Guideline Development Tool

Author(s): Marta Matisen

Question: Kas kõigile kroonilise südamepuudulikkusega täiskasvanud patsientidele, kellel esineb rauavaegus, tuleb parema ravitulemuse saamiseks määrata intravenoosne rauavaeguse asendusravi?

Setting: Kas kõigile kroonilise südamepuudulikkusega täiskasvanud patsientidele, kellel esineb rauavaegus, tuleb parema ravitulemuse saamiseks määrata intravenoosne rauavaeguse asendusravi?

Bibliography:

Certainty assessment	№ of patients	Effect	Certainty	Importance
Üldsuremus; ainult iv (p=0,078)^a
6^1,^2,^3,^4,^5,^6,⁷	randomised trials	not serious	not serious	not serious	serious^b	none	24/597 (4.0%)	34/427 (8.0%)	OR 0.59 (0.33 to 1.06)	31 fewer per 1,000 (from 52 fewer to 4 more)	⨁⨁⨁◯ Moderate
Kardiovaskulaarne suremus; ainult iv (p=0,54)^a
3^2,^3,^6,⁷	randomised trials	not serious	not serious	not serious	serious^b	none	16/479 (3.3%)	16/316 (5.1%)	OR 0.80 (0.39 to 1.63)	10 fewer per 1,000 (from 30 fewer to 29 more)	⨁⨁⨁◯ Moderate
Kardiovaskulaarsetel põhjustel hospitaliseerimine; ainult iv (p=0,049)^a
6^2,^3,^4,^5,^6,^7,⁸	randomised trials	not serious	very serious^c	not serious	not serious	none	58/607 (9.6%)	89/442 (20.1%)	OR 0.35 (0.12 to 0.99)	120 fewer per 1,000 (from 172 fewer to 2 fewer)	⨁⨁◯◯ Low
Kõrvaltoimed rauaasendusravi vs platseebo ; iv ja po^a
7^2,^3,^4,^9,^10,^11,¹²	randomised trials	not serious	serious^d	not serious^e	serious^b	none	98/516 (19.0%)	98/350 (28.0%)	OR 0.91 (0.43 to 1.92)	19 fewer per 1,000 (from 137 fewer to 147 more)	⨁⨁◯◯ Low
Tõsised kõrvaltoimed rauaasendusraviga vs platseeboga ; iv ja po^a
6^2,^3,^9,^10,^12,¹³	randomised trials	not serious	not serious	not serious^f	serious^b	none	46/507 (9.1%)	38/342 (11.1%)	OR 0.92 (0.50 to 1.71)	8 fewer per 1,000 (from 52 fewer to 65 more)	⨁⨁⨁◯ Moderate
NYHA klass; ainult iv^a
7^2,^3,^4,^6,^7,^8,^10,¹⁴	randomised trials	not serious	very serious^g	not serious	not serious	none	532	370	-	MD 0.73 lower (0.99 lower to 0.47 lower)	⨁⨁◯◯ Low
Füüsiline võimekus 6 MKT alusel; iv ja po (assessed with: meetrid)
7^2,^6,^7,^8,^9,^10,^12,¹³	randomised trials	not serious	very serious^h	not serious^f	not serious	none	591	452	-	MD 35.44 more (11.55 more to 59.33 more)	⨁⨁◯◯ Low
Füüsiline võimekus 6 MKT alusel; ainult iv (assessed with: m)
3^2,^6,^8,¹⁵	randomised trials	not serious	not serious	not serious	not serious	none	413	275	-	MD 39.5 higher (25.11 higher to 53.88 higher)	⨁⨁⨁⨁ High
NT-proBNP tase; iv ja po
6^7,^8,^9,^10,^11,^14,¹⁶	randomised trials	not serious	very seriousⁱ	not serious^j	very serious^k	none	210	208	-	MD 6.63 lower (231.53 lower to 218.28 higher)	⨁◯◯◯ Very low
Füüsiline võimekus (maksimaalne VO2); iv ja po
7^1,^3,^5,^7,^9,^10,¹¹	randomised trials	not serious	very serious^l	not serious^m	not serious^k	none	260	243	-	MD 0.47 higher (0.27 lower to 1.21 higher)	⨁⨁◯◯ Low
Füüsiline võimekus (maksimaalne VO2) (p<0.001); ainult iv
4^1,^3,^5,^7,¹⁰	randomised trials	not serious	not serious	not serious	not serious	none	131	116	-	MD 1.04 higher (0.9 higher to 1.19 higher)	⨁⨁⨁⨁ High
LVEF (po ravi p=0,950; iv ravi p=0,013)
6^3,^4,^7,^8,^10,^11,¹⁴	randomised trials	not serious	very seriousⁿ	not serious	not serious	none	122	106	-	MD 4.35 higher (0.69 higher to 8 higher)	⨁⨁◯◯ Low
Elukvaliteet KCCQ skoori alusel; ainult iv ravi (MID=5)
2^2,^6,¹⁵	randomised trials	not serious	not serious	not serious	serious^o	none			-	MD 5.43 higher (2.84 higher to 8.02 higher)	⨁⨁⨁◯ Moderate
Elukvaliteet KCCQ skoori alusel; iv ja po ravi (PO ravi p=0,926; iv ravi p=0,025)
6^2,^6,^7,^9,^10,^12,¹⁶	randomised trials	not serious	serious^p	not serious^q	serious^k	none	573	427	-	MD 3.13 higher (0.57 lower to 6.83 higher)	⨁⨁◯◯ Low
Elukvaliteet EQ-5D skoori alusel (p=0,014); ainult iv ravi
2^2,^6,⁷	randomised trials	not serious	not serious	not serious	not serious	none	399	252	-	MD 4.07 higher (0.84 higher to 7.31 higher)	⨁⨁⨁⨁ High

