Updated generic search filters for finding studies of adverse drug effects in Ovid medline and Embase may retrieve up to 90% of relevant studies.

BACKGROUND: The most current objectively derived search filters for adverse drug effects are 15 years old and other strategies have not been developed and tested empirically. OBJECTIVE: To develop and validate search filters to retrieve evidence on adverse drug effects from Ovid medline and Ovid Embase. METHODS: We identified systematic reviews of adverse drug effects in Epistemonikos. From these reviews, we collated their included studies which we then randomly divided into three tests and one validation set of records. We constructed a search strategy to maximise relative recall using word frequency analysis with test set one. This search strategy was then refined using test sets two and three and validated on the final set of records. RESULTS: Of 107 systematic reviews which met our inclusion criteria, 1948 unique included studies were available from medline and 1980 from Embase. Generic adverse drug effects searches in medline and Embase achieved 90% and 89% relative recall, respectively. When specific adverse effects terms were added recall was improved. CONCLUSION: We have derived and validated search filters that retrieve around 90% of records with adverse drug effects data in medline and Embase. The addition of specific adverse effects terms is required to achieve higher recall.

Direct composite resin fillings versus amalgam fillings for permanent posterior teeth.

BACKGROUND: Traditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income countries due to its effectiveness and relatively low cost. However, there are concerns over the use of amalgam restorations (fillings) with regard to mercury release in the body and the environmental impact of mercury disposal. Dental composite resin materials are an aesthetic alternative to amalgam, and their mechanical properties have developed sufficiently to make them suitable for restoring posterior teeth. Nevertheless, composite resin materials may have potential for toxicity to human health and the environment. The United Nations Environment Programme has established the Minamata Convention on Mercury, which is an international treaty that aims "to protect the [sic] human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds". It entered into force in August 2017, and as of February 2021 had been ratified by 127 governments. Ratification involves committing to the adoption of at least two of nine proposed measures to phase down the use of mercury, including amalgam in dentistry. In light of this, we have updated a review originally published in 2014, expanding the scope of the review by undertaking an additional search for harms outcomes. Our review synthesises the results of studies that evaluate the long-term effectiveness and safety of amalgam versus composite resin restorations, and evaluates the level of certainty we can have in that evidence. OBJECTIVES: To examine the effects (i.e. efficacy and safety) of direct composite resin fillings versus amalgam fillings. SEARCH METHODS: An information specialist searched five bibliographic databases up to 16 February 2021 and used additional search methods to identify published, unpublished and ongoing studies SELECTION CRITERIA: To assess efficacy, we included randomised controlled trials (RCTs) comparing dental composite resin with amalgam restorations in permanent posterior teeth that assessed restoration failure or survival at follow-up of at least three years. To assess safety, we sought non-randomised studies in addition to RCTs that directly compared composite resin and amalgam restorative materials and measured toxicity, sensitivity, allergy, or injury. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included a total of eight studies in this updated review, all of which were RCTs. Two studies used a parallel-group design, and six used a split-mouth design. We judged all of the included studies to be at high risk of bias due to lack of blinding and issues related to unit of analysis. We identified one new trial since the previous version of this review (2014), as well as eight additional papers that assessed safety, all of which related to the two parallel-group studies that were already included in the review. For our primary meta-analyses, we combined data from the two parallel-group trials, which involved 1645 composite restorations and 1365 amalgam restorations in 921 children. We found low-certainty evidence that composite resin restorations had almost double the risk of failure compared to amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35; P < 0.001), and were at much higher risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74; P < 0.001). We found low-certainty evidence that composite resin restorations were not more likely to result in restoration fracture (RR 0.87, 95% CI 0.46 to 1.64; P = 0.66). Six trials used a split-mouth design. We considered these studies separately, as their reliability was compromised due to poor reporting, unit of analysis errors, and variability in methods and findings. Subgroup analysis showed that the findings were consistent with the results of the parallel-group studies. Three trials investigated possible harms of dental restorations. Higher urinary mercury levels were reported amongst children with amalgam restorations in two trials, but the levels were lower than what is known to be toxic. Some differences between amalgam and composite resin groups were observed on certain measures of renal, neuropsychological, and psychosocial function, physical development, and postoperative sensitivity; however, no consistent or clinically important harms were found. We considered that the vast number of comparisons made false-positive results likely. There was no evidence of differences between the amalgam and composite resin groups in neurological symptoms, immune function, and urinary porphyrin excretion. The evidence is of very low certainty, with most harms outcomes reported in only one trial. AUTHORS' CONCLUSIONS: Low-certainty evidence suggests that composite resin restorations may have almost double the failure rate of amalgam restorations. The risk of restoration fracture does not seem to be higher with composite resin restorations, but there is a much higher risk of developing secondary caries. Very low-certainty evidence suggests that there may be no clinically important differences in the safety profile of amalgam compared with composite resin dental restorations. This review supports the utility of amalgam restorations, and the results may be particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Of note, however, is that composite resin materials have undergone important improvements in the years since the trials informing the primary analyses for this review were conducted. The global phase-down of dental amalgam via the Minamata Convention on Mercury is an important consideration when deciding between amalgam and composite resin dental materials. The choice of which dental material to use will depend on shared decision-making between dental providers and patients in the clinic setting, and local directives and protocols.

