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The Cochrane Collaboration was established in 1993, following the opening of the UK Cochrane Centre in 1992, at a time when searching for studies for inclusion in systematic reviews was not well-developed. Review authors largely conducted their own searches or depended on medical librarians, who often possessed limited awareness and experience of systematic reviews. Guidance on the conduct and reporting of searches was limited. When work began to identify reports of randomized controlled trials (RCTs) for inclusion in Cochrane Reviews in 1992, there were only approximately 20,000 reports indexed as RCTs in MEDLINE and none indexed as RCTs in Embase. No search filters had been developed with the aim of identifying all RCTs in MEDLINE or other major databases. This presented The Cochrane Collaboration with a considerable challenge in identifying relevant studies.
Over time, the number of studies indexed as RCTs in the major databases has grown considerably and the Cochrane Central Register of Controlled Trials (CENTRAL) has become the best single source of published controlled trials, with approximately 700,000 records, including records identified by the Collaboration from Embase and MEDLINE. Search filters for various study types, including systematic reviews and the Cochrane Highly Sensitive Search Strategies for RCTs, have been developed. There have been considerable advances in the evidence base for methodological aspects of information retrieval. The Cochrane Handbook for Systematic Reviews of Interventions now provides detailed guidance on the conduct and reporting of searches. Initiatives across The Cochrane Collaboration to improve the quality inter alia of information retrieval include: the recently introduced Methodological Expectations for Cochrane Intervention Reviews (MECIR) programme, which stipulates 'mandatory' and 'highly desirable' standards for various aspects of review conduct and reporting including searching, the development of Standard Training Materials for Cochrane Reviews and work on peer review of electronic search strategies. Almost all Cochrane Review Groups and some Cochrane Centres and Fields now have a Trials Search Co-ordinator responsible for study identification and medical librarians and other information specialists are increasingly experienced in searching for studies for systematic reviews.
Prospective registration of clinical trials is increasing and searching trials registers is now mandatory for Cochrane Reviews, where relevant. Portals such as the WHO International Clinical Trials Registry Platform (ICTRP) are likely to become increasingly attractive, given concerns about the number of trials which may not be registered and/or published. The importance of access to information from regulatory and reimbursement agencies is likely to increase. Cross-database searching, gateways or portals and improved access to full-text databases will impact on how searches are conducted and reported, as will services such as Google Scholar, Scopus and Web of Science. Technologies such as textual analysis, semantic analysis, text mining and data linkage will have a major impact on the search process but efficient and effective updating of reviews may remain a challenge.
In twenty years' time, we envisage that the impact of universal social networking, as well as national and international legislation, will mean that all trials involving humans will be registered at inception and detailed trial results will be routinely available to all. Challenges will remain, however, to ensure the discoverability of relevant information in diverse and often complex sources and the availability of metadata to provide the most efficient access to information. We envisage an ongoing role for information professionals as experts in identifying new resources, researching efficient ways to link or mine them for relevant data and managing their content for the efficient production of systematic reviews.
BACKGROUND: A systematic and extensive search for as many eligible studies as possible is essential in any systematic review. When searching for diagnostic test accuracy (DTA) studies in bibliographic databases, it is recommended that terms for disease (target condition) are combined with terms for the diagnostic test (index test). Researchers have developed methodological filters to try to increase the precision of these searches. These consist of text words and database indexing terms and would be added to the target condition and index test searches.Efficiently identifying reports of DTA studies presents challenges because the methods are often not well reported in their titles and abstracts, suitable indexing terms may not be available and relevant indexing terms do not seem to be consistently assigned. A consequence of using search filters to identify records for diagnostic reviews is that relevant studies might be missed, while the number of irrelevant studies that need to be assessed may not be reduced. The current guidance for Cochrane DTA reviews recommends against the addition of a methodological search filter to target condition and index test search, as the only search approach.
OBJECTIVES: To systematically review empirical studies that report the development or evaluation, or both, of methodological search filters designed to retrieve DTA studies in MEDLINE and EMBASE.
SEARCH METHODS: We searched MEDLINE (1950 to week 1 November 2012); EMBASE (1980 to 2012 Week 48); the Cochrane Methodology Register (Issue 3, 2012); ISI Web of Science (11 January 2013); PsycINFO (13 March 2013); Library and Information Science Abstracts (LISA) (31 May 2010); and Library, Information Science & Technology Abstracts (LISTA) (13 March 2013). We undertook citation searches on Web of Science, checked the reference lists of relevant studies, and searched the Search Filters Resource website of the InterTASC Information Specialists' Sub-Group (ISSG).
SELECTION CRITERIA: Studies reporting the development or evaluation, or both, of a MEDLINE or EMBASE search filter aimed at retrieving DTA studies, which reported a measure of the filter's performance were eligible.
