Cohort studyindependent cross-checkabstract checked I-ODD-111 standard review
Most leg amputations in a Swedish region were in people without diabetes
Incidence of lower-limb amputation in the diabetic and nondiabetic general population: a 10-year population-based cohort study of initial unilateral and contralateral amputations and reamputations.
Overview
Johannesson A et al.. Diabetes Care 2009 · PMID 19001192 · DOI 10.2337/dc08-1639
157 of 290 amputees had no diabetes; risk 8 times higher with diabetes.
Does the study support the specific claim? No · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Compare amputation rates with and without diabetes.
- How was the study done?
10-year regional registry.
- How many people, animals or samples were studied?
290 amputees.
- What was actually found?
Amputations occur in people without diabetes too; diabetes raises the rate eightfold.
- How large was the observed effect?
About 195 vs 23 per 100,000 person-years.
- What do the results mean in everyday life?
Amputations are caused by blood-vessel disease and diabetes, not only by medicines.
- What are the study's limitations?
Drug use not studied.
- What does it say about Elawady's specific claim?
Refutes 'only'.
- Do the results apply to Germany and Europe?
High.
- What can explicitly not be concluded from this study?
Effects of individual drugs.
Scientific in-depth review
1. Full reference
- Authors
- Johannesson A et al.
- Journal
- Diabetes Care
- Year
- 2009
- Identifier
- PMID 19001192 DOI 10.2337/dc08-1639
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract.
2. Research question
How does the incidence of vascular lower-limb amputation differ between people with and without diabetes?
3. Study design and population
- Study design
- Cohort study – Population-based cohort (10-year registration of all vascular lower-limb amputations in a Swedish region)
- Population
General population aged >=45 years in a representative Swedish region
- Country
Sweden
- Period
1997-2006
- Sample size
290 amputees (133 with diabetes, 157 without)
- Inclusion and exclusion criteria
All vascular amputations at or proximal to transmetatarsal level
4. Methods and endpoints
- Exposure / intervention
Diabetes status
- Comparator
No diabetes
- Endpoints
Initial unilateral amputation, contralateral amputation, reamputation
- Statistical methods
Incidence per 100,000 person-years with 95% CI
5. Actual results
- Results
Initial amputation per 100,000 PY: diabetic women 192 (145-241), diabetic men 197 (152-244), nondiabetic women 22 (17-26), nondiabetic men 24 (19-29). 157 of 290 amputees had no diabetes.
- Absolute risks
About 2 per 1,000 person-years with diabetes vs about 0.2 per 1,000 without.
- Authors' conclusion
Incidence of vascular amputation is eight times higher in diabetic than nondiabetic individuals aged >=45.
6. Strengths
- Complete population registration
7. Weaknesses
- Single region
- Treatment of diabetes not analysed
8. Risk of bias
- Orienting tool
- ROBINS-E
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Descriptive incidence study.
9. Assessment of the statistical interpretation
54% of amputees had no diabetes (stats/C-ODD-06.py).
10. Relevance to the specific claim
Refutes 'leg amputations happen only to people taking diabetes drugs and insulin': more than half of amputees had no diabetes at all; diabetes itself (vascular disease, neuropathy) is the main driver.
11. Independent contrary findings
Canagliflozin increased toe/metatarsal amputations in CANVAS (A-ODD-09).
12. Transferability to Germany and Europe
High (EU population).
13. Overall methodological judgement
Directly contradicts the 'only' wording.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | indirect |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None.