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Background: Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown.

Methods: In this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival.

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Conclusions: In this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. (Funded by Bayer and Orion Pharma; ARASENS ClinicalTrials.gov number, NCT02799602.).

Sensitive Species in eBird are those for which demonstrable harm could occur from public display of site-level records, including (but not limited to): 1) targeted capture for the cage bird trade; 2) targeted hunting; 3) targeted disturbance of nests, roosts, or individual birds from birdwatchers or photographers. Species that are rare but are not under pressure from targeted human exploitation or disturbance generally are not considered Sensitive.

eBird's Sensitive Species protections only apply to clear cases where public information about a species may place that species at risk. There are other cases where it may be best to not report specific observations publicly on eBird, even if the species isn't sensitive as a whole, either due to restricted site access concerns or because the bird may be harmed in some way. eBirders must take it upon themselves to understand the situation locally and to use their best judgment, as the status of a species may change from place to place.

Owls sensitive to targeted disturbance. Disturbance at their day roosts or use of playback can repeatedly disturb individuals, pairs, or small populations. Large crowds surrounding and following certain owls in winter (sometimes engaging in unethical baiting practices) disrupts natural hunting and exposes owls to great risk from vehicle collisions or habituation to humans. We currently treat certain species as globally Sensitive because of known issues with publicizing specific locations. However, we encourage ethical behavior around all owls.

Species sensitive to targeted hunting. Some species are under particular pressure from hunting, either for food or for use of the bird's body parts (e.g., Helmeted Hornbill), and hunters may specifically target individuals or concentrations of birds.

Results showed a greater number of hits from the PICO searches, in comparison to the SPIDER searches, with greater sensitivity. SPIDER searches showed greatest specificity for every database. The modified PICO demonstrated equal or higher sensitivity than SPIDER searches, and equal or lower specificity than SPIDER searches. The modified PICO demonstrated lower sensitivity and greater specificity than PICO searches.

Systematic reviews are a crucial method, underpinning evidence based practice and informing health care decisions [1],[2]. Traditionally systematic reviews are completed using an objective and primarily quantitative approach [3] whereby a comprehensive search is conducted, attempting to identify all relevant articles which are then integrated and assimilated through statistical analysis. The comprehensiveness of the search process has been viewed as a key factor in preventing bias and providing a true representation of available research [4]. Current research investigating the process of quantitative systematic reviews therefore focuses on methods for ensuring the most comprehensive and bias free searches possible [5]. Because of the time and resources required to complete a systematic and comprehensive search, efforts have been made to investigate the sensitivity of searches, and thus lessen the amount of time spent reviewing irrelevant articles with no benefit [6].

However, conducting comprehensive searches also forms the bedrock of qualitative or narrative reviews, now commonly referred to as qualitative evidence syntheses [7]. Qualitative evidence syntheses are now acknowledged as a necessary and valuable type of information to answer health services research questions [8]. However, difficulties in completing a sensitive yet comprehensive search of qualitative literature have been previously noted [9]-[11] including: poor indexing and use of key words of qualitative studies, the common use of titles that lack the keywords describing the article, and unstructured abstracts.

Cooke et al. recommended that the SPIDER tool was tested further in qualitative literature searches [9]. Although it has been used previously in a scoping review to investigate gaps in an evidence base on community participation in rural health care [13], SPIDER has not yet been tested and evaluated in a qualitative systematic narrative review context. The authors of this article recently completed a systematic review of the qualitative research investigating experiences of health care services for people with Multiple Sclerosis [14]. On embarking on this review topic we faced many of the difficulties commonly discussed in identifying qualitative literature on a given topic, and identified SPIDER as a potential way of overcoming some of these difficulties. Therefore, the aim of this article was to test SPIDER by broadly replicating the work of Cooke et al. [9], specifically by comparing the two approaches: 1) the traditional PICO method of searching electronic databases with 2) the newly devised SPIDER tool, developed for qualitative and mixed-method research. In addition we wished to build and expand on the work of Cooke et al. [9] and so our third aim was to compare PICO and SPIDER to a modified PICO with qualitative study designs (PICOS, see Table 1 by investigating specificity and sensitivity across 3 major databases.

The PICOS tool was more specific than the PICO tool, but did not identify any additional relevant hits to the SPIDER tool, suggesting it is of approximately equal sensitivity. PICOS identified the same number of papers as the SPIDER tool and both demonstrated a substantially lower number of hits generated than a regular PICO search. The SPIDER tool showed the greatest specificity due the small number of hits generated. This may mean that review teams with very limited resources or time, and who are not aiming for a totally comprehensive search (i.e. in the case of scoping studies), would benefit from using the SPIDER tool. This might be applicable particularly to studies such as qualitative syntheses, where the research aim is theoretical saturation, not a comprehensive search [34]. In addition, articles written to influence policy often require swift publication, providing another area in which either SPIDER or PICOS might improve current practice.

The issue of time was also related to the number of relevant articles identified per database. Whilst EMBASE generated nearly twice as many hits as MEDLINE, only one additional paper was found. The PICO tool identified all articles, suggesting that where time is not a factor, it might be of more benefit to use this tool, as SPIDER demonstrated lower sensitivity, did not identify any new articles and identified fewer relevant articles than PICO.

SPIDER greatly reduced the initial number of articles identified on a given search due to increased specificity, however because of lower sensitivity omitted many relevant papers. The PICOS tool resulted in an overall more sensitive search, but still demonstrated poor specificity on this topic. Further investigations of the specificity and sensitivity of SPIDER and PICOS on varied topics will be of benefit to research teams with limited time and resources or articles necessary to impact on policy or change current practice. However, where comprehensiveness is a key factor we suggest that the PICO tool should be used preferentially. Part of the lower identification rate for SPIDER (in comparison to PICO) was poor labelling and use of qualitative keywords in indexing studies. As both individual research submissions and journal/database indexers improve, or standardise, the indexing of qualitative studies, it is likely that the relevance of the SPIDER tool will increase. The recommendation for current practice therefore is to use the PICO tool across a variety of databases. In this article we have shown that SPIDER is relevant for those researchers completing systematic narrative reviews of qualitative literature but not as effective as PICO. Future research should investigate the use of SPIDER and PICOS across varied databases.

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated.

Sensitivity Analysis is a tool used in financial modeling to analyze how the different values of a set of independent variables affect a specific dependent variable under certain specific conditions. In general, sensitivity analysis is used in a wide range of fields, ranging from biology and geography to economics and engineering. 17dc91bb1f