The development of search filters for adverse effects of medical devices in medline and embase.

BACKGROUND: Objectively derived search filters for adverse drug effects and complications in surgery have been developed but not for medical device adverse effects. OBJECTIVE: To develop and validate search filters to retrieve evidence on medical device adverse effects from ovid medline and embase. METHODS: We identified systematic reviews from Epistemonikos and the Health Technology Assessment (hta) database. Included studies within these reviews that reported on medical device adverse effects were randomly divided into three test sets and one validation set of records. Using word frequency analysis from one test set, we constructed a sensitivity maximising search strategy. This strategy was refined using two other test sets, then validated. RESULTS: From 186 systematic reviews which met our inclusion criteria, 1984 unique included studies were available from medline and 1986 from embase. Generic adverse effects searches in medline and embase achieved 84% and 83% sensitivity. Recall was improved to over 90%, however, when specific adverse effects terms were added. CONCLUSION: We have derived and validated novel search filters that retrieve over 80% of records with medical device adverse effects data in medline and embase. The addition of specific adverse effects terms is required to achieve higher levels of sensitivity.

Almost half of references in reports on new and emerging nondrug health technologies are grey literature.

OBJECTIVE: The research investigated how frequently grey literature is used in reports on new and emerging nondrug health technologies, which sources are most cited, and how grey literature searching is reported. METHODS: A retrospective review of references cited in horizon scanning reports on nondrug health technologies-including medical devices, laboratory tests, and procedures-was conducted. A quasi-random sample of up to three reports per agency was selected from a compilation of reports published in 2014 by international horizon scanning services and health organizations. RESULTS: Twenty-two reports from 8 agencies were included in the analysis. On average, 47% (288/617) of references listed in the bibliographies of the horizon scanning reports were grey literature. The most frequently cited type of grey literature was information from manufacturers (30% of all grey literature references), regulatory agencies (10%), clinical trial registries (9%), and other horizon scans or evidence synthesis reports (9%). The US Food and Drug Administration (FDA) and ClincalTrials.gov were the most frequently cited specific sources, constituting 7% and 8% of grey literature references, respectively. Over two-thirds (15/22) of the analyzed reports provided some details on search methodology; all 15 of these reported searching some grey literature. CONCLUSIONS: In this sample, grey literature represented almost half of the references cited in reports on new and emerging nondrug health technologies. Of these grey literature references, almost half came from three sources: the manufacturers, ClincalTrials.gov, and the FDA. There was wide variation in the other sources cited. Literature search methodology was often insufficiently reported for analysis.

The impact of the peer review of literature search strategies in support of rapid review reports.

