Evidence map›Paper›PMID 39850505›Full record

ReviewThe Journal of clinical and aesthetic dermatology

Review of Statistical Considerations and Data Imputation Methodologies in Psoriasis Clinical Trials.

Douglas DiRuggiero, Cynthia Trickett, Lauren Hippeli, Sang Hee Park, Amy Baum-Jones, David S Davidson

Abstract readReview
In one paragraph

Review in The Journal of clinical and aesthetic dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Interpreting Safety Analyses in Psoriasis Clinical Trials.The Journal of clinical and aesthetic dermatology
    Review
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

6 authors.

Douglas DiRuggieroDr. DiRuggiero is with the Skin Cancer and Cosmetic Dermatology Center in Rome, Georgia.
Cynthia TrickettMs. Trickett is with North Dallas Dermatology Associates in Dallas, Texas.
Lauren HippeliMs. Hippeli, Ms. Park, and Ms. Baum-Jones are with Bristol Myers Squibb in Princeton, New Jersey.
Sang Hee ParkMs. Hippeli, Ms. Park, and Ms. Baum-Jones are with Bristol Myers Squibb in Princeton, New Jersey.
Amy Baum-JonesMs. Hippeli, Ms. Park, and Ms. Baum-Jones are with Bristol Myers Squibb in Princeton, New Jersey.
David S DavidsonMr. Davidson is with Fallon Medica in Tinton Falls, New Jersey, and was an employee of Bristol Myers Squibb at the time of manuscript development.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Numerous clinical trials have established that various biologic and oral small-molecule therapies are efficacious in patients with psoriasis. However, as there are limited head-to-head trials, healthcare providers may compare results across multiple trials when providing treatment recommendations. Direct comparisons among agents are challenging because psoriasis trials differ in terms of study design, patient population, and data analysis methodologies. Long-term clinical trials present additional challenges because the number of patients enrolled generally declines over time. The missing patient data that might occur, coupled with the specific approach used to substitute or impute that missing data, might introduce bias and skew efficacy results. In this review, we discuss how variations in study design and analytical methodologies affect efficacy outcomes in clinical trials. We also review published trials of biologic and oral small-molecule therapies for psoriasis to illustrate how issues related to missing data and choices in data imputation methodologies can affect the interpretation of efficacy outcomes. Imputation methodologies discussed include nonresponder imputation, modified nonresponder imputation, treatment failure rules, last observation carried forward, modified baseline observation carried forward, and multiple imputation. This review provides a foundation for the healthcare provider's critical evaluation of the psoriasis literature and emphasizes the importance of considering the level of evidence provided in a clinical trial when making treatment decisions.

Indexed as

Data imputationpsoriasisstatistical analysisstudy design

Identifiers

PMID39850505
PMCPMC11753760

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.