence synthesis is threatened by problematic randomised controlled trials (RCTs). These are RCTs where there are serious concerns about the trustworthiness of the data or findings....

www.medrxiv.org

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 5

Thanks Peter!

Reposted

Jack Wilkinson @jdwilko.bsky.social · Sep 5

A detailed guidance document and editable template are available here: osf.io/b74wj/files/...

OSF

osf.io

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Reposted

Jack Wilkinson @jdwilko.bsky.social · Sep 5

www.medrxiv.org/content/10.1...

INSPECT-SR: A tool for assessing trustworthiness of randomised controlled trials.

INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials

The integrity of evidence synthesis is threatened by problematic randomised controlled trials (RCTs). These are RCTs where there are serious concerns about the trustworthiness of the data or findings....

www.medrxiv.org

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Reposted

hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

🎯 TARGET Guideline published 🎉

TARGET is a reporting guideline for observational studies of interventions that use the target trial framework.

Over 3 years the @TARGETGuideline was rigorously developed and was co-published today in @jama.com & @bmj.com

doi.org/10.1001/jama.2025.13350

#episky

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Reposted

Darren Dahly @statsepi.bsky.social · Sep 5

One of the most common misunderstandings about the use and value of placebos in clinical RCTs, often made by both methodological experts and experienced trialists:

(from @stephensenn.bsky.social in academic.oup.com/jrsssa/advan...)

A further problem is illustrated by the authors equating no treatment with placebo. For example, describing their second assumption, they state, ‘Implicit in this notation is that there is a single version of ‘no treatment’ that is consistently defined across all subjects in the RCT and external controls’ (p4). However, most clinical trials are add-on trials (Senn, 2002), even if not specifically identified as such. In placebo-controlled trials, one starts with standard of care and then subjects are either allocated to receive in addition the active treatment or a placebo to it. The statistical analysis plan for SUNFISH (F Hoffman-La-Roche Ltd, 2020) has a protocol summary as Appendix 1, which has this to say, ‘In addition to the study drug treatment, patients may continue to receive concomitant drug medication…’ (p186). This is very standard for clinical trials. It highlights that a key assumption in borrowing control data in this way is that there has been no evolution in the standard of care in the period since the trial.

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Reposted

Peer Review Congress #PRC10 @peerreviewcongress.bsky.social · Sep 4

In the med literature, statements like “to our knowledge [TOK], this is the FIRST...” often replace a proper systematic search. Among 4488 PMC articles in 6 leading medical journals published 2020-2024, TOK prevalence was 21.7%, w @PLOSMedicine highest (48.4%) and @NEJM lowest (1.3%) #CornellVet

In 2 journals, Journal of Small Animal Practice (JSAP) and Journal of Exotic Pet Medicine (JEPM), an intervention to advise authors against use of these phrases and in favor of a scoping search of the literature was implemented in 2020, w decreases from 37.4% to 7.6% after the intervention.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 4

Thanks David!

Reposted

Tim Feeney @tfeend.bsky.social · Sep 3

Out this morning, TARGET a guideline to help get target trial emulation studies to report a standard set of items

#prc10
@peerreviewcongress.bsky.social
@bmj.com
@societyforepi.bsky.social

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Reposted

Miguel Hernan @miguelhernan.org · Sep 3

When using observational data for #causalinference, the choice isn’t between emulating or not emulating a #TargetTrial, but between reporting or not reporting the target trial that we are emulating.

For those who prefer to be explicit about what they do, we have developed the TARGET Statement 👇

hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

🎯 TARGET Guideline published 🎉

TARGET is a reporting guideline for observational studies of interventions that use the target trial framework.

Over 3 years the @TARGETGuideline was rigorously developed and was co-published today in @jama.com & @bmj.com

doi.org/10.1001/jama.2025.13350

#episky

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

As part of the ongoing refinement of the guideline, we'd love any feedback you have on it. We've made a survey to house this - redcap.link/target-feedb...
We are eager for all feedback good and bad!

Follow @TARGETGuideline for updates as they come along.

Feedback on the TARGET Guidelines

redcap.link

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

@james-mcauley.bsky.social @miguelhernan.org @lizstuart.bsky.social @margaritamb.bsky.social @sharpmelk.bsky.social and everyone who isn't on Bluesky - Aidan, Sonja, Matt, Hopin, Matthias, Jonathan, Barbra, Xabier, Rob, Sara, Sallie, Sebastian, and Issa

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

It has been an absolute joy to work with the team that made this guideline possible and we all hope it is useful!

We're still working to produce an E&E document to provide more information about the items and help users of the guideline implement it in their practice.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Overall, we hope TARGET will be help standardise how target trial emulations are reported. This should help journals, reviewers and readers more easily identify the quality of studies, make the studies more replicable, and help policymakers decide whether to use these studies.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Other information: This section contains information about whether and where other materials may be available (protocol’s, data, code) and how the study was funded or any potential conflicts.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Discussion: this section we highlight the limitations, causal inference from observational data is challenging and we should be interpreting our results in light of uncertainty of our assumptions.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Results: Reporting key results such as how participants were selected into the cohort (flow diagrams available target-guideline.org), baseline data, follow-up, missing data and estimates, as well as (ideally) a comprehensive set of sensitivity analyses.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

The target trial emulation section is how the target trial was operationalised with the data, e.g., what codes were used to identify eligibility, etc. Its helpful to report the target trial, and how it was emulated using a table (templates @ target-guideline.org)

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Methods 1/2. The methods have three parts, the data source (item 5), the target trial specification (item 6), and the target trial emulation (item 7). The specification outlines the hypothetical ‘target’ trial, the causal estimand, that the authors sought to emulate with the data.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Introduction: This section has 3 items that introduce the clinical question and why the authors thought it was helpful to use the target trial framework.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

Abstract: This section has 3 sub-items with the main goal to quickly orient readers to the causal question with a summary of the target trial, alert readers that this is an observational study and the key assumptions involved to avoid mix-ups with ACTUAL randomised trials.

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

The guideline is organised like a scientific manuscript, with abstract, introduction, methods, results and discussion.
Below I’ll outline the goals of each sections, but the checklist and materials to support users are available at target-guideline.org

The TARGET Guideline

target-guideline.org

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hjhansford.bsky.social @hjhansford.bsky.social · Sep 3

We set up an absolutely all star team to produce this guideline, with expertise in epidemiology, causal inference, clinical trials, biostatistics, as well as journal editors to ensure the guideline would include critical components of these studies. doi.org/10.1136/bmjopen-2023-074626

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Background Observational studies are increasingly used to inform health decision-making when randomised trials are not feasible, ethical or timely. The target trial approach provides a framework to he...

doi.org

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