Patient selection |
Patient selection based on age and temperature limits | Include age or temperature as predictors |
Selection and definition of predictors |
Heterogeneity of selected predictors | Use a defined set of clinical predictors |
Use objective clinical predictors |
Broad validation |
Clinical value | Stepwise analysis of patient history and examination, with evaluation of the added value of diagnostic tests (new markers) |
Use rule out symptoms (‘green flags’) |
Diagnostic value of ‘new’ predictors and ‘time course’ | Parental concern |
Diagnostic value of ‘safety-netting’ |
Outcomes |
Lack of reference test to confirm bacterial origin | Pragmatic clinical definitions or composite reference test |
Include follow up time in the definition of outcome |
The changing definition of serious infection/low prevalence of serious outcome | Consider other important outcomes such as need for referral, hospitalisation |
Adjust outcome definition to setting |
Focus on ruling out versus ruling in serious infections |
Heterogeneous outcomes/intermediate outcomes (severity or probability) | Polytomous modelling |
Generalisability to different clinical settings |
Setting with differences in prior risk/(geographic or temporal) changes in case mix | Studies in low prevalence settings (primary care) are required |
Continuous validation studies |
Mismatch of the diagnostic research approach to the clinical diagnostic process | Include repeated assessment of children |
Include reassessment plan (safety-netting) in the implementation of decision rule |
Lack of impact of the prediction rule on patient outcome/lack of implementation of rule in routine practice | Impact analysis |
Implementation strategies |