The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion.
BACKGROUND
The most effective sources to search to identify adverse effects data for medical devices are currently unknown.


METHODS
The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used for analysis. For each source searched, a record was made for each relevant publication of whether it was retrieved by the search strategy used and whether it was available in the database but not retrieved. To account for multiple publications of the same study, a record was made of the relevant studies identified. The sensitivity, precision, and number needed to read were calculated as well as the minimum combination of sources to identify all the publications or studies.


RESULTS
There were eighty-two publications (forty-nine studies) included in the systematic review. Only one article was available in a database searched but not retrieved by our search strategy. Science Citation Index (SCI) and EMBASE both achieved the highest sensitivity (62 percent), followed closely by MEDLINE/PubMED (56 percent). With the search strategies used, the minimum combination of sources needed to identify all the publications was SCI, EMBASE, CENTRAL, and either MEDLINE or PubMED, in addition to reference checking, contacting authors and an automated current awareness service. In relation to identifying all the relevant studies, the minimum combination of studies was similar with the exclusion of CENTRAL.


CONCLUSIONS
To identify all the relevant publications or studies included in this case study systematic review, several different sources needed to be searched.
Centre for Reviews and Dissemination (CRD),University of York,Yorksu.golder@york.ac.uk.
Su
S
Golder
Centre for Reviews and Dissemination (CRD),University of York,Yorksu.golder@york.ac.uk.
Kath
K
Wright
Centre for Reviews and Dissemination (CRD),University of York,Yorksu.golder@york.ac.uk.
Mark
M
Rodgers
D055396:Bone Morphogenetic Protein 2 / Q000008:administration & dosage / Q000009:adverse effects*; D016022:Case-Control Studies; D016206:Databases, Bibliographic; D004869:Equipment Safety; D006801:Humans; D016247:Information Storage and Retrieval; D012196:Review Literature as Topic; D013123:Spinal Fusion; D015503:Surgical Sponges / Q000009:adverse effects*; D014025:Titanium
D055396:Bone Morphogenetic Protein 2; D014025:Titanium
Bibliographic databases