DATA COLLECTION AND ANALYSIS: The main outcome was a measure of filter performance, such as sensitivity or precision. We extracted data on the identification of the reference set (including the gold standard and, if used, the non-gold standard records), how the reference set was used and any limitations, the identification and combination of the search terms in the filters, internal and external validity testing, the number of filters evaluated, the date the study was conducted, the date the searches were completed, and the databases and search interfaces used. Where 2 x 2 data were available on filter performance, we used these to calculate sensitivity, specificity, precision and Number Needed to Read (NNR), and 95% confidence intervals (CIs). We compared the performance of a filter as reported by the original development study and any subsequent studies that evaluated the same filter.
MAIN RESULTS: Ninteen studies were included, reporting on 57 MEDLINE filters and 13 EMBASE filters. Thirty MEDLINE and four EMBASE filters were tested in an evaluation study where the performance of one or more filters was tested against one or more gold standards. The reported outcome measures varied. Some studies reported specificity as well as sensitivity if a reference set containing non-gold standard records in addition to gold standard records was used. In some cases, the original development study did not report any performance data on the filters. Original performance from the development study was not available for 17 filters that were subsequently tested in evaluation studies. All 19 studies reported the sensitivity of the filters that they developed or evaluated, nine studies reported the specificities and 14 studies reported the precision.No filter which had original performance data from its development study, and was subsequently tested in an evaluation study, had what we defined a priori as acceptable sensitivity (> 90%) and precision (> 10%). In studies that developed MEDLINE filters that were evaluated in another study (n = 13), the sensitivity ranged from 55% to 100% (median 86%) and specificity from 73% to 98% (median 95%). Estimates of performance were lower in eight studies that evaluated the same 13 MEDLINE filters, with sensitivities ranging from 14% to 100% (median 73%) and specificities ranging from 15% to 96% (median 81%). Precision ranged from 1.1% to 40% (median 9.5%) in studies that developed MEDLINE filters and from 0.2% to 16.7% (median 4%) in studies that evaluated these filters. A similar range of specificities and precision were reported amongst the evaluation studies for MEDLINE filters without an original performance measure. Sensitivities ranged from 31% to 100% (median 71%), specificity ranged from 13% to 90% (median 55.5%) and precision from 1.0% to 11.0% (median 3.35%).For the EMBASE filters, the original sensitivities reported in two development studies ranged from 74% to 100% (median 90%) for three filters, and precision ranged from 1.2% to 17.6% (median 3.7%). Evaluation studies of these filters had sensitivities from 72% to 97% (median 86%) and precision from 1.2% to 9% (median 3.7%). The performance of EMBASE search filters in development and evaluation studies were more alike than the performance of MEDLINE filters in development and evaluation studies. None of the EMBASE filters in either type of study had a sensitivity above 90% and precision above 10%.
AUTHORS' CONCLUSIONS: None of the current methodological filters designed to identify reports of primary DTA studies in MEDLINE or EMBASE combine sufficiently high sensitivity, required for systematic reviews, with a reasonable degree of precision. This finding supports the current recommendation in the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy that the combination of methodological filter search terms with terms for the index test and target condition should not be used as the only approach when conducting formal searches to inform systematic reviews of DTA.
OBJECTIVE: To model the benefit of an innovative measure to manage patients with diabetes and a foot ulcer, or at high risk of ulceration, using a soft-heel casting, which can be applied by a podiatrist or other trained staff member and used in the hospital or community setting.
METHOD: An audit of the patient outcomes associated with the casting at NHS Borders was undertaken for inpatients with ulcers. These data were combined with other published data and expert opinion to model the benefit of the casting for prevention and curative purposes compared to standard practice. Cost of healed and unhealed ulcers in various settings was estimated based on the treatment pathways adopted.
RESULTS: The data from the economic model suggest that soft-heel castings could reduce the costs of managing these patients by approximately 10%; about £500 per inpatient and £425 per outpatient with an ulcer, and £205 per high-risk patient, when used for prevention.
CONCLUSION: This cost-consequence analysis suggests the intervention could save about 10% of costs for managing patients with an active ulcer in inpatients or outpatients and offers potential savings if used as a preventative measure. Further studies are required to confirm the estimated clinical benefit and reduced resource use.
No abstract available
BACKGROUND: Everolimus (EVE), an oral mammalian target of rapamycin (mTOR) inhibitor, is approved in combination with exemestane (EXE) to treat postmenopausal women (PMW) with HR+, human epidermal growth factor receptor-2–negative (HER2–) ABC that progressed after nonsteroidal aromatase inhibitor therapy. Fulvestrant (FUL), an estrogen receptor antagonist, is another treatment option for PMW previously treated with endocrine therapy. However, the comparative efficacy of EVE + EXE vs FUL is unknown.