Certainty assessment

№ of patients

Effect

Certainty

Importance

№ of studies

Study design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerations

intravenoosne rauaasendusravi

mitte

Relative
(95% CI)

Absolute
(95% CI)

Üldsuremus; ainult iv (p=0,078)^a

6^1,^2,^3,^4,^5,^6,⁷

randomised trials

not serious

serious^b

none

24/597 (4.0%)

34/427 (8.0%)

OR 0.59
(0.33 to 1.06)

31 fewer per 1,000
(from 52 fewer to 4 more)

⨁⨁⨁◯
Moderate

Kardiovaskulaarne suremus; ainult iv (p=0,54)^a

3^2,^3,^6,⁷

randomised trials

not serious

serious^b

none

16/479 (3.3%)

16/316 (5.1%)

OR 0.80
(0.39 to 1.63)

10 fewer per 1,000
(from 30 fewer to 29 more)

⨁⨁⨁◯
Moderate

Kardiovaskulaarsetel põhjustel hospitaliseerimine; ainult iv (p=0,049)^a

6^2,^3,^4,^5,^6,^7,⁸

randomised trials

not serious

very serious^c

not serious

none

58/607 (9.6%)

89/442 (20.1%)

OR 0.35
(0.12 to 0.99)

120 fewer per 1,000
(from 172 fewer to 2 fewer)

⨁⨁◯◯
Low

Kõrvaltoimed rauaasendusravi vs platseebo ; iv ja po^a

7^2,^3,^4,^9,^10,^11,¹²

randomised trials

not serious

serious^d

not serious^e

serious^b

none

98/516 (19.0%)

98/350 (28.0%)

OR 0.91
(0.43 to 1.92)

19 fewer per 1,000
(from 137 fewer to 147 more)

⨁⨁◯◯
Low

Tõsised kõrvaltoimed rauaasendusraviga vs platseeboga ; iv ja po^a

6^2,^3,^9,^10,^12,¹³

randomised trials

not serious

not serious^f

serious^b

none

46/507 (9.1%)

38/342 (11.1%)

OR 0.92
(0.50 to 1.71)

8 fewer per 1,000
(from 52 fewer to 65 more)

⨁⨁⨁◯
Moderate

NYHA klass; ainult iv^a

7^2,^3,^4,^6,^7,^8,^10,¹⁴

randomised trials

not serious

very serious^g

not serious

none

532

370

MD 0.73 lower
(0.99 lower to 0.47 lower)

⨁⨁◯◯
Low

Füüsiline võimekus 6 MKT alusel; iv ja po (assessed with: meetrid)

