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Abstract Background Guideline development on testing is known to be difficult for guideline developers. It requires consideration of various aspects, such as accuracy, purpose of testing, and consequences on management and people-important outcomes. This can be outlined in a test-management pathway. We aimed to create and user-test a step-by-step guide for guideline developers for designing a test-management pathway. Methods Developmental design with a co-creative strategy. We created a draft step-by-step guide, that was user tested in a workshop with 19 experts, and by interviewing 7 guideline panel members. Results Our proposed guide consists of five blocks of signalling questions: patients/population, index test(s), current practice/comparison/control, people-important outcomes, and the link between testing and outcome(s). The user testing led to refinement of the signalling questions, the use of inclusive terminology, and addition of a test-management pathway figure with detailed explanation. Conclusions The step-by-step guide for formulating focused guideline questions regarding healthcare related testing can help in identifying relevant characteristics of the population, tests, and outcomes and to create a test management pathway. This should facilitate the formulation of evidence-based guideline recommendations about healthcare related testing.

The observation of photosynthetic biofilms growing on the Fine Residue Deposit (FRD) kimberlite produced by the Venetia Diamond Mine, Limpopo, South Africa suggests that processed kimberlite supports bacterial growth. The presence of this biofilm may aid in the acceleration of weathering of this ultra-mafic host material – a process that can sequester CO2 via carbon mineralization. Laboratory and field trial experiments were undertaken to understand the microbe–mineral interactions occurring in these systems, and how these interactions impact geochemical cycling and carbonate precipitation. At laboratory scale it was discovered that using kimberlite as a growth supplement increased biomass production (up to 25-fold) and promoted microbiome diversity, while the inoculation of FRD systems aided in the aggregation, settling, and dewatering of kimberlitic slurries. Field trial studies combining photosynthetic biofilms (cultured in 3 × 1,000 L bioreactors) with FRD material were initiated to better understand microbially enhanced mineral carbonation across different depths, and under field environmental conditions. Over the 15-month experiment the microbial populations shifted with the kimberlitic environmental pressure, with the control and inoculated systems converging. The natural endogenous biosphere (control) and the inoculum accelerated carbonate precipitation across the entire 40 cm bioreactor depth, producing average 15-month carbonation rates of 0.57 wt.% and 1.17 wt.%, respectively. This corresponds to an annual CO2e mine offset of ~4.48% and ~ 9.2%, respectively. Millimetre-centimetre scale secondary carbonate that formed in the inoculated bioreactors was determined to be biogenic in nature (i.e., possessing microbial fossils) and took the form of radiating colloform precipitates with the addition of new, mineralized colonies. Surficial conditions resulted in the largest production of secondary carbonate, consistent with a ca. 12% mine site CO2e annual offset after a 15-month incubation period.

Since the early 1990s the number of systematic reviews (SR) of animal studies has steadily increased. There is, however, little guidance on when and how to conduct a meta-analysis of human-health-related animal studies. To gain insight about the methods that are currently used we created an overview of the key characteristics of published meta-analyses of animal studies, with a focus on the choice of effect size measures. An additional goal was to learn about the rationale behind the meta-analysis methods used by the review authors. We show that important details of the meta-analyses are not fully described, only a fraction of all human-health-related meta-analyses provided rationales for their decision to use specific effect size measures. In addition, our data may suggest that authors make post-hoc decisions to switch to another effect size measure during the course of their meta-analysis, and possibly search for significant effects. Based on analyses in this paper we recommend that review teams: 1) publish a review protocol before starting the conduct of a SR, prespecifying all methodological details (providing special attention to the planned meta-analysis including the effect size measure and the rational behind choosing a specific effect size, prespecifying subgroups and restricting the number of subgroup analyses), 2) always use the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) checklist to report your SR of animal studies, and 3) use the random effects model (REM) in human-health-related meta-analysis of animal studies, unless the assumptions for using the fixed effect model (FEM) are all met.

