From code to care: Clinician and researcher perspectives on an optimal therapeutic web portal for acute myeloid leukemia.

BACKGROUND: Acute myeloid leukemia (AML), a rapidly progressing cancer of the blood and bone marrow, is the most common and fatal type of adult leukemia. Therapeutic web portals have great potential to facilitate AML research advances and improve health outcomes by increasing the availability of data, the speed and reach of new knowledge, and the communication between researchers and clinicians in the field. However, there is a need for stakeholder research regarding their optimal features, utility, and implementation. METHODS: To better understand stakeholder perspectives regarding an ideal pan-Canadian web portal for AML research, semi-structured qualitative interviews were conducted with 17 clinicians, researchers, and clinician-researchers. Interview guides were inspired by De Laat's "fictive scripting", a method where experts are presented with scenarios about a future technology and asked questions about its implementation. Content analysis relied on an iterative process using themes extracted from both existing scientific literature and the data. RESULTS: Participants described potential benefits of an AML therapeutic portal including facilitating data-sharing, communication, and collaboration, and enhancing clinical trial matchmaking for patients, potentially based on their specific genomic profiles. There was enthusiasm about researcher, clinician, and clinician-researcher access, but some disagreement about the nature of potential patient access to the portal. Interviewees also discussed two key elements they believed to be vital to the uptake and thus success of a therapeutic AML web portal: credibility and user friendliness. Finally, sustainability, security and privacy concerns were also documented. CONCLUSIONS: This research adds to existing calls for digital platforms for researchers and clinicians to supplement extant modes of communication to streamline research and its dissemination, advance precision medicine, and ultimately improve patient prognosis and care. Findings are applicable to therapeutic web portals more generally, particularly in genomic and translational medicine, and will be of interest to portal end-users, developers, researchers, and policymakers.

Direct-to-Consumer Genetic Tests and Canadian Genetic Counselors: A Pilot Exploration of Professional Roles in Response to Novel Biotechnologies.

The role of genetic counselors is evolving in response to health-related direct-to-consumer genetic tests (DTC-GT). While there is consensus in the literature that pre- and post-DTC-GT genetic counseling would benefit consumers, genetic counselors have reservations about DTC-GTs, and there is a paucity of research on providing DTC-GT counseling. This pilot quantitative survey is the first study to examine Canadian genetic counselors' views on DTC-GTs and how this disruptive biotechnology affects their role, and consumer informed consent and privacy. Canadian genetic counselors are cognizant of the harm to informed consent and privacy associated with DTC-GT, but are hesitant to engage directly, wary of misusing clinical time and resources. However, counselors are open to producing educational materials on DTC-GTs and collaborating with other stakeholders and the DTC-GT industry to support consumers. In this study, practical considerations for DTC-GT counseling sessions are discussed, including the unique needs of DTC-GT patients and the challenges posed by DTC-GTs to the genetic counseling duty to inform. This research benefits genetic counselors and physicians by examining how best to utilize genetic counselors' skills in the DTC-GT context, to minimize burdens on the healthcare system and support DTC-GT consumers.

Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov.

We investigated whether sponsor-imposed publication restrictions for ClinicalTrials.gov trials were reasonable, based on consistency with Good Publication Practice 2 (GPP2). ClinicalTrials.gov trial record data were electronically imported (October 7, 2012) and screened for eligibility (phase 2-4, interventional, recruitment closed, results available, first received for registration after November 10, 2009, any sponsor type, investigators not sponsor employees). Two authors categorized restrictions information as consistent or not consistent with GPP2, resolving discrepancies by consensus. Of the eligible trials (388/484, n = 81,768 participants), 80.7% (313/388) had restrictions disclosed, and 92.5% (311/388) were industry-sponsored. Significantly more trials had restrictions that were consistent with GPP2 than not (74.1% [232/313], n = 55,280 participants vs. 25.9% [81/313], n = 19,677 participants; P < .001). Reasons for inconsistency were insufficient, unclear, or ambiguous information (48.1%, 39/81), sponsor-required approval for publication (35.8%, 29/81), sponsor-required text changes (8.6%, 7/81), and outright bans (7.4%, 6/81). Follow-up of trials with insufficient information and a contact email (response rate, 46.9% [15/32]) revealed 2 additional bans. A total of 776 participants had consented to trials that had publication bans. Many, but not all, sponsor-imposed publication restrictions disclosed on ClinicalTrials.gov may be considered reasonable. Sponsors should ensure restrictions are appropriately disclosed. Volunteers should be alerted to any restrictions before consenting to participate in a clinical trial.

Publication misconduct and plagiarism retractions: a systematic, retrospective study.

OBJECTIVES: To investigate whether plagiarism is more prevalent in publications retracted from the medical literature when first authors are affiliated with lower-income countries versus higher-income countries. Secondary objectives included investigating other factors associated with plagiarism (e.g., national language of the first author's country affiliation, publication type, journal ranking). DESIGN: Systematic, controlled, retrospective, bibliometric study. DATA SOURCE: Retracted publications dataset in MEDLINE (search filters: English, human, January 1966-February 2008). DATA SELECTION: Retracted misconduct publications were classified according to the first author's country affiliation, country income level, and country national language, publication type, and ranking of the publishing journal. Standardised definitions and data collection tools were used; data were analysed (odds ratio [OR], 95% confidence limits [CL], chi-squared tests) by an independent academic statistician. RESULTS: Of the 213 retracted misconduct publications, 41.8% (89/213) were retracted for plagiarism, 52.1% (111/213) for falsification/fabrication, 2.3% (5/213) for author disputes, 2.3% (5/213) for ethical issues, and 1.4% (3/213) for unknown reasons. The OR (95% CL) of plagiarism retractions (other misconduct retractions as reference) were higher (P < 0.001) for first authors affiliated with lower-income versus higher-income countries (15.4 [4.5, 52.9]) and with non-English versus English national language countries (3.2 [1.8, 5.7]), for non-original research versus original research publications (8.4 [3.3, 21.3]), for case reports and series versus other original research types (4.2 [1.4, 13.0]), and for publications in low-ranked versus high-ranked journals (4.9 [2.4, 9.9]). Up until 2012, there were significantly (P < 0.007) fewer 'serial offenders' (first authors with >1 retraction) with publications retracted for plagiarism (11.5%, 9/78) than other types of misconduct (28.9%, 24/83). CONCLUSIONS: This is the first study to demonstrate that publications retracted for plagiarism are significantly associated with first authors affiliated with lower-income countries. These findings have implications for developing appropriate evidence-based strategies and allocation of resources to help mitigate plagiarism misconduct.