Interventions for hereditary haemochromatosis

Elena Buzzetti; Maria Kalafateli; Douglas Thorburn; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy

doi:10.1002/14651858.CD011647.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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$Trial Sequential Analysis of adverse events (proportion) performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction of 20%, control group proportion (Pc) observed in trials (21.6% for proportion of people with adverse events), and observed diversity (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS) that the boundaries could not be drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.$

Figure 4

Trial Sequential Analysis of adverse events (proportion) performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction of 20%, control group proportion (Pc) observed in trials (21.6% for proportion of people with adverse events), and observed diversity (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS) that the boundaries could not be drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.

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Analysis 1.1

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 1 Adverse events (proportion).

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Analysis 1.2

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 2 Adverse events (number).

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Analysis 1.3

Comparison 1 Therapeutic erythrocytapheresis versus phlebotomy, Outcome 3 Health‐related quality of life (EQ‐VAS).

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Summary of findings for the main comparison. Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis

Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis
Patient or population: people with hereditary haemochromatosis Settings: secondary or tertiary Intervention: erythrocytapheresis Comparison: phlebotomy
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Phlebotomy	Therapeutic erythrocytapheresis
Long‐term mortality	None of the included trials reported mortality beyond 1 year.
Mortality Follow‐up period: 8 months	There was no mortality in either group in the short‐term in the 1 trial that reported this information.			38 (1 study)	⊕⊝⊝⊝ Very low^1,2
Serious adverse events Follow‐up period: 8 months	There were no serious adverse events in either group in the 1 trial that reported this information.			38 (1 study)	⊕⊝⊝⊝ Very low^1,2
Health‐related quality of life EQ‐VAS. Scale from: 0 to 100. Follow‐up period: 8 months	The mean health‐related quality of life in the control groups was 68	The mean health‐related quality of life in the intervention groups was 1 higher (10.8 lower to 12.8 higher)	‐	38 (1 study)	⊕⊝⊝⊝ Very low^1,2
Health‐related quality of life beyond one year	None of the included trials reported health‐related quality of life beyond one year
The basis for the assumed risk* is the mean control group proportion or control event rate. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval.
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate.
¹ Downgraded one level for risk of bias. ² Downgraded two levels for imprecision (one level for small sample size and one level for wide confidence intervals).

Summary of findings for the main comparison. Erythrocytapheresis versus phlebotomy for hereditary haemochromatosis

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Comparison 1. Therapeutic erythrocytapheresis versus phlebotomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adverse events (proportion) Show forest plot	2	100	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.36, 2.43]

2 Adverse events (number) Show forest plot	1		Rate Ratio (Fixed, 95% CI)	Totals not selected

3 Health‐related quality of life (EQ‐VAS) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. Therapeutic erythrocytapheresis versus phlebotomy

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