Agile development methods are growing in popularity with a recent survey reporting that more than 80% of organizations now following an agile approach. Agile methods were seen initially as best suited to small, co-located teams developing non-critical systems. The first two constraining characteristics (small and co-located teams) have been addressed as research has emerged describing successful agile adoption involving large teams and distributed contexts. However, the applicability of agile methods for developing safety-critical systems in regulated environments has not yet been demonstrated unequivocally, and very little rigorous research exists in this area. Some of the essential characteristics of agile approaches appear to be incompatible with the constraints imposed by regulated environments. In this study we identify these tension points and illustrate through a detailed case study how an agile approach was implemented successfully in a regulated environment. Among the interesting concepts to emerge from the research are the notions of continuous compliance and living traceability.

Research Summary: We use a microfoundations lens to challenge the assumption of a simple relationship between organizational‐level context (subsidiary entrepreneurial orientation) and entrepreneurial outcomes (initiative realization). Drawing on middle manager and subsidiary literature, we argue that the strategic activities of the subsidiary's central actor, the subsidiary CEO (referred to as the subsidiary manager), translates the benefits of subsidiary entrepreneurship for initiative realization. We test this mediating effect of subsidiary manager micro‐level activities on data from 186 individuals. The results of our multilevel mediation analysis show that micro‐activities of subsidiary managers mobilize subsidiary entrepreneurship for initiative realization, “downward” through facilitating subsidiary adaptability and “horizontally” through enabling embeddedness in the local environment. Our findings also challenge the accepted value of “upward” championing alternatives. Revealing the centrality of subsidiary manager activities for unlocking entrepreneurship demonstrates the value of adopting a microfoundations lens for understanding organizational phenomena. Managerial Summary: Multinational companies (MNCs) increasingly expect their subsidiary units to contribute through realizing initiatives, such as new product, service, or process designs. Such outcomes are encouraged through a supporting organizational context for entrepreneurship. But to understand how an entrepreneurial context translates into realized initiatives demands that we apply a microfoundations lens and consider the activities of the subsidiary's central actor, the subsidiary chief executive officer—referred to as the “subsidiary manager.” The subsidiary manager is responsible for mobilizing the subsidiary to develop relationships to access the knowledge, ideas, and opportunities implicit in the initiative process. Revealing the impact of these micro‐activities advances our understanding of how to liberate the benefits of entrepreneurship for realizing initiatives. This study offers key insights for both subsidiary managers and headquarters.

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Background: Optimal management of the endometrium in patients with oestrogen receptor-positive breast cancer taking extended tamoxifen therapy (for 10 years) remains uncertain. A meta-analysis was performed to determine the cumulative risk ratio (RR) for endometrial malignancy following extended compared with standard tamoxifen treatment. A systematic review was undertaken to identify whether routine endometrial surveillance in patients receiving tamoxifen is associated with earlier detection and reduced incidence of endometrial malignancy.Methods: Two independent searches were undertaken in the Cochrane Library, PubMed and MEDLINE. A meta-analysis was performed of RCTs reporting on endometrial malignancy risk in extended tamoxifen therapy. A systematic review included prospective studies investigating the benefit of endometrial surveillance during tamoxifen therapy.Results: Four RCTs reported on endometrial risk in extended tamoxifen therapy. The cumulative risk of endometrial malignancy increased twofold from 1⋅5 to 3⋅2 per cent with extended therapy compared with the standard 5 years of tamoxifen (RR 2⋅29, 95 per cent c.i. 1⋅60 to 3⋅28; P < 0⋅001). Four studies analysed the value of endometrial screening in 5-year cohorts. Endometrial cancer rates of up to 2 per cent were reported, which is higher than rates in the large extended tamoxifen trials. Conclusion:Extended adjuvant tamoxifen is associated with an increase in endometrial cancer. No clear benefit has been shown for routine endometrial surveillance in asymptomatic patients on tamoxifen therapy.

OBJECTIVE: To compare maternal outcomes in patients with morbidly adherent placenta managed in a multidisciplinary team setting compared with standard care. DATA SOURCES: A literature search was performed for publications reporting multidisciplinary pathways in the management of cesarean delivery for patients with morbidly adherent placenta. EMBASE, MEDLINE, PubMed, PubMed Central, ClinicalTrials.gov, and Cochrane databases were searched. METHODS OF STUDY SELECTION: Databases were searched for studies reporting maternal morbidity of patients with morbidly adherent placenta managed by a multidisciplinary team in a specialist center compared with standard care. Two independent reviewers applied inclusion and exclusion criteria to select included articles, with differences agreed by consensus. A total of 252 citations were reviewed; six studies comprising 461 patients were selected for the analysis. TABULATION, INTEGRATION, AND RESULTS: Literature search was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results were reported as mean differences or pooled odds ratios (ORs) with 95% CIs. Estimated blood loss was significantly reduced in the multidisciplinary team group (mean difference −1.1 L, 95% CI −1.9 to −0.4, P=.004) and these patients had lower transfusion requirements (mean difference −2.7 units, 95% CI −4.1 to −1.2, P=.040). Those treated in a standard care setting were more likely to develop complications (OR 2.5, 95% CI 1.5–4.0, P<.001); however, there was no difference in length of stay between the two groups. CONCLUSION: This meta-analysis highlights the improved maternal outcomes in patients with morbidly adherent placenta when managed by a multidisciplinary team in a specialist center. High-risk complex cases warrant expert management in centralized units.