TL;DR: It is hoped IESR will become the preferred choice for registration of eHealth studies and, as an secondary benefit, will become an international repository of ongoing eHealth projects, thereby enhancing global collaboration and reducing duplication of effort.
Abstract: Beginning in July 2005, several major medical journals, including the Journal of Medical Internet Research, will only consider trials for publication that have been registered in a trial registry before they started. This is to reduce publication bias and to prevent selective reporting of positive outcomes. As existing clinical trial registers seem to be unsuitable or suboptimal for eHealth studies, a free International eHealth Study Registry (IESR) has been set up, allowing registration of trials (including non-randomized studies) in the field of health informatics and assigning an International eHealth Study Number (IESN). The IESR should meet the requirements of journal editors for a-priori registration of a study. We hope IESR will become the preferred choice for registration of eHealth studies and, as an secondary benefit, will become an international repository of ongoing eHealth projects, thereby enhancing global collaboration and reducing duplication of effort.
TL;DR: A greater belief of gain and less concern over privacy were associated with willingness to enroll, even after controlling for age, education, facility, and ethnic group.
Abstract: Objective: To investigate differences between African American and white respondents in willingness to enroll in a rehabilitation research registry for future research and to determine if reasons for consenting and refusing to enroll differ by ethnicity. Design: Inpatient recruitment results from 739 African American and white respondents in which patients were admitted to a rehabilitation hospital with a diagnosis of stroke or traumatic brain injury. Results: A similar proportion of African American and white respondents (both patients and surrogates) consented to enroll in the registry (72% of all African American respondents vs. 68% of all white respondents). African Americans and whites provided similar reasons for consenting and refusing to enroll. Demographic variables associated with consent were: higher education, younger age, and facility. The odds of consenting to enroll in the registry were 5 times as high for those who thought they had a great deal to gain from enrollment compared with those who thought they had less to gain and were nearly 2 times as high for those who reported little concern about privacy compared with those who were more concerned about privacy. Conclusions: Ethnicity was not found to be a predictor of willingness to enroll in a study registry. A greater belief of gain and less concern over privacy were associated with willingness to enroll, even after controlling for age, education, facility, and ethnic group.
TL;DR: Practical recommendations and observations are offered for avoiding pitfalls and obtaining the full benefits of study registration, based on the experience operating a study registry.
Abstract: The need for improved methodology for psychological research has recently received much attention. The primary recommendation has been increased emphasis on confirmatory or replication research that is carefully planned with adequate sample size and is pre-registered (Wagenmakers et al., 2012; Nosek and Lakens, 2014; Simons et al., 2014). Study registration options are currently being developed and implemented. Based on our experience operating a study registry, we offer practical recommendations and observations that may be useful when implementing study registration more widely.
In the fall of 2012, we opened a study registry at the University of Edinburgh's Koestler Parapsychology Unit (KPU) (KPU Registry, 2012). Consistent with the standards for registering clinical trials (International Committee of Medical Journal Editors, 2005), the registry focuses on public, prospective registration with specified registration information, and is not affiliated with a specific journal. The present discussion addresses methodology, not the findings of the registered studies. Parapsychological researchers have strived to utilize the established research methods of experimental psychology. This aspiration has resulted in increasing publications in high profile psychology journals (Bosch et al., 2006; Storm et al., 2010; Bem, 2011), but has not provided noticeable progress in resolving the debates about parapsychology. This situation was a significant factor in the recognition by psychologists that improved research methodology was needed (Pashler and Wagenmakers, 2012; Wagenmakers et al., 2012).
Based on experience working in regulated medical research, the second author has long advocated that the standard research methods for academic psychology were not adequate for controversial research like parapsychology and that formal, pre-registered, well-powered confirmatory research was needed (Kennedy, 2004). The first author also pointed out the value of pre-registered confirmatory research (Watt, 2005). However, these proposals received little interest at that time. The limitations of the common psychological research methods became increasingly apparent over the years and we began developing the KPU Registry (2012). As we were starting to send notices that the registry was open, a group of articles was published (Pashler and Wagenmakers, 2012) that significantly increased awareness of the need for these practices. Discussions of study registration now usually focus on how registration should be done rather than whether registration is beneficial. In the present paper we make several recommendations for avoiding pitfalls and obtaining the full benefits of study registration.
TL;DR: Examination of the basic and methodological characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) and the progress of implementation of good clinical practice (GCP) are explored.
Abstract: Objective: This research aims to examine the basic and methodological characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) and explores the progress of implementation of good clinical practice (GCP) and the challenges it poses for anticancer drug research in China. Methods: The studies from 2007 to 2015 were downloaded from the ChiCTR and those involving anticancer drugs with evaluation of the main dimensions. The numerical trend of the studies registered each year was analyzed. Chi-square tests were performed to test for significant differences between different funding sources, types of drug and study phases. Results: Six hundred and four anticancer drug studies were collected. The overall number of anticancer drug studies was increased. Significant differences could be seen in the dimensions of multicentre study (P = 0.000), participant number (P = 0.029) and randomization procedure (P = 0.005) for the three funding sources. There were significant differences in the dimensions of multicentre study (P = 0.001), participant number (P = 0.025), collecting samples from participants (P = 0.006), and randomization procedure (P = 0.009) between different kinds of drugs. There were also significant differences in the dimension of participant number (P = 0.025) and randomization procedure (P = 0.016) between different study phases. Conclusion: There are problems with study registry criteria and study type classification method. Also, within the studies researched, heterogeneity exists for various dimensions. Different sources of funding, distinct types of drug and disparate phases of study lead to significant differences in certain dimensions of anticancer drug studies.
TL;DR: In this paper, the authors estimate the overall health impact of transferring commuting trips from car to bicycle using registry information on the location of home and work for residents in Stockholm, Sweden.
Abstract: Aims:To estimate the overall health impact of transferring commuting trips from car to bicycle.Methods:In this study registry information on the location of home and work for residents in Stockholm...