Spatially Explicit Data: Stewardship and Ethical Challenges in Science

Scholarly communication is at an unprecedented turning point created in part by the increasing saliency of data stewardship and data sharing. Formal data management plans represent a new emphasis in research, enabling access to data at higher volumes and more quickly, and the potential for replication and augmentation of existing research. Data sharing has recently transformed the practice, scope, content, and applicability of research in several disciplines, in particular in relation to spatially specific data. This lends exciting potentiality, but the most effective ways in which to implement such changes, particularly for disciplines involving human subjects and other sensitive information, demand consideration. Data management plans, stewardship, and sharing, impart distinctive technical, sociological, and ethical challenges that remain to be adequately identified and remedied. Here, we consider these and propose potential solutions for their amelioration

An interdisciplinary guideline development process: the Clinic on Low-back pain in Interdisciplinary Practice (CLIP) low-back pain guidelines

<p>Abstract</p> <p>Background</p> <p>Evaluation of low-back pain guidelines using Appraisal of Guidelines Research and Evaluation (AGREE) criteria has shown weaknesses, particularly in stakeholder involvement and applicability of recommendations. The objectives of this project were to: 1) develop a primary care interdisciplinary clinical practice guideline aimed at preventing prolonged disability from low-back pain, using a community of practice approach, and 2) assess the participants' impressions with the process, and evaluate the relationship between participant characteristics and their participation.</p> <p>Methods</p> <p>Ten stakeholder representatives recruited 136 clinicians to participate in this community of practice. Clinicians were drawn from the following professions: physiotherapists (46%), occupational therapists (37%), and family physicians (17%). Using previously published guidelines, systematic reviews, and meta-analyses, a first draft of the guidelines was presented to the community of practice. Four communication tools were provided for discussion and exchanges with experts: a web-based discussion forum, an anonymous comment form, meetings, and a symposium. Participants were prompted for comments on interpretation, clarity, and applicability of the recommendations. Clinical management recommendations were revised following these exchanges. At the end of the project, a questionnaire was sent to the participants to assess satisfaction towards the guidelines and the development process.</p> <p>Results</p> <p>Twelve clinical management recommendations on management of low-back pain and persistent disability were initially developed. These were discussed through 188 comments posted on the discussion forum and 103 commentary forms submitted. All recommendations were modified following input of the participants. A clinical algorithm summarizing the guidelines was also developed. A response rate of 75% was obtained for the satisfaction questionnaire. The majority of respondents appreciated the development process and agreed with the guideline content. Most participants thought recommendations improved between versions, and that participant comments contributed to this improvement. All stakeholders officially endorsed the guidelines.</p> <p>Conclusion</p> <p>The community of practice approach was a successful method to develop guidelines on low-back pain, with participants providing information to improve guideline recommendations. The information technology infrastructure that was developed remains for continuous interdisciplinary exchanges and updating of the guidelines.</p

Genomics and premalignant breast lesions: clues to the development and progression of lobular breast cancer

Advances in genomic technology have improved our understanding of the genetic events that parallel breast cancer development. Because almost all mammary carcinomas develop in the terminal duct lobular units of the breast, understanding the events involved in mammary gland development make it possible to recognize those events that, when altered, contribute to breast neoplasia. In this review we focus on lobular carcinomas, discussing the pathology, development, and progression of premalignant lobular lesions from a genomic point of view. We highlight studies utilizing genomic approaches and describe how these investigations have furthered our understanding of the complexity of premalignant breast lesions

Are Child and Adolescent Responses to Placebo Higher in Major Depression than in Anxiety Disorders? A Systematic Review of Placebo-Controlled Trials

BACKGROUND: In a previous report, we hypothesized that responses to placebo were high in child and adolescent depression because of specific psychopathological factors associated with youth major depression. The purpose of this study was to compare the placebo response rates in pharmacological trials for major depressive disorder (MDD), obsessive compulsive disorder (OCD) and other anxiety disorders (AD-non-OCD). METHODOLOGY AND PRINCIPAL FINDINGS: We reviewed the literature relevant to the use of psychotropic medication in children and adolescents with internalized disorders, restricting our review to double-blind studies including a placebo arm. Placebo response rates were pooled and compared according to diagnosis (MDD vs. OCD vs. AD-non-OCD), age (adolescent vs. child), and date of publication. From 1972 to 2007, we found 23 trials that evaluated the efficacy of psychotropic medication (mainly non-tricyclic antidepressants) involving youth with MDD, 7 pertaining to youth with OCD, and 10 pertaining to youth with other anxiety disorders (N = 2533 patients in placebo arms). As hypothesized, the placebo response rate was significantly higher in studies on MDD, than in those examining OCD and AD-non-OCD (49.6% [range: 17-90%] vs. 31% [range: 4-41%] vs. 39.6% [range: 9-53], respectively, ANOVA F = 7.1, p = 0.002). Children showed a higher stable placebo response within all three diagnoses than adolescents, though this difference was not significant. Finally, no significant effects were found with respect to the year of publication. CONCLUSION: MDD in children and adolescents appears to be more responsive to placebo than other internalized conditions, which highlights differential psychopathology