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. 2000 Oct 23;2000(4):CD001481. doi: 10.1002/14651858.CD001481

Rith‐Najarian 1998.

Methods ITS 
 Intervention independent of other changes: DONE 
 Sufficient data points to enable reliable statistical inference: NOT DONE 
 Formal test of trend: N/A Intervention unlikely to affect data collection: DONE 
 Blinded assessment: DONE 
 Completeness of data set: DONE 
 Reliable outcomes: NOT CLEAR
Participants Rural primary care clinic in northern Minnesota (US). 
 A foot‐care team was formed consisting of a family physician, two clinic nurses, a home care nurse, a nutritionist and a registrar. 
 Patients were American Indians identified through surveillance having diabetes. They were entered into a diabetes registry and followed thereafter (not clear which type of diabetes). 
 Provider ‐ 1 physician 
 + 3 nurses 
 (+nutritionist+registrar) 
 patients ‐ 449 
 practices ‐ 1
Interventions Intervention group: Professional intervention (distribution of educational materials + reminders) + organisational intervention (clinical multidisciplinary team)
Control group: N/A
Length of intervention: 
 3 years
Outcomes PROCESS: 
 NONE
PATIENT: 
 Lower‐extremity amputation (LEA) 
 First LEA 
 Major LEA (defined as either a "below the knee amputation" or an "above the knee amputation")
Notes Local guidelines 
 ‐directed at diagnosis, treatment, monitoring and risk factor assessment 
 ‐targets: to reduce lower‐extremity amputations
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk D ‐ Not used