The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis

Ibargoyen-Roteta, Nora; Gutiérrez-Ibarluzea, Iñaki; Rico-Iturrioz, Rosa; López-Argumedo, Marta; Reviriego-Rodrigo, Eva; Cabriada-Nuño, Jose Luis; Schünemann, Holger J

doi:10.1186/1748-5908-5-48

Implementation Science

Table 3 GRADE evidence Profile for the second clinical question.

From: The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis

Quality assessment							Summary of findings					Importance
							No of patients		Effect		Quality
No of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Apheresis systems plus Corticosteroid treatment	Corticosteroid treatment	Relative (95% CI)	Absolute
Percentage of patients wihtout corticosteroids one month after treatment (follow-up mean 14 weeks)
1	randomised trial	no serious limitations¹	no serious inconsistency	no serious indirectness	serious^2,3	none	10/46 (21.7%)	3/23 (13%)	OR 1.85 (0.46 to 7.52)	91 more per 1000 (from 67 fewer to 454 more)	⊕⊕⊕O MODERATE	CRITICAL
Mean reduction of corticosteroid dose (follow-up median 7.5)
2	randomised trial	serious⁴	serious⁵	no serious indirectness	serious³	none	55	33	-	not pooled	⊕OOO VERY LOW	IMPORTANT
Clinical remission one month after (follow-up median 1 weeks)
3	randomised trial	serious⁴	no serious inconsistency⁶	serious	serious³	none	49/98 (50%)	22/70 (31.4%)	RR 1.31 (0.93 to 1.83)	97 more per 1000 (from 22 fewer to 261 more)	⊕OOO VERY LOW	CRITICAL
Endoscopic remission one month after treatment (follow-up median 1 weeks)
2	randomised trial	serious⁴	no serious inconsistency	serious^7,8	serious³	none	52	47	-	-	⊕OOO VERY LOW	IMPORTANT
Colectomy rate in the follow up (follow-up median 2 weeks)
2	randomised trial	serious⁴	no serious inconsistency	no serious indirectness	serious³	none	3/56 (5.4%)	7/19 (36.8%)	OR 0.21 (0.04 to 1.02)	275 fewer per 1000 (from 350 fewer to 6 more)	⊕⊕OO LOW	CRITICAL
Quality of life improvement - not measured
0	-	-	-	-	-	-	-	-	-	-		CRITICAL
Long term side effects - not measured
0	-	-	-	-	-	-	-	-	-	-		CRITICAL
Clinical remission 12 months after treatment (follow-up mean 3.5 months)
1	randomised trial	no serious limitations	no serious inconsistency	serious⁹	serious^2,3	none	39/46 (84.8%)	16/23 (69.6%)	RR 1.22 (0.9 to 1.36)	153 more per 1000 (from 70 fewer to 251 more)	⊕⊕OO LOW	CRITICAL

¹Information about the randomization process is not provided in the main text, although it's pointed out that each patient was blindly assessed.
²There is only one study.
³Small sample size and less than 300 events.
⁴Patients included in selected studies could be different because the criteria used to define their steroid-response pattern were not the same. This was considered a limitation and, as a consequence, the quality was downgraded.
⁵The patients treated with apheresis and corticosteroids do not take the same dose of corticosteroids at the beginning. moreover, the pointing time when 'final' corticosteroid dose is measured is not the same in both studies (this is why we did not pool the data).
⁶In Sawada's both studies, clinical remission was more strictly defined (CAI = 0). nevertheless, consistency among results was found (see Figure 1B).
⁷They do not assess the Endoscopic remission as defined, but give data about the Mean EI before and after the treatment for both groups. we could pool the Mean EI before and after the treatment and compare them (See Figure 1B). Before the treatment, the mean EI was similar between groups, but after the treatment, the mean EI was almost 3 points lower for the apheresis plus corticosteroids group than for the corticosteroids group.
⁸None of the studies defined endoscopic remission taken into account the withdrawal of corticosteroids.
⁹In this study, the mean follow-up was 3.5 months, and not 12 months as defined for the outcome of interest

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ISSN: 1748-5908

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