Abstract The Middle-Jurassic Opalinus Clay is the foreseen host rock for radioactive waste disposal in central northern Switzerland. An extensive drilling campaign aiming to characterize the argillaceous formation resulted in a comprehensive drill core data set. The rheologically weak Opalinus Clay is only mildly deformed compared to the over- and underlying rock units but shows a variety of natural fractures. While these structures are hydraulically indistinguishable from macroscopically non-deformed Opalinus Clay today, their analysis allows for a better understanding of the deformation behaviour in the geological past. Here, we present an overview of the different fracture and fault types recorded in the Opalinus Clay and a detailed microstructural characterization of veins—natural dilational fractures healed by secondary calcite and celestite mineralizations. Macroscopic drill core analysis revealed five different natural fracture types that encompass tension gashes of various orientations with respect to bedding and small-scale faults with displacements typically not exceeding the drill core diameter. The occurrence of different fault types generally fits well with the local tectonic setting of the different drilling sites and with respect to the neighbouring regional fault zones. The microstructural investigations of the various vein types revealed their often polyphase character. Fibrous bedding-parallel veins of presumable early age were found to be overprinted by secondary slickenfibres. The polyphase nature of fibrous bedding parallel veins and slickenfibres is supported by differing elemental compositions, pointing towards repeated fracturing and mineralization events. Direct dating of vein calcites with U–Pb was unsuccessful. Nevertheless, age constraints can be inferred from structural orientations and fault slip kinematics. Accordingly, some of the veins already formed during sediment compaction in Mesozoic times, others possibly relate to Early Cenozoic foreland uplift. The youngest veins are most likely related to Late Cenozoic regional tectonic events, such as the Jura fold-and-thrust belt to the south and the Hegau-Lake Constance Graben to the northeast of the study area. During these latest tectonic events, previously formed veins acted as rheologically stiff discontinuities in the otherwise comparably weak Opalinus Clay along which deformation of the rock formation was re-localized.

Abstract Background Work participation is important for health and can be considered as engagement in a major area of life which is of significance for most people, but it can also be thought of as fulfilling or discharging a role. Currently, academic research lacks a comprehensive classification of work participation outcomes. The International Classification of Functioning is the foremost model in defining work functioning and its counterpart work disability, but it does not provide a critical (core) set of outcomes. Standardizing the definitions and nomenclature used in the research of work participation would ensure that the outcomes of studies are comparable, and practitioners and guideline developers can better decide what works best. As work participation is a broad umbrella term including outcome categories which need unambiguous differentiation, a framework needs to be developed first. Aim To propose a framework which can be used to develop a generic core outcome set for work participation. Methods First, we performed a systematic literature search on the concept of (work) participation, views on how to measure it, and on existing classifications for outcome measurements. Next, we derived criteria for the framework and proposed a framework based on the criteria. Last, we applied the framework to six case studies as a proof of concept. Results Our literature search provided 2106 hits and we selected 59 studies for full-text analysis. Based on the literature and the developed criteria we propose four overarching outcome categories: (1) initiating employment, (2) having employment, (3) increasing or maintaining productivity at work, and (4) return to employment. These categories appeared feasible in our proof-of-concept assessment with six different case studies. Conclusion We propose to use the framework for work participation outcomes to develop a core outcome set for intervention studies to improve work participation.

Objective Synthesising evidence of the effects of interventions to improve work participation among people with health problems is currently difficult due to heterogeneity in outcome measurements. A core outcome set for work participation is needed.Study design and setting Following the Core Outcome Measures in Effectiveness Trials methodology, we used a five-step approach to reach international multistakeholder consensus on a core outcome set for work participation. Five subgroups of stakeholders took part in two rounds of discussions and completed two Delphi voting rounds on 26 outcomes. A consensus of ≥80% determined core outcomes and 50%–80% consensus was required for candidate outcomes.Results Fifty-eight stakeholders took part in the Delphi rounds. Core outcomes were: ‘any type of employment including self-employment’, ‘proportion of workers that return to work after being absent because of illness’ and ‘time to return to work’. Ten candidate outcomes were proposed, among others: ‘sustainable employment’, ‘work productivity’ and ‘workers’ perception of return to work’.Conclusion As a minimum, all studies evaluating the impact of interventions on work participation should include one employment outcome and two return to work outcomes if workers are on sick leave prior to the intervention.