7^2,^6,^7,^8,^9,^10,^12,¹³

randomised trials

not serious

very serious^h

not serious^f

not serious

none

591

452

MD 35.44 more
(11.55 more to 59.33 more)

⨁⨁◯◯
Low

Füüsiline võimekus 6 MKT alusel; ainult iv (assessed with: m)

3^2,^6,^8,¹⁵

randomised trials

not serious

none

413

275

MD 39.5 higher
(25.11 higher to 53.88 higher)

⨁⨁⨁⨁
High

NT-proBNP tase; iv ja po

6^7,^8,^9,^10,^11,^14,¹⁶

randomised trials

not serious

very seriousⁱ

not serious^j

very serious^k

none

210

208

MD 6.63 lower
(231.53 lower to 218.28 higher)

⨁◯◯◯
Very low

Füüsiline võimekus (maksimaalne VO2); iv ja po

7^1,^3,^5,^7,^9,^10,¹¹

randomised trials

not serious

very serious^l

not serious^m

not serious^k

none

260

243

MD 0.47 higher
(0.27 lower to 1.21 higher)

⨁⨁◯◯
Low

Füüsiline võimekus (maksimaalne VO2) (p<0.001); ainult iv

4^1,^3,^5,^7,¹⁰

randomised trials

not serious

none

131

116

MD 1.04 higher
(0.9 higher to 1.19 higher)

⨁⨁⨁⨁
High

LVEF (po ravi p=0,950; iv ravi p=0,013)

6^3,^4,^7,^8,^10,^11,¹⁴

randomised trials

not serious

very seriousⁿ

not serious

none

122

106

MD 4.35 higher
(0.69 higher to 8 higher)

⨁⨁◯◯
Low

Elukvaliteet KCCQ skoori alusel; ainult iv ravi (MID=5)

2^2,^6,¹⁵

randomised trials

not serious

serious^o

none

MD 5.43 higher
(2.84 higher to 8.02 higher)

⨁⨁⨁◯
Moderate

Elukvaliteet KCCQ skoori alusel; iv ja po ravi (PO ravi p=0,926; iv ravi p=0,025)

6^2,^6,^7,^9,^10,^12,¹⁶

randomised trials

not serious

serious^p

not serious^q

serious^k

none

573

427

MD 3.13 higher
(0.57 lower to 6.83 higher)

⨁⨁◯◯
Low

Elukvaliteet EQ-5D skoori alusel (p=0,014); ainult iv ravi

2^2,^6,⁷

randomised trials

not serious

none

399

252

MD 4.07 higher
(0.84 higher to 7.31 higher)

⨁⨁⨁⨁
High

a. Intravenoosne rauaasendusravi kroonilise südamepuudulikkuse ja rauavaegusega (aneemiaga või ilma) patsientidel.

b. Sekkumise mõju usaldusvahemik lai, läbib 1-te.

c. Uuringute heterogeensus suur, I2=80.9%

d. Uuringute heterogeensus suur, I2=69,2%

e. Seitsmest uuringust kahes rakendati patsientidele po rauaasendusravi (Gentil 2017, Lewis 2017)

f. Seitsmest uuringust kahes rakendati patsientidele rauaasendusravi po (Lewis 2017, Sagita 2017)

g. Uuringute heterogeensus suur, I2 = 88,1%

h. Uuringute heterogeensus väga suur, I2=94,1%

i. Uuringute heterogeensus väga suur, I2=92,7

j. Kuuest uuringust kahes rakendati rauaasendusravi po (Lewis 2017, Gentil 2017)

k. Sekkumise mõju hinnangu usaldusvahemik lai

l. Uuringute heterogeensus väga suur - I2=87%

m. Seitsmest uuringust kolmes manustati rauaasendusravi po (Beck Da Silva 2013, Lewis 2017, Gentil 2017)

n. Uuringute heterogeensus väga suur, I2=92,9%

o. Tulemuse usaldusvahemiku alumine piir jääb allapoole MID-i)

p. Uuringute heterogeensus suur, I2=69,5%

q. Ühes uuringus (Lewis 2017, n=225) said patsiendid po rauaasendusravi

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Explanations

References