Evidence map›Paper›PMID 38365817›Full record

ArticleTrials2024

The analysis of continuous data from n-of-1 trials using paired cycles: a simple tutorial.

Stephen Senn

2 registry-linked trialsAbstract read
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06721871 phase2 / phase3active not recruitingnot on this mapstarted 2025, after this paper: background citation

Evaluation of Safety, Tolerability and Efficacy of Crofelemer Following Multiple Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Participants With Microvillus Inclusion Disease (MVID)

TypeinterventionalSponsorNapo Pharmaceuticals, Inc.Ran2025 to 2026Enrolled6ConditionsMicrovillus Inclusion Disease, Congenital Disorders, Rare DiseasesArmsCrofelemer Powder for Oral Solution, Placebo Powder for Oral Solution
NCT07190989 nacompletednot on this mapstarted 2025, after this paper: background citation

Inter-individual Variability of Sleep Outcome Measures in Response to Nutritional Blend Supplementation: a Replicate Crossover Trial

TypeinterventionalSponsorAspire AcademyRan2025 to 2025Enrolled15ConditionsHealthyArmsNutritional Supplement, Maltodextrin (Placebo)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Stephen SennThe University of Sheffield, Sheffield, UK. stephen@senns.uk.ORCID http://orcid.org/0000-0002-7558-8473

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

N-of-1 trials are defined and the popular paired cycle design is introduced, together with an explanation as to how suitable sequences may be constructed.Various approaches to analysing such trials are explained and illustrated using a simulated data set. It is explained how choosing an appropriate analysis depends on the question one wishes to answer. It is also shown that for a given question, various equivalent approaches to analysis can be found, a fact which may be exploited to expand the possible software routines that may be used.Sets of N-of-1 trials are analogous to sets of parallel group trials. This means that software for carrying out meta-analysis can be used to combine results from N-of-1 trials. In doing so, it is necessary to make one important change, however. Because degrees of freedom for estimating variances for individual subjects will be scarce, it is advisable to estimate local standard errors using pooled variances. How this may be done is explained and fixed and random effect approaches to combining results are illustrated.

Indexed as

Clinical Trials as TopicSoftware

Identifiers

PMID38365817
PMCPMC10870460

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.