. 2011 Mar 15;183(6):788–824. doi: 10.1164/rccm.2009-040GL

TABLE 17.

SILDENAFIL GRADE EVIDENCE PROFILE^*

	Quality Assessment
	No. of Studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other Considerations
Mortality (Copy) (follow-up 12–24 wk)	2	Randomized trials	No serious limitations	No serious inconsistency^‡	No serious indirectness	Very serious^§	None
Exacerbations (follow-up mean 12 wk)	1^¶	Randomized trials	No serious limitations	No serious inconsistency	No serious indirectness	Very serious^‖	None
Quality of Life (SGRQ) (follow-up mean 12 wk; better indicated by lower values)	1	Randomized trials	No serious limitations	No serious inconsistency	No serious indirectness	Serious^**	None
FVC (follow-up 12–24 wk; better indicated by lower values)	2	Randomized trials	No serious limitations	No serious inconsistency	Serious^††	Serious^**	None
Dyspnea Change Scores Borg (follow-up 12–24 wk; better indicated by lower values)	2	Randomized trials	No serious limitations	No serious inconsistency	No serious indirectness^‡‡	Serious^**	None
Dl_CO (better indicated by lower values)	2	Randomized trials	No serious limitations	No serious inconsistency	Serious^§§	Serious^**	None
Six-Minute-Walk Distance (better indicated by lower values)	2	Randomized trials	No serious limitations	No serious inconsistency	Serious^¶¶	Serious^**	None
Oxygen Saturation (better indicated by lower values)	2	Randomized trials	No serious limitations	No serious inconsistency	Serious^‖‖	Serious^**	None

	Summary of Findings
	No. of Patients			Effect
	Sildenafil	No Sildenafil	Relative (95% CI)	Absolute	Quality	Importance^†^†
Mortality (Copy) (follow-up 12–24 wk)	2/103 (1.9%)	4/106 (3.8%)	RR 0.51 (0.1–2.72)	18 fewer per 1,000 (from 34 fewer to 65 more)	⊕⊕○○ Low	Critical
Exacerbations (follow-up mean 12 wk)	1/89 (1.1%)	3/91 (3.3%)	RR 0.34 (0.04–3.22)	22 fewer per 1,000 (from 32 fewer to 73 more)	⊕⊕○○ Low	Critical
		3.3%		22 fewer per 1,000 (from 32 fewer to 73 more)	⊕⊕○○ Low
Quality of Life (SGRQ) (follow-up mean 12 wk; better indicated by lower values)	89	91	—	MD 4.09 lower (7.31 to 0.87 lower)	⊕⊕⊕○ Moderate	Critical
FVC (follow-up 12–24 wk; better indicated by lower values)	103	106	—	SMD 0.07 higher (0.2 lower to 0.34 higher)	⊕⊕○○ Low	Critical
Dyspnea Change Scores Borg (follow-up 12–24 wk; better indicated by lower values)	103	106	—	MD 0.18 lower (0.61 lower to 0.25 higher)	⊕⊕⊕○ Moderate	Important
Dl_CO (better indicated by lower values)	103	106	—	SMD 0.01 lower (0.33 lower to 0.31 higher)	⊕⊕○○ Low	Important
Six-Minute-Walk Distance (better indicated by lower values)	103	106	—	MD 2.75 lower (50.99 lower to 45.5 higher)	⊕⊕○○ Low	Important
Oxygen Saturation (better indicated by lower values)	103	106	—	SMD 0.04 lower (0.82 lower to 0.74 higher)	⊕⊕○○ Low	Important

Data are from References 272 and 273.

^{^*}

The overall quality of evidence rating is listed in the first row and is the one used in the text of the document. The quality rating for outcomes listed in other rows may differ. How these additional outcomes are rated in terms of quality does not influence the final quality rating as they are to inform, but not to make, decisions.

^{^†}

Importance rating: the relative importance of the outcome for decision making. The rating “critical” indicates making recommendations on choice of testing and treatment strategies. The rating “important” indicates that the outcome is important but not critical for making recommendations.

^{^‡}

No events in the trial by Jackson.

^{^§}

Only six events in total.

^{^¶}

Reported in only one of the two trials. The follow-up period was very short.

^{^‖}

Only four events observed in an overall relatively small sample size.

^{^**}

There are very few patients in these trials—the continuous outcome measure may mask that there are few patients.

^{^††}

It is not clear how important a change in FVC% or FVC is for patients.

^{^‡‡}

Dyspnea is a fairly direct outcome, and this outcome measure has been validated.

^{^§§}

Dl_CO is not a patient important outcome.

^{^¶¶}

There is some question whether 6-minute-walk distance is a patient-important outcome or not.

^{^‖‖}

The importance of this outcome measure for patients and the relation to patient important outcomes is uncertain.