Table IV.

Checklist for quality assessment of case reports or case series describing innovative therapies

Checklist for reporting cases and case series
Diagnosis	Are diagnostic criteria clearly identified, and met by patient(s)?
Informed consent	Has patient consent been documented? For prospective studies: is IRB approval documented?
Natural disease course	Is there any reference to natural course of disease, or, if applicable, course on standard treatment?
Dosages	Are treatments’ dosage, duration, and titration described adequately?
Oucome measures	Are outcomes well defined and clinically relevant? Are they subjective, standardized, or subjective?
Patient perception	Is there any documentation of the patients’ perception of outcome and of the intervention?
Safety	Do the authors describe known risks associated with intervention?
Authors’ conclusions	Do the authors abstain from unfounded claims about safety and efficacy?
Inclusion and exclusion criteria*	Are inclusion and exclusion criteria clearly stated?
Consecutive cases*	Are all consecutive patients treated by one physician or at one institution included?

IRB, Institutional review board.

^*For case series.