27.09.2013 Aufrufe

Wien, 28 - Repository of the LBI-HTA - Ludwig Boltzmann Gesellschaft

Wien, 28 - Repository of the LBI-HTA - Ludwig Boltzmann Gesellschaft

Wien, 28 - Repository of the LBI-HTA - Ludwig Boltzmann Gesellschaft

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Tabelle 5-1: Evidence pr<strong>of</strong>ile: efficacy and safety <strong>of</strong> radi<strong>of</strong>requency ablation in renal cell carcinoma<br />

No <strong>of</strong> studies/patients<br />

Design Limitations Consistency<br />

<strong>of</strong> results<br />

1/208 case series serious limitations<br />

2/339 case series serious limitations<br />

1/20 case series serious limitations<br />

2/151 case series serious limitations<br />

1/131 case series serious limitations<br />

Radi<strong>of</strong>requenzablation bei Tumoren des Urogenitaltrakts<br />

(Nierenzellkarzinom, Prostatakarzinom, Leiomyome des Uterus)<br />

Directness Effect size O<strong>the</strong>r modifying<br />

factors*<br />

34 <strong>LBI</strong>-<strong>HTA</strong> | 2012<br />

Efficacy<br />

Outcome: overall survival rate<br />

Quality <strong>of</strong><br />

evidence<br />

only one trial direct 85% at 5 yrs sparse data very low<br />

no important direct<br />

Outcome: recurrence rate<br />

10% at 1 month<br />

inconsistency<br />

20 lack <strong>of</strong> precise very low<br />

Outcome: quality <strong>of</strong> life<br />

data, sparse data<br />

only one trial direct score: SF-36<br />

lack <strong>of</strong> precise very low<br />

no significant improvement at 6 months compared to baseline<br />

Safety<br />

Outcome: overall complications (major)<br />

data; sparse data<br />

no important<br />

inconsistency<br />

direct 0% at n/a<br />

Outcome: overall complications (minor)<br />

sparse data very low<br />

21<br />

only one trial direct 17-24% at n/a<br />

Outcome: mortality (procedure-related)<br />

no evidence<br />

lack <strong>of</strong> precise<br />

data; sparse data<br />

very low<br />

* low incidence, lack <strong>of</strong> precise data, sparse data, strong or very strong association, high risk <strong>of</strong> publication bias, dose-efficacy gradient, residual confounding plausible<br />

20 refers to 41 endophytic tumors in one case series only; in <strong>the</strong> second case-series recurrenct RCC occured in 9 pts with biopsy-proven RCC at ≤36 months <strong>of</strong> follow-up, however, <strong>the</strong><br />

total number <strong>of</strong> pts with biopsy-proven RCC remains unclear.<br />

21 including haematuria, urinary retention, lower extremity paraes<strong>the</strong>sia, flank bruising

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