OBJECTIVE: The objective of this study was to investigate the impact of the peer review of literature search strategies prepared in support of rapid reviews. METHODS: A sample of 200 CADTH rapid reviews was selected. For each rapid review meeting the inclusion criteria, the pre-peer-reviewed and corresponding post-peer-reviewed search strategies were run, and the search results were compared. Bibliographic records retrieved solely by the post-peer-reviewed search strategy and included in the rapid review report were identified as representing "included studies." The publication type of each included study was determined, and the attributes of the corresponding record were analyzed to determine the reason for its retrieval by the post-peer-reviewed search. RESULTS: The peer review of search strategies resulted in the retrieval of one or more additional records for 75% of the searches investigated, but only a small proportion of these records (4%) represented included studies. The main publication types of the included studies were nonrandomized studies (60%) and narrative reviews (20%). The principal changes to search strategies that resulted in the retrieval of additional included studies were the inclusion of more keywords or subject headings or a change in the way concepts were combined. CONCLUSIONS: The peer review of literature search strategies aids in the retrieval of relevant records particularly those representing nonrandomized studies. The scrutiny of keywords, subject headings, and the relation between search concepts are key components of the peer review process.

Effectiveness of adverse effects search filters: drugs versus medical devices.

OBJECTIVE: The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. METHODS: The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. RESULTS: For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. CONCLUSIONS: In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

The effect of English-language restriction on systematic review-based meta-analyses: a systematic review of empirical studies.

OBJECTIVES: The English language is generally perceived to be the universal language of science. However, the exclusive reliance on English-language studies may not represent all of the evidence. Excluding languages other than English (LOE) may introduce a language bias and lead to erroneous conclusions. STUDY DESIGN AND SETTING: We conducted a comprehensive literature search using bibliographic databases and grey literature sources. Studies were eligible for inclusion if they measured the effect of excluding randomized controlled trials (RCTs) reported in LOE from systematic review-based meta-analyses (SR/MA) for one or more outcomes. RESULTS: None of the included studies found major differences between summary treatment effects in English-language restricted meta-analyses and LOE-inclusive meta-analyses. Findings differed about the methodological and reporting quality of trials reported in LOE. The precision of pooled estimates improved with the inclusion of LOE trials. CONCLUSIONS: Overall, we found no evidence of a systematic bias from the use of language restrictions in systematic review-based meta-analyses in conventional medicine. Further research is needed to determine the impact of language restriction on systematic reviews in particular fields of medicine.

Preoperative skin antiseptic preparations for preventing surgical site infections: a systematic review.

OBJECTIVE: To evaluate the clinical effectiveness of preoperative skin antiseptic preparations and application techniques for the prevention of surgical site infections (SSIs). DESIGN: Systematic review of the literature using Medline, EMBASE, and other databases, for the period January 2001 to June 2011. METHODS: Comparative studies (including randomized and nonrandomized trials) of preoperative skin antisepsis preparations and application techniques were included. Two researchers reviewed each study and extracted data using standardized tables developed before the study. Studies were reviewed for their methodological quality and clinical findings. RESULTS: Twenty studies (n = 9,520 patients) were included in the review. The results indicated that presurgical antiseptic showering is effective for reducing skin flora and may reduce SSI rates. Given the heterogeneity of the studies and the results, conclusions about which antiseptic is more effective at reducing SSIs cannot be drawn. CONCLUSIONS: The evidence suggests that preoperative antiseptic showers reduce bacterial colonization and may be effective at preventing SSIs. The antiseptic application method is inconsequential, and data are lacking to suggest which antiseptic solution is the most effective. Disinfectant products are often mixed with alcohol or water, which makes it difficult to form overall conclusions regarding an active ingredient. Large, well-conducted randomized controlled trials with consistent protocols comparing agents in the same bases are needed to provide unequivocal evidence on the effectiveness of one antiseptic preparation over another for the prevention of SSIs.

A pragmatic critical appraisal instrument for search filters: introducing the CADTH CAI.

OBJECTIVE: To identify or develop a critical appraisal instrument (CAI) to aid in the selection of search filters for use in systematic review searching. The CAI is to be used by experienced searchers without specialized training in statistics or search filter design. METHODS: Through extensive searching and consultation, one candidate instrument was identified. Through expert consultation and several rounds of testing, the instrument was extensively revised to become the Canadian Agency for Drugs and Technologies in Health (CADTH) CAI. RESULTS: The CADTH CAI consists of ten questions and can be applied by experienced searchers with a moderate knowledge of search filter methodology. CONCLUSION: The CADTH CAI provides experienced searchers with a means of selecting the search filter that is most methodologically sound.