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KCE Reports 118 <strong>Pay</strong> <strong>for</strong> <strong>Quality</strong> 9<br />

2.1.1.3 <strong>Quality</strong> appraisal<br />

<strong>Quality</strong> appraisal of systematic reviews was based on the criteria of the Dutch<br />

Cochrane Center (Form Va). 18 Validity rating by use of this Cochrane tool was based on<br />

7 items (namely research question, search strategy, relevance selection, quality appraisal<br />

included studies, data extraction, study description, heterogeneity and pooling). If more<br />

than three items were assessed as unclear or insufficient, a publication was excluded.<br />

However, <strong>for</strong> the majority of excluded reviews the reason was the narrative nature of<br />

the review or the lack of specification of methods used (Appendix 5).<br />

<strong>Quality</strong> appraisal of primary studies was per<strong>for</strong>med using a specifically constructed tool,<br />

based on a combination of existing tools 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 . The tool<br />

consists of ten generic items (namely research question, patient population and setting,<br />

intervention, comparison, outcome, design, sample size, statistics, generalisability,<br />

confounders addressed) and four design specific items (randomization, blinding,<br />

clustering effect, number of data points) (Appendix 6). For each primary study, a score<br />

has been given to each of the 14 items, ranging from -1 to +1. A score of +1 on a<br />

certain item corresponds with ‘a good result’, a score of -1 corresponds with ‘a bad<br />

result’, and a score of 0 corresponds with ‘this item has not been discussed in the<br />

article’. To pass the quality appraisal, an article has to gain a score of minimum 8 out of<br />

14. An article can be excluded on the basis of an ‘overrule’ argument when a certain<br />

criteria was not met, hence the overall validity has to be questioned (<strong>for</strong> example no<br />

significance testing, too small sample size etc…).<br />

<strong>Quality</strong> appraisal of the studies reporting cost-effectiveness and modelling effects of<br />

P4Q programmes, was also per<strong>for</strong>med by using two specifically constructed tools (See<br />

appendix 7). The quality appraisal tool <strong>for</strong> the modelling studies is based on the<br />

modelling guidelines from the KCE and on the ISPOR guidelines by Weinstein et al.<br />

It consists of the following items: model design (transparent and as simple as possible);<br />

assumptions and data input tested in extensive sensitivity analysis; original data set<br />

provided; sources used presented and described in detail; scenarios (<strong>for</strong> models that<br />

extrapolate to longer time periods); calibration (results should be logically consistent<br />

with real-life observations and data); face validity (the results of the model should be<br />

intuitively correct) and cross-validation (transparent enough to allow an explanation of<br />

the differences with other models <strong>for</strong> the same intervention). The tool used <strong>for</strong> the<br />

cost-effectiveness studies is based on the pharmaco-economic guidelines from the KCE<br />

31<br />

. It consists of the following items: literature review; perspective of the evaluation;<br />

target population; comparator; analytic technique; study design; calculation of costs;<br />

valuation of outcomes; data sources; incremental cost-effectiveness; time horizon;<br />

modelling; handling uncertainty; discount rate.<br />

For each item one of the following scores have been assigned: +, +/-, -. A ‘+’ score on<br />

given item corresponds with a good result, a ‘-‘ score corresponds with a bad result, a<br />

‘+/-‘ score corresponds with an in between result. Given the limited amount of<br />

modelling and cost-effectiveness studies, the quality appraisal is only per<strong>for</strong>med to<br />

in<strong>for</strong>m the reader about the quality of the studies, but was not used to exclude any<br />

study. Overall the quality of the modelling and cost-effectiveness studies was acceptable.<br />

Comparison between reviewers (DDS and PVH) identified seven non corresponding<br />

review publications out of 5480 potentially relevant reviews (Cohen’s Kappa 99.9%<br />

interrater reliability) and 18 non corresponding primary publications out of 5517<br />

potentially relevant primary publications (Cohen’s Kappa 99.7% interrater reliability).<br />

Appendix 8 and 9 list the citations that were included in full text analysis.<br />

As a result 103 primary P4Q evaluation articles, 5 modelling articles and 3 costeffectiveness<br />

articles, resulting from the primary publication search (phase 2) and from<br />

the review search (phase 1), are included in this review.<br />

31, 32

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