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BackgroundConcomitant with the development of in vitro diagnostic multivariate index assays (IVDMIAs) to improve the diagnostic efficiency of ovarian cancer detection is the need to identify appropriate biostatistical approaches to assess improvements in risk predication. In this study, we assessed the utility of three different approaches for comparing diagnostic efficiency of an ovarian cancer multivariate assay in a retrospective case - control phase 2 biomarker trial. The control cohort included both disease-free women and women with benign gynecological conditions to more accurately reflect the target population of symptomatic women.MethodsThe study cohort comprised plasma samples from 244 healthy controls, 223 women with benign gynecological conditions, 53 borderline ovarian cancer cases and 222 women with malignant epithelial ovarian cancer. A multivariate classification model was developed that incorporated plasma concentrations of CA125, C-reactive protein (CRP), serum amyloid-A (SAA), interleukin-6 (IL6) and interleukin-8 (IL8) that were measured using in vitro diagnostics assays on medical device approved clinical analysers. The posterior probability values derived from the implemented algorithm were used for comparisons of the diagnostic performance between the multianalyte panel and CA125 using multiple methods; area under the curve (AUC) of the receiver operating characteristics curve, integrated discrimination improvement (IDI) and net reclassification improvement (NRI).ResultsEach of the biomarkers displayed significantly elevated plasma concentrations in malignant ovarian cancer patients compared with either benign or control subjects. For the discrimination of borderline and malignant ovarian cancer from control and benign subjects, the multivariate classification model showed a significantly greater AUC than that for CA125 alone (88.4% versus 84.3%, respectively, p < 0.001). At a posterior probability threshold of 0.5, the IVDMIA delivered a specificity of 92.3% and a sensitivity of 76.4%. When set at a specificity of 95%, the multimarker diagnostic delivered a sensitivity of 69.5% compared with 62.5% for CA125. Enhanced diagnostic performance of the IVDMIA over the use of CA125 alone was confirmed statistically by alternative comparisons using IDI and NRI.ConclusionsThis study confirms in an independent sample set that a blood-based multianalyte assay has significant advantages over CA125 for distinguishing symptomatic women with borderline and malignant ovarian cancer from controls or those with benign disease.

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Ethical guidance for research involving Indigenous and traditional communities, cultural knowledge, and associated biological resources has evolved significantly over recent decades. Formal guidance for ethnobiological research has been thoughtfully articulated and codified in many helpful ways, including but by no means limited to the Code of Ethics of the International Society of Ethnobiology. We have witnessed a successful and necessary era of "research ethics codification" with ethical awareness raised, fora established for debate and policy development, and new tools evolving to assist us in treating one another as we agree we ought to within the research endeavor. Yet most of us still struggle with ethical dilemmas, conflicts, and differences that arise as part of the inevitable uncertainties and lived realities of our crosscultural work. Is it time to ask what more (or what else) might we do, to lift the words on a page that describe how we should conduct ourselves, to connecting with the relational intention of those ethical principles and practices in concrete, meaningful ways? How might we discover ethics as relationship and practice while we necessarily aspire to follow adopted ethical codes as prescription? This paper brings together Willie Ermine's concept of "ethical space" and Darrell Posey's recognition of the spiritual values of biodiversity with a unique selection of insights from other fields of practice, such as intercultural communication, conflict resolution and martial arts, to invite a new conceptualization of research ethics in ethnobiology as ethical praxis.