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Het volume van chirurgische ingrepen en de impact ervan op ... - KCE

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<strong>KCE</strong> Reports 113 Volume Outcome 11<br />

On the basis of Guyatt’s gra<strong>de</strong>s of evid<strong>en</strong>ce, four criteria were formulated for the<br />

assignm<strong>en</strong>t of a Gra<strong>de</strong> B or Gra<strong>de</strong> C level of evid<strong>en</strong>ce to primary studies that were<br />

analysed in systematic reviews. Gra<strong>de</strong> A level of evid<strong>en</strong>ce was consi<strong>de</strong>red impossible.<br />

1. Fitness of the SRs to support evid<strong>en</strong>ce, as assessed in the second quality<br />

appraisal (see App<strong>en</strong>dix 7):<br />

• Gra<strong>de</strong> B: ++ or +++<br />

• Gra<strong>de</strong> C: +<br />

2. Number of primary studies in the SR that study the VOA for this procedure<br />

or condition:<br />

• Gra<strong>de</strong> B: > 5 primary studies<br />

• Gra<strong>de</strong> C: < 5 primary studies<br />

3. Study period of the primary studies:<br />

• Gra<strong>de</strong> B: in or after 1988<br />

• Gra<strong>de</strong> C: before 1988<br />

4. Perc<strong>en</strong>tage of studies with a positive or negative <strong>volume</strong> outcome<br />

association:<br />

• Gra<strong>de</strong> B: at least 75% of primary studies show a statistically significant<br />

relation (positive or negative) betwe<strong>en</strong> <strong>volume</strong> and outcome<br />

• Gra<strong>de</strong> C: at least 75% of primary studies show a statistically not significant<br />

relation (positive or negative) betwe<strong>en</strong> <strong>volume</strong> and outcome, or there is a<br />

mix of statistically significant and not statistically significant primary<br />

studies.<br />

This last criterion can be criticized as statistical significance <strong>de</strong>p<strong>en</strong>ds on size<br />

of effects and of sample size. A typical characteristic of <strong>volume</strong> outcome<br />

studies is that sample size <strong>de</strong>p<strong>en</strong>ds on the preval<strong>en</strong>ce of the disease or the<br />

interv<strong>en</strong>tion.<br />

CONCLUSION<br />

The conclusion on the association betwe<strong>en</strong> <strong>volume</strong> (i.e. number of procedures or<br />

conditions in hospitals or by surgeons) and the differ<strong>en</strong>t outcomes will preferably be<br />

based on systematic reviews with a Gra<strong>de</strong> B level of evid<strong>en</strong>ce. Outcome measures, for<br />

which there is insuffici<strong>en</strong>t evid<strong>en</strong>ce, will not be summarized in the conclusions.<br />

In relation to the threshold, an attempt is ma<strong>de</strong> to summarize the differ<strong>en</strong>t thresholds<br />

(i.e. high-<strong>volume</strong> and low-<strong>volume</strong>) into one single minimal hospital <strong>volume</strong> threshold,<br />

and, if possible, one minimal surgeon <strong>volume</strong> threshold. Such <strong>volume</strong> standards seem to<br />

make more s<strong>en</strong>se than ext<strong>en</strong>sively overlapping thresholds. For some procedures, the<br />

thresholds are also based on those issued by organisations such as the US Ag<strong>en</strong>cy for<br />

Healthcare Research and Quality and the US Leapfrog Group. The rationale behind the<br />

threshold is explained in the tables of evid<strong>en</strong>ce (App<strong>en</strong>dix 8, 9 and 10).<br />

2.2.3.4 Search protocol in relation to additional primary studies<br />

In chapters 5, 6 and 7 of this report, the results of the analysis of the Belgian data will be<br />

compared with the results from the sci<strong>en</strong>tific literature. For a limited amount of<br />

procedures and conditions, the number of studies that was retrieved through the<br />

selected systematic reviews was consi<strong>de</strong>red insuffici<strong>en</strong>t as comparison material for this<br />

discussion. For these procedures and conditions, an additional literature search was<br />

performed in an attempt to complem<strong>en</strong>t the systematic reviews with more rec<strong>en</strong>t<br />

primary studies.<br />

Such an additional search was done for the following procedures: heart valve<br />

replacem<strong>en</strong>t or repair, hip fracture surgery, oes<strong>op</strong>hageal, pancreatic, colon, breast and<br />

lung cancer surgery.

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