Counterfactual Consent and the Use of Deception in Research

The use of deception for the purposes of research is a widespread practice within many areas of study. If we want to avoid either absolute acceptance or absolute rejection of this practice then we require some method of distinguishing between those uses of deception which are morally acceptable and those which are not. In this article I discuss the concept of counterfactual consent, and propose a related distinction between counterfactual‐defeating deception and counterfactual‐compatible deception. The aim is to show that this proposed distinction will be useful in furthering the debate regarding the use of deception for the purposes of research.     

心电数据管理系统中标准数据格式的分析

介绍了心电图机中三种标准化的存储格式,SCP,HL7aECG,DICOM,对这三种数据格式结构和主要特点进行了分析比较,对各自的优缺点进行了对比,随着网格化的发展,市场上会有会有越来越多的产家支持这几种通用的心电数据存储方式。     

Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.     

Improving the Prognostic Ability through Better Use of Standard Clinical Data - The Nottingham Prognostic Index as an Example

Background

Prognostic factors and prognostic models play a key role in medical research and patient management. The Nottingham Prognostic Index (NPI) is a well-established prognostic classification scheme for patients with breast cancer. In a very simple way, it combines the information from tumor size, lymph node stage and tumor grade. For the resulting index cutpoints are proposed to classify it into three to six groups with different prognosis. As not all prognostic information from the three and other standard factors is used, we will consider improvement of the prognostic ability using suitable analysis approaches.

Methods and Findings

Reanalyzing overall survival data of 1560 patients from a clinical database by using multivariable fractional polynomials and further modern statistical methods we illustrate suitable multivariable modelling and methods to derive and assess the prognostic ability of an index. Using a REMARK type profile we summarize relevant steps of the analysis. Adding the information from hormonal receptor status and using the full information from the three NPI components, specifically concerning the number of positive lymph nodes, an extended NPI with improved prognostic ability is derived.

Conclusions

The prognostic ability of even one of the best established prognostic index in medicine can be improved by using suitable statistical methodology to extract the full information from standard clinical data. This extended version of the NPI can serve as a benchmark to assess the added value of new information, ranging from a new single clinical marker to a derived index from omics data. An established benchmark would also help to harmonize the statistical analyses of such studies and protect against the propagation of many false promises concerning the prognostic value of new measurements. Statistical methods used are generally available and can be used for similar analyses in other diseases.     

超说明书用药法律评价标准探讨

目前超说明书用药存在一定必要性与合理性，但从患者安全和医生执业角度都存在一定风险。通过对常见规避超说明书用药风险方法的法律属性及效力进行分析，区分超说明书用药的不同情况，提出超说明书用药法律评价标准，以期对司法审判及医疗机构的临床应用提供帮助。     

The Use of Tumor Registry Data

The End Results Group, sponsored by the National Cancer Institute, coordinates a national cooperative program for evaluating the results of cancer therapy. Three central tumor registries (in California, Connecticut and Massachusetts) plus nine individual hospital registries (in university hospitals) are participating in the program.During the period 1940-59, there was an encouraging increase in five-year survival rates among patients with carcinomas and sarcomas (solid tumors). Preliminary data for 1955-59 suggest that the upward trend is leveling off. A smaller absolute increase in five-year survival rates occurred among patients with lymphomas and leukemia. These increases in patient survival rates coincided with more frequent use of surgical operation for solid tumors and more frequent use of chemotherapy for lymphomas and leukemia.     

Neonatal Euthanasia: Why Require Parental Consent?

The Dutch rules governing neonatal euthanasia, known as the Groningen Protocol, require parental consent for severely disabled infants with poor prognoses to have their lives terminated. This paper questions whether parental consent should be dispositive in such cases, and argues that the potential suffering of the neonate or pediatric patient should be the decisive factor under such unfortunate circumstances.     

Effect of Publicly Reporting Performance Data of Medicine Use on Injection Use: A Quasi-Experimental Study

Background

Inappropriate use of prescribing pharmaceuticals, particularly injections, not only affects the quality of medical care, but also leads to an increase in medical expenses. Publicly reporting performance data of medical care is becoming a common health policy tool adopted to supervise medical quality. To our knowledge, few studies about public reporting applied to medicine use have been reported. This study intended to introduce public reporting in the field of medicine use, and evaluate the effect of publicly reporting performance data of medicine use on the use of injections.

Methods

The research sites were 20 primary healthcare institutions in Q City, Hubei. By matching, the institutions were divided into the intervention group and control group. A quasi-experimental design was applied in this study. In the intervention group, the performance data of medicine use were publicly reported. The injection prescribing rates of the two groups before and after intervention were measured and compared. Difference-in-difference method and logistic regression were employed to estimate the effect of public reporting on injection use.

Results

Public reporting led to a reduction of approximately 4% in the injection prescribing rate four months after intervention (OR = 0.96; 95%CI: 0.94, 0.97). The intervention effect was inconsistent in each month after intervention, and it was most positive in the second month after intervention (OR = 0.90; 95%CI: 0.89, 0.92).

Conclusions

In general, publicly reporting performance data of medicine use may have positive effects on injection use to some extent. Further research is needed to investigate the mechanism by which public reporting influences injection use. Comprehensive measures are also necessary to promote the rational use of injections.     

Clinical Use of Aromatase Inhibitors: Current Data and Future Perspectives

Abstract

A systematic procedure for the kinetic study of irreversible inhibition when the enzyme is consumed in the reaction which it catalyses, has been developed and analysed. Whereas in most reactions the enzymes are regenerated after each catalytic event and serve as reusable transacting effectors, in the consumed enzymes each catalytic center participates only once and there is no enzyme turnover. A systematic kinetic analysis of irreversible inhibition of these enzyme reactions is presented. Based on the algebraic criteria proposed in this work, it should be possible to evaluate either the mechanism of inhibition (complexing or non-complexing), or the type of inhibition (competitive, non-competitive, uncompetitive, mixed non-competitive). In addition, all kinetic constants involved in each case could be calculated. An experimental application of this analysis is also presented, concerning peptide bond formation in vitro. Using the puromycin reaction, which is a model reaction for the study of peptide bond formation in vitro and which follows the same kinetic law as the enzymes under study, we have found that: (i) the antibiotic spiramycin inhibits the puromycin reaction as a competitive irreversible inhibitor in a one step mechanism with an association rate constant equal to 1.3 × 10⁴M^-1s^-1 and, (ii) hydroxylamine inhibits the same reaction as an irreversible non-competitive inhibitor also in a one step mechanism with a rate constant equal to 1.6 × 10^-3 M^-1s^-1.     

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.