Outbreak reportindependent cross-checkabstract checked★ key study I-VEG-135 standard review

Germany 2011: sprouts the likely source

Epidemic profile of Shiga-toxin-producing Escherichia coli O104:H4 outbreak in Germany.

Overview

Frank C et al.. N Engl J Med 2011 · PMID 21696328 · DOI 10.1056/NEJMoa1106483

The outbreak caused 3,816 cases and 54 deaths; sprouts were identified as the most likely vehicle.

Does the study support the specific claim? No · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Describe the 2011 outbreak.

How was the study done?

Outbreak report.

How many people, animals or samples were studied?

3,816 cases.

What was actually found?

Sprouts most likely vehicle.

How large was the observed effect?

54 deaths.

What do the results mean in everyday life?

Cucumbers were not the cause.

What are the study's limitations?

Descriptive.

What does it say about Elawady's specific claim?

Contradicts the cucumber part.

Do the results apply to Germany and Europe?

German.

What can explicitly not be concluded from this study?

Not applicable.

Scientific in-depth review

1. Full reference

Authors
Frank C et al.
Journal
N Engl J Med
Year
2011
Identifier
PMID 21696328 DOI 10.1056/NEJMoa1106483
Verification
verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

What was the epidemic profile of the 2011 German STEC O104:H4 outbreak?

3. Study design and population

Study design
Outbreak report – Outbreak description from national surveillance and hospital cohort
Population

Reported cases in Germany

Country

Germany

Period

1 May-4 July 2011

Sample size

3,816 cases (845 HUS; 54 deaths)

Inclusion and exclusion criteria

not stated in abstract

4. Methods and endpoints

Exposure / intervention

Outbreak strain

Comparator

none

Endpoints

Cases, HUS, deaths; incubation

Statistical methods

Descriptive

5. Actual results

Results

3,816 cases incl. 54 deaths; 845 (22%) HUS; median incubation 8 days; consumption of sprouts identified as the most likely vehicle of infection.

Absolute risks

not reported

Authors' conclusion

HUS occurred predominantly in adults, mostly women; HUS developed in more than 20% of identified cases.

6. Strengths

  • National data

7. Weaknesses

  • Descriptive

8. Risk of bias

Orienting tool
none applicable
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
not assessable
Rationale

Outbreak report.

9. Assessment of the statistical interpretation

not applicable

10. Relevance to the specific claim

Names sprouts (not cucumbers) as the most likely vehicle.

11. Independent contrary findings

none

12. Transferability to Germany and Europe

German.

13. Overall methodological judgement

Contradicts the cucumber part of the claim.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biasnot assessable
Precision of resultsnot applicable
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

none

15. Linked fact checks