Abstract
BackgroundResearch has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase. However, it is unknown whether adverse effects terms are present in the database records of articles that contain adverse effects data of medical devices, and thus, to what extent the development of an adverse effects search filter for medical devices may be feasible.MethodsA case study systematic review of a medical device was selected. The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used in the analysis. For each included study, the corresponding database record on MEDLINE and Embase was assessed to measure the presence or absence of adverse effects terms in the title, abstract or indexing. The performance of each potential adverse effects search term was also measured and compared.ResultsThere were 82 publications (49 studies) included in the systematic review with 51 of these indexed on MEDLINE and 55 on Embase. Ninety-four percent (48/51) of the records on MEDLINE and 95% (52/55) of the records on Embase contained at least one adverse effects related search term. The wide variety of adverse effects terms included in the title, abstract or indexing of bibliographic records, and the lack of any individual high-performing search terms suggests that a combination of terms in different fields is required to identify adverse effects of medical devices. In addition, the most successful search terms differed from the most successful terms for identifying adverse drug effects.ConclusionsThe search filters currently available for adverse drug effects are not necessarily useful for searching adverse effects data of medical devices. The presence of adverse effects terms in the bibliographic records of articles on medical devices, however, indicates that combinations of adverse effects search terms may be useful in search strategies in MEDLINE and Embase. The results, therefore, suggest that not only a search filter for the adverse effects of medical devices is feasible, but also that it should be a research priority.
Highlights
Research has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase
We explore the presence or absence of terms related to adverse effects in the bibliographic records of those articles included in a systematic review of a medical device
This review was undertaken after a number of sources raised concerns about the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2): during the post-marketing period, several non-industry observational studies reported adverse events possibly associated with the use of rhBMP-2; the Food and Drug Administration (FDA) issued a public health notification of potentially life-threatening complications associated with swelling of the neck and throat tissue after rhBMP-2 use in the cervical spine; and a subsequent review of publicly available data suggested an increased risk of complications and adverse events for patients receiving rhBMP-2 that was 10 to 50 times higher than the original randomised controlled trial (RCT) estimates
Summary
Research has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase It is unknown whether adverse effects terms are present in the database records of articles that contain adverse effects data of medical devices, and to what extent the development of an adverse effects search filter for medical devices may be feasible. Adverse effects are an important consideration in decisionmaking by patients, clinicians and other health care professionals, policy makers and regulators. The regulatory process for medical devices is less stringent than for pharmaceutical interventions, the adverse effects of medical devices can be just as serious and can be an important factor in decisionmaking for health care professionals, policy makers and patients. Identifying the evidence on adverse effects for medical devices is, paramount to inform health care decisions
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