METHODS: Six randomized, controlled trials in HR+, HER2–ABC patients were identified by systematic literature review (Cochrane library, National Horizon Scanning Centre, and NICE Web sites) that formed a network permitting indirect comparisons of EVE + EXE or EVE + tamoxifen (TAM) vs FUL: BOLERO-2, CONFIRM, EFECT, Paridaens (2008), SoFEA, and TAMRAD. All 6 trials had EXE, TAM, or FUL 250 mg as the common comparator to form the network. Relative efficacy of EVE and FUL was obtained using a Bayesian network meta-analysis based on these 6 trials. The primary endpoint was local assessment of progression-free survival (PFS) or time to progression (TTP). The hazard ratio (HR) of EVE + EXE relative to FUL and its 95% credible intervals (CrI) were calculated. Evidence of a difference between treatments is suggested by the 95% CrI not including 1. A HR <1 indicates that the hazard rate is higher in the comparator group and that the treatment is more effective. RESULTS: EVE + EXE was found to be more efficacious for PFS/TTP than FUL 250 mg (HR = 0.47; 95% Crl, 0.38-0.58) and more efficacious than FUL 500 mg (HR = 0.59; 95% Crl, 0.45-0.77). EVE + TAM was found to be numerically better for PFS/TTP than FUL 250 mg (HR = 0.65; 95% Crl, 0.40-1.04) and numerically better than FUL 500 mg (HR = 0.81; 95% Crl, 0.49-1.33). CONCLUSIONS: The indirect evidence from this analysis suggests that EVE in combination with EXE is more efficacious than FUL 250 and 500 mg in PMW with HR+, HER2– ABC that progresses after endocrine therapy. These data should be interpreted with caution as there is no randomized trial that directly compares EVE + EXE vs FUL.
AIMS: To establish the resource and cost savings from the early use of transjugular intrahepatic portosystemic shunts (TIPS) procedures with ePTFE covered stent-grafts configured for TIPS (SG) compared to endoscopic procedures and pharmaceuticals in high risk patients (Child–Pugh class B/C) with acute variceal bleeding.
BACKGROUND: Endoscopic therapies are currently the primary treatment for bleeding varices, with TIPS used when endoscopic treatment fails or when patients are not amenable to endoscopic intervention. Trials have shown clinical benefit (lower mortality, fewer re-bleeds and lower hepatic encephalopathy (HE)) from the earlier use of TIPS in patients with persistent bleeding. There are currently no published cost-effectiveness analyses of this earlier use.
METHODS: A Markov economic model was developed to measure the incremental resources and costs of early TIPS with SG, compared to endoscopic band ligation (EBL) plus pharmaceuticals, with TIPS as rescue therapy. Clinical data came mainly from published studies including an RCT (Garcia-Pagan 2010), whilst healthcare costs were from UK national databases. Events & costs were modelled over two years.
RESULTS: Using early TIPS with SG compared to EBL plus pharmaceuticals was estimated to save £1,655 per patient over 2 years. The total treatment costs were £6,455 for TIPS and £8,110 for EBL, providing a net saving of £1,655 per patient. Early TIPS and subsequent re-interventions cost £4,332 more than the EBL arm. However, savings were accrued from fewer EBL procedures and pharmaceuticals (saving £3,223); fewer episodes of recurrent bleeding (saving £2,475) and reduced rate of severe HE (saving £290). Modelling 100 patients, mortality was reduced in the early TIPS arm, 28 patients compared to 63 in the EBL plus pharmaceuticals arm. Sensitivity analyses showed the results were sensitive to device costs, frequency of EBL procedures and the relative rates of severe HE per patient. Using TIPS with SG earlier to manage variceal bleeding was cost saving under all sensitivity analyses.
CONCLUSION: The model showed that early utilisation of TIPS with ePTFE covered stent-grafts configured for TIPS was cost saving and improved survival compared to EBL and pharmaceuticals for high risk patients (Child–Pugh class B/C) with acute variceal bleeding.
RATIONALE, AIMS, OBJECTIVES: Demand for both Emergency Department (ED) and radiology services continues to increase across the UK while simultaneously, healthcare organisations are being asked to evaluate the quality of care provided and constrain service costs. National guidance on radiograph reporting times recommends ED radiographs are reported on day of patient attendance but in practice, delays in reporting persist. This study considers whether a radiographer led immediate reporting service for ED referrals could provide a cost-effective service improvement solution.
METHODS: A pragmatic multi-centre randomised controlled trial was undertaken. 1502 patients were recruited and randomly assigned to an immediate or delayed reporting arm and treated according to group assignment. Patient health gain was measured in terms of change in utilities derived from EQ-5D responses at baseline and 8 week follow-up. Resources used and the costs of an immediate reporting service were analysed at the patient level and compared to standard reporting practices.
RESULTS: 1688 radiographic examinations were performed (1502 patients). 79 discordant radiographic interpretations were identified (n = 79/1688; 4.7%). Interpretive errors were significantly reduced within immediate reporting arm. No significant difference was noted in the relative improvement in patient perceived health status between the 2 arms of the study. The average cost saving per patient in the immediate reporting arm was £23.40.
CONCLUSIONS: Radiographer led immediate reporting of ED radiographs is a cost-effective service development and its universal introduction could make a significant contribution to the current drive to increase service productivity within current budget constraints.
