Table 4.

Assessment of Methodologic Quality of Individual Studies

Article	Randomized	Concealed Allocation	Double Blind	Complete patient follow-up	Sample Size calculation	CFA before study1	Controlled timing of fecal fat collection2	Monitoring fat intake during fecal fat collection.3	Assessment of Symptom Improvement6
Borowitz et al, 2006 [10]	Yes	Unkown	Yes	Yes	Yes	Yes-fecal elastase measurement	Yes, used FD&C blue 2 stool marker.	Yes	No
O'keefe et al, 2001 [12]	Yes	unknown	placebo group but unclear if investigators blinded	Yes	No	Yes	No	Yes	Yes
Safdi et al, 2006 [13]	Yes	Unkown	Yes	Yes	No	Yes	No4	No	Yes
Stern et al, 2000 [11]	Yes	unknown	open-label run-in/ double-blind treatment phase	Yes	No	Yes	Yes, used food dye during double-blind treatment phase	Yes	Yes

¹Confirmed fat malabsorption before study enrollment with CFA

²Demonstrated appropriate timing of fecal fat collection through the use of stool markers to ensure that the patient monitored diet at the beginning and end of fecal fat collection.

³Monitored in an inpatient setting

⁴2 consecutive outpatient phases: a 2 week, single blind, placebo run-in phase (“wash out”) and a 2 week, double blind, treatment phase

⁵Open label phase was to stabilize patient on a high fat diet (100g fat/day) and adjust pancrealipase dose

⁶Assessment of symptom assessment includes stool frequency, stool consistency, abdominal discomfort, and/or global symptom improvement.