Evidence map›Paper›PMID 38650049›Full record

ArticleAdvances in rheumatology (London, England)2024

Effect size varies based on calculation method and may affect interpretation of treatment effect: an illustration using randomised clinical trials in osteoarthritis.

Thomas J Schnitzer, Philip G Conaghan, Francis Berenbaum, Lucy Abraham, Joseph C Cappelleri, Andrew G Bushmakin, Lars Viktrup, Ruoyong Yang, Mark T Brown

3 registry-linked trialsOpen access · diamondAbstract read
In one paragraph

Article in Advances in rheumatology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.4field-weighted citation impact, top 20% of its field
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.

NCT02528188 phase3completednot on this map

A phase 3 randomized, double-blind, active-controlled, multicenter study of the long-term safety and efficacy of subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee

TypeinterventionalSponsorPfizerRan2015 to 2019Enrolled3,021ConditionsChronic Pain, Osteoarthritis, Hip, Osteoarthritis, KneeArmsNSAID, Tanezumab 2.5 mg, Tanezumab 5 mg
NCT02697773 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of a dose titration regimen for the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee

TypeinterventionalSponsorPfizerRan2016 to 2018Enrolled698ConditionsOsteoarthritis, Knee, Osteoarthritis, HipArmsPlacebo, Tanezumab 2.5 mg, Tanezumab 2.5mg/5mg
NCT02709486 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee

TypeinterventionalSponsorPfizerRan2016 to 2018Enrolled849ConditionsOsteoarthritis, Hip, Osteoarthritis, KneeArmsTanezumab, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

9 authors at 6 institutions in 3 countries.

Thomas J SchnitzerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA. tjs@northwestern.edu.ORCID 0000-0002-4048-5431
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, National Institute for Health Research, Leeds Biomedical Research Centre-University of Leeds, Leeds, UK.
Francis BerenbaumSorbonne University, INSERM CRSA, AP-HP Saint-Antoine hospital, Paris, France.
Lucy AbrahamPfizer R&D UK Ltd, Surrey, UK.
Joseph C CappelleriPfizer Inc, Groton, CT, USA.
Andrew G BushmakinPfizer Inc, Groton, CT, USA.
Lars ViktrupEli Lilly and Co, Indianapolis, IN, USA.
Ruoyong YangPfizer Inc, New York, NY, USA.
Mark T BrownPfizer Inc, Groton, CT, USA.
Pfizer (United States) · USEli Lilly (United States) · USInserm · FRNorthwestern University · USPfizer (United Kingdom) · GBUniversity of Leeds · GB

Funding

Eli Lilly and Company NAPfizer NA
6 · The paper itself

Abstract

backgroundTo illustrate how (standardised) effect sizes (ES) vary based on calculation method and to provide considerations for improved reporting.

methodsData from three trials of tanezumab in subjects with osteoarthritis were analyzed. ES of tanezumab versus comparator for WOMAC Pain (outcome) was defined as least squares difference between means (mixed model for repeated measures analysis) divided by a pooled standard deviation (SD) of outcome scores. Three approaches to computing the SD were evaluated: Baseline (the pooled SD of WOMAC Pain values at baseline [pooled across treatments]); Endpoint (the pooled SD of these values at the time primary endpoints were assessed); and Median (the median pooled SD of these values based on the pooled SDs across available timepoints). Bootstrap analyses were used to compute 95% confidence intervals (CI).

resultsES (95% CI) of tanezumab 2.5 mg based on Baseline, Endpoint, and Median SDs in one study were - 0.416 (- 0.796, - 0.060), - 0.195 (- 0.371, - 0.028), and - 0.196 (- 0.373, - 0.028), respectively; negative values indicate pain improvement. This pattern of ES differences (largest with Baseline SD, smallest with Endpoint SD, Median SD similar to Endpoint SD) was consistent across all studies and doses of tanezumab.

conclusionDifferences in ES affect interpretation of treatment effect. Therefore, we advocate clearly reporting individual elements of ES in addition to its overall calculation. This is particularly important when ES estimates are used to determine sample sizes for clinical trials, as larger ES will lead to smaller sample sizes and potentially underpowered studies.

trial registrationClinicaltrials.gov NCT02697773, NCT02709486, and NCT02528188.

Indexed as

Antibodies, Monoclonal, HumanizedOsteoarthritisRandomized Controlled Trials as TopicClinical Trials, Phase III as TopicData Interpretation, StatisticalHumansMulticenter Studies as TopicPain MeasurementTreatment OutcomeAntibodies, Monoclonal, HumanizedtanezumabEffect sizeOsteoarthritisPainRandomised controlled trialVariability

Identifiers

PMID38650049
PMCPMC13488644
OpenAlexW4395010805

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.