An integrated knowledge translation approach to develop a shared decision-making strategy for use by Inuit in cancer care: a qualitative study.

Background: In relation to the general Canadian population, Inuit face increased cancer risks and barriers to health services use. In shared decision-making (sdm), health care providers and patients make health care decisions together. Enhanced participation in cancer care decisions is a need for Inuit. Integrated knowledge translation (kt) supports the development of research evidence that is likely to be patient-centred and applied in practice. Objective: Using an integrated kt approach, we set out to promote the use of sdm by Inuit in cancer care. Methods: An integrated kt study involving researchers with a Steering Committee of cancer care system partners who support Inuit in cancer care ("the team") consisted of 2 theory-driven phases:■ using consensus-building methods to tailor a previously developed sdm strategy and developing training in the sdm strategy; and■ training community support workers (csws) in the sdm strategy and testing the sdm strategy with community members. Results: The team developed a sdm strategy that included a workshop and a booklet with 6 questions for use by csws with patients. The sdm strategy (training and booklet) was finalized based on feedback from 5 urban-based Inuit csws who were recruited and trained in using the strategy. Trained csws were matched with 8 community members, and use of the sdm strategy was assessed during interviews, reported as 6 themes. Participants found the sdm strategy to be useful and feasible for use. Conclusions: An integrated kt approach of structured research processes with partners developed a sdm strategy for use by Inuit in cancer care. Further work is needed to test the sdm strategy.

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. RESULTS: A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. CONCLUSION: The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study.

BACKGROUND: Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants. METHODS: We searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second. RESULTS: The search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12-6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined "sex" and/or "gender." No publication carried out a comprehensive sex and gender analysis. CONCLUSIONS: Findings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research.

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

BACKGROUND: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). METHODS/DESIGN: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. DISCUSSION: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

The effect of time on the incidence of carcinomas obtained by the implantation of paraffin wax pellets into mouse bladder.

Paraffin wax pellets were implanted surgically into the mouse bladder lumen and animals killed after 40-50, 70-80 and 100-110 weeks. The number and malignancy of bladder carcinomas increased considerably with the time after implantation. Pellets containing 1-phenylazo-2-naphthol significantly increased at each time the incidence of bladder carcinomas relative to that observed with paraffin wax. Pellets containing N-2-fluorenylacetamide or its metabolites gave very similar incidences or carcinomas whether or not they were carcinogenic by oral or parenteral administration.

Steroidogenic pathways and trophic response to adrenocorticotrophin of cultured adrenocortical cells in different states of differentiation.

Adrenocortical cells obtained from adult rats were propagated in monolayer culture. Depending on culture conditions, they grew either as lipid-containing epithelial-like cells with a high level of steroid production, or as fibroblast-like cells with a low level of steroid production. The major fluorogenic steroid secreted by both morphologic forms of adrenal cortical cell was corticosterone as determined by chromatography and acid fluorometry. Basal fluorogenic steroid production per 10(6) cells over 24 h was: epithelial-like cells, 5.0-mug; fibroblast-like cells, 0-014 mug. Stimulation with ACTH for 5 days increased fluorogenic steroid production and induced morphologic changes in both adrenal cell forms. ACTH stimulation of fluorogenic steroid production by both cell forms reached a maximum after 3 days, then dropped to a refractory state after 5 days. With maximal ACTH stimulation, production increased 25-fold in fibroblast-like cells and five-fold in epithelial-like cells. The latter rate of corticosterone production is similar, per cell, to ACTH-stimulated adrenal glands in vivo. Progressive morphologic changes were observed with ACTH stimulation: epithelial-like cells retracted from the substratum and lost lipid inclusions; fibroblast-like cells became more epithelial-like. Both adrenal cell types formed intermediates from [4-(14)C] pregnenolone including pregn-5-ene-3 phi, 20 alpha-diol and 20 alpha-hydroxy-pregn-4-en-3-one. Control cultures of muscle fascia fibroblasts did not produce corticosterone or intermediates from [4-(14)C[ pregnenolone and did not respond to ACTH functionally or morphologically.