Abstract Background Diagnostic mammography projections (DxMM) have been traditionally used in the assessment of women recalled after a suspicious screening mammogram. Digital breast tomosynthesis (DBT) reduces the tissue overlap effect, thus improving image assessment. Some studies have suggested DBT might replace DxMM with at least equivalent performance. Objective To evaluate the replacement of DxMM with DBT in women recalled at screening. Methods We searched PubMed, EMBASE, and the Cochrane Library databases to identify diagnostic paired cohort studies or RCTs comparing DBT vs DxMM, published in English that: reported accuracy outcomes, recruited women recalled for assessment at mammography screening, and included a reference standard. Subgroup analysis was performed over lesion characteristics. We provided pooled accuracy estimates and differences between tests using a quadrivariate model. We assessed the certainty of the evidence using the GRADE approach. Results We included ten studies that reported specificity and sensitivity. One study included 7060 women while the remaining included between 52 and 738 women. DBT compared with DxMM showed a pooled difference for the sensitivity of 2% (95% CI 1%–3%) and a pooled difference for the specificity of 6% (95%CI 2%–11%). Restricting the analysis to the six studies that included women with microcalcification lesions gave similar results. In the context of a prevalence of 21% of breast cancer (BC) in recalled women, DBT probably detects 4 (95% CI 2–6) more BC cases and has 47 (95%CI 16–87) fewer false‐positive results per 1000 assessments. The certainty of the evidence was moderate due to risk of bias. Conclusion The evidence in the assessment of screen‐recalled findings with DBT is sparse and of moderate certainty. DBT probably has higher sensitivity and specificity than DxMM. Women, health care providers and policymakers might value as relevant the reduction of false‐positive results and related fewer invasive diagnostic procedures with DBT, without missing BC cases.

The observation of photosynthetic biofilms growing on the Fine Residue Deposit (FRD) kimberlite produced by the Venetia Diamond Mine, Limpopo, South Africa suggests that processed kimberlite supports bacterial growth. The presence of this biofilm may aid in the acceleration of weathering of this ultra-mafic host material - a process that can sequester CO2 via carbon mineralization. Laboratory and field trial experiments were undertaken to understand the microbe-mineral interactions occurring in these systems, and how these interactions impact geochemical cycling and carbonate precipitation. At laboratory scale it was discovered that using kimberlite as a growth supplement increased biomass production (up to 25-fold) and promoted microbiome diversity, while the inoculation of FRD systems aided in the aggregation, settling, and dewatering of kimberlitic slurries. Field trial studies combining photosynthetic biofilms (cultured in 3 × 1,000 L bioreactors) with FRD material were initiated to better understand microbially enhanced mineral carbonation across different depths, and under field environmental conditions. Over the 15-month experiment the microbial populations shifted with the kimberlitic environmental pressure, with the control and inoculated systems converging. The natural endogenous biosphere (control) and the inoculum accelerated carbonate precipitation across the entire 40 cm bioreactor depth, producing average 15-month carbonation rates of 0.57 wt.% and 1.17 wt.%, respectively. This corresponds to an annual CO2e mine offset of ~4.48% and ~ 9.2%, respectively. Millimetre-centimetre scale secondary carbonate that formed in the inoculated bioreactors was determined to be biogenic in nature (i.e., possessing microbial fossils) and took the form of radiating colloform precipitates with the addition of new, mineralized colonies. Surficial conditions resulted in the largest production of secondary carbonate, consistent with a ca. 12% mine site CO2e annual offset after a 15-month incubation period. [ABSTRACT FROM AUTHOR]

Abstract Background In 2017, the European Commission’s Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). Methods A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. Results Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. Conclusions The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

Abstract Background Although quality indicators are frequently derived from guidelines, there is a substantial gap in collaboration between the corresponding parties. To optimise workflow, guideline recommendations and quality assurance should be aligned methodologically and practically. Learning from the European Commission Initiative on Breast Cancer (ECIBC), our objective was to bring the key knowledge and most important considerations from both worlds together to inform European Commission future initiatives. Methods We undertook several steps to address the problem. First, we conducted a feasibility study that included a survey, interviews and a review of manuals for an integrated guideline and quality assurance (QA) scheme that would support the European Commission. The feasibility study drew from an assessment of the ECIBC experience that followed commonly applied strategies leading to separation of the guideline and QA development processes. Secondly, we used results of a systematic review to inform our understanding of methodologies for integrating guideline and QA development. We then, in a third step, used the findings to prepare an evidence brief and identify key aspects of a methodological framework for integrating guidelines QA through meetings with key informants. Results Seven key themes emerged to be taken into account for integrating guidelines and QA schemes: (1) evidence-based integrated guideline and QA frameworks are possible, (2) transparency is key in clearly documenting the source and rationale for quality indicators, (3) intellectual and financial interests should be declared and managed appropriately, (4) selection processes and criteria for quality indicators need further refinement, (5) clear guidance on retirement of quality indicators should be included, (6) risks of an integrated guideline and QA Group can be mitigated, and (7) an extension of the GIN-McMaster Guideline Development Checklist should incorporate QA considerations. Discussion We concluded that the work of guideline and QA developers can be integrated under a common methodological framework and we provided key findings and recommendations. These two worlds, that are fundamental to improving health, can both benefit from integration.