Prescribing unproven cancer drugs: Physician perspectives on expanded access and right to try

BACKGROUND: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. METHODS: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. RESULTS: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. CONCLUSION: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine

Dynamic Changes of Convolutional Neural Network-based Mammographic Breast Cancer Risk Score Among Women Undergoing Chemoprevention Treatment.

INTRODUCTION: We investigated whether our convolutional neural network (CNN)-based breast cancer risk model is modifiable by testing it on women who had undergone risk-reducing chemoprevention treatment. MATERIALS AND METHODS: We conducted a retrospective cohort study of patients diagnosed with atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ at our institution from 2007 to 2015. The clinical characteristics, chemoprevention use, and mammography images were extracted from the electronic health records. We classified two groups according to chemoprevention use. Mammograms were performed at baseline and subsequent follow-up evaluations for input to our CNN risk model. The 2 chemoprevention groups were compared for the risk score change from baseline to follow-up. The change categories included stayed high risk, stayed low risk, increased from low to high risk, and decreased from high to low risk. Unordered polytomous regression models were used for statistical analysis, with P < .05 considered statistically significant. RESULTS: Of 541 patients, 184 (34%) had undergone chemoprevention treatment (group 1) and 357 (66%) had not (group 2). Using our CNN breast cancer risk score, significantly more women in group 1 had shown a decrease in breast cancer risk compared with group 2 (33.7% vs. 22.9%; P < .01). Significantly fewer women in group 1 had an increase in breast cancer risk compared with group 2 (11.4% vs. 20.2%; P < .01). On multivariate analysis, an increase in breast cancer risk predicted by our model correlated negatively with the use of chemoprevention treatment (P = .02). CONCLUSIONS: Our CNN-based breast cancer risk score is modifiable with potential utility in assessing the efficacy of known chemoprevention agents and testing new chemoprevention strategies

Religious Collections in Kansas

Oral histories created by University of Kansas students, staff and faculty as part of the Religion in Kansas Project are archived at http://hdl.handle.net/1808/12524 in KU ScholarWorks, the digital repository of the University of Kansas.During the summers of 2014 and 2015, the Summer Fieldwork interns for the Religion in Kansas Project visited small repositories--mostly county historical societies and public libraries--across the state of Kansas to compile an index of the collections related to religion that are held by such organizations throughout the state. This work was partially supported by a Carnegie-Whitney Grant from the American Library Association.Friends of the Department of Religious Studie

Researching the future: scenarios to explore the future of human genome editing

Abstract Background Forward-looking, democratically oriented governance is needed to ensure that human genome editing serves rather than undercuts public values. Scientific, policy, and ethics communities have recognized this necessity but have demonstrated limited understanding of how to fulfill it. The field of bioethics has long attempted to grapple with the unintended consequences of emerging technologies, but too often such foresight has lacked adequate scientific grounding, overemphasized regulation to the exclusion of examining underlying values, and failed to adequately engage the public. Methods This research investigates the application of scenario planning, a tool developed in the high-stakes, uncertainty-ridden world of corporate strategy, for the equally high-stakes and uncertain world of the governance of emerging technologies. The scenario planning methodology is non-predictive, looking instead at a spread of plausible futures which diverge in their implications for different communities’ needs, cares, and desires. Results In this article we share how the scenario development process can further understandings of the complex and dynamic systems which generate and shape new biomedical technologies and provide opportunities to re-examine and re-think questions of governance, ethics and values. We detail the results of a year-long scenario planning study that engaged experts from the biological sciences, bioethics, social sciences, law, policy, private industry, and civic organizations to articulate alternative futures of human genome editing. Conclusions Through sharing and critiquing our methodological approach and results of this study, we advance understandings of anticipatory methods deployed in bioethics, demonstrating how this approach provides unique insights and helps to derive better research questions and policy strategies

Additional file 1 of Researching the future: scenarios to explore the future of human genome editing

Supplementary Material

Androgen Deprivation Therapy Is Associated With Prolongation of QTc Interval in Men With Prostate Cancer

Abstract Context Androgen deprivation therapy (ADT) for prostate cancer (PCa) is associated with increased cardiovascular mortality and sudden cardiac death, with some events occurring early after initiation of ADT. Testosterone levels are inversely associated with corrected QT (QTc) interval duration; therefore, prolongation of QTc duration could be responsible for some of these events during ADT. Objective: To evaluate changes in QTc duration during ADT. Design and Interventions A 6-month prospective cohort study that enrolled men with PCa about to undergo ADT (ADT group) and a control group of men who previously underwent prostatectomy for PCa and never received ADT (non-ADT group). Patients At study entry, all participants were eugonadal and had no history of cardiac arrhythmias or complete bundle branch block. Outcomes Difference in change in QTc duration from baseline on a 12-lead electrocardiogram at 6, 12, and 24 weeks after initiation of ADT compared with electrocardiograms performed at the same intervals in the non-ADT group. PR, QRS, and QT interval durations were also evaluated. Results: Seventy-one participants formed the analytical sample (33 ADT and 38 non-ADT). ADT was associated with prolongation of the QTc by 7.4 ms compared with the non-ADT group [95% confidence interval (CI) 0.08 to 14.7 ms; P = 0.048]. ADT was also associated with shortening of the QRS interval by 2.4 ms (95% CI −4.64 to −0.23; P = 0.031). Electrolytes did not change. Conclusions: Men undergoing ADT for PCa experienced prolongation of the QTc. These findings might explain the increased risk of sudden cardiac death seen in these patients

Occupational therapy for children with cerebral palsy.

Objectives: The object of our systematic review, therefore, was to determine whether OT interventions improve functional abilities and social participation in children with cerebral palsy. Criteria for considering Studies for this Review: Types of studies: Studies with one of the following designs will be entered in the review. 1) Randomised controlled clinical trial (RCT): An experiment in which investigators randomly allocate eligible people into treatment and control groups. Cross-over trials will be considered as RCTs according to the Cochrane Collaboration Guidelines (Clarke 2000). 2) Controlled clinical trial (CCT): an experiment in which eligible people are in a non-randomized way allocated to the treatment and the control groups 3) Other than controlled designs (OD): patient series and pre-post studies. Such ODs can only contribute in a limited way to the best evidence synthesis. Types of participants: Studies with children/ adolescents aged <20 years with a clinical diagnosis of cerebral palsy will be included. Types of intervention: Occupational therapy interventions will be regarded as "comprehensive OT" (when all five intervention categories are part of the evaluated OT treatment) or will be classified into five specific intervention categories: 1) training of sensory-motor functions; 2) training of skills; 3) parental counselling; 4) advice or instruction regarding the use of assistive devices; and 5) provision of splints. All studies with above specified interventions according to a group of four experienced occupational therapists and reviewer CHME (see Methods of the review) are eligible for inclusion in this review. Types of outcome measures: Primary outcome measures: Functional ability and/or social participation. Secondary outcome measures: Motor-function (either balance or arm-hand function) and/or muscle tone

Reporter

Issue subtitle: Apath