Evidence map›Paper›PMID 27453361›Full record

ArticleInternational journal of epidemiology2016

Observational studies and the difficult quest for causality: lessons from vaccine effectiveness and impact studies.

Marc Lipsitch, Ayan Jha, Lone Simonsen

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 83 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 6 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.

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

83 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Trial
  8. Effectiveness of the 10-valent pneumococcal non-typeableHuman vaccines & immunotherapeutics · 2026
    Article
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  10. Review
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  12. Observational
  13. Institutional spillover effects of antimicrobial use on antimicrobial resistance andAntimicrobial stewardship & healthcare epidemiology : ASHE · 2026
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  15. Article
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23 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

3 authors.

Marc LipsitchDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Ayan JhaDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Lone SimonsenDepartment of Global Health, George Washington University, Washington, DC, USA.

Funding

Understanding and controlling antibiotic resistanceU54GM088558 · NIGMS · HARVARD SCHOOL OF PUBLIC HEALTH · PI LIPSITCH, MARC · 2009 to 2018
$26.4M
NIGMS NIH HHS U54 GM088558
6 · The paper itself

Abstract

Although randomized placebo-controlled trials (RCT) are critical to establish efficacy of vaccines at the time of licensure, important remaining questions about vaccine effectiveness (VE)-used here to include individual-level measures and population-wide impact of vaccine programmes-can only be answered once the vaccine is in use, from observational studies. However, such studies are inherently at risk for bias. Using a causal framework and illustrating with examples, we review newer approaches to detecting and avoiding confounding and selection bias in three major classes of observational study design: cohort, case-control and ecological studies. Studies of influenza VE, especially in seniors, are an excellent demonstration of the challenges of detecting and reducing such bias, and so we use influenza VE as a running example. We take a fresh look at the time-trend studies often dismissed as 'ecological'. Such designs are the only observational study design that can measure the overall effect of a vaccination programme [indirect (herd) as well as direct effects], and are in fact already an important part of the evidence base for several vaccines currently in use. Despite the great strides towards more robust observational study designs, challenges lie ahead for evaluating best practices for achieving robust unbiased results from observational studies. This is critical for evaluation of national and global vaccine programme effectiveness.

Indexed as

Epidemiologic Research DesignBiasHumansImmunization ProgramsInfluenza, HumanInfluenza VaccinesObservational Studies as TopicInfluenza Vaccinescase-control studiesecological studyepidemiologic methodsnegative controlobservational studiestest-negative design

Identifiers

PMID27453361
PMCPMC5841615

What OpenQuestion holds

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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.