Evidence map›Paper›PMID 23855337›Full record

ArticleBMC medical research methodology2013

A tutorial on sensitivity analyses in clinical trials: the what, why, when and how.

Lehana Thabane, Lawrence Mbuagbaw, Shiyuan Zhang, Zainab Samaan, Maura Marcucci, Chenglin Ye, Marroon Thabane, Lora Giangregorio, Brittany Dennis, Daisy Kosa and 7 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical research methodology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03196258 (Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures), which is not on this map. Cited by 415 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
415citing papers in PubMed, 16 pooled it
–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.

NCT03196258 naterminatednot on this mapstarted 2018, after this paper: background citation

Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures: A Randomized Controlled Trial (SPOC-CBT)

TypeinterventionalSponsorMcMaster UniversityRan2018 to 2019Enrolled8ConditionsPain, Postoperative, Fractures, Closed, Fractures, OpenArmsCognitive behavioural therapy
3 · Its place in the literature

Who cites it

415 citing papers in PubMed, 16 syntheses or guidelines pooled it.

  1. Effects of Integrated Sports Vision Training Batteries on Time- and Accuracy-Dependent Outcomes in Sport-Specific Tasks: A Systematic Review and Meta-Analysis.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
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  3. Efficacy of eyelid warming therapies in contact lens-related dry eye and comfortable wearing time: a systematic review with meta-analysis.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
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355 more citing papers are in PubMed but not listed here.

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

17 authors.

Lehana ThabaneDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. ThabanL@mcmaster.ca
Lawrence Mbuagbaw
Shiyuan Zhang
Zainab Samaan
Maura Marcucci
Chenglin Ye
Marroon Thabane
Lora Giangregorio
Brittany Dennis
Daisy Kosa
Victoria Borg Debono
Rejane Dillenburg
Vincent Fruci
Monica Bawor
Juneyoung Lee
George Wells
Charles H Goldsmith

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations--such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers--on the overall conclusions of a study.The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials. DISCUSSION: In this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials. SUMMARY: When reporting on a clinical trial, we recommend including planned or posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.

Indexed as

Sensitivity and SpecificityClinical Trials as TopicHumansOutcome and Process Assessment, Health CareResearch Design

Identifiers

PMID23855337
PMCPMC3720188

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.